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EP1903967A2 - Dispositif extensible et procedes pour l'utiliser - Google Patents

Dispositif extensible et procedes pour l'utiliser

Info

Publication number
EP1903967A2
EP1903967A2 EP06786452A EP06786452A EP1903967A2 EP 1903967 A2 EP1903967 A2 EP 1903967A2 EP 06786452 A EP06786452 A EP 06786452A EP 06786452 A EP06786452 A EP 06786452A EP 1903967 A2 EP1903967 A2 EP 1903967A2
Authority
EP
European Patent Office
Prior art keywords
expandable body
wall portion
expandable
radiopaque
expansion
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP06786452A
Other languages
German (de)
English (en)
Inventor
Gorman Gong
Avram Allan Edidin
Reynaldo A. Osorio
Hugues Malandain
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic PLC
Original Assignee
Kyphon 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
Priority claimed from US11/177,042 external-priority patent/US20070010844A1/en
Priority claimed from US11/177,666 external-priority patent/US20070010845A1/en
Application filed by Kyphon Inc filed Critical Kyphon Inc
Publication of EP1903967A2 publication Critical patent/EP1903967A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/885—Tools for expanding or compacting bones or discs or cavities therein
    • A61B17/8852—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc
    • A61B17/8855—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc inflatable, e.g. kyphoplasty balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/60—Supports for surgeons, e.g. chairs or hand supports
    • 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
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00535—Surgical instruments, devices or methods pneumatically or hydraulically operated
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30014—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1059—Balloon catheters with special features or adapted for special applications having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1084—Balloon catheters with special features or adapted for special applications having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1088—Balloon catheters with special features or adapted for special applications having special surface characteristics depending on material properties or added substances, e.g. for reducing friction

Definitions

  • the invention relates to systems and methods for directionally controlling expansion and/or radioscopic visualization of the positioning of an expandable device useful for providing cavities in interior body regions for diagnostic or therapeutic purposes.
  • a balloon may be deployed to form a cavity in cancellous bone tissue, as part of a therapeutic procedure that fixes fractures or other abnormal bone conditions, both osteoporotic and non-osteoporotic in origin.
  • the balloon or other expandable body may compress the cancellous bone to form an interior cavity.
  • a filling material such as a bone cement, may be inserted into the cavity in order to provide interior structural support for cortical bone.
  • This procedure can be used to treat cortical bone, which — due to osteoporosis, avascular necrosis, cancer, trauma, or other disease — is fractured or is prone to compression fracture or collapse. These conditions, if not successfully treated, can result in deformities, chronic complications, and an overall adverse impact upon the quality of life.
  • an expandable balloon can be manipulated to an expanded geometry. Positioning and orientation of the balloon in the internal body region can be monitored indirectly by use of markings or other externally viewable indicia on the catheter and/or attached fittings. It is desirable to more precisely direct balloon expansion and to monitor balloon integrity during use by monitoring balloon positioning in a more direct manner.
  • One approach to more directly monitoring balloon movement in an interior body region is by radioscopic visualization.
  • Conventional medical balloons are constructed of materials that are radio-lucent, or translucent to radiation, and thus would not show up under x-ray or fluoroscopy. Instead, a fluid injected through the catheter to expand the balloon can be radiopaque, or opaque to radiation, to facilitate visualization of the balloon under x-ray fluoroscopy.
  • radiopaque contrast media A disadvantage of using radiopaque contrast media is that accidental exposure to such radiopaque media can cause hypersensitivity reactions in some patients. Other disadvantages include difficulty in handling radiopaque media that are more viscous than, for example, a saline solution, and that radiopaque media are generally more expensive than non-radiopaque fluids.
  • Embodiments of the present invention provide systems and methods for directionally controlling expansion of an expandable device useful for providing cavities in interior body regions.
  • One illustrative embodiment comprises a device having an expandable body comprising a wall having two portions.
  • the first wall portion comprises a high elasticity material.
  • the second wall portion comprises a material having an elasticity lower than the elasticity of the material in the first wall portion.
  • expansion of the second wall portion is constrained more than expansion of the first wall portion.
  • expansion of the expandable body is directed outwardly from the high elasticity first wall portion.
  • the expandable body is coupled to the distal end of an elongate member.
  • a cannula is introduced into an interior body region.
  • the elongate member is inserted through the cannula such that the expandable body is positioned for expanding in a selected direction in the interior body region.
  • the body is then expanded, and the first wall portion expands in the selected direction.
  • the directed expansion creates a cavity within the interior body region.
  • the cavity can then be filled with a filler material.
  • an illustrative embodiment comprises an expandable body and a radiopaque marking pattern in communication with the expandable body.
  • the radiopaque marking pattern can include a plurality of radiopaque markers. Each of the radiopaque markers can be in communication with a predetermined location on the expandable body.
  • a directionally controlled expandable device a radiopaque expandable body, and methods for use of the present invention may be accomplished singularly, or in combination, in one or more of the embodiments of the present invention.
  • many different embodiments of a directionally controlled expandable device, a radiopaque expandable body, and methods for use according to the present invention are possible. Additional uses, advantages, and features of the invention are set forth in the illustrative embodiments discussed in the detailed description herein and will become more apparent to those skilled in the art upon examination of the following.
  • FIG. 1 is a side view of a cannula having an expandable body coupled to the distal end of an elongate member inserted through the cannula in an embodiment of the present invention.
  • FIG. 2 is an enlarged side view of the expandable body shown in the embodiment in
  • FIG. 3 is an elevation (lateral) view of several human vertebrae, with a cannula establishing a path to a vertebral body of one of the vertebrae.
  • FIG. 4 is a plan (coronal) view of a human vertebra being accessed by a cannula, with portions of the vertebra removed to reveal cancellous bone within a vertebral body.
  • FIGS. 5A - 14A are cross-sectional views of expandable bodies having various configurations of high elasticity wall portions and low elasticity wall portions in embodiments of the present invention.
  • FIGS. 5B - 14B are diagrammatic views of the expanded shapes of the expandable bodies having the cross-sections in the corresponding FIGS. 5 A - 14A embodiments of the present invention.
  • FIG. 15A is a cross-sectional view of an expandable body having high elasticity wall portions and low elasticity wall portions and an internal restraint in an embodiment of the present invention.
  • FIG. 15B is diagrammatic view of the expanded shape of the expandable body having the cross-section in FIG. 15 A.
  • FIG. 16A is a cross-sectional view of an expandable body having high elasticity wall portions and low elasticity wall portions and an internal restraint in an embodiment of the present invention.
  • FIG. 16B is diagrammatic view of the expanded shape of the expandable body having the cross-section in FIG. 16A.
  • FIG. 17A is a cross-sectional view of an expandable body having a high elasticity wall portion and a low elasticity wall portion in the configuration of a semi-circle in an embodiment of the present invention.
  • FIG. 17B is diagrammatic view of the expanded shape of the expandable body having the cross-section in FIG. 17A.
  • FIG. 18A is a cross-sectional view of an expandable body having a low elasticity wall portion along a portion of the length of one side of the body in an embodiment of the present invention.
  • FIG. 18B is diagrammatic view of the expanded "bean" shape of the expandable body having the cross-section in FIG. 18A.
  • FIG. 19 is a plan view of the expandable body having the cross-section shown in FIG. 6 A in expanded shape in a vertebral body, with portions of the vertebral body removed to reveal compression of cancellous bone in a selected direction.
  • FIG. 20 is a side view of the expandable body in expanded shape in a vertebral body shown in FIG. 19.
  • FIG. 21 is a plan view of the expandable body having the cross-section shown in FIG. 7A in expanded shape in a vertebral body, with portions of the vertebral body removed to reveal compression of cancellous bone in a selected direction.
  • FIG. 22 is a side view of the expandable body in expanded shape in a vertebral body shown in FIG. 21.
  • FIG. 23 is a plan view of a human vertebra being accessed by cannulae bilaterally, with portions of the vertebra removed to reveal cancellous bone within a vertebral body.
  • FIG. 24 is a plan view of the expandable body having the cross-section shown in FIG.
  • FIG. 25 is a flow chart of a method according to an embodiment of the present invention.
  • FIG. 26 is a side view of an expandable body comprising a radiopaque marking pattern in another embodiment of the present invention.
  • FIG. 27 is a plan (coronal) view of the human vertebra shown in Fig. 4, showing a radiopaque marking pattern in the expandable body expanded in a directionally controlled manner.
  • FIG. 28 is a side view of an expandable body having a radiopaque marking pattern laminated between two tubing layers in an embodiment of the present invention.
  • FIG. 29 is a side view of an expandable body surrounded by an expandable radiopaque cage in unexpanded condition in an embodiment of the present invention.
  • FIG. 30 a side view of the expandable body surrounded by an expandable radiopaque cage shown in Fig. 29, in expanded condition in an embodiment of the present invention.
  • FIG. 31 is a flow chart of a method according to an embodiment of the present invention.
  • FIG. 32 is a flow chart of a method according to another embodiment of the present invention.
  • Embodiments of the present invention provide systems and methods for directionally controlling expansion of an expandable device useful for providing cavities in interior body regions.
  • the systems and methods embodying the invention can be adapted for use in many suitable interior body regions, wherever the formation of a cavity within or adjacent one or more layers of tissue may be required for a therapeutic or diagnostic purpose.
  • the illustrative embodiments show the invention in association with systems and methods used to treat bones.
  • the present invention may be used in other interior body regions or types of tissues.
  • Fig. 1 is a view of a system 10 according to an embodiment of the present invention configured to allow an user to provide a cavity in a targeted treatment area in an interior body region.
  • the system 10 can include a directionally controlled expandable device 20 configured to be used in a kyphoplasty procedure.
  • Kyphoplasty is a minimally invasive surgical procedure for restoring height to an injured or diseased vertebra.
  • a filler material is introduced into the resulting cavity to provide increased height and stability to the vertebra.
  • the system 10 comprises a cannula 30 comprising a proximal end and a distal end 31.
  • the cannula 30 may be fabricated from a material selected to facilitate advancement and rotation of an elongate member 40 movably disposed within the cannula 30.
  • the cannula 30 can be constructed, for example, using standard flexible, medical grade plastic materials, such as vinyl, polyamides, polyolefins, ionomers, polyurethane, polyether ether ketone (PEEK), polycarbonates, polyimides, and polyethylene tetraphthalate (PET).
  • PEEK polyether ether ketone
  • PET polyethylene tetraphthalate
  • the cannula 30 can be constructed as a bi-layer or a ⁇ ri-layer of one or more of these materials.
  • the cannula 30 can also comprise more rigid materials to impart greater stiffness and thereby aid in its manipulation and torque transmission capabilities. More rigid materials useful for this purpose include stainless steel, nickel-titanium alloys (such as Nitinol), and other metal alloys.
  • the system shown in Fig. 1 comprises the elongate member 40 movably disposed within the cannula 30.
  • the elongate member 40 may be made from a resilient inert material providing torsion transmission capabilities, for example, stainless steel, a nickel-titanium alloy such as Nitinol, and other suitable metal alloys.
  • the elongate member 40 may be fashioned from a variety of suitable materials, such as a carbon fiber, a glass, or a flexible material, for example, as a plastic or rubber.
  • the elongate member 40 may be formed, for example, from twisted wire filaments, such stainless steel, nickel-titanium alloys (such as Nitinol), and other suitable metal alloys.
  • the elongate member 40 shown is hollow, allowing for movement of a flowable material, for example, a liquid or a gas, through the elongate member 40.
  • the elongate member 40 may comprise a handle (not shown) at its proximal end 41 to aid in gripping and maneuvering the elongate member 40.
  • a handle can be formed from a foam material and secured about the proximal end 41 of the elongate member 40.
  • the system shown in Fig. 1 comprises a directionally controlled expandable device 20 configured to be deployed adjacent a tissue in the targeted treatment area via the cannula 30.
  • An expandable body 50 is disposed at the distal end 42 of the elongate member 40, and is thus configured to slide and rotate within the cannula 30.
  • the expandable body 50 may be configured to be deployed within a treatment area through a percutaneous path established by the cannula 30.
  • the expandable body 50 may be deployed within cancellous bone tissue 63 in a vertebral body 61, as shown in Figs. 3-4.
  • the expandable body 50 may be expanded by movement of a flowable material through the hollow elongate member 40 and into the interior of the expandable body 50.
  • a flowable material is introduced through the elongate member 40 to expand the expandable body 50.
  • the expandable body 50 may be contracted by withdrawing the flowable material out of the expandable body 50 through the bore of the elongate member 40. The elongate member 40 and the contracted expandable body 50 may then be withdrawn through the cannula 30.
  • the expandable body 50 is configured to constrain expansion in selected portions of the expandable body 50 as it expands.
  • the expandable body 50 may comprise an inflatable balloon tube 51, as shown in Fig. 1-2.
  • the expandable body 50 comprises a wall 52 having a first wall portion 53 comprising a high elasticity material 54 and a second wall portion 55 comprising a material 56 having an elasticity lower than the elasticity of the first wall portion 53.
  • Elasticity is defined as the condition or property of returning to an initial form or state following deformation. Deformation is defined as a change in shape due to an applied force, such as the force exerted on a balloon material when the balloon is expanded.
  • Elasticity refers to the degree to which a material is capable of deforming and returning to an initial form or state following deformation.
  • a high elasticity material will deform and return to an initial form or state following deformation more readily than will a low elasticity material.
  • expansion of the second wall portion 55 is constrained more than expansion of the first wall portion 53 such that expansion of the body 50 is directed outwardly 57 from the higher elasticity first wall portion 53.
  • the first wall portion 53 and the second wall portion 55 extend along an elongated axis 58 of the expandable body 50. Since expansion of the lower elasticity second wall portion 55 is constrained more than expansion of the higher elasticity first wall portion 53, expansion of the body 50 is constrained lengthwise along the elongated axis 58. Accordingly, the direction and degree of expansion of the expandable body 50 can be controlled.
  • the high elasticity material 54 may comprise a low durometer (softer) material
  • the low elasticity material 56 may comprise a high durometer (harder) material.
  • Durometer is defined as a measure of material hardness or the relative resistance to indentation of various grades of polymers. A higher durometer material may be more resistant to elastic deformation than a lower durometer material. Accordingly, expansion of a high durometer wall material may be constrained more than expansion of a low durometer wall material such that expansion of the expandable body 50 is directed outwardly from the lower durometer wall portion. As a result, a differential in durometer of materials in selected wall portions can be used to control the direction and degree of expansion of the expandable body 50.
  • the expandable body 50 may comprise one or more radiographic markers 59 to allow radiographic visualization of the expandable body 50 in an interior body region.
  • the first and/or second wall portions 53, 55, respectively, of the expandable body 5U may be tormed trom a radiopaque material.
  • the elongate member 40, and thereby the expandable body 50 may be in communication with a controller (not shown), such as a slide controller, a pistol grip controller, a ratcheting controller, a threaded controller, or any other suitable type of controller that can be configured to permit a user of the device to control the extent to which the expandable body 50 extends beyond the distal end 31 of the cannula 30.
  • a controller may permit a user of the device 20 to provide rotational torque and thereby control rotation of the elongate member 40 and the expandable body 50.
  • the system 10, and in particular the expandable body 50 may be used to provide a cavity in an interior body region.
  • a user of the system causes the expandable body 50 to expand and provide force to surrounding tissues to create a cavity of a desired shape and dimension.
  • the expandable body 50 comprises one or more wall portions 53, 55 having an elasticity relatively lower or higher than one or more other wall portions 53, 55, as described herein. As such, expansion of the expandable body 50 can be directed to create a cavity having a preferred size and shape, while avoiding pressure to undesired areas.
  • the expandable body 50 may be contracted and removed from the interior body region through the cannula 30.
  • a material or filler such as a bone cement, may then be used to fill the cavity provided by the system 10.
  • a filler material may be beneficial in certain treatment areas, for example, in a vertebra where the system 10 is used to restore height to a vertebral body (see Figs. 20 and 22, discussed below). Referring now to Figs.
  • FIG. 3-4 an elevation (lateral) view of several human vertebrae 60 is shown, with a cannula 30 establishing a percutaneous path along its elongated axis 58 to a vertebral body 61 of one of the several vertebrae 60.
  • the vertebral body 61 extends on the anterior (i.e., front or chest) side of the vertebrae 60.
  • the vertebral body 61 comprises an exterior formed from compact cortical bone 59.
  • Cortical bone (62) is defined as bone consisting of, or relating to, cortex, or outer layer of a bony structure.
  • the cortical bone 62 encloses an interior volume of reticulated cancellous 63, or spongy, bone (also called medullary bone or trabecular bone).
  • Cancellous bone (63) is defined as bone having a porous structure having many small cavities or cells in it. Due to various traumatic or pathologic conditions, such as osteoporosis, a vertebral body 61 can experience a vertebral compression fracture (VCF). In such conditions, cancellous bone 63 can be compacted, causing a decrease in height of the vertebra 60. In a VCF in particular, vertebral height is lost in the anterior region of the vertebral body 61. The user of the system 10 may utilize it to provide a cavity within the vertebral body 61, and to restore height to the vertebral body 61 lost when a fracture occurred.
  • VCF vertebral compression fracture
  • Systems and methods according to the present invention are not limited in application to human vertebrae 60, and may be used to provide cavities within other parts of a living or non-living organism.
  • the system 10 can be deployed in other bone types and within or adjacent other tissue types, such as in a vertebral disc, an ami bone, a leg bone, a knee joint, etc.
  • the vertebral body 61 is in the shape of an oval disc. As Figs. 3-4 show, access to the interior volume of the vertebral body 61 can be achieved, for example, by drilling an access portal through a rear side of the vertebral body 61 (a postero-lateral approach). The portal for the postero-lateral approach enters at a posterior side of the vertebral body 61 and extends anteriorly into the vertebral body 61. Alternatively, access into the interior volume of a vertebral body 61 can be accomplished by drilling an access portal through one or both pedicles 64 of the vertebra 60. This is known as a transpedicular approach.
  • Fig. 4 shows a vertebra 60 being accessed by the system 10 according to an embodiment of the present invention.
  • the vertebra 60 is shown with portions removed to reveal cancellous bone 63 within the vertebral body 61.
  • the user of the system 10 may slide the elongate member 40 and expandable body 50 axially, or lengthwise along the elongated axis 58, within the cannula 30 to deploy the expandable body 50 in the targeted treatment site. When deployed at the site, the user can extend the expandable body 50 outside the distal end 31 of the cannula 30 adjacent cancellous bone tissue 63 within the vertebral body 61.
  • the user may rotate the elongate member 40, and thereby the expandable body 50, to position the expandable body 50 for directed expansion in the targeted treatment area.
  • the expandable body 50 may be expanded from a contracted state to an expanded state to provide a cavity within the cancellous bone 63.
  • Systems and methods of the present invention comprise an expandable body 50, such as the inflatable balloon tube 51 shown in Fig. 2, that are adapted to assume an expanded geometry having a desired configuration when used.
  • Such an expandable body 50 can provide a cavity 81 inside the vertebral body 61 whose configuration is optimal for supporting the bone.
  • Conventional inflatable balloons become essentially spherical when inflated, creating a generally spherical cavity.
  • a spherical cavity with filler material results in single points of contact on vertebral body 61 surfaces (similar to a circle inside a square, or a sphere inside a cylinder). As a result, such spherical shapes do not typically permit a filler material to support the spine adequately.
  • the directionally-controlled expansion of an expandable body 50 of the present invention creates a preferred shape in a cavity which, when filled with filler material, desirably distributes the load transferred from the vertebral body 61 surfaces to the hardened filler material, ultimately strengthening the spine.
  • irregularly-shaped cavities 81 formed by embodiments of the present invention provide shapes, which when filled by filler material can reduce the opportunity for the filler material to shift or displace within the vertebral body 61 under compressive loading of the spine and thereby provide enhanced stability.
  • an expandable body 50 can optimally expand to a desired shape rather than simply towards areas of lowest bone density. That is, expansion of the body 50 can be controlled even when encountering areas in the bone of varying resistance.
  • vertebral compression fractures often result in collapse of the affected vertebra 60 in a more or less vertical orientation.
  • expansion of an expandable body 50 according to the present invention can be limited to the vertical direction only.
  • Such a directionally controlled expandable device 20 would allow most of the force of expansion to be directed toward the endplates between affected vertebral bodies 61, thereby increasing the mechanical capability of the expandable body 50 to reduce the fracture.
  • an expandable body 50 can move the top and bottom of the vertebral bodies 61 (i.e., the upper and lower vertebral end plates) toward a more normal anatomical position to restore height.
  • certain embodiments of the present invention can achieve directed expansion of an expandable body 50 into desired areas while avoiding expansion into areas that are not affected by injury or disease. For example, in a vertebral body 61 , the expansion can be prevented from entering an area not affected by a compression fracture. As a result, the outer dimensions of the sides of the vertebral body 61 can be maintained by avoiding fracturing the cortical sidewalls of the vertebral body 61 or by moving already fractured bone in the sidewalls.
  • Embodiments of an expandable body 50 according to the present invention include wall portions 53, 55 having elasticities 54, 56 sufficiently different to allow the body 50 to differentially expand when under internal pressure.
  • such expandable bodies 50 are able to expand preferentially along one or more axes so as to deliver a greater force and/or displacement of cancellous bone 63 toward one direction versus another.
  • the expandable body 50 comprises a wall 52 having a first wall portion 53 comprising a high elasticity material 54 and a second wall portion 55 comprising a material 56 having an elasticity lower than the first wall portion 53 elasticity.
  • the high elasticity material 54 in the first wall portion 53 can comprise a low durometer material
  • the lower elasticity material 56 in the second wall portion 55 can comprise a high durometer material.
  • Reference to the durometer, or hardness, of one material is made relative to the durometer, or hardness, of another material.
  • a high durometer material wall portion has a higher durometer, or is harder and less pliable, relative to another wall portion comprising a lower durometer, or softer, material.
  • Polymers such as polyurethanes are available in different hardnesses, according to a hardness, or durometer, scale used in plastics.
  • a durometer of 9OA is a degree of hardness on the "A" durometer scale.
  • a material having 9OB durometer rating would be harder than a material having a 9OA durometer rating.
  • the lower the durometer scale rating the softer and more pliable the material.
  • the lower the durometer scale rating of a material used in wall portions 55 having higher durometer rated materials 56 the more the expandable body 50 would elongate along an axis 58 in the longitudinal direction.
  • the amount of increase in expansion force on the softer portions 53 of the wall 52 relate to the durometer of the harder portions 55 of the wall 52. The higher the durometer of the harder portions 55, the greater the increase in expansion force on the softer portions 53.
  • the expandable body wall 52 can have one or more wall portions 55, or "stripes,” of less elastic material 56 disposed in the longitudinal direction along the elongated axis 58 of the device 20.
  • the portions 55 of the expandable body wall 52 comprising lower elasticity material 56 do not stretch as much as the portions 53 of the expandable body wall 52 comprising higher elasticity material 54.
  • the "stripes," or longitudinal portions 55 of less elastic material 56, in the expandable body wall 52 are constrained during expansion relative to the wall portions 53 of more elastic material 54.
  • Embodiments of the expandable body wall portions 55 made with low elasticity material 56 provide the advantage of greater torque control from the attached elongate member 40, or catheter, allowing easier radial, or rotational, movement of the expandable body 50.
  • the amount of directionality provided by wall portions 55 of lower elasticity material 56 can be adjusted by making those wall portions 55 either more broad or more narrow.
  • a broader wall portion 55 of low elasticity material 56 would force the expandable body 50 to expand less in the direction toward which that wall portion 55 is oriented than a more narrow wall portion 55 of material 56 having the same elasticity.
  • Location of placement of low elasticity wall portions 55 at selected locations around the circumference of the expandable body 50 can provide additional directional control of expansion. For example, two wall portions 55 of low elasticity material 56 located on the same half of a tube circumference would allow expansion from that half of the tube only in the direction outward 57 from the higher elasticity material portion 53 between the two low elasticity material portions 55.
  • multiple wall portion stripes 55 of low elasticity material 56 can be located about the circumference of the expandable body 50. In this way, expansion of the body 50 can be directed from multiple higher elasticity material wall portions 53 toward multiple and more discrete target areas. Directional control of expansion allows the expandable body 50 to expand into non-spherical shapes.
  • embodiments of a directionally-controlled expandable body of the present invention can comprise various cross-sections, for example, round, non-round and profiled cross-sections.
  • Fig. 5A shows a first wall portion 53 (high elasticity material 54) comprising more that three fourths of the cross-section of an expandable body, and a second wall portion 55 (low elasticity material 56) comprising less than one fourth and located on one side of the cross-section.
  • Fig. 5B shows the shape and direction 57 of expansion of the embodiment in Fig. 5 A outward from the first wall portion 55. This configuration provides an ovoid-shaped expansion.
  • Fig. 6A shows a first wall portion 53 (high elasticity material 54) and a second wall portion 55 (low elasticity material 56) each comprising approximately half of the cross- section of an expandable body.
  • Fig. 6B shows the shape and direction 57 of expansion of the embodiment in Fig. 6A outward from the first wall portion 55. This configuration provides a substantially rounded expansion beginning from the edges of the second wall portion 55.
  • the embodiment of an expandable body in Fig. 6A provides a differently shaped (and directed) expansion than the embodiment in Fig. 5A.
  • Fig. 7A shows two first wall portions 53 (high elasticity material 54) comprising the large majority of the cross-section of an expandable body, and two second wall portions 55 (low elasticity material 56) each comprising a relatively small portion on opposite sides of the cross-section at the "6" and "12" clock positions (if a clock face was overlaid onto the cross- section).
  • Fig. 7B shows the shape and direction 57 of expansion of the embodiment in Fig. 7A outward from constrained points of the second wall portions 55. This configuration provides an expansion having a "figure 8" shape.
  • Fig. 8A shows two first wall portions 53 (high elasticity material 54) comprising the large majority of the cross-section of an expandable body, and two second wall portions 55 (low elasticity material 56) each comprising a relatively small portion at the "7" and "11" o'clock positions of the cross-section.
  • Fig. 8B shows the shape and direction 57 of expansion of the embodiment in Fig. 8 A outward from constrained points of the second wall portions 55. This configuration provides an expansion having an uneven "figure 8" shape.
  • Fig. 9A shows two first wall portions 53 (high elasticity material 54) comprising the majority of the cross-section of an expandable body, and two second wall portions 55 (low elasticity material 56) comprising the portions of the cross-section between the "5" and “7” o'clock positions and between the "11" and “1” o'clock positions of the cross-section.
  • Fig. 9B shows the shape and direction 57 of expansion of the embodiment in Fig. 9 A outward from constrained second wall portions 55. This configuration provides an expansion having a "shortened dumbbell" shape.
  • Fig. 1OA shows four first wall portions 53 (high elasticity material 54) comprising the majority of the cross-section of an expandable body, and four second wall portions 55 (low elasticity material 56) comprising the portions of the cross-section at the "3,” “6,” “9,” and “12" o'clock positions of the cross-section.
  • Fig. 1OB shows the shape and direction 57 of expansion of the embodiment in Fig. 1OA outward from constrained second wall portions 55. This configuration provides an expansion having a "cloverleaf ' shape.
  • FIG. 1 IA shows a first wall portion 53 (high elasticity material 54) comprising approximately one fourth of the cross-section of an expandable body and a second wall portion 55 (low elasticity material 56) comprising approximately three fourths of the cross- section.
  • Fig. 1 IB shows the shape and direction 57 of expansion of the embodiment in Fig. 1 IA outward from the first wall portion 55. This configuration provides an expansion having a shape largely constrained by the second wall portion 55 and a small, rounded shape expanded from the area of the first wall portion 53.
  • Fig. 12A shows a first wall portion 53 (high elasticity material 54) comprising more that three fourths of the cross-section of an expandable body, and a second wall portion 55 (low elasticity material 56) comprising less than one fourth and located on one side of the cross-section.
  • the second wall portion 55 extends inwardly into the bore of the expandable body in a semi-circular shape.
  • Fig. 12B shows the shape and direction 57 of expansion of the embodiment in Fig. 12A outward from the first wall portion 55. This configuration provides an expansion having a shape similar to that of a light bulb.
  • FIG. 13 A shows two first wall portions 53 (high elasticity material 54) each comprising opposite sides of a rectangular-shaped expandable body cross-section, and two second wall portions 55 (low elasticity material 56) each comprising opposite sides of the rectangular-shaped cross-section that are shorter than the two first wall portion sides.
  • Fig. 13B shows the shape and direction 57 of expansion of the embodiment in Fig. 13A outward from the first wall portions 55. This configuration provides an oblong-shaped expansion.
  • Embodiments of an expandable body according to the present invention can achieve directionally-controlled expansion without using additional structures in the interior of the body.
  • the expandable body 50 comprising wall portions 53, 55 comprising differential elasticities can be configured to include an internal restraint.
  • Figs. 14A— 16A shown cross-sections of an expandable body having an internal restraint 70.
  • Fig. 14A shows two first wall portions 53 (high elasticity material 54) each comprising opposite sides of an expandable body having a partially flattened cross-section, and a second wall portion 55 (low elasticity material 56) in the form of a square, two sides of which are contiguous with the wall of the expandable body and two sides of which form internal restraints 70 connecting opposite sides of the body wall.
  • Fig. 14B shows the shape and direction 57 of expansion of the embodiment in Fig. 14A outward from the first wall portions 55 and in the opposite directions 71 of expansion away from internal restraint 70. This configuration provides an expansion having an "elongated dumbbell" shape.
  • FIG. 15A shows two first wall portions 53 (high elasticity material 54) each comprising opposite sides of an expandable body cross-section, and two second wall portions 55 (low elasticity material 56) comprising the portions of the cross-section around the "6" and "12" o'clock positions of the cross-section.
  • the internal restraint 70 connects the sides of the body wall adjacent the two second wall portions 55.
  • Fig. 15B shows the shape and direction 57 of expansion of the embodiment in Fig. 15A outward from the first wall portions 55 and in the opposite directions 71 of expansion away from internal restraint 70. This configuration provides an expansion having an "figure 8" shape.
  • ElevateTM inflatable balloon tamp which includes a dual web balloon
  • U.S. Patent Publication No. 2003/0032963 discloses such a dual-web IBT as comprising an uninflated cross-section having a round outer wall and two adjacent inner walls connecting the outer wall across the diameter of the circular shape. This configuration provides three hollow chambers inside the balloon. The two outer chambers have semicircular shapes and are inflatable. When inflated, each semi-circular chamber moves in opposite directions. The inner walls, or webs, serve as internal expansion restraints during inflation.
  • the internal walls undergo only limited elastic and/or plastic deformation during inflation, thereby maintaining the approximate original balloon diameter at the points where the inner walls are connected to the outer wall.
  • the balloon outer wall is not as significantly restrained from expanding in the directions transverse to the internal walls.
  • the balloon can expand substantially more in one direction than in a transverse direction, for example, more in the vertical direction than in the horizontal direction, resulting in a cross-sectional shape that is generally ovoid or somewhat similar to a "figure 8."
  • Such a dual web internal restraint can control expansion in a bi-directional manner.
  • Embodiments of an expandable body of the present invention provide further directional control of expansion not limited to two (opposite) directions.
  • two first wall portions 53 (high elasticity material 54) each comprise opposite sides of an expandable body cross-section
  • two second wall portions 55 (low elasticity material 56) comprise the portions of the cross-section around the "6" and "12" o'clock positions of the cross-section.
  • the internal restraint 70 connects the sides of the body wall adjacent the two second wall portions 55.
  • Fig. 16B shows the shape and direction 57 of expansion of the embodiment in Fig. 16A outward from the first wall portions 55 and in the opposite directions 71 of expansion away from internal restraint 70. This configuration provides an expansion having an "elongate figure 8" shape.
  • Internal restraints 70 can include, for example, mesh work, webbing, membranes, partitions or baffles, a winding, spooling or other material laminated to portions of the balloon body, and continuous or non-continuous strings across the interior of the expandable body 50 held in place at specific locations.
  • the low elasticity wall portions 55 of the expandable body 50 of the present invention provide improved control of lengthwise expansion along the elongated axis 58 of the expandable body 50.
  • Embodiments of an expandable body of the present invention can be configured to function in a manner similar to expandable bodies having an external restraint.
  • Fig. 17A shows a first wall portion 53 (high elasticity material 54) comprising a semi-circular cross-section of an expandable body, and a second wall portion 55 (low elasticity material 56) comprising the length of the diameter of the semi-circular cross-section.
  • the second wall portion 55 acts as a substantially rigid surface 72.
  • Fig. 17B shows the shape and direction 57 of expansion of the embodiment in Fig. 17A outward from the first wall portion 55.
  • This configuration provides an expansion having an ovoid shape, the expansion occurring primarily in one direction away from the axis of the second wall portion 55.
  • the second wall portion 55 can also prevent compression by the expanding body of anatomical structures behind the second wall portion 55 (substantially rigid surface 72).
  • Fig. 18A shows a first wall portion 53 (high elasticity material 54) comprising more that three fourths of the cross-section of the expandable body, and a second wall portion 55 (low elasticity material 56) comprising less than one fourth and located on one side of the cross-section.
  • the second wall portion 55 is a non-compliant material 76 located on one side 73 of the wall 52 and extends the length 74 along the elongated axis 58 of the expandable body 50, which is less than the entire length of the expandable body 50.
  • the body 50 expands in an asymmetric, "bean- shaped” or “banana-shaped” fashion, thereby providing expansion of the body 50 outwardly 57 and opposite from the center of the length 74 of the second wall portion 55.
  • the embodiment of the expandable body 50 whose cross-section is shown in Fig. 18A expands at an angle 75 from the elongated axis 58.
  • the angle the expandable body 50 curves from the elongated axis 58 is in the range of 30-90 degrees.
  • Fig. 23 is a plan view of a human vertebra 60 being accessed bilaterally across pedicles 64 by cannulae 30, with portions of the vertebra 60 removed to reveal cancellous bone 63 within the vertebral body 61.
  • the expandable body 50 is generally deployed via the elongate member 40 across the pedicle 64 on both sides of the vertebra 60.
  • the expandable body 50 is positioned lateral to the midline of the vertebra 60, or the disc when used for endplate extraction. In both cases, a bilateral approach is necessary.
  • the embodiment in Figs. 18A and 18B of the expandable body 50 having the cross-section shown and extending the length 74 is inserted in a typical manner using a trans-pedicular approach.
  • the expandable body 50 expands to a "bean" shape and curves at the angle 75 (shown in Fig. 18B) such that the body 50 expands beyond one side of the vertebral body 61.
  • the expandable body curves from the elongated axis 58 at an angle in the range of 30-90 degrees.
  • the expandable body 50 is inserted along the elongated axis 58 in line with the expandable member 40 when not expanded, the body can be directionally expanded in a curve to compress the cancellous bone 63 on the side of the vertebral body 61 contralateral to the insertion point.
  • Such a "bean- shaped" expandable body 50 would allow a physician to access the vertebral body 61 with a unilateral approach and reach areas not directly aligned with the access trajectory. Such a method would provide access to portions of the vertebral body 61 not reachable when an expandable body cannot be inserted in a direct line across the midline of the vertebral body 61.
  • the expandable body 50 having such a "bean-shaped" expansion would allow a less invasive procedure than a conventional bilateral approach, and would decrease cost by eliminating the need for a second expandable device.
  • an expandable body 50 comprises one or more wall portions 53 comprising a high elasticity material 54 and having a thickness 77 (as shown in Fig. 5A).
  • the expandable body 50 comprises one or more wall portions 55 comprising a relatively lower elasticity material 56 and having a thickness 78 (as shown in Fig. 5A).
  • thickness 78 of the low elasticity wall portion(s) 55 is different than the thickness 77 of the higher elasticity wall portion(s) 53.
  • the greater the thickness, or depth, of the low elasticity material wall portion 55 the greater amount of low elasticity material 56 in the wall portion 55.
  • the thicker a low elasticity material wall portion 55 the greater the rigidity of that wall portion 55.
  • the amount of low elasticity material 56 in wall portion(s) 55 should be controlled so as to not diminish the elasticity characteristics of the high elasticity material wall portions 53. That is, the total amount of low elasticity material 56 used to achieve a degree of inelasticity should be balanced with elasticity characteristics of the expandable body 50 in the high elasticity portions so that the body 50 can be expanded to a desired shape and dimension.
  • Expandable bodies 50 of the present invention can comprise low elasticity wall portions 55 made from, for example, polyurethanes, polyolefins (polyethylenes, polypropylenes, etc.), polyamides, acrylics, polyvinyl compounds, polyesters, polyethers, polycarbonates, polyether therephthalate, polyketones, and any of these materials combined with a filler.
  • a low elasticity material 56 useful for making wall portions 55 is PEBAXTTM, a polyether block amide available commercially from Archema. Other low elasticity rated engineered plastics may be used.
  • nanocomposites of such low elasticity materials 56 can be advantageously utilized in the wall 52 of expandable body 50.
  • Low elasticity materials 56 can be reinforced materials such nanocomposites, filler filled materials, and irradiation crosslinked resins.
  • a high elasticity material 54 useful for making the wall 52 of expandable body 50 is the polyurethane TEXIN®, commercially available from Bayer MaterialScience in South Deerfield, Massachusetts. Other materials such as silicone, rubber, thermoplastic rubbers, elastomers, and other medical balloon materials can be utilized to make high elasticity wall portions 53.
  • Embodiments of the directionally controlled expandable body 50 can comprise a single lumen or a multi-lumen tubing of such high elasticity materials 54. In directionally-controlled expandable bodies 50 of the present invention, distribution of pressure upon expansion is often uneven about the tubular circumference. This causes the expandable body 50 to tend to shift in a treatment area, for example, in a vertebral body 61 , into regions of lower tissue density.
  • Undesirable shifting and/or radial twisting of the expandable body 50 may also occur due to the higher elasticity of the wall 52 material. As a result, directional control of expansion can be compromised. Expandable bodies 50 having wall portions 55 of low elasticity material 56 provide greater rigidity to better maintain the expandable bodies 50 in the desired position in a treatment area. As such, expansion of bodies 50 having wall portions 55 of low elasticity material 56 can be more reliably maintained in desired locations and expanded in desired directions. As discussed herein, another advantage of wall portions 55 comprising low elasticity material 56 in a directionally-controlled expandable body 50 is greater torque control.
  • elastomer materials for example, polyurethane
  • a vertebral compression fracture is a fracture occurring in a vertebra 60 which, in addition to being painful, changes the alignment of the spine.
  • vertebral height is lost particularly in the anterior region of the vertebral body 60.
  • Such a decreased height is less than the height 80 shown in Figs. 20 and 22.
  • the user of tl ⁇ e system 10, shown in Fig. 1, may wish to use the system 10 to provide a cavity 81 within the vertebral body 61, and to restore the height 80 to the vertebral body 61 lost when the fracture occurred.
  • the expandable body 50 disposed at the distal end 42 of the elongate member 40 has been expanded as a result of inflation.
  • the wall portion 53 comprising a relatively higher elasticity material 54 and the wall portion 55 comprising a relatively lower elasticity material 56 cause expansion of the expandable body 50 to be constrained more in the lower elasticity wall portion 55, resulting in expansion in the direction of the higher elasticity wall portion 53.
  • a user of the system 10 may provide a cavity 81 having the desired dimensions. In this manner, a more normal height 80 and a pre- vertical compression fracture shape can be at least partially restored.
  • the expandable body 50 having the cross-section shown in Fig. 6A has been inserted through cannula 30 across pedicle 64 into cancellous bone 63 of the vertebra 60.
  • the expandable body 50 having this cross-section expands to the desired shape and in the desired direction as shown.
  • the direction of expansion can be changed by the user of the system 10 by rotating the elongate member 40, and thereby the expandable body 50 disposed thereon.
  • expansion of the body 50, and compression of cancellous bone 63 can be directed vertically more in one direction than in the opposite direction as shown in Fig. 20, to increase the height of the vertebral body 61 to pre- VCF height 80.
  • the expandable body 50 having the cross-section shown in Fig. 7 A has been inserted through cannula 30 across pedicle 64 into cancellous bone 63 of the vertebra 60.
  • the expandable body 50 having this cross-section expands to the desired shape and in the desired direction as shown.
  • the direction of expansion can be changed by the user of the system 10 by rotating the elongate member 40, and thereby the expandable body 50 disposed thereon.
  • expansion of the body 50, and compression of cancellous bone 63 can be directed vertically equally in both directions as shown in Figs.
  • the configuration of such an expandable body 50 can be defined by the surrounding cortical bone 62 and adjacent internal structures, and is designed to occupy up to 70-90% of the volume of the inside of the bone.
  • expandable bodies 50 that are as small as about 40% (or less) and as large as about 99% are workable for fractures.
  • the expanded body 50 size may be as small as 10% of the cancellous boiie 63 volume of the area of bone being treated, such as for the treatment of avascular necrosis and/or cancer, due to the localized nature of the fracture, collapse, and/or treatment area.
  • the fully expanded size and shape of the expandable body 50 is desirably regulated by low and high durometer materials, 54, 56, respectively, in selected portions of the body 50, as described.
  • an expandable body 50 may comprise a nanocomposite plastic material.
  • Nanocomposites include a resin matrix and a nano-sized reinforcing filler material.
  • Commercially available nano-fillers include clays, silicas, and ceramics. Nanocomposites and nano-fillers are available commercially from the Foster Corporation, Putnam, CT. These fillers are small enough to improve the strength of the resin matrix, while allowing a tube to be extruded in a thin walled film.
  • a first wall portion 53 of an expandable body 50 comprises a high elasticity material 54.
  • a second wall portion 55 comprises a lower elasticity nanocomposite of the same material as the high elasticity wall portion 53.
  • An advantage of using a nanocomposite material in a low elasticity wall portion 55 that is a nanocomposite of the same material used in a high elasticity wall portion 53 is that the nanocomposite material exhibits increased strength and stiffness relative to the non-reinforced material.
  • the wall portion 55 comprising a low elasticity nanocomposite material is more resistant to stretching upon expansion of the expandable body 50 than the high elasticity wall portion 53. As a result, expansion of the expandable body 50 can be directed in desired directions according to the present invention.
  • a low elasticity, less compliant wall portion 55, or “stripe,” comprising a nanocomposite that is coextruded with a higher elasticity, more compliant wall portion 53 allows directed expansion of the expandable body 50, as described herein.
  • the lower elasticity nanocomposite can be a material different than the high elasticity material 54.
  • Pre-determined amounts of nano-fillers in the nanocomposite can be used to selectively affect the elasticity, the degree of hardness, and the resistance to puncture, of the portions of the expandable body wall 52 comprising a nanocomposite.
  • An advantage of using a nanocomposite material in an expandable body 50 is that relatively high elasticity resins can be used in one wall portion 53 and the same material reinforced with a nanocomposite can be used for a relatively lower elasticity wall portion 55.
  • the entire circumference of the expandable body wall 52 is made from a nanocomposite resin.
  • a mono-layer of 100% nanocomposite resin can be extruded to make an expandable body wall 52.
  • An expandable body 50 comprising a i ⁇ % rianocomposrte resin has greater strength than an expandable body 50 made from the same resin that is not reinforced with the nanocomposite.
  • the addition of nanocomposites to an expandable body 50 can affect the ability of the body 50 to elongate.
  • the amount of nanocomposite used to lower the elasticity of an expandable body wall 52 should allow for sufficient elongation for achieving a desired expanded volume.
  • an expandable body 50 is extruded as a bi-layer, comprising one layer of nanocomposite resin and the other layer of non-reinforced resin.
  • the outer layer of the coextruded bi-layer body 50 such as a balloon tubing 51
  • the body 50 or tubing 51 is provided with increased puncture resistance.
  • the advantage of a bi-layer extrusion is that it avoids having to use nanocomposites in 100% of the balloon tubing 51.
  • the entire body 50 or tubing 51 includes nanocomposites, elasticity characteristics can be affected.
  • One way to maintain desired elasticity characteristics of a body 50 or tube 51 is to make an inner layer from a virgin material without nanocomposites and provide an outer layer, or coating, of the body 50 or tube 51 with a material comprising nanocomposites.
  • the nanocomposite outer layer provides increased puncture resistance, while the inner layer maintains desired elasticity characteristics.
  • a nanocomposite material in the lower elasticity wall portion 55 that is a nanocomposite of the same material used in the higher elasticity wall portion 53 can improve the bond at the interface between the two wall portions 55, 53, as compared to a bond between two different materials. This provides the advantage of significantly decreasing the risk of delamination at the interface between the wall portions 55, 53.
  • a nanocomposite provides the advantage of different material characteristics in different wall portions without compromising the interface bond between the two materials.
  • Utilization of a nanocomposite in an expandable body wall 52 can provide a more puncture-resistance body. Increased puncture-resistance of an expandable body 50 provides an advantage in anatomical treatment areas in which bone or other structures form sharp edges.
  • the degree of hardness and the resistance to puncture of an expandable body wall 52 is affected by the amount of nano-fillers comprising materials different than the virgin material used in a nanocomposite. For example, if 10% of the nanocomposite comprises a nano-f ⁇ ller, 10% of the original molecule is replaced, causing the expandable body 50 to have 10% less of the characteristics imparted by the nanocomposite material. Inclusion of a larger percentage of nano-filler in the nanocomposite material will reduce the desired characteristics of the nanocomposite material by a proportionate larger percentage in the material. Thus, during manufacture, hardness and elasticity characteristics of a nanocomposite material in the expandable body 50 should be balanced with a desired amount of puncture-resistance.
  • Another advantage of the expandable body 50 of the present invention comprising a nanocomposite resin is that the very small particles of the nanocomposite allow smoother surfaces of the finished body wall 52, such as in a balloon tubing 51. In contrast, fiber- reinforced resins, which are larger, can cause imperfections in the balloon tubing 51 surface.
  • Another advantage of the expandable body 50 of the present invention comprising a nanocomposite resin is that the body wall 52 can be thinner while achieving the same, or greater, hardness and similar elongation capabilities as in expandable bodies 50 having thicker walls 52.
  • Embodiments of the present invention include methods for directionally controlling expansion of an expandable body 50 in a targeted treatment area.
  • One such method 90 is shown in the flow chart in Fig. 25.
  • the expandable body 50 is provided (91) with a wall 52 having a first wall portion 53 comprising a high elasticity material 54 and a second wall portion 55 comprising a material 56 having an elasticity lower than the elasticity of the first wall portion 53.
  • the expandable body 50 is coupled (92) to the distal end 42 of the elongate member 40.
  • the cannula 30 is introduced (93) into an interior body region.
  • the elongate member 40 is then inserted (94) through the cannula 30.
  • the expandable body 50 can be positioned (95) for expanding in a selected direction in the interior body region, the expandable body is expanded (96) by injecting a flowable material.
  • the expandable body 50 comprises an elongated axis 58, and causing directed expansion (96) of the body 50 causes the first wall portion 53 to expand outwardly 57 in the selected direction along the elongated axis 58.
  • causing directed expansion (96) of the body 50 causes the first wall portion 53 to expand in a constrained manner (97) lengthwise along the elongated axis 58.
  • the directed expansion (96) creates (98) a cavity 81 within the interior body region.
  • the interior body region may comprise a bone, including, for example, a cancellous bone 63, which is compressed by the directed expansion (96).
  • the directed expansion (96) displaces a cortical bone 62.
  • the directed expansion (96) may be utilized to intervene in other interior body regions.
  • the directed expansion (96) may be utilized to lift vertebral end plates, tibial plateau depressions, and proximal humerus depressions, as well as for other purposes.
  • me memo ⁇ yO includes contracting (99) the expandable body 50 and removing the expandable body 50 from the interior body region.
  • the method 90 can include filling (100) the cavity 81 with a filler material.
  • the present invention can provide embodiments of a device, systems, and methods for radioscopic visualization of the positioning of the expandable body 50 in the interior body region 70.
  • the expandable body 50 may be directionally controlled.
  • the expandable body 50 may not be directionally controlled.
  • the expandable body 50 can include a radiopaque marking pattern 107.
  • the radiopaque marking pattern 107 is configured to allow for visualizing radioscopically the positioning, for example, movement and orientation, of the expandable body 50 in the interior body region 70. In this manner, the user can directly monitor positioning of the expandable body 50 in the interior body region 70 while expanding the expandable body 50 by introducing a flowable material that is a non-radiopaque contrast medium. As a result, the risk of exposing a patient to such a radiopaque contrast agent is eliminated.
  • Radiopaque is defined as being opaque to radiation and especially x-rays.
  • Radioscopy is defined as examination of the inner structure of optically opaque objects by x- rays or other penetrating radiation.
  • Fluoroscopy is defined as examination by means of a fluoroscope.
  • a fluoroscope is a device equipped with a fluorescent screen on which the internal structures of an optically opaque object, such as the human body, may be viewed as shadowy images fo ⁇ ned by the differential transmission of x-rays through the object.
  • the radiopaque marking pattern 107, 108 comprises a plurality of radiopaque markers 59.
  • Each of the radiopaque markers 59 is in communication with a predetermined location on the expandable body 50.
  • a radiopaque marker 59 can be placed at or near the distal end 102 of the expandable body 50 to indicate the most distal reach of the expandable body 50.
  • a radiopaque marker 59 can be placed at or near the proximal portion 101 of the expandable body 50 (attached to the elongate member 30 or catheter) to indicate the most proximal location of the expandable body 50 when viewed radioscopically.
  • Radiopaque markers 59 can be placed at spaced apart locations on the expandable body 50. In this manner, when the expandable body 50 is expanded, the positioning of the wall 52 of the expandable body 50 can be observed radioscopically.
  • Positioning of the expandable body 50 in the interior body region 70 can include movement that occurs during and after insertion, anterior-posterior, or axial, movement along the longitudinal axis 58 of the insertion device (cannula 30), rotating about a radial axis 109, movement of all or a portion of the wall 52 of the expandable body 50 during expansion and/or contraction, and any other orienting or movement of the expandable body 50 capable of being observed by radioscopic visualization of the radiopaque marking pattern 107, 108.
  • Certain embodiments of the present invention for visualizing the expandable body 50 under fluoroscopy provide the advantage of avoiding the need to inject a radiopaque contrast medium into the expandable body 50.
  • a non-radiopaque fluid such as a 0.9% sodium chloride solution (normal saline) can be injected into the expandable body 50 to expand the body 50.
  • a 0.9% sodium chloride solution normal saline
  • saline solution is less viscous and easier to handle than contrast media. Saline solution is also much less costly than contrast media.
  • Embodiments of the present invention can include the radiopaque marking patterns 107, 108 at various predetermined locations on the expandable body 50.
  • the expandable body 50 can include radiopaque markers 59 in the radiopaque marking pattern 107 (longitudinal pattern) along the longitudinal axis 58 of the expandable body 50, as shown in Figs. 26-28.
  • radiopaque markers 59 in the radiopaque marking pattern 107 (longitudinal pattern) along the longitudinal axis 58 of the expandable body 50, as shown in Figs. 26-28.
  • the expandable body 50 can include radiopaque markers 59 in the radiopaque marking pattern 108 (radial pattern) about the radial axis 109 of the expandable body 50, as shown in Fig. 26. Accordingly, rotation of the expandable body 50 and radially outward expansion of the expandable body 50 can be visualized radioscopically. This allows the user to use an appropriate amount of rotational torque to properly orient the expandable body 50 in directions desired for optimal effect on targeted tissue when the expandable body 50 is expanded.
  • the expandable body 50 can include radiopaque markers 59 located about the periphery 103 of the expandable body 50. Such placement of the radiopaque markers 59 during manufacture of the expandable body 50 provides essentially an outline of the shape of the expandable body 50 when expanded. As such, when the expandable body 50 is expanded, the periphery 103 of the expanded expandable body 50, and thereby the outer contact points of the body 50 onto tissue in the interior body region 70 can be visualized radioscopically.
  • the radiopaque marking pattern 107 can be located in communication with the higher elasticity wall portion 53 so that movement of the higher elasticity wall portion 53 can be visualized radioscopically.
  • the radiopaque marking pattern 107 can be located in communication with the higher elasticity wall portion 53, and a different radiopaque marking pattern 107 can be located in communication with the lower elasticity wall portion 55. In this configuration, movement of the higher elasticity wall portion 53 relative to the lower elasticity wall portion 55 can be visualized radioscopically.
  • a deployment device in addition to an expandable body 50 including a radiopaque marking pattern 107, 108, a deployment device, such as the elongate member 30, can include radiopaque material(s) or markers 59. In this manner, positioning of the deployment device itself can be visualized radioscopically. As a result, the user can monitor positioning of the entire deployment device-expandable body device and any differences in positioning of one component relative to the other component.
  • Embodiments of the present invention can include methods of making the expandable body 50 having the radiopaque marking pattern 107, 108.
  • the expandable body 50 can comprise an inner tubing layer 105 and an outer tubing layer 106.
  • the radiopaque markers 59 can be laminated between the inner and outer tubing layers 105, 106, respectively, to fo ⁇ n the radiopaque marking pattern 107.
  • the radiopaque marking pattern 107 allows visualization under fluoroscopy of the positioning of the expandable body 5(J, progress ot expansion ot tiie expandable body 50, and other orientation and/or movement of the expandable body 50. As a result, the need for the fluid to be injected for expanding the expandable body 50 to be a radiopaque contrast medium is eliminated.
  • a radiopaque material, or markers, 59 such as stainless steel, can be positioned onto the inner tubing layer 105.
  • the radiopaque markers 59 can be in the form of slivers, shavings, or flakes of the radiopaque material.
  • the outer tubing layer 106 is applied over the inner tubing layer 105 and radiopaque material applied to the inner tubing layer 105.
  • the two tubing layers 105, 106 are then placed into a mold and processed into an embodiment of the expandable body 50 in the form of a balloon. In this manner, the radiopaque markers 59 are encapsulated in position between two layers 105, 106.
  • the radiopaque markers 59 are preferably adhered to the inner tubing layer 105 so that when the outer tubing layer 106 is applied to the inner tubing layer 105, the markers 59 remain in stable contact with, and do not move relative to, the inner tubing layer 105. Stabilization of the markers 59 on the inner tubing layer 105 prior to applying the outer tubing layer 106 assures that the markers 59 are located in the final two-layered, laminated expandable body 50 in locations desired for monitoring positioning and movement of the expandable body 50 when it is expanded.
  • the outer tubing layer 106 can be extruded separately from the inner tubing layer 105.
  • the outer tubing layer 106 has a larger inside diameter than the outside diameter of the inner tubing layer 105.
  • the difference in the inside diameter of the outer tubing layer 106 and the outside diameter of the inner tubing layer 105 should be a tolerance that allows the outer tubing layer 106 to be easily applied to the inner tubing layer 105.
  • Such tolerance, or difference in the inside diameter of the outer tubing layer 106 and the outside diameter of the inner tubing layer 105 can be small, for example, approximately 7- 8/1000ths of an inch.
  • the outer tubing layer 106 can be applied to the inner tubing layer 105 by various methods.
  • One such method includes manually forcing the outer tubing layer 106 over the inner tubing layer 105.
  • the outer tubing layer 106 can be applied to the inner tubing layer 105 by sliding or rolling the outer tubing layer 106 over the inner tubing layer 105.
  • the outer tubing layer 106 can be applied to the inner tubing layer 105 by automated mechanical means.
  • the two tubing layers 105, 106 having the radiopaque markers 59 enclosed between the layers 105, 106 are placed in a mold.
  • the mold is clamped in position such that the two tubing layers 105, 106 do not move relative to each other.
  • the laminated tubing layers 105, 106 are heated to soften the tubing material.
  • Pressure is then exerted from the inside, or bore, of the inner tubing layer 105 onto the circumference of the two concentric tubing layers 105, 106 toward the walls of the mold.
  • This pressurization process known as "blowing,” causes the two layers 105, 106 to be permanently bonded together and the radiopaque markers 59 to be sealed in position between the layers 105, 106.
  • the radiopaque markers 59 can be applied to the expandable body wall 52 in various ways. For example, in a two-layered, laminated expandable body 50 as described, the radiopaque markers 59 can be sprayed onto the inner tubing layer 105. Spraying the radiopaque markers 59 in solution allows the markers 59 to readily adhere to the inner tubing layer 105 in desired locations and prevents uncontrolled disbursement of the markers 59 on the inner tubing layer 105. In an illustrative embodiment, the radiopaque markers 59 can be placed in a solution of a polyurethane, such as TEXIN ⁇ , and sprayed onto an inner tubing layer of TEXIN®. This technique allows the radiopaque markers 59 to reliably adhere to the inner tubing layer 105 in controlled locations.
  • a polyurethane such as TEXIN ⁇
  • the radiopaque markers 59 can be applied to the expandable body wall 52 by printing, such as with an ink jet printer, or the radiopaque markers 59 can be brushed onto the expandable body wall 52 in desired locations.
  • the radiopaque markers 59 comprising the radiopaque marking patterns 107, 108 can be adhered to the expandable body wall 52 with an adhesive.
  • the radiopaque markers 59 can be molded onto the expandable body wall 52.
  • the radiopaque markers 59 can be mixed with an expandable body material, and the expandable body 50 is extruded from that material such that the radiopaque markers 59 form the radiopaque marking patterns 107, 108 as desired in the resulting expandable body 50.
  • the material(s) used in the expandable body wall 52 can be selected according to the therapeutic objectives surrounding its use. If desired, the material for the expandable body wall 52 can be selected to exhibit generally elastic properties, for example, latex. Alternatively, the material can be selected to exhibit less elastic properties, for example, silicone.
  • the physician monitors expansion of expandable bodies 50 with generally elastic or generally semi-elastic properties to assure that over-expansion and wall 52 failure do not occur. Accordingly, it is important to monitor the movement of expandable bodies 50 during use directly, such as under fluoroscopy.
  • each of the expandable body 50 and the radiopaque marking patterns 107, 108 can comprise a radiopaque material.
  • the radiopaque material of the radiopaque marking patterns 107, 108 can be radioscopically visibly distinct from the radiopaque material of the expandable body 50. Such an embodiment allows radioscopic visualization of the positioning of different radiopaque materials, and thus different portions of the expandable body 50 relative to other portions of the expandable body 50.
  • the radiopaque markers 59 can be made from radiopaque materials including, for example, stainless steel, platinum, gold, calcium, tantalum, and other heavy metals.
  • Radiopaque fillers useful in the radiopaque markers 59 can include, for example, barium sulfate, tantalum, tungsten, and bismuth subcarbonate, among other materials.
  • a powder of such radiopaque materials can be compounded with selected materials for making the expandable body 50 and extruded together with the selected materials to form a tube.
  • radiopaque materials can be extruded as wires and arranged in different lumens of the cannula 30 such that the expandable body 50 can be visualized under a fluoroscope.
  • the radiopaque material or markers 59 utilized in embodiments of the present invention are sufficiently large to be readily visualized under fluoroscopy.
  • the size of the pieces of radiopaque material used also depends on the manner in which the radiopaque material is applied to the expandable body wall 52. For example, if the radiopaque material or markers 59 are sprayed onto expandable body wall 52, the markers 59 should be small enough to be aerosolized through a spraying device.
  • the radiopaque marking patterns 107, 108 comprise an expandable radiopaque cage 110 surrounding the expandable body 50.
  • the cage 110 is expandable in response to a pressure exerted by expanding the expandable body 50.
  • the cage 110 marks an expanded periphery 103 of the expandable body 50.
  • the expanded periphery 103 of the expandable body 50 can be visualized radioscopically.
  • the cage 1 10 expands around the periphery 103 of the expandable body 50 to provide essentially an outline of the borders, or periphery, 103 of the expandable body 50.
  • the radiopaque cage 110 allows visualization under fluoroscopy of the positioning of the expandable body 50, progress of expansion expandable body 50, and other movement of the expandable body 50. As a result, the need for the fluid to be injected for expanding the expandable body 50 to be a radiopaque contrast medium is eliminated.
  • the radiopaque cage 110 surrounding the expandable body 50 is non-structural, meaning that the cage 110 does not have a primary mechanical function. Because the cage 110 can be made to serve no primary structural purpose, it can be constructed from a less expensive material than if it were structurally functional. Alternatively, the radiopaque cage 110 can provide a structural mechanical function during or after its expansion around the expandable body 50. In an embodiment, the radiopaque cage 110 is adapted to remain expanded in the interior body region 70 after the expandable body 50 is contracted and removed from the interior body region 70. As such, the cage 110 can be manufactured with biocompatible materials to be an implantable device. The radiopaque cage 110 is designed so that a filler material can be injected about the expanded cage 110 in the interior body region 70.
  • a bone cement such as polymethyl methacralate (PMMA)
  • PMMA polymethyl methacralate
  • the expandable radiopaque cage 110 can be removed from the interior body region 70. Removal of the cage 110 can be accomplished, for example, by forming the cage 110 from a material that is collapsible after being expanded. When the expandable body 50 is deflated, the cage 1 10 structure can collapse back to its original shape such that it can be retracted from the interior body region 70 via the deployment cannula 30. To remove the cage 110, the deployment cannula 30 would accommodate removal of the cage 110 along with the deflated expandable body 50.
  • Embodiments of the radiopaque cage 1 10 can be made from the same or similar materials that are used for angioplasty stents and other implantable devices.
  • the radiopaque cage 110 can be made from stainless steel, nickel, titanium, or other radiopaque biocompatible material.
  • the radiopaque cage 110 can also comprise plastics, ceramics, or fibers. Such materials can have the capability of maintaining their expanded shape and thus remain in expanded position in the treatment area of the interior body region 70.
  • shape-memory alloys such as the nickel-titanium alloy Nitinol, can be used.
  • Embodiments of the radiopaque cage 110 can be made in the form of a metal netting, welded metal wires, and/or expandable slit metal tubing.
  • a radiopaque metal netting cage can be in the form of a fine mesh netting formed, for example, from a foamed polymer sheath material.
  • a radiopaque metal netting cage can be in the form of a fine mesh netting formed from a radiopaque, non-structural, compliant polymer sheath.
  • the cage 110 is made in such a manner as to be expandable in response to the pressure exerted by expanding the expandable body 50. In other embodiments, other means for radiographic visualization of the expandable body 50 can be used.
  • the location, size, and shape of the expandable body 50 can be visualized under fluoroscopy by expanding the body 50 with a radiopaque gas or liquid.
  • Embodiments of the present invention include methods for radioscopically visualizing positioning of the expandable body 50 in the interior body region 70. As shown in the embodiment of the method 120 in Fig. 31, the expandable body 50 is provided (121) with the radiopaque marking pattern 107, 108. The expandable body 50 is inserted (122) into the interior body region 70. A non-contrast fluid can then be injected (123) into the expandable body 50 to expand it. Positioning of the expandable body 50 in the interior body region 70 can be visualized (124) radioscopically, both before and after expansion with the injected fluid.
  • the expandable body 50 can be expanded in a selected direction (125), and the directionally expanded portion of the expandable body 50 can be visualized radioscopically (126).
  • expansion of the expandable body 50 according to the present invention can be utilized to create (127) a cavity within the interior body region 70.
  • expansion of the expandable body 50 can be utilized to compress (128) cancellous bone 63 and/or to displace (129) cortical bone 62.
  • the embodiment of the method 140 of the present invention includes providing the expandable body 50 surrounded (141) with the expandable radiopaque cage 110.
  • the expandable body 50 and radiopaque cage 110 are inserted (142) into the interior body region 70, where positioning of the radiopaque cage 110, and thereby the expandable body 50 (both in unexpanded condition), can be visualized radioscopically (143).
  • a non-contrast fluid is then injected (144) into the expandable body 50 to expand the expandable body 50 and to exert a pressure that expands the cage 110.
  • the expanded periphery 103 of the expandable body 50 marked by the cage 110 can then be visualized radioscopically (145).
  • expansion of the expandable body 50 and radiopaque cage 110 can be utilized to create (146) a cavity within the interior body region 70.
  • expansion of the expandable body 50 and radiopaque cage 110 can be utilized to compress (147) cancellous bone 63 and/or to displace (148) cortical bone 62.
  • the expandable body 50 can be contracted (149) and removed (150) from the interior body region 70.
  • the expanded cage 110 can be maintained (151) in the interior body region 70 after the expandable body 50 is removed (150).
  • a filler material can be injected (152) about the expanded cage 110.
  • the radiopaque cage 110 can also be contracted and removed from the interior body region 70.
  • expandable bodies 50 are by no means limited in their utility to use in a single treatment location within the body. Rather, while each embodiment may be disclosed in connection with an exemplary treatment location, these embodiments can be utilized in various locations within the human body, depending upon the treatment goals as well as the anatomy of the targeted bone.
  • embodiments of an expandable body 50 may be used in the treatment of areas within the body other than the vertebra, including, for example, the ribs, the femur, the radius, the ulna, the tibia, the humerus, the calcaneus, or the spine.
  • particular embodiments of such expandable bodies 50 may be utilized to lift, for example, tibial plateau depressions and proximal humeral depressions.

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Abstract

La présente invention concerne des systèmes et des procédés pour commander une direction d'extension et pour une visualisation radioscopique du positionnement d'un dispositif extensible. Un tel dispositif comprend un corps extensible qui présente une première partie de paroi et une seconde partie de paroi. La première partie de paroi comprend une matière à haute élasticité. La seconde partie de paroi comprend une matière qui présente une élasticité inférieure à l'élasticité de la première partie de paroi. Lorsque le corps est étendu, l'extension de la seconde partie de paroi est plus contrainte que l'extension de la première partie de paroi. L'extension du corps est orientée vers l'extérieur en raison de la grande élasticité de la première partie de paroi. Un tel dispositif est utilisé pour ménager des cavités dans des régions internes du corps. Un modèle de marquage radio-opaque peut être conçu pour permettre une visualisation radioscopique de l'orientation et du déplacement du corps extensible dans des états non étendus et étendus dans une région interne du corps.
EP06786452A 2005-07-08 2006-07-07 Dispositif extensible et procedes pour l'utiliser Withdrawn EP1903967A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11/177,042 US20070010844A1 (en) 2005-07-08 2005-07-08 Radiopaque expandable body and methods
US11/177,666 US20070010845A1 (en) 2005-07-08 2005-07-08 Directionally controlled expandable device and methods for use
PCT/US2006/026298 WO2007008568A2 (fr) 2005-07-08 2006-07-07 Dispositif extensible et procedes pour l'utiliser

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EP1903967A2 true EP1903967A2 (fr) 2008-04-02

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EP2446918A1 (fr) * 2010-10-29 2012-05-02 Biotronik AG Cathéter à ballonnet avec une section extensible asymétrique radiale
EP2793722A1 (fr) 2011-12-22 2014-10-29 DePuy Synthes Products, LLC Ballonnet à corps vertébral à longueur réglable
US9445918B1 (en) 2012-10-22 2016-09-20 Nuvasive, Inc. Expandable spinal fusion implants and related instruments and methods
US9795493B1 (en) 2013-03-15 2017-10-24 Nuvasive, Inc. Expandable intervertebral implant and methods of use thereof
CN109663202A (zh) * 2019-01-17 2019-04-23 南京普微森医疗科技有限公司 一种新型脑血管药物球囊扩张导管

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030032963A1 (en) * 2001-10-24 2003-02-13 Kyphon Inc. Devices and methods using an expandable body with internal restraint for compressing cancellous bone
US6261260B1 (en) * 1997-04-15 2001-07-17 Terumo Kabushiki Kaisha Balloon for medical tube and medical tube equipped with the same
IL133257A0 (en) * 1997-06-09 2001-04-30 Kyphon Inc Systems for treating fractured or diseased bone using expandable bodies
US6024752A (en) * 1998-05-11 2000-02-15 Scimed Life Systems, Inc. Soft flexible tipped balloon
US20030105469A1 (en) * 2001-05-09 2003-06-05 Regene Ex Ltd. Bioresorbable inflatable devices, incision tool and methods for tissue expansion and tissue regeneration

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2007008568A3 *

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WO2007008568A3 (fr) 2007-06-07

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