Patent EP0601804A1 successfully refreshed from Google Patents.
EP0601804A1
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Medical implants of biocompatible low modulus titanium alloy
Assignee: Smith and Nephew Inc
•
Filing: 1993-12-03
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Granted: —
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Expires: 2013-12-03
Abstract
Abstract Biocompatible medical implants from a high strength titanium alloy with low elastic modulus containing titanium, about 10-20 wt% or 35 to about 50 wt% niobium and up to 20 wt% zirconium. In particular, the titanium alloy has a modulus of elasticity closer to that of bone than other typically used metal alloys and does not include any elements which have been shown or suggested as having short or long term potential adverse effects from a standpoint of biocompatibility.
Inventors
- 👤 James A. Davidson
- 👤 Paul Kovacs
- 👤 Ajit K. Mishra
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-23 15:56
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/01; A61M25/09; A61B; A61B17/00; A61B17/56; A61B17/58; A61B17/68; A61B17/72; A61B17/74; A61B17/742; A61B17/746; A61B17/80; A61B17/84; A61B17/86; A61B17/866; A61C; A61C7/00; A61C7/12; A61C8/00; A61C8/0012; A61F; A61F2/00; A61F2/02; A61F2/04; A61F2/06; A61F2/24; A61F2/2403; A61F2/2442; A61F2/2445; A61F2/2448; A61F2/30; A61F2/30767; A61L; A61L27/00; A61L27/02; A61L27/04; A61L27/06; A61L27/50; A61L27/507; A61L31/00; A61L31/02; A61L31/022; A61L31/14; A61L33/00; A61L33/02; A61L33/022; A61M60/00; A61M60/10; A61M60/122; A61M60/126; A61M60/148; A61M60/165; A61M60/178; A61M60/196; A61M60/40; A61M60/424; A61M60/427; A61M60/43; A61M60/438; A61M60/441; A61M60/443; A61M60/446; A61M60/80; A61M60/855; A61M60/865; A61M60/867; A61N; A61N1/00; A61N1/02; A61N1/04; A61N1/05; A61N1/056; C; C22; C22C; C22C14/00; C22C30/00; A61B17/7233; A61B17/7258; A61B17/7275; A61B17/8061; A61B17/22; A61B2017/22038; A61F2/0077; A61F2/07; A61F2/2406; A61F2/2421; A61F2/2424; A61F2/32; A61F2/36; A61F2/3662; A61F2/367; A61F2/38; A61F2/3859; A61F2/389; A61F2/82; A61F2/86; A61F2/90; A61F2/91; A61F2/95; A61F2/958; A61F2002/30001; A61F2002/30667; A61F2002/30677; A61F2002/30922; A61F2/3609; A61F2002/3625; A61F2002/3631; A61F2002/3678; A61F2002/368; A61F2250/00; A61F2250/0058; A61F2250/0067; A61F2310/00; A61F2310/00005; A61F2310/00011; A61F2310/00023; A61F2310/00389; A61F2310/00574; A61F2310/0058; A61F2310/00592; A61F2310/00598; A61F2310/00616; A61F2310/00634; A61F2310/0064; A61F2310/00658; A61F2310/0073; A61F2310/00748; A61F2310/00766; A61F2310/00772; A61F2310/00856; A61F2310/0088; A61F2310/00892; A61F2310/00898; A61L2430/00; A61L2430/36; A61M25/0043; A61M2025/0062; A61M2205/00; A61M2205/02; A61M2205/025; A61M2205/32
Claims Analysis
Total Claims: 72
Claim 1
Independent Claim
108 words
A biocompatible medical implant of low modulus and high strength for implantation into a living body where it is subject to corrosive effects of body fluids, said medical implant comprising: a metallic alloy consisting essentially of: (i) titanium; (ii) from about 10 to 20 wt% niobium or from about 25 to about 50 wt% niobium; and (iii) optionally up to about 20 wt% zirconium; wherein said medical implant has an elastic modulus less than about 90 GPa and the corrosive effects of body fluids does not result in release of toxic or potentially toxic ions into the living body after surgical implantation of the implant into said body.
Claim 2
Dependent Claim
12 words
The medical implant according to claim 1 which is a cardiovascular implant.
Claim 3
Dependent Claim
30 words
The medical implant according to claims 1 or 2 consisting essentially of: (i) titanium; (ii) from about 10 to 20 wt% niobium; and (iii) up to about 20 wt% zirconium.
Claim 4
Dependent Claim
30 words
The medical implant according to claims 1 or 2 consisting essentially of: (i) titanium; (ii) from about 35 to 50 wt% niobium; and (iii) up to about 20 wt% zirconium.
Claim 5
Dependent Claim
26 words
The medical implant of claim 1 wherein the implant is selected from the group consisting of bone plates, bone screws, intramedullary rods, and compression hip screws.
Claim 6
Dependent Claim
30 words
The medical implant of claim 1 wherein the metallic alloy comprises tantalum in an amount sufficient to stabilise the β-phase without significantly affecting the modulus of elasticity of the implant.
Claim 7
Dependent Claim
23 words
The medical implant of claim 1 wherein the alloy is substantially in the β-phase and has a strength greater than about 620 MPa.
Claim 8
Dependent Claim
22 words
The medical implant of claim 1, wherein the alloy consists essentially of: 74 wt.% titanium, 13 wt.% niobium, and 13 wt.% zirconium.
Claim 9
Dependent Claim
23 words
The medical implant of claim 8 wherein the alloy is substantially in the β-phase and has a strength greater than about 620 MPa.
Claim 10
Dependent Claim
34 words
The medical implant of claim 1 further comprising at least a partial outer surface protective coating selected from the group consisting of the oxides, nitrides, carbides and carbonitrides of elements of the metal alloy.
Claim 11
Dependent Claim
27 words
The medical implant of claim 1 further comprising a protective coating of amorphous diamond-like carbon on at least a portion of an outer surface of the implant.
Claim 12
Dependent Claim
27 words
The medical implant of claim 1 wherein the metallic alloy is internally oxidised or nitrided beneath outer surfaces of the implant to produce a hardened medical implant.
Claim 13
Dependent Claim
29 words
The medical implant of claim 1 wherein the implant is selected from the components of a modular knee joint consisting of a femoral component and a tibial base component.
Claim 14
Dependent Claim
27 words
The medical implant of claim 13 wherein the metallic alloy is internally oxidised or nitrided beneath outer surfaces of the implant to produce a hardened medical implant.
Claim 15
Dependent Claim
23 words
The medical implant of claim 13 wherein the alloy is substantially in the β-phase and has a strength greater than about 620 MPa.
Claim 16
Dependent Claim
22 words
The medical implant of claim 13 wherein the alloy consists essentially of: 74 wt% titanium, 13 wt% niobium, and 13 wt% zirconium.
Claim 17
Dependent Claim
27 words
The medical implant of claim 13 further comprising a protective coating of amorphous diamond-like carbon on at least a portion of an outer surface of the implant.
Claim 18
Dependent Claim
34 words
The medical implant of claim 13 further comprising at least a partial outer surface protective coating selected from the group consisting of the oxides, nitrides, carbides and carbonitrides of elements of the metal alloy.
Claim 19
Dependent Claim
141 words
The medical implant according to claim 2 comprising a heart valve prosthesis for implantation in living body tissue of a patient, the heart valve having enhanced hemocompatibility, comprising: (a) a valve body having an aperture through which blood is able to flow when the heart valve is implanted in a patient, the valve body fabricated from a metal alloy comprising: (i) titanium; (ii) from about 10 to about 20 wt% niobium or from about 35 to about 50 wt% niobium; and (iii) optionally up to about 20 wt% zirconium; (b) a flow control element able to move relative to the valve body to close the aperture in the valve body thereby blocking blood flow through the aperture; and (c) means, attached to the valve body, for restraining said flow control component to close proximity to the aperture in the valve body.
Claim 20
Dependent Claim
20 words
The heart valve prosthesis of claim 19, wherein the metal alloy comprises from about 0.5 to about 20 wt.% zirconium.
Claim 21
Dependent Claim
37 words
The heart valve prosthesis of claim 20, wherein outer surfaces of the valve body are hardened by a process selected from the group consisting of oxygen diffusion hardening, nitrogen hardening, physical vapour deposition, and chemical vapour deposition.
Claim 22
Dependent Claim
18 words
The heart valve prosthesis of claim 19 further comprising a coating overlayed over outer surfaces comprising a medicament.
Claim 23
Dependent Claim
25 words
The heart valve prosthesis of claim 19 further comprising wear-resistant surfaces produced by a process selected from the group consisting of boronation and silver doping.
Claim 24
Dependent Claim
61 words
The medical implant according to claim 2 comprising a ventricular assist device including components with surfaces subject to mechanical wear and microfretting wear, the improvement comprising: components fabricated from a metal alloy comprising: (a) titanium; (b) from about 10 to about 20 wt% niobium or from about 25 to 50 wt% niobium; and (c) optionally up to about 20 wt% zirconium.
Claim 25
Dependent Claim
20 words
The ventricular assist device of claim 24, wherein the metal alloy comprises from about 0.5 to about 20 wt% zirconium.
Claim 26
Dependent Claim
40 words
The ventricular assist device of claim 25, wherein the surfaces subject to mechanical wear and microfretting wear are hardened by a process selected from the group consisting of oxygen diffusion hardening, nitrogen hardening, physical vapour deposition, and chemical vapour deposition.
Claim 27
Dependent Claim
15 words
The ventrical assist device of claim 24, wherein the surfaces are coated with a medicament.
Claim 28
Dependent Claim
36 words
The ventricular assist device of claim 24 further comprising a coating on the surfaces subject to mechanical and microfretting wear, the coating applied by a process selected from the group consisting of silver doping and boronation.
Claim 29
Dependent Claim
68 words
The medical implant according to claim 2 comprising a ventricular assist device including components with surfaces in contact with blood when the device is implanted in a patient, the improvement comprising: said components fabricated from a metal alloy comprising: (a) titanium; (b) from about 10 to about 20 wt% niobium or from about 35 to about 50 wt% niobium; and (c) optionally up to about 20 wt% zirconium.
Claim 30
Dependent Claim
18 words
The device of claim 29, wherein the metal alloy comprises from about 0.5 to about 20 wt% zirconium.
Claim 31
Dependent Claim
35 words
The device of claim 30, wherein the surfaces in contact with blood are hardened by a process selected from the group consisting of oxygen diffusion hardening, nitrogen hardening, physical vapour deposition, and chemical vapour deposition.
Claim 32
Dependent Claim
20 words
The device of claim 29, wherein the surfaces in contact with blood are coated with a composition comprising a medicament.
Claim 33
Dependent Claim
80 words
The medical implant according to claim 2 comprising a total artificial heart device for implantation into a chest cavity of a patient, the device including components with surfaces subject to mechanical wear and microfretting wear when in use in the patient, the improvement comprising: components fabricated from a metal alloy comprising: (a) titanium; (b) from about 10 to about 20 wt% niobium or from about 35 to about 50 wt% niobium; and (c) optionally up to about 20 wt% zirconium.
Claim 34
Dependent Claim
18 words
The device of claim 33, wherein the metal alloy comprises from about 0.5 to about 20 wt% zirconium.
Claim 35
Dependent Claim
38 words
The device of claim 34, wherein the surfaces subject to mechanical wear and microfretting wear are hardened by a process selected from the group consisting of oxygen diffusion hardening, nitrogen hardening, physical vapour deposition, and chemical vapour deposition.
Claim 36
Dependent Claim
32 words
The device of claim 33, wherein the surfaces subject to mechanical wear and microfretting wear are hardened by coating with a process selected from the group consisting of silver doping and boronation.
Claim 37
Dependent Claim
80 words
The medical implant according to claim 2 comprising a total artificial heart device for implantation into a chest cavity of a patient, the device including components presenting surfaces that are in contact with blood when in use in the patient, the improvement wherein the components are fabricated from an alloy comprising: (a) titanium (b) from about 10 to about 20 wt% niobium or from about 35 to about 50 wt% niobium; and (c) optionally up to about 20 wt% zirconium.
Claim 38
Dependent Claim
18 words
The device of claim 37, wherein the metal alloy comprises from about 0.5 to about 20 wt% zirconium.
Claim 39
Dependent Claim
34 words
The device of claim 38, wherein outer surfaces of the components are hardened by a process selected from the group consisting of oxygen diffusion hardening, nitrogen hardening, physical vapour deposition, and chemical vapour deposition.
Claim 40
Dependent Claim
20 words
The device of claim 37, wherein the surfaces in contact with blood are coated overlayed over outer surfaces comprising medicament.
Claim 41
Dependent Claim
106 words
The medical implant according to claim 2 comprising a flexible guide wire for insertion into a living body to perform surgical operations, the guide wire comprising: (a) an elongate, flexible guide wire body having a distal end, for insertion into a patient and into a catheter, and a proximal end for controlling the guide wire; (b) an elongate guide wire core disposed internally along the longitudinal axis of the elongate body, said core comprising a metal alloy comprising: (i) titanium; (ii) from about 10 to about 20 wt% niobium or from about 35 to 50 wt% niobium; and (iii) optionally up to about 20 wt% zirconium.
Claim 42
Dependent Claim
20 words
The guide wire of claim 41 further comprising a hardened cutting edge on the distal end of the elongate body.
Claim 43
Dependent Claim
18 words
The wire of claim 41, wherein the metal alloy comprises from about 0.5 to about 20 wt% zirconium.
Claim 44
Dependent Claim
35 words
The wire of claim 43, wherein the core has a hardened outer surface produced by a process selected from the group consisting of oxygen diffusion hardening, nitrogen hardening, physical vapour deposition, and chemical vapour deposition.
Claim 45
Dependent Claim
25 words
The wire of claim 41, where surfaces of the wire that come into contact with body tissue are coated with a composition comprising a medicament.
Claim 46
Dependent Claim
29 words
The wire of claim 41, further comprising a hardened outer surface, said hardened outer surface produced by a process selected from the group consisting of silver doping and boronation.
Claim 47
Dependent Claim
110 words
The medical implant according to claim 2 comprising an expandable stent for supporting a blood, urinary, or gastrointestinal vessel from collapsing inward, the stent comprising: (a) a radially outwardly expandable substantially cylindrical stent body of a metal alloy comprising: (i) titanium; (ii) from about 10 to about 20 wt% niobium or from about 35 to about 50 wt% niobium; and (iii) optionally up to about 20 wt% zirconium; the stent body in its unexpected state sized for ease of insertion into a vessel and in expanded state sized for propping open a vessel, the stent body having a bore therethrough for receiving a means for expanding the body radially outwardly.
Claim 48
Dependent Claim
18 words
The stent of claim 47, wherein the metal alloy comprises from about 0.5 to about 20 wt% zirconium.
Claim 49
Dependent Claim
34 words
The stent of claim 48, wherein surfaces of the stent are hardened by a process selected from the group consisting of oxygen diffusion hardening, nitrogen hardening, and physical vapour deposition, and chemical vapour deposition.
Claim 50
Dependent Claim
18 words
The stent of claim 47, wherein surfaces of the stent are coated with a composition comprising a medicament.
Claim 51
Dependent Claim
30 words
The stent of claim 47 further comprising a coating on surfaces of the stent, said coating applied by a process selected from the group consisting of silver doping and boronation.
Claim 52
Dependent Claim
86 words
The medical implant according to claim 2 comprising a biocompatible lead or sensor for conducting electrical signals to or from an organ in a living body, the lead comprising: an elongate flexible body having distal and proximal ends, the flexible body comprising: (a) an electrically conductive core of a metal alloy comprising: (i) titanium (ii) from about 10 to about 20 wt% niobium or from about 35 to about 50 wt% niobium; and (iii) optionally up to about 20 wt% zirconium; for carrying the electrical signals.
Claim 53
Dependent Claim
18 words
The lead of claim 52, wherein the metal alloy comprises from about 0.5 to about 20 wt% zirconium.
Claim 54
Dependent Claim
17 words
The lead of claim 53 further comprising a thin non-electrically conductive layer surrounding the electrically conductive core.
Claim 55
Dependent Claim
19 words
The lead of claim 53 further comprising a coating on the non-electrically conducting layer, said coating comprising a medicament.
Claim 56
Dependent Claim
98 words
The medical implant according to claim 2 comprising a low modulus, biocompatible, percutaneous implant that penetrates the skin of a living body and thereby protrudes from the body, the implant comprising: (a) a low modulus metallic implant body fabricated from a metal alloy comprising: (i) titanium; (ii) from about 10 to about 20 wt% niobium or from about 35 to about 50 wt% niobium; and (iii) optionally up to about 20 wt% zirconium; said implant body having a first end for insertion into said patient and a portion with a second end for extending outside of said patient.
Claim 57
Dependent Claim
19 words
The percutaneous implant of claim 56, wherein the metal alloy comprises from about 0.5 to about 20 wt% zirconium.
Claim 58
Dependent Claim
38 words
The percutaneous implant of claim 57 further comprising a hardened outer surface, said hardened outer surface produced by a process selected from the group consisting of oxygen diffusion hardening, nitrogen hardening, physical vapour deposition, and chemical vapour deposition.
Claim 59
Dependent Claim
21 words
The percutaneous implant of claim 56, further comprising a coating on surfaces of the implant body, said coating comprising a medicament.
Claim 60
Dependent Claim
34 words
The percutaneous implant of claim 56 further comprising a wear-resistant layer on surfaces of the implant body, the wear-resistant layer produced by a process selected from the group consisting of silver doping and boronation.
Claim 61
Dependent Claim
61 words
The medical implant according to claim 2 comprising an external mechanical heart including Components with surfaces subject to mechanical wear and microfretting wear, the improvement comprising: components of a metal alloy comprising: (a) titanium; (b) from about 10 to about 20 wt% niobium or from about 35 to about 50 wt% niobium; and (c) optionally up to about 20 wt% zirconium.
Claim 62
Dependent Claim
20 words
The mechanical heart of claim 61, wherein the metal metal alloy comprises from about 0.5 to about 20 wt% zirconium.
Claim 63
Dependent Claim
21 words
The mechanical heart of claim 62 further comprising a hardened outer surface on the components subject to mechanical and microfretting wear.
Claim 64
Dependent Claim
37 words
The mechanical heart of claim 61 further comprising a wear-resistant coating on surfaces subject to mechanical wear and microfretting wear, the wear-resistant coating produced by a process selected from the group consisting of silver doping and boronation.
Claim 65
Dependent Claim
68 words
The medical implant according to claim 2 comprising an external mechanical heart including components that contact blood when said heart is used to supply blood to a patient, the improvement comprising the components fabricated from a metal alloy comprising: (a) titanium; (b) from about 10 to about 20 wt% niobium or from about 35 to about 50 wt% niobium; and (c) optionally up to about 20 wt% zirconium.
Claim 66
Dependent Claim
19 words
The mechanical heart of claim 65, wherein the metal alloy comprises from about 0.5 to about 20 wt% zirconium.
Claim 67
Dependent Claim
24 words
The mechanical heart of claim 65 further comprising a coating on outer surfaces of the components that contact blood, the coating comprising a medicament.
Claim 68
Dependent Claim
70 words
The medical implant according to claim 2 comprising a vascular graft of enhanced durability, crush-resistance, low thrombogenicity, and hemocompatibility, said graft comprising: (a) titanium; (b) from about 10 to about 20 wt% niobium or from about 35 to about 50 wt% niobium; and (c) optionally up to about 20 wt% zirconium; said tubular body having a bore therethrough, said tubular body sized to replace a section of removed blood vessel.
Claim 69
Dependent Claim
19 words
The vascular graft of claim 68, wherein the metal alloy comprises from about 0.5 to about 20 wt.% zirconium.
Claim 70
Dependent Claim
40 words
The vascular graft of claim 69 further comprising a hardened surface on the tubular body, said hardened surface produced by a process selected from the group consisting of oxygen diffusion hardening, nitrogen hardening, physical vapour deposition and chemical vapour deposition.
Claim 71
Dependent Claim
28 words
The vascular graft of claim 68 further comprising a coating on the tubular body, said coating selected from the group consisting a heparin, phosphatidyl choline, and a medicament.
Claim 72
Dependent Claim
32 words
The vascular graft of claim 68, further comprising a wear-resistant coating on the tubular body, said wear-resistant coating applied by a process selected from the group consisting of silver doping and boronation.
References Cited (Backward Citations)
EP0359446A1
Cited
EP0437079A1
Cited
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