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WO2002098329A1 - Greffe biomedicale pour structures squelettiques - Google Patents

Greffe biomedicale pour structures squelettiques Download PDF

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Publication number
WO2002098329A1
WO2002098329A1 PCT/EP2002/005996 EP0205996W WO02098329A1 WO 2002098329 A1 WO2002098329 A1 WO 2002098329A1 EP 0205996 W EP0205996 W EP 0205996W WO 02098329 A1 WO02098329 A1 WO 02098329A1
Authority
WO
WIPO (PCT)
Prior art keywords
graft
main portion
bone
secondary insert
bone tissue
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2002/005996
Other languages
English (en)
Inventor
Rino Biasiolo
Sergio Maggi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
BIOTECK Srl
Original Assignee
BIOTECK Srl
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 BIOTECK Srl filed Critical BIOTECK Srl
Publication of WO2002098329A1 publication Critical patent/WO2002098329A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

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    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
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    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • 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
    • A61F2310/00179—Ceramics or ceramic-like structures

Definitions

  • the present invention relates to a biomedical graft particularly adapted to be used in surgical operations for reconstruction of skeletal structure.
  • Reconstruction surgery techniques of parts of the skeletal structure are known, that are required for instance because of traumatic fracture of bones, pathologic forms such- as tumors, osteoporosis or slipped disk and in tibial osteotomy surgery as well.
  • This kind of operations generally consists in inserting in the affected zones grafts that after surgery have the support function peculiar to bones or in other cases the spacing function as it happens for instance for intervertebral disks.
  • a first known surgery technique consists in replacing the injured bone portion with an autologous portion by removing and grafting suitable bone portions of the same patient or in other cases of a donor.
  • Such a method warrants a full reabsorption of the grafted bone by the receiving organism, with limited rejection problems because the graft is recognized as a part of the same organism.
  • a first problem of said method consists in that the portion of removed bone does not always have the characteristics of mechanical strength of the parts to be replaced, since the bony structure is different according to the kind of bone.
  • a second problem of this method is the need to carry out a preliminary surgery thus damaging the limb from which the portion is removed thus causing the inevitable post-operative troubles for the donor.
  • a first method belonging to the prior art consists in using a prosthesis with the main spacing function to keep constant distance between the bodies in which it is interposed.
  • this method is widely used in operations to replace injured intervertebral disks, for instance because of slipped disks.
  • These artificial prostheses generally consist of two shells of strong material, such as a chromium-cobalt alloy, inside which disks of plastic material are inserted, allowing by their elasticity the prosthesis to fit between the vertebras.
  • couples of said prostheses are arranged fore and aft or aside the invertebral zone, so as to keep integrity of the central zone concerned by the spinal cord.
  • a limitation of said technique consists in that the prosthesis being made of inert material, constitutes a foreign body that cannot be absorbed by the organism thus remaining permanently in it.
  • Another inconvenience of said technique consists in that the inert material of the prosthesis does not allow formation of biological bond between the skeletal structure and the prosthesis but only a mechanical link.
  • Another known technique consists in using prostheses in the form of grids generally called "cage" according to the English terminology. Said "cage” is generally formed by a cylindrical envelope with a cage-like structure of material of high compressive strength such as Titanium.
  • the "cage” is internally empty, once it is grafted, it is filled with a proper material such as bone dust, promoting formation of the bony bridge between the graft zones.
  • a proper material such as bone dust
  • a couple of "cages” is arranged in a horizontal direction in the intervertebral zone and outside the medullary zone of two lumbar vertebras.
  • grafts could be used consisting of non inert biocompatible bony tissue allowing to obtain after application a permanent biological bond by formation of a bony bridge and the full substitution with time of the graft for the endogenous bone.
  • first phase of removing any organic residue through solvents
  • second phase of removing any solvent trace through a process of ceramization making said tissue also inert.
  • the same applicant developed a method of preparing bony tissues wherein the treatment for removing organic animal residues allows the tissue to keep in any case the starting viable structure without being made inert.
  • Bone fragments of sufficient size to make a graft can be obtained only by spongy bone tissues that are known to have good absorption characteristics but at the same time a low compressive strength.
  • bone fragments with good compressive strength are contained in limited zones of the bones and do not allow to obtain grafts of sufficient size.
  • the present invention aims at removing the above-mentioned drawbacks and overcoming the cited limitations concerning the treated bone tissues.
  • the main object of the invention is to provide a biomedical graft that can be highly absorbed by the organism in which it is grafted.
  • Another object of the invention is to provide a biomedical graft having a high mechanical strength adapted to resist the high loads to which the skeletal structure is subject.
  • a further object of the invention is to provide a graft made using spongy bone tissue.
  • Another object of the invention is to provide a graft allowing to be absorbed in a short time relative to the prior art solutions.
  • a biomedical graft for skeletal structures particularly adapted to be inserted between bone members subject to high load that according to the contents of the main claim, is characterized by comprising at least a main portion inserted between said bone members and at least a secondary portion to be inserted in said main portion, said portions having different characteristics of mechanical strength, at least one of said portions consisting of antigen free and reabsorbable bone tissue.
  • the main portion has a generally disk-like shape consisting of antigen free spongy bone tissue. Between the upper and lower surface defining said disk, the secondary insert portions are transversally arranged, made of antigen free and reabsorbable compact bone tissue having high characteristics of mechanical strength.
  • the main portion consists of antigen free and reabsorbable compact bone tissue of generally cylindrical shape and the secondary insert portions are arranged perpendicularly to the main portion and are made with spongy tissue.
  • FIG. 4 is an isometric exploded view of the graft of the invention.
  • - Fig. 5 is a side view of fig. 4; - Fig. 6 shows an executive variation of fig. 4;
  • Fig. 7 is a side view of fig. 6;
  • Fig. 8 shows an application of the device of fig. 4.
  • Fig. 9 shows an application of the device of fig. 6;
  • FIG. 10 shows a further application of the device of fig. 4.
  • the graft of the invention is shown in figs. 4 and 5 where it is generally indicated with reference numeral 1.
  • the graft comprises a main portion 2 in which the secondary insert portions 3 are inserted, shown in fig. 4 separated from the main portion 2 for sake of simplicity, but inserted inside the main portion 2 in the final assembly. More particularly as shown in fig. 4, the main portion 2 has a generally disk-like shape defined by the upper plain surface 4 and the lower plain surface 5, said surfaces belonging to corresponding mutually converging planes giving to the graft 1 a wedge-like shape.
  • the secondary insert portions 3 are developed transversally to surfaces 4 and 5, being two in this embodiment, of generally cylindrical shape and defining a main axis X as shown in fig. 5.
  • the main portion 2 preferably consists of antigen free and reabsorbable spongy bone tissue while the secondary insert portions 3 are of the compact type.
  • Fig. 6 shows an executive variation of the graft of fig. 1 and is generally indicated with numeral 10.
  • the main portion 11 has a generally cylindrical shape and is developed along axis Y.
  • This portion preferably consists of antigen free and reabsorbable compact bone tissue.
  • two secondary insert portions 12 are inserted having a generally cylindrical shape, whose axes Z are arranged along a direction perpendicular to axis Y along which the main portion 11 is developed, and consist of antigen free and reabsorbable spongy bone tissue.
  • An application of the graft 1 of the invention is shown in fig. 8 concerning operations of reconstruction of intervertebral cortical bodies of the spinal cord.
  • a couple of grafts 1 of the invention is arranged between two vertebras V1 , V2 of the backbone, a first graft 1 being positioned before the central zone M concerning the spinal cord and the other graft behind it. More particularly one can see that the axis X defined by the secondary insert portions 3 is coincident with the load direction along which the backbone is stressed by the body weight.
  • the function of mechanical resistance to stress is carried out by the secondary insert portions 3 that being made of compact bone tissue, have a high mechanical strength.
  • the main portion 2 preferably made of spongy bone tissue, promotes absorption of graft 1 of the invention in the post operative phase by the organism so as to reach the intersomatic fusion between the two vertebras V1, V2.
  • the application of the graft 10 of fig. 6 is shown in the particular case of intervertebral application for cervical vertebras.
  • a couple of grafts 10 is positioned in the intervertebral zone defined between the two vertebras V3, V4 and arranged laterally relative to the central zone M concerning the spinal cord. More particularly as the main portion 11 consists of compact bone tissue, it is the same main portion carrying out the function of mechanical strength between the vertebras V3, V4.
  • the application of such a kind of grafts 10 will be advantageous as in the just described case, where the required dimensions are small and allow to make the main portion 11 with compact bone tissue that is present in the bones only in zones of limited size.
  • Fig. 10 shows the application of the graft 1 of the invention in case of operations of tibial-osteotomy wherein the graft 1 of the invention has the general function of shimming wedge between the zones in which it is inserted.
  • the secondary insert portions 3 carry out the function of load resistance along the direction X coincident with the direction of the load to which the tibial bone is subject, while the main portion 2 allows formation of the bony bridge.
  • the graft of the invention may also be used advantageously generally in applications not shown in the drawings for recovery of damaged bones that are not subject to a high load.
  • a permanent biological bond is obtained rather quickly, both for the main portion and the secondary insert portions, with consequent formation of the bony bridge ensuring its early stabilization.

Landscapes

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

Abstract

L'invention concerne une greffe biomédicale (1; 10) pour structures squelettiques, particulièrement appropriée pour être insérée entre des éléments osseux (V1; V2; V3; V4) soumis à une forte charge, comprenant une partie principale (2; 11) insérée entre lesdits membres osseux (V1; V2; V3; V4), et une partie d'insert secondaire (3; 12) insérée dans ladite partie principale (2; 11). Les deux parties (2; 3; 11; 12) présentent des caractéristiques différentes de résistance mécanique, et au moins une des deux parties est constituée d'un antigène libre et de tissu osseux réabsorbable.
PCT/EP2002/005996 2001-05-31 2002-05-31 Greffe biomedicale pour structures squelettiques Ceased WO2002098329A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT2001VI000128A ITVI20010128A1 (it) 2001-05-31 2001-05-31 Innesto biomedico per strutture scheletriche
ITVI2001A000128 2001-06-01

Publications (1)

Publication Number Publication Date
WO2002098329A1 true WO2002098329A1 (fr) 2002-12-12

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Country Status (2)

Country Link
IT (1) ITVI20010128A1 (fr)
WO (1) WO2002098329A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005030099A3 (fr) * 2003-09-24 2005-07-28 Sdgi Holdings Inc Implant de fusion renforce
US7252685B2 (en) 2003-06-05 2007-08-07 Sdgi Holdings, Inc. Fusion implant and method of making same
US7351262B2 (en) 2003-06-05 2008-04-01 Warsaw Orthopedic, Inc. Bone implants and methods of making same
FR2919488A1 (fr) * 2007-08-03 2009-02-06 Cabinet Francois Cale d'osteotomie
US7537617B2 (en) 2003-06-05 2009-05-26 Warsaw Orthopedic, Inc. Bone strip implants and method of making same

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4950296A (en) * 1988-04-07 1990-08-21 Mcintyre Jonathan L Bone grafting units
FR2741525A1 (fr) * 1995-11-24 1997-05-30 Voydeville Gilles Cale correctrice orthopedique
WO1998017209A2 (fr) * 1996-10-23 1998-04-30 Sdgi Holdings, Inc. Ecarteurs vertebraux
US5769897A (en) * 1991-12-13 1998-06-23 Haerle; Anton Synthetic bone
WO2000041654A2 (fr) * 1999-01-11 2000-07-20 Sdgi Holdings, Inc. Element d'espacement intervertebraux, ouverts et tronques
WO2001008714A1 (fr) * 1999-07-28 2001-02-08 Regeneration Technologies, Inc. Cartilage ou matrice osseuse servant de vehicules pour administrer des acides nucleiques
US6200347B1 (en) * 1999-01-05 2001-03-13 Lifenet Composite bone graft, method of making and using same
US20010039457A1 (en) * 2000-03-22 2001-11-08 Boyer Michael L. Plugs for filling bony defects

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4950296A (en) * 1988-04-07 1990-08-21 Mcintyre Jonathan L Bone grafting units
US5769897A (en) * 1991-12-13 1998-06-23 Haerle; Anton Synthetic bone
FR2741525A1 (fr) * 1995-11-24 1997-05-30 Voydeville Gilles Cale correctrice orthopedique
WO1998017209A2 (fr) * 1996-10-23 1998-04-30 Sdgi Holdings, Inc. Ecarteurs vertebraux
US6200347B1 (en) * 1999-01-05 2001-03-13 Lifenet Composite bone graft, method of making and using same
WO2000041654A2 (fr) * 1999-01-11 2000-07-20 Sdgi Holdings, Inc. Element d'espacement intervertebraux, ouverts et tronques
WO2001008714A1 (fr) * 1999-07-28 2001-02-08 Regeneration Technologies, Inc. Cartilage ou matrice osseuse servant de vehicules pour administrer des acides nucleiques
US20010039457A1 (en) * 2000-03-22 2001-11-08 Boyer Michael L. Plugs for filling bony defects

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7252685B2 (en) 2003-06-05 2007-08-07 Sdgi Holdings, Inc. Fusion implant and method of making same
US7351262B2 (en) 2003-06-05 2008-04-01 Warsaw Orthopedic, Inc. Bone implants and methods of making same
US7537617B2 (en) 2003-06-05 2009-05-26 Warsaw Orthopedic, Inc. Bone strip implants and method of making same
WO2005030099A3 (fr) * 2003-09-24 2005-07-28 Sdgi Holdings Inc Implant de fusion renforce
FR2919488A1 (fr) * 2007-08-03 2009-02-06 Cabinet Francois Cale d'osteotomie

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