WO2023208389A1 - Implants en alliage de titane pliables - Google Patents

Implants en alliage de titane pliables Download PDF

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Publication number
WO2023208389A1
WO2023208389A1 PCT/EP2022/061632 EP2022061632W WO2023208389A1 WO 2023208389 A1 WO2023208389 A1 WO 2023208389A1 EP 2022061632 W EP2022061632 W EP 2022061632W WO 2023208389 A1 WO2023208389 A1 WO 2023208389A1
Authority
WO
WIPO (PCT)
Prior art keywords
flange
cage
bending
implant
bend
Prior art date
Application number
PCT/EP2022/061632
Other languages
English (en)
Inventor
Edward Patrick Kavanagh
David Horne
Charlie WESTON
Ian FLATTERS
João Arranhado NEVES
Fionnán Aodhán Mcnamara
Enda LEAVY
Karen MCKINLAY
Nazir Ahmed KARBANEE
Phillipa CLARKSON
Original Assignee
Depuy Ireland Unlimited Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Depuy Ireland Unlimited Company filed Critical Depuy Ireland Unlimited Company
Priority to PCT/EP2022/061632 priority Critical patent/WO2023208389A1/fr
Publication of WO2023208389A1 publication Critical patent/WO2023208389A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/32—Joints for the hip
    • A61F2/34—Acetabular cups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4684—Trial or dummy prostheses
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
    • 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
    • A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
    • 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
    • A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30948—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/3097—Designing or manufacturing processes using laser
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30978—Designing or manufacturing processes using electrical discharge machining [EDM]
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/34—Acetabular cups
    • A61F2002/3401—Acetabular cups with radial apertures, e.g. radial bores for receiving fixation screws
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/34—Acetabular cups
    • A61F2002/3429—Acetabular cups with an integral peripheral collar or flange, e.g. oriented away from the shell centre line
    • A61F2002/3432—Acetabular cups with an integral peripheral collar or flange, e.g. oriented away from the shell centre line having apertures for receiving fixation screws
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/34—Acetabular cups
    • A61F2002/348—Additional features
    • A61F2002/3495—Spherical shell significantly smaller than a hemisphere, e.g. extending over less than 160 degrees
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Definitions

  • the present invention relates to titanium-alloy implants, and more particularly to processes for rapidly manufacturing such implants and providing such implants with increased malleability.
  • an implantable device includes a portion that is constructed such that at least a majority of the portion, as measured by volume, comprises Ti64 (Ti-6A1-4V) alloy. Additionally, the portion is bendable to a bend angle of at least about 50-degrees about a bend axis while maintaining structural integrity.
  • an acetabular cage has a dome for insertion within an acetabulum and a flange that is monolithic with the dome and is for affixation to a portion of an ilium.
  • the dome and the flange are constructed of Ti64 alloy. At least a portion of the flange is bendable to a bend angle of at least about 90 degrees about a bend axis while maintaining structural integrity.
  • a method of preparing an implant for implantation includes bending a portion of the implant to a bend angle of at least about 50-degrees about a bend axis. At least a majority of the portion as measured by volume comprises Ti64 alloy. The portion maintains structural integrity during and after the bending step.
  • FIG. 1 A is a perspective view of a surgical implant attached to patient anatomy, according to an embodiment of the present disclosure
  • Fig. IB is a perspective view of the implant attached to a complimentary second implant and to patient anatomy, according to an embodiment of the present disclosure
  • Fig. 1C is a perspective view of the implant illustrated in Fig. 1A;
  • Fig. ID is another perspective view of the implant illustrated in Fig. 1A;
  • FIGs. IE and IF are perspective views of additional embodiments of a surgical implant similar to the implant shown in Fig. 1 A, each according to an embodiment of the present disclosure
  • FIG. 2A is a perspective view of a partially manufactured version of the implant illustrated in Fig. 1 A, shown at an example build orientation with respect to an additive manufacturing powder bed;
  • FIG. 2B is a perspective view of a partially manufactured version of the implant illustrated in Fig. 1 A, shown at an alternative build orientation with respect to the powder bed;
  • FIGs. 3A and 3B show magnified views of exemplary grain structures of a Ti64 alloy having increased malleability for use in implant construction; the grain structures shown in Figs. 3A and 3B were produced in the same Ti64 material using slightly different custom heat treatment processes, which allow the size of the alpha-phase lamella to be tailored; for example, the average width of the alpha-phase lamella in Fig. 3B are larger than those of Fig. 3 A;
  • FIGs. 3C and 3D show additional magnified views of grain structure of the Ti64 alloy produced using the same custom heat treatment process used to produce the grain structure shown in Fig. 3B;
  • FIG. 3E shows a magnified view of a grain structure of a prior art sample of ISO 20160 alpha+beta titanium alloy
  • Figs. 4A and 4B are charts showing tensile test results of structural test members having grain structures that are substantially similar to the grain structure illustrated in Figs. 3A- 3B;
  • Fig. 5A is a chart comparing bend test data of structural test members having grain structures that are substantially similar to the grain structure illustrated in Figs. 3A-3B with structural test members lacking the aforementioned grain structure;
  • Fig. 5B is a photograph of the resulting bent structural test members having grain structures that are substantially similar to the grain structure illustrated in Figs. 3A-3B, following the bending tests used to generate the results illustrated in Fig. 5 A;
  • Fig. 5C is a photograph of the resulting bent structure test members that lack the grain structure illustrated in Figs. 3A-3B, following the bending tests used to generate the results illustrated in Fig. 5 A;
  • Fig. 5D is a chart comparing additional bend test data of structural test members having grain structures that are substantially similar to the grain structure illustrated in Figs. 3A- 3B with structural test members lacking the aforementioned grain structure;
  • Fig. 6 is a chart showing yet additional bend test data of structural test members having various thicknesses and having grain structures that are substantially similar to the grain structure illustrated in Figs. 3A-3B;
  • Fig. 7 is an exploded, perspective view of a surgical system having a bendable implant and a bendable, hardenable trial member, according to an embodiment of the present disclosure.
  • titanium-based as used herein with respect to an object, such as an implant, means constructed predominantly of titanium (Ti) or a titanium alloy.
  • the term “plurality”, as used herein, means more than one. When a range of values is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. All ranges are inclusive and combinable. [0028]
  • the terms “approximately”, “about”, and “substantially”, as used herein with respect to dimensions, angles, ratios, and other geometries, takes into account manufacturing tolerances. Further, the terms “approximately”, “about”, and “substantially” can include 10% greater than or less than the stated dimension, ratio, or angle. Further, the terms “approximately”, “about”, and “substantially” can equally apply to the specific value stated.
  • the embodiments disclosed herein pertain to titanium-alloy surgical implants having superior strength and also increased malleability, which allows the implants to be bent intra-operatively, such as for shaping to correspond to associated patient anatomy.
  • the surgical implants disclosed herein are also suitable for rapid manufacturing via additive manufacturing processes and subsequent heat treatment processes configured to provide the manufactured implant with increased malleability.
  • Titanium (Ti) and various titanium alloys have mechanical properties that make them desirable for surgical implants, including strength, lighter weights (lower density) compared to other implant materials (e.g., stainless steel), durability, resistance to repeated loads, the ability to withstand strain (e.g., during internal fixation to patient anatomy), corrosion resistance, biocompatibility, and the ability to bond with bone.
  • Ti-alloy implants possess many of these superior properties, they tend to be difficult to bend, particularly during intra-operative shaping processes for matching the implant shape to patient anatomy.
  • the titanium-alloy implants disclosed herein have grain structures that provide the implants with increased malleability, which allows for intra-operative bending, such as for shaping the implants to associated patient anatomy.
  • Non-limiting examples of types of surgical implants that benefits from the malleable titanium-alloy discloses herein includes acetabular cages, craniomaxillofacial (CMF) plates, and trauma bone plates.
  • FIG. 1A-1C an exemplary implant 2 for hip repair is shown.
  • the illustrated implant 2 is referred to herein as an “acetabular cage” 2 and is configured for affixation to the acetabulum 5 for repair of various acetabular defects in the pelvis 3.
  • the cage 2 includes a socket portion or “dome” 4 shaped for insertion and affixation within the acetabulum 5.
  • the cage 2 also includes a first flange 6 that extends from the dome 4 and is configured for affixation to the ilium 7 of the pelvis 3.
  • the first flange 6 is also referred to herein as the “iliac flange” 6.
  • the iliac flange 6 also defines a bend 8, particularly an S-type bend (“S-bend”) 8, at a portion thereof proximate the dome 4.
  • the S-bend 8 is configured to accommodate and generally conform to the geometry of the acetabular margin (rim) 11 and the body of ilium 13.
  • the iliac flange 6 can also define a neck 15 adjacent the dome 4. The neck 15 is configured for facilitating engagement of the iliac flange 6 with the acetabular margin 11 and also for facilitating bending and/or twisting of the iliac flange 6 to match patient anatomy.
  • the cage 2 can also include an optional second flange 10 that extends from the dome 4 at a location generally opposite the iliac flange 6 and is configured for affixation to the ischium 9 of the pelvis 3.
  • the second flange 10 is also referred to herein as the “ischial flange” 10.
  • the cage 2 can be formed having the iliac flange 6 but lacking an ischial flange.
  • the dome 4 can be configured to seat within the acetabulum 5 and contact the acetabular surface(s) (e.g., the articulate (lunate) surface, the acetabular fossa, and/or reamed or otherwise surgically modified portions thereof), as shown in Fig. 1A, and can also be configured to seat within an acetabular cup 12 that is, in turn, in direct contact with the acetabular surfaces, as shown in Fig. IB
  • the cage 2 has sufficient malleability to allow a surgeon to manipulate, bend, and shape portions thereof so as to conform to the shape of adjacent patient anatomy.
  • the iliac flange 6 and the optional ischial flange 10 can be bent and shaped to have contours that match the associated contours of the ilium 7 and ischium 9, respectively.
  • One or more portions of the cage 2 can have geometric features that further facilitate bending.
  • the neck 15 of the iliac flange 6 is configured to facilitate bending, twisting, and shaping of the iliac flange 6.
  • the cage 2 has a first or inner surface 14 that is configured to face the pelvis when implanted and an opposed second or outer surface 16 that is configured to face away from the pelvis 3 when implanted.
  • the cage 2 defines a thickness T measured between corresponding portions of the inner and outer surfaces 14, 16 along a direction orthogonal thereto.
  • the cage thickness T is preferably in a range of about 0.5 mm to about 3.0 mm, and more particularly in a range of about 0.9 mm to about 2.2 mm, and more particularly in a range of about 0.9 mm to about 1.5 mm.
  • one or more portions of the cage 2 can have a reduced thickness relative to various other portions of the cage 2.
  • the portion(s) having reduced thickness can be configured to facilitate bending and shaping along such portion(s).
  • the cage 2 has a first or superior end 18, which is located at the end of the iliac flange 6, and a second or inferior end 20, which, in the embodiments having the ischial flange 10, is located at the end of the ischial flange 10. In embodiments lacking an ischial flange, the inferior end 20 of the cage 2 can be at the inferior-most edge of the dome 4.
  • the cage 2 also has an anterior side 22 and an opposed posterior side 24.
  • anatomical directional terms such as “medial”, “lateral”, “superior”, “inferior”, “anterior”, and “posterior”, when used herein with reference to an implant, such as the acetabular cage 2, refer generally to the relative positions of the implant as it is configured to be oriented when implanted.
  • the cage 2 includes fixation features for affixation to bone.
  • the dome 4, the iliac flange 6, and the optional ischial flange 10 can each include one or more respective fixation holes 26a, b for receiving respective fixation members, such as bone screws, for affixing the associated portion of the cage 2 to underlying bone.
  • the iliac flange 6 and/or the optional ischial flange 10 can include one or more flange holes 26a for affixing the respective flange 6, 10 to underlying bone.
  • One or more of the flange holes 26a can also have interior threads for locking with complimentary threads on the exterior of a head of a locking screw.
  • one or more of the flange holes 26a can extend through the respective flange 6, 10 along a central hole axis 27 that is oriented at an angle Al offset from a transverse axis 29 extending orthogonally through the inner and outer surfaces 14, 16 of the cage 2 adjacent the hole 26a.
  • a hole 26a can be referred to as an “angled hole.”
  • one or more of the flange holes 26a, including angled and non-angled holes 26a can have threads or other locking structures for engaging, in locking fashion, complimentary threads on the head of a variable-angle (VA) locking screw, thereby providing VA fixation therewith.
  • VA variable-angle
  • the inclusion of at least one angled flange hole 26a can provide significant advantages for the cage 2.
  • One such advantage is that the angle Al of the hole 26a can be tailored to provide a targeted insertion trajectory for the associated bone screw.
  • the angle Al can be adapted for tailoring the insertion trajectory to the particular geometry of the target portion of bone, which can provide enhanced fixation with the target portion of bone.
  • the angle Al of a hole 26a on the iliac flange 6 can be adapted to provide an insertion trajectory that is tailored for the particular geometry of the target portion of ilium, such as an insertion trajectory that is substantially parallel with the bone stock at the target ilium portion.
  • the angle Al can be adapted to increase the efficiency at which the bone screw bites into or otherwise engages the target bone.
  • Another advantage of angled holes 26a is that the angle Al can be adapted to reduce the amount of soft tissue disruption (e.g., incision, resection, and/or retraction) adjacent the hole 26a.
  • the angle Al of a hole 26a in the iliac flange 6 can be tailored to reduce the amount of gluteal muscle resection necessary to affix the iliac flange 6 to the associated portion of the ilium.
  • VA locking hole(s) 26a in the iliac and/or ischial flange 6, 10 can be configured as more fully described in U.S. Patent 10,772,665, issued September 15, 2020, in the name of Bosshard et al. (“the '665 Reference”); and U.S. Patent 11,013,541, issued May 25, 2021, in the name of Bosshard et al. (“the '541 Reference”), the entire disclosures of each of which are hereby incorporated by reference herein.
  • one or more of the holes 26a in the iliac and/or ischial flange 6, 10 can be a VA locking hole 26a having a polygonal hole shape (as viewed in a reference plane orthogonal to a central axis of the respective hole), such as a trigonal hole shape.
  • the iliac flange 6 and/or the optional ischial flange 10 can include one or more trigonal VA locking flange holes 26a, which can be configured as more fully described in U.S. Patent 11,179,180, issued November 23, 2021, in the name of Oberli et al. (“the '180 Reference”); and U.S. Patent Publication No.
  • the dome 4 can have one or more fixation holes 26b that are preferably configured to align with one or more corresponding fixation holes in the acetabular cup 12.
  • Select portions of the cage 2 can have grip features for providing a stronger contact interface with the underlying bone.
  • one or more select portions of the inner surface 18 can have ridges thereon for pressing into underlying bone in a manner enhancing fixation.
  • the cage 2 material along one or more select portions of the inner surface 18 can be porous, i.e., can have a porous three-dimensional (3D) structure that defines a multiplicity of pores, which can be tailored according to various design objectives, such as for promoting boney ingrowth into the pores for enhanced post-surgery fixation with the underlying bone, by way of a non-limiting example.
  • 3D three-dimensional
  • the implants of the present disclosure are constructed of a titanium alloy, particularly a titanium-aluminum-vanadium alloy: Ti-6A1-4V (“Ti64”).
  • Ti64 titanium-aluminum-vanadium alloy
  • This particular titanium alloy (Ti64) is advantageous for the construction of implants because Ti64 is stronger and withstands fatigue better than titanium (including grades of “commercially pure” titanium (Ti-CP)) and other titanium alloys.
  • prior art implants, such as acetabular cages that are constructed of Ti64 are difficult to bend, particularly by a physician intra-operatively, and particularly without crack formation at the bend regions.
  • Ti64 as the implant material also allows the cage 2 to be rapidly manufactured by an additive manufacturing process, such as a laser-activated powder bed fusion (PBF) process, which forms the cage 2 into a desired, pre-operative shape.
  • PPF laser-activated powder bed fusion
  • the geometry of the cage 2 can be created in three-dimensional (3D) virtual space, thereby providing a 3D virtual model of the cage 2.
  • the rapid additive manufacturing processes can be employed to create the physical version of the cage 2 possessing the geometry and features of 3D virtual model.
  • the 3D virtual model of the cage 2 can optionally be designed with the assistance of patient scan data of the specific anatomy to which the cage 2 will be affixed.
  • Such patient scan data can include, by way of a non-limiting example, a series of CT-scan slices of the acetabulum and the adjacent portions of the ilium 7 and ischium 9.
  • the iliac flange 6 and the optional ischial flange 10 can be tailored in 3D virtual space to have contours that correspond to those of the respective portions of the ilium 7 and ischium 9 to which the flanges 6, 10 will affix.
  • the rapid additive manufacturing processes can be employed to create the cage 2 possessing the tailored, patient-specific 3D virtual geometry.
  • the cage 2 can be constructed using a laser-activated PBF process, which can also be referred to as a laser-fusion process, which encompasses selective laser sintering (SLS) and selective laser melting (SLM) processes.
  • SLS selective laser sintering
  • SLM selective laser melting
  • a non-limiting example of a laser-fusion process for building a cage 2 will now be described.
  • a thin layer of powder is dispensed on a working table (frequently referred to as the “build platform”), so that at least one layer of powder forms a powder bed.
  • the powder comprises constituent particles of Ti64 material, which particles can be of various sizes, size distributions, and geometrical shapes, which powder characteristics can be selected based parameters conducive for favorable fusing and fused grain structure of the built cage 2.
  • the terms “build”, “built”, and derivates thereof refer to the construct formed by fusing particles within the powder bed together by the PBF process. Selected areas of the top surface of the powder layer (the “build surface”) are fused by exposure to a directed energy source, typically a laser beam. The exposure pattern of the laser beam thus forms a cross-section of the three-dimensional object.
  • the cage 2 is built through consecutive fusion of so-formed cross-sections that are stacked in layer-by-layer fashion along a vertical direction. Between the fusion of each layer, the build platform is incremented downward and a new layer of powder is deposited onto the build surface.
  • steps e.g., lowering the working table, distributing a new powder layer atop the powder bed, and exposing the new powder layer to the laser source 1 are repeated, layer-by-layer, as needed, thereby fabricating the cage 2 as a plurality of consecutively fused cross-sectional layers.
  • the laser-fusion process can also be characterized as a 3D printing process. Accordingly, the term “built” can be used synonymously herein with the term “printed.”
  • the cage 2 can be built at various orientations in the power bed. Two non-limiting examples of such build orientation are shown in Figs. 2A-2B. As shown in Fig. 2A, the cage 2 can be built so that the outer surface 16 faces downward in the powder bed (and so that the inner surface 14 faces upward in the powder bed). Alternatively, as shown in Fig. 2B, the cage 2 can be built so that the anterior side 22 faces downward (and the posterior side 24 faces upward) in the powder bed. At either of these build orientations (and at other build orientations), the cage 2 can be built with a base member 30 of stock material underneath, which base member 30 can be employed as a support structure during post-build processes and subsequently removed.
  • the cage 2 can be built in the powder bed without fixation holes, which can be subsequently formed in the cage 2 during a machining process, such as by a multi-axis Computer Numerical Control (CNC) machine.
  • CNC Computer Numerical Control
  • the cage 2 can be built having fixation holes, which can be further machined and finished in a subsequent machining process.
  • the dome 4 can optionally be built without support structures (i.e., stock material) under the dome 4, as shown. In other embodiments, the dome 4 can be built with support structures underneath, which are subsequently removed.
  • the majority of the cage 2 can be built having a solid structure (e.g., having a 100 percent infill density).
  • one or more portions of the cage 2 can have less than 100 percent infill density, such as an infill density in a range from about 50 percent to about 99.9 percent, and can thus have less density than the solid portion(s).
  • the infill density being less than 100 percent can be caused by such portions being porous.
  • such one or more portions of the inner surface 14 of the cage 2 can be porous, as described above, for promoting bone growth into such surface portion(s) of the cage 2.
  • Such porous portions of the cage 2 can be rapidly manufactured according to the techniques and features more fully described in U.S. Patent Application No.
  • the cage 2 is subjected to one or more treatment processes, such as one or more heat treatment processes, for modifying the grain structure of the as-printed Ti64 implant material in a manner increasing the malleability of the cage 2, particularly for allowing a surgeon to bend portions of the cage 2 intra-operatively, without cracking, breaking, or otherwise causing mechanical failure in such portions.
  • the Ti64 grain structure is modified from the as-printed metastable martensitic structure to lamellar alpha+beta phase with tailorable lamella size to provide the increased malleability disclosed herein.
  • Figs. 3A-3D the resulting grain structure is shown of samples of Ti64 that were printed and treated according to the embodiments herein.
  • Figs. 3A and 3B show magnified views of exemplary grain structures of respective printed Ti64-alloy samples that were produced using Ti64 powder having the same characteristics and subjecting the printed samples to slightly different custom heat treatment processes. It can be seen that the average width of the alpha-phase lamella a in Fig. 3B are larger than those of Fig. 3A, indicating that the size of the alpha-phase lamella a can be tailored, particularly increased, which has been observed to increase malleability. Referring now to Figs.
  • Fig. 3D The treatment processes herein allow for the production of alpha-phase lamella a have an increased size, including an increased width Wa (Fig. 3D), which results in more malleable material, albeit at the expense of material strength.
  • Cylindrical samples of printed, treated Ti64 produced according to the embodiments herein have been observed to undergo elongation in a range of 15%-23% during testing, which is a significant improvement over prior art Ti64.
  • Fig. 3E shows the grain structure (including lamella) of a sample of a ISO 20160 alpha+beta titanium alloy.
  • the image shown in Fig. 3E is a micrograph Al 1 from ISO 20160-2006 taken at 200x magnification.
  • the built, treated cage 2 can be subjected to further processes, such as one or more machining, polishing, roughening, and/or coating processes as needed.
  • one or more additional holes can be formed in the cage 2, such as by drilling, milling, punching, and cutting, by way of non-limiting examples. It should be appreciated that hole(s) can be formed in the cage 2 for the purpose of increasing the cage bendability at portions adjacent the hole(s).
  • additional machining processes such as wire electrical discharge machining (wire EDM), for profile cutting the cage 2, including for removing the support structures.
  • the built, treated cage 2 demonstrates material properties that have superior malleability than prior art Ti64 components of similar thickness.
  • Figs. 4A-4B two sets of tension test results are shown for printed and finished Ti64 tensile bars produced with tailored heat treatments.
  • Fig. 4A six (6) specimens of printed, treated Ti64 cylinders were subjected to tensile tests at room temperature measuring the following four (4) qualities: (1) ultimate tensile strength (measured in megapascals (MPa)); (2) yield strength at 0.2% offset (also referred to as a 0.2% proof test) (measured in MPa); (3) percent elongation after fracture; and (4) percent reduction in area.
  • MPa megapascals
  • yield strength at 0.2% offset also referred to as a 0.2% proof test
  • Fig. 4B three (3) specimens of printed, treated Ti64 cylinders were subjected to similar tensile tests, measuring various qualities, among which are the same four (4) qualities measured in Fig. 4A: (1) ultimate tensile strength (“UTS”) (measured in MPa); (2) yield strength at 0.2% offset (“0.2% proof test”) (measured in MPa); (3) percent elongation after fracture (“Elongation A%”); and (4) percent reduction in area (“Reduction of area Z%”).
  • UTS ultimate tensile strength
  • Elongation A% percent elongation after fracture
  • Reduction of area Z% percent reduction in area
  • Figs. 4A-4B demonstrate that the printed, treated Ti64 samples measured significantly high elongations, specifically from about 15% to about 23%, at mere modest sacrifices in yield strength and ultimate tensile strength. It should be noted that elongations of 15-23% represent a significant advantage over prior art 3D-printed Ti64 constructs.
  • Figs. 5A-5C results are shown for three-point bending tests performed on five different samples of plate-like test coupons: (1) “Ti CP2 Anneal 1.34 mm” - annealed Commercially Pure (CP) Grade 2 titanium having a thickness of 1.34 mm; (2) “Ti CP2 Stress Relief 1.34 mm” - stress relieved Commercially Pure (CP) Grade 2 titanium having a thickness of 1.34 mm; (3) “Ti CP2 Anneal 1.57 mm” - annealed Commercially Pure (CP) Grade 2 titanium having a thickness of 1.57 mm; (4) “Ti64 CHT 1.34 mm” - Ti64 alloy, heat treated (custom heat treatment (CHT)), having a thickness of 1.34 mm; and (5) “Ti64 HIP 1.34 mm” - Ti64 alloy, heat-treated via Hot Isostatic Pressing (HIP), having a thickness of 1.34 mm.
  • CHT custom heat treatment
  • test coupons of samples (1 )-(5) were rapidly manufactured using a laser-fusion PBF process and an approximate length of 50 mm and a width of 20 mm. Each sample was subject to a bending displacement target of 8 mm, which would be equivalent to a bend angle superior to 90 degrees using a test setup consistent with the requirements of ASTM E290, and the displacement versus applied force was charted. Furthermore, the bend tests were performed by bending the test coupons about a mandrel having a 5-mm diameter.
  • sample (4) (Ti64 CHT 1.34 mm) was able to bend to the full test displacement (equivalent to a minimum bend angle of 90 degrees), with a maximum applied force of about 3.25 kN, which is satisfactory for a cage 2 (particularly, a flange thereof) having the same thickness to be bent intra-operatively by a surgeon, such as for conforming the shape of the cage 2 to associated patient anatomy.
  • These results compare favorably to the samples of commercially pure titanium, particularly considering the increased strength of Ti64 relative to commercially pure titanium.
  • Fig. 5A sample (4) (Ti64 CHT 1.34 mm) was able to bend to the full test displacement (equivalent to a minimum bend angle of 90 degrees), with a maximum applied force of about 3.25 kN, which is satisfactory for a cage 2 (particularly, a flange thereof) having the same thickness to be bent intra-operatively by a surgeon, such as for conforming the shape of the cage 2 to associated patient anatomy.
  • FIG. 5D further bending tests indicate that cage thickness is a significant factor for bendability.
  • the results shown in Fig. 5D are based on similar three-point bending tests discussed above with reference to Figs. 5A-5C, performed on three different test coupons: (6) “Ti64 CHT 1.34 mm” - Ti64 alloy, heat treated, having a thickness of 1.34 mm (the same sample parameters as sample (4) shown in Fig.
  • portions of the cage 2 that are adapted for bending should be formed at a thickness less than 1.64 mm and preferably closer to 1.5 mm.
  • FIG. 6 yet further bending tests indicate that implant thicknesses up to about 1.5 mm can be bent to a target test displacement of about 8 mm (equivalent to a bend angle superior to 90 degrees using a test setup consistent with the requirements of ASTM E290) without failing.
  • a target test displacement of about 8 mm (equivalent to a bend angle superior to 90 degrees using a test setup consistent with the requirements of ASTM E290) without failing.
  • four (4) sample groups of test coupons having thicknesses of 0.9 mm, 1.1 mm, 1.3 mm, and 1.5 mm, respectively, were subjected to three-point bending tests similar to those discussed above with reference to Figs. 5A-5D.
  • Each sample group shown in Fig. 6 included eight (8) test coupons of the respective thickness. As shown, each of these sample groups was able to achieve the target test displacement (8 mm, 90+ degrees) without failure.
  • the bendable Ti64 acetabular cages 2 disclosed herein provide the strength and other associated benefits of Ti64 while also allowing a surgeon to bend portions of the cage 2 intra-operatively as needed to correspond to patient anatomy.
  • a hip repair surgery such as a surgery for treating an acetabular defect, such as a Type 2A, Type 2B, Type 2C, Type 3A, or Type 3B acetabular defect
  • the surgeon can expose and prepare the acetabulum for receiving an acetabular cup 12, such as by removing soft tissue from the acetabulum and surrounding area and optionally reaming the acetabulum. With the acetabulum prepared, the surgeon can insert the cup 12 therein with the cup holes at the desired orientation.
  • the surgeon can move the acetabular cage 2 into position adjacent the cup 12, particularly by bringing the dome 4 of the cage 2 into contact with, or at least close proximity to, the concave, exposed surface of the cup 12 so that at least one of the holes 26b in the dome 4 align with at least one corresponding hole in the cup 12.
  • the surgeon can bend and shape the iliac flange 6 so as to have a contour that approximates the contour of the portion of the ilium to which the iliac flange 6 will contact.
  • the surgeon need not maintain the cage 2 in contact with or close proximity to the cup 2 while bending the iliac flange 6 to the desired shape.
  • the surgeon can elect to bring the cage 2 into such position to visually reference the iliac flange 6 with respect to the corresponding portion of the ilium and then bring the cage 2 into a more comfortable position for performing the bending.
  • This bending and shaping process can also be iterative, whereby the physician can bring the cage 12 into contact with and/or close proximity to the cup 12 to visually reference the iliac flange 6 with respect to the corresponding portion of the ilium, can then bring the cage 2 to a more comfortable position for performing the bending, and can return the cage 2 to contact with or close proximity to the cup to further visually reference the iliac flange 6 relative to the corresponding portion of the ilium, repeating these steps until a satisfactory contour and shape is implanted to the iliac flange 6.
  • the surgeon can bend and shape the ischial flange 10 so as to have a contour that approximates the contour of the portion of the ischium to which the ischial flange 10 will contact. It should be appreciated that the surgeon can employ similar steps for shaping the ischial flange 10 as those described above for shaping the iliac flange 6. To affix the cage 2 and the cup 12 to the acetabulum, the surgeon can insert locking members, such as bone screws, through one or more of the aligned holes in the dome 4 and cup 12.
  • the surgeon will also insert one or more additional locking members, such as bone screws, through one or more holes 26a in the iliac flange 6 and into underlying bone to affix the iliac flange to the corresponding portion of the ilium.
  • additional locking members such as bone screws
  • the surgeon can also insert one or more additional locking members, such as bone screws, through one or more holes 26a in the ischial flange 10 and into underlying bone to affix the ischial flange 10 to the corresponding portion of the ischium.
  • the surgeon can insert a portion and up to an entirety of the ischial flange 10 into the ischium, such as by drilling or otherwise forming a slot or opening in the ischium and inserting the ischial flange 10 therein. It should be appreciated that the surgeon can elect to affix a certain portion of the cage 2 to underlying bone, such as the dome 4, and shape a separate portion of the cage 2, such as the iliac flange 6 and/or the ischial flange 10, to the corresponding bone. [0056] Referring now to Fig.
  • a trial system 100 for shaping an acetabular cage 2 can include a trial member 52, which is configured to be manipulated, bent, or otherwise shaped in substantially conformal fashion with associated anatomy for assisting a surgeon in bending the cage 2 to a similar shape.
  • the trial member 52 is preferably configured to transition from a neutral state to a first state, in which the trial member 52 can be readily bent so as to match the contour of underlying anatomy.
  • the trial member 52 is also preferably configured to transition from the first state to a second state, in which the trial member 52 substantially retains its bent/contoured shape. In this manner, a surgeon can employ the trial member 52 intra- operatively to assist in the patient-specific bending and shaping of an acetabular cage 2.
  • the trial member 52 can be employed in its first state to conform to an acetabulum (or a cup 12 disposed therein) and adjacent portions of the ilium and optionally the ischium.
  • the surgeon can bend the trial member 52, while in its first state, to form fit around the acetabulum and adjacent portions of the ilium and optionally the ischium to which cage 2 affixation is desired.
  • the surgeon can allow the trial member 52 to transition to the second state.
  • the surgeon can remove the trial member 52 from the underlying anatomy, and employ the trial member 52 as a visual reference for bending corresponding portions of the acetabular cage 2 to the desired shape.
  • the cage 2 After the cage 2 is in the desired shape, as referenced to the trial member 52, the cage 2 can be placed against the associated anatomy (and/or an associated cup 12) and affixed thereto. It should be appreciated that the cage 2 bending and shaping processes using the trial member 52 can be performed iteratively, whereby the surgeon can bend a portion of the cage 2 based on visual reference to the associated portion of the trial member 52, and place the bent portion of the cage 2 in contact with, or close proximity to, the associated anatomy to visually reference the cage 2 shape against the associated anatomy, and subsequently move the cage 2 away from the patient anatomy for further visual reference with the trial member 52 and subsequent bending.
  • the trial member 52 can be constructed of a material that can be activated to transition from the first state to the second state on command and within a period of time suitable for intra-operative bending and shaping.
  • the material for the trial member 52 is also suitable for rapid manufacturing.
  • Non-limiting examples of such materials that are suitable for rapid manufacturing and are also activatable into the first or second state include polymeric materials, such as polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), and the like, and metals, such as titanium (e.g., commercially pure titanium), titanium alloys, stainless steel, and other medical-grade metals.
  • PLA polylactic acid
  • PLGA poly(lactic-co-glycolic acid)
  • metals such as titanium (e.g., commercially pure titanium), titanium alloys, stainless steel, and other medical-grade metals.
  • PLA, PLGA, and similar polymeric materials can be 3D-printed in a neutral state, and can be activated into the first (malleable) state by heating the material beyond its glass transition temperature. While in this first state, the surgeon can bend, shape, or otherwise form fit the trial member 52 to the corresponding anatomy. Afterward, the material will set (i.e., harden) in the shaped form, thereby providing a hardened, shaped trial member 52 that the surgeon can employ as a visual and tactile reference when bending and shaping the cage 2. In other embodiments, the material for the trial member 52 can be activated into the first or second state by application of UV light or other energies.
  • the material for the trial member 52 need not be 3D-printable but can instead be formed from stock sheet material that can be cut, trimmed, or otherwise shaped similar to the geometry of the cage 2.
  • the trial member 52 can be formed from a stock sheet of PLA, PLGA, or similar material, which is placed in a rapidly manufactured (e.g., 3D-printed) mould and subsequently molded therein to a shape replicating the shape of the cage 2.
  • the material of the trial member 52 can be substantially transparent when in the neutral and/or first state.
  • the stock sheet can be constructed of titanium, a titanium alloy, stainless steel, or another medical-grade metal.
  • trial member 52 need not have fixation holes 26a, b formed therein.
  • Materials such as PLA and PLGA are beneficial candidates for constituent materials of the trial member 52 because they can be 3D-printed into the shape of the cage 2 or into a mould for vacuum forming the trial member 52, can be provided in sheet form, and are substantially transparent in the neutral state.
  • the cage 2 and one or more trial members 52 can be included together in a kit, in which each trial member 52 can be a single-use trial member.
  • a numerical preposition e.g., “first”, “second”, “third”
  • an element, component, dimension, or a feature thereof e.g., “first” flange, “second” flange, “first” state, “second” state
  • such numerical preposition is used to distinguish said element, component, dimension, and/or feature from another such element, component, dimension and/or feature, and is not to be limited to the specific numerical preposition used in that instance.
  • first member can also be referred to as a “second” member in a different context without departing from the scope of the present disclosure, so long as said elements, components, dimensions and/or features remain properly distinguished in the context in which the numerical prepositions are used.

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

Abstract

Un dispositif implantable (2) comprend une partie qui est réalisée de telle sorte qu'en volume, elle est majoritairement composée d'un alliage Ti64 (Ti-6AI-4V). De plus, la partie peut être pliée selon un angle de pliage d'au moins environ 50 degrés autour d'un axe de pliage tout en conservant une intégrité structurale.
PCT/EP2022/061632 2022-04-29 2022-04-29 Implants en alliage de titane pliables WO2023208389A1 (fr)

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Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE29712201U1 (de) * 1996-07-23 1997-09-25 HOFER GmbH + Co. KG, Aldrans Vorrichtung zur Stabilisierung und Rekonstruktion des Ellengriffels
US5702477A (en) * 1996-05-09 1997-12-30 Osteonics Corp. Acetabular shell with supplemental support and method
ES2133074B1 (es) * 1996-09-11 2000-04-01 Levante Ind Quirurgicas Protesis acetabular de reconstruccion.
US20050288793A1 (en) * 2004-06-28 2005-12-29 Howmedica Osteonics Corp. Internal fixation element for hip acetabular shell
US10456262B2 (en) * 2016-08-02 2019-10-29 Howmedica Osteonics Corp. Patient-specific implant flanges with bone side porous ridges
US10772665B2 (en) 2018-03-29 2020-09-15 DePuy Synthes Products, Inc. Locking structures for affixing bone anchors to a bone plate, and related systems and methods
US20210015526A1 (en) 2019-06-11 2021-01-21 DePuy Synthes Products, Inc. Deformable Threaded Locking Structures, And Related Systems And Methods
US11013541B2 (en) 2018-04-30 2021-05-25 DePuy Synthes Products, Inc. Threaded locking structures for affixing bone anchors to a bone plate, and related systems and methods
US11179180B2 (en) 2019-06-11 2021-11-23 DePuy Synthes Products, Inc. Deformable threaded locking structures, and related systems and methods
WO2022061416A1 (fr) * 2020-09-24 2022-03-31 Signature Orthopaedics Europe Ltd Prothèse acétabulaire modulaire

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5702477A (en) * 1996-05-09 1997-12-30 Osteonics Corp. Acetabular shell with supplemental support and method
DE29712201U1 (de) * 1996-07-23 1997-09-25 HOFER GmbH + Co. KG, Aldrans Vorrichtung zur Stabilisierung und Rekonstruktion des Ellengriffels
ES2133074B1 (es) * 1996-09-11 2000-04-01 Levante Ind Quirurgicas Protesis acetabular de reconstruccion.
US20050288793A1 (en) * 2004-06-28 2005-12-29 Howmedica Osteonics Corp. Internal fixation element for hip acetabular shell
US10456262B2 (en) * 2016-08-02 2019-10-29 Howmedica Osteonics Corp. Patient-specific implant flanges with bone side porous ridges
US10772665B2 (en) 2018-03-29 2020-09-15 DePuy Synthes Products, Inc. Locking structures for affixing bone anchors to a bone plate, and related systems and methods
US11013541B2 (en) 2018-04-30 2021-05-25 DePuy Synthes Products, Inc. Threaded locking structures for affixing bone anchors to a bone plate, and related systems and methods
US20210015526A1 (en) 2019-06-11 2021-01-21 DePuy Synthes Products, Inc. Deformable Threaded Locking Structures, And Related Systems And Methods
US11179180B2 (en) 2019-06-11 2021-11-23 DePuy Synthes Products, Inc. Deformable threaded locking structures, and related systems and methods
WO2022061416A1 (fr) * 2020-09-24 2022-03-31 Signature Orthopaedics Europe Ltd Prothèse acétabulaire modulaire

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