WO2014076157A1 - Ancrages osseux prétendus et leurs procédés d'utilisation et de fabrication - Google Patents
Ancrages osseux prétendus et leurs procédés d'utilisation et de fabrication Download PDFInfo
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- WO2014076157A1 WO2014076157A1 PCT/EP2013/073769 EP2013073769W WO2014076157A1 WO 2014076157 A1 WO2014076157 A1 WO 2014076157A1 EP 2013073769 W EP2013073769 W EP 2013073769W WO 2014076157 A1 WO2014076157 A1 WO 2014076157A1
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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
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/8625—Shanks, i.e. parts contacting bone tissue
- A61B17/863—Shanks, i.e. parts contacting bone tissue with thread interrupted or changing its form along shank, other than constant taper
-
- 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
- A61B17/8685—Pins or screws or threaded wires; nuts therefor comprising multiple separate 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
- A61B17/869—Pins or screws or threaded wires; nuts therefor characterised by an open form, e.g. wire helix
-
- 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
- A61F2/30721—Accessories
- A61F2/30749—Fixation appliances for connecting prostheses to the body
-
- 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
- A61F2/38—Joints for elbows or knees
- A61F2/389—Tibial components
-
- 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
- A61B17/8052—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded
-
- 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
- A61B2017/568—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor produced with shape and dimensions specific for an individual patient
-
- 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
- A61F2002/30476—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
- A61F2002/305—Snap connection
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30565—Special structural features of bone or joint prostheses not otherwise provided for having spring elements
- A61F2002/30566—Helical springs
-
- 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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/3085—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
Definitions
- the present disclosure relates to medical devices and methods of using and manufacturing the same. More particularly, the disclosure relates to orthopedic devices used to secure implants or other materials to bone. The disclosure also relates to methods for using and manufacturing orthopedic anchoring devices.
- Knee and hip arthroplasties are becoming increasingly prevalent in our aging society.
- orthopedic implant devices are often used to replace joints that have degenerated, for example, due to traumatic injury or arthritis.
- Many orthopedic implants such as the tibial component of a total knee prosthesis, are fixed in the patient by means of an intramedullary stem.
- Such a stem has certain drawbacks.
- surgical insertion of an intramedullary stem requires reaming out the medullary cavity of a bone.
- Such an invasive procedure can cause damage to weakened or brittle bones, can cause loss of bone stock and bone density in already weakened bones, and can result in long recovery times.
- the stems are typically cemented in place, introducing polymer bone cements into the human body.
- the long-term biocompatibility of these polymer cements has not been fully established. Additionally, fixating an implant in this manner does not correspond with the natural loading, bone growth and bone remodeling mechanisms of the human body. Consequently, the bone stem can loosen over time and may result in implant failure.
- the pre-tensioned device includes a base element having a bone engagement portion, a head element having an implant engagement portion, and a tensioning element configured to create a pre-determined amount of tension within the pre-tensioned device.
- the base element also includes a base shaft extending proximally from the bone engagement portion
- the head element includes a head shaft extending distally from the implant engagement portion.
- the tensioning element has a distal end secured to the base element and a proximal end secured to the head element.
- the tensioning element extends through a central bore that includes an interior bore of the head shaft and an interior bore of the base shaft.
- the tensioning element wraps around at least a portion of an outer surface of the base shaft and at least a portion of an outer surface of the head shaft.
- the pre-tensioned device further includes a spreading element configured to move the base element distally relative to the head element to define an amount of tension in the tensioning element.
- the base shaft is disposed at least partially within or around the head shaft and is configured to move longitudinally relative to the head shaft.
- the base shaft is configured to interact with the head shaft to limit rotational movement and lateral movement of the base shaft relative to the head shaft.
- the tensioning element includes a spring having a distal end secured to the base element and a proximal end secured to the head element
- the spreading element includes a pin configured to stretch the spring by a pre-determined amount. The amount of tension within the device may be determined, in part, by the length of the pin.
- the pin is removable and the spring is configured to exert a compressive force between the implant and the bone upon removal of the pin.
- the pin is fixed, at least in part, between the base element and the head element.
- the base element, the head element, and the spring form a single, integrated unit.
- Another aspect of the disclosure provides a method of anchoring an implant to bone.
- the method includes inserting a pre-tensioned anchoring device through a hole in an implant and into a bone, wherein the anchoring device includes abase element, ahead element, and a tensioning element.
- the tensioning element has a distal end secured to the base element and a proximal end secured to the head element, and the tensioning element is set to a predetermined tension.
- the method further includes securing the base element to the bone and coupling the head element to the implant. Some embodiments further include releasing the tension in the tensioning element to exert a compressive force between the implant and the bone.
- securing the base element to the bone includes screwing or drilling at least a portion of the base element into cortical bone.
- releasing tension in the tensioning element includes at least partially removing a pin positioned at least partially between the base element and the head element.
- the anchoring device further includes a spreading element configured to move the base element distally relative to the head element to create tension in the tensioning element.
- An additional aspect of the disclosure provides a method of manufacturing a pre-tensioned orthopedic anchoring device.
- the method includes creating a device design for an orthopedic anchoring device, and manufacturing the orthopedic anchoring device based on the device design, wherein the orthopedic anchoring device is manufactured one layer at a time.
- the device design includes a base element having a bone engagement portion, a head element having an implant engagement portion, and a tensioning element having a distal end secured to the base element and a proximal end secured to the head element, wherein the tensioning element can be set to a predetermined tension.
- the device design is a digital model created on a computer.
- manufacturing the orthopedic anchoring device is performed using rapid prototyping and manufacturing techniques.
- manufacturing the orthopedic anchoring device is performed using metal sintering.
- FIG. 1 A illustrates an example of a knee with a total knee prosthesis secured using prior art methods and devices.
- FIG. IB illustrates an example of a knee with a total knee prosthesis secured, at least in part, with one embodiment of a presently disclosed anchoring device.
- FIG. 2 illustrates a perspective view of one embodiment of an anchoring device in a neutral position.
- FIG. 3 illustrates a perspective view of one embodiment of an anchoring device in a stretched position.
- FIG. 4 illustrates a perspective view of one embodiment of a spreading element.
- FIG. 5A illustrates a side view of one embodiment of an anchoring device.
- FIG. 5B illustrates a cross-section of the anchoring device of FIG. 5A taken along line 5B-5B.
- FIG. 6 illustrates a perspective view of one embodiment of an anchoring device with a spreading element in place.
- FIG. 7 illustrates a flow diagram depicting one embodiment of a method of manufacturing an anchoring device.
- the "longitudinal axis" of the anchoring device is the elongated axis running through the length of the device from a proximal head to a distal tip.
- Connected and “coupled,” and variations thereof, as used herein include direct connections, such as being contiguously formed with, or glued or otherwise attached directly to, on, within, etc. another element, as well as indirect connections where one or more elements are disposed between the connected elements.
- Connected and “coupled” may refer to a permanent or non-permanent (i.e., removable) connection.
- Siliconecured and variations thereof as used herein include methods by which an element is directly secured to another element, such as being glued, screwed or otherwise fastened directly to, on, within, etc. another element, as well as indirect means of securing two elements together where one or more elements are disposed between the secured elements.
- Proximal and distal are relational terms used herein to describe position from the perspective of a medical professional using the anchoring device.
- proximal refers to a position that is located more closely to the medical professional and to the insertion point through which the anchoring device enters a patient's body.
- Embodiments disclosed herein relate to orthopedic anchoring devices for securing materials, such as implants, to bone.
- the orthopedic anchoring devices of the present invention are configured to engage with both implants and bone and may advantageously be used to secure implants to bone without the need for an intramedullary stem.
- the orthopedic anchoring devices of various illustrated embodiments may include tensioning mechanisms configured to achieve higher compressive forces between bone and implant man can be achieved with conventional bone screws.
- the compressive forces generated by the presently disclosed orthopedic anchoring devices may pull an implant and bone towards one another, thereby reinforcing the connection between the two.
- the compressive forces may stimulate bone growth around the orthopedic anchoring device, facilitating a secure fixation within the bone.
- bone may adapt to the loads under which it is placed. When loading on a bone increases, the bone tends to adapt by growing and remodeling itself over time. Such bone growth and remodeling about the site of the orthopedic anchoring device may facilitate long-term fixation of the orthopedic anchoring device within the bone.
- FIG. 1A illustrates an example of a knee 100 with a total knee prosthesis secured using prior art methods and devices.
- the bones surrounding the knee include the femur 101 and the tibia 105.
- Knee arthroplasty i.e., total knee replacement surgery
- the joint of the knee is replaced, at least by a femoral component implant 102 and a tibial component implant 103.
- the tibial component implant 103 typically comprises a long intramedullary stem 104, included to secure the tibial component implant 103 in place.
- a patient's medullary canal inside the tibia bone 1 OS is reamed out and marrow and/or other bone components are removed. Bone cement and the intramedullary stem 104 are then inserted. This is considered an extremely invasive procedure, with long and painful recoveries.
- the embodiments described herein create an improved anchoring device such that intramedullary stems 104 may no longer be needed in at least some joint replacement surgeries.
- FIG. IB illustrates an example of a knee 100 with a total knee prosthesis secured, at least in part, with one embodiment of the presently disclosed orthopedic anchoring device 200.
- the anchoring device 200 may be inserted through a hole in an implant, such as the tibial component implant 103 of FIG. IB, and into bone 105.
- the anchoring device 200 is inserted in a pre-tensioned state and configured to engage with both the implant 103 and the bone 105.
- the anchoring device 200 of various embodiments is configured such that, once fully inserted into the implant 103 and bone 105, the anchoring device 200 can exert a compressive force between the implant 103 and the bone 105. This compressive force may advantageously stimulate bone growth about the anchoring device 200 and thus facilitate long-term fixation of the orthopedic anchoring device 200 within the bone 105.
- orthopedic anchoring device 200 for use with a knee arthroplasty implant
- one of skill in the art will readily appreciate that the presently described orthopedic anchoring device 200 can equally be used with other joint arthroplasty implants, as well as other partial joint replacement implant devices, and other bone implants more generally.
- the orthopedic anchoring device 200 set forth in this disclosure can be broadly used to secure implants, plates, and/or other materials to bone.
- FIG. 2 illustrates a perspective view of one embodiment of an anchoring device 200.
- the anchoring device 200 includes a base element 210 configured for insertion into, and engagement with, bone.
- the base element 210 includes one or more engagement features to facilitate such insertion and engagement.
- the base element 210 includes external threads 211 configured to facilitate the drilling of the base element 210 into cortical bone.
- the threads 211 are disposed on at least a portion of an outer surface of the base element 210.
- the base element 210 has a tapered and/or sharp distal tip 212 configured to facilitate insertion of the anchoring device 200 into bone.
- additional and/or different engagement features may be present, such as, for example, teem, barbs, or other protrusions disposed on the surface of the base element 210.
- the anchoring device 200 further includes a head element 220 configured for insertion into, and engagement with, an orthopedic implant.
- the head element 220 of some embodiments includes one or more engagement features or characteristics to facilitate such engagement.
- the head element 220 may be over-sized in relation to a hole within the implant through which the remainder of the anchoring device 200 passes. Such a configuration would cause a distal face of the head element 220 to contact and engage at least a portion the implant.
- the head element 220 includes external threads 221 disposed on at least a portion of an outer surface of the head element 220.
- the threads 221 of some embodiments are configured to create a frictional connection between the head element 220 and the implant into which the head element 220 is placed.
- the head element 220 of some embodiments includes a screw drive design 222 configured to facilitate rotation, and consequently insertion, of the anchoring device 200. Any screw drive design 222 known to those skilled in the art may be used, including, for example, Phillips, hex, hex socket, or a slotted design.
- the anchoring device 200 also includes a mechanism for generating tension between the base element 210 and the head element 220.
- a pre-tensioned anchoring device 200 can advantageously create a compressive force between an implant and bone, thereby facilitating long-term fixation of the anchoring device 200. Any suitable mechanism for generating tension known to those skilled in the art may be used.
- the anchoring device 200 includes a tensioning element in the form of a coiled spring 230.
- the spring 230 has a distal end secured to the base element 210 and a proximal end secured to the head element 220.
- the base element 210, the head element 220, and the spring 230 are all directly or indirectly connected.
- the base element 210 and the head element 220 can translate with respect to each other along the longitudinal axis of the anchoring device 200.
- tension can be created by stretching the spring 230 longitudinally beyond its neutral position.
- the amount of tension that can be created in a spring 230 is determined by the spring's properties, such as, for example, the material of the spring, the thickness of the spring, the free length of the spring, the number of active windings, and the size of the spring's outer diameter.
- the amount of pre-tensioning exerted on the anchoring device 200 varies according to the distance over which the spring 230 is stretched.
- the spring 230 depicted in FIG. 2 is in a relaxed or neutral position.
- FIG. 3 illustrates a perspective view of one embodiment of an anchoring device 200 wherein the spring 230 is in a stretched position.
- the base element 210 of some embodiments includes a bone engagement portion 213 and a base shaft 214.
- the base shaft 214 extends proximally from the bone engagement portion 213.
- the threads 211 and/or other bone engagement features are positioned on the bone engagement portion 213 of the base element 210.
- the head element 220 of some embodiments includes an implant engagement portion 223 and a head shaft 224.
- the head shaft 224 extends distally from the implant engagement portion 223.
- the threads 221 and/or other implant engagement features are positioned on the implant engagement portion 223 of the head element 220.
- the base shaft 214 is formed of an outer base shaft wall 215, which defines an inner bore 216
- the head shaft 224 is formed of an outer head shaft wall 225, which defines an inner bore 226.
- one of either the base shaft 214 or head shaft 224 is positioned at least partially inside the other shaft 214, 224. In such a configuration, at least a distal portion of the head shaft 224 and a proximal portion of the base shaft 214 overlap.
- the inner bores 216, 226 form one continuous central bore 240.
- the head shaft 224 and base shaft 214 are configured to translate relative to each other along the longitudinal axis of the anchoring device 200.
- the central bore 240 shortens, and as the shafts 214, 224 translate away from each other, the central bore 240 lengthens.
- the spring 230 is housed within the central bore 240.
- the head shaft 224 decreases its overlap with the base shaft 214, the central bore 240 lengthens, and the spring 230 stretches.
- the spring or other tensioning element is wrapped around at least a portion of an outer base shaft wall and at least a portion of an outer head shaft wall. Similar to the embodiment depicted in FIG. 3, in such embodiments, when a head element slides distally relative to abase element, an implant engagement portion moves closer to a bone engagement portion, the head shaft increases its overlap with the base shaft, and the spring compresses.
- the inner of the head shaft and the base shaft may be hollow or partially or substantially solid. In the various embodiments, all movement is relative, and the head element 220 and the base element 210 are configured to slide relative to the other.
- the base shaft wall 215 comprises a plurality of fixed struts 217 indirectly connected to each other by a ring 218 disposed at a proximal end of the base element 210.
- the base shaft wall 215 may be substantially uniform, forming a solid circumferential wall around the inner bore 216.
- other wall designs may be used.
- the head shaft wall 225 may be substantially uniform, forming a solid circumferential wall around the inner bore 226. In other embodiments, other wall designs may be used.
- the head shaft wall 225 comprises a plurality of struts 227 and one or more feet 228.
- the feet 228 are disposed on the distal ends of one or more of the struts 227.
- the feet 228 may connect to one, two, or more struts 227 on the head element 220.
- the feet 228 are configured to protrude radially outward from the longitudinal axis of the anchoring device 200.
- the feet 228 of the head shaft 224 are configured to extend radially outward between the struts 217 of the base shaft 214.
- the width of both the feet 228 and the spaces between the struts 217 of the base shaft 214 may be selected such that the feet 228 have a close fit, but not a tight fit, between adjacent struts 217.
- Such a configuration may advantageously allow the shafts 214, 224 to slide relative to each other along the longitudinal axis without significant frictional resistance between the feet 228 and the struts 217, while at the same time blocking all other relative movements.
- the struts 217 that comprise the base shaft wall 215 are indirectly connected to each other by a ring 218 disposed at a proximal end of the base element 210.
- a configuration may advantageously create a longitudinal blocking mechanism between the two shafts 214, 224.
- the longitudinal blocking mechanism blocks the distal end of the head shaft 224 from sliding proximally beyond the proximal end of the base shaft 214. That is, the longitudinal blocking mechanism prevents the two shafts 214, 224 from sliding so far away from each other that they completely disengage from one another. Imposing such a limit on translational movement may help protect the spring 230 from damage or failure that could result if the spring 230 were stretched too far.
- different longitudinal blocking mechanisms may be used to prevent the distal end of the head shaft 224 from sliding proximally beyond the proximal end of the base shaft 214.
- other blocking mechanisms may also have the added benefit of limiting rotational and lateral movement of the shafts 214, 224 relative to each other.
- the walls of the shafts may be solid.
- the outermost shaft may have a groove running longitudinally along an interior portion of the shaft wall.
- the inner shaft may have a complimentary ridge line that fits within the groove. Such an embodiment limits movement of the shafts to longitudinal sliding of the ridge within the groove. Rotational and lateral movement is restricted.
- the embodiment will also serve as a longitudinal blocking mechanism.
- the inner-most shaft may have an outer wall having a non-circular cross-section.
- the cross-section of the wall may form a square, hexagon, star, or other non-circular shape.
- the outer-most shaft may have a complementary-shaped inner bore.
- Various embodiments of the pre-tensioned anchoring device provide the ability to include a predetermined amount of tension in the device.
- setting a specific predetermined amount of tension is provided by controlling the longitudinal movement (e.g., the amount of stretching) experienced by the spring 230.
- the longitudinal movement e.g., the amount of stretching
- the head shaft 224 decreases its overlap with the base shaft 214, the central bore 240 lengthens, and the spring 230 stretches.
- the amount of stretching experienced by the spring 230 can be regulated by controlling the distance between the head element 220 and base element 210.
- Various components and/or mechanisms can be used to control the distance between the elements 220, 210 of the anchoring device 200.
- This disclosure contemplates and incorporates the use of any suitable component and/or mechanism known to those skilled in the art, which can hold the head element 220 and base element 210 at a fixed distance relative to each other while the anchoring device 200 is inserted through an orthopedic implant and into bone.
- FIG. 4 illustrates a perspective view of one example of a spreading element 400 configured to hold the head element 220 and base element 210 at a fixed distance relative to each other.
- the spreading element shown in FIG. 4 includes a pin 400 comprising a pin head 420 and a pin shaft 410.
- the pin 400 is sized for placement within the central bore 240 of the anchoring device and is configured to be coupled with the head element 220 and the base element 210.
- the pin head 420 comprises external threading 421 or other coupling feature(s) disposed on at least a portion of the pin head 420 for engaging the implant engagement portion 223 of the head element 220.
- the pin head 420 can be held securely in a fixed position within an inner lumen 242 of an implant engagement portion 223 (such as that shown in FIG. 5B) via a frictional fit, a snap fit, or other means of coupling known to those skilled in the art.
- the pin head 420 comprises a screw drive 422.
- the screw drive 422 may be configured to facilitate insertion, rotation, and engagement of the pin head 420 with at least part of the implant engagement portion 223.
- the pin shaft 410 has a distal tip 411 designed to interact with the bone engagement portion 213 of the base element 210.
- the distal tip 411 may comprise a flat distal face suitable for abutting and applying forces to a proximal- facing surface of the bone engagement portion 213.
- the bone engagement portion 213 may have a trough or recess 243 (see FIG. SB) configured to cradle the distal tip 411.
- the length of the selected pin 400 controls the amount of expansion and stretching experienced by the anchoring device 200. If the longitudinal length of a selected pin 400 exceeds the longitudinal length of the central bore 240 in the neutral position, the distal tip 411 will exert a translational force on the bone engagement portion 213 during insertion of the pin 400 into the anchoring device 200. The translational force results in distal longitudinal movement of the base element 210 and continues until the length of the central bore 240 accommodates the length of the selected pin 400. The spring 230 will correspondingly stretch with the longitudinal movement of the base element 210. Upon securing the pin head 420 within the head element 220, the anchoring device 200 will be held in place in this lengthened position.
- the spring 230 held in a stretched position, exerts tension on the anchoring device 200.
- a longer pin 400 will result in increased stretching of the spring 230 and increased tension, and a shorter pin 400 will result in less stretching of the spring 230 and less tension.
- Such tension will remain until the pin 400 is at least partially removed.
- the pin 400 can be removed by unscrewing the pin 400 from its position within the implant engagement element 223.
- the spring 230 upon partially or fully unscrewing the pin 400, the spring 230 is biased back towards its neutral configuration, thereby creating compressive forces on the head element 220 (and attached implant) and on the base element 210 (and attached bone).
- the pin 400 may be fixedly and/or integrally attached within the anchoring device 200, positioned at least partially between the implant engagement element 223 and the bone engagement element 213, thereby holding the spring 230 at a fixed level of tension.
- FIG. 5A and 5B illustrate a side view and a cross-sectional view, respectively, of one embodiment of an anchoring device 200.
- the base element 210 and head element 220 are connected via a spring 230, and the spring 230 is in a neutral position.
- FIG. SA illustrates the cut line used to create the cross-section illustrated in FIG. 5B.
- the above-mentioned inner lumen 242 of the implant engagement portion 223 of the head element 220 and the recess 243 within the bone engagement portion 213 of the base element 210 are visible. As shown in FIG.
- the inner lumen 242 has complementary threading or other feature(s) to facilitate insertion and stabilization of the pin head 420 within the lumen 242. Additionally, in some embodiments, the inner lumen 242 connects to the central bore 240 to form a contiguous bore through which the pin 400 can extend. In some embodiments, the pin 400 may be inserted into, and removed from, the inner lumen 242 through the aperture 241 positioned on the proximal end of the head element 220.
- FIG. 6 illustrates a perspective view of one embodiment of an anchoring device 200 with a spreading element 400 positioned within the lumen 242 (not visible) of the implant engagement portion 223 and extending through the central bore 240.
- the anchoring device 200 of FIG. 6, as currently depicted, is in a neutral position.
- the anchoring device 200 could be transitioned into a stretched position by using the threads 421 and the screw drive 422 to move the spreading element 400 distally, advancing it further into the anchoring device 200.
- the distal tip 411 (not visible) of the spreading element 400 is in contact with a proximal portion of the bone engagement element 213.
- the spreading element 400 As the spreading element 400 is advanced distally into the anchoring device 200, it will result in translational movement of the bone engagement element 213 in the distal direction and cause resultant stretching of the spring 230. Thus by advancing the spreading element 400 into the anchoring device 200, tension can be created within the anchoring device 200. The amount of tension created is dependent on the amount of stretching of the spring 230, and therefore, is dependent on the length of the spreading element 400.
- the orthopedic anchoring device 200 may be a single, integrated structure. All of the orthopedic anchoring device components, including the base element 210, the head element 220, and the tensioning element 230, may be contiguously fabricated (e.g., formed from a single mold or a single additive manufacturing process). In some embodiments, the spreading element 400 may also form part of the contiguously fabricated structure. In other embodiments, the spreading element 400 is formed separately and removably inserted into the anchoring device 200 before surgical use. In still other embodiments, no spreading element is present. In some embodiments, each component of the anchoring device 200 may be a separately-formed structure.
- fixation means must be used to securely affix the tensioning element 230 to the head element 220 and the base element 210.
- Any suitable fixation means may be used including, for example, glue, cement, welding or overmolding.
- fixation means may also be used to affix the spreading element 400 in a set position at least partially between at least a portion of the head element 220 and a portion of the base element 210.
- FIG. 7 illustrates a method of manufacturing a pre-tensioned orthopedic anchoring device, such as, for example the anchoring device 200.
- the method includes creating a device design for an orthopedic anchoring device, wherein the device design includes: a base element comprising a bone engagement portion, a head element comprising an implant engagement portion, and a tensioning element having a distal end secured to the base element and a proximal end secured to the head element, wherein the tensioning element can be set to a predetermined tension.
- the device design is a digital model formed on a computer.
- the method includes manufacturing the orthopedic anchoring device based on the device design. In the embodiment illustrated in FIG. 7, the orthopedic anchoring device is manufactured one layer at a time.
- the design of the orthopedic anchoring device may be personalized by taking into account patient-specific features when designing the device. For example, the length and/or width of the anchoring device may be tailored according to the size of the bone, the density of the bone, the size of the implant, and/or the location of implantation. Similarly, the material used to form the anchoring device and/or the amount of tension set in the tensioning element may be tailored in accordance with such factors. In some embodiments, any pre-tensioned orthopedic anchoring device, including, for example, the pre-tensioned orthopedic anchoring device embodiments described above, may be manufactured through the manufacturing method described herein.
- the pre-tensioned orthopedic anchoring device is partially or completely made by additive manufacturing, which creates a three-dimensional (3- D) object by laying down successive layers of material.
- additive manufacturing allows for the creation of a single unit in which the base element, head element, and tensioning element are formed together as an integrated device (in contrast to separately molded components that need to be coupled together after the molding process).
- Additive manufacturing technologies enable the manufacturing of intricately detailed devices at a sufficiently small scale to be useful for orthopedic anchoring.
- the 3-D object is often created directly from a digital model. Building from a digital model rather than, for example, a pre-formed mold, allows for relatively quick and inexpensive personalization and modification of the design. Accordingly, additive manufacturing allows for the integration of patient-specific features. For converting the design's digital image information into a three-dimensional object, any suitable technique known in the art may be used, such as, for example, a rapid prototyping technique.
- Rapid Prototyping and Manufacturing may be defined as a group of techniques used to quickly fabricate a scale model of an object typically using three- dimensional (3-D) computer aided design (CAD) data of the object.
- CAD computer aided design
- SLA stereolithography
- SLS Selective Laser Sintering
- FDM Fused Deposition Modeling
- foil-based techniques including, for example, foil-based techniques.
- a common feature of these techniques is that objects are typically built layer by layer.
- Stereolithography presently the most common RP&M technique, utilizes a vat of liquid photopolymer "resin" to build an object one layer at a time.
- an electromagnetic ray e.g. one or several laser beams that are computer-controlled
- traces a specific pattern on the surface of the liquid resin the pattern defined by the two-dimensional cross-sections of the object to be formed.
- Exposure to the electromagnetic ray cures, or solidifies, the pattern traced on the resin and adheres it to the layer below.
- the platform descends by a single layer thickness and a subsequent layer pattern is traced, adhering to the previous layer.
- a complete 3-D object can be formed by this process.
- Fused deposition modeling (FDM) and related techniques make use of a temporary transition from a solid material to a liquid state, usually due to heating.
- the material is driven through an extrusion nozzle in a controlled way and deposited in the required place as described, for example, in U.S. Pat. No. 5,141,680, the entire disclosure of which is hereby incorporated by reference.
- Foil-based techniques fix coats to one another by means of gluing or photo polymerization or other techniques and cut the object from these coats or polymerize the object.
- Such a technique is described in, for example, U.S. Pat. No. 5,192,539, also incorporated by reference in its entirety.
- RP&M techniques start from a digital representation of the 3-D object to be formed.
- the digital image is sliced into a series of cross-sectional layers which can be overlaid to form the object as a whole.
- the RP&M apparatus uses this data for building the object on a layer-by-layer basis.
- the cross-sectional data representing the layer data of the 3-D object may be generated using a computer system and computer aided design and manufacturing (CAD/CAM) software.
- a selective laser sintering (SLS) apparatus may be used for the manufacture of an orthopedic anchoring device template, instead of a computer model.
- Selective laser sintering (SLS) uses a high power laser or another focused heat source to sinter or weld small particles of plastic, metal, or ceramic powders into a mass representing the 3-D object to be formed. It should be understood however, that various types of rapid manufacturing and tooling may be used for accurately fabricating these orthopedic anchoring devices including, but not limited to, stereolithography (SLA), Fused Deposition Modeling (FDM) or milling.
- SLA stereolithography
- FDM Fused Deposition Modeling
- the orthopedic anchoring devices described above may be manufactured using different materials.
- the orthopedic anchoring device may be fabricated from a polyamide such as PA 2200 supplied by EOS, Kunststoff, Germany.
- PA 2200 supplied by EOS, Kunststoff, Germany.
- only materials that are biocompatible (e.g. USP class VI compatible) with human bone are used.
- the base element may be formed from any biocompatible material that attaches well to bone, and the head element may be formed from a material that attaches well to the selected orthopedic implant.
- polylactic acid (PLA), polyether-emer- ketone (PEEK), titanium, or any other suitable plastic, metal, metal alloy, or composite material may be used to form all or part of the orthopedic anchoring device.
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medical Informatics (AREA)
- Neurology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Physical Education & Sports Medicine (AREA)
- Prostheses (AREA)
Abstract
L'invention concerne des dispositifs et des procédés pour ancrer des implants dans un os. Un dispositif prétendu (200) pour ancrer un implant dans un os comprend un élément de base (210), un élément de tête (220) et un élément de mise sous tension (230). L'élément de base comprend une partie de mise en prise d'os (213), et l'élément de tête comprend une partie de mise en prise d'implant (223). L'élément de mise sous tension peut servir à créer un degré de tension prédéterminé à l'intérieur du dispositif. Un procédé d'ancrage d'un implant dans un os peut comprendre l'introduction dans un os d'un tel dispositif, à travers un trou dans un implant, avec l'élément de mise sous tension réglé à une tension prédéterminée.
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US201261726499P | 2012-11-14 | 2012-11-14 | |
US61/726,499 | 2012-11-14 |
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WO2014076157A1 true WO2014076157A1 (fr) | 2014-05-22 |
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PCT/EP2013/073769 WO2014076157A1 (fr) | 2012-11-14 | 2013-11-13 | Ancrages osseux prétendus et leurs procédés d'utilisation et de fabrication |
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EP3226787A4 (fr) * | 2014-12-02 | 2018-08-15 | Activortho, Inc. | Dispositifs de compression active, procédés d'assemblage et procédés d'utilisation |
US10575886B2 (en) | 2018-05-09 | 2020-03-03 | Warsaw Orthopedic, Inc. | Bone screw and method of manufacture |
US10939944B2 (en) | 2018-04-18 | 2021-03-09 | Glw, Inc. | Removable orthopedic screws |
US10993753B2 (en) | 2018-05-09 | 2021-05-04 | Warsaw Orthopedic, Inc. | Bone screw and method of manufacture |
US11191582B2 (en) | 2018-05-09 | 2021-12-07 | Warsaw Orthopedic, Inc. | Bone screw and method of manufacture |
US11224470B2 (en) | 2018-05-09 | 2022-01-18 | Warsaw Orthopedic, Inc. | Bone screw and method of manufacture |
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