GB2259253A - Modular implant system using plastics film to join components - Google Patents

Modular implant system using plastics film to join components Download PDF

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Publication number
GB2259253A
GB2259253A GB9217846A GB9217846A GB2259253A GB 2259253 A GB2259253 A GB 2259253A GB 9217846 A GB9217846 A GB 9217846A GB 9217846 A GB9217846 A GB 9217846A GB 2259253 A GB2259253 A GB 2259253A
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GB
United Kingdom
Prior art keywords
components
modular implant
implant system
assembly
modular
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.)
Withdrawn
Application number
GB9217846A
Other versions
GB9217846D0 (en
Inventor
Roy Yoshikazu Hori
William H Harris
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.)
Bristol Myers Squibb Co
Original Assignee
Bristol Myers Squibb Co
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
Priority to US75449191A priority Critical
Application filed by Bristol Myers Squibb Co filed Critical Bristol Myers Squibb Co
Publication of GB9217846D0 publication Critical patent/GB9217846D0/en
Publication of GB2259253A publication Critical patent/GB2259253A/en
Application status is Withdrawn legal-status Critical

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    • AHUMAN NECESSITIES
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    • 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
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    • 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
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    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
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    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30065Properties of materials and coating materials thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30383Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
    • A61F2002/30387Dovetail connection
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    • 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
    • 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
    • A61F2220/005Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • 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

Abstract

A modular implant system for assembly by a surgeon comprises at least two implant components 1, 20 and a solid plastic film 21 layer to be positioned between the components, the plastic film being able to adhere to the components when activated by heating. The plastic film may be composed of a thermoplastic resin such as a polyaryletherketone.

Description

MODULAR IMPLANT AND METHOD OF ASSEMBLY 3A.CKGROUND OF THT INVENTION The present invention relates to the attachment of modular orthopaedic implant components to one another and, more specifically, to the use of plastic materials to isolate and adhere these components.

In applying orthopaedic implants to the human body, especially hip and knee implants, a surgeon often encounters a less than optimal fit of the implant' to a bone. To acccomodate the variations in patients and surgical situations that lead to poor fi, many designers have developed modular implant systems.

Modular implant systems allow optional, pre-operative or intraoperative assembly of components by a surgeon as needed to fit z specific patient.

Previous modular implants have employed a variety of mechanical fixation means as illustrated in U.S. 4,4S2,606 and U.S.

4,995,883 directed to hip implants and U.S. 4,950,293 and U.S.

4,936,847 directed to knee implants. These mechanical connecting means can be problematic in that they allow small relative motion between components and between the connecting members. This motion in turn generates wear debris, compromises the implant fixation to the bone, and concentrates stress on the components and connecting members. All of these results of component relative motion have been implicated in failure of implant procedures.

It is also known in the field of modular joint implants to use polymethylmethacrylate bone cement to attach components. The cement is applied in licuid form, the components assembled, an tne cement allowed to cure. The cement, in this case, sirnply fills the space between the components and forms a mechanical interlock so far as interlocking surfaces are provided. There is substantially no adhesion of the cement to the implant surface. This form of connection is characterised by low overall fixation strength as well as potential separation between the cement and component resulting in relative motion and debris.In addition, liquid cement is messy and awkward to work with for this purpose in that it must be mixed and then used within a specific working time, it tends to run onto articular and bone interface surfaces from which it must be removed and it gives off noxious fumes.

The invention of this disclosure addresses the deficiencies of the above-mentioned attachment means by providing a solid, heat activated, adhesive to join modular implant components.

According to one aspect, the invention provides a modular implant system for assembly during surgery comprising at least two implant components to be connected together and a solid plastic film to be positioned between the components, the plastic film adhering to the components when activated.

In another aspect the invention provides a method of bonding modular implant components during surgery comprising the steps of: selecting the components to be joined, positioning the components with a solid plastic layer disposed therebetween to form an assembly, applying heat to the assembly to effect bonding between the plastic layer and each of the components.

The invention thus aims to isolate components to prevent debris generation between components and to achieve tight adherence between the components surfaces to prevent motion and debris generation between the components and the adhesive. In addition, the secure bond promotes even stress distribution between the components. It does this while being clean and convenient to use both pre-operatively and intra-operatively.

The before mentioned features and advantages of the present invention are apparent from the following detailed description and the drawings wherein: Figure 1 is an exploded perspective view of a tibial knee embodiment of the invention; FIG. 2 is a perspective vie of a tibial augnentaton component.

FIG. 3 is an exploded side view of a tenoral knee er & aiment of the invention.

FIG. 4 is an exploded perspective view at a femoral hip embodiment of the invention.

DO TAILED DESCRIPTION OF TThtI INVENTION An embodiment of the present invention as shown in FIG. 1 comprises a modular orthopaedic implant with a tibial base component 1, a tibial augment component 3, and a thin plastic water or film 2 for adhesively joining and preventing relative motion between components 1 and 3. The film 2 is a thermoplastic with a lower melting point than the components 1 and 3.It also exhibits goad adhesive bonding characteristics with the components n and Experiments have shown members of the polyaryletherketone (PAEK) family of thermoplastic polymers to develop strong adhesive bonds with commonly used implant metals such as cobalt-chromium- molybdenum alloy (Co-Cr-Mo) and titanium-vanadium-aluminum allay (Ti-6AI-4v). specifically, a PAEK sold by BASF under the tradename Ultrapek~ KR477 was tested to determine its bonding strength witn Co-Cr-Ho and Ti-6A1-4V. Pairs of cylindrical rod samples with .6 souare inch faces were adhered together with Ultrapek KR4177 -ully engaging the faces. The polymer was placed between the faces and the assembly heated in a furnace at 770 F for 45 minutes. The samples were then coaled to room temperature and subjected to tensile testing to determine the stress required to separate the sample pairs.The testing showed that for Co-Cr-Mo samples that were cleaned, glass bead blasted and passivated prior to banding; te separation stress was e##al to the ultimate tensile strength the PAEK at 17 KS. Far similarly treated Ti-6Al-4V samples the separation stress was 7 KSI. The lower strength band as determined to be due to the build-up of an oxide layer on the samples during heating in the furnace. When the experiment was repeated with Ti-6Al-4V samples that were titanium nitride coated, the stress increased to 10 KSI. In addition, when the samples were heated by induction for 4 minutes rather than in the furnace, the stress increased to 13 KSI.

The referred embodiment of the present invention comprises the tibial base component 1 and a tibial augment component 5 (FIG. 2) with a thin layer of PAEK 4 pre-bonded to it. After a surgeon has selected the proper components for use with a specific patient, he assembles the chosen components and positions then with a bonding fixture such as.a clamp as is well known in the art. Fe then applies heat to the assembly such as in a furnace or by induction heating. The assembly is allowed to cool and the oustor assembled implant is implanted.

While the foregoing has described a preferred embodiment at the present invention, variations in design, materials and method are possible to attach any modular implant component. For example, FIG. 3 shows a femoral knee component 6 with a variet o augmentation components. An anterior augmentation component 7, a distal augmentation component 8, and a stem extension component 9 can all be attached to the femoral component 6 via banding with 2 thermoplastic polymer as described above.FIG. 4 shows a femoral hip stem component 10 with a lateral augmentation component 11, an anteriar/pasterior augmentation 12, a distal stem augmentation 13, and a femoral head 14 all of which can be assembled according to the present invention in order to securely attach then and prevent relative motion and debris generation between components.

As noted previously the thermoplastic layer may be supplied pre-bonded to one of the components of a mating pair or the layer may be supplied as a separate wafer shaped to conform to ne corresponding components. The present invention is also useful in combination with a primary mechanical fixation means, such as screws, dovetail interlocks, snap fits, etc. For example, in FIG.

1, the thermoplastic adhesive layer 18 prevents micromotion and debris generation between system components such as the tibial base plate 1, an augmentation block 16 and an attachment screw 17. In addition, materials other than metals may be joined in the disclosed manner so long as the thermoplastic layer has a lower melting point than the components to be joined and exhibits good adhesive bonding characteristics with the components. The tibial base component 1 can be joined to a polymer tibial articular surface 20 with a thermoplastic bonding layer 21. It is also within the scope of this invention to use an operating room autoclave to heat the components provided that the thermoplastic has a sufficiently low melting point to be within the range of autoclave temperatures. Finally, various surface modifications such as grooving, roughening or porous coating may be employed to compliment the adhesion of the thermoplastic to the component.

It will be understood by those skilled in the art that the aforementioned embodiments and modifications and numerous others may be made without departing from the spirit and scope of the invention defined by the appended claims.

Claims (14)

1. A modular implant system for assembly during surgery comprising at least two implant components to be connected together and a solid plastic film to be positioned between the components, the plastic film adhering to the components when activated.
2. The modular implant system of Claim 1, wherein the plastic film is composed of a thermoplastic resin which is activated by heating when in contact with the components.
3. The modular implant system of Claim 2, wherein the thermoplastic resin has a lower melting temperature than the implant components.
4. The modular implant system of Claim 2 or Claim 3, wherein the themoplastic resin is from the polyaryletherketone family.
5. The modular implant system of any preceding claim, wherein the components are composed of a metal alloy which has been blasted with abrasive media.
6. The modular implant of any preceding claim, wherein the plastic film is supplied pre-bonded to one of the implant components.
7. The modular implant system of any preceding claim, further comprising mechanical fixation means for connecting the components.
8. The modular implant system of Claim 7, wherein the mechanical fixation means comprises a screw threadably engageable with one of the components.
9. A method of bonding modular implant components during surgery comprising the steps of: selecting the components to be joined, positioning the components with a solid plastic layer disposed therebetween to form an assembly, applying heat to the assembly to effect bonding between the plastic layer and each of the components.
10. The method of Claim 9, wherein the step of applying heat is accomplished by placing the assembly in a furnace.
11. The method of Claim 9, wherein the step of applying heat is accomplished by inductively heating the assembly.
12. The method of Claim 9, wherein the step of applying heat is accomplished by placing the assembly in an operating room autoclave.
13. A modular implant system substantially as herein described with reference to any of the accompanying drawings.
14. A method of bonding modular implant components substantially as herein described with reference to any of the accompanying drawings.
GB9217846A 1991-09-03 1992-08-21 Modular implant system using plastics film to join components Withdrawn GB2259253A (en)

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EP0598450A1 (en) * 1992-11-12 1994-05-25 Bristol-Myers Squibb Company Prosthetic implant and method of making same
EP0599426A1 (en) * 1992-11-23 1994-06-01 Bristol-Myers Squibb Company Set of prosthetic implants and method for converting a cementable implant to a press fit implant
US5387241A (en) * 1994-01-28 1995-02-07 Zimmer, Inc. Ribbed augment for a prosthetic implant
US5458637A (en) * 1994-11-21 1995-10-17 Zimmer, Inc. Orthopaedic base component with modular augmentation block
US5702464A (en) * 1996-02-20 1997-12-30 Smith & Nephew Inc. Modular trial tibial insert
EP0834294A1 (en) * 1996-10-07 1998-04-08 Sulzer Orthopädie AG Cemented modular prosthesis
US6063122A (en) * 1998-06-22 2000-05-16 Johnson & Johnson Professional, Inc. Jack screw adapter for joint prosthesis
US6071311A (en) * 1998-08-14 2000-06-06 Johnson & Johnson Professional, Inc. Cylindrical box femoral stem
US6171342B1 (en) 1996-07-23 2001-01-09 Depuy Orthopaedics, Inc. Medical fastening system
US6527807B1 (en) 1998-09-09 2003-03-04 Johnson & Johnson Professional, Inc. Femoral stem attachment for a modular knee prosthesis
US7338498B2 (en) 2003-03-31 2008-03-04 Depuy Products, Inc. Prosthetic implant, trial and associated method
US7517364B2 (en) 2003-03-31 2009-04-14 Depuy Products, Inc. Extended articulation orthopaedic implant and associated method
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US7842093B2 (en) 2006-07-18 2010-11-30 Biomet Manufacturing Corp. Method and apparatus for a knee implant
US7879042B2 (en) 2004-03-05 2011-02-01 Depuy Products, Inc. Surface replacement extractor device and associated method
US7998217B1 (en) 2005-02-02 2011-08-16 Biomet Manufacturing Corp. Modular offset stem implants
US8105327B2 (en) 2003-03-31 2012-01-31 Depuy Products, Inc. Punch, implant and associated method
US8366713B2 (en) 2003-03-31 2013-02-05 Depuy Products, Inc. Arthroplasty instruments and associated method
US8545506B2 (en) 2003-03-31 2013-10-01 DePuy Synthes Products, LLC Cutting guide for use with an extended articulation orthopaedic implant
US8592531B2 (en) 2007-09-11 2013-11-26 Solvay Advanced Polymers, L.L.C. Prosthetic devices
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EP0599426A1 (en) * 1992-11-23 1994-06-01 Bristol-Myers Squibb Company Set of prosthetic implants and method for converting a cementable implant to a press fit implant
US5387241A (en) * 1994-01-28 1995-02-07 Zimmer, Inc. Ribbed augment for a prosthetic implant
US5458637A (en) * 1994-11-21 1995-10-17 Zimmer, Inc. Orthopaedic base component with modular augmentation block
US5702464A (en) * 1996-02-20 1997-12-30 Smith & Nephew Inc. Modular trial tibial insert
US6171342B1 (en) 1996-07-23 2001-01-09 Depuy Orthopaedics, Inc. Medical fastening system
EP0834294A1 (en) * 1996-10-07 1998-04-08 Sulzer Orthopädie AG Cemented modular prosthesis
US5938698A (en) * 1996-10-07 1999-08-17 Sulzer Orthopaedie Ag Kit system for cemented prostheses
US6063122A (en) * 1998-06-22 2000-05-16 Johnson & Johnson Professional, Inc. Jack screw adapter for joint prosthesis
US6071311A (en) * 1998-08-14 2000-06-06 Johnson & Johnson Professional, Inc. Cylindrical box femoral stem
US6527807B1 (en) 1998-09-09 2003-03-04 Johnson & Johnson Professional, Inc. Femoral stem attachment for a modular knee prosthesis
US8814943B2 (en) 2003-03-31 2014-08-26 DePuy Synthes Products,LLC Bone preparation tool kit and associated method
US7517364B2 (en) 2003-03-31 2009-04-14 Depuy Products, Inc. Extended articulation orthopaedic implant and associated method
US7527631B2 (en) 2003-03-31 2009-05-05 Depuy Products, Inc. Arthroplasty sizing gauge
US9445911B2 (en) 2003-03-31 2016-09-20 DePuy Synthes Products, Inc. Bone preparation tool kit and associated method
US9254135B2 (en) 2003-03-31 2016-02-09 DePuy Synthes Products, Inc. Arthroplasty instruments and associated method
US9107758B2 (en) 2003-03-31 2015-08-18 DePuy Synthes Products, Inc. Bone preparation tool kit and associated method
US7338498B2 (en) 2003-03-31 2008-03-04 Depuy Products, Inc. Prosthetic implant, trial and associated method
US8105327B2 (en) 2003-03-31 2012-01-31 Depuy Products, Inc. Punch, implant and associated method
US8182541B2 (en) 2003-03-31 2012-05-22 Depuy Products, Inc. Extended articulation orthopaedic implant
US8974458B2 (en) 2003-03-31 2015-03-10 DePuy Synthes Products, LLC Arthroplasty instruments and associated method
US8366713B2 (en) 2003-03-31 2013-02-05 Depuy Products, Inc. Arthroplasty instruments and associated method
US8444646B2 (en) 2003-03-31 2013-05-21 Depuy Products, Inc. Bone preparation tool kit and associated method
US8545506B2 (en) 2003-03-31 2013-10-01 DePuy Synthes Products, LLC Cutting guide for use with an extended articulation orthopaedic implant
US8882776B2 (en) 2003-03-31 2014-11-11 DePuy Synthes Products, LLC Extended articulation orthopaedic implant
US8070755B2 (en) 2003-03-31 2011-12-06 Depuy Products, Inc. Joint arthroplasty kit and method
US8282649B2 (en) 2004-03-05 2012-10-09 Depuy Products, Inc. Extended articulation orthopaedic implant
US7879042B2 (en) 2004-03-05 2011-02-01 Depuy Products, Inc. Surface replacement extractor device and associated method
US7998217B1 (en) 2005-02-02 2011-08-16 Biomet Manufacturing Corp. Modular offset stem implants
US7842093B2 (en) 2006-07-18 2010-11-30 Biomet Manufacturing Corp. Method and apparatus for a knee implant
US8592531B2 (en) 2007-09-11 2013-11-26 Solvay Advanced Polymers, L.L.C. Prosthetic devices
US9144628B2 (en) 2007-09-11 2015-09-29 Solvay Specialty Polymers Usa, Llc Prosthetic devices
US9539361B2 (en) 2007-09-11 2017-01-10 Solvay Specialty Polymers Usa, L.L.C. Prosthetic devices
AU2015394224B2 (en) * 2015-05-08 2018-10-18 Jiansu Okani Medical Technology Co., Ltd Tibial support of artificial knee joint
EP3298989A4 (en) * 2015-05-08 2019-03-13 Jiangsu Okani Medical Tech Co Ltd Tibial support of artificial knee joint

Also Published As

Publication number Publication date
CA2075848A1 (en) 1993-03-04
DE4228710A1 (en) 1993-03-04
JPH0767898A (en) 1995-03-14
FR2680689A1 (en) 1993-03-05
AU2037692A (en) 1993-03-18
GB9217846D0 (en) 1992-10-07

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