USRE49667E1 - Shape changing bone implant and method of use for enhancing healing - Google Patents

Shape changing bone implant and method of use for enhancing healing Download PDF

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Publication number
USRE49667E1
USRE49667E1 US17/506,545 US201217506545A USRE49667E US RE49667 E1 USRE49667 E1 US RE49667E1 US 201217506545 A US201217506545 A US 201217506545A US RE49667 E USRE49667 E US RE49667E
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bone
segment
implant
shape
healing
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William Casey Fox
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • A61B17/7291—Intramedullary pins, nails or other devices for small bones, e.g. in the foot, ankle, hand or wrist
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8004—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with means for distracting or compressing the bone or bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/844—Fasteners therefor or fasteners being internal fixation devices with expandable anchors or anchors having movable parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/866—Material or manufacture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8695—Washers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect

Definitions

  • This application relates to promoting bone healing with a new class of shape changing bone implants used for fixation of the musculoskeletal system.
  • Bone healing is promoted because the implants change shape to constantly hold the healing interface of bone segments in apposition while compressing.
  • the implants change shape through their metallurgic (or polymeric) properties and mechanisms to use mechanically stored strain energy pull together and compresses bone to induced an enhanced healing response.
  • These implants can also act as a scaffolding for bone thus conducting bone formation through the implant during the healing process.
  • Rigid bone implants are commonly hammered, wedged, screwed, or fixed with wire into bone. Surgical techniques involve alignment of the bone segments, approximating the edges where healing should occur, and using implants to rigidly hold the bones in place.
  • the first phase of bone healing is inflammation. This normal response recruits cells into the wound to remove debris including necrotic tissue. In this process the bone edges that were surgically approximated are broken down by tissue digesting cells causing gaps between the bone edges to form. These gaps, caused by difficult surgical reduction and/or inflammation mediated bone resorbtion, delay healing because more bone tissue must form to fill the gaps and bone healing may stop if soft tissue infiltrates the gaps and impedes or blocks bone fusion.
  • Wolff's Law has resulted in a clinical recommendation to exercise to delay osteoporosis or bone loss in the weightlessness of outer space. Like muscle, exercise that mechanically loads bone also seems to increase the bone size and strength. This phenomena associated with Wolff's Law is known as mechanotransduction.
  • Chamay 1972 reported about compression induced microlesions and a bone formation and hypertrophy response in three different test groups. They studied three loading conditions: (1) a dynamic fatigue test group, (2) a static overload group, and (3) single load group, and showed that each resulted in various degrees, locations, and timing of new bone formation.
  • Chao 2003 stated that, though it has long been hypothesized that that there is a link between mechanical stimulation and fracture healing, the biologic pathways and regulating cellular mechanisms remain unknown. Chao 2003 further stated that when the mechanisms at the cellular levels became understood, physiological conditions or pharmacological agents may be developed to enhance bone healing.
  • the embodiments of the subject invention describe an improved bone implant that stores recoverable mechanical energy in its structure or mechanism and changes shape to pull together and compress the bone fixation interface.
  • This is a new class of implant that not only compresses but can translate bone segments to hold them into constant apposition which has multiple advantages over prior bone fixation devices that are rigid.
  • This invention further describes a method of manipulating bone to promote healing and minimize non-healing events by holding the bone edges in constant contact and applying pressure to the healing interface to promote a biologic response to form bone. This method is further enhanced by implants that can act as a scaffolding for bone, thus conducting bone formation through the implant so as to fuse the bone segments.
  • the invention features a bone healing method that includes selecting a bone implant operable for pulling together a first bone segment and a second bone segment and operable for compressing the first bone segment and the second bone segment at a bone healing interface.
  • the method further includes positioning the bone implant in a position to pull the first bone segment and the second bone segment together and to compress the first bone segment and the second bone segment at the bone healing interface.
  • the bone implant applies no mechanical force to pull the first bone segment and the second bone segment together.
  • the bone implant applies no mechanical force to compress the first bone segment and the second bone segment at the bone healing interface.
  • the method further comprises that, after positioning of the bone implant, mechanically activating the bone implant.
  • the mechanically activated bone implant pulls together the first segment and the second bone segment.
  • the mechanically activated bone implant compresses the first bone segment and the second bone segment at the bone healing interface.
  • the mechanically activated bone implant maintains the first bone segment and the second bone segment at the bone healing interface while the first bone segment and the second bone segment heal.
  • Implementations of the invention can include one or more of the following features:
  • the bone implant can be a cage, wire, staple, plate, screw, rod, tubular structure, external fixation device, or a combination thereof.
  • the bone implant can have a first shape.
  • the first shape can be an expanded shape.
  • the bone implant can be in the first shape during the step of positioning.
  • the bone implant can have a second shape.
  • the second shape can be a contracted shape.
  • the bone implant can move from the first shape toward the second shape during or after the step of mechanically activating the bone implant.
  • the bone implant can have a first shape change in first direction and a second shape change in another direction.
  • the first shape change and the second shape change can be different.
  • the first shape change can be a shape expansion or contraction.
  • the second shape change can be a shape expansion or contraction.
  • the bone implant can change to a different shape during or after the step of mechanically activating the bone implant.
  • the transition of the bone implant to the different shape can be operable for pulling together the first bone segment and the second bone segment.
  • the transition of the bone implant to the different shape can be operable for compressing the first bone segment and the second bone segment at the bone healing interface.
  • the bone implant can include nitinol.
  • the bone implant can include an activator. Before the activator is removed from the bone implant, the activator can retain the bone implant in a first shape in which at least some of the nitinol in the bone implant is in the form of stress induced or retained martensite. The activator can be removed from the bone implant during the step of mechanically activated bone implant. After the activator is removed from the bone implant, the bone implant can change shape, during which at least some of the nitinol in the bone implant can change in form to austenite.
  • the bone healing implant can include a shape memory metal, an elastic biocompatible metal, an elastic biocompatible polymer, or a combination thereof.
  • the bone healing implant can include stainless steel, titanium, or a combination thereof.
  • the bone implant can include a spring.
  • the spring can be released during the step of mechanical activating the bone implant.
  • the spring can provide the mechanical force that pulls together the first bone segment and the second bone segment.
  • the spring can provide the mechanical force that compresses the first bone segment and a second bone segment at the bone healing interface.
  • the spring can provide the mechanical force that maintains the bone under compression while the bone heals.
  • the bone implant can include nitinol. Before the spring is released, the spring can hold the bone implant in a shape in which at least some of the nitinol in the bone implant is in the form of martensite. The bone implant can hold together the first bone segment and the second bone segment such that soft tissue infiltration is blocked.
  • the bone implant can include a shape changing cage.
  • the shape changing cage can include at least one bone conducting scaffold feature.
  • the shape changing cage can include a first component, a second component, and a spring.
  • a locking pin can be removed from the bone implant.
  • the first component and the second component can be pulled together.
  • the pulling together of the first component and the second component can pulls together the first bone segment and the second bone segment.
  • the pulling together of the first component and the second component can compress. the first bone segment and the second bone segment at the bone healing interface.
  • the pulling together of the first component and the second component can maintain the first bone segment and the second bone segment at the bone healing interface while the first bone segment and the second bone segment heal.
  • the shape changing cage can include nitinol.
  • the shape changing cage can include a shape memory metal, an elastic biocompatible metal, an elastic biocompatible polymer, or a combination thereof.
  • the shape changing cage can include stainless steel, titanium, or a combination thereof.
  • the shape changing cage can include polyether ether ketone (PEEK), polyethylene, or a combination thereof.
  • PEEK polyether ether ketone
  • the shape changing cage can include a first cylindrical component and a second cylindrical component.
  • the first cylindrical component and second cylindrical component can be locked in place to prevent them from moving together.
  • the bone implant can further include a mandrel that locks the shape changing cage in a first shape.
  • the step of mechanically activating the bone implant in the method can include unlocking the cage by removing the mandrel from the implant. Unlocking the cage can allow the cage to change its shape.
  • the change in shape of the cage can pull together the first segment and the second bone segment.
  • the change in shape of the cage can compress the first bone segment and the second bone segment at the bone healing interface.
  • the change in shape of the cage can maintain the first bone segment and the second bone segment at the bone healing interface while the first bone segment and the second bone segment heal.
  • the shape changing cage can include nitinol.
  • the shape changing cage can include a shape memory metal, an elastic biocompatible metal, an elastic biocompatible polymer, or a combination thereof.
  • the shape changing cage can include stainless steel, titanium, or a combination thereof.
  • the shape changing cage can include polyether ether ketone (PEEK), polyethylene, or a combination thereof.
  • PEEK polyether ether ketone
  • the invention features a bone implant that includes a biocompatible material structure that is in a first shape.
  • the first shape allows the section to be positioned proximate to a first bone segment and a second bone segment without the biocompatible material structure applying mechanical forces to pull together the first bone segment and the second bone segment.
  • the first shape allows the section to be positioned proximate to a first bone segment and a second bone segment without the biocompatible material structure applying mechanical forces to compress the first bone segment and the second bone segment at a bone healing interface.
  • the bone implant further includes an actuator holding the biocompatible material structure in the first shape.
  • the biocompatible material structure is operable to move toward a second shape upon actuation of the actuator.
  • the movement of the biocompatible material structure toward the second shape is operable to pull together the first segment and the second bone segment.
  • the movement of the biocompatible material structure toward the second shape is operable to compress the first bone segment and the second bone segment at the bone healing interface.
  • the movement of the biocompatible material structure to the second shape is operable to maintain the first bone segment and the second bone segment at the bone healing interface while the first bone segment and the second bone segment heal.
  • Implementations of the invention can include one or more of the following features:
  • the biocompatible material structure can include at least one bone conducting scaffold feature.
  • the biocompatible material structure can be a cage, wire, staple, plate, screw, rod, tubular structure, external fixation device, or a combination thereof.
  • the first shape can be an expanded shape.
  • the second shape can be a contracted shape.
  • the first shape can be a contracted shape.
  • the second shape can be an expanded shape.
  • the biocompatible material structure can include nitinol.
  • At least some of the nitinol in the biocompatible material structure can be in the form of stress induced or retained martensite when the biocompatible material structure is in the first shape. At least some of the nitinol can be operable for changing in form from martensite to austenite due to change in the biocompatible material structure from the first shape toward the second shape.
  • the bone healing implant can include a shape memory metal, an elastic biocompatible metal, an elastic biocompatible polymer, or a combination thereof.
  • the bone healing implant can include stainless steel, titanium, or a combination thereof.
  • the bone healing implant can include polyether ether ketone (PEEK), polyethylene, or a combination thereof.
  • PEEK polyether ether ketone
  • the bone implant can further include a spring.
  • the spring can be operatively connected to the biocompatible material structure and the actuator such that actuation of the actuator is operable for releasing of the spring.
  • the spring can be operatively connected to the biocompatible material structure and the actuator such that releasing of the spring is operable for releasing the biocompatible material structure such that the biocompatible material structure can change from the first shape toward the second shape.
  • the biocompatible material structure can include nitinol.
  • the biocompatible material structure can include a shape memory metal, an elastic biocompatible metal, an elastic biocompatible polymer, or a combination thereof.
  • the shape changing cage can include stainless steel, titanium, or a combination thereof.
  • the shape changing cage can include polyether ether ketone (PEEK), polyethylene, or a combination thereof.
  • PEEK polyether ether ketone
  • the movement of the biocompatible material structure toward the second shape can be operable to compress the first bone segment and the second bone segment at the bone healing interface to block soft tissue infiltration.
  • the movement of the biocompatible material structure toward the second shape can be operable to deform the first bone segment and the second bone segment so as to create an electrical current flow in the first bone segment and the second bone segment.
  • the biocompatible material structure can include a shape changing cage.
  • the shape changing cage can include at least one bone conducting scaffold feature.
  • the shape changing cage can include a first component and a second component.
  • the bone implant can further include a spring.
  • the spring can be operable to maintain the first component and the second component so that the shape changing cage is in the first shape.
  • the spring can be operable to be released by the actuation of the actuator.
  • the first component and the second component can be operable to pull together, upon release of the spring, to move the shape changing cage toward the second shape.
  • the activator can be a plate, tong, clip, wire, rod, or a combination thereof.
  • the activator can be a locking pin.
  • the first component and the second component can be operable for pulling together when the locking pin is removed from the bone implant.
  • the pulling together of the first component and the second component can be operable for pulling together the first bone segment and the second bone segment.
  • the pulling together of the first component and the second component can be operable for compressing the first bone segment and the second bone segment at the bone healing interface.
  • the pulling together of the first component and the second component can be operable for maintaining the first bone segment and the second bone segment at the bone healing interface while the first bone segment and the second bone segment heal.
  • the biocompatible material structure can include nitinol.
  • the biocompatible material structure can include a shape memory metal, an elastic biocompatible metal, an elastic biocompatible polymer, or a combination thereof.
  • the biocompatible material structure can include stainless steel, titanium, or a combination thereof.
  • the biocompatible material structure can include polyether ether ketone (PEEK), polyethylene, or a combination thereof.
  • PEEK polyether ether ketone
  • the shape changing cage can include a first component and a second component.
  • the first component and the second component can be locked in place by the actuator.
  • the first component and the second component can be operable for pulling toward each other upon actuation of the actuator.
  • the actuator can be a mandrel that locks the cage in the first shape.
  • the mandrel can include a bone cutting insertion tip.
  • the actuator can be operable for removal from the shape changing cage to allow the shape changing cage to change its shape from the first position toward the second position.
  • the shape changing cage can include nitinol.
  • the shape changing cage can include a shape memory metal, an elastic biocompatible metal, an elastic biocompatible polymer, or a combination thereof.
  • the shape changing cage can include stainless steel, titanium, or a combination thereof.
  • the shape changing cage can include polyether ether ketone (PEEK), polyethylene, or a combinations thereof.
  • PEEK polyether ether ketone
  • the invention features a bone healing implant that includes a shape changing washer and a threaded bone screw.
  • the shape changing washer and the threaded bone screw are operable for use to pull together a first bone segment and a segment bone segment.
  • the shape changing washer is operable for storing mechanical energy by changing its shape as the threaded bone screw is rotated when used to pull together the first bone segment and the segment bone segment.
  • the stored mechanical energy of the shape changing washer is operable to pull together the first bone segment and a second bone segment.
  • the stored mechanical energy of the shape changing washer is operable to compress the first bone segment and the second bone segment at the bone healing interface.
  • the movement of the biocompatible material structure to the second shape is operable to maintain the first bone segment and the second bone segment at the bone healing interface while the first bone segment and the second bone segment heal.
  • Implementations of the invention can include one or more of the following features:
  • the shape changing washer can have changing bellows.
  • the bone healing implant can further include at least one bone conducting scaffold feature.
  • the shape changing washer can include nitinol.
  • the shape changing washer can include a shape memory metal, an elastic biocompatible metal, an elastic biocompatible polymer, or a combination thereof.
  • the shape changing washer can include stainless steel, titanium, or a combination thereof.
  • the shape changing washer can include polyether ether ketone (PEEK), polyethylene, or combination thereof.
  • PEEK polyether ether ketone
  • the invention features a bone healing method that includes selecting a bone implant.
  • the bone implant has at least one bone scaffold feature.
  • the method further includes positioning the bone implant in a position to pull first bone segment and a second bone segment together and to compress the first bone segment and the second bone segment at the bone healing interface.
  • the bone implant pulls together the first segment and the second bone segment.
  • the bone implant compresses the first bone segment and the second bone segment at the bone healing interface.
  • the bone implant maintains the first bone segment and the second bone segment at the bone healing interface while the first bone segment and the second bone segment heal.
  • the bone scaffold feature conducts bone through the bone implant and across the healing bone interface utilizes while the first bone segment and the second bone segment heal.
  • Implementations of the invention can include one or more of the following features:
  • the bone scaffold feature can be a fenestration for bone ingrowth.
  • the bone scaffold feature can be a circular fenestration for bone ingrowth, an elongated fenestration for bone growth, a slot fenestration for bone growth, a lumen for bone ingrowth, or a combination thereof.
  • the bone scaffold feature can be a shape changing feature.
  • the bone implant can include nitinol.
  • the bone implant can include a shape memory metal, an elastic biocompatible metal, an elastic biocompatible polymer, or a combination thereof.
  • the bone implant can include stainless steel, titanium, or a combination thereof.
  • the bone implant can include polyether ether ketone (PEEK), polyethylene, or a combination thereof.
  • PEEK polyether ether ketone
  • the invention features a bone implant that includes biocompatible material structure that is in a first shape.
  • the first shape allows the biocompatible material structure to be positioned proximate to a first bone segment and a second bone segment.
  • the biocompatible material structure is operable to move from a first shape to a second shape. Movement of the biocompatible material structure toward the second shape is operable to pull together the first segment and the second bone segment. Movement of the biocompatible material structure toward the second shape is operable to compress the first bone segment and the second bone segment at the bone healing interface. Movement of the biocompatible material structure to the second shape is operable to maintain the first bone segment and the second bone segment at the bone healing interface while the first bone segment and the second bone segment heal.
  • the bone implant further includes at least one bone scaffold feature incorporated with the biocompatible material structure. The bone scaffold feature is operable to conduct bone through the implant and across the healing bone interface while the first bone segment and second bone segment heal.
  • Implementations of the invention can include one or more of the following features:
  • the bone scaffold feature can be a fenestration for bone ingrowth.
  • the bone scaffold feature can be a circular fenestration for bone ingrowth, an elongated fenestration for bone growth, a slot fenestration for bone growth, a lumen for bone ingrowth, or a combination thereof.
  • the bone scaffold feature can be a shape changing feature.
  • the biocompatible material structure can include nitinol.
  • the biocompatible material structure can include a shape memory metal, an elastic biocompatible metal, an elastic biocompatible polymer, or a combination thereof.
  • the biocompatible material structure can include stainless steel, titanium, or a combination thereof.
  • the biocompatible material structure can include polyether ether ketone (PEEK), polyethylene, or a combination thereof.
  • PEEK polyether ether ketone
  • FIG. 1 illustrates a rigid bone fixation plate and screw system of the prior art.
  • FIG. 2 illustrates the rigid bone fixation plate and screw system of FIG. 1 holding the bone segments apart.
  • FIG. 3 illustrates a shape changing bone plate with displacement section extended, unstable, and able to pull together and compress bone segments so as to close the gap and compress the bone segments at the healing interfaces.
  • FIG. 4 illustrates the shape changing bone plate with displacement section of FIG. 3 contracted to hold the gap closed and compress the bone segments.
  • FIG. 5 illustrates a shape changing bone staple with the bridge extended, legs straightened, and mechanically unstable so that its spontaneous shape change closes the gap.
  • FIG. 6 illustrates the shape changing bone staple of FIG. 5 with the bridge contracted and legs deflected inward to hold the gap closed and compress the bone segments.
  • FIG. 7 illustrate a shape changing cylindrical fenestrated hollow cage, in its extended length, contracted diameter and unstable state, which uses an internal spring to close the gap and compress the bone interfaces.
  • FIG. 8 illustrates the shape changing cylindrical fenestrated hollow cage of FIG. 7 in its contracted length and expanded diameter using the internal spring's strain energy to expand the cage diameter, lock into the central lumen of bone and shorten the cage's length so as to closed and compress the gap between bone segment and interfaces.
  • FIG. 9 illustrates an orthogonal view of the bone fixation cylindrical cage of FIG. 7 with lock pin in its elongated and diametrically contracted pre-implantation condition with maximum stored mechanical strain energy.
  • FIG. 10 illustrates an orthogonal view of the bone fixation cylindrical cage of FIG. 8 in its shortened and expanded post-implantation condition with no stored mechanical strain energy.
  • FIG. 11 illustrates a plane view of a bone fixation cylindrical cage of the bone fixation cylindrical cage of FIG. 8 in its shortened and expanded post-implantation condition with no stored mechanical strain energy showing bone locking members, bone in growth fenestrations, circular fenestrations, and lock pin receiver.
  • FIG. 12 illustrates an orthogonal view of the components of the bone fixation cylindrical cage of FIGS. 7 - 8 that is disassembled to show the two cylindrical components and spring.
  • FIG. 13 illustrates a shape changing cylindrical fenestrated hollow cage in its extended length, contracted diameter, and unstable state that uses its elastic material properties to close the gap and compress the bone interfaces.
  • FIG. 14 illustrates the shape changing cylindrical fenestrated hollow cylinder of FIG. 13 in its contracted length and expanded diameter using its material properties to pull the gap closed and compress the bone interfaces.
  • FIG. 15 illustrates an orthogonal view of a bone fixation cylindrical cage of FIG. 13 in its elongated and diametrically contracted pre-implantation condition with bone ingrowth fenestrations and holes, and elongated ribs storing maximum mechanical strain energy.
  • FIG. 16 illustrates an orthogonal view of the bone fixation cylindrical cage of FIG. 14 in its shortened and expanded post-implantation condition with bulging ribs and no stored mechanical strain energy.
  • FIG. 17 illustrates an orthogonal view of the bone fixation cylindrical cage of FIG. 13 in its extended and diametrically contracted pre-implantation state while locked on an implantation mandrel having a bone cutting insertion tip, with the mandrel lobe engaged in cage instrument fenestration and the driver fenestrations accessible to facilitate release.
  • FIG. 18 illustrates an orthogonal view of the bone fixation cylindrical cage of FIG. 14 in its shortened and expanded post-implantation configuration following release from the implantation mandrel through release of the mandrel lobe and cage instrument release fenestration.
  • FIG. 19 illustrates a shape changing washer it its unstable state that, using the material's elastic properties, pulls on a bone screw to pull together bone segments to close the gap.
  • FIG. 20 illustrates the changing washer of FIG. 19 that, using the material's elastic properties, deflects its structure to pull on a bone screw to pull together bone segments, hold the gap closed, and compress the bone segments at the healing interface.
  • FIG. 21 illustrates a threaded bone screw with mechanical energy storing shape changing washer of fully strained and storing maximum energy.
  • FIG. 22 illustrates the threaded bone screw and mechanical energy shape changing washer of FIG. 21 with the mechanical energy storing shape changing washer partially strained and storing an intermediate amount of energy.
  • FIG. 23 illustrates the threaded bone screw and mechanical energy storing shape changing washer of FIG. 21 with the mechanical energy storing shape changing washer fully recovered in its shape and storing no energy.
  • FIG. 24 illustrates an orthogonal view of an alternate embodiment of a shape changing washer that can be used with a threaded bone screw, showing the shape changing washer fully recovered in its shape changing bellows section and storing no energy.
  • FIG. 25 illustrates an orthogonal view of the alternate embodiment of the shape changing washer of FIG. 24 showing the shape changing washer fully extended in its shape changing bellows section and storing maximum energy.
  • the invention consist of a method of enhancing bone healing by actively pulling the bone segments together at the healing interface and squeezing so as to continuously hold the bones in contact and create mechanical stress in the bone.
  • the invention further includes bone fixation implants that change shape to implement this method.
  • the enhanced bone healing due to mechanical shape change is further advanced through embodiments of the implant invention that conduct bone healing through fenestrations and its lumen.
  • Bone fixation shape changing implant designs that use this method include screws, washers, cylindrical cages, plates, staples, rods, and external fixators.
  • Bone is composed of collagen and calcium phosphate.
  • the calcium phosphate forms crystalline hydroxyapatite.
  • the crystalline hydroxyapatite is strained and through its piezoelectric properties creates current flow.
  • Electrical current flow has been reported in bone when strained.
  • Electronic bone healing stimulators that place electrodes in the bony wound or pulse electromagnetic fields through bone report that their mechanism of healing is cell recruitment driven due to the induced current flow in bone. This mechanical strain induced current flow is one of two mechanisms of enhanced bone healing activated with the implants that use this method of enhanced healing.
  • the second of two mechanisms is the effect of compression and increased environmental pressure on the bone forming cells within the compression region.
  • Bone cells in intact healthy bone have been shown to respond to mechanical loading to build more and stronger bone. Applicant's unexpected observation is that this response occurred in healing bone, which is a much different process than the remodeling that strengthens intact healthy bone.
  • Bone healing includes inflammation, bone resorbtion, non-mineralized matrix formation, and mineralization of the matrix. Remodeling of intact bone does not include all of these processes. Implants designed to change shape to pull together and compress a healing bone fracture, cut or fusion is a significant advance in skeletal healthcare.
  • the bone healing method and devices that change shape and pull together and compress bone can be applied throughout the skeletal system.
  • the invention can be an implant device for healing of fingers and toe bones.
  • the method and devices provide the clinician the ability to implant the devices in their proper position and then release the device so that it can have the mechanical energy to (a) compress the bone segments, and (b) maintain the compression during the bone healing process.
  • the devices have an activator that can be withdrawn from the device (such as, for example, a rod that can be withdrawn allowing a spring to provide the mechanical energy) or can remain with the device (such as, for example, a screw that can be rotated to allow a spring to provide the mechanical energy). Because the bone healing device is not activated until after it is in place, this allows the clinician to fully position it before activation. Moreover, when the device is not properly positioned, the bone healing device can be removed by the clinician before activation and then correctly positioned.
  • the implants can act as a scaffolding for bone thus conducting bone formation through the implant. This further facilitates the healing of bone segments.
  • the embodiments of the present inventions thus overcome the deficiencies of the prior rigid bone fixation implants, such as (1) not closing a gap formed at the edges of the fracture or cut due to inflammation, (2) holding the bone ends at a distance that is too far for bone cells to bridge to facilitate healing, (3) holding the bone so that compression loads in bone do not occur, (4) holding a gap between the ends of bone so that soft tissue can infiltrate into the gap and delay or prevent healing, (5) not mechanically straining bone to illicit piezoelectric current flow, (6) not mechanically straining or modulating bone cell pressure to stimulate these cells to form and model bone, (7) providing a scaffolding to conduct bone to grow through the implant and (8) others deficiencies that will become more clear in the review of the embodiments of the subject invention.
  • the implants allow the clinician the ability to implant the devices in their proper position and then activate them. This combination significantly eases the burdens on the clinicians when using implants. Moreover, by doing so, this increases the clinicians' ability to properly place the implants. Proper placement is additionally beneficial as the implants can be utilized for scaffolding for bone growth.
  • the implant can include a shape memory metal (such as nitinol), which can utilize the pseudo elastic properties of such materials.
  • the implant can be made of any elastic biocompatible metal (such as stainless steel, titanium, etc.) or can be made of an elastic biocompatible polymer (such as polyether ether ketone (PEEK),), polyethylene, etc.).
  • FIGS. 1 - 4 are illustrative of how the present invention overcome the deficiencies of the prior rigid bone fixation implants.
  • FIG. 1 illustrates a rigid bone fixation plate and screw system of the prior art. This system includes a rigid bone plate 30 and rigid bone plate screws 40 . As illustrated in FIG. 1 , this system is utilized to hold in contact a first bone segment 10 and a second bone segment 20 at the bone healing junction 50 between these two bone segments.
  • FIG. 2 illustrates the rigid bone fixation plate and screw system of FIG. 1 holding first bone segment 10 and second bone segment 20 apart after formation of an inflammation, motion or procedure induced gap 60 between the bone healing interface 62 (of second bone segment 20 ) and bone healing interface 64 (of first bone segment 10 ).
  • a shape changing plate 90 utilizes a shape changing section 70 between first bone segment 10 and second bone segment 20 that can deform to become section 80 and pull so the fragments together so as to close the bony gap 60 and hold the bone healing interfaces 62 and 64 in contact.
  • the activator is not shown in FIGS. 3 - 4 .
  • FIGS. 5 - 6 are illustrative of a shape changing bone staple.
  • Such shape changing bone staple does not include an activator.
  • FIG. 5 illustrates a shape changing bone staple 100 with the bridge extended, legs straightened and mechanically unstable so that its spontaneous shape change can close the gap 60 .
  • FIG. 6 illustrates the shape changing bone staple 100 of FIG. 5 with the bridge contracted and legs deflected inward to hold the gap 50 closed and compress the bone segments 10 and 20 .
  • the contracted shape changing bone staple 100 of FIG. 5 is shape changing bone staple 110 of FIG. 6 .
  • the shape changing staple 100 (in its uncontracted state) can shorten its bridge and swings its legs inward its contract to close the gap 60 and hold the healing interface 50 in contact.
  • the shape changing bridge and legs of staple 100 act together to pull together and compress the bone segments to avoid bone gaping and strain the healing bone.
  • FIGS. 7 - 12 are illustrative of a shape changing cage used to pull together and compress bone segments.
  • This is an example of a bone healing implant that can be positioned by the clinician while the implant does not apply mechanical force to compress the bone segments (to be healed) and, after positioning, the bone healing implant can be mechanically activated to apply the compressive mechanical force.
  • FIG. 7 illustrates a shape changing cylindrical fenestrated hollow cage 120 , in its extended length, contracted diameter and unstable state, which uses an internal spring to close the gap 60 and compress the bone interfaces 62 and 64 .
  • FIG. 8 illustrates the shape changing cylindrical fenestrated hollow cage 120 of FIG. 7 in its contracted length and expanded diameter (shape changing cylindrical fenestrated hollow cage 130 ) using an internal spring's strain energy to expand the cage diameter, lock into the central lumen of bone and shorten the length of cage shape changing cylindrical fenestrated hollow cage 130 (as compared to shape changing cylindrical fenestrated hollow cage 120 ) so as to closed and compress the gap 50 between bone segments 10 and 20 .
  • FIG. 9 illustrates an orthogonal view of the bone fixation cylindrical cage 120 of FIG. 7 with lock pin 250 in its elongated and diametrically contracted pre-implantation condition with maximum stored mechanical strain energy.
  • Lock pin 250 includes lock pin manipulator 260 .
  • FIG. 9 further shows the movable connected expansion members 190 and the circular fenestrations 200 (for bone growth) of bone fixation cylindrical cage 120 .
  • FIG. 10 illustrates an orthogonal view of the bone fixation cylindrical cage 130 of FIG. 8 in its shortened and expanded post-implantation condition with no stored mechanical strain energy. (When utilized, the bone fixation cylindrical cage does not fully shorten, so some of the stored mechanical strain energy remains to maintain compression.)
  • FIG. 10 shows the movable connected expansion members 190 (after movement) and the circular fenestrations 200 of bone fixation cylindrical cage 130 .
  • FIG. 10 also shows elongated fenestrations for bone growth 210 and lock pin receiver 270 .
  • FIG. 11 illustrates a plane view of the bone fixation cylindrical cage 130 of FIG. 8 in its shortened and expanded post-implantation condition with no stored mechanical strain energy showing bone locking members 190 , bone in growth fenestrations 210 , circular fenestrations 200 , and lock pin receiver 270 .
  • FIG. 12 illustrates an orthogonal view of the components of the bone fixation cylindrical cage of FIGS. 7 - 8 that disassembled to show its two cylindrical components 280 and 290 and spring 220 .
  • FIG. 12 also shows the movably connected expansion member actuator 230 and the shape changing cylindrical internal locking fenestration 240 .
  • the shape changing cylindrical fenestrated hollow cage 120 is inserted in its extended length and contracted diameter. Once properly positioned by the clinician, the shape changing cage 120 is activated so that it takes on a shortened and diametrically expanded configuration of shape changing cage 130 . In the illustrated embodiment, activation is accomplished by pulling the mechanism lock pin 250 by its manipulator 260 to remove it from the shape changing cage. Once activated the spring 220 elongates to pull together the cage components 280 and 290 . As the cage components over slide one another the locking member actuators 230 push out on the expansion member 190 to lock into the lumen of bone and pull the two bone segments 10 and 20 together and hold and compress their healing interface. The cage's fenestrations and lumens act to conduct bone to form within the lumen and across the healing site.
  • the lock pin 250 is utilized to keep the shape changing cylindrical fenestrated hollow cage 120 in its extended length and, once the lock pin 250 is withdrawn the spring 220 acts on the shape changing cylindrical fenestrated hollow cage 120 to transition to the shortened and diametrically expanded configuration of shape changing cage 130 due to mechanical properties of the spring 220 and cage materials used.
  • the materials used in fabricating the shape changing cage 120 can include nitinol, and the spring 220 maintains nitinol in the shape changing cage 120 in the form of stress induced or stress retained martensite.
  • the spring 220 When the spring 220 is released, some or all of the nitinol in the form of martensite changes in form to the form of austenite. Stress induced martensite is created when nitinol in its austenitic crystalline structure is strained.
  • shape changing cage 120 can include a different shape memory metal or can include only metal that is not a shape memory metal. With respect to the later, the shape changing cage 120 would be held in a different shape without exceeding the elastic deformation limits of the metal utilized.
  • the spring 220 is exerting effort to extend and is not used to apply compressive forces.
  • a spring can be used to provide compressive forces; however, such design is viewed as being less stable (and less advantageous) because the tension in the spring can be compromised over time.
  • FIGS. 13 - 18 are illustrative of a shape changing cage used to pull together and compress bone segments.
  • This is another example of a bone healing implant that can be positioned by the clinician while the implant does not apply mechanical force to compress the bone segments (to be healed) and, after positioning, the bone healing implant can be mechanically activated to apply the compressive mechanical force.
  • this shape changing cage does not utilize an internal spring.
  • FIG. 13 illustrates a shape changing cylindrical fenestrated hollow cage 140 in its extended length, contracted diameter and unstable state that uses its elastic material properties to close the gap 60 and compressing the bone interfaces 62 and 64 .
  • FIG. 14 illustrates the shape changing cylindrical fenestrated hollow cylinder 140 of FIG. 13 in its contracted length and expanded diameter (shape cylindrical fenestrated hollow cylinder 150 ) using its material properties to pull the gap 50 closed and compress the bone interfaces 62 and 64 .
  • FIG. 15 illustrates the orthogonal view of a bone fixation cylindrical cage 140 of FIG. 13 in its elongated and diametrically contracted pre-implantation condition with bone ingrowth fenestrations 520 and holes 510 , and elongated ribs 570 storing maximum mechanical strain energy.
  • FIG. 15 further shows instrument driving fenestrations 540 , instrument release fenestrations 550 , and shape changing bone fixation cylinder lumen 560 (for bone ingrowth).
  • FIG. 16 illustrates the orthogonal view of a bone fixation cylindrical cage 150 of FIG. 14 in its shortened and expanded post-implantation condition with bulging ribs 530 and no stored mechanical strain energy.
  • FIG. 17 illustrates the orthogonal view of the bone fixation cylindrical cage 140 of FIG. 13 in its extended and diametrically contracted pre-implantation state while locked on the implantation mandrel 153 having a bone cutting insertion tip 156 , with the mandrel lobe 155 engaged in cage instrument fenestration 550 and the driver fenestrations 540 accessible to facilitate release.
  • the mandrel lobe 155 is shown in FIG. 18 ).
  • FIG. 18 illustrates an orthogonal view of the bone fixation cylindrical cage 150 in its shortened and expanded post-implantation configuration following release from the implantation mandrel 153 through release of the mandrel lobe 155 and cage instrument release fenestration 550 .
  • the shape changing cage 140 is inserted while in its extended length and contracted diameter by the use of the insertion mandrel 153 .
  • the mandrel 153 is sharp with a cutting tip 156 on one end and is advanced into bone while turning.
  • the shape changing cage 140 is released and takes on a shortened and diametrically expanded configuration (of shape changing cage 150 ).
  • the cage 140 and mandrel 153 are counter rotated so as to unlock the cage 140 from the mandrel 153 .
  • the diameter expansion locks the cage into bone, the shortening brings the bones together and compresses, the fenestrations and lumen conduct bone through the cage and across the healing interface.
  • FIGS. 19 - 25 are illustrative of a shape changing washer and bone screw system used to pull together and compress bone segments.
  • This is an example of a bone healing implant in which compressive mechanical force is applied while the implant is being positioned by the clinician.
  • This embodiment is unique in that it uses elastic and pseudo-elastic deformation of the shape changing washer to implement and maintain the compressive forces.
  • FIG. 19 illustrates a shape changing washer 170 it its unstable state that, using the material's elastic properties, pulls on a bone screw 160 to pull together bone segments 10 and 20 to close the gap 60 .
  • FIG. 20 illustrates the shape changing washer 170 of FIG. 19 that, using the material's elastic properties, deflects its structure (shape changing washer 180 ) to pull on the bone screw 160 to pull together bone segments 10 and 20 , hold the gap 50 closed, and compress the bone segments 10 and 20 at the healing interface.
  • FIGS. 21 - 23 illustrate the shape changing of the shape changing washer 170 as it is utilized with threaded bone screw 160 .
  • FIG. 21 illustrates threaded bone screw 160 with mechanical energy storing shape changing washer 170 fully strained and storing maximum energy.
  • FIG. 22 illustrates the threaded bone screw 160 and mechanical energy storing shape changing washer 170 of FIG. 21 partially strained (mechanical energy storing shape changing washer 180 ) and storing an intermediate amount of energy.
  • FIG. 23 illustrates the threaded bone screw 160 and mechanical energy storing shape changing washer 170 of FIG. 21 fully recovered in its shape (mechanical energy storing shape changing washer 185 ) and storing no energy.
  • FIGS. 24 - 25 illustrate orthogonal views of an alternate embodiment of a shape changing washer 400 that can be used with a threaded bone screw (such as threaded bone screw 160 shown in FIGS. 21 - 23 ).
  • shape changing washer 400 is shown fully recovered in its shape changing bellows section 420 and storing no energy.
  • shape changing washer 400 is shown fully extended in its shape changing bellows section 410 and storing maximum energy.
  • the shape changing washer 170 converts its elastic mechanical energy to pull the screw 160 by deflecting to a second shape (shape changing washer 180 ).
  • the shape changing washer 185 (having no stored elastic energy) is on screw 160 .
  • the shape changing washer 185 is strained and conforms to the screw 160 and takes on the strained shape (shape changing washer 170 ). If a gap forms, the shape changing washer 170 transitions to the partially deflected stated (shape changing washer 180 ) and pulls the screw 160 to hold the gap 60 closed so that the interface 50 is in constant contact and compressed.
  • shape changing washer 400 has a bellows section that elongates and contracts to pull the bone screw 160 . Fenestrations can be placed in the walls of the washer 400 to facilitate bone ingrowth and retention.
  • the embodiments illustrated in this application are a significant advancement over the prior art rigid bone fixation implants in light of: (1) the simultaneous method of fixating bone and promoting healing, (2) the method of pulling together healing bone segments to that a gap does not form, (3) the method of minimizing non-healing due to fibrous tissue infiltration by blocking infiltration by not allowing a gap to form, (4) the method of stimulating bone cells and matrix by mechanical compression, (5) the method of stimulating bone healing through deformation of the hydroxyapitite calcium phosphate bone crystals to create current flow and bone cell recruitment to the healing wound, (6) the method of bone ingrowth and conduction through the implant and across the healing interface and (7) the incorporation of shape changing features into implants including but not limited to screws, washers, cylinders, plates, staples, rods, and external fixation devices.
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