WO1998029058A1 - A modular implant for pelvis reconstruction - Google Patents

A modular implant for pelvis reconstruction Download PDF

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Publication number
WO1998029058A1
WO1998029058A1 PCT/IL1997/000305 IL9700305W WO9829058A1 WO 1998029058 A1 WO1998029058 A1 WO 1998029058A1 IL 9700305 W IL9700305 W IL 9700305W WO 9829058 A1 WO9829058 A1 WO 9829058A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant
end surface
bending
pelvic bone
main surface
Prior art date
Application number
PCT/IL1997/000305
Other languages
French (fr)
Inventor
Isaac Meller
Kalman Shvartsman
Lev Goldenberg
Original Assignee
M.P.R.S. Ltd.
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 M.P.R.S. Ltd. filed Critical M.P.R.S. Ltd.
Priority to AU42180/97A priority Critical patent/AU4218097A/en
Publication of WO1998029058A1 publication Critical patent/WO1998029058A1/en

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Classifications

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    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
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    • A61B17/8061Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • A61B17/8066Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones for pelvic reconstruction
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    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30879Ribs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/34Acetabular cups
    • A61F2002/3412Acetabular cups with pins or protrusions, e.g. non-sharp pins or protrusions projecting from a shell surface
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0041Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels or rivets, e.g. connecting screws
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0006Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting angular orientation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00017Iron- or Fe-based alloys, e.g. stainless steel

Definitions

  • the present invention relates to a modular implant for pelvis reconstruction and, more particularly, to a versatile implant which can be adapted to a specific patient during a real-time operation.
  • Implants for pelvis reconstruction are widely used in orthopedic oncology. Such implants are often used in cases of bone and soft tissue sarcomas located in or around the pelvis, and in cases of metastatic bone disease (M.B.D.).
  • M.B.D. metastatic bone disease
  • pelvic endoprostheses specifically adapted for replacement of a selected portion of a patient's pelvis, depending on the site of origin of the tumor and the location of metastases.
  • Such pelvic endoprostheses may be adapted to replace selected portions of the ilium, sacrum, acetabulum ,ischium and pubis of the patient.
  • the flat configuration of the currently used implants is mechanically unfavorable since it fails to provide firm and stable long-term connection to the pelvis and sacrum of a patient, mainly because such portions of the patient's body feature a complex three dimensional configuration.
  • the load on the screws connecting such implants to the bone surfaces of the pelvis and sacrum is not distributed in an optimized manner, exposing the screws to harsh transverse for ⁇ es which decrease the long-term bio-mechanical stability, integrity and durability of the implant.
  • Various attempts have been made to design pelvic implants of a three dimensional configuration specifically adapted for a specific patient
  • a modular versatile implant for pelvis reconstruction which can be adapted to any specific patient during a real-time operation. It would be further advantageous to have a versatile implant capable of adopting a desired three dimensional shape by changing the orientation of its surfaces. It would also be advantageous to have an implant whose shape can be determined and formed real-time in an operation so as to allow immediate transplantation. It would be further advantageous to have such an implant which has favorable mechanical features. It would be further advantageous to have an implant which allows a reliable, firm and stable long-term connection to the bone surfaces of a patient, and which is prepared by using simple and inexpensive production methods.
  • an implant for replacement of a region of a pelvic bone preferably between the acetabulum and the sacrum of a patient, including: (a) a main surface for connecting a first portion of the pelvic area and a second portion of the pelvic area; (b) at least one end surface connected to the main surface; and (c) at least one bending zone for changing the orientation of the at least one end surface relative to the main surface.
  • the implant may further include: (a) at least one cantilever element connected to the at least one end surface; and (b) at least one bending zone for changing the orientation of the at least one cantilever element relative to the at least one end surface.
  • Each of the cantilever elements may include at least one bending zone for changing the orientation of a portion of the cantilever element.
  • the implant may include a first cantilever element connected to a first end surface and a second cantilever element connected to a second end surface, the first cantilever element for connection to an acetabulum of a patient and the second cantilever element for connection to a sacrum of a patient.
  • the end surface may be bent along any line within the limits of the bending zone so as to form an angle of between about 0 and about 30 degrees with the main surface.
  • the cantilever element may be bent along any line within the limits of the bending zone so as to form an angle of between about 0 and about 30 degrees with the end surface.
  • a portion of the cantilever element may be bent along any line within the limits of the bending zone so as to form an angle of between about 0 and about 90 degrees, or alternatively, between about 0 and about 120 degrees with the rest of the cantilever element.
  • the implant includes a stiffening rib.
  • the stiffening rib may feature a convexo-concave shape in cross section.
  • An implant according to the present invention further includes holes for connecting the implant to the bony surfaces of the pelvis of a patient, preferably by means of screws.
  • an implant according to the present invention may include an extension extending substantially along the longitudinal side of the main surface, the extension being oriented so as to form a predetermined angle with the main surface, thereby forming a stiffening crest between the main surface and the extension.
  • the extension may feature a longitudinal bend extending along its longitudinal axis, the bend defining a first portion and a second portion of the extension such that the second portion being oriented so as to form a predetermined angle with the first portion, thereby enabling to substantially enclose a portion of the patient's pelvis.
  • An implant according to the present invention may further include openings for receiving a thread therein so as to allow to suture patient's muscles to said implant.
  • a bending tool for bending a pelvic implant comprising: (a) an accommodating member having a slot for receiving a surface of the implant therein; (b) a bending member having at least one bending extension for bending a portion of the surface, the accommodating member featuring a convex surface and the bending member featuring a concave surface so as to allow sliding of the bending member over the accommodating member.
  • an implant for replacement of a pelvic bone by connecting a first portion and a second portion of the pelvic bone comprising: (a) a cup acetabular prosthesis; (b) a first main surface for connecting the first portion of the pelvic bone to the cup acetabulum prosthesis; (c) a second main surface for connecting the second portion of the pelvic bone to the cup acetabulum prosthesis, wherein each of said first and second main surfaces includes: (i) at least one end surface connected thereto; and (ii) at least one bending zone located between the main surface and the at least one end surface for changing the orientation of the at least one end surface relative to the main surface.
  • the at least one end surface may include at least one circumferential protrusion, the at least one protrusion including a hole for receiving a screw therein, the at least one protrusion including a bending zone for individually bending the at least one protrusion relative to the at least one end surface.
  • the first main surface is connected to the cup acetabulum prosthesis by means of a first adapter
  • the second main surface is connected to the cup acetabulum prosthesis by means of a second adapter.
  • the cup acetabulum prosthesis includes a protrusion
  • at least one of the adapters includes a depression for accommodating said protrusion therein, such that the protrusion is movable within the depression, thereby allowing to change the orientation of the cup acetabulum prosthesis relative to the at least one adapter.
  • the implant may include a lock screw for fixing the position of the cup acetabulum prosthesis with relation to the at least one adapter.
  • the first adapter is preferably movable with relation to the first main surface.
  • the first portion of the pelvic bone includes the patient's ilium.
  • the first portion of the pelvic bone includes the patient's sacrum.
  • the second portion of the pelvic bone includes the patient's pubis.
  • a method for reconstructing a region of a pelvic bone comprising: (a) resecting a portion of the pelvic bone; (b) manually shaping a substantially flexible template so as to so as to connect selected remaining portions of the pelvic bone; (c) substantially immediately shaping a pelvic implant according to the shape of said template by means of a bending tool; and (d) connecting said implant to the selected remaining portions of the pelvic bone.
  • the present invention successfully addresses the shortcomings of the presently known configurations by providing a modular versatile implant for pelvis reconstruction capable of adopting a desired three dimensional shape by changing the orientation of its surfaces.
  • a modular versatile implant for pelvis reconstruction capable of adopting a desired three dimensional shape by changing the orientation of its surfaces.
  • the shape of such an implant can be determined and formed during a real-time operation, thereby allowing immediate transplantation.
  • Such an implant has favorable bio-mechanical features since it provides an optimized distribution of load on the screws connecting the implant to the bony surfaces of the pelvis, thereby not exposing such screws to harsh transverse forces which decrease the long term stability and durability of the implant.
  • the present invention discloses a novel modular implant for pelvis reconstruction. While using an implant according to the present invention, the exact size and three-dimensional shape of the implant required for a specific patient is determined during surgery by means of a template which is easy to bend and is identical in shape and size to the required implant. The template is shaped by the surgeon so as to fit the exact dimensions of the pelvic area of a given patient after resection. The implant is then shaped according to the template by using a hand bending tool. BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is a perspective view of an implant according to the present invention before adopting its three dimensional conformation
  • FIG. 2 is a partial cross sectional view across line A- A in FIG. 1 ;
  • FIG. 3 is a perspective view of an implant according to the present invention while adopting its three dimensional conformation;
  • FIG. 4 is a schematic view of an implant attached to a pelvic girdle of a patient;
  • FIG. 5 is a cross sectional view across line B-B in FIG. 4;
  • FIG. 6 is a top view of another embodiment of an implant according to the present invention;
  • FIG. 7 is a cross sectional view across line A- A in FIG. 6;
  • FIG. 8 is a top view of yet another embodiment of an implant according to the present invention.
  • FIG. 9 is a cross sectional view across line D-D in FIG. 8.
  • FIG. 10 is a schematic view of a bending tool according to the present invention.
  • FIG. 11 is a cross sectional view of across line A-A in FIG. 10;
  • FIG. 12 illustrates the operation of a bending tool according to the present invention
  • FIG. 13a is a schematic view of another embodiment of a bending tool according to the present invention.
  • FIG. 13b is a cross sectional view across line A-A in FIG. 13a;
  • FIG. 14 is a cross sectional view of a pelvic endoprosthesis adapted for total-hip replacement;
  • FIG. 15a is a top view of a selected surface of the endoprosthesis shown in FIG. 14, for connection to the patient's ilium;
  • FIG. 15b is a perspective view of another embodiment of the surface shown in FIG. 14a;
  • FIG. 16 is a cross sectional view of another embodiment of a pelvic endoprosthesis adapted for total hip replacement
  • FIG. 17a is a view, partially in cross section, of yet another embodiment of a pelvic endoprosthesis adapted for total hip replacement
  • FIG. 17b is a cross sectional view of zone I in FIG. 17a;
  • the present invention is of a modular implant for pelvis reconstruction which can be adapted to a specific patient during a real-time operation.
  • an implant which may be used for the replacement of pelvic portions between the acetabulum and the sacrum of a treated patient.
  • a versatile implant according to the present invention is capable of adopting a desired three dimensional shape from a given, preferably flat, configuration by changing the orientation of its surfaces. The shape of such implant can be determined and formed during a real-time operation so as to allow an immediate transplantation.
  • an implant which may be used for total hip replacement, wherein reconstruction of the proximal femur and the periacetabular area is needed.
  • FIGs. 1-5 illustrate an implant according to the present invention, preferably for replacement of pelvic portions between the acetabulum and the sacrum of a patient.
  • an implant according to the present invention preferably includes: a main surface 1 having a stiffening rib 2 disposed along the longitudinal axis of surface 1 ; two end surfaces 3 and 4 located at each end of surface 1; and two cantilevers 10 and 11 connected to end surfaces 3 and 4, respectively.
  • Stiffening rib 2 is preferably of a convexo-concave shape in cross section, as shown in FIG. 2.
  • the longitudinal side 19 and the transverse sides 20 and 26 of main surface 1 feature a rounded shape so as to minimize damage to soft tissues.
  • slot 5 defines the dimensions and shapes of cantilevers 10 and 11.
  • slot 5 includes a longitudinal portion 6 and a cutout portion 7, such that the edges 8 and 9 of cantilevers 10 and 11, respectively, form an angle of between about 60 degrees and about 90 degrees with the edge of longitudinal portion 6.
  • an implant according to the present invention further includes bending zones, preferably zones 13, 14, 15, 16, 17 and
  • each of end surfaces 3 and 4 and each of cantilevers 10 and 11 include a group of holes 12 for screws, such that bending zones
  • end surfaces 3 and 4 may be bent along any line within the limits of bending zones 13 and 18, respectively, so as to form an angle of preferably between about 0 and about 30 degrees with main surface 1.
  • Cantilever 10 preferably for attachment to the acetabulum of a patient, may be bent along any line within the limits of each of bending zones 14 and 15.
  • cantilever 10 is bent along a line within the limits of bending zone 14 to form an angle of between about 0 and about 30 degrees with end surface 3, and along a line withm the limits of bending zone 15 to form an angle_ of between about 0 and about 120 degrees between the two parts of cantilever 10 spaced by bending zone 15.
  • Cantilever 11, preferably for attachment to the sacrum of a patient may be bent along any line within the limits of bending zones 16 and 17.
  • cantilever 11 is bent along a line within the limits of bending zone 17 to form an angle of between about 0 and about 30 degrees with end surface 4, and along a line within the limits of bending zone 16 to form an angle of between about 0 and about 90 degrees between the two parts of cantilever 11 spaced by bending zone 16.
  • the edge 21 of cantilever 10 preferably features a rounded shape so as to facilitate the attachment of end surface 3 and cantilever 10 to the acetabulum.
  • the exact size and three-dimensional shape of the implant required for a specific patient is determined during surgery by using a thin metal template which is easy to bend and is identical in shape and size to the required implant.
  • the template is shaped by the surgeon so as to fit the exact dimensions of the pelvis and sacrum of a given patient after resection.
  • the implant is then shaped according to the template by using a hand bending tool (Figs. 10-13).
  • cantilever 10 is preferably supported by, and attached to, bony surface 24 formed by the resection of the pelvis, while end surface 3 is supported by, and attached to, bony surface 22 in the immediate proximity of the acetabulum.
  • Cantilever 11 and end surface 4 are preferably supported by, and attached to, bony surface 23 of the sacrum.
  • the present invention is preferably provided as a set of modular units of templates and pertinent implants of different size, and a hand bending tool for bending the implants.
  • a set of modular units may include templates and pertinent implants having lengths of between about 80 mm and about 140 mm, and graded with differences of about 5- 10 mm.
  • the templates and implants are preferably made of stainless steel commonly used for endoprostheses.
  • the method of production used for preparing the implants preferably includes cold stamping and electro- polishing of the implant surface. Referring now to Figs.
  • the implant of the present invention does not include a stiffening rib, but rather includes an extension 30 for conferring a desired stiffness to the implant.
  • extension 30 is preferably in the form of a flat surface connected to or integrally made with main surface 1 and extends along its longitudinal axis. Extension 30 is preferably oriented so as to form a predetermined angle with main surface 1, thereby defining a crest 33 for conferring a desired rigidity to the implant. Extension 30 preferably includes holes 12 for screws. Further, extension 30 preferably includes openings 32 for insertion of medical thread therethrough so as to allow a surgeon to secure the patient's pelvic muscles to the implant by means of stitches, thereby facilitating recovery of the pelvic area.
  • extension 30 includes a first surface 30a and a second surface 30b, the second surface 30b being oriented so as to form a predetermined angle with first surface 30b, thereby defining a crest 30c therebetween.
  • first surface 30a is oriented so as to form about 90 degrees with main surface 1. Since such configuration includes a plurality of crests - crest 33 and crest 30, it features an improved stiffness relative to the configuration shown in Figs. 6 and 7. Further, such configuration enables to substantially enclose bony portions of the pelvis, thereby allowing to effectively secure the implant to the pelvis.
  • openings 32 for suturing the patient's muscles to the implant are preferably included within main surface 1.
  • a hand bending tool 40 for shaping an implant of the present invention is shown. As specified above, the exact three dimensional shape of the implant required for a specific patient is determined during surgery by using a thin metal template which is easily bent and shaped by the surgeon. The implant is then immediately shaped according to the template by means of hand banding tool 40.
  • bending tool 40 preferably includes: an accommodating member 46 including a slot 51 for receiving a selected surface of the implant; and a bending member 48 including a bending extension 53 for bending a portion of the selected surface relative to the rest of the implant while the selected surface is received within slot 51.
  • accommodating member 46 features a convex edge 50
  • bending member 48 features a concave edge 52, convex edge 50 being received within concave edge 52, so as to allow sliding of bending member 48 over accommodating member 46.
  • accommodating member 46 and bending member 48 include respective handles, 47 and 49, for holding bending tool 40 by a user.
  • handles 47 and 49 feature bends, 41 and 42 respectively, for facilitating bending of the implant.
  • slot 51 preferably extends through a portion of the width of accommodating member 46.
  • slot 51 preferably extends completely through the thickness of accommodating member 46.
  • Accommodating member 46 and bending member 48 are preferably interconnected by means of a connecting element 54 having a "U" shape, which connecting element being secured to each of members 46 and 48 by means of screws 55.
  • Fig. 12 exemplify the operation of a bending tool 40 according to the present invention, wherein cantilever 10 is bent along bending zone 15 as concave bending member 48 slides over convex accommodating member 46.
  • Fig. 13a another embodiment of bending tool 40 is shown, wherein bending member 48 includes a pair of bending extensions, 53a and 53b, so as to facilitate the manipulation of the implant by means of bending tool 40.
  • slot 51 preferably extends completely through the width of accommodating member 46 so as to allow symmetrical operation of bending tool 40.
  • cantilever 10 may be bent by means of extension 53a and cantilever 11 may be bent by means of extension 53b, thereby enabling symmetrical manipulation of the implant without the need to substantially change the orientation of the implant relative to bending tool 40.
  • accommodating member 46 is preferably thick in cross section and slot 51 extends through a portion of the thickness of accommodating member 46.
  • Connecting member 54 for connecting member 46 and member 48 preferably features an "L" shape, and is secured to each of members 46 and 48 by means of screws 55.
  • an endoprosthesis which may be used for total hip replacement, wherein reconstruction of the proximal femur and the periacetabular area is needed.
  • a transverse section of a patient's body is shown, wherein a resection of the left pelvic portion has been performed, which resection including the proximal femur, the periacetabular area, the left portion of the pubis, and a portion of the ilium.
  • a pelvic endoprosthesis includes a cup acetabulum prosthesis 70 for receiving a conventional femur prosthesis therein.
  • Prosthesis 70 is mechanically connected to a first surface 74 by means of a first adapter 72, and to a second surface 75 by means of a second adapter 73, the first surface for attachment to the patient's ilium, and the second surface for attachment to the right portion of the patient's pubis.
  • cup acetabulum prosthesis 70 and first adapter 72 are interconnected by means of screws 77; first adapter 72 and first surface 74 are interconnected by means of screws 78; and first surface 74 is secured to the patient's ilium by means of screws (not shown in the figure) .
  • cup acetabulum prosthesis 70 and second adapter 73 are interconnected by means of screws 77; second adapter 73 and second surface 75 are interconnected by means of screws 76; and second surface 75 is secured to the left portion of the patient's pubis by means of screws 79.
  • Cup acetabulum prosthesis 70 may feature specific sizes.
  • adapters 72 and 73 may feature specific dimensions and shapes so as to allow adaptation of the prosthesis to different patients.
  • First and second surfaces 74 and 75 may be shaped by means of hand bending tool 40 so as to adopt a specific three dimensional shape, as required.
  • first and second surfaces 74 and 75 are determined during surgery by using a thin metal template which is easily bent and shaped by the surgeon. Surfaces 74 and 75 are then immediately shaped by means of hand banding tool 40. Figs. 15a and 15b show possible configurations of first surface 74.
  • Surface 74 preferably includes two bending zones, 92a and 92b, extending along the longitudinal axis of surface 74, along which surface 74 is bent by bending tool 40. Such configuration allows to substantially enclose a bony portion of the patient's ilium so as to effectively fix surface 74 thereto.
  • surface 74 preferably includes holes 12 for screws, the .screws for securing surface 74 to the patient's ilium.
  • surface 74 includes a plurality of circumferential protrusions 91 separated by depressions 90 such that each of holes 12 is located on a distinct protrusion. As shown in Fig. 15b, each of circumferential 5 protrusions 91 may be independently bent along a specific protrusion bending zone 93, thereby enabling to specifically adapt surface 74 to a specific bone structure.
  • Surface 75 may feature a similar configuration as shown for surface 74.
  • Fig. 16 shows another embodiment of a pelvic endoprosthesis according to the present invention.
  • the patient's ilium has been resected, and first surface 74 extends to reach the patient's sacrum and is preferably connected to the patient's sacrum by means of screws (not shown in the figure).
  • surface 74 extends to reach the patient's sacrum and is preferably connected to the patient's sacrum by means of screws (not shown in the figure).
  • 15 74 may include a cantilever element, substantially as shown in Fig. 4.
  • cup acetabulum prosthesis 70 is adjustable so as to prevent displacement of the femur prosthesis .
  • cup acetabulum prosthesis 70 preferably
  • cup acetabulum prosthesis 70 may be rotated along the longitudinal axis of cylindrical extension 85 (designated as A) by rotating cylindrical extension 85 within the hollow cylindrical chamber of adapter 72. Since cup acetabulum prosthesis 70 is
  • adapter 72 is preferably connected to

Abstract

This invention is an implant and method for reconstruction of a pelvic region. The implant including: (a) a main surface portion (1) for connecting a first and second portion of the pelvic region; (b) at least one end surface (3) connected to the main surface; (c) at least one bending zone (13-15) for changing the orientation of the at least one end surface relative to the main surface; and (d) at least one cantilever element (10) connected to the at least one end surface. According to a second embodiment the implant further includes an acetabular cup prosthesis, and additionally includes a method of (a) resecting a pelvic bone; (b) shaping a flexible template to connect selected remaining portions of the pelvic bone; (c) shaping a pelvic implant according to the template by a bending tool means; and (d) connecting said implant to the selected remaining portion of the pelvic bone.

Description

A MODULAR IMPLANT FOR PELVIS RECONSTRUCTION
FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to a modular implant for pelvis reconstruction and, more particularly, to a versatile implant which can be adapted to a specific patient during a real-time operation.
Implants for pelvis reconstruction are widely used in orthopedic oncology. Such implants are often used in cases of bone and soft tissue sarcomas located in or around the pelvis, and in cases of metastatic bone disease (M.B.D.).
The prior art discloses a variety of pelvic endoprostheses specifically adapted for replacement of a selected portion of a patient's pelvis, depending on the site of origin of the tumor and the location of metastases. Such pelvic endoprostheses may be adapted to replace selected portions of the ilium, sacrum, acetabulum ,ischium and pubis of the patient.
Most of the implants currently used for the replacement of pelvic parts between the acetabulum and the sacrum of a patient usually feature low bio-mechanical stability and integrity owing to their flat configuration. Currently, such configuration is the most commonly used since it makes it possible to immediately transplant the implant without the need to specifically pre-design the implant to a specific patient.
The flat configuration of the currently used implants is mechanically unfavorable since it fails to provide firm and stable long-term connection to the pelvis and sacrum of a patient, mainly because such portions of the patient's body feature a complex three dimensional configuration. The load on the screws connecting such implants to the bone surfaces of the pelvis and sacrum is not distributed in an optimized manner, exposing the screws to harsh transverse forςes which decrease the long-term bio-mechanical stability, integrity and durability of the implant. Various attempts have been made to design pelvic implants of a three dimensional configuration specifically adapted for a specific patient
(customized implants) so as to provide better bio-mechanical stability and integrity to the complex bone-implant. Most of these implants are tailor- made by using methods of precision casting.
Further, various attempts have been made to design three- dimensional pelvic endoprostheses for total hip replacement, wherein the proximal femur and the periacetabular area of the patient have to be reconstructed. However, such implants can be made only after the precise boundaries of the malignant areas have been determined. The preparation of such implants usually takes between four to six weeks. Such a waiting period may be too long for a patient with a failing pelvis due to a metastatic bone disease. Moreover, since the dimensions and shape of such implants are not changeable, the implant may become unsuitable for implantation after that period of time owing to progress of the disease. Furthermore, the production method of precision casting is complex and expensive.
There is thus a widely recognized need for, and it would be highly advantageous to have, a modular versatile implant for pelvis reconstruction which can be adapted to any specific patient during a real-time operation. It would be further advantageous to have a versatile implant capable of adopting a desired three dimensional shape by changing the orientation of its surfaces. It would also be advantageous to have an implant whose shape can be determined and formed real-time in an operation so as to allow immediate transplantation. It would be further advantageous to have such an implant which has favorable mechanical features. It would be further advantageous to have an implant which allows a reliable, firm and stable long-term connection to the bone surfaces of a patient, and which is prepared by using simple and inexpensive production methods. SUMMARY OF THE INVENTION
According to the present invention there is provided an implant for replacement of a region of a pelvic bone, preferably between the acetabulum and the sacrum of a patient, including: (a) a main surface for connecting a first portion of the pelvic area and a second portion of the pelvic area; (b) at least one end surface connected to the main surface; and (c) at least one bending zone for changing the orientation of the at least one end surface relative to the main surface.
According to further features in preferred embodiments of the invention described below, the implant may further include: (a) at least one cantilever element connected to the at least one end surface; and (b) at least one bending zone for changing the orientation of the at least one cantilever element relative to the at least one end surface.
Each of the cantilever elements may include at least one bending zone for changing the orientation of a portion of the cantilever element.
Specifically, the implant may include a first cantilever element connected to a first end surface and a second cantilever element connected to a second end surface, the first cantilever element for connection to an acetabulum of a patient and the second cantilever element for connection to a sacrum of a patient.
According to still further features in the described preferred embodiments, the end surface may be bent along any line within the limits of the bending zone so as to form an angle of between about 0 and about 30 degrees with the main surface. The cantilever element may be bent along any line within the limits of the bending zone so as to form an angle of between about 0 and about 30 degrees with the end surface.
Further, a portion of the cantilever element may be bent along any line within the limits of the bending zone so as to form an angle of between about 0 and about 90 degrees, or alternatively, between about 0 and about 120 degrees with the rest of the cantilever element.
According to still further features in the described preferred embodiments, the implant includes a stiffening rib. The stiffening rib may feature a convexo-concave shape in cross section.
An implant according to the present invention further includes holes for connecting the implant to the bony surfaces of the pelvis of a patient, preferably by means of screws.
Further, an implant according to the present invention may include an extension extending substantially along the longitudinal side of the main surface, the extension being oriented so as to form a predetermined angle with the main surface, thereby forming a stiffening crest between the main surface and the extension.
Further, the extension may feature a longitudinal bend extending along its longitudinal axis, the bend defining a first portion and a second portion of the extension such that the second portion being oriented so as to form a predetermined angle with the first portion, thereby enabling to substantially enclose a portion of the patient's pelvis.
An implant according to the present invention may further include openings for receiving a thread therein so as to allow to suture patient's muscles to said implant.
Further according to the present invention there is provided a bending tool for bending a pelvic implant, comprising: (a) an accommodating member having a slot for receiving a surface of the implant therein; (b) a bending member having at least one bending extension for bending a portion of the surface, the accommodating member featuring a convex surface and the bending member featuring a concave surface so as to allow sliding of the bending member over the accommodating member. Further according to the present invention there is provided an implant for replacement of a pelvic bone by connecting a first portion and a second portion of the pelvic bone, comprising: (a) a cup acetabular prosthesis; (b) a first main surface for connecting the first portion of the pelvic bone to the cup acetabulum prosthesis; (c) a second main surface for connecting the second portion of the pelvic bone to the cup acetabulum prosthesis, wherein each of said first and second main surfaces includes: (i) at least one end surface connected thereto; and (ii) at least one bending zone located between the main surface and the at least one end surface for changing the orientation of the at least one end surface relative to the main surface.
Further, the at least one end surface may include at least one circumferential protrusion, the at least one protrusion including a hole for receiving a screw therein, the at least one protrusion including a bending zone for individually bending the at least one protrusion relative to the at least one end surface.
Preferably, the first main surface is connected to the cup acetabulum prosthesis by means of a first adapter, and the second main surface is connected to the cup acetabulum prosthesis by means of a second adapter.
According to still further features of the invention described below, the cup acetabulum prosthesis includes a protrusion, and at least one of the adapters includes a depression for accommodating said protrusion therein, such that the protrusion is movable within the depression, thereby allowing to change the orientation of the cup acetabulum prosthesis relative to the at least one adapter. The implant may include a lock screw for fixing the position of the cup acetabulum prosthesis with relation to the at least one adapter. Further, the first adapter is preferably movable with relation to the first main surface. Preferably, the first portion of the pelvic bone includes the patient's ilium. Alternatively, the first portion of the pelvic bone includes the patient's sacrum. Preferably, the second portion of the pelvic bone includes the patient's pubis. Further according to the present invention there is provided a method for reconstructing a region of a pelvic bone, comprising: (a) resecting a portion of the pelvic bone; (b) manually shaping a substantially flexible template so as to so as to connect selected remaining portions of the pelvic bone; (c) substantially immediately shaping a pelvic implant according to the shape of said template by means of a bending tool; and (d) connecting said implant to the selected remaining portions of the pelvic bone.
The present invention successfully addresses the shortcomings of the presently known configurations by providing a modular versatile implant for pelvis reconstruction capable of adopting a desired three dimensional shape by changing the orientation of its surfaces. Thus, the shape of such an implant can be determined and formed during a real-time operation, thereby allowing immediate transplantation. Such an implant has favorable bio-mechanical features since it provides an optimized distribution of load on the screws connecting the implant to the bony surfaces of the pelvis, thereby not exposing such screws to harsh transverse forces which decrease the long term stability and durability of the implant.
The present invention discloses a novel modular implant for pelvis reconstruction. While using an implant according to the present invention, the exact size and three-dimensional shape of the implant required for a specific patient is determined during surgery by means of a template which is easy to bend and is identical in shape and size to the required implant. The template is shaped by the surgeon so as to fit the exact dimensions of the pelvic area of a given patient after resection. The implant is then shaped according to the template by using a hand bending tool. BRIEF DESCRIPTION OF THE DRAWINGS
The mvention is herein described, by way of example only, with reference to the accompanying drawings, wherein: FIG. 1 is a perspective view of an implant according to the present invention before adopting its three dimensional conformation;
FIG. 2 is a partial cross sectional view across line A- A in FIG. 1 ; FIG. 3 is a perspective view of an implant according to the present invention while adopting its three dimensional conformation; FIG. 4 is a schematic view of an implant attached to a pelvic girdle of a patient;
FIG. 5 is a cross sectional view across line B-B in FIG. 4; FIG. 6 is a top view of another embodiment of an implant according to the present invention; FIG. 7 is a cross sectional view across line A- A in FIG. 6;
FIG. 8 is a top view of yet another embodiment of an implant according to the present invention;
FIG. 9 is a cross sectional view across line D-D in FIG. 8. FIG. 10 is a schematic view of a bending tool according to the present invention;
FIG. 11 is a cross sectional view of across line A-A in FIG. 10; FIG. 12 illustrates the operation of a bending tool according to the present invention;
FIG. 13a is a schematic view of another embodiment of a bending tool according to the present invention;
FIG. 13b is a cross sectional view across line A-A in FIG. 13a; FIG. 14 is a cross sectional view of a pelvic endoprosthesis adapted for total-hip replacement;
FIG. 15a is a top view of a selected surface of the endoprosthesis shown in FIG. 14, for connection to the patient's ilium; FIG. 15b is a perspective view of another embodiment of the surface shown in FIG. 14a;
FIG. 16 is a cross sectional view of another embodiment of a pelvic endoprosthesis adapted for total hip replacement; FIG. 17a is a view, partially in cross section, of yet another embodiment of a pelvic endoprosthesis adapted for total hip replacement;
FIG. 17b is a cross sectional view of zone I in FIG. 17a;
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention is of a modular implant for pelvis reconstruction which can be adapted to a specific patient during a real-time operation.
Specifically, according to the present invention there is provided an implant which may be used for the replacement of pelvic portions between the acetabulum and the sacrum of a treated patient. A versatile implant according to the present invention is capable of adopting a desired three dimensional shape from a given, preferably flat, configuration by changing the orientation of its surfaces. The shape of such implant can be determined and formed during a real-time operation so as to allow an immediate transplantation. Further, according to the present invention there is provided an implant which may be used for total hip replacement, wherein reconstruction of the proximal femur and the periacetabular area is needed.
The principles and operation of an implant according to the present invention may be better understood with reference to the drawings and the accompanying description.
Referring now to the drawings, FIGs. 1-5 illustrate an implant according to the present invention, preferably for replacement of pelvic portions between the acetabulum and the sacrum of a patient. As shown in FIG. 1 , an implant according to the present invention preferably includes: a main surface 1 having a stiffening rib 2 disposed along the longitudinal axis of surface 1 ; two end surfaces 3 and 4 located at each end of surface 1; and two cantilevers 10 and 11 connected to end surfaces 3 and 4, respectively. Stiffening rib 2 is preferably of a convexo-concave shape in cross section, as shown in FIG. 2. Preferably, the longitudinal side 19 and the transverse sides 20 and 26 of main surface 1 feature a rounded shape so as to minimize damage to soft tissues. As shown in FIG. 1 , cantilevers 10 and 11 are connected to end surfaces 3 and 4. A slot 5 defines the dimensions and shapes of cantilevers 10 and 11. Preferably, slot 5 includes a longitudinal portion 6 and a cutout portion 7, such that the edges 8 and 9 of cantilevers 10 and 11, respectively, form an angle of between about 60 degrees and about 90 degrees with the edge of longitudinal portion 6.
As shown in FIG. 3, an implant according to the present invention further includes bending zones, preferably zones 13, 14, 15, 16, 17 and
18. Preferably, each of end surfaces 3 and 4 and each of cantilevers 10 and 11 include a group of holes 12 for screws, such that bending zones
13, 14, 15, 16, 17 and 18 are formed between the groups of holes 12.
When using an implant according to the present invention, end surfaces 3 and 4 may be bent along any line within the limits of bending zones 13 and 18, respectively, so as to form an angle of preferably between about 0 and about 30 degrees with main surface 1.
Cantilever 10, preferably for attachment to the acetabulum of a patient, may be bent along any line within the limits of each of bending zones 14 and 15. Preferably, cantilever 10 is bent along a line within the limits of bending zone 14 to form an angle of between about 0 and about 30 degrees with end surface 3, and along a line withm the limits of bending zone 15 to form an angle_ of between about 0 and about 120 degrees between the two parts of cantilever 10 spaced by bending zone 15. Cantilever 11, preferably for attachment to the sacrum of a patient, may be bent along any line within the limits of bending zones 16 and 17. Preferably, cantilever 11 is bent along a line within the limits of bending zone 17 to form an angle of between about 0 and about 30 degrees with end surface 4, and along a line within the limits of bending zone 16 to form an angle of between about 0 and about 90 degrees between the two parts of cantilever 11 spaced by bending zone 16.
When bending the implant of the present invention into a three- dimensional shape as described above and attaching the implant to a patient's pelvic area, the load is distributed among screws 25 (FIG. 5) in an optimized manner. Since cantilevers 10 and 11 are bent with relation to main surface 1, screws 25 are not susceptible to harsh transverse forces.
Thus, the long-term bio-mechanical stability of the implant is improved.
The edge 21 of cantilever 10 preferably features a rounded shape so as to facilitate the attachment of end surface 3 and cantilever 10 to the acetabulum. The edges 8 and 9 of cantilevers 10 and 11, respectively, feature a rounded shape so as to minimize damage to soft tissues.
While using an implant according to the present invention, the exact size and three-dimensional shape of the implant required for a specific patient is determined during surgery by using a thin metal template which is easy to bend and is identical in shape and size to the required implant. The template is shaped by the surgeon so as to fit the exact dimensions of the pelvis and sacrum of a given patient after resection. The implant is then shaped according to the template by using a hand bending tool (Figs. 10-13). When fitting the implant to a pelvic area (FIG. 4), cantilever 10 is preferably supported by, and attached to, bony surface 24 formed by the resection of the pelvis, while end surface 3 is supported by, and attached to, bony surface 22 in the immediate proximity of the acetabulum. Cantilever 11 and end surface 4 are preferably supported by, and attached to, bony surface 23 of the sacrum. The present invention is preferably provided as a set of modular units of templates and pertinent implants of different size, and a hand bending tool for bending the implants. For example, a set of modular units may include templates and pertinent implants having lengths of between about 80 mm and about 140 mm, and graded with differences of about 5- 10 mm. The templates and implants are preferably made of stainless steel commonly used for endoprostheses. The method of production used for preparing the implants preferably includes cold stamping and electro- polishing of the implant surface. Referring now to Figs. 6 and 7, according to another embodiment the implant of the present invention does not include a stiffening rib, but rather includes an extension 30 for conferring a desired stiffness to the implant. As shown in the figures, extension 30 is preferably in the form of a flat surface connected to or integrally made with main surface 1 and extends along its longitudinal axis. Extension 30 is preferably oriented so as to form a predetermined angle with main surface 1, thereby defining a crest 33 for conferring a desired rigidity to the implant. Extension 30 preferably includes holes 12 for screws. Further, extension 30 preferably includes openings 32 for insertion of medical thread therethrough so as to allow a surgeon to secure the patient's pelvic muscles to the implant by means of stitches, thereby facilitating recovery of the pelvic area.
Referring now to Figs. 8 and 9, according to yet another embodiment extension 30 includes a first surface 30a and a second surface 30b, the second surface 30b being oriented so as to form a predetermined angle with first surface 30b, thereby defining a crest 30c therebetween. Preferably, first surface 30a is oriented so as to form about 90 degrees with main surface 1. Since such configuration includes a plurality of crests - crest 33 and crest 30, it features an improved stiffness relative to the configuration shown in Figs. 6 and 7. Further, such configuration enables to substantially enclose bony portions of the pelvis, thereby allowing to effectively secure the implant to the pelvis.
As shown in Fig. 8, openings 32 for suturing the patient's muscles to the implant are preferably included within main surface 1. Referring now to Figs. 10-12, a hand bending tool 40 for shaping an implant of the present invention is shown. As specified above, the exact three dimensional shape of the implant required for a specific patient is determined during surgery by using a thin metal template which is easily bent and shaped by the surgeon. The implant is then immediately shaped according to the template by means of hand banding tool 40.
As shown in Fig. 10, bending tool 40 preferably includes: an accommodating member 46 including a slot 51 for receiving a selected surface of the implant; and a bending member 48 including a bending extension 53 for bending a portion of the selected surface relative to the rest of the implant while the selected surface is received within slot 51. Preferably, accommodating member 46 features a convex edge 50 and bending member 48 features a concave edge 52, convex edge 50 being received within concave edge 52, so as to allow sliding of bending member 48 over accommodating member 46. As shown in the figure, accommodating member 46 and bending member 48 include respective handles, 47 and 49, for holding bending tool 40 by a user. Preferably, handles 47 and 49 feature bends, 41 and 42 respectively, for facilitating bending of the implant.
As shown in Fig. 10, slot 51 preferably extends through a portion of the width of accommodating member 46.
As shown in Fig. 11 , slot 51 preferably extends completely through the thickness of accommodating member 46. Accommodating member 46 and bending member 48 are preferably interconnected by means of a connecting element 54 having a "U" shape, which connecting element being secured to each of members 46 and 48 by means of screws 55. Fig. 12 exemplify the operation of a bending tool 40 according to the present invention, wherein cantilever 10 is bent along bending zone 15 as concave bending member 48 slides over convex accommodating member 46. Referring now to Fig. 13a, another embodiment of bending tool 40 is shown, wherein bending member 48 includes a pair of bending extensions, 53a and 53b, so as to facilitate the manipulation of the implant by means of bending tool 40. Further, as shown in Fig. 13a, slot 51 preferably extends completely through the width of accommodating member 46 so as to allow symmetrical operation of bending tool 40.
Thus, for example, cantilever 10 may be bent by means of extension 53a and cantilever 11 may be bent by means of extension 53b, thereby enabling symmetrical manipulation of the implant without the need to substantially change the orientation of the implant relative to bending tool 40.
As shown in Fig. 13b, accommodating member 46 is preferably thick in cross section and slot 51 extends through a portion of the thickness of accommodating member 46. Connecting member 54 for connecting member 46 and member 48 preferably features an "L" shape, and is secured to each of members 46 and 48 by means of screws 55.
According to the present invention there is further provided an endoprosthesis which may be used for total hip replacement, wherein reconstruction of the proximal femur and the periacetabular area is needed. Referring to Fig. 14, a transverse section of a patient's body is shown, wherein a resection of the left pelvic portion has been performed, which resection including the proximal femur, the periacetabular area, the left portion of the pubis, and a portion of the ilium.
As shown in the figure, a pelvic endoprosthesis according to the present invention includes a cup acetabulum prosthesis 70 for receiving a conventional femur prosthesis therein. Prosthesis 70 is mechanically connected to a first surface 74 by means of a first adapter 72, and to a second surface 75 by means of a second adapter 73, the first surface for attachment to the patient's ilium, and the second surface for attachment to the right portion of the patient's pubis. As shown in the figure, cup acetabulum prosthesis 70 and first adapter 72 are interconnected by means of screws 77; first adapter 72 and first surface 74 are interconnected by means of screws 78; and first surface 74 is secured to the patient's ilium by means of screws (not shown in the figure) . Further as shown in the figure, cup acetabulum prosthesis 70 and second adapter 73 are interconnected by means of screws 77; second adapter 73 and second surface 75 are interconnected by means of screws 76; and second surface 75 is secured to the left portion of the patient's pubis by means of screws 79. Cup acetabulum prosthesis 70 may feature specific sizes. Further, adapters 72 and 73 may feature specific dimensions and shapes so as to allow adaptation of the prosthesis to different patients.
First and second surfaces 74 and 75 may be shaped by means of hand bending tool 40 so as to adopt a specific three dimensional shape, as required.
The exact three dimensional shapes of first and second surfaces 74 and 75 are determined during surgery by using a thin metal template which is easily bent and shaped by the surgeon. Surfaces 74 and 75 are then immediately shaped by means of hand banding tool 40. Figs. 15a and 15b show possible configurations of first surface 74.
Surface 74 preferably includes two bending zones, 92a and 92b, extending along the longitudinal axis of surface 74, along which surface 74 is bent by bending tool 40. Such configuration allows to substantially enclose a bony portion of the patient's ilium so as to effectively fix surface 74 thereto. As shown in the figures, surface 74 preferably includes holes 12 for screws, the .screws for securing surface 74 to the patient's ilium. Preferably, surface 74 includes a plurality of circumferential protrusions 91 separated by depressions 90 such that each of holes 12 is located on a distinct protrusion. As shown in Fig. 15b, each of circumferential 5 protrusions 91 may be independently bent along a specific protrusion bending zone 93, thereby enabling to specifically adapt surface 74 to a specific bone structure.
Surface 75 may feature a similar configuration as shown for surface 74.
10 Fig. 16 shows another embodiment of a pelvic endoprosthesis according to the present invention. As shown in the figure, the patient's ilium has been resected, and first surface 74 extends to reach the patient's sacrum and is preferably connected to the patient's sacrum by means of screws (not shown in the figure). When using such embodiment, surface
15 74 may include a cantilever element, substantially as shown in Fig. 4.
Referring to Figs. 17a and 17b, according to another embodiment the orientation of cup acetabulum prosthesis 70 is adjustable so as to prevent displacement of the femur prosthesis .
As shown in the figures, cup acetabulum prosthesis 70 preferably
20 includes a hollow cylindrical extension 85 received within a hollow cylindrical chamber of adapter 72. Thus, cup acetabulum prosthesis 70 may be rotated along the longitudinal axis of cylindrical extension 85 (designated as A) by rotating cylindrical extension 85 within the hollow cylindrical chamber of adapter 72. Since cup acetabulum prosthesis 70 is
25 unsymmetrical with reference to longitudinal axis A (best shown in FIG. 17a), such rotation results in changing the orientation of cup acetabulum prosthesis 70 relative to adapter 72. Lock screw 80 is used to fix cup acetabulum prosthesis 70 at a desired position.
As . shown in the figure, adapter 72 is preferably connected to
30 surface 74 by means of an excentric pin 82. Such connection allows to slightly change the orientation of adapter 72 with reference to surface 74, substantially as designated by arrow B. Lock screw 84 is used to fix adapter 72 at a desired position.
While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications and other applications of the invention may be made.

Claims

WHAT IS CLAIMED IS:
1. An implant for replacement of a region of a pelvic bone by connecting a first portion and a second portion of the pelvic bone, comprising:
(a) a main surface for connecting the first portion of the pelvic bone and the second portion of the pelvic bone;
(b) at least one end surface connected to said main surface; and
(c) at least one primary bending zone located between said main surface and said at least one end surface for changing the orientation of said at least one end surface relative to said main surface.
2. The implant of claim 1 , wherein the implant includes a first end surface and a second end surface, said first end surface for connection to the first portion of the pelvic bone and said second end surface for connection to the second portion of the pelvic bone.
3. An implant for replacement of a region of a pelvic bone by connecting an acetabulum and a sacrum of a patient, comprising:
(a) a main surface for connecting the acetabulum and the sacrum;
(b) a first end surface and a second end surface connected to said main surface; and
(c) primary bending zones located between said main surface and each of said end surfaces.
4. The implant of claim 1, further comprising: (a) at least one cantilever element connected to said at least one end surface; and
(b) at least one secondary bending zone located between said at least one end surface and said at least one cantilever element for changing the orientation of said at least one cantilever element relative to said at least one end surface.
5. The implant of claim 4, wherein said at least one cantilever element includes at least one tertiary bending zone for changing the orientation of a portion of said cantilever element.
6. The implant of claim 5, wherein said implant includes a first cantilever element connected to a first end surface and a second cantilever element connected to a second end surface, said first cantilever element for connection to the first portion of the pelvic bone and said second cantilever element for connection to the second portion of the pelvic bone.
7. The implant of claim 3, further comprising:
(a) a first cantilever element connected to said first end surface and a second cantilever element connected to said second end surface, said first cantilever element for connection to the acetabulum and said second cantilever element for connection to the sacrum; and
(b) two secondary bending zones, each of which being located between a cantilever element and a respective end surface.
8. . The implant of claim 7, wherein each of said cantilever elements includes a tertiary bending zone.
9. An implant for replacement of a region of a pelvic bone by connecting a first portion and a second portion of the pelvic bone, comprising:
(a) a main surface for connecting the first portion of the pelvic bone and the second portion of the pelvic bone;
(b) at least one cantilever element connected to said main surface; and
(c) at least one primary bending zone located between said main surface and said at least one cantilever element for changing the orientation of said at least one cantilever element relative to said main surface.
10. The implant of claim 9, wherein said at least one cantilever element includes at least one secondary bending zone for changing the orientation of a portion of said cantilever element.
11. The implant of claim 1 , wherein said at least one end surface is bent along a line within the limits of said at least one primary bending zone so as to form an angle of between about 0 and about 30 degrees with said main surface.
12. The implant of claim 4, wherein said at least one cantilever element is bent along a line within the limits of said at least one secondary bending zone so as to form an angle of between about 0 and about 30 degrees with said at least one end surface.
13. The implant of claim 5, wherein said portion of said at least one cantilever element is bent along a line within the limits of said at least one tertiary bending zone so as to form an angle of between about 0 and about 90 degrees with the rest of said cantilever element.
14. The implant of claim 5, wherein said portion of said at least one cantilever element is bent along a line within the limits of said at least one tertiary bending zone so as to form an angle of between about 0 and about 120 degrees with the rest of said cantilever element.
15. The implant of claim 1 , wherein said implant includes a stiffening rib.
16. The implant of claim 15, wherein said stiffening rib has a convexo-concave shape in cross section.
17. The implant of claim 1, wherein said implant includes holes for screws.
18. The implant of claim 6, wherein the dimensions and shapes of said cantilever elements are defined by a slot having a longitudinal portion and a cut-out portion.
19. The implant of claim 1 , wherein said implant features a longitudinal side.
20. The implant of claim 19, wherein said implant further comprising an extension extending substantially along said longitudinal side, said extension being oriented so as to form a predetermined angle with said main surface, thereby forming a stiffening crest between said main surface and said extension.
21. The implant of claim J20, wherein said extension features a longitudinal bend extending along the longitudinal axis of said extension, said bend defining a first portion and a second portion of said extension such that said second portion being oriented so as to form a predetermined angle with said first portion, thereby enabling to substantially enclose a portion of the patient's pelvis.
22. The implant of claim 20, further including openings for receiving a thread therein so as to allow to suture patient's muscles to said implant.
23. A bending tool for bending a pelvic implant, comprising:
(a) an accommodating member having a slot for receiving a surface of the implant therein;
(b) a bending member having at least one bending extension for bending a portion of the surface, said accommodating member featuring a convex surface and said bending member featuring a concave surface so as to allow sliding of said bending member over said accommodating member.
24. The bending tool of claim 23, wherein said slot extends completely through the thickness of said accommodating member.
25. The bending tool of claim 23, wherein said slot extends through a portion of the thickness of said accommodating member.
26. The implant of claim 1 , wherein said at least one end surface includes at least one circumferential protrusion, said at least one protrusion including a hole for receiving a screw therein, said at least one protrusion including a bending zone for individually bending said at least one protrusion relative to said at least one end surface.
27. An implant for replacement of a pelvic bone by connecting a first portion and a second portion of the pelvic bone, comprising:
(a) a cup acetabular prosthesis;
(b) a first main surface for connecting the first portion of the pelvic bone to said cup acetabulum prosthesis;
(c) a second main surface for connecting the second portion of the pelvic bone to said cup acetabulum prosthesis, wherein each of said first and second main surfaces includes:
(i) at least one end surface connected thereto; and
(ii) at least one bending zone located between said main surface and said at least one end surface for changing the orientation of said at least one end surface relative to said main surface.
28. The implant of claim 27, wherein said at least one end surface includes at least one circumferential protrusion, said at least one protrusion including a hole for receiving a screw therein, said at least one protrusion including a bending zone for individually bending said at least one protrusion relative to said at least one end surface.
29. The implant of claim 27, wherein said first main surface is connected to said cup acetabulum prosthesis by means of a first adapter, and said second main surface is connected to said cup acetabulum prosthesis by means of a second adapter.
30. The implant of claim 29, wherein said cup acetabulum prosthesis .includes a protrusion and wherein at least one of said adapters includes a depression for accommodating said protrusion therein, and wherein said protrusion is movable within said depression, thereby allowing to change the orientation of said cup acetabulum prosthesis relative to said at least one adapter.
31. The implant of claim 30, further including a lock screw for fixing the position of said cup acetabulum prosthesis with relation to said at least one adapter.
32. The implant of claim 29, wherein said first adapter is movable with relation to said first main surface.
33. The implant of claim 32, wherein said first adapter is connected to said first main surface by means of an excentric pin.
34. The implant of claim 33, wherein said implant further includes a screw lock for fixing the position of said first adapter with relation to said first surface.
35. The implant of claim 27, wherein the first portion of the pelvic bone includes the patient's ilium.
36. The implant of claim 27, wherein the first portion of the pelvic bone includes the patient's sacrum.
37. The implant of claim 27, wherein the second portion of the pelvic bone includes the patient's pubis.
38. A method for reconstructing a region of a pelvic bone, comprising:
(a) resecting a portion of the pelvic bone; (b) manually shaping a substantially flexible template so as to connect selected remaining portions of the pelvic bone;
(c) substantially immediately shaping a pelvic implant according to the shape of said template by means of a bending tool; and
(d) connecting said implant to the selected remaining portions of the pelvic bone.
PCT/IL1997/000305 1996-12-31 1997-09-12 A modular implant for pelvis reconstruction WO1998029058A1 (en)

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IL11994296A IL119942A (en) 1996-12-31 1996-12-31 Modular implant for pelvis reconstruction

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WO2006031767A3 (en) * 2004-09-10 2006-11-23 Otologics Llc Adjustable bone bracket
US7141073B2 (en) 1993-11-01 2006-11-28 Biomet, Inc. Compliant fixation of external prosthesis
FR2902640A1 (en) * 2006-06-27 2007-12-28 Xavier Renard Bending pliers for emerging end of medical broach, have support jaw including free end with part placed at specific distance from axis, and unit controlling rotation of branches, where one of branches has groove receiving broach to be bent
CN100593395C (en) * 2007-12-18 2010-03-10 中国人民解放军第四军医大学 Multi-axis assembled anti-infective semi-pelvis false body
WO2013138294A1 (en) * 2012-03-14 2013-09-19 Synthes Usa, Llc Pelvic bone plate
US8915970B2 (en) 2013-02-08 2014-12-23 Biomet Manufacturing, Llc Transdermal prosthesis
US8968415B2 (en) 2012-02-07 2015-03-03 Biomet Manufacturing, Llc Implant fixation device
WO2014140886A3 (en) * 2013-03-15 2015-03-05 Merete Medical Gmbh Fixation device and method of use for a lapidus-type plantar hallux valgus procedure
USD740943S1 (en) 2009-04-01 2015-10-13 Merete Medical Gmbh Bone plate
US9161795B2 (en) 2009-12-22 2015-10-20 Merete Medical Gmbh Bone plate system for osteosynthesis
USD745162S1 (en) 2014-01-27 2015-12-08 Merete Medical Gmbh Bone plate
CN105250019A (en) * 2015-09-01 2016-01-20 郭晓东 Acetabula pre/posterior column fracture fixing device and method
US9668793B2 (en) 2011-08-31 2017-06-06 Aristotech Industries Gmbh Anatomically customized plantar bone plate and bone plate system
RU2626122C2 (en) * 2016-07-11 2017-07-21 Федеральное государственное бюджетное учреждение "Российский онкологический центр имени Н.Н. Блохина" Министерства здравоохранения Российской Федерации Device for pelvic bones reconstruction
US9788874B2 (en) 2012-05-03 2017-10-17 Aristotech Industries Gmbh Bone plate system for osteosynthesis
US9820787B2 (en) 2009-04-07 2017-11-21 Aristotech Industries Gmbh Apparatus for the constant-angle fixation and compression of a fracture or osteotomy of a bone
WO2018006429A1 (en) * 2016-07-08 2018-01-11 北京爱康宜诚医疗器材有限公司 Ilium repair device
WO2018230613A1 (en) * 2017-06-14 2018-12-20 ノーベルファーマ株式会社 Tool for molding dysphonia treatment tool, and method for bending front piece of dysphonia treatment tool
IT201800006534A1 (en) * 2018-06-21 2019-12-21 Improved prosthesis.
EP3549539A4 (en) * 2016-11-29 2020-04-01 Nikolaenko, Andrej Nikolaevich Personalized endoprosthesis device for skeletal bones and method for the implantation of same

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Publication number Priority date Publication date Assignee Title
US7141073B2 (en) 1993-11-01 2006-11-28 Biomet, Inc. Compliant fixation of external prosthesis
EP1792519A2 (en) * 2004-09-10 2007-06-06 Otologics, LLC Adjustable bone bracket
US7326171B2 (en) * 2004-09-10 2008-02-05 Otologics, Llc Adjustable bone bracket
EP1792519A4 (en) * 2004-09-10 2010-09-15 Otologics Llc Adjustable bone bracket
WO2006031767A3 (en) * 2004-09-10 2006-11-23 Otologics Llc Adjustable bone bracket
FR2902640A1 (en) * 2006-06-27 2007-12-28 Xavier Renard Bending pliers for emerging end of medical broach, have support jaw including free end with part placed at specific distance from axis, and unit controlling rotation of branches, where one of branches has groove receiving broach to be bent
CN100593395C (en) * 2007-12-18 2010-03-10 中国人民解放军第四军医大学 Multi-axis assembled anti-infective semi-pelvis false body
USD740943S1 (en) 2009-04-01 2015-10-13 Merete Medical Gmbh Bone plate
US9820787B2 (en) 2009-04-07 2017-11-21 Aristotech Industries Gmbh Apparatus for the constant-angle fixation and compression of a fracture or osteotomy of a bone
US9161795B2 (en) 2009-12-22 2015-10-20 Merete Medical Gmbh Bone plate system for osteosynthesis
US9668793B2 (en) 2011-08-31 2017-06-06 Aristotech Industries Gmbh Anatomically customized plantar bone plate and bone plate system
US8968415B2 (en) 2012-02-07 2015-03-03 Biomet Manufacturing, Llc Implant fixation device
WO2013138294A1 (en) * 2012-03-14 2013-09-19 Synthes Usa, Llc Pelvic bone plate
US9788874B2 (en) 2012-05-03 2017-10-17 Aristotech Industries Gmbh Bone plate system for osteosynthesis
US8915970B2 (en) 2013-02-08 2014-12-23 Biomet Manufacturing, Llc Transdermal prosthesis
WO2014140886A3 (en) * 2013-03-15 2015-03-05 Merete Medical Gmbh Fixation device and method of use for a lapidus-type plantar hallux valgus procedure
US9545276B2 (en) 2013-03-15 2017-01-17 Aristotech Industries Gmbh Fixation device and method of use for a lapidus-type plantar hallux valgus procedure
USD860456S1 (en) 2013-03-15 2019-09-17 Aristotech Industries Gmbh Plantar lapidus plate
USD745162S1 (en) 2014-01-27 2015-12-08 Merete Medical Gmbh Bone plate
CN105250019A (en) * 2015-09-01 2016-01-20 郭晓东 Acetabula pre/posterior column fracture fixing device and method
WO2018006429A1 (en) * 2016-07-08 2018-01-11 北京爱康宜诚医疗器材有限公司 Ilium repair device
US10828164B2 (en) 2016-07-08 2020-11-10 Beijing AK Medical Co., Ltd. Iliac prosthesis
RU2626122C2 (en) * 2016-07-11 2017-07-21 Федеральное государственное бюджетное учреждение "Российский онкологический центр имени Н.Н. Блохина" Министерства здравоохранения Российской Федерации Device for pelvic bones reconstruction
EP3549539A4 (en) * 2016-11-29 2020-04-01 Nikolaenko, Andrej Nikolaevich Personalized endoprosthesis device for skeletal bones and method for the implantation of same
WO2018230613A1 (en) * 2017-06-14 2018-12-20 ノーベルファーマ株式会社 Tool for molding dysphonia treatment tool, and method for bending front piece of dysphonia treatment tool
CN110831524A (en) * 2017-06-14 2020-02-21 耐贝医药株式会社 Forming clamp of sound production obstacle treatment tool and bending method of front surface piece of sound production obstacle treatment tool
JPWO2018230613A1 (en) * 2017-06-14 2020-04-16 ノーベルファーマ株式会社 Molding jig for dysphonia treatment device and method for bending front piece of dysphonia treatment device
US11517424B2 (en) 2017-06-14 2022-12-06 Nobelpharma Co., Ltd. Tool for molding dysphonia treatment tool, and method for bending front piece of dysphonia treatment tool
CN110831524B (en) * 2017-06-14 2023-05-16 耐贝医药株式会社 Forming clamp of sounding disorder treatment tool and bending method of front piece of sounding disorder treatment tool
IT201800006534A1 (en) * 2018-06-21 2019-12-21 Improved prosthesis.
EP3586799A1 (en) * 2018-06-21 2020-01-01 Adler Ortho S.p.a. Bone prosthesis

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