EP3307335A1 - Osteoinductive orthopedic prosthesis - Google Patents
Osteoinductive orthopedic prosthesisInfo
- Publication number
- EP3307335A1 EP3307335A1 EP16722141.5A EP16722141A EP3307335A1 EP 3307335 A1 EP3307335 A1 EP 3307335A1 EP 16722141 A EP16722141 A EP 16722141A EP 3307335 A1 EP3307335 A1 EP 3307335A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- osteoinductive
- orthopedic prosthesis
- metallic body
- orthopedic
- prosthesis according
- 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
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
- A61L27/045—Cobalt or cobalt alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
- A61L27/06—Titanium or titanium alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/28—Materials for coating prostheses
- A61L27/34—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/56—Porous materials, e.g. foams or sponges
Definitions
- the present invention relates to an osteoinductive orthopedic prosthesis, particularly but not exclusively useful and practical in the field of orthopedic surgery procedures for arthroplasty, i.e., for complete replacement of the damaged joint of a patient with an orthopedic prosthetic implant of the non-cemented type, constituted by mechanical elements that functionally replace the natural joint.
- the prosthetic replacement procedure is one of the most frequently performed procedures for the treatment of severe joint pathologies characterized by pain, loss of joint function and deformity, such as for example arthrosis, rheumatoid arthritis, cephalic necrosis, and the outcomes of previous traumas (fracture and/or dislocation).
- This orthopedic surgical procedure for arthroplasty is an effective biomechanical solution for these joint pathologies and allows patients affected by said pathologies to solve pain or alleviate it significantly, recovering a high quality of life.
- one of the factors that determine the risk of aseptic mobilization is the degree of osteointegration of the orthopedic prosthesis in the bone.
- Osteointegration is the process that causes the orthopedic prosthesis to join stably the newly formed trabecular bone; the osteointegrated prosthesis thus becomes firmly incorporated in the bone and cannot be extracted from it or moved.
- a non-cemented orthopedic prosthesis of the known type is made of biocompatible material, usually titanium alloy, and has a shape and/or a coating of the external surface, constituted by bioactive molecules such as for example collagen, which are adapted to favor and stimulate the growth of bone tissue around it, indeed osteointegration, allowing its final stabilization.
- osteointegration of the known orthopedic prosthesis in the bone may not reach a degree sufficient to ensure the solidity of the bond between the prosthesis and the bone, leading to situations of aseptic mobilization of the prosthetic implant, the only solution to which is a surgical procedure to revise the arthroplasties.
- Aseptic mobilization of the orthopedic prosthesis can occur not only due to the insufficient degree of bone integration but also due to the forming of particles of debris, i.e., fragments produced by the wear of the prosthetic implant, in the periarticular space, usually after long periods of repetitive mechanical stress associated with walking.
- the aim of the present invention is to overcome the limitations of the known art described above, by providing an osteoinductive orthopedic prosthesis that allows to achieve better effects than those obtainable with known orthopedic prostheses, facilitating osteointegration of the orthopedic prosthesis proper in the bone and consequently allowing to have a more stable and durable prosthesis-bone coupling, as well as a reduced risk of revision of the arthroplasty due to aseptic mobilization or prosthetic infection, with an improvement of the quality of life for the prosthetic patient.
- an object of the present invention is to devise an osteoinductive orthopedic prosthesis that stimulates the process for the forming and taking of trabecular bone around the orthopedic prosthesis proper and within any micro-openings with which it is provided.
- Another object of the present invention is to devise an osteoinductive orthopedic prosthesis that can be implanted not only a short time after its preparation/manufacture but also after a time period of months or years.
- a further object of the present invention is to devise an osteoinductive orthopedic prosthesis that allows to minimize bacterial adhesion and, consequently, the risk of infections of the prosthetic implant due to the presence of bacteria.
- an object of the present invention is to devise an osteoinductive orthopedic prosthesis that allows to reduce the production of particles of debris in the periarticular space.
- Another object of the present invention is to provide an osteoinductive orthopedic prosthesis that is highly reliable, is relatively simple to provide and at low costs.
- an osteoinductive orthopedic prosthesis comprising a metallic body, the particularity of which resides in that the external surface of said metallic body comprises a coating of lyophilized collagen.
- the osteoinductive orthopedic prosthesis according to the invention substantially comprises a body made of metallic material and a coating made of lyophilized collagen arranged on the external surface of the metallic body or on a part of said external surface.
- the metallic body is preferably made of titanium alloy, even more preferably made of titanium alloy of the Ti6A14V type.
- the metallic body is preferably made of cobalt alloy, even more preferably of cobalt alloy of the CoCrMo type.
- the osteoinductive orthopedic prosthesis can also comprise other elements in addition to the above cited metallic body, which usually constitutes its main element, said additional elements depending on the requirements of the case and/or on the uses of the osteoinductive orthopedic prosthesis.
- the metallic body of the osteoinductive orthopedic prosthesis according to the invention is preferably provided by additive production, i.e., by using additive powder technology, which allows to obtain, at the end of the production cycle, a finished product of high precision without the need to perform additional finishing with traditional machines.
- calibrated porous lattices having complex structures also made of metallic material, preferably titanium alloy.
- the external surface of the metallic body has a layer of metal having a three-dimensional porous lattice that comprises undercuts or pores, or more generally empty spaces, formed for example by numerous sharp metallic cusps, which are particularly efficient in providing a seal and accordingly ensure an optimum primary seal with the bone of the prosthetic patient.
- the metallic cusps of the layer of porous metal of the metallic body have a substantially triangular shape and are inclined at an acute angle, preferably comprised between 3° and 20° and even more preferably equal to 7°.
- This layer of porous metal of the metallic body of the osteoinductive orthopedic prosthesis according to the invention comprises, as mentioned, undercuts or pores, which are filled with the lyophilized collagen of the coating and allow to accommodate the bone trabeculae of the new bone of the prosthetic patient.
- Collagen is the most abundant protein in mammals and is the main macromolecular components of the extracellular matrix (ECM) of connective tissue, i.e., of the structure that acts as a support for the cells and connects all tissues of eukaryote organisms, including humans.
- ECM extracellular matrix
- This protein due to its very nature and its characteristics, has a great affinity with bone cells, facilitating and stimulating the process for forming and taking of trabecular bone around the metallic body of the osteoinductive orthopedic prosthesis according to the invention, as well as within any undercuts or pores of the layer of porous metal of the metallic body of the osteoinductive orthopedic prosthesis.
- the lyophilized collagen coating is placed on the external surface of the metallic body of the osteoinductive orthopedic prosthesis according to the invention by means of a dense collagen solution that is subsequently lyophilized.
- the collagen used for this purpose and more generally the collagen used for medical purposes, is usually extracted from animal tissues.
- Lyophilization of the collagen coating is performed by means of a corresponding known technological process, which allows to eliminate the water from said organic substance, collagen indeed, with the smallest possible deterioration of the structure and of the components of the substance proper.
- this process for lyophilization of the collagen coating which as mentioned is arranged on the external surface of the metallic body, allows easy and durable preservation of the osteoinductive orthopedic prosthesis according to the invention, and said preservation can be performed even at ambient temperature and for example for up to five years after the date of preparation/manufacture of the prosthesis proper.
- the osteoinductive orthopedic prosthesis thus conceived allows to overcome the qualitative limitations of the background art, since it facilitates osteointegration of the orthopedic prosthesis proper in the bone and accordingly allows to have a more stable and durable prosthesis-bone coupling, as well as a reduced risk of revision of the arthroprosthesis due to aseptic mobilization or prosthetic infection, with an improvement of the quality of life for the prosthetic patient.
- the osteoinductive orthopedic prosthesis according to the invention stimulates the process for the forming and taking of the trabecular bone around the orthopedic prosthesis proper, as well as within any undercuts or pores of the layer of porous metal with which it is provided.
- osteoinductive orthopedic prosthesis resides in that it can be implanted not only a short time after its preparation/manufacture but also after a period of time of months or years, for example up to a maximum of 5 years.
- a further advantage of the osteoinductive orthopedic prosthesis according to the invention resides in that it allows to minimize bacterial adhesion and consequently the risk of infections of the prosthetic implant due to the presence of bacteria.
- osteoinductive orthopedic prosthesis resides in that it allows to reduce the production of debris particles in the periarticular space, in particular by way of the increase in the degree of osteointegration of the orthopedic prosthesis in the bone.
- osteoinductive orthopedic prosthesis according to the invention has been conceived in particular for orthopedic surgery procedures for arthroplasty, it can in any case be used more generally in the field of any orthopedic surgical procedure, for example as a mechanical elements for the surgical treatment of orthopedic trauma such as fractures and/or dislocations.
- the invention thus conceived is susceptible of numerous modifications and variations, all of which are within the scope of the appended claims. All the details may further be replaced with other technically equivalent elements.
- the materials used may be any according to requirements and to the state of the art.
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Dispersion Chemistry (AREA)
- Prostheses (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ITUB20151337 | 2015-06-11 | ||
PCT/EP2016/060172 WO2016198215A1 (en) | 2015-06-11 | 2016-05-06 | Osteoinductive orthopedic prosthesis |
Publications (1)
Publication Number | Publication Date |
---|---|
EP3307335A1 true EP3307335A1 (en) | 2018-04-18 |
Family
ID=54199941
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP16722141.5A Ceased EP3307335A1 (en) | 2015-06-11 | 2016-05-06 | Osteoinductive orthopedic prosthesis |
Country Status (2)
Country | Link |
---|---|
EP (1) | EP3307335A1 (en) |
WO (1) | WO2016198215A1 (en) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN107998446B (en) * | 2017-12-27 | 2021-10-15 | 北京银河巴马生物技术股份有限公司 | Medical titanium mesh with tissue engineering stent covering film and preparation method thereof |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2664501B1 (en) * | 1990-07-16 | 1995-05-12 | Osteal Medical Laboratoires | COMPOSITE MATERIAL FOR BONE IMPLANT AND METHOD FOR IMPLEMENTING SAME. |
CN101229394B (en) * | 2007-01-24 | 2013-05-22 | 张立海 | Titanium alloy-collagen-hydroxyl apatite bone repairing material and preparing method thereof |
US8790402B2 (en) * | 2012-01-09 | 2014-07-29 | Zimmer, Inc. | Composite device that combines porous metal and bone stimuli |
WO2015116646A1 (en) * | 2014-01-28 | 2015-08-06 | Mccoy Enterprises, Llc | Collagen permeated medical implants |
-
2016
- 2016-05-06 WO PCT/EP2016/060172 patent/WO2016198215A1/en active Application Filing
- 2016-05-06 EP EP16722141.5A patent/EP3307335A1/en not_active Ceased
Also Published As
Publication number | Publication date |
---|---|
WO2016198215A1 (en) | 2016-12-15 |
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Legal Events
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Effective date: 20200513 |