US20180319057A1 - Mould and a method for forming an orthopaedic spacer made of medical cement - Google Patents
Mould and a method for forming an orthopaedic spacer made of medical cement Download PDFInfo
- Publication number
- US20180319057A1 US20180319057A1 US15/608,304 US201715608304A US2018319057A1 US 20180319057 A1 US20180319057 A1 US 20180319057A1 US 201715608304 A US201715608304 A US 201715608304A US 2018319057 A1 US2018319057 A1 US 2018319057A1
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- US
- United States
- Prior art keywords
- mould
- forming
- moulding
- insert
- spacer
- 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.)
- Abandoned
Links
- 125000006850 spacer group Chemical group 0.000 title claims abstract description 43
- 239000004568 cement Substances 0.000 title claims abstract description 21
- 238000000034 method Methods 0.000 title claims description 11
- 238000000465 moulding Methods 0.000 claims abstract description 30
- 239000002639 bone cement Substances 0.000 claims description 12
- 230000003014 reinforcing effect Effects 0.000 claims description 7
- 230000000295 complement effect Effects 0.000 claims description 3
- 238000003825 pressing Methods 0.000 claims description 2
- 239000000463 material Substances 0.000 description 4
- 239000004743 Polypropylene Substances 0.000 description 3
- 210000000988 bone and bone Anatomy 0.000 description 3
- 238000003780 insertion Methods 0.000 description 3
- 230000037431 insertion Effects 0.000 description 3
- -1 polypropylene Polymers 0.000 description 3
- 229920001155 polypropylene Polymers 0.000 description 3
- 230000008878 coupling Effects 0.000 description 2
- 238000010168 coupling process Methods 0.000 description 2
- 238000005859 coupling reaction Methods 0.000 description 2
- 229920001935 styrene-ethylene-butadiene-styrene Polymers 0.000 description 2
- 229910000831 Steel Inorganic materials 0.000 description 1
- 210000003275 diaphysis Anatomy 0.000 description 1
- 210000002745 epiphysis Anatomy 0.000 description 1
- 210000003414 extremity Anatomy 0.000 description 1
- 210000004394 hip joint Anatomy 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 210000000629 knee joint Anatomy 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- 210000000323 shoulder joint Anatomy 0.000 description 1
- 239000010959 steel Substances 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/0046—Details relating to the filling pattern or flow paths or flow characteristics of moulding material in the mould cavity
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30965—Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C39/00—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
- B29C39/003—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor characterised by the choice of material
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C39/00—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
- B29C39/22—Component parts, details or accessories; Auxiliary operations
- B29C39/26—Moulds or cores
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/0001—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor characterised by the choice of material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
- A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
- A61F2/3662—Femoral shafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
- A61F2002/30672—Features concerning an interaction with the environment or a particular use of the prosthesis temporary
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
- A61F2002/30957—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using a positive or a negative model, e.g. moulds
-
- 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
- A61F2310/00353—Bone cement, e.g. polymethylmethacrylate or PMMA
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C39/00—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
- B29C39/02—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles
- B29C39/10—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles incorporating preformed parts or layers, e.g. casting around inserts or for coating articles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2033/00—Use of polymers of unsaturated acids or derivatives thereof as moulding material
- B29K2033/04—Polymers of esters
- B29K2033/12—Polymers of methacrylic acid esters, e.g. PMMA, i.e. polymethylmethacrylate
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7532—Artificial members, protheses
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2274/00—Thermoplastic elastomer material
Definitions
- the present invention relates to a mould and a method for forming a temporary orthopaedic spacer.
- orthopaedic spacers are made of medical bone cement and have the purpose of temporarily replacing fixed prostheses up to a conclusion of treatment for septic infections, or like issues.
- a prior art method for realising orthopaedic spacers includes modelling the starting bone cement directly in the operation theatre, so as to give the cement the predetermined shape.
- moulds are often used that comprise two moulding shells that are couplable to one another so as to realise a volume to be filled with the cement.
- the shells can have shapes for realising a spacer that can be adapted to the shoulder, knee or hip joints, and others besides.
- the known moulds disadvantageously enable only a partial flexibility of use.
- An aim of the present invention is therefore to make available a mould and a method for forming a temporary orthopaedic spacer which enable obviating the drawbacks of the prior art.
- an aim of the present invention is to provide a unitary modular mould which enables realising orthopaedic spacers different for patients having different physiques.
- FIG. 1 is a schematic representation of the mould of the present invention
- FIG. 2 is a view from above of a first component of the mould of the present invention
- FIG. 3 is a schematic representation of a second component of the mould of the present invention.
- FIG. 4 is a schematic representation of a third component of the mould of the present invention.
- reference number 1 indicates a forming mould of an orthopaedic spacer made of medical cement, in accordance with the present invention.
- the invention can also be used with known medical cements, which are however not described in detail in the following.
- the mould 1 defines a moulding cavity 2 delimited by a moulding surface 3 .
- the surface 3 is configured to impart a predetermined shape on the medical cement and to create an orthopaedic spacer.
- the mould 1 comprises a first moulding element 4 a and a second moulding element 4 b.
- the first moulding element 4 a comprises a first moulding surface 5 a and the second element 4 b comprises a second moulding surface 5 b.
- first element 4 a and the second element 4 b are configured for being superposed on one another, at an open lateral surface which comprises the first surface 5 a (in the case of the first element 4 a ) and the second surface 5 b (in the case of the second element 4 b ).
- the two moulding elements 4 a , 4 b can be specular and therefore symmetrical with respect to a join plane, at which they contact to define the closed mould.
- a passage hole 6 is defined that is shaped by a first channel 6 a of the first element 4 a and by a second channel 6 b of the second element 4 b (see for example FIG. 1 ).
- the passage hole 6 enables inserting medical cement in liquid state into the mould 1 .
- the first moulding element 4 a and/or the second moulding element 4 b are preferably made of polypropylene or of a polypropylene based material.
- the first and the second element 4 a , 4 b are substantially specular, for simplicity of description, in the following a detailed description will be made of only the first element 4 a , and what is described is also valid for the second element 4 b.
- the first element 4 a comprises a first sector 7 a and a second sector 7 b defining the moulding surface 3 .
- the first sector 7 a defines at least a first portion 8 of the moulding surface 3 and is for forming a first part of the orthopaedic spacer.
- the mould preferably comprises a second forming insert 9 (illustrated in FIG. 3 ) suitable for inserting in the moulding cavity 2 of the mould 1 .
- the second forming insert 9 is insertable between the first portion 8 of the first moulding surface 5 a of the first element 4 a and the first portion 8 of the second moulding surface 5 b of the second element 4 b.
- the second forming insert 9 has a complementary shape to a head portion 8 a of the first portion 8 .
- the second forming insert 9 is configured for shaping the “head” of the spacer, i.e. the rounded part of the conformation destined to take the place of the missing epiphysis of the bone.
- the second forming insert 9 preferably comprises positioning means 10 configured for enabling the correct insertion of the forming insert 9 in the first portion 8 of the first surface 5 a (and/or the second surface 5 b ).
- the positioning means 10 comprises at least a pair of ribs 11 in relief on an external surface of the second forming insert 9 .
- the ribs 11 are suitable for being operatively inserted into respective profiled portions 11 a of the first moulding element 4 a and/or the second moulding element 4 b.
- the second forming insert 9 has a forming surface shaped as a concave spherical cap shape 11 b , so as to be able to impress, on the bone cement, the form of the head of the spacer.
- the second forming insert is made of a TPE-SEBS based material; this is however not a unique solution.
- the second sector 7 b defines a second portion 12 of the surface 3 and is for forming a second part of the orthopaedic spacer, adjacent to the first part.
- the second sector 7 b comprises a housing 13 in which at least a half-part 14 a (illustrated in FIG. 4 ) is insertable, of at least a first forming insert 14 of the mould 1 (with reference to the second element 4 b , reference will be made to the half-part 14 b represented in FIG. 1 and complementary to the half-part 14 a ).
- the half-part 14 a comprises the second portion 12 of the surface 3 and has an elongate shape along a prevalent development direction configured for forming an elongate portion of the orthopaedic spacer in the superposed configuration of the first 4 a and the second element 4 b (and therefore in a superposed configuration of the half-part 14 a and the half-part 14 b , thus going to form the first forming insert 14 ).
- the first forming insert 14 is preferably configured for forming a portion of rod or “stalk” of the orthopaedic spacer, i.e. the part having an elongate shape which is destined to couple with the residual diaphysis of the bone.
- the second portion 12 of the surface 3 preferably has a tapered shape along the development direction in a distancing direction from the first portion 8 .
- the second portion 12 of the surface 3 has a cone shape.
- the mould 1 preferably comprises a plurality of first forming inserts 14 that are inter-replaceable, on the basis of the dimension of the spacer that is to be obtained.
- each first forming insert 14 has a different width and/or length of the second portion 12 , i.e. of the concave part, so as to realise orthopaedic spacers having different dimensions.
- spacers can be obtained having different transversal and/or longitudinal dimensions.
- the second portion 12 of the surface 3 has the rod portion 12 a and a conduit 12 b configured for enabling insertion and distribution of the medical cement.
- the first forming insert 14 is preferably made of a TPE-SEBS based material; this is however not a unique solution, as the first insert could also be made of polypropylene or another material besides.
- the invention provides a good degree of modularity, as by replacing the first insert 14 , spacers of different thickness can be obtained.
- the invention enables a continuous modularity, as the length of the stalk or rod of the spacer is a direction function of the quantity of bone cement poured into the mould during the forming operations.
- the mould 1 is positioned so as to have the first portion 8 thereof inferiorly located with respect to the second portion 12 , so that the passage hole 6 enables easy insertion of a portion of bone cement.
- the mould further comprises a reinforcing element 15 , possibly of known type, insertable in the two forming inserts.
- the reinforcing element 15 is preferably made of steel and is constituted by a profiled plate 15 a , defined by a first portion 15 b and a second portion 15 c that are angled with respect to one another.
- the reinforcing element 15 is sunken into the cement, with the first portion 15 b remaining sunken in the head of the spacer, while the second portion 15 b is incorporated in the stalk.
- the mould 1 comprises coupling means 17 configured for joining the first element 4 a and the second element 4 b in a superposed configuration of the first element 4 a with the second element 4 b .
- the coupling means 17 is conformed so as to join the first element 4 a and the second element 4 b by locking and/or jointing in order to position them correctly one on the other.
- the mould 1 is pressed by a press of known type that is therefore not a part of the present description.
- the cement Once the cement has hardened, it defines the spacer with can therefore be removed from the mould and inserted in the patient's body.
- the present invention relates to a method for forming an orthopaedic spacer.
- the method includes predisposing a mould 1 realised according to the invention.
- the first forming insert 14 and the second forming insert 9 are selected on the basis of the characteristics of the patient's physique, i.e.
- a reinforcing element 15 is also predisposed, to be located internally of the two forming inserts, the dimensions of which element 15 are also a function of the physical characteristics of the patient.
- the mould 1 is positioned so that the head portion 8 a is located inferiorly of the rod portion 12 a and the mould 1 is filled with bone cement, sliding the bone cement through the passage hole 6 .
- the quantity of cement inserted defines the longitudinal dimensions of the spacer.
- the pressing step of the mould 1 then follows, and the consequent solidifying step of the bone cement, so as to obtained the desired spacer.
- the above-mentioned mould 1 advantageously enables obtaining an orthopaedic spacer that is specific for a specific patient by modelling the head portion 8 a by means of a second forming insert 9 and regulating the longitudinal and transversal dimensions of the rod portion 12 a by means of the first forming insert 14 .
- the first forming insert 14 enables both obtaining a plurality of transversal dimensions that are different from the rod or “stalk” of the spacer, simply by replacing the first forming insert 14 with another forming insert 14 , and obtaining any longitudinal dimension of the rod portion, in the above-explained ways.
Abstract
Description
- The present invention relates to a mould and a method for forming a temporary orthopaedic spacer.
- As is known, orthopaedic spacers are made of medical bone cement and have the purpose of temporarily replacing fixed prostheses up to a conclusion of treatment for septic infections, or like issues.
- A prior art method for realising orthopaedic spacers includes modelling the starting bone cement directly in the operation theatre, so as to give the cement the predetermined shape.
- In detail, with this method forming moulds are often used that comprise two moulding shells that are couplable to one another so as to realise a volume to be filled with the cement.
- The shells can have shapes for realising a spacer that can be adapted to the shoulder, knee or hip joints, and others besides.
- The known moulds disadvantageously enable only a partial flexibility of use.
- In fact, the patients, as is well-known, have very different physiques and naturally require prostheses and spacers having dimensions corresponding to those of the limbs they will be used for.
- Therefore, at present, either the surgeon uses a multiplicity of moulds for treating patients having different physiques or can treat only patients having those specific physiques which can be adapted to moulds placed on the market by manufacturers.
- An aim of the present invention is therefore to make available a mould and a method for forming a temporary orthopaedic spacer which enable obviating the drawbacks of the prior art.
- In particular, an aim of the present invention is to provide a unitary modular mould which enables realising orthopaedic spacers different for patients having different physiques.
- The stated technical task and specified aims are attained by a mould and a method for forming a temporary orthopaedic spacer according to the appended claims.
- Further characteristics and advantages of the present invention will become more apparent from the indicative, and hence non-limiting, description of the mould and the method of the invention.
- This description will be set out below with reference to the attached drawings, provided solely for indicative and therefore non-limiting purposes, in which:
-
FIG. 1 is a schematic representation of the mould of the present invention; -
FIG. 2 is a view from above of a first component of the mould of the present invention; -
FIG. 3 is a schematic representation of a second component of the mould of the present invention; -
FIG. 4 is a schematic representation of a third component of the mould of the present invention; - With reference to the accompanying figures, reference number 1 indicates a forming mould of an orthopaedic spacer made of medical cement, in accordance with the present invention.
- The invention can also be used with known medical cements, which are however not described in detail in the following.
- The mould 1 defines a
moulding cavity 2 delimited by a mouldingsurface 3. Thesurface 3 is configured to impart a predetermined shape on the medical cement and to create an orthopaedic spacer. - In the embodiment illustrated in
FIG. 1 , the mould 1 comprises afirst moulding element 4 a and asecond moulding element 4 b. - The
first moulding element 4 a comprises afirst moulding surface 5 a and thesecond element 4 b comprises asecond moulding surface 5 b. - In particular, the
first element 4 a and thesecond element 4 b are configured for being superposed on one another, at an open lateral surface which comprises thefirst surface 5 a (in the case of thefirst element 4 a) and thesecond surface 5 b (in the case of thesecond element 4 b). - In still greater detail, the two
moulding elements - The
first element 4 a and thesecond element 4 b together define a containing volume of the medical cement and further components able to form the spacer, which will be described in the following. - In the closed configuration of the mould 1, a
passage hole 6 is defined that is shaped by afirst channel 6 a of thefirst element 4 a and by asecond channel 6 b of thesecond element 4 b (see for exampleFIG. 1 ). - The
passage hole 6 enables inserting medical cement in liquid state into the mould 1. - The
first moulding element 4 a and/or thesecond moulding element 4 b are preferably made of polypropylene or of a polypropylene based material. - Since, in the preferred embodiment of the invention, the first and the
second element first element 4 a, and what is described is also valid for thesecond element 4 b. - The
first element 4 a comprises afirst sector 7 a and asecond sector 7 b defining themoulding surface 3. - The
first sector 7 a, defines at least afirst portion 8 of themoulding surface 3 and is for forming a first part of the orthopaedic spacer. - The mould preferably comprises a second forming insert 9 (illustrated in
FIG. 3 ) suitable for inserting in themoulding cavity 2 of the mould 1. - In particular, the second forming
insert 9 is insertable between thefirst portion 8 of thefirst moulding surface 5 a of thefirst element 4 a and thefirst portion 8 of thesecond moulding surface 5 b of thesecond element 4 b. - For the sake of precision, the second forming
insert 9 has a complementary shape to ahead portion 8 a of thefirst portion 8. - In greater detail, the second forming
insert 9 is configured for shaping the “head” of the spacer, i.e. the rounded part of the conformation destined to take the place of the missing epiphysis of the bone. - The second forming
insert 9 preferably comprises positioning means 10 configured for enabling the correct insertion of the forminginsert 9 in thefirst portion 8 of thefirst surface 5 a (and/or thesecond surface 5 b). - The positioning means 10 comprises at least a pair of
ribs 11 in relief on an external surface of the second forminginsert 9. In particular, theribs 11 are suitable for being operatively inserted into respective profiledportions 11 a of thefirst moulding element 4 a and/or thesecond moulding element 4 b. - In still greater detail, the second forming
insert 9 has a forming surface shaped as a concavespherical cap shape 11 b, so as to be able to impress, on the bone cement, the form of the head of the spacer. - Preferably, the second forming insert is made of a TPE-SEBS based material; this is however not a unique solution.
- The
second sector 7 b defines asecond portion 12 of thesurface 3 and is for forming a second part of the orthopaedic spacer, adjacent to the first part. - In particular, the
second sector 7 b comprises ahousing 13 in which at least a half-part 14 a (illustrated inFIG. 4 ) is insertable, of at least a first forminginsert 14 of the mould 1 (with reference to thesecond element 4 b, reference will be made to the half-part 14 b represented inFIG. 1 and complementary to the half-part 14 a). - The half-
part 14 a comprises thesecond portion 12 of thesurface 3 and has an elongate shape along a prevalent development direction configured for forming an elongate portion of the orthopaedic spacer in the superposed configuration of the first 4 a and thesecond element 4 b (and therefore in a superposed configuration of the half-part 14 a and the half-part 14 b, thus going to form the first forming insert 14). - The first forming
insert 14 is preferably configured for forming a portion of rod or “stalk” of the orthopaedic spacer, i.e. the part having an elongate shape which is destined to couple with the residual diaphysis of the bone. - The
second portion 12 of thesurface 3 preferably has a tapered shape along the development direction in a distancing direction from thefirst portion 8. - Further, the
second portion 12 of thesurface 3 has a cone shape. - The mould 1 preferably comprises a plurality of first forming
inserts 14 that are inter-replaceable, on the basis of the dimension of the spacer that is to be obtained. - In particular, each first forming
insert 14 has a different width and/or length of thesecond portion 12, i.e. of the concave part, so as to realise orthopaedic spacers having different dimensions. - In practice, on the basis of the physical characteristics of the patient, spacers can be obtained having different transversal and/or longitudinal dimensions.
- In the embodiment of
FIG. 4 , thesecond portion 12 of thesurface 3 has therod portion 12 a and aconduit 12 b configured for enabling insertion and distribution of the medical cement. - The first forming
insert 14 is preferably made of a TPE-SEBS based material; this is however not a unique solution, as the first insert could also be made of polypropylene or another material besides. - As concerns the transversal dimensions of the spacer, the invention provides a good degree of modularity, as by replacing the
first insert 14, spacers of different thickness can be obtained. - As concerns the longitudinal dimension, the invention enables a continuous modularity, as the length of the stalk or rod of the spacer is a direction function of the quantity of bone cement poured into the mould during the forming operations.
- In fact, during the filling of the mould 1 with bone cement, the mould 1 is positioned so as to have the
first portion 8 thereof inferiorly located with respect to thesecond portion 12, so that thepassage hole 6 enables easy insertion of a portion of bone cement. - In this way, it is possible to regulate, with absolute precision, the longitudinal dimensions of the
second portion 12 on the basis of the volume of cement inserted through thehole 6. - The mould further comprises a reinforcing
element 15, possibly of known type, insertable in the two forming inserts. - The reinforcing
element 15 is preferably made of steel and is constituted by aprofiled plate 15 a, defined by afirst portion 15 b and asecond portion 15 c that are angled with respect to one another. - In this way, during the filling step of the mould 1 with the bone cement, the reinforcing
element 15 is sunken into the cement, with thefirst portion 15 b remaining sunken in the head of the spacer, while thesecond portion 15 b is incorporated in the stalk. - The mould 1 comprises coupling means 17 configured for joining the
first element 4 a and thesecond element 4 b in a superposed configuration of thefirst element 4 a with thesecond element 4 b. The coupling means 17 is conformed so as to join thefirst element 4 a and thesecond element 4 b by locking and/or jointing in order to position them correctly one on the other. - Once loaded with the medical cement (in the quantity necessary for obtaining the desired longitudinal dimensions), the mould 1 is pressed by a press of known type that is therefore not a part of the present description.
- Once the cement has hardened, it defines the spacer with can therefore be removed from the mould and inserted in the patient's body.
- The present invention relates to a method for forming an orthopaedic spacer.
- The method includes predisposing a mould 1 realised according to the invention.
- Therefore, the first forming
insert 14 and the second forminginsert 9 are selected on the basis of the characteristics of the patient's physique, i.e. - on the basis of the dimensions of the portions of bone on which the spacer intervenes.
- A reinforcing
element 15 is also predisposed, to be located internally of the two forming inserts, the dimensions of whichelement 15 are also a function of the physical characteristics of the patient. - At this point, the mould 1 is positioned so that the
head portion 8 a is located inferiorly of therod portion 12 a and the mould 1 is filled with bone cement, sliding the bone cement through thepassage hole 6. The quantity of cement inserted defines the longitudinal dimensions of the spacer. - The pressing step of the mould 1 then follows, and the consequent solidifying step of the bone cement, so as to obtained the desired spacer.
- The mould 1 and the method described in the foregoing are able to obviate the drawbacks that have emerged in the prior art.
- The above-mentioned mould 1 advantageously enables obtaining an orthopaedic spacer that is specific for a specific patient by modelling the
head portion 8 a by means of a second forminginsert 9 and regulating the longitudinal and transversal dimensions of therod portion 12 a by means of the first forminginsert 14. - Still more advantageously, the first forming
insert 14 enables both obtaining a plurality of transversal dimensions that are different from the rod or “stalk” of the spacer, simply by replacing the first forminginsert 14 with another forminginsert 14, and obtaining any longitudinal dimension of the rod portion, in the above-explained ways.
Claims (8)
Applications Claiming Priority (2)
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IT102017000048295 | 2017-05-04 | ||
IT102017000048295A IT201700048295A1 (en) | 2017-05-04 | 2017-05-04 | Mold and method for forming an orthopedic spacer in medical cement. |
Publications (1)
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US20180319057A1 true US20180319057A1 (en) | 2018-11-08 |
Family
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US15/608,304 Abandoned US20180319057A1 (en) | 2017-05-04 | 2017-05-30 | Mould and a method for forming an orthopaedic spacer made of medical cement |
US16/759,207 Pending US20200316824A1 (en) | 2017-05-04 | 2018-01-22 | A mould and a method for forming an orthopaedic spacer made of medical cement |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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US16/759,207 Pending US20200316824A1 (en) | 2017-05-04 | 2018-01-22 | A mould and a method for forming an orthopaedic spacer made of medical cement |
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US (2) | US20180319057A1 (en) |
EP (1) | EP3618772B1 (en) |
AU (1) | AU2018262340B2 (en) |
BR (1) | BR112019023086B1 (en) |
DK (1) | DK3618772T3 (en) |
ES (1) | ES2938481T3 (en) |
FI (1) | FI3618772T3 (en) |
HR (1) | HRP20230141T1 (en) |
HU (1) | HUE061131T2 (en) |
IT (1) | IT201700048295A1 (en) |
LT (1) | LT3618772T (en) |
PL (1) | PL3618772T3 (en) |
PT (1) | PT3618772T (en) |
RS (1) | RS63979B1 (en) |
SI (1) | SI3618772T1 (en) |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP3939546B1 (en) * | 2020-07-17 | 2023-10-11 | Heraeus Medical GmbH | Device and method for producing spacers |
Families Citing this family (3)
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IT201700048295A1 (en) | 2017-05-04 | 2018-11-04 | G21 S R L | Mold and method for forming an orthopedic spacer in medical cement. |
CN107190604B (en) * | 2017-05-24 | 2019-11-05 | 中建钢构有限公司 | A kind of bicycle expressway girder steel paving structure and its paving method |
EP3900680B1 (en) * | 2020-04-24 | 2022-06-29 | Heraeus Medical GmbH | Device and method for producing spacers with variable head |
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US20160332328A1 (en) * | 2015-03-27 | 2016-11-17 | Heraeus Medical Gmbh | Spacer mould and method for producing hip spacers |
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JP6722662B2 (en) | 2014-11-06 | 2020-07-15 | コッシングトン リミテッド | Mold for forming a joint spacer device or part thereof |
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-
2017
- 2017-05-04 IT IT102017000048295A patent/IT201700048295A1/en unknown
- 2017-05-30 US US15/608,304 patent/US20180319057A1/en not_active Abandoned
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2018
- 2018-01-22 ES ES18705020T patent/ES2938481T3/en active Active
- 2018-01-22 LT LTEPPCT/IB2018/050375T patent/LT3618772T/en unknown
- 2018-01-22 HR HRP20230141TT patent/HRP20230141T1/en unknown
- 2018-01-22 PT PT187050208T patent/PT3618772T/en unknown
- 2018-01-22 PL PL18705020.8T patent/PL3618772T3/en unknown
- 2018-01-22 AU AU2018262340A patent/AU2018262340B2/en active Active
- 2018-01-22 RS RS20230116A patent/RS63979B1/en unknown
- 2018-01-22 HU HUE18705020A patent/HUE061131T2/en unknown
- 2018-01-22 SI SI201830847T patent/SI3618772T1/en unknown
- 2018-01-22 EP EP18705020.8A patent/EP3618772B1/en active Active
- 2018-01-22 WO PCT/IB2018/050375 patent/WO2018203150A1/en unknown
- 2018-01-22 FI FIEP18705020.8T patent/FI3618772T3/en active
- 2018-01-22 BR BR112019023086-6A patent/BR112019023086B1/en active IP Right Grant
- 2018-01-22 US US16/759,207 patent/US20200316824A1/en active Pending
- 2018-01-22 DK DK18705020.8T patent/DK3618772T3/en active
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US20070222114A1 (en) * | 2006-03-23 | 2007-09-27 | Ziran Bruce H | Method of forming a temporary implant and mold assembly for same |
US20160332328A1 (en) * | 2015-03-27 | 2016-11-17 | Heraeus Medical Gmbh | Spacer mould and method for producing hip spacers |
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EP3939546B1 (en) * | 2020-07-17 | 2023-10-11 | Heraeus Medical GmbH | Device and method for producing spacers |
Also Published As
Publication number | Publication date |
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US20200316824A1 (en) | 2020-10-08 |
SI3618772T1 (en) | 2023-04-28 |
IT201700048295A1 (en) | 2018-11-04 |
DK3618772T3 (en) | 2023-02-06 |
FI3618772T3 (en) | 2023-03-22 |
PL3618772T3 (en) | 2023-03-20 |
LT3618772T (en) | 2023-03-10 |
EP3618772B1 (en) | 2022-12-21 |
RS63979B1 (en) | 2023-03-31 |
ES2938481T3 (en) | 2023-04-11 |
PT3618772T (en) | 2023-02-13 |
AU2018262340A1 (en) | 2019-10-31 |
AU2018262340B2 (en) | 2023-11-16 |
EP3618772A1 (en) | 2020-03-11 |
BR112019023086B1 (en) | 2023-12-12 |
WO2018203150A1 (en) | 2018-11-08 |
HRP20230141T1 (en) | 2023-03-31 |
HUE061131T2 (en) | 2023-05-28 |
BR112019023086A2 (en) | 2020-05-26 |
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