WO2023114718A2 - Cage de fusion vertébrale souple extensible - Google Patents

Cage de fusion vertébrale souple extensible Download PDF

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Publication number
WO2023114718A2
WO2023114718A2 PCT/US2022/081366 US2022081366W WO2023114718A2 WO 2023114718 A2 WO2023114718 A2 WO 2023114718A2 US 2022081366 W US2022081366 W US 2022081366W WO 2023114718 A2 WO2023114718 A2 WO 2023114718A2
Authority
WO
WIPO (PCT)
Prior art keywords
support segments
implantable device
support
end portion
segments
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.)
Ceased
Application number
PCT/US2022/081366
Other languages
English (en)
Other versions
WO2023114718A3 (fr
Inventor
Daniel Orr
Ronald Alek SPERRY
James Anderson
Christian Payne
Brandon SARGENT
Anton E. Bowden
Larry Howell
Michael Bruce FRANKEL
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.)
Brigham Young University
Original Assignee
Brigham Young University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Brigham Young University filed Critical Brigham Young University
Priority to US18/870,043 priority Critical patent/US20250331996A1/en
Publication of WO2023114718A2 publication Critical patent/WO2023114718A2/fr
Publication of WO2023114718A3 publication Critical patent/WO2023114718A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/447—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2/4603—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30405—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by screwing complementary threads machined on the parts themselves
    • A61F2002/30411—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by screwing complementary threads machined on the parts themselves having two threaded end parts connected by a threaded central part with opposite threads at its opposite ends, i.e. for adjusting the distance between both end parts by rotating the central part
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30462—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements retained or tied with a rope, string, thread, wire or cable
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30471—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30476—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/30507—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism using a threaded locking member, e.g. a locking screw or a set screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30518—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements with possibility of relative movement between the prosthetic parts
    • A61F2002/3052—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements with possibility of relative movement between the prosthetic parts unrestrained in only one direction, e.g. moving unidirectionally
    • A61F2002/30522—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements with possibility of relative movement between the prosthetic parts unrestrained in only one direction, e.g. moving unidirectionally releasable, e.g. using a releasable ratchet
    • 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
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    • 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
    • A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
    • 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
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    • 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
    • A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
    • A61F2002/30538—Special structural features of bone or joint prostheses not otherwise provided for adjustable for adjusting angular orientation
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
    • A61F2002/30553—Special structural features of bone or joint prostheses not otherwise provided for adjustable for adjusting a position by translation along an axis
    • A61F2002/30555—Special structural features of bone or joint prostheses not otherwise provided for adjustable for adjusting a position by translation along an axis along two perpendicular axes
    • 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
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    • 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
    • A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
    • A61F2002/30556—Special structural features of bone or joint prostheses not otherwise provided for adjustable for adjusting thickness
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/4415—Joints for the spine, e.g. vertebrae, spinal discs elements of the prosthesis being arranged in a chain like manner
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/4625—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4627—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument

Definitions

  • This description relates, in general, to expandable compliant devices that can be stowed in a compact state and expanded to a larger state, and in particular, to implantable medical devices and equipment that can be stowed in a compact state for placement, and expanded to a larger state.
  • Devices and structures that can be stowed in a compact state and deployed to a larger, expanded state may be desirable in many applications.
  • One area of application of these types of devices is medical equipment. Decreases in the insertion size and/or volume of an implantable device may decrease an incision size for implanting of the device, thus decreasing surgical risk, susceptibility to infection and the like.
  • an implantable device includes a cage portion including a plurality of first support segments, and a plurality of first compliant connectors connecting adjacent first support segments of the plurality of first support segments; an insert portion insertable into an interior space defined by the cage portion; and an actuation device configured to actuate the insert portion, wherein the plurality of first support segments are moved so as to change a configuration of the cage portion in response to actuation of the insert portion.
  • the insert portion includes a plurality of second support segments; and a plurality of second compliant connectors connecting adjacent second support segments of the plurality of second support segments.
  • the plurality of first support segments are arranged substantially symmetrically with respect to a central longitudinal axis of the cage portion, the plurality of first support segments are arranged substantially in parallel with respect to the central longitudinal axis of the cage portion in a stowed state of the implantable device, and the plurality of first support segments move radially outward with respect to the central longitudinal axis of the cage portion in response to actuation of the insert portion inserted into the interior space defined in the cage portion.
  • the actuation device includes a wedge portion positioned at a first end portion of the plurality of second support segments; and a threaded rod having a first end portion thereof threadably engaged with the wedge portion.
  • the wedge portion includes a body portion; and a plurality of protrusions extending outward from the body portion, and the plurality of second support segments include a plurality of guide grooves formed in an inner surface thereof, at positions corresponding to the plurality of protrusions, wherein the plurality of protrusions are configured to be respectively received in the plurality of guide grooves so as to guide movement of the wedge portion along the threaded rod.
  • the wedge portion moves on the threaded rod, from the first end portion of the threaded rod toward a second end portion of the threaded rod, and into an interior space defined by the plurality of second support segments of the insert portion; and the plurality of second support segments move outward relative to a central longitudinal axis of the implantable device in response to movement of the wedge portion into the interior space defined by the plurality of second support segments.
  • the plurality of first support segments and the plurality of second support segments move outward relative to the central longitudinal axis to laterally expand the implantable device; and in response to continued rotation of the threaded rod in the first direction, the plurality of first support segments the plurality of second support segments move outward relative to the central longitudinal axis to vertically expand the implantable device.
  • the plurality of first support segments of the cage portion move outward relative to the central longitudinal axis of the implantable device in response to the outward movement of the plurality of second support segments of the insert portion.
  • an amount of expansion of the implantable device at the first end portion of the plurality of first support segments of the cage portion is greater than an amount of expansion of the implantable device at a second end portion of the plurality of first support segments of the cage portion.
  • an amount of expansion of the implantable device is variable based on a position of the wedge portion on the threaded rod.
  • the plurality of second support segments are movable relative to each other, and the plurality of first support segments are movable relative to each other in response to movement of the plurality of second support segments, to provide varying amounts of expansion of the implantable device.
  • the implantable device is expandable between a fully stowed state and a fully expanded state, and wherein the implantable device is expandable to a plurality of intermediate states between the fully stowed state and the fully expanded state.
  • the implantable device includes an engagement mechanism that selectively engages at least one of the plurality of second support segments with at least one of the plurality of first support segments, the engagement mechanism including a plurality of first detents formed on a mating surface of the at least one of the plurality of first support segments; and a plurality of second detents formed on a mating surface of the at least one of the plurality of second support segments, wherein the plurality of first detents and the plurality of second detents are releasably engageable to maintain a relative position of the at least one of the plurality of first support segments and the at least one of the plurality of second support segments.
  • the plurality of second support segments move apart in response to actuation of the insert portion, and the plurality of first support members move apart in response to the movement of the plurality of second support segments, to expand the implantable device including the insert portion and the cage portion; and in a second mode, in which the insert portion forms the implantable device, the plurality of second support segments move apart in response to actuation of the insert portion, to expand the implantable device including the insert portion.
  • At least one of the plurality of first compliant connectors is a Deployable Euler Spiral Connector (DESC), and at least one of the plurality of second compliant connectors is a DESC.
  • DESC Deployable Euler Spiral Connector
  • At least one slot is formed in at least one of the plurality of first compliant connectors connecting adjacent first support segments of the cage portion.
  • texturing is formed on one or more surfaces of one or more of the plurality of first support segments of the cage portion.
  • an implantable device in another general aspect, includes a plurality of support segments, wherein the plurality of support segments are movable relative to each other, between a stowed configuration and a deployed configuration of the implantable device; a plurality of compliant connectors connecting adjacent support segments of the plurality of support segments, wherein, in the stowed configuration, strain energy is stored in the plurality of compliant connectors; and an actuation device coupled to at least two support segments of the plurality of support segments, wherein the plurality of support segments are configured to move in a first direction in response to release of a holding force that releases the strain energy stored in the plurality of compliant connectors in the stowed configuration of the implantable device, and wherein the plurality of support segments are configured to move in a second direction, toward the deployed configuration, in response to actuation of the actuation device.
  • the first direction is a lateral direction in which the plurality of support segments move apart from each other in the lateral direction relative to a central longitudinal axis of the implantable device, from the stowed configuration to an intermediate configuration between a fully stowed configuration and a fully deployed configuration
  • the second direction is a vertical direction in which the plurality of support segments move apart from each other in the vertical direction relative to the central longitudinal axis of the implantable device from the intermediate configuration toward the fully deployed configuration.
  • the actuation device includes a rod, including a first end portion pivotably coupled in a first channel formed in a first support segment of the plurality of support segments; and a second end portion movably positioned in a second channel formed in a second support segment of the plurality of support segments, and configured to selectively engage a plurality of teeth formed in the second channel; and an actuation mechanism coupled to the second end portion of the rod, wherein the second end portion of the rod is configured to move in the second channel and selectively engage a plurality of teeth formed in the second channel in response to an external force applied to the actuation mechanism that moves the second end portion of the rod in the second channel, the first end portion of the rod is configured to pivot in response to the movement of the second end portion of the rod in the second channel, and the first support segment and the second support segment are configured to move apart in response to the movement of the second end portion of the rod in the second channel and the pivoting of the first end portion of the rod in the first channel.
  • the actuation device includes a hinge, including a first arm having a first end portion pivotably coupled to a first support segment of the plurality of support segments; a second arm having a first end portion pivotably coupled to a second support segment of the plurality of support segments, and a pivot portion pivotably coupling a second end portion of the first arm and a second end portion of the second arm; and an actuation mechanism coupled to the pivot portion, wherein, in response to an external force applied to the actuation mechanism that moves the pivot portion from a first vertical position to a second vertical position between the first support segment and the second support segment, the first pivot arm pivots in a first direction relative to the firs support segment; the second pivot arm pivots in a second direction relative to the second support segment; and the first support segment and the second support segment move apart in response to the pivoting of the first pivot arm in the first direction and the pivoting of the second pivot arm in the second direction.
  • the actuation device includes a hinge, including a first arm having a first end portion pivotably coupled to a first support segment and a second support segment of the plurality of support segments; a second arm having a first end portion pivotably coupled to a third support segment and a fourth support segment of the plurality of support segments; and a pivot portion pivotably coupling a second end portion of the first arm and a second end portion of the second arm; and an actuation mechanism coupled to the pivot portion, wherein, in response to an external force applied to the actuation mechanism that moves the pivot portion from a first end portion of the plurality of support segments to an intermediate portion of the plurality of support segments, between the first end portion and a second end portion thereof, the first pivot arm moves in a first channel formed in the first support segment and a second channel formed in the second support segment, from the first end portion to the intermediate portion of the plurality of support segments; the second pivot arm moves in a third channel formed in the third support segment and a fourth channel formed in the
  • the actuation device includes a threaded rod positioned between a first support segment and a second support segment of the plurality of support segments; a first shim threadably coupled on a first portion of the threaded rod, the first shim contacting a first inclined surface of one of the first support segment or the second support segment; and a second shim threadably coupled on a second portion of the threaded rod, the first shim contacting a second inclined surface of one of the first support segment or the second support segment, wherein, in response to rotation of the threaded rod, the first shim moves in a first direction along the first portion of the threaded rod, and in the first direction along the first inclined surface; the second shim moves in a second direction along the second portion of the threaded rod, and in the second direction along the second inclined surface; and the first support segment and the second support segment move apart in response to the movement of the first shim along the first inclined surface and the movement of the second shim along the
  • FIG. 1 A is a side view
  • FIG. IB is a perspective view, of an example expandable implantable device in a de-coupled state.
  • FIG. 1C is a side view of an example insert portion coupled in an example cage portion of the example expandable implantable device shown in FIGs. 1 A and IB, in a stowed state.
  • FIG. 1D(1) is a first axial end view
  • FIG. 1D(2) is a second axial end view, of the stowed state of the example expandable implantable device shown in FIGs. 1A-1C.
  • FIG. IE is a perspective view of the expandable implantable device shown in FIGs. 1 A-1D(2), illustrating lateral expansion of the example expandable implantable device.
  • FIG. 1F( 1 ) is a perspective view
  • FIG. 1F(2) is a side view, of the example expandable implantable device shown in FIGs. 1A-1D(2), illustrating an expanded state of the example expandable implantable device.
  • FIG. 2A is a perspective view, of an example cage portion of the example expandable implantable device shown in FIGs. 1A-1F(2).
  • FIG. 2B is a side view
  • FIG. 2C is an axial end view, of the example cage portion shown in FIG. 2A.
  • FIG. 3 A is a perspective view of an example insert portion of the example expandable implantable device shown in FIGs. 1 A-1F(2).
  • FIG. 3B is a side view
  • FIG. 3C is an axial end view, of the example insert portion shown in FIG. 3 A.
  • FIG. 3D(1) is a plan view of a first side portion of a first configuration of an example wedge portion of the example insert portion shown in FIGs. 3A-3C, inserted into the example insert portion.
  • FIG. 3D(2) is a perspective view of a second side portion of the example wedge portion shown in FIG. 3D(1).
  • FIG. 3D(3) illustrates an example nut cap that can be selectively coupled to the example insert portion shown in FIG. 3D(1).
  • FIG. 3E(1) is a plan view of a first side portion of a second configuration of an example wedge portion of the example insert portion shown in FIGs. 3A-3C, inserted into the example insert portion.
  • FIG. 3E(2) is a perspective view of a second side portion of the example wedge portion shown in FIG. 3E(1).
  • FIG. 3E(3) illustrates an example nut cap that can be selectively coupled to the example insert portion shown in FIG. 3E(1).
  • FIG. 3F is a side view of the example insert portion in a stowed state.
  • FIG. 3G is a perspective view of the example insert portion in an expanded state.
  • FIG. 4A is a cross-sectional view taken along line D-D of FIG. 1D(2).
  • FIG. 4B is a cross-sectional view taken along line E-E of FIG. 1D(2).
  • FIG. 5 illustrates an example instrument that is couplable with an expandable implantable device.
  • FIGs. 6A-6E illustrate an example expandable implantable device.
  • FIGs. 7A-7D illustrate an example expandable implantable device.
  • FIGs. 8A-8D illustrate an example expandable implantable device.
  • FIGs. 9A-9D illustrate an example expandable implantable device.
  • FIGs. 10A-10H illustrate concepts related to expandable implantable devices.
  • MIS Minimally invasive surgery
  • mini-open approaches to tubular procedures
  • endoscopic procedures there remains an unmet need for increasingly smaller interbody fusion devices that can be deployed in both the vertical direction and the horizontal direction.
  • Existing spinal fusion cages that fit through a typical surgical approach window may not cover sufficient lateral area to prevent subsidence.
  • a typical surgical approach window may be approximately 7mm by approximately 9mm. In some situations, the surgical approach window may be somewhat larger than 7mm by 9mm, or somewhat smaller than 7mm by 9mm, or differently proportioned.
  • compliant mechanisms may facilitate the design of devices that can achieve two or more states, including, for example, deployment from a relatively compact stowed state and a relatively larger expanded state.
  • Some forms of compliant mechanisms can sustain relatively large deflections and store strain energy which can be applied for actuation of the device.
  • the strained shape of the compliant mechanisms may be determined at least in part by loads, boundary conditions, material properties, geometry, and other such factors.
  • a configuration (i.e., a shape, a size, and the like) of a device having a relatively compact stowed volume may take into consideration the use of compliant support segments, or compliant members, or compliant connectors, based on the principles of an Euler spiral defined by a curve that exhibits a linear change of curvature along its arc length, and that lie substantially flat when a force is applied at an end portion thereof.
  • Compliant support segments configured based on the Euler spiral may be used to connect rigid support segments such that the rigid support segments can be stowed in a relatively flat manner.
  • a functional prototype of the device was 3D printed from Ti6A14V using a laser-sintering process.
  • the device(s) can be made of titanium, polyetheretherketone (PEEK), a metal alloy, a plastic, and other such materials.
  • the functional prototype was inserted and deployed into sawbone models, and into a cadaveric lumbar spine, by a neurosurgeon, to perform initial deployment validation.
  • FIG. 1 A is a decoupled side view of an example cage portion 110 and an example insert portion 150 of the example expandable implantable device 100.
  • FIG. IB is a de-coupled perspective view of the example cage portion 110 and the example insert portion 150 of the example expandable implantable device 100.
  • FIG. 1C is a side view
  • FIG. 1D(1) is a first axial end view
  • FIG. 1D(2) is a second axial end view, illustrating the insert portion 150 coupled in the cage portion 110 of the example expandable implantable device 100.
  • FIG. 1D(1) is a first axial end view
  • FIG. 1D(2) is a second axial end view
  • FIG. 1 IE is a perspective view of the example expandable implantable device 100, illustrating lateral expansion of the example expandable implantable device 100.
  • FIG. 1F(1) is a perspective view
  • FIG. 1F(2) is a side view, of an expanded state of the example expandable implantable device 100.
  • the insert portion 150 can be used as an implantable device without the cage portion 110.
  • FIG. 2A is a perspective view
  • FIG. 2B is a side view
  • FIG. 2C is an isometric view, of the example cage portion 110 of the example expandable implantable device 100 shown in FIGs. 1 A-1F(2).
  • FIG. 3A is a perspective view
  • FIG. 3B is a side view
  • FIG. 3C is an axial end view, of the example insert portion 150 of the example expandable implantable device 100 shown in FIGs. 1 A-1F(2).
  • FIGs. 3D(1) and 3D(2) illustrate a first configuration of the example wedge portion 155 of the example insert portion 150.
  • FIG. 3D(3) illustrates an example nut cap that can be selectively coupled to the threaded rod 151 on which the example wedge portion 155 shown in FIG. 3D(1) is mounted.
  • FIGs. 3E(1) and 3E(2) illustrate a second configuration of the example wedge portion.
  • FIG. 3E(3) illustrates an example nut cap that can be selectively coupled to the threaded rod 151 on which the example wedge portion 155 A shown in FIG. 3E(1) is mounted.
  • FIG. 3F is a side view of the example insert portion 150 in a stowed state.
  • FIG. 3G is a perspective view of the example insert portion 150in an expanded state.
  • the cage portion 110 includes a plurality of support segments 112.
  • the plurality of support segments 112 may be substantially rigid support segments 112 so as to provide for the desired support in the implanted, deployed state of the expandable implantable device 100.
  • Each support segment 112 may be connected to at least one adjacent support segment 112 by at least one compliant connector 114.
  • the support segments 112 are substantially symmetrically arranged about a longitudinal central axis A. In the stowed state, the plurality of support segments 112 are arranged substantially in parallel with respect to the longitudinal central axis A.
  • the cage portion 110 includes four rigid support segments 112, simply for purposes of discussion and illustration.
  • the cage portion 110 can include more, or fewer, rigid support segments 112, arranged symmetrically or asymmetrically about the longitudinal central axis A.
  • the cage portion 110 can include more, or fewer, compliant connectors 114, arranged similarly to or differently from the arrangement shown in FIGs. 1A-1F(2) and 2A-2C.
  • the insert portion 150 includes a plurality of support segments 152, for example, substantially rigid support segments 152. Each support segment 152 may be connected to at least one adjacent support segment 152 by at least one compliant connector 154.
  • the support segments 112 are substantially symmetrically arranged about the longitudinal central axis A.
  • the insert portion 150 includes four rigid support segments 152, simply for purposes of discussion and illustration.
  • the insert portion 150 can include more, or fewer, rigid support segments 152, arranged symmetrically or asymmetrically about the longitudinal central axis A.
  • the insert portion 150 can include more, or fewer, compliant connectors 154, arranged similarly to or differently from the arrangement shown in FIGs. 1A- 1F(2) and 3A-3G.
  • a wedge portion 155 is positioned at a first end portion of the insert portion 150/first end portion of the plurality of support segments 152.
  • a threaded rod 151 may be positioned within the arrangement of support segments 152 defining the insert portion 150.
  • a first end portion 151 A of the threaded rod 151 may be engaged with an opening 153 in the wedge portion 155.
  • the opening 153 may be a threaded opening 153, such that the first end portion 151 A of the threaded rod 151 is threadably engaged with the wedge portion 155 via the opening 153.
  • a second end portion of the threaded rod 151 may be accessible at a second end portion of the insert portion 150/second end portion of the plurality of support segments 152.
  • the second end portion 15 IB of the threaded rod 151 may be accessible to a surgeon, for adjustment of an amount of expansion of the insert portion 150, and a corresponding amount of expansion of the cage portion 110.
  • the insert portion 150 has been inserted into the cage portion 110, for example in the direction of the arrow B shown in FIG. 1 A.
  • insertion of the insert portion 150 into the cage portion 110 may represent a first state of the expandable implantable device 100.
  • insertion of the insert portion 150 into the cage portion 110 may cause little to no movement of the support segments 112 and compliant connectors 114 of the cage portion 110, i.e., little to no expansion of the cage portion 110 from the stowed state shown in FIGs. 1 A and IB.
  • insertion of the insert portion 150 into the cage portion 110 may cause the support segments 112 of the cage portion 110 to move apart from each other. For example, for some relative configurations of the cage portion 110 and the insert portion 150, insertion of the insert portion 150 into the cage portion 110 may cause the support segments 112 of the cage portion 110 to move outward with respect to the longitudinal central axis A, for example, somewhat radially outward from the longitudinal central axis A. This initial movement of the support segments 112 may in turn cause some amount of expansion of the cage portion 110, with the compliant connectors 114 moving to a corresponding expanded position between the adjacent support segments 112.
  • this initial expansion of the cage portion 110 (in response to insertion of the insert portion 150) may represent a first expanded state, or an initial expanded state, of the expandable implantable device 100.
  • the expandable implantable device 100 may be further expanded from the first expanded state, or the initial expanded state, to a plurality of further expanded states, in response to manipulation of the threaded rod 151, as shown in FIGs. 1E-1F(2).
  • a configuration of the insert portion 150 relative to the cage portion 110, and an interaction therebetween, for example in response to manipulation of the threaded rod 151, may first cause expansion in a lateral, or horizontal direction, as shown in FIG. IE. Continued or additional manipulation of the threaded rod 151 may cause further expansion, for example, in a vertical direction, as shown in FIGs. 1F( 1 ) and 1F(2).
  • an amount of expansion, or an amount of displacement of the support segments 112 of the cage portion 110, and a corresponding shape and/or volume defined by the expandable implantable device 100 may be adjusted to accommodate the needs of a particular patient/particular surgical implant procedure.
  • an amount, or a degree, of expansion of the expandable implantable device 100 may be controlled (i.e., increased or decreased) in response to manipulation of the threaded rod 151 within the insert portion 150.
  • rotation of the threaded rod 151 about the central axis A in a first rotational direction corresponding to the arrow Cl may draw the wedge portion 155 into an interior portion of the insert portion 150, i.e., an interior space defined by the support segments 152 and the compliant connectors 154, away from the first end portion 151A of the threaded rod 151, and toward the second end portion 151B of the threaded rod 151.
  • movement of the wedge portion 155 along the threaded rod 151 in in response to rotation of the threaded rod 151 in the direction of the arrow Cl may cause the insert portion 150 to transition from the stowed state shown in FIG. 3F toward the expanded state shown in FIG. 3G as the wedge portion 155 moves along the threaded rod 151 and pushes the support segments 152 outward, for example, radially outward, with respect to the central axis A.
  • the movement of the support segments 152 of the insert portion 150 in a direction away from the central axis A in turn causes the support segments 112 of the cage portion 110 to also move further apart, thus causing further expansion of the expandable implantable device 100.
  • rotation of the threaded rod 151 about the central axis A in a second rotational direction corresponding to the arrow C2 may cause the wedge portion 155 to move along the threaded rod 151 in a direction away from the second end portion 15 IB and toward the first end portion 151 A of the threaded rod 151. Movement of the wedge portion 155 along the threaded rod 151 in this manner may cause the support segments 152 of the insert portion 150 to move toward the central axis A, in turn causing the support segments 112 of the cage portion 110 to also move toward the central axis A, thus reducing an amount of expansion of the expandable implantable device 100.
  • the interaction between the wedge portion 155 and the insert portion 150 may cause initial expansion in the lateral, or horizontal direction, as shown in FIG. IE, with further/continued interaction between the wedge portion 155 and the insert portion 150 (for example, in response to further/continued manipulation of the threaded rod 151) causing expansion in the vertical direction, as shown in FIGs. 1F( 1 ) and 1F(2).
  • this initial horizontal, or lateral expansion, followed by vertical expansion, of the expandable implantable device 100 may be facilitated by the interaction of the wedge portion 155 with one or more corresponding guide grooves 159 formed an interior portion of the insert portion 150.
  • the wedge portion 155 includes a body portion 157 in which the opening 153 is formed.
  • the wedge portion 155 shown in FIGs. 3D(1) and 3D(2) includes protrusions 158 formed at peripheral portions of the body portion 157.
  • the protrusions 158 are configured to be movably, or slidably received in the guide groove 159 of a corresponding support segment 152. Movement of the wedge portion 155 along the threaded rod 151 (in response to manipulation of the threaded rod 151) is guided by the movement of the protrusions 158 received in the guide grooves 159. As shown in FIGs.
  • the guide grooves 159 may be configured in a manner that guides expansion of the expandable implantable device 100.
  • the guide grooves 159, and interaction with the protrusions 158 may be configured such that manipulation of the threaded rod 151 initially causes horizontal, or lateral, expansion of the expandable implantable device 100, with continued manipulation of the threaded rod 151 causing vertical expansion of the expandable implantable device 100. In the example shown in FIGs.
  • a distance between the guide grooves 159 in adjacent support segments 152 at a first end portion of the adjacent support segments 152 is less than a distance between the guide grooves 159 at a second end of the adjacent support segments 152 (corresponding to a substantially fully deployed state).
  • a washer 160 may be positioned at an interior facing side of the wedge portion 155. In some examples, the washer 160 may be positioned so as to support a position of the wedge portion 155 on the threaded rod 151. In some examples, a nut cap 165 may be coupled to a distal end portion of the threaded rod 151. In some examples, the nut cap 165 may support a position of the threaded rod 151 in the wedge portion 155. In some examples, the nut cap 165 may provide for support of the wedge portion 155 on the threaded rod 151.
  • the nut cap 165 may buttress the wedge portion 155, particularly in response to rotation of the threaded rod 151 in the direction C2, to facilitate a collapsing of the insert portion 150 and/or the cage portion 110 of the expandable implantable device 100.
  • the ability to substantially fully expand the expandable implantable device 100 in the horizontal, or lateral, direction, prior to expanding the expandable implantable device 100 in the vertical direction, may provide for increased lordotic angle in the placement of the expandable implantable device 100.
  • Full expansion of the expandable implantable device 100 in the horizontal, or lateral direction may spread load over as broad a surface as possible.
  • Full expansion of the expandable implantable device 100 in the horizontal, or lateral direction may provide for engagement with as much cortical bone as possible.
  • the cortical bone at the peripheral portion of the vertebrae is harder than the cancellous bone at the interior portion of the vertebrae.
  • FIGs. 3E(1) and 3E(2) illustrate another configuration of an example wedge portion 155 A which can be coupled in the insert portion 150 described above.
  • the wedge portion 155A includes a body portion 157A in which an opening 153 A is formed to receive the threaded rod 151. Corner portions 156A of the wedge portion 155 A shown in FIGs.
  • 3E(1) and 3E(2) formed at peripheral portions of the body portion 157A interact with interior corner portions 159A of a corresponding support segment 152. Movement of the wedge portion 155 A along the threaded rod 151 (in response to manipulation of the threaded rod 151) is guided by the movement of the corner portions 156A received in the respective interior corner portions 159A of the support segments 152.
  • the interior corner portions 195 A of the support segments 152 may be formed so as to interact with the comer portions 156A of the wedge portion 155 A so as to guide the movement of the wedge portion 155 A similarly to the wedge portion 155 described above with respect to FIGs. 3D(1) and 3D(2).
  • a washer 160 may be positioned at an interior facing side of the wedge portion 155. In some examples, the washer 160 may be positioned so as to support a position of the wedge portion 155 A on the threaded rod 151.
  • a nut cap 165 as shown in FIG. 3E(3) may be coupled to a distal end portion of the threaded rod 151. In some examples, the nut cap 165 may support a position of the threaded rod 151 in the wedge portion 155 A. In some examples, the nut cap 165 may provide for support of the wedge portion 155 A on the threaded rod 151.
  • the nut cap 165 may buttress the wedge portion 155, particularly in response to rotation of the threaded rod 151 in the direction C2, to facilitate a collapsing of the insert portion 150 and/or the cage portion 110 of the expandable implantable device 100.
  • an engagement mechanism 400 may be provided between mating surfaces of the support segments 112 of the cage portion 110 and the support segments 152 of the insert portion 150.
  • FIG. 4A is a cross-sectional view of the expandable implantable device 100, taken along line D-DF of FIG. 1D(2).
  • FIG. 4B is a cross-sectional view of the expandable implantable device 100, taken along line E-E of FIG. 1D(2).
  • the engagement mechanism 400 includes a protrusion 430 formed at the mating surface of the support segment 112 of the cage portion 110 is received in a groove 440 formed in the support segment 152 of the insert portion 150.
  • the protrusion 430 may be formed on the support segment 152 of the insert portion 150 and the groove 440 may be formed in the support segment 112 of the cage portion 110. Engagement of the protrusion 430 in the groove 440 may provide for lateral stability of the expandable implantable device 100, particularly as the expandable implantable device 100 is expanded beyond the stowed state.
  • the engagement mechanism 400 includes a plurality of first detents 410 formed on the support segment 112 that selectively engage a plurality of second detents 420 formed on the support segment 152.
  • Engagement of the plurality of first detents 410 and the plurality of second detents 420 may maintain a relative position of the insert portion 150 in the cage portion 110, and between respective support segments 152 of the insert portion 150 and support segments 112 of the cage portion cage portion 110.
  • a pattern or contour of the first detents 410 and the second detents 420 may be complementary, such that the mating surfaces of the support segments 112, 152 can be steadily seated against each other.
  • a contour of the plurality of first detents 410 and second detents 420 may be angled so as to facilitate insertion of the insert portion 150 into the cage portion 110.
  • engagement between the plurality of first detents 410 and second detents 420 at a first relative position may be released in response to a force applied thereto (for example, in response to rotation of the threaded rod 151 in the direction C2 that causes movement of the insert portion 150 in a direction that collapses the expandable implantable device 100).
  • the plurality of first detents 410 and second detents 420 may be reengaged at a different relative position, corresponding to a desired degree of expansion of the expandable implantable device 100.
  • slots 115 may be formed in one or more of the compliant connectors 114 of the cage portion 110 of the expandable implantable device 100.
  • the slots 115 may facilitate the expansion of the cage portion 110.
  • the slots 115 are detailed in the inset portion shown in FIG. 1 A, and the close in views of the cage portion 110 shown in FIGs. 2A and 2B.
  • one or more surfaces of the support segments 112 of the cage portion 110 of the expandable implantable device 100 may include some form of texturing 113, as shown in the inset portion of FIG. 1 A, and also in the close in views of the cage portion 110 shown in FIGs. 2A and 2B.
  • the texturing 113 at one or more surfaces of the support segments 112 may promote the attachment of bone to the expandable implantable device 100 as bone in the area surrounding the expandable implantable device 100 grows and attaches to the textured surfaces.
  • FIG. 5 illustrates an example instrument 500 which may facilitate the insertion of the expandable implantable device 100 into a patient.
  • the insert portion 150 of the expandable implantable device 100 may be coupled to an end portion of the instrument 500 for insertion into the cage portion 110.
  • the instrument 500 (for example, an actuation device provided in a handle portion of the instrument 500) may be manipulated to in turn manipulate the threaded rod 151 as described above, to move the insert portion 150 between the stowed state and the expanded state.
  • the insert portion 150 is inserted into the cage portion 110, and expanded to, in turn, cause expansion of the cage portion 110.
  • the insert portion 150 may be used by itself, without the cage portion 110, with expansion of the insert portion 150 once placed in the patient providing the desired vertebral support.
  • the cage portion 110 may be added with the insert portion 150 to provide for an increased, or augmented, volume or size of the expandable implantable device 100.
  • the advantages provided by the use of DESCs for the compliant connectors 114 of the cage portion 110 and/or the compliant connectors 114 of the insert portion 150 of the expandable implantable device 100 as described above enable a significant increase in post-implantation deployment height expansion of the expandable implantable device 100.
  • the expandable implantable device 100 described above may demonstrate an approximately 225% increase in deployment height expansion over comparable devices, making the expandable implantable device 100 applicable for a wide variety of minimally invasive surgical procedures.
  • the threaded engagement of the wedge portion 155 on the threaded rod 151 provides for substantially continuously variable adjustment in lordotic angle.
  • the substantially continuously variable adjustment in lordotic angle may be from between approximately 0 degrees to approximately 9.8 degrees.
  • the substantially continuously variable adjustment in lordotic angle may be greater than 9.8 degrees. The continuously variable adjustment of lordotic angle may further enhance the applicability of the expandable implantable device 100 to a wider variety of minimally invasive surgical procedures.
  • an expandable implantable device in accordance with implementations described herein, may have a relatively compact stowed configuration, and a relatively larger deployed configuration.
  • the relatively compact stowed configuration of the implantable device may facilitate the minimally invasive placement of the implantable device in a patient, with the implantable device being deployable to the larger configuration after placement/implant in the patient.
  • the coupling of the plurality support segments of the cage portion and the plurality of support segments of the insert portion by the compliant connectors may provide for a compact arrangement of the plurality of support segments in the stowed configuration, and for separation of the plurality of support segments to the deployed state.
  • Implantable medical devices such as spinal implant devices used in spinal fusion procedures, may benefit from the efficient stowing and deployment afforded by the use of compliant connectors, in the form of DESCs as described above.
  • Expandable implantable spinal disc devices may be implanted to maintain disc height and stabilize the spinal column while bone fusion occurs. In some examples, expandable implantable spinal disc devices may also guide bone growth through the implanted device, allowing the bones to fuse.
  • expandable implantable device While it may be desirable to make use of the smallest possible expandable implantable device to enable the smallest possible incision, in some situations the use of a relatively small, or undersized, implantable device can lead to subsidence involving the sinking of the implantable device into the surrounding bone due to differences in mechanical stiffness of the implantable device in comparison with the supporting bone (i.e., stress overload of the bone).
  • An expandable implantable device having a relatively small insertion size/profile, and that is expandable to a larger deployed configuration may provide for smaller incision areas while also providing the necessary support area of contact with cortical bone when implanted.
  • expandable implantable devices may address the contradictory desires for a relatively smaller incision and a relatively larger implant to provide stability and reduce subsidence.
  • FIGs. 6A-6E illustrate an example expandable implantable device 600, in accordance with implementations described herein.
  • the example expandable implantable device 600 includes a plurality of support segments 620, for example, substantially rigid support segments 620, with compliant connectors 640 connecting adjacent support segments 620.
  • the example expandable implantable device 600 can include more, or fewer, support segments 620, arranged similarly or differently than shown in FIGs. 6A-6E.
  • at least some of the support segments 620 are at least partially hollow.
  • components of an actuation device 630 and/or a ratcheting mechanism 650 of the example device 600 may be at least partially accommodated within the hollow portions of the support segments 620 in the stowed state shown in FIG. 6 A.
  • the actuation device 630 may provide for at least a portion of the expansion and/or deployment of the example device 600.
  • the ratcheting mechanism 650 may maintain a desired level of expansion of the example device 600.
  • FIG. 6A is a perspective view of the example device 600 in the stowed state.
  • the support segments 620 are positioned substantially against each other, or abutting each other, defining the most compact state of the example device 600.
  • FIG. 6B is a perspective view
  • FIG. 6C is a side view, of the example device 600 in a state in which a lateral retaining force has been released, and the compliant connectors 640 have released the stored strain energy, causing adjacent support segments 620 to separate, or move apart laterally, or laterally expand.
  • the release of the lateral retaining force may be done, for example, after insertion/placement of the example device 600 in the patient.
  • FIGs. 6D and 6E are side views of the example device 600 at varying degrees of vertical expansion of the example device 600.
  • the vertical expansion of the example device 600 will be described with respect to two of the plurality of support segments 620, for example, a first support segment 620A and a second support segment 620B.
  • the principles to be described may be applied to the actuation of remaining pairs of support segments 620 of the example device 600.
  • the actuation device 630 is coupled to a rod 652 of the ratchet mechanism 650.
  • a first end portion 652A of the rod 652 may extend into the hollow portion of the first support segment 620A and be pivotably coupled to the first support segment 620A.
  • a second end portion 652B of the rod 652 may extend into the hollow portion of the second support segment 620B and be movable along a length of the hollow portion of the second support segment 620B.
  • Components of the actuation device 630 and the ratcheting mechanism 650 may be similarly arranged in remaining pairs of support segments 620 of the example device 600.
  • a force for example, in the direction of the arrow F, may be applied to the actuation device 630 to initiate vertical expansion of the example device 600.
  • Movement of the actuation device 630 in the direction of the arrow F draws the second end portion 652B of the rod 652 in the direction of the arrow F, as the first end portion 652A of the rod 652 pivots. Movement in of the rod 652 in this manner causes the first support segment 620A to move upward (in the example orientation shown in FIGs. 6D and 6E), away from the second segment 620.
  • the ratcheting mechanism 650 includes a plurality of teeth positioned in the hollow portions of the support segments 620. The plurality of teeth may be configured to interact with the corresponding rods 652, to maintain a position of the rod 652 relative to the segment 620, and a corresponding amount of vertical expansion of the example device 600.
  • the rod 652 (for example, the second end portion 652B of the rod 652) is engaged by a first tooth 654A, of the plurality of teeth in the second support segment 620B. Engagement of the second end portion 652 of the rod 652 with the first tooth 654 maintains the position of the rod 652 relative to the first and second support segments 620A, 620B, and a corresponding amount of vertical expansion of the example device 600.
  • a force to the actuation device 630 in the direction of the arrow F draws the second end portion 652B of the rod 652 further along the hollow portion of the second support segment 620B, as the first end portion 652A of the rod 652 pivots.
  • This continued movement of the second end portion 65B2 of the rod 652 causes the first support segment 620A to move further upward (in the orientation shown in FIGs. 6D and 6E), further away from the second segment 620.
  • the rod 652 is engaged by a second tooth 654B, of the plurality of teeth in the second support segment 620B, to maintain the position of the rod 652 relative to the first and second support segments 620A, 620B and a corresponding amount of vertical expansion of the example device 600.
  • Engagement of the rod 652 in one of the teeth may lock a position of the rod 652 with respect to the support segments 620, and in turn secure the corresponding amount of vertical expansion of the example device 600.
  • FIGs. 7A-7D illustrate an example expandable implantable device 700, in accordance with implementations described herein.
  • the example expandable implantable device 700 includes a plurality of support segments 720, for example, substantially rigid support segments 720, with compliant connectors 740 connecting adjacent support segments 720.
  • the example expandable implantable device 700 can include more, or fewer, support segments 720, arranged similarly or differently than shown in FIGs. 7A-7D.
  • at least some of the support segments 720 are at least partially hollow.
  • components of an actuation device 730 and/or a hinge mechanism 750 of the example expandable implantable device 700 may be at least partially accommodated within the hollow portions of the support segments 720 in the stowed state shown in FIGs. 7A and 7B.
  • the actuation device 730 may provide for at least a portion of the expansion and/or deployment of the expandable implantable example device 700.
  • the hinge mechanism 750 may maintain a desired level of expansion of the example device 700.
  • FIG. 7A is a perspective view of the stowed state of the example expandable implantable device 700, from a first end portion of the example expandable implantable device 700.
  • FIG. 7B is a perspective view of the stowed state of the example expandable implantable device 700, from a second end portion of the example expandable implantable device 700.
  • the support segments 720 are positioned substantially against each other, or abutting each other, defining the most compact state of the example expandable implantable device 700.
  • FIG. 7C is a perspective view of the example expandable implantable device 700 in a state in which a lateral retaining force has been released, and the compliant connectors 740 have released the stored strain energy, causing adjacent support segments 720 to separate, or move apart laterally, or laterally expand.
  • the release of the lateral retaining force may be done, for example, after insertion/placement of the example expandable implantable device 700 in the patient.
  • FIG. 7D is a side view of the example expandable implantable device 700, in an expanded, for example a vertically expanded state.
  • the vertical expansion of the example expandable implantable device 700 will be described with respect to two of the plurality of support segments 720, for example, a first support segment 720 A and a second support segment 720B.
  • the principles to be described may be applied to the actuation of remaining pairs of support segments 720 of the example device 600.
  • the hinge mechanism 750 includes a first arm 751 pivotably coupled to a second arm 752 at a pivot portion 753 of the hinge mechanism 750.
  • An end portion of the first arm 751 is pivotably coupled to the first support segment 720A
  • an end portion of the second arm 752 is pivotably coupled to the second support segment 720B.
  • the first arm 751, the second arm 752 and the pivot portion 753 are in a folded state within the hollow portions of the first support segment 720 A and the second support segment 720B.
  • the actuation device 730 is coupled to the pivot portion 753.
  • a force for example, in the direction of the arrow F, may be applied to the actuation device 730 to initiate vertical expansion of the example expandable implantable device 700. Movement of the actuation device 730 in the direction of the arrow F draws the pivot portion 753 in the direction of the arrow F. Movement of the pivot portion 753 in the direction of the arrow F causes the first and second arms 751, 752 to rotate about the pivot portion 753, and to push the first support segment 720A away from the second support segment 720B as the first and second arms 751, 752 continue to rotate.
  • first and second arms 751, 752 may be locked in place, thus securing the relative position of the first and second support segments 720A, 720B, and the corresponding amount of vertical expansion of the example expandable implantable device 700.
  • FIGs. 8A-8D illustrate an example expandable implantable device 800, in accordance with implementations described herein.
  • the example expandable implantable device 800 includes a plurality of support segments 820, for example, substantially rigid support segments 820, with compliant connectors 840 connecting adjacent support segments 820.
  • the example expandable implantable device 800 can include more, or fewer, support segments 820, arranged similarly or differently than shown in FIGs. 8A-8D.
  • at least some of the support segments 820 include a hollow portion 825, or a channel 825.
  • components of an actuation device 830 and/or a hinge mechanism 850 of the example expandable implantable device 800 may be accommodated in channels 825 formed in the support segments 820.
  • the actuation device 830 may provide for at least a portion of the expansion and/or deployment of the example expandable implantable device 800.
  • the hinge mechanism 850 may provide for a portion of the expansion of the example device 800 and/or may maintain a desired level of expansion of the example expandable implantable device 800.
  • FIG. 8A is a perspective view of the stowed state of the example device 800.
  • the support segments 820 are positioned substantially against each other, or abutting each other, defining the most compact state of the example expandable implantable device 800.
  • FIG. 8B is a side view
  • FIG. 8C is a perspective view, of the example expandable implantable device 800 in a state in which a lateral retaining force has been released, and the compliant connectors 840 have released the stored strain energy, causing adjacent support segments 820 to separate, or move apart laterally, or laterally expand.
  • the release of the lateral retaining force may be done, for example, after insertion/placement of the example expandable implantable device 800 in the patient.
  • FIG. 8D is a side view of the example expandable implantable device 800, in an expanded, for example a vertically expanded state.
  • the vertical expansion of the example expandable implantable device 800 will be described with respect to two pairs of the plurality of support segments 820, for example, a first pair of support segments 820A and 820B, and a second pair of support segments 820C and 820D.
  • the principles to be described may be applied to other pairs of support segments 820 of the example expandable implantable device 800, spaced apart as shown in the example arrangement illustrated in FIGs. 8A-8D, or other arrangements.
  • the hinge mechanism 850 may include a first arm 851 pivotably coupled to a second arm 852 at a pivot portion 853 of the hinge mechanism 850.
  • the first arm 851 may be coupled to a first pivot arm 855, with opposite ends of the first pivot arm 855 received in channels 825 formed in the first pair of support segments 820 A and 820B to pivotably couple the first pivot arm 855 to the first pair of support segments 820A, 820B.
  • the second arm 852 may be coupled to a second pivot arm 857, with opposite ends of the second pivot arm 857 received in channels 825 formed in the second pair of support segments 820C and 820D to pivotably couple the first pivot arm 855 to the second pair of support segments 820C, 820D.
  • the hinge mechanism 850 In the stowed state shown in FIG. 8A, the hinge mechanism 850 extends outward from the example device 800, with the first and second pivot arms 855, 857 positioned at end portions of the channels 825 of the respective pair of support segments 820A, 820B, 820C, 820D.
  • the actuation device 830 is coupled to the pivot portion 853 of the hinge mechanism 850.
  • the hinge mechanism 850 rotates to a lateral position as shown in FIGs. 8B and 8C. In some examples, the hinge mechanism 850 may be locked in position and restricted from further rotation at this lateral position.
  • a force for example, in the direction of the arrow F, may be applied to the actuation device 830 to initiate vertical expansion of the example device 800. Movement of the actuation device 830 in the direction of the arrow F draws the pivot portion 853, the first and second arms 851, 852, and the first and second pivot arms 855, 857, in the direction of the arrow F. Movement of the hinge mechanism 850 in the direction of the arrow F may be guided by the position of the first and second pivot arms 855, 857 in the respective channels 825 formed in the support segments 820A, 820B, 820C, 820D.
  • Movement of the hinge mechanism 850 in the direction of the arrow F in this manner in response to continued application of the force in the direction of the arrow F draws the hinge mechanism 850 further along the channels 825 in the support segments 820A, 820B, 820C, 820D in the direction of the arrow F, pushing apart the first pair of support segments 820A, 820B, and pushing apart the second pair of support segments 820C, 820D to provide for expansion of the example expandable implantable device 800.
  • FIGs. 9A-9D illustrate an example expandable implantable device 900.
  • the example expandable implantable device 900 includes a plurality of support segments 920, for example, substantially rigid support segments 920, with compliant connectors 940 connecting adjacent support segments 920.
  • the example expandable implantable device 900 can include more, or fewer, support segments 920, arranged similarly or differently than shown in FIGs. 9A-9D.
  • at least some of the support segments 920 are at least partially hollow.
  • components of an actuation device 930 of the example device 900 may be at least partially accommodated within the hollow portions of the support segments 920.
  • the actuation device 930 may provide for at least a portion of the expansion and/or deployment of the example expandable implantable device 900.
  • FIG. 9A is a top view of the stowed state of the example expandable implantable device 900.
  • the support segments 920 are positioned substantially against each other, or abutting each other, defining the most compact state of the example expandable implantable device 900.
  • FIG. 9B is a perspective view of the example expandable implantable device 900 in a state in which a lateral retaining force has been released, and the compliant connectors 940 have released the stored strain energy, causing adjacent support segments 920 to separate, or move apart laterally, or laterally expand.
  • the release of the lateral retaining force may be done, for example, after insertion/placement of the example expandable implantable device 900 in the patient.
  • FIGs. 9C and 9D are perspective views of the example expandable implantable device 900, in an expanded, for example a vertically expanded state.
  • the actuation device 930 may include a threaded rod 935 that is externally manipulatable, for example, by a surgeon, for expansion of the example expandable implantable device 900 after insertion in the patient during a surgical procedure.
  • the threaded rod 935 includes a first portion 931 that is threaded in a first direction, and a second portion 932 that is threaded in a second direction, for example, opposite the first direction.
  • a first shim 933 is fitted on the first portion 931 of the threaded rod 935.
  • the first shim 933 may be threadably engaged with the first portion 931 of the threaded rod 935.
  • a second shim 937 is fitted on the second portion 932 of the threaded rod 935.
  • the second shim 937 may be threadably engaged with the second portion 932 of the threaded rod 935.
  • the actuation device 930 can be provided in some, or all of the adjacent pairs of support segments 920.
  • Rotation of the threaded rod 935 causes movement of the first shim 933 on the threaded rod 935 in the direction of the arrow DI, and movement of the second shim 937 on the threaded rod 935 in the direction of the arrow D2.
  • the opposite threading of the first portion 931 and the second portion 932 of the threaded rod 935 causes movement of the first and second shims 933, 937 in opposite directions.
  • This movement of the first and second shims 933, 937 along the incliner, or wedge shaped, inner surface of the support segment(s) 920 causes the support segments 920 to move apart, providing for vertical expansion of the example expandable implantable device 900.
  • an opposite rotation of the threaded rod 935 causes movement of the first shim 933 in the direction of the arrow D2, and movement of the second shim 937 in the direction of the arrow DI, to draw the support segments 920 back together and/or collapsing the expandable implantable device 900.
  • the expandable implantable device 900 may include a first screw with a shim that interacts with first inclined or wedge shaped surface to provide for horizontal, or lateral spreading or expansion of the expandable implantable device 900.
  • the horizontal, or lateral, spreading or expansion provided by the first screw/first shim/first inclined surface may augment the horizontal, or lateral, spreading or expansion provided by the force exerted in response to release of the holding force and corresponding release of strain energy held by the compliant connectors 940.
  • the expandable implantable device 900 may include a second screw, second shim(s) and second inclined or wedge shaped surfaces as described above with respect to FIGs. 9A-9D to provide for vertical expansion of the expandable implantable device 900.
  • FIGs. 10A-10I illustrate concepts that may be considered for incorporation into expandable implantable devices in accordance with implementations described herein.
  • FIG. 10A illustrates the use of a ball member received in tracks formed in adjacent support segments to provide for expansion of the adjacent support segments.
  • FIG. 10B illustrates the use of a separator element at the end of a rod, for example, a rotating rod, with the separator element received in tracks formed in adjacent support segments to provide of expansion of the adjacent support segments.
  • FIG. 10C illustrates a hinged matrix type structure that may be included in an expandable implantable device to provide for the selective expansion of the device.
  • FIG. 10A illustrates the use of a ball member received in tracks formed in adjacent support segments to provide for expansion of the adjacent support segments.
  • FIG. 10B illustrates the use of a separator element at the end of a rod, for example, a rotating rod, with the separator element received in tracks formed in adjacent support segments to provide of expansion of the adjacent support segments.
  • FIG. 10C illustrates a
  • FIG. 10D illustrates the use of an anchoring type of device that provides for expansion of two adjacent support segments as a threaded rod is rotated and arms of the anchoring device are pushed apart and exert a force on the adjacent support segments, pushing the adjacent support segments apart.
  • FIG. 10E illustrates the use of a shim that is selectively inserted between adjacent support segments to provide for expansion of the adjacent support segments.
  • FIG. 10F illustrates the use of a hinged jacking type element that can be positioned between adjacent support segments in a contracted state, and then actuated to expand the jacking element at hinged portions, to provide for expansion of the adjacent support segments.
  • FIG. 10G illustrates a material structure employing DESCs, that mimics a grain structure of a material.
  • FIG. 10H illustrates a ramp structure that can be positioned between adjacent support segments, and actuated to provide for expansion of the adjacent support segments.
  • FIG. 101 illustrates the use of DESCs between adjacent nesting support segments that provide for expansion of the device from a nested configuration of the support segments.
  • spatially relative terms such as “beneath,” “below,” “lower,” “above,” “upper,” and the like, may be used herein for ease of description to describe one element or feature in relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the term “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 70 degrees or at other orientations) and the spatially relative descriptors used herein may be interpreted accordingly.
  • Example embodiments of the concepts are described herein with reference to cross-sectional illustrations that are schematic illustrations of idealized embodiments (and intermediate structures) of example embodiments. As such, variations from the shapes of the illustrations as a result, for example, of manufacturing techniques and/or tolerances, are to be expected. Thus, example embodiments of the described concepts should not be construed as limited to the particular shapes of regions illustrated herein but are to include deviations in shapes that result, for example, from manufacturing. Accordingly, the regions illustrated in the figures are schematic in nature and their shapes are not intended to illustrate the actual shape of a region of a device and are not intended to limit the scope of example embodiments.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Neurology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)

Abstract

Des connecteurs souples peuvent couvrir des espaces entre des segments de support d'un dispositif vertébral implantable extensible. Les connecteurs souples peuvent reposer à plat lorsqu'ils sont sous contrainte dans une position rangée et peuvent se dilater pour maintenir une configuration étendue définie par la pluralité de segments de support lorsqu'ils sont libérés. Une taille et/ou un profil minimalement compacts du dispositif implantable extensible peuvent être obtenus, ce qui permet également d'obtenir une taille relativement grande dans la configuration déployée du dispositif.
PCT/US2022/081366 2021-12-13 2022-12-12 Cage de fusion vertébrale souple extensible Ceased WO2023114718A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US18/870,043 US20250331996A1 (en) 2022-05-31 2022-12-12 Expandable compliant spinal fusion cage

Applications Claiming Priority (4)

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US202163288887P 2021-12-13 2021-12-13
US63/288,887 2021-12-13
US202263365593P 2022-05-31 2022-05-31
US63/365,593 2022-05-31

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WO2023114718A2 true WO2023114718A2 (fr) 2023-06-22
WO2023114718A3 WO2023114718A3 (fr) 2023-09-28

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Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU5701200A (en) * 1999-07-02 2001-01-22 Petrus Besselink Reinforced expandable cage
US6773460B2 (en) * 2000-12-05 2004-08-10 Roger P. Jackson Anterior variable expandable fusion cage
JP5504182B2 (ja) * 2008-03-14 2014-05-28 ジンテス ゲゼルシャフト ミット ベシュレンクテル ハフツング 入子式の拡張可能なスリーブインプラント
US9119726B2 (en) * 2013-03-18 2015-09-01 Chih-Hsuan Wei Expandable implant of a minimally invasive surgery

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