CA2560001A1 - Stent - Google Patents

Stent Download PDF

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Publication number
CA2560001A1
CA2560001A1 CA002560001A CA2560001A CA2560001A1 CA 2560001 A1 CA2560001 A1 CA 2560001A1 CA 002560001 A CA002560001 A CA 002560001A CA 2560001 A CA2560001 A CA 2560001A CA 2560001 A1 CA2560001 A1 CA 2560001A1
Authority
CA
Canada
Prior art keywords
stent
sections
segment
section
struts
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
Application number
CA002560001A
Other languages
French (fr)
Inventor
Thomas Nissl
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.)
Merit Medical Systems Inc
Original Assignee
Alveolus, Inc.
Thomas Nissl
Merit Medical Systems, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Alveolus, Inc., Thomas Nissl, Merit Medical Systems, Inc. filed Critical Alveolus, Inc.
Publication of CA2560001A1 publication Critical patent/CA2560001A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • 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
    • 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • 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
    • 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • 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
    • 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • 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
    • 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91575Adjacent bands being connected to each other connected peak to trough
    • 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0054V-shaped

Abstract

A stent (1) is a vascular prosthesis for a constricted body vessel. The stent (1) comprises a tubular supporting structure (2) consisting of annular segments (3, 4, 5), which follow one another in an axial manner and which, in an initial state, are formed from segment braces (6, 7) continuously joined to another via transition sections (8, 9). Adjacent annular segments (3-5) are linked by connector braces (10). The segment braces (6, 7) are curved in a wave-like manner. Each front transition section (8) on at least one annular segment (3), which is located at the end with regard to longitudinal axis (L), has an axially protruding widened head end (22, 23). Head ends (22, 23) that are adjacent in the peripheral direction (U) are offset from one another along the longitudinal axis (L) of the stent and are connected to the adjacent annular segment (4) via connector braces (10). Each connector brace (10) comprises a wave-like curved axial section (11) and a V-shaped compensating section (12) oriented in the peripheral direction (U) of the supporting structure (2).

Description

Stent The invention relates to a stent having the features set forth in the preamble of patent claim 1.
Stents are used for permanent or also only temporary splinting of body conduits that have become occluded or constricted as a result of stenosis.

The stents have a tubular metal supporting structure consisting of several annular segments. These are formed from segment struts continuously adjoining one another via transition sections. Annular segments adjacent to one another in the longitudinal axis of the stent are coupled by connector struts.

The stents are introduced into the intracorporeal vessel by catheter techniques or by using similar insertion aids and are positioned in the area of the stenosis, the supporting structure being able to expand from a contracted insertion state to a supporting state of suitably increased diameter. This expansion can take place automatically in what are called self-expanding stents, but it can also be effected with the aid of a suitable instrument, for example a balloon catheter. In the vessel, the stents function as vascular prostheses for supporting the inside walls of the vessel.

In many applications, for example when used as a biliary stent in the bile ducts, the stent has to be removed again after it has been in the body conduit for a relatively short time, for instance a few months.
This is normally done by pulling the stent back into a catheter. The diameter of the expanded stent, sometimes covered with bodily secretions or the like, has to be reduced again. For this, it is desirable that no aspect of the stent geometry gets in the way of pulling it back into a catheter of smaller diameter.

_: -The object of the invention is therefore to make available a stent which, having good compatibility with the vessels in the supporting state, possesses a sufficiently high degree of flexibility and can be easily contracted in order to remove it from a body conduit.

According to the invention, this object is achieved by ...10 a stent having the features of patent claim 1.

The stent according to the invention comprises a tubular supporting structure that can be expanded from an insertion state to a supporting state. The supporting structure consists of annular segments which follow one another in the longitudinal axis of the stent and which are formed from segment struts continuously adjoining one another in the peripheral direction of the supporting structure. Adjacent annular 29 segments are coupled by connector struts. The core feature of the invention is that the segment struts are curved in a wave shape, and that each front transition section has an axially protruding widened head end on at least one annular segment located at the end as seen in the longitudinal axis of the stent, head ends that are adjacent in the peripheral direction being arranged offset from one another in the longitudinal axis of the stent and being attached to the adjacent annular segment via connector struts. Furthermore, each .30 connector strut comprises an axial section curved in a wave shape, and also a V-shaped compensating section pointing in the peripheral direction of the supporting structure.

Advantageous embodiments and developments of the stent according to the invention are characterized in the dependent patent claims 2 through 8.

_ 3 -In the stent according to the invention, at least at one end, all the transition sections of the segment struts are attached to the nearest adjacent annular segment in each case via a flexible connector strut. In order to remove it, the stent can be gripped at this end and pulled into a catheter of smaller diameter. By virtue of the design according to the invention, the supporting structure can be contracted without any difficulty, and without any outwardly protruding sections of the supporting structure blocking the removal procedure. The stent slides as it were into the catheter in a smooth contracting movement. Even stents covered with adherences or mucous material can be drawn back into the catheter without any problem.
The rounded head ends ensure a gentle contact of the front ends of the stent on the vessel wall. In the stent according to the invention, the vessel walls are therefore exposed to less trauma both during insertion and also removal of a stent.

The supporting structure has a wave design, without parallel rectilinear strut sections, and the segment struts can widen from the middle area towards their ends following a continuous profile. This shaping of the segment struts leads to uniformly distributed tension in the segment struts.

The stent is made of metal. All deformable metals or '0 metal alloys that are medically compatible can be used here, for example stainless steel, cobalt alloys (Phynox), pure iron or, in particular, nickel-titanium alloys (Nitinol).

,5 It may be of interest in practice for the stent according to the invention to be designed also as a plastic stent. In this connection, the use of bioabsorbable plastics is envisaged in particular. The stent is then preferably configured as an injection-molded part.

The flexibility and contractibility of the supporting structure is advantageously promoted if the V-shaped compensating sections in each case have two arms running out in parallel end sections, and the inclined linear sections of the arms have a curved linear course. In this case, the compensating sections all point with their closed end in the same peripheral direction of the supporting structure. Moreover, the compensating sections are attached directly to the transition sections of an adjacent annular segment.

The width of the connector struts, in particular the width of the axial sections in the connector struts, is preferably less than the width of the segment struts of the annular segments.

A measure improving the use of the stent according to the invention is that the transition sections have an axially protruding widened head end on the annular segment located at the end as seen in the longitudinal axis of the stent, adjacent head sections being arranged offset from one another in the longitudinal axis of the stent. Every second head end is connected to a transition section via a coupling section, the coupling section having concavely rounded side grooves.
The side grooves engage partially around the adjacent head ends when the supporting structure is in the insertion state and cover these.

The advantageously rounded head ends ensure gentle contact of the ends of the stent on a vessel wall. In this way, the vessel walls are exposed to less trauma both during the insertion and also during the removal of a stent. In the contracted state, the head ends cover the adjacent transition sections. The risk of - 5 _ injury to the surrounding vessel walls is considerably reduced by this means.

The function of the head ends can be further improved if they are designed in the form of eyelets and are provided with a recess. Thus, the head ends can be used for gripping the stent with a suitable instrument or in order to wind or loop a thread through the head ends.
The thread ends are preferably deflected into the 13 interior of the supporting structure and are there connected to one another by a connector, preferably made of a material that is visible under X-ray. For removing the stent, the thread ends can be gripped at the connector. By pulling it, the thread is contracted and the looped annular segment of the supporting structure is drawn together, whereupon the stent can be removed from the body conduit. This procedure makes the explantation of a stent much easier.

The invention is described in more detail below on the basis of an illustrative embodiment shown in the drawing. The drawing shows a developed view of an end E
of a stent 1 according to the invention in the expanded supporting state.
The stent 1 is made of metal and comprises a tubular supporting structure 2 consisting of several annular segments 3, 4, 5 following one behind the other. The length of the stent 1 can in principle vary. As has -70 been mentioned, only one end section is shown here, not the full number of annular segments 3, 4, 5 of the stent 1.

The annular segments 3, 4, 5 are formed from segment struts 6, 7 curved in a wave shape and extending obliquely with respect to the longitudinal axis L of the stent 1, said segment struts 6, 7 continuously adjoining one another in a zigzag pattern via transition sections 8, 9. The annular segments 3, 4, 5 - 6 y are coupled to one another by connector struts 10. It will be noted that each transition section 8 of the annular segment 3 located at the end in the longitudinal axis L of the stent is connected via a connector strut 10 to the transition section 9 of the adjacent annular segment 4. Each connector strut 10 comprises an axial section 11 curved in a wave shape, and also a V-shaped compensating section 12 pointing in the peripheral direction U of the supporting structure.
The compensating sections 12 are in each case arranged in the space between the adjacent annular segments 3, 4 and 4, 5 with axial spacing a. The width BA of the axial sections 11 is thinner than the width Bs of the segment struts 6, 7. The compensating sections 12 each have two arms 15, 16 that run out and converge into parallel end sections 13, 14. The inclined linear sections 17, 18 of the arms 15, 16 have a curved linear course.

The connector struts 10 each extend from the transition section 8 at the deepest point 19 of two closed segment struts 6, 7 of an annular segment 3 or 4 as far as the transition section 9 at the peak 20 of two closed segment struts 6, 7 of the adjacent annular segment 4 or 5, the compensating sections 12 being attached 45 directly to the transition sections 9. The compensating sections 12 all point with their closed ends 21 in the same peripheral direction U.

The front transition sections 8 on the end annular segment 3 each have an axially protruding widened head end 22, 23 with a concavely rounded front section 24.
Head ends 22, 23 that are adjacent in the peripheral direction U are arranged offset from one another. For this purpose, the head ends 22 are connected to the transition sections 8 via a coupling section 25, such that the head ends 22 protrude axially in relation to the head ends 23.

The coupling sections 25 have concavely rounded side grooves 26. In the contracted state for insertion of the supporting structure 2, the head ends 22 engage partially around the adjacent head ends 23 and cover them. The head ends 23 are thus protected and concealed by the head ends 22.

In this way, the vessel walls suffer less trauma both during insertion and also during removal of a stent 1.
Moreover, the rounded head ends 22, 23 ensure that the stent 1 bears gently on the vessel wall when it is being inserted.

It will also be noted that the head ends 22, 23 are designed in the form of eyelets and have recesses 27.
The stent 1 can be gripped at the recesses 27 in order to remove it from a body conduit and can be pulled into a catheter in the direction of the arrow P. The proximal end E can also be additionally contracted, for example with the aid of a thread looped through the recesses 27.

Of particular advantage for explantation of a stent 1 is the inventive design of the supporting structure 2 with the wave-shaped segment struts 6, 7 and the configuration of the connector struts 10 with the wave-shaped axial section 11 and the compensating section 12, where the axial sections 12 are thinner than the segment struts 6, 7. This enhances the flexibility and sliding properties of the stent 1. A further important aspect of the invention is that all the transition sections 8 at the free end E of the stent 1 or of the annular segment 3 are each connected to the adjacent annular segment 4 via a connector strut 10. This has the effect that the stent 1 can be drawn together and pulled in the direction of the arrow P, without any aspect of the stent geometry obstructing the explantation procedure. The stent 1 can thus be gripped and removed from a body conduit in the direction of the arrow P.

List of reference signs 1 stent 2 supporting structure 3 annular segment 4 annular segment 5 annular segment 6 segment strut 7 segment strut 8 transition section 9 transition section 10 connector strut 11 axial section 12 compensating section 13 end section 14 end section 15 arm 16 arm 17 linear section 18 linear section 19 deepest part 20 peak 21 end of 12 22 head end 23 head end 24 front section 25 coupling section 26 side groove 27 clearance L longitudinal axis of stent U peripheral direction a spacing E end of 1 p arrow BA width of 11 Bs width of 6, 7

Claims (8)

1. A stent with a tubular supporting structure (2) consisting of annular segments (3, 4, 5) which follow one another axially and which are formed from segment struts (6, 7) continuously adjoining one another via transition sections (8, 9), and adjacent annular segments (3, 4, 5) being coupled by connector struts (10), characterized in that the segment struts (6, 7) are curved in a wave shape, and in that each front transition section (8) has an axially protruding widened head end (22, 23) on at least one annular segment (3) located at the end as viewed in the longitudinal axis (L) of the stent, head ends (22, 23) that are adjacent in the peripheral direction (U) being arranged offset from one another in the longitudinal axis (L) of the stent and being attached to the adjacent annular segment (4) via connector struts (10), each connector strut (10) comprising an axial section (11) curved in a wave shape and also a V-shaped compensating section (12) pointing in the peripheral direction (U) of the supporting structure (2).
2. The stent as claimed in claim 1, characterized in that the compensating sections (12) in each case have two arms (15, 16) running out in parallel end sections (13, 14).
3. The stent as claimed in claim 2, characterized in that the inclined linear sections (17, 18) of the arms (15, 16) have a curved linear course.
4. The stent as claimed in one of claims 1 through 3, characterized in that the width (B A) of the axial sections (11) is thinner than the width (Bs) of the segment struts (6, 7).
5. The stent as claimed in one of claims 1 through 4, characterized in that the head ends (22, 23) are designed in the form of eyelets.
6. The stent as claimed in one of claims 1 through 5, characterized in that every second head end (22) is connected to a transition section (8) via a coupling section (25), the coupling section (25) having concavely rounded side grooves (26), and the side grooves (26) engage partially around the adjacent head ends (23) when the supporting structure (2) is in the insertion state.
7. The stent as claimed in one of claims 1 through 6, characterized in that the compensating sections (12) point with their closed ends (21) in the same peripheral direction (U).
8. The stent as claimed in one of claims 1 through 7, characterized in that the compensating sections (12) are attached directly to the transition sections (9) of the adjacent annular segment (4, 5).
CA002560001A 2004-03-16 2004-12-11 Stent Abandoned CA2560001A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102004012981.9 2004-03-16
DE102004012981A DE102004012981B4 (en) 2004-03-16 2004-03-16 stent
PCT/DE2004/002719 WO2005089672A1 (en) 2004-03-16 2004-12-11 Stent

Publications (1)

Publication Number Publication Date
CA2560001A1 true CA2560001A1 (en) 2005-09-29

Family

ID=34959855

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002560001A Abandoned CA2560001A1 (en) 2004-03-16 2004-12-11 Stent

Country Status (7)

Country Link
US (1) US8652196B2 (en)
EP (1) EP1725184B1 (en)
JP (1) JP4695639B2 (en)
AU (1) AU2004317383B2 (en)
CA (1) CA2560001A1 (en)
DE (1) DE102004012981B4 (en)
WO (1) WO2005089672A1 (en)

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AU2004317383A1 (en) 2005-09-29
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JP2007529245A (en) 2007-10-25
US20070150049A1 (en) 2007-06-28
WO2005089672A1 (en) 2005-09-29
DE102004012981A1 (en) 2005-10-06
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AU2004317383B2 (en) 2009-05-14

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