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EP1956990A2 - Appareil et méthodes pour traiter un tissu osseux - Google Patents

Appareil et méthodes pour traiter un tissu osseux

Info

Publication number
EP1956990A2
EP1956990A2 EP06839198A EP06839198A EP1956990A2 EP 1956990 A2 EP1956990 A2 EP 1956990A2 EP 06839198 A EP06839198 A EP 06839198A EP 06839198 A EP06839198 A EP 06839198A EP 1956990 A2 EP1956990 A2 EP 1956990A2
Authority
EP
European Patent Office
Prior art keywords
implant
balloon
vertebral body
expandable
bone
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Withdrawn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
EP06839198A
Other languages
German (de)
English (en)
Inventor
Christof Dutoit
Andreas Appenzeller
Thierry Stoll
Alfred Benoit
Stefan Mathys
Simon Stucki
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.)
Synthes GmbH
Original Assignee
Synthes GmbH
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 US11/471,169 external-priority patent/US8080061B2/en
Priority claimed from US11/523,202 external-priority patent/US20070093822A1/en
Priority claimed from US11/527,280 external-priority patent/US20070093899A1/en
Priority claimed from US11/546,579 external-priority patent/US8157806B2/en
Application filed by Synthes GmbH filed Critical Synthes GmbH
Publication of EP1956990A2 publication Critical patent/EP1956990A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61B17/34—Trocars; Puncturing needles
    • 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
    • A61B17/686—Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • 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
    • A61B17/8858—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 laterally or radially expansible
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • 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
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00491—Surgical glue applicators
    • A61B2017/005—Surgical glue applicators hardenable using external energy source, e.g. laser, ultrasound
    • 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
    • A61B2017/00557—Surgical instruments, devices or methods pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect

Definitions

  • the invention relates to surgical implants, and more particularly to minimally invasive apparatus and methods for augmenting bone, preferably vertebrae and/or restoring spinal lordosis.
  • Vertebral compression fractures represent a generally common spinal injury and may result in prolonged disability.
  • Spinal compression fractures can result in deformation of the normal alignment or curvature, e.g., lordosis, of vertebral bodies in the affected area of the spine.
  • Spinal compression fractures and/or related spinal deformities can result, for example, from metastatic diseases of the spine, from trauma or can be associated with osteoporosis.
  • doctors were limited in how they could treat such compression fractures and related deformities. Pain medications, bed rest, bracing or invasive spinal surgery were the only options available.
  • vertebroplasty which literally means fixing the vertebral body, and may be done without first repositioning the bone.
  • a cannula or special bone needle is passed slowly through the soft tissues of the back.
  • X-ray image guidance along with a small amount of x-ray dye, allows the position of the needle to be seen at all times.
  • PMMA polymethylmethacrylate
  • other orthopedic cement is pushed through the needle into the vertebral body.
  • PMMA is a medical grade substance that has been used for many years in a variety of orthopedic procedures.
  • the cement is mixed with an antibiotic to reduce the risk of infection, and a powder containing barium or tantalum, which allows it to be seen on the X-ray.
  • Vertebroplasty can be effective in the reduction or elimination of fracture pain, prevention of further collapse, and a return to mobility in patients.
  • this procedure may not reposition the fractured bone and therefore may not address the problem of spinal deformity due to the fracture. It generally is not performed except in situations where the kyphosis between adjacent vertebral bodies in the effected area is less than 10 percent.
  • this procedure requires high-pressure cement injection using low-viscosity cement, and may lead to cement leaks in 30-80% of procedures, according to recent studies. Truumees, Comparing Kyphoplasty and Vertebroplasty, Advances in Osteoporotic Fracture Management, Vol. 1, No. 4, 2002. In most cases, the cement leakage does no harm.
  • More advanced treatments for vertebral compression fractures generally involve two phases: (1) reposition, augmentation or restoration of the original height of the vertebral body and consequent lordotic correction of the spinal curvature; and (2) filling or addition of material to support or strengthen the fractured bone.
  • FIGS 2A-D A catheter having an expandable balloon tip is inserted through a cannula, sheath or other introducer into a central portion of a fractured vertebral body comprising relatively soft cancellous bone surrounded by fractured cortical bone (FIG. 2A).
  • Kyphoplasty then achieves the reconstruction of the lordosis, or normal curvature, by inflating the balloon, which expands within the vertebral body restoring it to its original height (FIG. 2B).
  • the balloon is removed, leaving a void within the vertebral body, and PMMA or other filler material is then injected through the cannula into the void (FIG. 2C) as described above with respect to vertebroplasty.
  • the cannula is removed and the cement cures to fill or fix the bone (FIG. 2D).
  • Cement embolization occurs by a similar mechanism to a cement leak.
  • the cement may be forced into die low resistance venous system and travel to the lungs or brain resulting in a pulmonary embolism or stroke.
  • the kyphon balloon is elastic and is not suited to expand a stent. Due to stent resistance, the kyphon balloon will expand anteriorly and posteriorly of the stent and suddenly explode when the stent borders cut the balloon. Additional details regarding balloon kyphoplasty may be found, for example, in U.S. Patent Nos.
  • Optimesh system Spineology, Inc., Stillwater, MN
  • Spineology, Inc. Stillwater, MN
  • the balloon graft remains inside the vertebral body after its inflation, which prevents an intraoperative loss of reposition, such as can occur during a kyphoplasty procedure when the balloon is withdrawn.
  • die mesh implant is not well integrated in the vertebral body. This can lead to relative motion between the implant and vertebral body, and consequently to a postoperative loss of reposition. Additional details regarding this procedure may be found, for example, in published U.S. Patent Publication Number 20040073308, which is incorporated by reference herein in its entirety.
  • Still another procedure used in the treatment of vertebral compression fractures is an inflatable polymer augmentation mass known as a SKy Bone Expander.
  • This device can be expanded up to a pre-designed size and Cubic or Trapezoid configuration in a controlled manner.
  • the SKy Bone Expander is removed and PMMA cement or other filler is injected into the void. This procedure therefore entails many of the same drawbacks and deficiencies described above with respect to kyphoplasty.
  • a proposed improved procedure for repositioning and augmenting vertebral body compression fractures is vertebral body stenting, for example as described in Furderer et al, "Vertebral body stenting", Orthopdde 31:356-361, 2002; European Patent Application publication number EP1308134A3; and United States Patent
  • Veterbral body stenting generally involves inserting into a vertebral body a balloon-tipped catheter (e.g., such as a kyphoplasty balloon) surrounded by a stent (e.g., such as those used in angioplasty). After insertion of the balloon and stent, the balloon is inflated, e.g., using fluid pressure, thereby expanding the stent within the vertebral body. After expansion of the stent, the balloon may be deflated and removed, with the stent remaining inside the vertebral body in an expanded state to fill the vertebral body.
  • a balloon-tipped catheter e.g., such as a kyphoplasty balloon
  • a stent e.g., such as those used in angioplasty
  • the balloon is inflated, e.g., using fluid pressure, thereby expanding the stent within the vertebral body.
  • the balloon may be deflated and removed, with the stent remaining inside the vertebral
  • the present invention provides apparatus and methods for minimally invasive augmentation of vertebral bodies.
  • the present invention provides an implant and method for correction of vertebral fractures and other disorders of the spine.
  • one or more stents or other expandable implants may be inserted into a vertebral body damaged by a vertebral compression fracture. As the one or more implants are inserted into a vertebral body and expanded, they may fill a central portion of the vertebral body and may push against the inner sides of the endplates of the vertebral body, thereby providing structural support and tending to restore the vertebra to its original height.
  • the one or more expandable implants may comprise a shape-memory alloy or other material that expands or changes configuration after implantation, which may lead to a thorough integration of the implant into the bone and/or help restore the height of the damaged vertebral body.
  • a bone cement e.g., PMMA or tricalcium phosphate
  • bone chips e.g., demineralized bone, or other filler material may be added to aid in stabilizing the bone and securing the implant in place within the bone.
  • the stents or other expandable implants may be comprised of any biocompatible material having desired characteristics, for example a shape memory alloy (e.g., nitinol or other nickel-titanium alloy, copper-based alloys, iron-based alloys, etc.), titanium, stainless steel, a biocompatible polymer, another metal or metal alloy, a ceramic, a composite or any combination thereof.
  • the other implant may have any desired configuration to facilitate expansion, to resist contraction, and/or to impart a desired force on a structure during or after expansion.
  • One or more expandable implants may be individually inserted into a bone, or may be joined or linked coaxially, in parallel, or in series to form a structure having desired characteristics.
  • die stents or other expandable implants may be resorbable.
  • the stents preferably should be constraint, particularly semi-constraint, in order to expand the stent where the stent should be deformed.
  • a method of treating bone may include inserting inside a fractured or osteoporotic bone, for example a vertebrae, two or more coaxial stents that cooperate to augment a vertebral body.
  • a bone cement or other filler may be added with or without the implanted devices to aid in stabilizing the bone and securing the implants in place within the bone.
  • bone grafting material such as bone chips or demineralized bone may be added within the bone, and about the stent a plug of bone cement may be used to fix the stent hi the vertebrae, m some embodiments, one or more additional implants may be used in combination with a stent, e.g., an expandable plug, an expandable bobbin, an expandable sheet metal implant, a chain, a pedicle screw, and the like, for example to expand the stent and/or provide additional augmentation.
  • a stent e.g., an expandable plug, an expandable bobbin, an expandable sheet metal implant, a chain, a pedicle screw, and the like, for example to expand the stent and/or provide additional augmentation.
  • an apparatus for osteopathic augmentation includes a first expandable implant having a first configuration and a second configuration, the expandable implant capable of undergoing plastic deformation in its second
  • the expansion device and the implant are configured and dimensioned for insertion into a region of bone through a cannula, where the implant is capable of sustaining between about 5 N and 300 N force applied to its perimeter.
  • a method of augmenting a vertebral body includes providing a balloon catheter having a shaft with a lumen and a balloon portion ⁇ peratively associated with the lumen, providing an expandable implant having a first implantable size and configuration capable of undergoing plastic deformation to a second expandable size larger than the implantable size and an expandable configuration different than the implantable configuration, the expandable implant mounted on the balloon portion of the balloon catheter, and inserting the balloon catheter with implant mounted thereon into the interior of a vertebral body so that the balloon portion and implant at least partially resides within the vertebral body.
  • the method further includes expanding the balloon portion of the balloon catheter to change the implant to its expandable size and configuration, and removing at least the balloon shaft from the vertebral body.
  • kits may comprise various combinations of components according to the present invention.
  • a kit may include, for example, a cannula and one or more expandable implants.
  • a kit may additionally include one or more balloons or other expandable members for imparting an expansion force to the one or more implants.
  • a kit may additionally include a syringe or other apparatus for injecting a cement or other filler into a vertebral body.
  • one or more other implants or devices may be included in a kit.
  • FIG. 1 is an illustration of a spine having a vertical compression fracture in one vertebral body
  • FIGS. 2A-D are illustrations of a prior art method for treating a vertical compression fracture
  • FIG. 3 is an illustration depicting a prior art method of stenting a vertebral body
  • FIG. 4 is a perspective view of an expandable implant according to an embodiment of the present invention.
  • FIG. 5 is a side view of the implant of FIG. 4, along with balloon device for expanding the implant;
  • FIG. 6 is a cross-sectional side view of a vertebra depicting a method of inserting a cannula through the pedicle of the vertebra;
  • FIG. 7 is a cross-sectional side view of the vertebra of FIG. 6, showing a balloon-tipped catheter carrying an expandable implant that is inserted through the cannula and into the vertebral body;
  • FIG. 8 is a cross-sectional side view of the vertebra of FIG. 6, showing a balloon and implant inserted over a guide wire;
  • FIG. 9A is a cross-sectional top view of a vertebra having implants inserted bilaterally into a vertebral body
  • FIG. 9B is another cross-sectional top view of a vertebra having one or more implants inserted over a guide wire within the vertebral body;
  • FIG. 10 is a cross-sectional side view of the vertebra of FIG. 7, with the balloon inflated to expand the implant;
  • FIG. 11 is a cross-sectional side view of the vertebra of FIG. 10, showing the expanded implant within the vertebral body and the balloon removed;
  • FIG. 12 is a cross-sectional side view of the vertebra of FIG. 11, showing insertion of a balloon carrying a second implant;
  • FIG. 13 is a cross-sectional side view of the vertebra of FIG. 12, showing inflation of the balloon carrying the second implant;
  • FIG. 14 is a cross-sectional side view of the vertebra of FIG. 13, showing removal of the balloon;
  • FIG. 15 is a cross-sectional side view of the vertebra of FIG. 14, showing insertion of a third implant inside of the expanded second implant;
  • FIG. 16A-C are cross-sectional side view of a vertebra, showing insertion of bone cement prior to insertion of an expandable implant;
  • FIG. 17 is a cross-sectional side view of a vertebra showing a catheter having a lumen for injection of bone cement along with a balloon-implant;
  • FIG. 18 is a cross-sectional side view of a vertebra having an expanded implant and bone cement being inserted after removal of the balloon;
  • FIG. 19 is a cross-sectional side view of a vertebral showing a balloon filled with cement inside of an expanded implant
  • FIGS. 2OA and B are side view illustrations of an embodiment of an expandable implant before and after expansion, respectively;
  • FIG. 21 is a side view of another embodiment of an expandable implant
  • FIG. 22 is a side view of another embodiment of an expandable implant
  • FIGS. 23 A and B are perspective views of an embodiment of an expandable sheet implant before expansion (left) and after expansion (right);
  • FIG. 24 and B are cross-sectional end view of an implant assembly before and after expansion, respectively;
  • FIG. 25-C are cross-sectional end views of another embodiment of an implant assembly
  • FIG. 26 is an end view of a ratchet mechanism of another embodiment of an implant assembly
  • FIG. 27 is a side view of helical shaped implants according to another embodiment of the invention.
  • FIG. 28 is a cross-sectional side view of the helical implants of FIG. 27 inserted into a vertebral body
  • FIG. 29 A is a side view of two helical implants having converse windings
  • FIG. 29B is a side view of the helical implants of FIG. 29A joined together;
  • FIGS. 30A-D are side views of implant assemblies incorporating expandable plugs for expanding the outer implants
  • FIGS. 3 IA-C are cross-sectional side views showing use of another embodiment of an expandable implant assembly
  • FIG. 32 is a cross-sectional side view of a another embodiment of an expandable implant assembly within a vertebral body.
  • FIGS. 33 A and B are perspective views of an expandable implant before
  • FIG. 4 shows a three dimensional view of an expandable implant 100 in an unexpanded state.
  • Such an implant 100 may be inserted into a vertebral body (not shown) or other bone to repair damage to the bone, e.g., a spinal compression fracture.
  • the lordosis of the spine is reconstructed using a balloon catheter (e.g., such as described above for kyphoplasty) that carries one or more expandable implants that remain inside of the vertebral body and prevents the loss of reposition after removal of the balloon catheter or other device used for expanding the implant.
  • the implants are preferably expandable and resist collapsing forces, preferably forces, for example, between about 5N and about 300N. In some
  • the implants may have the form of a tube and may comprise one or more parts. Several implants may be inserted into each other to achieve a stable construct that can hold the interoperative compression forces acting on the vertebral body.
  • the implants may be made out of a biocompatible shape memory alloy, stainless steel, cobalt chromium alloy, titanium or alloy thereof, a polymer, tricalcium phosphate, or any other material having desired characteristics.
  • the implant may be covered or coated, for example with a biodegradable polymer.
  • implants may expand when heated to a temperature over an actuation temperature, for example as the shape memory alloy undergoes a phase transformation between a Martensite state (e.g., at a low temperature) state and an Austensite state (e.g., at a higher temperature).
  • the actuation temperature of shape-memory alloy fibers within the implant may preferably be, for example, between about 28 0 C and about 36 C C.
  • an implant mass may expand, contract, or otherwise change shape or configuration when it is activated by an energy source (e.g., an ultraviolet light, ultrasonic radiation, radio waves, heat, electric filed, or magnetic field).
  • An unexpended implant may have any desired diameter that preferably fits through a lumen of a cannula and into a vertebral body.
  • the diameter of an implant 100 of FIG. 4 before insertion may be between about 2 mm and 10 mm.
  • the diameter of implant 100 may be between about 15 mm and 25 mm.
  • other sizes may be used without departing from the scope of the invention.
  • FIGS. 5 to 15 depict a method of using an expandable implant 100 to reposition and augment a collapsed vertebral body 10, for example to reposition the endplates of the vertebral body 10 and to hold the reposition after reconstruction of spinal lordosis.
  • the method and implants may be used to reposition and augment other bones.
  • FIG. 5 shows an expandable implant dimensioned to fit around a balloon catheter assembly 200 or other device, also referred to herein as an "expansion device” for imparting an expansion force to the implant.
  • the balloon catheter assembly 200 may comprise a balloon 210 and a catheter shaft 220 connected to one end of the balloon 210.
  • Implant 100 disposed on a balloon 210 or other expansion device is referred to herein as a balloon-implant assembly 300.
  • the implant 100, or a portion thereof, may in some embodiments be similar to a "stent" used to maintain patentcy of vessels during an angioplasty procedure.
  • the stent, balloon, balloon-stent assembly, and/or balloon-catheter assembly may be coated with an adhesive, antibiotics, osteoinductive material, or osteoconductive material.
  • an energy source e.g., heat, ultraviolet light, ultrasonic radiation, radio waves, electricity, magnetic field, etc.
  • the balloon 210 used as the expansion mechanism to expand the implant from its first insertion size to its second expanded size preferably is at least semi- constraint so that the balloon 210 can exert sufficient force on the areas of the implant desired to be expanded.
  • the balloon 210 or expansion device is not compliant (not elastic) or semi-compliant like some balloon catheters on the market such as the balloon used in kyphoplasty where due to stent resistance it is believed the balloon would expand around the implant without providing necessary force to expand the stent.
  • the balloon may expand anteriorly and posteriorly of the stent, and may even explode if the stent ends cut into the balloon.
  • the balloon be relatively inelastic so the force from the balloon can be directed to desirable areas of the stent.
  • a relatively elastic balloon utilized with an outer jacket to restrain the elastic expansion may suffice as an expansion device.
  • the expandable stent is preferably undergoes plastic deformation when it expands to its second size so that when the balloon is deflated it returns its first insertion size, or thereabouts, allowing the user to remove the balloon, if necessary, leaving the expanded implant within the vertebral body.
  • FIG. 6 shows an access hole 11 drilled through a vertebral body 10 in a transpedicular approach.
  • Such an access hole 11 may be formed through the outer cortical bone of the vertebra 10 by a drill, trocar, or other instrument (not shown).
  • a cannula 20 may be inserted into each access hole 11 in order to provide passage of expandable implant 100.
  • FIG. 7 shows a balloon catheter assembly 200 introduced by a single or bilateral transpedicular approach, with an expandable implant 100 disposed over the expandable balloon tip 211 of the catheter shaft 220.
  • the insertion of the catheter 220 may take place with a guiding device 30, e.g., a guide wire as shown in FIGS. 8 and 9B.
  • the guiding device 30 may be used to position the implant 100 in a desired location or orientation within the vertebral body 10.
  • FIGS. 9 A and 9B show different possible positions of the balloon-implant assembly 300 (stent device). Both a cannula and a guide wire may be used together, or separately, to guide the balloon-implant assembly 300. Alternatively, neither the cannula or guide wire may be used to position the implant, rather the balloon-implant assembly 300 may be inserted down the passage way formed in the bone by a physician manipulating the catheter shaft 220 from outside the patient.
  • FIG. 10 depicts an exemplary method of repositioning and augmenting a vertebral body 10 using an expandable implant 100 by inflating the balloon 210 (e.g., witfi a radiolucent fluid), which imparts a radial force on the surrounding implant 100, thereby expanding the implant 100 to fill the space within the vertebral body 10 and restore the height of the vertebral body 10.
  • the balloon 210 e.g., witfi a radiolucent fluid
  • the balloon 210 may be deflated and removed from the cannula 20, as shown for example in FIG. 11.
  • the implant 100 is preferably configured to maintain its expanded dimension and to maintain the height of the vertebral body 10 even after the balloon 210 is removed.
  • the balloon 210 and implant may detach from the catheter shaft 220 so that the balloon-implant assembly 300 remains in the bone.
  • the interior expansion device may be removed as shown in FIG. 14.
  • FIG. 14 the interior expansion device may be removed as shown in FIG. 14.
  • FIG. 15 depicts the insertion of a third balloon-implant assembly 300" (comprising balloon catheter assembly 200" which includes catheter shaft 220", and implant lOOC) coaxially arranged with the first and second implants. Any desired number of implants may be inserted within the first implant.
  • Bone cement, bone chips, or other filler 60 may be added to further augment a vertebral body 10, and to lock the one or more implants (stents) into place.
  • the filler 60 may further comprise antibiotics, bone morphogenic protein (BMP), growth hormones, etc. Such bone cement or other filler 60 could be put into the vertebral body 10 before, during or after insertion of the implant.
  • BMP bone morphogenic protein
  • the cement or other filler 60 may be inserted into the vertebral body 10 before insertion of the implant or expansion of the implant, as shown in FIG. 16 A, for example.
  • FIG. 16B depicts an expanded balloon-implant assembly 300 in the vertebral body 10 such that the cement or other filler 60 is dispersed around the balloon 210 and the implant.
  • FIG. 16C depicts the cement or other filler 60 dispersed around the expanded implant 100 after the balloon 210 has been removed.
  • bone cement or other filler 60 may be injected into the interior of the implant after its expansion and removal of the balloon catheter assembly. Li other embodiments, bone cement or other filler 60 may be injected into the vertebral space during expansion of the implant.
  • bone cement or other filler 60 may be injected into the balloon catheter assembly 200 to expand the balloon and consequently the implant.
  • the catheter shaft 220 may thereafter be detached from the balloon and the balloon filed with filler as well as the expanded implant may remain in the bone.
  • the passage way 225 of the catheter shaft 220 may be used to inject additional filler 60 or different filler 60' in the bone, and to surround or assist in stabilizing the expanded implant.
  • a catheter may have multiple lumens, for example two lumens 221, 222 shown in FIG. 17, may be used to provide access to the vertebral body 10 and to provide a passage for injecting other materials into the bone.
  • Bone cement or filler 60 may be inserted through lumen 221.
  • the material inserted through lumen 221 may contact the expandable implant, the exterior surface of the balloon 210 or both.
  • Material can be inserted through second lumen 222 before expansion of the balloon so that the material can be distributed within the bone void upon expansion of the balloon 210, the implant, or both.
  • a material such as a biocompatible polymer
  • a material can be inserted through lumen 221 into the bone void, or onto the exterior surface of the balloon 210, the implant 100 or both, and distributed in the bone void upon expansion of the balloon 210 to form an enclosure, or bag to prevent any balloon filler material from escaping the bone void.
  • the biocompatible polymer can act to seal the otherwise porous cancellous bone to prevent any leakage of the balloon filler material.
  • Cement or other filler 60 may also be inserted using, for example a syringe 40, after the removal of the balloon 210 (but with the implant remaining in the bone (FIG. 18)).
  • the balloon 210 may be filled directly with bone cement or another filler 60, as shown in FIG. 19.
  • such a balloon 210 may be expanded within the vertebral body 10 until the balloon 210 bursts.
  • the balloon 210 may be filled with and expanded by bone cement or other filler 60 and the expanded balloon 210 thereafter detached from the catheter shaft 220 so that it remains in the patient.
  • the balloon may be formed of a biosorbable material so that it will be absorbed by the body over time.
  • the balloon 210 may also be perforated with holes as described by Publication WO 03/099171 Al (PCT/EP03/05407) to Gr ⁇ nemeyer et al.
  • the balloon 210 may be filled with hardenable cement that will harden in situ. After the cement has hardened in the balloon 210, the balloon 210 may be detached from the catheter shaft 220.
  • FIGS. 2OA to 33 depict implants, or stents, with different configurations and/or patterns, including a continuous cylinder with perforations. It is important that an expanded implant resists the pressure exerted by the environment that is inserted. For example, if positioned within the vertebral body the expandable implant preferably is capable of withstanding the force that will b exerted on the vertebral body during a patient's routine activity following insertion of the implant. Preferably the implant will not shorten significantly after expansion (e.g., deviation between Ll-LO needs to be small).
  • FIGS. 20 to 22 show various mesh-like patterns that may be used by the expandable implants. In FIG. 2OA, the mesh-like pattern of an unexpanded implant may form angles ⁇ .
  • FIGS. 23A and B show an expandable implant formed of folded sheet metal for insertion.
  • FIG. 23A depicts the implant 400 before expansion and
  • FIG. 23B depicts the implant 400' after expansion.
  • a folded sheet metal insertion device is made from a shape memory alloy (e.g., nitinol).
  • FIGS. 24-26 show different principles of how the cross-section of the implants/stents (100' and 100") may be configured to wedge the implants into each other.
  • implant A, the inner implant, and B, the outer implant may be shaped like a cone, with a serrated (teethed) surface.
  • the outer diameter may be expanded from “hi” to "h3”. Due to the serrated surface, B, the outer implant keeps the expanded shape.
  • the one or more implants may have a helical configuration.
  • Several helical implants may be screwed into each other, such that a stable implant is achieved.
  • FIGS. 27 and 28 depict helical implants having coils in the same direction.
  • FIGS 29A and B show helical implants having coils in different directions. Regardless of the direction of the coils, the helical implants are configured to screw into each other, thereby strengthening the implant.
  • FIGS. 30-33 show alternatives to a balloon 210 for providing the expansion force to expand an implant 100.
  • FIGS. 30A-D show another embodiment of an implant 110, which uses an expandable plug 50 instead of a balloon 210 to expand the implant 110.
  • the plug 50 may consist of a expansion mechanism 51 such as a screw (FIGS 30A and C) or a L-handle (FIGS. 30B and D).
  • a expansion mechanism 51 such as a screw (FIGS 30A and C) or a L-handle (FIGS. 30B and D).
  • Other expansion mechanism 51 such as a screw (FIGS 30A and C) or a L-handle (FIGS. 30B and D).
  • the plug 50 may also have a distal end 52, a proximal end 53 and a plurality of expansion supports 54 connecting the distal end 52 with the proximal end 53.
  • the expansion mechanism 51 is threaded onto both the distal end 52 and proximal end 53 such that as a user rotates the expandion mechanism 51, the distal end 52 moves towards the proximal end 53 causing the plurality of expansion supports 54 to expand outward thereby expanding implant 110.
  • the user continues rotating the expansion mechanism 51 until the implant 110 reaches its desired diameter.
  • the implant 110 and plug 50 may be inserted into the vertebral body (not shown) in the unexpanded state as illustrated in FIGS. 3OA and B.
  • die implant 110 can be expanded as shown by FIGS. 30C and D by turning the expansion mechanism 51, (e.g., for example the screw) of the plug 50.
  • the plug 50 may be removed. In other embodiments, the plug 50 may be left in the bone.
  • FIGS. 31A-C show another mechanism for expanding the implant.
  • the implant may be expanded using a jack mechanism 70, for example working in a manner similar to a car jack.
  • an implant assembly 500 may be inserted into the vertebral body 10 through a cannula 20.
  • the implant assembly may consist of an implant 120 and the jack mechanism 70.
  • the jack mechanism 70 may consist of a plurality of expansion members 71, preferably at least two expansion members 71, a plurality of diagonal braces 72, and a drive mechanism 73. Operation of the drive mechanism 73 causes the plurality of diagonal braces 72 to extend outward from the drive mechanism 73 pushing the plurality of expansion members 71 similarly outward from the drive mechanism 73.
  • the outward movement of the expansion members 71 causes the implant 120 to expand (FIG. 31B) until the desired diameter of the implant 120 is achieved. After the implant 120 is expanded to the desired diameter, the drive mechanism is removed leaving the expansion members 71 and diagonal braces 72 (FIG. 31C).
  • FIG. 32 shows the use of a bobbin complex 80 for expanding the implant
  • FIG. 33 shows a method of expanding implant 140 using a sheet metal coil 90, for example as described also in U.S. Patent Application No. 11/471,169.
  • one or more implants comprising expandable stents may be used to reposition and/or augment other damaged bone regions such as a fractured or weak proximal femur.
  • one or more implants may be inserted into a head of a femur, e.g., through a cannula or other introducer, or for tibia plateau fracture repositioning.
  • the implants may expand and compact material within the head of the femur and provide solid support to augment the head.
  • the implant may comprise a shape memory alloy and expand or otherwise change its configuration after insertion (e.g., after heating to a temperature above an activation temperature).
  • a bone cement or other filler may also be used to aid augmentation.
  • another implant such as a screw or other device may be inserted in addition to or instead of one or more implants.
  • the implants and methods described herein may be used in conjunction with other apparatus and methods to restore lordosis and augment a vertebral body.
  • one or more expandable implants may be used in conjunction with known procedures, e.g., a balloon, kyphoplasty, which may be used to begin repositioning of a vertebral body and/or create a space within the body for the implant.
  • one or more implants described herein may be used in conjunction with other tools or devices, e.g., an external fixation apparatus for helping to manipulate or fix the vertebrae or other bones in a desired position.
  • kits may comprise various combinations of components according to the present invention.
  • a kit may include, for example, a cannula and one or more expandable implants.
  • a kit may additionally include one or more balloons, balloon catheters or other expandable members for imparting an expansion force to the one or more implants.
  • a kit may additionally include a syringe or other apparatus for injecting a cement or other filler into a vertebral body, or into the balloon or balloon catheter.
  • one or more other implants or devices may be included in a kit.
  • One skilled in the art will appreciate that various other combinations of devices, components and assemblies can be made and are intended to fall within the scope of the present invention.
  • various minimally invasive implants and methods for alleviating discomfort associated with die spinal column may employ an expandable implant having one or more of the features described herein.
  • an expandable implant having one or more of the features described herein.
  • expandable implant or other implant comprising a shape-memory alloy may be implanted between spinous processes of adjacent vertebrae, and the implant may be expanded or otherwise altered in its configuration to distract the spinal processes and alleviate pain and other problems caused for example by spinal stenosis, facet arthropathy, and the like.
  • augmentation systems described herein may be used instead of or in addition to expandable interspinous process apparatus and methods described in U.S. Patent Publication number 2004/018128 and U.S. Patent Application 6,419,676 to Zuche ⁇ nan et al.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Neurology (AREA)
  • Pathology (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

L’invention concerne des implants et des méthodes pour augmenter et repositionner des vertèbres de manière très peu invasive pouvant comprendre un ou plusieurs membres extensibles, par exemple, des stents, des implants, entourant un cathéter avec embout à ballon ou autre appareil d'expansion inséré dans un corps vertébral ou une autre structure osseuse. Une expansion dudit membre extensible dans le corps vertébral ou autre structure osseuse permet de repositionner l'os fracturé à une hauteur désirée et d'augmenter l'os pour maintenir la hauteur désirée. Un ciment osseux, ou autre matière de remplissage, peut être ajouté pour augmenter et stabiliser davantage le corps vertébral ou autre structure osseuse.
EP06839198A 2005-12-08 2006-12-08 Appareil et méthodes pour traiter un tissu osseux Withdrawn EP1956990A2 (fr)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US74837705P 2005-12-08 2005-12-08
US75378205P 2005-12-23 2005-12-23
US78995606P 2006-04-05 2006-04-05
US11/471,169 US8080061B2 (en) 2005-06-20 2006-06-19 Apparatus and methods for treating bone
US11/523,202 US20070093822A1 (en) 2005-09-28 2006-09-18 Apparatus and methods for vertebral augmentation using linked expandable bodies
US11/527,280 US20070093899A1 (en) 2005-09-28 2006-09-25 Apparatus and methods for treating bone
US11/546,579 US8157806B2 (en) 2005-10-12 2006-10-10 Apparatus and methods for vertebral augmentation
PCT/US2006/046822 WO2007067726A2 (fr) 2005-12-08 2006-12-08 Appareil et méthodes pour traiter un tissu osseux

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EP1956990A2 true EP1956990A2 (fr) 2008-08-20

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JP (1) JP2009518137A (fr)
KR (1) KR20080081911A (fr)
AU (1) AU2006321837A1 (fr)
BR (1) BRPI0619585A2 (fr)
CA (1) CA2632680A1 (fr)
TW (1) TW200727854A (fr)
WO (1) WO2007067726A2 (fr)

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TW200727854A (en) 2007-08-01
WO2007067726A2 (fr) 2007-06-14
BRPI0619585A2 (pt) 2019-09-24
KR20080081911A (ko) 2008-09-10
JP2009518137A (ja) 2009-05-07
CA2632680A1 (fr) 2007-06-14
AU2006321837A1 (en) 2007-06-14
WO2007067726A3 (fr) 2007-10-18

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