WO2002085227A1 - Inflatable device and method for reducing fractures in bone and in treating the spine - Google Patents
Inflatable device and method for reducing fractures in bone and in treating the spine Download PDFInfo
- Publication number
- WO2002085227A1 WO2002085227A1 PCT/US2002/011828 US0211828W WO02085227A1 WO 2002085227 A1 WO2002085227 A1 WO 2002085227A1 US 0211828 W US0211828 W US 0211828W WO 02085227 A1 WO02085227 A1 WO 02085227A1
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- WO
- WIPO (PCT)
- Prior art keywords
- balloon
- inflatable device
- ofthe
- bone
- component
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
- A61B17/025—Joint distractors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
-
- 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
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
-
- 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
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
- A61B17/7258—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone
-
- A—HUMAN NECESSITIES
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
- A61B17/7258—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone
- A61B17/7275—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone with expanding cylindrical parts
-
- A—HUMAN NECESSITIES
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7216—Intramedullary pins, nails or other devices for bone lengthening or compression
- A61B17/7225—Intramedullary pins, nails or other devices for bone lengthening or compression for bone compression
-
- A—HUMAN NECESSITIES
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- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
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- A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
- A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
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- A61B2017/0084—Material properties low friction
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- A61B2017/00858—Material properties high friction, non-slip
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/3094—Designing or manufacturing processes
- A61F2/30965—Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
- A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Definitions
- Medical balloons are commonly known for dilating and unblocking arteries that feed the heart (percutaneous translumenal coronary angioplasty) and for arteries other than the coronary arteries (noncoronary percutaneous translumenal angioplasty).
- angioplasty the balloon is tightly wrapped around a catheter shaft to minimize its profile, and is inserted through the skin and into the narrowed section ofthe artery.
- the balloon is inflated, typically, by saline or a radiopaque solution, which is forced into the balloon through a syringe. Conversely, for retraction, a vacuum is pulled through the balloon to collapse it.
- a balloon ofthe present invention may be designed and configured to replace a vertebral disk, or may serve as a distraction instrument and implant for intervertebral fusion.
- the invention is constructed in a manner specialized to restore the anatomy of a fractured bone which has sufficient normal cancellous volume to contain the device.
- the device is constructed for controlled deployment and reliability at pressures between about
- the invention comprises a rigid catheter which allows for the placement and deployment of the Walloon tipped catheter without internal structural reinforcement. This provides the catheter with surprising advantages, including improved 0 surgical control over placement of the balloon tip and rotational control over the balloon during deployment.
- the shape ofthe inflatable device and/or catheter may be curved, shaped or otherwise configured to allow for an easier approach to the bone cavity or to correspond to the portion of the bone which is to be restored.
- an axial balloon is 5 constructed with a uniform bulge and blunt distal end to allow the deployment ofthe balloon against the wall of the prepared bone cavity, and to facilitate uniform expansive pressure in the cavity when inflated.
- an offset balloon of circular cross section is employed, while another embodiment uses an offset balloon with a non- circular cross section.
- the balloon may be curved to correspond to the interior wall of the cortical bone.
- a shape memory catheter is used to better position the inflatable device within right or left bones, or in the left or right side of bones that possess a sagittal plane of symmetry.
- the rate at which the region is filled with bone filler material is approximately the same rate at which the balloon is deflated so that the volume ofthe treated region within the bone remains approximately the same.
- the cavity may be treated with a sealing material prior to or after deployment ofthe balloon.
- a sealant may assist in reducing or preventing leakage of filler material from the cavity, or to prevent bone materials or body fluids from leaching into the cavity.
- sealants comprising fibrin or other suitable natural or synthetic constituents may be used for this purpose.
- the sealant materials may be delivered to the cavity walls by spray application, irrigation, flushing, topical application, or other suitable means, including applying sealant materials to the balloon exterior as a coating.
- the sealant also, may be placed inside the treated area first, and then an inflatable device may be used to push the sealant outward toward the cavity walls.
- the bone cavity may be irrigated and/or aspirated.
- Irrigation media may comprise saline, water, antibiotic solution or other appropriate fluids to wash the bony interior and release debris.
- Aspiration ofthe bone cavity may be used to help clear the bone cavity of bony debris, fatty marrow, and blood products that may prevent adequate dispersal of filler material or that may constrict the cavity.
- Each ofthe steps of applying a sealant, irrigating and aspirating may be considered optional, and may be performed after inflation ofthe balloon, or before, or not at all.
- the invention also relates to a method for reducing bone fractures comprising forming a cavity within a damaged bone, inserting the inflatable device into the cavity, inflating the device so that it restores collapsed or deteriorated portions ofthe cortical bone, preferably returning the bone approximately to its natural anatomy.
- a cavity is created in the portion ofthe bone in which the device is to be deployed and inflated.
- the cavity is irrigated before the device is inserted into the bone in order to remove bone marrow and cancellous b& ⁇ e.from the area where the device will be inflated.
- the inflatable device is inserted into thel)one and positioned so that inflation of the balloon will assist in restoration ofthe cortical bone.
- FIG. 1 shows a perspective view of a medical balloon catheter system according to the present invention.
- FIG. 5 shows a partial sectional view along the longitudinal axis of another embodiment ofthe balloon catheter of FIG 1.
- FIG. 8 shows a partial sectional view along the longitudinal axis of another embodiment ofthe balloon catheter of FIG 1.
- FIG. 9 shows a partial sectional view along the longitudinal axis of another embodiment ofthe balloon catheter of FIG 1.
- FIG. 10 shows a sectional view perpendicular to the longitudinal .axis ofthe balloon of FIG. 9.
- FIG. 11 shows a partial sectional view along the longitudinal axis of another embodiment of the balloon catheter of FIG 1.
- FIG. 13 shows a perspective view of another embodiment ofthe balloon of FIG. 1.
- FIG. 14 shows a perspective view of another embodiment ofthe balloon of FIG. 1.
- FIG. 15 shows an elevation view of another embodiment ofthe balloon of FIG. 1.
- FIG. 16 shows an elevation view of another embodiment ofthe balloon of FIG. 1.
- FIG. 17 shows a plan view ofthe catheter of FIG. 13.
- FIG. 18 shows a plan view of an reinforcing insert for the catheter of FIG 17.
- FIG. 19 shows an enlarged sectional view along line 19—19 of FIG. 18.
- FIG. 20 shows a enlarged sectional view along line 19—19 of another embodiment ofthe reinforcing insert of FIG 18.
- FIG. 21 shows an enlarged sectional view along line 19—19 of another embodiment ofthe reinforcing insert of FIG 18.
- FIG. 22 shows an enlarged sectional view along line 19—19 of another embodiment of the reinforcing insert of FIG 18.
- FIG. 23 shows an enlarged sectional view along line 19—19 of another embodiment ofthe reinforcing insert of FIG 18.
- FIG. 27 shows a sectional view through line 27-27 of FIG 26
- FIG. 28 shows a perspective view of another embodiment ofthe balloon of FIG. 1.
- FIG. 29 shows a perspective view of another embodiment of the ballodn of FIG. 1.
- FIG. 30 shows an intermediate perspective view of another embodiment ofthe balloon of FIG. 1.
- FIG 32 shows a schematic representation ofthe catheter construction ofthe balloon of FIG. 30.
- FIG. 33 shows a perspective view of another embodiment ofthe balloon of FIG. 1.
- FIG. 34 shows a perspective view of another embodiment of the balloon of FIG. 1.
- FIG. 35 shows a perspective view of another embodiment of the balloon of FIG. 1.
- FIG. 36 shows a plan view of another embodiment ofthe balloon catheter of FIG 1.
- FIG. 37 shows a sectional view through line 37-37 of FIG. 36.
- the balloon 30 may be used to treat any bone with an interior cavity sufficiently large enough to receive the balloon 30:
- bones that are suitable candidates for anatomical restoration using the device and method ofthe present invention include vertebral bodies, the medullary canals of long bones, the calcaneus and the tibial plateau.
- the balloon 30 can be designed and adapted to accommodate particular bone anatomies and different cavity shapes, which may be made in these and other suitably large bones.
- the balloon may be designed and configured to be deployed and remain in the bone cavity for an extended period of time.
- the balloon may be inflated with natural or synthetic bone filler material or other suitable inflation fluid once the balloon is located within the bone cavity. Once filled, the balloon is allowed to remain within the bone for a prescribed period or perhaps indefinitely.
- the duration of time that the balloon remains within the bone may depend upon specific conditions in the treated bone or the particular objective sought by the treatment. For example, the balloon may remain within the cavity for less than a day, for several days, weeks, months or years, or even may remain within the bone permanently.
- the balloon may also be adapted to serve as a prosthetic device outside of a specific bone cavity, such as between two adjacent vertebrae.
- the outer surface of the balloon may be treated with a coating or texture to help the balloon become more integral with the surrounding bone matter or to facilitate acceptance the balloon by the patient.
- the selection of balloon materials, coatings and textures also may help prevent rejection ofthe balloon by the body.
- the inner surface ofthe balloon likewise may be textured or coated to improve the performance ofthe balloon. For instance, the inner surface of the balloon may be textured to increase adhesion between the balloon wall and the material inside.
- the balloon may be designed to rupture, tear or otherwise open after the filler material injected inside the balloon has set up or sufficiently gelled, cured or solidified. The balloon may then be removed from the bone while leaving the filler material inside.
- This approach may result in a more controlled deployment of bone filler material to a treated area. It also may allow the bone filler material to be at least partially preformed before being released into the bone. This may be particularly beneficial where leakage of bone filler material out of damaged cortical bone maybe a concern, although there may be other situations where this configuration would also be beneficial.
- the balloon may be opened or ruptured in a manner that would permit the filler material to allow the inflation fluid to be released into the cavity.
- the opening ofthe balloon may be predetermined so that the flow of filler material travels in a desired direction.
- the filler material may be held within the balloon until it partially sets so that, upon rupture ofthe balloon, the higher viscosity ofthe filler material limits the extent to which the filler material travels.
- the balloon also may be designed and configured to release inflation fluid into the cavity in a more controlled fashion.
- the balloon catheter might be provided with a mechanism to initiate the rupture process in a highly controlled fashion.
- predetermined seams in the balloon might fail immediately and rupture at a certain pressure.
- the seams might fail only after prolonged exposure to a certain pressure, temperature, or material.
- the balloon may be dissolved until the filler material is released into the bone cavity.
- the balloon may rupture and become harmlessly incorporated into the inflation fluid medium.
- the filler material may be designed to congeal when contacted to a chemical treatment applied to the surface ofthe balloon.
- two balloons (or a single balloon having two chambers) may be designed and configured to release a combination of fluids that when mixed together react to form an inert filler material within the cavity.
- different areas ofthe seam or balloon might be designed to rupture at different predetermined pressures or at different times.
- a balloon may be constructed with failure zones that are adapted so that structural failure under a triggering condition would occur preferentially in a localized area.
- a balloon might have a failure zone comprising a thinner membrane.
- the balloon might be designed to lack tensile reinforcing elements in a particular region.
- a region ofthe balloon might be comprised of a material that would fail due to a chemical reaction.
- the chemical reaction may be an oxidation or reduction reaction wherein the material might sacrificially neutralize a weak acid or base.
- the sacrificial region might comprise a pattern of pore like regions.
- This sacrificial region may comprise a specific pattern of pores that might form a latent perforation in the balloon membrane or may be randomly distributed in a localized area.
- the ruptured balloon may then be removed from the bone cavity, leaving behind the deployed bone filler material.
- the balloon may be treated with special coating chemicals or substances or may be textured to prevent the balloon from sticking to the filler material or cavity walls.
- the balloon might open at the distal end. This configuration may allow the balloon to be more readily removed from the bone cavity after the balloon has opened or ruptured.
- the preeise nature ofthe stress reduction may be adapted to a particular anatomy.
- An implanted balloon may also be designed such that it can be resorbed only after certain conditions are met.
- a balloon designed to provide containment in a particular region of unhealthy or damaged cortical bone may eventually be resorbed following one or more triggering conditions.
- the triggering condition may involve relative temperature, pH, alkalinity, redox potential, and osmotic pressure conditions between the balloon and surrounding bone or cancellous materials.
- a controlled chemical or radiological exposure would trigger the break down ofthe balloon.
- a chemically triggered resorption may include, without limitation, a physician prescribed medicament or specially designed chemical delivered to the balloon via oral ingestion or intravenous injection.
- An electrical charge or current, exposure to high frequency sound, or X-rays may also.-b.e- used to trigger biological resorption ofthe balloon.
- the balloon 30 is inserted into a bone cavity that has been prepared to allow the balloon to be placed near the damaged cortical bone.
- the cancellous tissue and bone marrow inside the bone and in the area to be treated may be cleared from the region in advance of deploying the balloon. Clearing the treated region may be accomplished by either shifting or relocating the cancellous bone and marrow to untreated regions inside the bone, or alternatively by removing the materials from the bone.
- removing substantially all the bone marrow from the treated region ofthe bone may reduce the potential for inadvertent and systemic damage caused by embolization of foreign materials released to the vascular system.
- removing the bone marrow may also reduce the potential for damaging the spinal cord from uncontrolled displacement during deployment ofthe balloon or a subsequent compression ofthe vertebrae and implant mass.
- the viscosity or other properties ofthe sealant may be varied according to the type of delivery and the procedure used.
- the sealant is a gel if it is placed inside the cavity and the balloon is used to apply it to the cavity walls.
- each of these optional steps regarding the use of a sealant may be performed after inflation ofthe balloon, or before, or not at all.
- the balloon 30 is inserted into the prepared cavity, where it is inflated by fluid, (e.g., saline or a radiopaque solution) under precise pressure control.
- fluid e.g., saline or a radiopaque solution
- the balloon 30 is inflated directly against the cortical bone to be restored, by an inflation device 15.
- the deployed balloon presses the damaged cortical bone into a configuration that reduces fractures and restores the anatomy ofthe damaged cortical bone.
- the balloon is deflated by releasing the inflation pressure from the apparatus.
- the balloon may be further collapsed by applying negative pressure to the balloon by using a suction syringe.
- the suction syringe may be the inflation device itself, or an additional syringe, or any other device suitable for deflating the balloon.
- the balloon may be removed from the cavity, and the bone cavity may be irrigated or aspirated.
- the cavity also may be treated with a sealant.
- the cavity then can be filled with bone filler material.
- the bone filler material may be natural or synthetic bone filling material or any other suitable bone cement. As previously described, each of these optional steps may be performed after inflation ofthe balloon, or before, or not at all.
- the balloon is inflated with a radio-opaque material to restore the natural spacing and alignment ofthe vertebrae.
- the inflating solution or material may be cured or reacted to form a viscous liquid or deformable and elastic solid.
- a balloon may comprise an implant possessing material and mechanical properties which approximate a natural and healthy disk.
- the balloon may be designed for long term resistance to puncture and rupture damage, and the filler material may be designed and configured to provide pliable, elastic, or fluid like properties.
- filler material for a replacement disk balloon may comprise any suitable substance, including synthetic and bio-degradable polymers, hydrogels, and elastomers.
- a balloon may be partially filled with a hydrogel that is capable of absorbing large volumes of liquid and undergoing reversible swelling.
- a hydrogel filled balloon may also have a porous or selectively porous containment membrane which allows fluid to move in and out of the balloon as it compressed or expanded.
- the filler material may also be designed and configured to form a composite structure comprising a solid mass of materials.
- Balloons ofthe present invention also may be adapted for use as a distraction instrument and an implant for interbody fusion, such as for the lumbar or cervical regions.
- a inflatable device ofthe present invention may be used for posterior lumbar interbody fusion (PLIF).
- PLIF posterior lumbar interbody fusion
- a laminotomy may be performed to expose a window to the operation site comprising a disc space.
- the disc and the superficial layers of adjacent cartilaginous endplates may then be removed to expose bleeding bone in preparation for receiving a pair of PLIF spacers.
- a balloon ofthe present invention may then be inserted into the disk space and inflated to distract the vertebrae.
- the radio-opacity of each implant may be varied by incorporating different concentrations of a radio-opaque material within the filler material which inflates the balloon.
- a radio-opaque material for example, filler materials comprising two different concentrations of barium sulfate may be used.
- different radio-opaque materials having distinguishable flouroscopic characteristics may be used.
- FIG. 2 shows a medical balloon 40 ofthe construction described above inflated to approximately 200 psi.
- the balloon 40 is made from a single layer of polyurethane material. Multiple balloon layers, and coatings of other materials such as silicone may also be used. For example, the silky texture of an outer silicone layer or coating may be used to facilitate insertion ofthe balloon 40 or to achieve another clinical objective.
- additional materials, layers, and coatings, and combinations thereof, may be used to improve the serviceability ofthe balloon 40, for example, by increasing the ability ofthe inflated vessel to resist puncture and tearing.
- the single wall thickness ofthe balloon 40 may range from approximately about 1.5 mils to about 2.5 mils.
- a composite balloon comprising at least two materials that may serve as a reinforcing component and as a boundary forming component.
- the boundary forming component may be any suitable material used for forming a balloon. Examples of such materials are described more fully herein.
- the reinforcing component may provide added tensile strength to the balloon by picking up tensile stress normally applied to the boundary forming component ofthe balloon.
- the reinforcing component may be designed and configured to distribute these forces evenly about its structure, or may be designed and configured to form a space frame for the deployed balloon structure.
- the reinforcing component may facilitate better shape control for the balloon and provide for a thinner boundary forming component.
- the reinforcing member component may be a braided matrix extending over selected areas ofthe balloon.
- the reinforcing strength ofthe braided matrix may be determined by the tightness ofthe weave. For example, a more dense pattern for the braided matrix might provide greater strength but less flexability, than a less dense weave of a similar pattern. Also, different patterns may have different combinations of physical characteristics.
- the angle ofthe intersecting braided members may also be varied to optimize the physical properties ofthe balloon.
- the braided matrix may therefore be customized to provide a certain combination of physical or chemical properties. These properties may include tensile and compressive strength, puncture resistance, chemical inertness, shape control, elasticity, flexability, collapsability, and ability to maintain high levels of performance over the long term.
- the braided materials may be comprised of any suitable material including nitinol, polyethylene, polyurethane, nylon, natural fibers (e.g., cotton), or synthetic fibers.
- suitable material including nitinol, polyethylene, polyurethane, nylon, natural fibers (e.g., cotton), or synthetic fibers.
- Zynergy Core Technology One firm which manufactures braided matrices ofthe type described above is Zynergy Core Technology.
- the boundary forming component may comprise a synthetic membrane formed from polyurethane or other materials as described for the general balloon construction.
- the membrane may be coated on the exterior to enhance non-reactive properties between the balloon and the body, or to ensure that a balloon will not become bonded to the balloon inflation materials. Thus, a lysed balloon may be withdrawn without significant disturbance to the filled cavity. It is expected that a balloon formed from a membrane and braided matrix may designed to operate at an internal pressure of about 300 psi.
- FIG. 3 illustrates a general construction of a balloon ofthe present invention.
- the features described in FIG 3. include: DI (the outer diameter ofthe balloon tubing); D2 (the outer diameter ofthe working body ofthe balloon); LI (the length ofthe balloon); L2 (the working length of the balloon 70); ⁇ (the tapered angle ofthe balloon's proximal end); and ⁇ (the angle ofthe balloon's distal end). Angles ⁇ and ⁇ are measured from the longitudinal axis 80 of the balloon.
- Table 1 presents preferred values for the features ofthe balloon construction depicted in FIG. 3, as they may apply to particular bone anatomies. Nalues presented in range 1 represent generally preferred dimensions and characteristics. Nalues presented in range 2, by comparison, represent more preferred criteria.
- a preferred balloon for a vertebral body would have tubing 60 with outer diameter DI that ranges from about 1.5 mm to about 3.0 mm.
- the tubing 60 preferably would also be suitable for attachment to a 16 gauge catheter. As best shown in
- the distal end 85 ofthe balloon 70 may also taper at an approximately uniform angle ⁇ from the longitudinal axis 80 ofthe balloon 70.
- the angle ⁇ ranges from about 90 degrees to about 50 degrees, and more preferably ranges from about 60 to 86.
- length LI ofthe balloon 70 preferably ranges from about 15 mm to about 30 mm, and the working length L2 ofthe
- balloon 70 preferably ranges from about 10 mm to about 20 mm. More preferably, however, length LI ofthe balloon 70 ranges from about 20 mm to 25 mm, and the working length L2 ofthe balloon 70 ranges from about 12 mm to about 15 mm.
- FIGS. 4-6 show preferred embodiments ofthe axial balloon 70 described in FIG. 3 and Table 1. Although, the following discussion is directed toward exenjplary balloon embodiments for deployment in vertebral bodies, these balloons may be used in any suitable bone. Thus, the dimensions and configurations ofthe balloon styles described in this figures may be varied to accommodate the type of bone or cavity in which the balloon is to be deployed.
- FIG. 4 depicts a balloon embodiment style with an uniform bulge 90 having an axially uniform diameter D3 with a blunt distal end 95.
- the total length L3 is about 20 mm
- the working length L4 is about 15 mm
- the outer diameter D3 is about 12 mm.
- the total length L3 is about 20 mm
- the working length L4 is about 15 mm
- the outer diameter D3 is about 8 mm.
- the total length L3 is about 15 mm
- the working length L4 is about 10 mm
- the outer diameter D3 is about 8 mm.
- the total length L5 is about 15 mm
- the working length L4 is about 8 mm
- the horizontal length L7 ofthe tapered distal end is about 5 mm
- the overall outer diameter D4 ofthe balloon is about 8 mm.
- the tapered end of this balloon style may have other configurations.
- the balloon may have a series of uniform tapered lengths, rather than a single uniform tapered end.
- the balloon may have a curved tapered end, rather than one or more uniform tapered lengths.
- the balloon may have a combination of uniform and curved lengths comprising the tapered end ofthe balloon.
- the tapered end also may be unsymmetrical about the central axis ofthe balloon.
- a balloon comprising a braided matrix and membrane components may be of particular use in developing balloons having a tapered .end or unsymmetrical geometry because the braided material can be used to improve shape control or create a space frame for the deployed balloon.
- FIG. 6 depicts a balloon embodiment style with an distal bulge 110 having a constant outer diameter D5 in a region abutting a blunt distal end 115, and a uniformly tapered proximal end 120.
- the total length L8 is about 20 mm
- the working length L9 is about 8 mm
- the outer diameter D5 is. about 12,-mr ⁇ .
- the total length L8 is about 20 mm
- the working length L9 is about 8 mm
- the outer diameter D5 is about 8 mm.
- the total length L8 is about 15 mm
- the working length L9 is about 8 mm
- the outer diameter D5 is about 8 mm.
- the tapered end of this balloon style may have other configurations. Further, the surprising advantages ofthe balloon styles depicted in FIGS. 4-6 may be achieved by using a curved or bent catheter.
- FIGS. 4-6 and the more general balloon configurations defined by FIG. 3 and Table 1 may be angled from the central catheter.
- FIG. 8 depicts an exemplary embodiment of balloon 70 with an angled uniform bulge 92.
- Angle ⁇ preferably, is acute.
- balloons shaped for particular bone cavities or with additional surprising advantages may be developed by using an angled or curved catheter made from shape memory metal as previously described.
- FIGS. 9-16 preferred balloon configurations may also be developed from offset balloons, including constructions with curved or angled catheters.
- FIGS. 9-12 depict general embodiments of an exemplary offset balloon.
- FIGS. 9 and 10 show an embodiment style of a balloon 128, which is characterized by an offset balloon 130 having an uniform circular bulge 135 in the center ofthe balloon 130 and uniformly tapering ends 140.
- the total length L10 of the balloon 130 is divided into a proximal tapered end, a central working section having uniform outer diameter D6, and a distal tapered end.
- the horizontal length of each of these sections may be defined with respect to the distal end ofthe balloon.
- length LI 1 represents the horizontal distance ofthe distal tapered end plus the length of th ⁇ centrakworking section.
- the following exemplary embodiments are primarily directed toward vertebral bodies.
- the total length L10 is about 20 mm
- the working length Lll is about 15 mm
- the horizontal distance LI 2 ofthe tapered distal end is about 3 mm
- the outer diameter D6 ofthe circular bulge is about 6 mm.
- the balloon has similar dimensions except that the outer diameter D6 is about 8 mm.
- the balloon diameter D6 is about 12 mm.
- FIG. 11 and 12 show an embodiment style of a balloon 140, which is characterized by an offset balloon 145 having a non-uniform circular bulge 150 in the center of the balloon 145 and uniformly tapering ends 155.
- the total length L13 of the balloon 140 is divided into a tapered distal end, central working section, and proximal tapered end. 5
- the balloon has non uniform cross-section which may be defined by vertical length LI 6 and cross sectional width LI 7.
- Length L14 represents the horizontal distance from the distal end ofthe balloon. Table 3 presents general and prefe ⁇ ed siz&ranges fof this balloon configuration by target bone anatomy. Nalues presented in range 1 represent generally preferred dimensions and characteristics. Nalues presented in range 2, by comparison, 10 represent more preferred criteria.
- the following exemplary embodiment is primarily directed toward vertebral bodies.
- the total length LI 3 is about 20 mm
- the working length L14 is about 15 mm
- the horizontal distance L15 ofthe tapered distal end is about 3 mm.
- 30 145 are 14 mm and 14 mm, respectively.
- FIG. 14 depicts an embodiment of a single balloon 162 with two chambers 163 and 164 each of which are shaped like offset balloon style 145.
- FIG. 15 depicts another
- FIG. 16 shows balloon
- FIGS. 17-25 depict exemplary embodiments of a catheter construction ofthe present invention.
- the basic components of the catheter are shown in FIGS. 17-19. Additional, 0 illustrative embodiments of structural reinforcing elements are presented in FIGS 20-25.
- the catheter may be constructed with a plurality of openings through which a balloon or plurality of balloons may be deployed.
- the catheter may have two openings through which a single balloon may be deployed.
- the reinforcing members ofthe catheter that define the openings cause the balloon to expand 5 outwardly away from the catheter.
- a plurality of balloons may be deployed through the windows either at approximately the same time or in a staged succession.
- the balloons also may have differing shapes, surface characteristics, or pressures to suit a particular clinical application.
- the following discussion illustrates non-limiting examples ofthe present invention using a catheter with windows through which a balloon or balloons 0 are deployed.
- FIG. 17 depicts the distal end 175 ofthe catheter 165 of FIG. 13 in an elevation view.
- the catheter 165 has an outer diameter D7, a proximal tip length L20, and two circumferentially opposed balloon deployment openings 170.
- Lengths LI 8 and LI 9 ofthe balloon deployment openings 170 preferably, are the same length.
- the openings 170, 5 may be of different length and size to accommodate a particular balloon.
- the remaining catheter material 180 between the balloon deployment openings 170 form strips of width L21.
- the number of strips 180 co ⁇ espond to the number of balloon deployment openings 170 provided in the catheter 165.
- the width L21 of each strip 180 may depend on the number of strips 180 provided and the outer diameter D7 ofthe catheter 165.
- FIG. 18 shows the principle structural components ofthe catheter of FIGS. 17 and 18.
- the catheter 165 is constructed with inner dimension D8, and an U-jod.185 that is inserted into the catheter 165 via an opening 190 in the distal tip 175.
- the width L22 ofthe outer dimension ofthe U-rod 185 may be sized according to the inner diameter D8, such that the U-rod 185 fits within and bears against the inside wall 190 ofthe catheter 165.
- Length L24 the outer dimension ofthe individual rod 195, is related to the structural reinforcement required for the intermediate catheter strips 180 located between the balloon deployment windows 170.
- the interior width L23 ofthe U-rod 185 is related to the geometry ofthe catheter interior, width L23 is also operably configured to cooperate with the deployed balloon or balloons.
- length L25 and length L26 ofthe U-rod 185 preferably extend beyond the distal edge 200 ofthe balloon deployment opening 170 to provide a suitable anchoring length L27 for the U-rod 185 within the catheter 165.
- U-rod segment lengths L25 and L26 need not be equal.
- the rounded tip 205 ofthe U-rod 185 may be fully recessed or may partially extend from the proximal end 175 ofthe catheter 165.
- the tip 205 ofthe U-rod 185 is secured to the catheter 165 by a soldered, brazed or welded connection. A glued fastener or other attachment means may also be used. For instance, a snap together fastening method may be used.
- the number of reinforcing rods 185 will vary. Also, the means for joining a plurality of reinforcing rods 185 together and connecting the reinforcing rods 185 to the catheter 165 may vary from the embodiments shown.
- FIG. 19 is a sectional view through line 19-19 of FIG. 18 and shows individual reinforcing rods 195 with an exemplary cross section.
- reinforcing rod 206 is circular in cross-section.
- the geometry ofthe reinforcing rod may be selected to provide a beneficial combination of clearance and strength.
- FIGS. 20-25 depict individual reinforcing rods 195 with other illustrative geometric cross sections.
- the reinforcing rod of FIG. 20 shows an embodiment with kidney bean shaped cross-section.
- FIG. 21 shows a reinforcing rod with oval shaped cross-section.
- FIGS. 22 and 23 show reinforcing rod embodiments with rectangular and triangular shaped cross-sections, respectively.
- Reinforcing elements may be individual rails which are connected to and oriented around the catheter perimeter by a plurality of spacer rings which are mounted on an internal lumen.
- the reinforcing elements may further be wire elements that are post tensioned at the distal tip ofthe catheter. For this reason, the relative sizing ofthe balloon deployment window, the catheter strips and the reinforcing elements may be reconfigured to accommodate a particular anatomical, mechanical, therapeutic, or clinical need.
- FIG 25 shows an alternative reinforcing structure to the rods depicted in FIGS. 17-24.
- the reinforcing member of FIG. 25 may be tubular in construction and provided with a slot 213 for deploying one or more inflatable devices.
- the tubular reinforcing element may formed by a special extrusion that provides, for example, thicker (i.e., stronger) walls in selected locations.
- a tubular catheter reinforcing member may require more than one slot to accommodate a device with a plurality of balloon deployment windows.
- more than one balloon may be deployed through each deployment window.
- a single balloon with a plurality of chambers may be deployed through on?- deployment window.
- two separate balloons may be deployed through a single deployment opening.
- a single balloon with a plurality of chambers may be deployed through an equal number of balloon deployment openings.
- FIGS. 26-35 show illustrative complex balloon embodiments constructed from the balloons described in the fore going figures and tables.
- FIGS. 26 and 27 show a balloon catheter with three balloons and three deployment windows.
- the complex balloon 210 comprises three offset circular balloons 215 stemming from a central catheter 220 and enclosed by an optional outer layer 225.
- the individual balloons 215 are comprised of single layers.
- the individual balloons may be formed from a plurality of layers and materials.
- the complex balloon may comprise a single balloon with three chambers enclosed by an optional outer layer 225.
- the thickness of each of these layers may be different, and that complex balloons may achieve large effective outer diameters, with thinner balloon walls.
- FIGS. 28 and 29 depict axial balloon embodiments 230 and 235 having uniform diameter and at least one integral hinge 240, which separates the working length ofthe balloon into a plurality of segments. Adjacent balloon segments are free to move about the common hinge.
- FIG. 30, represents an offset balloon 250 with two large chambers 255 connected in serial.
- a catheter tip 260 is inserted into the balloon 250 to a point 265 about equidistant from the balloon chambers 255.
- the second chamber 270 ofthe balloon 250 is then folded over the tip 260 and doubled back along the length ofthe catheter 275. Further, the folded over portion 270 of the balloon 255 may be secured to the non- folded portion 280 and tied to the catheter 275 near the proximal end ofthe balloon.
- the doubled chambered balloon is constructed of two layers.
- an inner balloon is folded about the catheter and then the entire composite structure is then wrapped within an additional outer layer.
- the outer diameter D9 ofthe balloon 250 ranges from 2 mm to 12 mm.
- a specially constructed catheter 290 may be used to provide fluid to the balloon chambers 255 in a sequential manner.
- fluid is prevented from being transported directly into the second chamber 270 ofthe balloon 250, by a closed valve or blockage 295 in the athetec.
- the inflation fluid is directed into the first chamber 280 ofthe balloon 250 via an aperture 300 located on the distal side ofthe blockage 295 in the catheter 290.
- the fluid partially fills the first balloon chamber 280, and then renters the catheter 290 via an additional aperture 305 located on the proximal side ofthe blockage 295 in the catheter 290.
- fluid As the fluid continues to fill the first chamber 280 ofthe balloon 250, fluid also starts to migrate through the proximal end ofthe blocked catheter 290 to the second balloon chamber 270 via an opening in the tip 260 ofthe catheter 290. As shown further in FIG. 32, the proximal tip 260 ofthe catheter 290 provides a fluid connection between the first 280 and second 270 balloon chambers 255.
- the balloon 250 is deflated, the direction of fluid transport is reversed.
- the blockage 295 in the catheter 290 is removed to allow fluid flow throughout the length ofthe catheter 290.
- a pressure activated valve opens to permit free fluid flow through the catheter, when the pressure in the second chamber 270 of the balloon 250 becomes larger than a predetermined pressure in the first balloon chamber 280.
- the catheter blockage 295 may be selectively controlled by the ' surgeon and formed from a shape memory metal, that would provide by-pass flow in one state, and direct catheter flow in a second state.
- more apertures may be used as appropriate to effect the desired rate of fluid transfer, and that a folded multi-chamber balloon may be simple to assemble and test during manufacturing. Thus, creating complex balloons from a folded multi-chamber balloon 250 embodiments may also provide cost savings.
- FIG. 33-35 depict additional exemplary balloon embodiments 310, 315, and 320.
- FIG. 33 depicts an axially offset balloon 325 with a uniform diameter D10 and curved shape.
- the curved balloon 325 having longitudinal axis 330 may intimately contact the walls ofthe prepared bone cavity. Alignment of balloon-applied forces with the bone damage facilitates a shape appropriate restoration ofthe bone anatomy.
- the curve is provided by a curved catheter or a catheter made from shape memory metal, rather, than molding the shape into the balloon.
- the curved balloon is formed from an axially offset balloon 335 having non uniform diameter.
- the balloon of FIG. 34 has a diameter that varies along the longitudinal axis ofthe balloon.
- the largest diameter DI 1 is located at the longitudinal 330 mid-point 340 ofthe balloon 335.
- the balloon 320 has three chambers 350, two hinges 355, and a curved central section 365.
- the structure ofthe balloon 320 allows for the controlled inflation and deflation ofthe individual chambers 365, 370, and 375.
- FIG. 36 depicts a sectional view through the longitudinal axis ofthe spine, and shows a multi-chambered and hinged balloon 385 within a vertebral bone 390.
- the complex balloon has the advantage of allowing selected chambers (e.g., chamber 395) to be deflated first before the other sections (e.g. chambers 400 and 405).
- cavity 410 could then be partially filled with bone cement without deflating or removing the outer balloon chambers 400 and 405 and the restored anatomy ofthe bone 390 could be fully or nearly fully maintained during the transition from bone fracture reduction to bone fixation.
- bone filling material can be applied to the cavity as the balloon sections are deflated.
- the multiple balloon chambers of FIGS. 35-37 may be formed from shared septum membranes, rather, than na ⁇ owed passageways or hinges.
- FIG. 37 which is taken along line 37-37 of FIG. 36, depicts a central catheter 420 with offset circular balloons 425 and 430.
- bone cement 430 is filled against the outer wall 435 ofthe cavity 410 in the restored vertebrae 390.
- a controlled volume exchange between the inflated structure 430 and 425 and the bone filling material 430 is accomplished.
- multiple- chambered balloons offer the potential for surprising advantages, such as controlled volume exchange between the restorative balloon and the bone filling material.
- multi-chamber balloons may also be used for sequential filling of restored bone cavities.
- the inflated structure in a stronger part of the bone may be deflated while balloons supporting weaker portions of the bone remain deployed.
- the region ofthe bone where the balloon is deflated may then be filled with bone filler material and allowed to harden or gel.
- neighboring or other balloons may be selectively deflated and the regions filled in a similar manner.
- controlled deflation of a multi-chambered balloon provides temporary support to selected areas of the restored bone anatomy while other areas are filled with bone filler material.
- the balloon can be modified or extended to accommodate particular formulations of balloon construction materials or fabrication techniques which may require multiple layers with different relative locations one to another .(e ⁇ g., plaqi*ng_one layer on the outside and a second layer on the inside.)
- the number and spacing ofthe balloon openings in the catheter and the reinforcing method may be changed to better implement the window deployment of one or more inflatable structures.
- balloons with dimple forming projections may be produced to the extent they do not impede significantly ultimate balloon performance.
Abstract
Description
Claims
Priority Applications (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP02728771.3A EP1379185B1 (en) | 2001-04-19 | 2002-04-15 | Inflatable device for reducing fractures in bone and treating the spine |
NZ529130A NZ529130A (en) | 2001-04-19 | 2002-04-15 | Inflatable device and method for reducing fractures in bone and in treating the spine |
MXPA03009502A MXPA03009502A (en) | 2001-04-19 | 2002-04-15 | Inflatable device and method for reducing fractures in bone and in treating the spine. |
KR1020037013732A KR100918261B1 (en) | 2001-04-19 | 2002-04-15 | Inflatable device for reducing fractures in bone and in treating the spine |
JP2002582809A JP4436045B2 (en) | 2001-04-19 | 2002-04-15 | Inflatable device and method for reducing bone and spinal injury |
AU2002258804A AU2002258804B2 (en) | 2001-04-19 | 2002-04-15 | Inflatable device and method for reducing fractures in bone and in treating the spine |
IL15845302A IL158453A0 (en) | 2001-04-19 | 2002-04-15 | Inflatable device and method for reducing fractures in bone and in treating the spine |
CA2444557A CA2444557C (en) | 2001-04-19 | 2002-04-15 | Inflatable device and method for reducing fractures in bone and in treating the spine |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US28451001P | 2001-04-19 | 2001-04-19 | |
US60/284,510 | 2001-04-19 | ||
US09/908,899 US6632235B2 (en) | 2001-04-19 | 2001-07-20 | Inflatable device and method for reducing fractures in bone and in treating the spine |
US09/908,899 | 2001-07-20 |
Publications (1)
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US9492152B2 (en) | 2009-03-17 | 2016-11-15 | Pivot Medical, Inc. | Method and apparatus for distracting a joint |
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US10426453B2 (en) | 2009-03-17 | 2019-10-01 | Pivot Medical, Inc. | Method and apparatus for distracting a joint |
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CN102974027A (en) * | 2012-12-20 | 2013-03-20 | 范勤 | Bone expanding device |
Also Published As
Publication number | Publication date |
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US20020177866A1 (en) | 2002-11-28 |
KR20040020890A (en) | 2004-03-09 |
US20040098015A1 (en) | 2004-05-20 |
CN1535660B (en) | 2012-07-18 |
IL158453A0 (en) | 2004-05-12 |
RU2005115171A (en) | 2006-11-27 |
EP1379185A1 (en) | 2004-01-14 |
EP1379185B1 (en) | 2014-03-26 |
CA2444557C (en) | 2010-02-09 |
ZA200308176B (en) | 2004-10-21 |
RU2003133668A (en) | 2005-04-20 |
CN1518431A (en) | 2004-08-04 |
MXPA03009502A (en) | 2004-12-06 |
TW200420268A (en) | 2004-10-16 |
JP4436045B2 (en) | 2010-03-24 |
JP2004526525A (en) | 2004-09-02 |
NZ529130A (en) | 2005-05-27 |
US6632235B2 (en) | 2003-10-14 |
AU2002258804B2 (en) | 2007-04-26 |
KR100918261B1 (en) | 2009-09-18 |
US7666205B2 (en) | 2010-02-23 |
TWI290459B (en) | 2007-12-01 |
CA2444557A1 (en) | 2002-10-31 |
TWM263909U (en) | 2005-05-11 |
CN1535660A (en) | 2004-10-13 |
MY134183A (en) | 2007-11-30 |
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