US20080221662A1 - Endoluminal Prosthesis - Google Patents
Endoluminal Prosthesis Download PDFInfo
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- US20080221662A1 US20080221662A1 US11/568,468 US56846804A US2008221662A1 US 20080221662 A1 US20080221662 A1 US 20080221662A1 US 56846804 A US56846804 A US 56846804A US 2008221662 A1 US2008221662 A1 US 2008221662A1
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- endoluminal prosthesis
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- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents 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
- A61F2/91—Stents 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
- A61F2/915—Stents 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
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents 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
- A61F2/91—Stents 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
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents 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
- A61F2/91—Stents 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
- A61F2/915—Stents 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
- A61F2002/91508—Stents 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 the meander having a difference in amplitude along the band
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents 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
- A61F2/91—Stents 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
- A61F2/915—Stents 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
- A61F2002/91516—Stents 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 the meander having a change in frequency along the band
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents 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
- A61F2/91—Stents 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
- A61F2/915—Stents 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
- A61F2002/91525—Stents 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 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents 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
- A61F2/91—Stents 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
- A61F2/915—Stents 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
- A61F2002/91533—Stents 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
- A61F2002/91541—Adjacent bands are arranged out of phase
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents 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
- A61F2/91—Stents 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
- A61F2/915—Stents 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
- A61F2002/9155—Adjacent bands being connected to each other
- A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
Definitions
- the object of the present invention is an endoluminal prosthesis to be used in passages or ducts of a human body, such as to restore the passage in blood vessels narrowed or occluded by diseases such as a stenosis, in bile ducts or other similar organs of living bodies.
- the present invention also relates to such type of endoluminal prosthesis which are self-expanding, e.g. made of superelastic or shape memory materials such as Nitinol.
- the present invention also relates to an endoluminal prosthesis provided with means for a prompt location thereof, e.g. by radioscopy.
- Endoluminal prosthesis i.e. stents, particularly of the self-expanding type, are known for example by U.S. Pat. No. 4,665,771, U.S. Pat. No. 4,665,905, U.S. Pat. No. 4,925,445 or EP-A-0928606.
- endoluminal prosthesis though being acceptable in many respects, particularly for their great flexibility and resilience, which enable them to be easily positioned in narrow and tortuous passages in their collapsed state, in some cases they are not sufficiently suitable, when expanded, to support the vessel walls, in order to maintain a proper free lumen for blood to pass therethrough.
- the complex geometry of such known stents may be harmful, since it can hang up to or pinch the vessel wall, thus favouring the re-forming of obstructions, such as plaques and stenosis.
- the problem at the heart of the present invention is to provide an endoluminal prosthesis, having such structural and functional characteristics to overcome the drawbacks mentioned with reference to the prior art.
- FIG. 1 is a perspective view of an expanded endoluminal prosthesis portion, in accordance with a first embodiment
- FIG. 2 is a plane development of a portion of the prosthesis from FIG. 1 ;
- FIG. 3 is a plane development of the prosthesis from FIG. 1 in the collapsed state
- FIG. 4 a is a perspective view of a portion of the prosthesis from FIG. 1 in the collapsed state
- FIG. 4 b is a perspective view of the collapsed prosthesis in accordance with a further embodiment
- FIG. 5 illustrates a detail of the plane development of the prosthesis from FIG. 1 when collapsed
- FIG. 6 is a view of a detail of the prosthesis from FIG. 1 when expanded;
- FIG. 7 illustrates a detail of a plane development of a collapsed endoluminal prosthesis according to a further embodiment
- FIG. 8 is a view of a detail of the prosthesis from FIG. 7 when expanded;
- FIG. 9 illustrates a detail of a plane development of a collapsed endoluminal prosthesis according to a still further embodiment
- FIG. 10 is a view of a detail of the prosthesis from FIG. 9 when expanded;
- FIG. 11 illustrates a detail of a plane development of a collapsed endoluminal prosthesis according to a further embodiment
- FIG. 12 is a view of a detail of the prosthesis from FIG. 11 , when expanded;
- FIGS. 13 and 14 are perspective views of a detail of the prosthesis from FIG. 1 when expanded, wherein the stress condition and the corresponding strain condition are highlighted;
- FIGS. 15 and 16 are perspective views of a detail of the prosthesis from FIG. 7 when expanded, wherein the stress condition and the corresponding strain condition are highlighted;
- FIGS. 17 and 18 are perspective views of a detail of the prosthesis from FIG. 9 when expanded, wherein the stress condition and the corresponding strain condition are highlighted;
- FIGS. 19 and 20 are a perspective view of a detail of the prosthesis from FIG. 11 when expanded, wherein the stress condition and the corresponding strain condition are highlighted;
- FIGS. 21 to 26 are views of six expansion steps of the prosthesis from FIG. 1 .
- an endoluminal prosthesis as a whole, such as a prosthesis of the self-expanding type for ducts or vessels of living bodies, such as blood vessels and bile ducts or gastro-intestinal ducts or similar.
- the endoluminal prosthesis comprises a tubular body 502 suitable to turn from a collapsed condition to an expanded or partially expanded condition.
- collapsed condition is meant a state of the prosthesis as being contracted such as to have a smaller bulk than in an operating use condition, e.g. a condition where the tubular body 502 has a smaller size or outer diameter than in an operating use condition.
- the prosthesis is arranged in a collapsed condition when it is either accommodated or arranged on a transport and delivery device suitable to travel along a duct or vessel to the area to be treated.
- a transport and delivery device suitable to travel along a duct or vessel to the area to be treated.
- this is accommodated in a sheath such as to be maintained in the collapsed condition ( FIGS. 4 and 21 ).
- expanded or partially expanded condition is meant a condition where the prosthesis is free from restrictions or an operating use condition with the prosthesis being widened upon pressure contact against the inner surfaces of a duct or vessel walls (FIGS. 1 , 6 and 26 where it is illustrated with an expanded and a partially expanded length).
- the tubular body 502 develops along a longitudinal axis 504 .
- longitudinal axis is meant for example either a symmetry axis of a cylindrical body or the stretch axial direction of a tubular body.
- the tubular body 502 comprises a plurality of serpentines 506 a , 506 b , 506 c , or closed meander paths, developing along a substantially circumpherential direction.
- swipetine is meant a zig-zag/to-and-fro developing element around a main direction of stretching.
- Each of these serpentines comprising either arm portions or arms 510 of predetermined length 600 transversal to their main longitudinal stretch.
- Each of said serpentines 506 a , 506 b , 506 c comprises either bended portions or bends 512 , which join two subsequent arms 510 to form said meander path.
- At least a bridge 514 a , 514 b of a main longitudinal stretch connects two adjacent serpentines 506 a and 506 b or 506 b and 506 c or 506 c and 506 b.
- the bends 512 facing an adjacent serpentine 506 b or 506 c are circumpherentially staggered 620 relative to the opposite bends 512 of the adjoining serpentine 506 b or 506 c , both when the prosthesis is collapsed and when the prosthesis is expanded or partially expanded.
- the at least one bridge 514 a and 514 b connecting adjacent serpentines 506 a and 506 b or 506 b and 506 c or 506 c and 506 b stretches substantially straight.
- the at least one bridge 514 a and 514 b has a length 602 transversal to its main longitudinal direction which has a greater value than the length 600 of arms 510 .
- an endoluminal prosthesis 500 comprises a tubular body 502 developing along a longitudinal axis 504 .
- the tubular body comprises a plurality of serpentines or meander paths 506 a , 506 b , 506 c preferably closed, which develop according to a circumpherential direction 508 relative to the direction of the longitudinal axis of the endoluminal prosthesis.
- the circumpherential direction 508 is illustrated in FIG. 4 a with reference to the perspective view of the prosthesis in a closed configuration and in FIGS. 3 and 5 with reference to the plane development of the tubular body 502 of the prosthesis in a closed configuration.
- a serpentine comprises arms 510 connected by bends 512 .
- the arms are substantially straight.
- the arms are connected by bends such as to form a sequence of peaks and valleys along the circumpherential direction of the corresponding serpentines.
- bends such as to form a sequence of peaks and valleys along the circumpherential direction of the corresponding serpentines.
- peaks 516 a those bends being convex towards the outside of the prosthesis will be identified as peaks 516 a and those bends being concave towards the outside of the prosthesis, i.e. moving away from a middle axis 524 , will be identified as valleys 516 b.
- Two adjacent serpentines are connected by at least one bridge 514 a , 514 b thus forming at least two cells between both adjacent serpentines.
- “cell” is meant a closed periphery defined by a length of a first serpentine, a first connecting bridge, a length of a second serpentine adjacent to the first one (with the path developing in the opposite way along the circumpherential direction) and a second connecting bridge immediately next to the first one.
- references 518 a and 518 b there have been represented two different cells and the perimeters or areas thereof have been outlined.
- the plurality of serpentines comprise a first serpentine 506 a , a second serpentine 506 b and a third serpentine, 506 c .
- the second serpentine 506 b and the third serpentine 506 c repeat alternatively along the longitudinal axis.
- the second serpentine and the third serpentine are substantially identical.
- they can be arranged specularly relative to a circumpherential direction 520 intermediate between both serpentines.
- the second and third serpentines can be arranged specularly relative to a circumpherential direction 520 intermediate between both serpentines and staggered to one another along the circumpherential direction.
- said at least one bridge 514 is joined with a bend 512 of a serpentine 506 a or 506 b or 506 c and with a bend 512 of an opposite serpentine 506 b or 506 c or 506 a.
- the at least one bridge 514 a and 514 b has a substantially constant width 602 all along its longitudinal stretch.
- the at least one bridge 514 a , 514 b has a width 602 substantially equal to twice the width 600 of arms 510 .
- the at least one bridge 514 a and 514 b has substantially straight edges. In other words, a bridge 514 a , 514 b extends without forming any bend, or folds, between a connecting or joint portion thereof to a first serpentine and a second connecting or joint portion thereof to a second serpentine.
- At least one bridge 514 a , 514 b is comprised between all the adjacent serpentines 506 a , 506 b and 506 c.
- a plurality of bridges 514 a , 514 b is comprised between adjacent serpentines 506 a and 506 b or 506 b and 506 c or 506 c and 506 b.
- a bridge 514 b is provided every four bends 512 as counted along the path of each serpentine.
- a bridge 514 b is provided every six bends 510 as counted along the path of each serpentine.
- a bridge 514 b is provided every ten bends 510 as counted along the path of each serpentine.
- the at least one bridge 514 a and 514 b develops according to a direction 606 tangential to the tubular body 502 and biased relative to an axis 604 parallel to the longitudinal axis 504 of said body (for example by an angle designated with the reference a or b).
- all the bridges 514 b between at least two adjacent serpentines 506 b and 506 c are parallel to one another.
- the prosthesis comprises a cell 518 a , 518 b comprising opposite lengths of two adjoining serpentines 506 a and 506 b or 506 b and 506 c or 506 c and 506 b comprised between two subsequent bridges 514 a , 514 b , and said subsequent bridges 514 a and 514 b forming a closed path (such as indicated by dotted line 518 b in FIG. 2 ).
- the arms 510 are substantially straight. In other words, an arm extends without forming any bend, or fold, between a connecting or joint portion thereof to a first bend 512 and a second connecting or joint portion thereof to a second bend 512 .
- the arms 510 comprise substantially straight edges.
- At least one cell 518 b comprises six complete bends 512 .
- At least one cell 518 b comprises ten complete bends 512 .
- At least one cell 518 b comprises eighteen complete bends 512 .
- At least one prosthesis 500 length when being in a collapsed state, comprises a plurality of serpentines 506 b and 506 c equal to one another, having corresponding bends 512 , facing the same end as the prosthesis 500 , such as the proximal end, either circumpherentially aligned with one another, or on the same axis 610 parallel to longitudinal axis 504 of tubular body 502 .
- said at least one length of prosthesis is an intermediate portion of the prosthesis or, preferably, a middle length of the prosthesis 500 .
- said prosthesis 500 is a unique body.
- said body 502 is obtained by cutting a tubular element, preferably by laser cutting.
- said body is made of a superelastic material.
- said body is made of a strain hardened pseudoelastic material.
- a material being in the austenitic state at room temperature (Af ⁇ 15° C.) when annealed can be used, to which is then applied a sufficient strain hardening, such as greater than 30%, which allows to get 3%-4% elastic recovery after deformation or greater.
- a sufficient strain hardening such as greater than 30%, which allows to get 3%-4% elastic recovery after deformation or greater.
- 50% strain hardening is applied.
- said body 502 is made of a shape memory material.
- said body is made of Nitinol, or a Ni and Ti based alloy, such as with Nickel nominal weight percentage of 55.8%.
- a material with Austenite-to-Martensite phase transition can be used that, when being in the annealed or stress-relieved state, during a heating of the same the higher temperature of the end of austenite transformation, or Af, is lower than 15° C.
- the first serpentine 506 a comprises at least one frame 521 defining a slot or housing 522 .
- the frame 521 is arranged at a bend between two arms.
- the frame 521 and the slot 522 can be arranged in place of at least two arms and one bend relative to the second or third serpentines.
- the second serpentine and the third serpentine comprise the same number of arms and the same number of bends.
- the frame 521 and the slot 522 are arranged at the bend between two arms in place of four arms and three bends relative to the second or third serpentines.
- the arms and the bends replaced by the slot have been illustrated with a dotted line.
- the frame 521 occupies the whole length left free by the replaced arms and bends, as measured along the circumpherential direction and when the endoluminal prosthesis is in the collapsed condition.
- the slot or housing 522 passes all through the thickness of the tubular body 502 .
- the frame 521 is arranged in the concave part of the bend between both arms directly connected to the frame 521 .
- the prosthesis is formed as a unique body from a tubular body 502 by cutting, such as laser cutting of a cylindrical wall thereof.
- the frame 521 is formed as a unique body in the tubular body 502 obtained by laser cutting of a cylindrical wall.
- the slot 522 has an elongated shape in the direction of the longitudinal axis of the prosthesis, preferably elliptical or rectangular with short rounded sides.
- the frame 522 has an elongated shape in the direction of the longitudinal axis of the prosthesis.
- the short side of frame 521 corresponding to the bend between both arms directly connected to the frame itself is substantially straight along the circumpherential direction, when considered in a plane development of the prosthesis.
- both arms directly connected to the frame 521 join to the frame itself at end points.
- the frame 521 comprises two elongated sides 523 having substantially the same width as the arms 510 of the prosthesis, as measured along the circumpherential direction 508 , and a shorter length than the arms 510 of the prosthesis, as measured along the longitudinal direction 504 thereof.
- a radiopaque material is provided within the slot 522 , preferably melted within the slot.
- the radiopaque material may be any material having a greater visibility to X-rays than the material used for the prosthesis.
- the radiopaque material can be selected from Tantalum, Gold, Platinum, Tungsten or other materials suitable for the purpose.
- the first serpentine 506 a housing the frame 521 is an end serpentine of the prosthesis.
- both end serpentines of the prosthesis i.e. the first and last serpentines, comprise at least one frame 521 , respectively.
- the last serpentine or further end serpentine specularly reproduces the first serpentine relative to a middle axis 524 of the prosthesis, possibly staggered along the circumpherential direction.
- the frame 522 is arranged at an end bend, i.e. a bend belonging to the end serpentine and with its concavity facing the inside of the prosthesis, i.e. the middle axis 524 .
- the frame 521 is arranged at or in place of a peak 516 a , preferably within the concavity thereof.
- the frame 521 is advantageously arranged inside the respective cell.
- the frame 521 has an elongated shape in the direction of the longitudinal axis of the prosthesis and develops from the end bend towards a middle axis 524 of the endoluminal prosthesis.
- this cell comprises two bridges 514 a developing along directions 526 tangential to the tubular body.
- Both bridges 514 a may be advantageously arranged along directions 526 substantially parallel to one another and further parallel to the development directions of the remaining bridges 514 b between the first and the second serpentines. Still more advantageously, both bridges 514 a may be arranged along directions 526 incident to one another, both in a closed configuration and in an expanded configuration of the prosthesis ( FIGS. 2 , 3 ).
- the bridges 514 a belonging to the cell 518 a comprising the frame 521 develop along directions 526 converging from the end of the prosthesis towards a middle axis 524 of the prosthesis itself.
- the bridges 514 a develop according to directions 526 tangential to the tubular body and biased relative to an axis parallel to the longitudinal axis 504 of the endoluminal prosthesis.
- the bridges 514 a of cell 518 a comprising the frame 521 develop along directions 526 tangential to the tubular body and biased relative to the longitudinal axis 504 of the endoluminal prosthesis.
- these bridges 514 b are substantially parallel to at least one of the bridges 514 a belonging to the cell 518 a comprising the slot 522 .
- the number of arms and bends of the first serpentine length is lower than the number of arms and bends of the second serpentine length.
- the length belonging to the first serpentine may comprise at least two arms and two bends less than the arms and bends of the length belonging to the second serpentine, as specularly counted between both serpentines.
- the length of the first serpentine belonging to the cell 518 a containing the slot comprises six arms and five bends while the length of second serpentine belonging to the cell 518 containing the frame 521 comprises eight arms and seven bends.
- FIG. 5 is shown a plane development of a possible embodiment of the endoluminal prosthesis according to the present invention.
- 528 has been designated a further cell of a different shape than the cell 518 a containing the frame 521 and the remaining cells 518 b of the endoluminal prosthesis.
- the further cell 528 will be indicated as the “anomalous” cell.
- the anomalous cell 528 is defined between the first and second serpentines and preferably adjacent to the cell 518 a containing the slot.
- the anomalous cell 528 shares a bridge 514 a with cell 518 a containing the slot and preferably shares that bridge which develops along a direction tangential to the tubular body incident to the development directions of the remaining bridges provided between the first and the second serpentines.
- the “anomalous” cell comprises two arms and two bends more than the remaining cells 518 b of the prosthesis.
- the anomalous cell comprises six arms and five bends on the length relative to the second serpentine while the remaining cells 518 b of the prosthesis comprise four arms and three bends, with reference to a length relative to a serpentine.
- an endoluminal prosthesis allows to meet the requirement of visibility to X-rays, or however to radioscopy, of the prosthesis itself while maintaining its structure solid and avoiding that parts may protrude outside the prosthesis.
- the cell comprising the frame with arms developing along directions tangential to the tubular body which are incident to one another, local distortions due to the difference in arms and bends between the serpentines can be prevented.
- This aspect is enhanced by the presence of the anomalous cell adjacent to the cell containing the slot.
- FIG. 6 illustrates a partial perspective view of the above prosthesis in a deformed configuration with reference to the end comprising the frame 521 .
- FIGS. 7 , 9 , 11 illustrate the plane development of respective three possible embodiments of the prosthesis according to the present invention.
- FIG. 7 represents an embodiment similar to that of FIG. 3 or 5 wherein the bridges 514 a corresponding to the cell comprising the frame 521 develop along directions 526 tangential to the tubular body, biased relative to the longitudinal axis 504 and parallel to one another. These directions are further parallel to the tangential directions along which the other bridges 514 b develop between the first and second serpentines.
- FIGS. 9 and 11 represent two types of prosthesis where the cells defined between the second and third serpentines are of a different configuration compared to that of the cells between the second and third serpentines of the embodiments from FIG. 3 , 5 or 7 . Furthermore, the prosthesis from FIG.
- FIGS. 8 , 10 , 12 illustrate the prosthesis from FIGS. 7 , 9 , 11 respectively, in an expanded or widened configuration.
- FIGS. 13 , 14 illustrate the stresses and strains at the frame 521 in the prosthesis from FIGS. 3 , 5 , respectively.
- FIGS. 15 , 16 illustrate the stresses and strains at the frame 521 in the prosthesis from FIGS. 7 , 8 , respectively.
- FIGS. 17 , 18 illustrate the stresses and strains at the frame 521 in the prosthesis from FIGS. 9 , 10 , respectively.
- FIGS. 19 , 20 illustrate the stresses and strains at the frame 521 in the prosthesis from FIG. 11 , 12 , respectively.
- Arrow F designates the greatest stress-strain area.
- the prosthesis illustrated in FIGS. 3 , 5 allows to achieve a very low stress-strain peak value, and however a more constant distribution or gradual variation of the stress state.
- the prosthesis thus provided, it is possible to carry out endoluminal operations in tortuous vessels or ducts, and at the same time, an optimum and constant support of the treated vessel wall can also be ensured with the prosthesis being in the expanded state.
- FIGS. 21 to 26 illustrate six release steps from a sheath 612 of a self-expanding endoluminal prosthesis 500 .
- This procedure is, for example, carried out by withdrawing the sheath such that the prosthesis is left free to expand, such as from a housing where it is accommodated as provided in a transport and release device, such as a catheter (not shown herein).
- the slot can be of any shape other than that illustrated in the figures. Furthermore, it could be provided in a serpentine different from the serpentine end, or in a bend corresponding to a valley with reference to the meaning of the term “valley” such as discussed above.
- serpentines The number of serpentines, arms or bends may be changed from what has been described or illustrated.
- shape of the serpentines may also be changed, particularly the alternate repetition between the second and third serpentines.
- the second and third serpentines may be either equal, or perfectly specular without resulting staggered in the circumpherential direction.
Abstract
Description
- The object of the present invention is an endoluminal prosthesis to be used in passages or ducts of a human body, such as to restore the passage in blood vessels narrowed or occluded by diseases such as a stenosis, in bile ducts or other similar organs of living bodies.
- The present invention also relates to such type of endoluminal prosthesis which are self-expanding, e.g. made of superelastic or shape memory materials such as Nitinol.
- The present invention also relates to an endoluminal prosthesis provided with means for a prompt location thereof, e.g. by radioscopy.
- Endoluminal prosthesis, i.e. stents, particularly of the self-expanding type, are known for example by U.S. Pat. No. 4,665,771, U.S. Pat. No. 4,665,905, U.S. Pat. No. 4,925,445 or EP-A-0928606.
- These endoluminal prosthesis, though being acceptable in many respects, particularly for their great flexibility and resilience, which enable them to be easily positioned in narrow and tortuous passages in their collapsed state, in some cases they are not sufficiently suitable, when expanded, to support the vessel walls, in order to maintain a proper free lumen for blood to pass therethrough.
- Furthermore, in some cases the complex geometry of such known stents may be harmful, since it can hang up to or pinch the vessel wall, thus favouring the re-forming of obstructions, such as plaques and stenosis.
- The problem at the heart of the present invention is to provide an endoluminal prosthesis, having such structural and functional characteristics to overcome the drawbacks mentioned with reference to the prior art.
- This problem is resolved by means of an endoluminal prosthesis of the type described in
claims 1 or 68. - Further embodiments are described in the secondary claims.
- Further characteristics and the advantages of the prosthesis according to the invention will become apparent from the description given below of the preferred embodiments thereof, being merely illustrative and non-limiting, with reference to the annexed figures, where:
-
FIG. 1 is a perspective view of an expanded endoluminal prosthesis portion, in accordance with a first embodiment; -
FIG. 2 is a plane development of a portion of the prosthesis fromFIG. 1 ; -
FIG. 3 is a plane development of the prosthesis fromFIG. 1 in the collapsed state; -
FIG. 4 a is a perspective view of a portion of the prosthesis fromFIG. 1 in the collapsed state; -
FIG. 4 b is a perspective view of the collapsed prosthesis in accordance with a further embodiment; -
FIG. 5 illustrates a detail of the plane development of the prosthesis fromFIG. 1 when collapsed; -
FIG. 6 is a view of a detail of the prosthesis fromFIG. 1 when expanded; -
FIG. 7 illustrates a detail of a plane development of a collapsed endoluminal prosthesis according to a further embodiment; -
FIG. 8 is a view of a detail of the prosthesis fromFIG. 7 when expanded; -
FIG. 9 illustrates a detail of a plane development of a collapsed endoluminal prosthesis according to a still further embodiment; -
FIG. 10 is a view of a detail of the prosthesis fromFIG. 9 when expanded; -
FIG. 11 illustrates a detail of a plane development of a collapsed endoluminal prosthesis according to a further embodiment; -
FIG. 12 is a view of a detail of the prosthesis fromFIG. 11 , when expanded; -
FIGS. 13 and 14 are perspective views of a detail of the prosthesis fromFIG. 1 when expanded, wherein the stress condition and the corresponding strain condition are highlighted; -
FIGS. 15 and 16 are perspective views of a detail of the prosthesis fromFIG. 7 when expanded, wherein the stress condition and the corresponding strain condition are highlighted; -
FIGS. 17 and 18 are perspective views of a detail of the prosthesis fromFIG. 9 when expanded, wherein the stress condition and the corresponding strain condition are highlighted; -
FIGS. 19 and 20 are a perspective view of a detail of the prosthesis fromFIG. 11 when expanded, wherein the stress condition and the corresponding strain condition are highlighted; -
FIGS. 21 to 26 are views of six expansion steps of the prosthesis fromFIG. 1 . - With reference to the above mentioned figures, with 500 has been indicated an endoluminal prosthesis as a whole, such as a prosthesis of the self-expanding type for ducts or vessels of living bodies, such as blood vessels and bile ducts or gastro-intestinal ducts or similar.
- In accordance with a general embodiment of the present invention, the endoluminal prosthesis comprises a
tubular body 502 suitable to turn from a collapsed condition to an expanded or partially expanded condition. - By “collapsed condition” is meant a state of the prosthesis as being contracted such as to have a smaller bulk than in an operating use condition, e.g. a condition where the
tubular body 502 has a smaller size or outer diameter than in an operating use condition. For example, the prosthesis is arranged in a collapsed condition when it is either accommodated or arranged on a transport and delivery device suitable to travel along a duct or vessel to the area to be treated. For example, in the case of a self-expanding prosthesis, this is accommodated in a sheath such as to be maintained in the collapsed condition (FIGS. 4 and 21 ). - By “expanded or partially expanded condition” is meant a condition where the prosthesis is free from restrictions or an operating use condition with the prosthesis being widened upon pressure contact against the inner surfaces of a duct or vessel walls (FIGS. 1,6 and 26 where it is illustrated with an expanded and a partially expanded length).
- The
tubular body 502 develops along alongitudinal axis 504. - By “longitudinal axis” is meant for example either a symmetry axis of a cylindrical body or the stretch axial direction of a tubular body.
- The
tubular body 502 comprises a plurality ofserpentines - By “serpentine” is meant a zig-zag/to-and-fro developing element around a main direction of stretching.
- Each of these serpentines comprising either arm portions or
arms 510 ofpredetermined length 600 transversal to their main longitudinal stretch. - Each of said
serpentines bends 512, which join twosubsequent arms 510 to form said meander path. - Advantageously, at least a
bridge adjacent serpentines - With further advantage, the
bends 512 facing anadjacent serpentine opposite bends 512 of theadjoining serpentine - Preferably, the at least one
bridge adjacent serpentines - Advantageously, the at least one
bridge length 602 transversal to its main longitudinal direction which has a greater value than thelength 600 ofarms 510. - According to a possible embodiment, an
endoluminal prosthesis 500 comprises atubular body 502 developing along alongitudinal axis 504. The tubular body comprises a plurality of serpentines ormeander paths circumpherential direction 508 relative to the direction of the longitudinal axis of the endoluminal prosthesis. Thecircumpherential direction 508 is illustrated inFIG. 4 a with reference to the perspective view of the prosthesis in a closed configuration and inFIGS. 3 and 5 with reference to the plane development of thetubular body 502 of the prosthesis in a closed configuration. - A serpentine comprises
arms 510 connected bybends 512. According to a possible embodiment, the arms are substantially straight. - In accordance with a possible embodiment, the arms are connected by bends such as to form a sequence of peaks and valleys along the circumpherential direction of the corresponding serpentines. With reference to an end portion of a prosthesis such as illustrated in
FIG. 1 or 5, for simplicity of exposition those bends being convex towards the outside of the prosthesis will be identified aspeaks 516 a and those bends being concave towards the outside of the prosthesis, i.e. moving away from amiddle axis 524, will be identified asvalleys 516 b. - Two adjacent serpentines are connected by at least one
bridge - With
references - According to a possible embodiment, the plurality of serpentines comprise a
first serpentine 506 a, asecond serpentine 506 b and a third serpentine, 506 c. Preferably, thesecond serpentine 506 b and thethird serpentine 506 c repeat alternatively along the longitudinal axis. Still more preferably, the second serpentine and the third serpentine are substantially identical. Furthermore, they can be arranged specularly relative to acircumpherential direction 520 intermediate between both serpentines. With reference to the embodiment illustrated in the figures, the second and third serpentines can be arranged specularly relative to acircumpherential direction 520 intermediate between both serpentines and staggered to one another along the circumpherential direction. - In accordance with one embodiment, said at least one
bridge 514 is joined with abend 512 of aserpentine bend 512 of anopposite serpentine - Advantageously, the at least one
bridge constant width 602 all along its longitudinal stretch. Preferably, the at least onebridge width 602 substantially equal to twice thewidth 600 ofarms 510. With a further advantage, the at least onebridge bridge - In accordance with one embodiment, at least one
bridge adjacent serpentines - Advantageously, a plurality of
bridges adjacent serpentines - In accordance with one embodiment, between at least two
adjacent serpentines bridge 514 b is provided every four bends 512 as counted along the path of each serpentine. - In accordance with a further embodiment, between at least two
adjacent serpentines bridge 514 b is provided every six bends 510 as counted along the path of each serpentine. - In accordance with a still further embodiment, between at least two
adjacent serpentines bridge 514 b is provided every ten bends 510 as counted along the path of each serpentine. - Advantageously, the at least one
bridge direction 606 tangential to thetubular body 502 and biased relative to anaxis 604 parallel to thelongitudinal axis 504 of said body (for example by an angle designated with the reference a or b). - Preferably, all the
bridges 514 b between at least twoadjacent serpentines - In accordance with one embodiment, by going through the
prosthesis 500 in a longitudinal way, e.g. from a first proximal end to a second distal end of the prosthesis, one encounter bridges 514 b alternating with one another with opposite way direction biases (a and b) relative to anaxis 604 parallel to the longitudinal axis of the tubular body. - Advantageously, by going through the
prosthesis 500 in a longitudinal way, one encounters thebridges 514 b alternating with one another with direction biases a, b of opposite value (“a” having the same value as and opposite way to “b”) relative to anaxis 604 parallel to the longitudinal axis of the tubular body. - In accordance with one embodiment, the prosthesis comprises a
cell adjoining serpentines subsequent bridges subsequent bridges dotted line 518 b inFIG. 2 ). - In accordance with one embodiment, the
arms 510 are substantially straight. In other words, an arm extends without forming any bend, or fold, between a connecting or joint portion thereof to afirst bend 512 and a second connecting or joint portion thereof to asecond bend 512. - Advantageously, the
arms 510 comprise substantially straight edges. - In accordance with one embodiment, at least one
cell 518 b comprises sixcomplete bends 512. - In accordance with a further embodiment, at least one
cell 518 b comprises tencomplete bends 512. - In accordance with a still further embodiment, at least one
cell 518 b comprises eighteencomplete bends 512. - Advantageously, according to one embodiment, at least one
prosthesis 500 length, when being in a collapsed state, comprises a plurality ofserpentines bends 512, facing the same end as theprosthesis 500, such as the proximal end, either circumpherentially aligned with one another, or on thesame axis 610 parallel tolongitudinal axis 504 oftubular body 502. With further advantage, said at least one length of prosthesis is an intermediate portion of the prosthesis or, preferably, a middle length of theprosthesis 500. - In accordance with one embodiment, said
prosthesis 500 is a unique body. For example, saidbody 502 is obtained by cutting a tubular element, preferably by laser cutting. - Advantageously, said body is made of a superelastic material. In accordance with a different embodiment, said body is made of a strain hardened pseudoelastic material. In other words, a material being in the austenitic state at room temperature (Af<15° C.) when annealed can be used, to which is then applied a sufficient strain hardening, such as greater than 30%, which allows to get 3%-4% elastic recovery after deformation or greater. Preferably, 50% strain hardening is applied.
- In accordance with an embodiment, said
body 502 is made of a shape memory material. - Advantageously, said body is made of Nitinol, or a Ni and Ti based alloy, such as with Nickel nominal weight percentage of 55.8%.
- For example, a material with Austenite-to-Martensite phase transition can be used that, when being in the annealed or stress-relieved state, during a heating of the same the higher temperature of the end of austenite transformation, or Af, is lower than 15° C.
- In accordance with one embodiment, the
first serpentine 506 a comprises at least oneframe 521 defining a slot orhousing 522. Theframe 521 is arranged at a bend between two arms. Particularly, theframe 521 and theslot 522 can be arranged in place of at least two arms and one bend relative to the second or third serpentines. - According to a possible embodiment, the second serpentine and the third serpentine comprise the same number of arms and the same number of bends.
- Preferably the
frame 521 and theslot 522 are arranged at the bend between two arms in place of four arms and three bends relative to the second or third serpentines. InFIG. 5 the arms and the bends replaced by the slot have been illustrated with a dotted line. - Advantageously the
frame 521 occupies the whole length left free by the replaced arms and bends, as measured along the circumpherential direction and when the endoluminal prosthesis is in the collapsed condition. - In accordance with a possible embodiment, the slot or
housing 522 passes all through the thickness of thetubular body 502. - Advantageously the
frame 521 is arranged in the concave part of the bend between both arms directly connected to theframe 521. - According to a possible embodiment, the prosthesis is formed as a unique body from a
tubular body 502 by cutting, such as laser cutting of a cylindrical wall thereof. - Advantageously, the
frame 521 is formed as a unique body in thetubular body 502 obtained by laser cutting of a cylindrical wall. - In accordance with a possible embodiment, the
slot 522 has an elongated shape in the direction of the longitudinal axis of the prosthesis, preferably elliptical or rectangular with short rounded sides. Advantageously, theframe 522 has an elongated shape in the direction of the longitudinal axis of the prosthesis. Preferably the short side offrame 521 corresponding to the bend between both arms directly connected to the frame itself is substantially straight along the circumpherential direction, when considered in a plane development of the prosthesis. - Advantageously both arms directly connected to the
frame 521 join to the frame itself at end points. - Advantageously the
frame 521 comprises twoelongated sides 523 having substantially the same width as thearms 510 of the prosthesis, as measured along thecircumpherential direction 508, and a shorter length than thearms 510 of the prosthesis, as measured along thelongitudinal direction 504 thereof. - Advantageously, a radiopaque material is provided within the
slot 522, preferably melted within the slot. The radiopaque material may be any material having a greater visibility to X-rays than the material used for the prosthesis. - In the case where the prosthesis is made of a superelastic or shape memory material, such as Nitinol (or an alloy with Ni and Ti as the main part), the radiopaque material can be selected from Tantalum, Gold, Platinum, Tungsten or other materials suitable for the purpose.
- According to a possible embodiment, the
first serpentine 506 a housing theframe 521 is an end serpentine of the prosthesis. Advantageously, both end serpentines of the prosthesis, i.e. the first and last serpentines, comprise at least oneframe 521, respectively. In other words, in a possible embodiment of the prosthesis according to the present invention, by going through the prosthesis along thelongitudinal axis 504 starting from an end of the prosthesis itself, such as a proximal end, one encounters a first serpentine or end serpentine, a sequence of alternated second and third serpentines and a last serpentine or further end serpentine, or distal end serpentine. In accordance with a possible embodiment, the last serpentine or further end serpentine specularly reproduces the first serpentine relative to amiddle axis 524 of the prosthesis, possibly staggered along the circumpherential direction. - In accordance with an advantageous embodiment, the
frame 522 is arranged at an end bend, i.e. a bend belonging to the end serpentine and with its concavity facing the inside of the prosthesis, i.e. themiddle axis 524. In other words, theframe 521 is arranged at or in place of a peak 516 a, preferably within the concavity thereof. - Considering a
cell 518 a comprising theframe 521 and defined between a length of theend serpentine 506 a and a length of thesecond serpentine 506 b, theframe 521 is advantageously arranged inside the respective cell. - In accordance with a possible embodiment, the
frame 521 has an elongated shape in the direction of the longitudinal axis of the prosthesis and develops from the end bend towards amiddle axis 524 of the endoluminal prosthesis. - By designating with 518 a the cell defined between the first and the second serpentines and comprising the
frame 521, this cell comprises twobridges 514 a developing alongdirections 526 tangential to the tubular body. Bothbridges 514 a may be advantageously arranged alongdirections 526 substantially parallel to one another and further parallel to the development directions of the remainingbridges 514 b between the first and the second serpentines. Still more advantageously, bothbridges 514 a may be arranged alongdirections 526 incident to one another, both in a closed configuration and in an expanded configuration of the prosthesis (FIGS. 2 , 3). - In accordance with a possible embodiment, the
bridges 514 a belonging to thecell 518 a comprising theframe 521 develop alongdirections 526 converging from the end of the prosthesis towards amiddle axis 524 of the prosthesis itself. - In accordance with an embodiment, the
bridges 514 a develop according todirections 526 tangential to the tubular body and biased relative to an axis parallel to thelongitudinal axis 504 of the endoluminal prosthesis. - Advantageously, the
bridges 514 a ofcell 518 a comprising theframe 521 develop alongdirections 526 tangential to the tubular body and biased relative to thelongitudinal axis 504 of the endoluminal prosthesis. - In accordance with a possible embodiment, by designating with 514 b the bridges connecting the first and the second serpentines which do not belong to
cell 518 a comprising theframe 521, thesebridges 514 b are substantially parallel to at least one of thebridges 514 a belonging to thecell 518 a comprising theslot 522. - Advantageously, in the
cell 518 a comprising theframe 521, the number of arms and bends of the first serpentine length is lower than the number of arms and bends of the second serpentine length. For example in thecell 518 a comprising theframe 521, the length belonging to the first serpentine may comprise at least two arms and two bends less than the arms and bends of the length belonging to the second serpentine, as specularly counted between both serpentines. In the example fromFIG. 2 , starting from one of thebridges 514 a, the length of the first serpentine belonging to thecell 518 a containing the slot comprises six arms and five bends while the length of second serpentine belonging to the cell 518 containing theframe 521 comprises eight arms and seven bends. - In
FIG. 5 is shown a plane development of a possible embodiment of the endoluminal prosthesis according to the present invention. - According to a possible embodiment, such as illustrated in
FIG. 5 , with 528 has been designated a further cell of a different shape than thecell 518 a containing theframe 521 and the remainingcells 518 b of the endoluminal prosthesis. For simplicity of description thefurther cell 528 will be indicated as the “anomalous” cell. - The
anomalous cell 528 is defined between the first and second serpentines and preferably adjacent to thecell 518 a containing the slot. Advantageously theanomalous cell 528 shares abridge 514 a withcell 518 a containing the slot and preferably shares that bridge which develops along a direction tangential to the tubular body incident to the development directions of the remaining bridges provided between the first and the second serpentines. The “anomalous” cell comprises two arms and two bends more than the remainingcells 518 b of the prosthesis. For example, the anomalous cell comprises six arms and five bends on the length relative to the second serpentine while the remainingcells 518 b of the prosthesis comprise four arms and three bends, with reference to a length relative to a serpentine. - From what has been discussed above, it should be appreciated that providing an endoluminal prosthesis according to the present invention allows to meet the requirement of visibility to X-rays, or however to radioscopy, of the prosthesis itself while maintaining its structure solid and avoiding that parts may protrude outside the prosthesis.
- The original provision of replacing some arms and bends of the serpentine to insert the slot and the radiopaque material enables the prosthesis to deploy evenly all along the longitudinal development thereof, simplifying at the same time the manufacturing steps of the prosthesis itself.
- By providing the cell comprising the frame with arms developing along directions tangential to the tubular body which are incident to one another, local distortions due to the difference in arms and bends between the serpentines can be prevented. This aspect is enhanced by the presence of the anomalous cell adjacent to the cell containing the slot.
-
FIG. 6 illustrates a partial perspective view of the above prosthesis in a deformed configuration with reference to the end comprising theframe 521. -
FIGS. 7 , 9, 11 illustrate the plane development of respective three possible embodiments of the prosthesis according to the present invention. FIG. 7 represents an embodiment similar to that ofFIG. 3 or 5 wherein thebridges 514 a corresponding to the cell comprising theframe 521 develop alongdirections 526 tangential to the tubular body, biased relative to thelongitudinal axis 504 and parallel to one another. These directions are further parallel to the tangential directions along which theother bridges 514 b develop between the first and second serpentines.FIGS. 9 and 11 represent two types of prosthesis where the cells defined between the second and third serpentines are of a different configuration compared to that of the cells between the second and third serpentines of the embodiments fromFIG. 3 , 5 or 7. Furthermore, the prosthesis fromFIG. 9 has the bridges ofcell 518 a containing theframe 521 that develop alongdirections 526 tangential to the tubular body and biased relative to the longitudinal axis and incident to one another. On the other hand, in the prosthesis fromFIG. 11 the bridges of thecell 518 a containing theframe 521 develop alongdirections 526 tangential to the tubular body and biased relative to the longitudinal axis and parallel to one another. -
FIGS. 8 , 10, 12 illustrate the prosthesis fromFIGS. 7 , 9, 11 respectively, in an expanded or widened configuration. -
FIGS. 13 , 14 illustrate the stresses and strains at theframe 521 in the prosthesis fromFIGS. 3 , 5, respectively.FIGS. 15 , 16 illustrate the stresses and strains at theframe 521 in the prosthesis fromFIGS. 7 , 8, respectively.FIGS. 17 , 18 illustrate the stresses and strains at theframe 521 in the prosthesis fromFIGS. 9 , 10, respectively.FIGS. 19 , 20 illustrate the stresses and strains at theframe 521 in the prosthesis fromFIG. 11 , 12, respectively. Arrow F designates the greatest stress-strain area. The prosthesis illustrated inFIGS. 3 , 5 allows to achieve a very low stress-strain peak value, and however a more constant distribution or gradual variation of the stress state. - The above has been achieved both by the advantageous embodiment of the
frame 521 to accommodate the radiopaque material and by the overall synergy between theframe 521 and the overall geometry of the prosthesis. - Thanks to the prosthesis thus provided, it is possible to carry out endoluminal operations in tortuous vessels or ducts, and at the same time, an optimum and constant support of the treated vessel wall can also be ensured with the prosthesis being in the expanded state.
-
FIGS. 21 to 26 illustrate six release steps from asheath 612 of a self-expandingendoluminal prosthesis 500. This procedure is, for example, carried out by withdrawing the sheath such that the prosthesis is left free to expand, such as from a housing where it is accommodated as provided in a transport and release device, such as a catheter (not shown herein). - It should be understood that variants and/or additions may be provided to what has been described and illustrated above.
- The slot can be of any shape other than that illustrated in the figures. Furthermore, it could be provided in a serpentine different from the serpentine end, or in a bend corresponding to a valley with reference to the meaning of the term “valley” such as discussed above.
- The number of serpentines, arms or bends may be changed from what has been described or illustrated. The shape of the serpentines may also be changed, particularly the alternate repetition between the second and third serpentines. For example, the second and third serpentines may be either equal, or perfectly specular without resulting staggered in the circumpherential direction.
- Generally all the embodiments which have been described as possible above, can be made as such, in the absence of those characteristics described as belonging to other possible embodiments.
- To the above preferred embodiments of the endoluminal prosthesis, those skilled in the art, aiming at satisfying contingent and specific needs, may carry out a number of modifications, variants and replacements of elements with others functionally equivalent, without departing from the scope of the claims below.
Claims (104)
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GB0020491D0 (en) | 2000-08-18 | 2000-10-11 | Angiomed Ag | Stent with attached element and method of making such a stent |
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- 2004-05-05 US US11/568,468 patent/US7722659B2/en active Active
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Also Published As
Publication number | Publication date |
---|---|
JP5007888B2 (en) | 2012-08-22 |
WO2005104991A8 (en) | 2006-12-07 |
WO2005104991A1 (en) | 2005-11-10 |
US20090182414A9 (en) | 2009-07-16 |
CN1988857A (en) | 2007-06-27 |
EP1744705B8 (en) | 2009-10-07 |
ES2331129T3 (en) | 2009-12-22 |
EP1744705B1 (en) | 2009-08-05 |
CN1988857B (en) | 2010-09-08 |
JP2007536056A (en) | 2007-12-13 |
EP1744705A1 (en) | 2007-01-24 |
US7722659B2 (en) | 2010-05-25 |
DE602004022461D1 (en) | 2009-09-17 |
ATE438364T1 (en) | 2009-08-15 |
HK1099195A1 (en) | 2007-08-10 |
BRPI0418719A (en) | 2007-09-11 |
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