CA2191307A1 - A stent and a method of use - Google Patents
A stent and a method of useInfo
- Publication number
- CA2191307A1 CA2191307A1 CA002191307A CA2191307A CA2191307A1 CA 2191307 A1 CA2191307 A1 CA 2191307A1 CA 002191307 A CA002191307 A CA 002191307A CA 2191307 A CA2191307 A CA 2191307A CA 2191307 A1 CA2191307 A1 CA 2191307A1
- Authority
- CA
- Canada
- Prior art keywords
- stent
- cells
- shape memory
- memory material
- skeletal frame
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—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
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
-
- 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
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
-
- 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
- A61F2/848—Devices 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
- A61F2002/8483—Barbs
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2002/9534—Instruments specially adapted for placement or removal of stents or stent-grafts for repositioning of stents
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
- A61F2210/0023—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/009—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof magnetic
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
- A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
-
- 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
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-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
- 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
- A61F2230/0017—Angular shapes
-
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
-
- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/901—Method of manufacturing prosthetic device
Abstract
This invention is a stent comprising a skeletal frame (2) of thermal shape memory material which has been annealed at a temperature sufficient to set a memory shape. The frame (2) is adapted to assume a first condition in which the frame is relatively rigid and substantially tubular in configuration, and a second condition in which the frame is flexible, of reduced stress, and collapsible, such that in the second condition walls (6) of cells (18) of the frame are adapted to be positioned against each other to form a stent diameter substantially equal to the combined thickness of the frame walls in abutting engagement with each other. The cell walls (6) are joined by fusion welds formed before the frame (2) is annealed.
Description
~W095/32757 219I3Q7 P~
A STENT AND A METHOD OF USE
This ~rrli~otit-n is a t~n-in-part q~, ' of copending orrl~ fi~ Serial No. 08/167,661 filled December 16, 1993, which is a ,-,.";. ,~;.. of Serial No. 071878,184 filed May 1, 1992.
BA-'K~'TROUND OF TFF. INVFNTION
FTT~T n OF TE~F INVFNTION
This invention relates to stents and is directed more IJ~uLi~,ul~ly to a self-expanding stent which is rer~Q;ti~ ' '- after being set in place.
gRTT~T~ DF~cRTl~loN OF T~F PRIOR ART
Self-expanding stents are generally known in the art. U.S. Patent No. 4,580,568, issued April 8, 1986, to Cesare Gianturco, discloses an CII.;IUV ' stent formed of stainless steel wire. The stent is cull~ a~,d into a reduced size having an outer diameter ' "y smaller than the 15 stent in its expanded shape. The stent is held in its , ~,aa~,d state during its paasage through a small bore catheter until delivered into a vascular system ~laa~6~,w~y~ Wh.,l._r the stress in the stent causes the stent to expand in the ITarger bore vascular ~ 6~ ~Iy to hold open fhe PQ~ _6~,W~IY. When the stent is . , ~ , the bends in the wire, which 20 is of a zig-zag ',, store stress, and the stent is çYp^ ~o~l~ by the release of the stress stored in the bends. Once set in place, the radial ~ LIulll~ a of the stent bear against the inside walls of the pdaa~,wQly.
WO 95132757 . P~ 931 2191~07 --2 .
,r -There is no ready means by wbich the stent may be again . 1, or softened, so that the stent may be ~ "~
It would be beneficial to the medical arts to have available a stent adapted for ~ into a small size to facilitate illl~ ' ido a 5 vascular ~ a~,way, and adapted for self-expansion in the vascular pâO~a~;~,way to hold open the pàS5~wa,y~ ard also adapted to be softened and/or contracted to permit r rnr;~ of the stent.
SUMMARY OF TH~ INVl~'l~TION
It is, therefore, an object of tbe invention to provide a stent adapted 10 to assume a first r~-nfi~--" iri which the stent is expanded, capable of exercising . ' ' '- stress if confined, as by a vessel waU, and r~ y tubular in ~- fi~,..,~;t)n for holding open a vascular ~àSS~way~ and a second 5~, 1 in which the stent is flexible, in a reduced stress state, and adapted to be c , ~ ~l into a small enough lS size to fit within the smaU bore of a delivery catheter.
A further object of the invention is to provide such a stent which is adapted to change from the first condition of relative rigidity to the second condition of flexibility and reduced stress, by exposure to a ~I~,i",l~.,~
trânsition ~ l c, such that tne stent may be relaxed in place in a 20 vascular I ~ .. ay by cooling to facilitate rep~citi~min~ thereof without damage to waUs of the pàS`~ ,wa.~.
A stiU further object of the invention is to provide such a stent laminated within an ~ rit~ sleeve, the sleeve being ~ . ' ' 1~ to conform to the stent's first, i.e. rigid, condition and having therein a bias 25 towards assuming a smaUer size, such that upon the stent's assuming the _ _ _ _ . , , . . ,,,, ,,,,, , ,,, _ , _, .. .. . .
WO 95132757 . r~ 31 f3~7 second, i.e. flexible, condition, the sleeve opeMtes to compress the stent to a size less than its expanded size.
Yet another object of the present invention is to provide such a stent formed from a plurality of cells each having first and second spaced, S ' -'ly parallel cell sides which are joined to one of the first or second cell sides of an adjacent cell. The cell sides of all of tne cells are " lly parallel to the centMI l~ "~ 1 axis of the stent or the stent section which the cells form.
A further object of the present invention is to provide such a stent 10 formed from a plUMIity of cells, each of which includes first and second spaced, straight side portions which are joined to one of the first or second StMight side portions of an adjacent cell. The stMight side portions of all cells are ' '1~ parallel to the centMI 1 , " ' axis of the stent or the stent section which the cells form. The ends of each cell are closed 15 by end portions which extend between the adjacent ends of each side portion at an angle to the central 1~ axis of the stent or the stent section which the cells form. These end portions are not connected to adjacent cells.
A further object of the present invention is to provide such a stent 20 formed from stent sections having different struch~ , and/or which provide different amounts of outward radial force when the stent sections are expanded from a collapsed ~
A further object of this invention is to provide a stent delivery unit which facilitates anchoring of the proximal end of the stent in place before 25 expansion of the distal end.
A still further object of the present invention is to provide a novel and improved method and appaMtus for forming a stent of thermal memory WO 95/3~757 21 913 0 7 ; . ~ r~lm~ )31 ~
material wherein the cells forming the stent are welded before the stent is heat treated to thennally determine the shape memory for the stent.
With the above and other objects in view, as will 1~ ~ appear, a feature of the present invention is the provision of a stent c.. ~ a 5 wire skeletal frame, the frame being adapted to assume a first condition in which the frame is expanded and resiliently d. ful-ll~lc but relatively ngid, the frame being further adapted to assume a second condition in which the frame is flexible, of reduced stress and cn11Dpr;hl~ such that in the second condition walls of the frame are adapted to be positioned in their collapsed lO .~ and further adapted to be positioned against each other to form a stent diameter s~lh~Dn~ ly equal to tbe combined thickness of the frame walls in abutting; ,,, with each other, and further adapted to be positioned between the expanded ~' sE -- and the walls abutting c ~ crl~;ti/~n the frame in the second condition being 15 ! ' ' '' "~ devoid of bias present therein urging the frame to assume the first configl~r.Dtir~n In accul~ with a fi~ther feature of the invention, there is provided a stent, as described " '~/ above, and further , an ~' - sleeve disposed on the stent and c,~ .r therewith to 20 confonn to the stent's expanded condition, the sleeve having therein a bias exerting a CUII~ force on the stent, such that upon cooling of the stent below a selected transition i ~ c, the sleeve urges the flexible and low stress stent to a third ~ ~ ~ smaller than the stent in its expanded condition and larger than the stent in its walls abutting 25 cnnfi~lr~ti~n The above and other features of the invention, including various novel details of cu~Llu~Lu,. and c~ ;.. of parts, will now be more w0 95132757 r~
~g`~07 y described with refcrence to the aCc~ ril.g drawings and pointed out in the claims. It will be ~ f~ tbat the particular devices c ~odyi lg the invention are shown by way of illllc~P~io" only and not as 1' " "~mc of the invention. The principles and features of this invention S may be employed in various and numerous ~lhb~ '' ' without departing from the scope of the invention.
RRTFF l ~F~(~RIlYrlON OF I~F DR~WINGS
Reference is made to the accù..l~all~ihg drawings in which are shown ill v~, el..~' of the invention, from which its novel 10 fedtures and ~Iv~ulL~s will be apparent.
In the drawings:
Fig. I is a ~la~,live view of one form of stent ilLIalldtive of an e ' ' of the invention;
Fig. 2 is a side cl.,v I view thereof;
Fig. 3 is a side clev I view of an alternative c.. ~, ' therecof;
Fig. 4 is a side el.,v ' view of a second r' ' v~
thereof;
Fig. S is a side el~,v I view of the stent shown in Fig. 1, but 20 shown in a CUI~1Caa~1 condition;
Fig. 6 is a side el~Ya~iul~l view of the stent shown in Figs. I and
A STENT AND A METHOD OF USE
This ~rrli~otit-n is a t~n-in-part q~, ' of copending orrl~ fi~ Serial No. 08/167,661 filled December 16, 1993, which is a ,-,.";. ,~;.. of Serial No. 071878,184 filed May 1, 1992.
BA-'K~'TROUND OF TFF. INVFNTION
FTT~T n OF TE~F INVFNTION
This invention relates to stents and is directed more IJ~uLi~,ul~ly to a self-expanding stent which is rer~Q;ti~ ' '- after being set in place.
gRTT~T~ DF~cRTl~loN OF T~F PRIOR ART
Self-expanding stents are generally known in the art. U.S. Patent No. 4,580,568, issued April 8, 1986, to Cesare Gianturco, discloses an CII.;IUV ' stent formed of stainless steel wire. The stent is cull~ a~,d into a reduced size having an outer diameter ' "y smaller than the 15 stent in its expanded shape. The stent is held in its , ~,aa~,d state during its paasage through a small bore catheter until delivered into a vascular system ~laa~6~,w~y~ Wh.,l._r the stress in the stent causes the stent to expand in the ITarger bore vascular ~ 6~ ~Iy to hold open fhe PQ~ _6~,W~IY. When the stent is . , ~ , the bends in the wire, which 20 is of a zig-zag ',, store stress, and the stent is çYp^ ~o~l~ by the release of the stress stored in the bends. Once set in place, the radial ~ LIulll~ a of the stent bear against the inside walls of the pdaa~,wQly.
WO 95132757 . P~ 931 2191~07 --2 .
,r -There is no ready means by wbich the stent may be again . 1, or softened, so that the stent may be ~ "~
It would be beneficial to the medical arts to have available a stent adapted for ~ into a small size to facilitate illl~ ' ido a 5 vascular ~ a~,way, and adapted for self-expansion in the vascular pâO~a~;~,way to hold open the pàS5~wa,y~ ard also adapted to be softened and/or contracted to permit r rnr;~ of the stent.
SUMMARY OF TH~ INVl~'l~TION
It is, therefore, an object of tbe invention to provide a stent adapted 10 to assume a first r~-nfi~--" iri which the stent is expanded, capable of exercising . ' ' '- stress if confined, as by a vessel waU, and r~ y tubular in ~- fi~,..,~;t)n for holding open a vascular ~àSS~way~ and a second 5~, 1 in which the stent is flexible, in a reduced stress state, and adapted to be c , ~ ~l into a small enough lS size to fit within the smaU bore of a delivery catheter.
A further object of the invention is to provide such a stent which is adapted to change from the first condition of relative rigidity to the second condition of flexibility and reduced stress, by exposure to a ~I~,i",l~.,~
trânsition ~ l c, such that tne stent may be relaxed in place in a 20 vascular I ~ .. ay by cooling to facilitate rep~citi~min~ thereof without damage to waUs of the pàS`~ ,wa.~.
A stiU further object of the invention is to provide such a stent laminated within an ~ rit~ sleeve, the sleeve being ~ . ' ' 1~ to conform to the stent's first, i.e. rigid, condition and having therein a bias 25 towards assuming a smaUer size, such that upon the stent's assuming the _ _ _ _ . , , . . ,,,, ,,,,, , ,,, _ , _, .. .. . .
WO 95132757 . r~ 31 f3~7 second, i.e. flexible, condition, the sleeve opeMtes to compress the stent to a size less than its expanded size.
Yet another object of the present invention is to provide such a stent formed from a plurality of cells each having first and second spaced, S ' -'ly parallel cell sides which are joined to one of the first or second cell sides of an adjacent cell. The cell sides of all of tne cells are " lly parallel to the centMI l~ "~ 1 axis of the stent or the stent section which the cells form.
A further object of the present invention is to provide such a stent 10 formed from a plUMIity of cells, each of which includes first and second spaced, straight side portions which are joined to one of the first or second StMight side portions of an adjacent cell. The stMight side portions of all cells are ' '1~ parallel to the centMI 1 , " ' axis of the stent or the stent section which the cells form. The ends of each cell are closed 15 by end portions which extend between the adjacent ends of each side portion at an angle to the central 1~ axis of the stent or the stent section which the cells form. These end portions are not connected to adjacent cells.
A further object of the present invention is to provide such a stent 20 formed from stent sections having different struch~ , and/or which provide different amounts of outward radial force when the stent sections are expanded from a collapsed ~
A further object of this invention is to provide a stent delivery unit which facilitates anchoring of the proximal end of the stent in place before 25 expansion of the distal end.
A still further object of the present invention is to provide a novel and improved method and appaMtus for forming a stent of thermal memory WO 95/3~757 21 913 0 7 ; . ~ r~lm~ )31 ~
material wherein the cells forming the stent are welded before the stent is heat treated to thennally determine the shape memory for the stent.
With the above and other objects in view, as will 1~ ~ appear, a feature of the present invention is the provision of a stent c.. ~ a 5 wire skeletal frame, the frame being adapted to assume a first condition in which the frame is expanded and resiliently d. ful-ll~lc but relatively ngid, the frame being further adapted to assume a second condition in which the frame is flexible, of reduced stress and cn11Dpr;hl~ such that in the second condition walls of the frame are adapted to be positioned in their collapsed lO .~ and further adapted to be positioned against each other to form a stent diameter s~lh~Dn~ ly equal to tbe combined thickness of the frame walls in abutting; ,,, with each other, and further adapted to be positioned between the expanded ~' sE -- and the walls abutting c ~ crl~;ti/~n the frame in the second condition being 15 ! ' ' '' "~ devoid of bias present therein urging the frame to assume the first configl~r.Dtir~n In accul~ with a fi~ther feature of the invention, there is provided a stent, as described " '~/ above, and further , an ~' - sleeve disposed on the stent and c,~ .r therewith to 20 confonn to the stent's expanded condition, the sleeve having therein a bias exerting a CUII~ force on the stent, such that upon cooling of the stent below a selected transition i ~ c, the sleeve urges the flexible and low stress stent to a third ~ ~ ~ smaller than the stent in its expanded condition and larger than the stent in its walls abutting 25 cnnfi~lr~ti~n The above and other features of the invention, including various novel details of cu~Llu~Lu,. and c~ ;.. of parts, will now be more w0 95132757 r~
~g`~07 y described with refcrence to the aCc~ ril.g drawings and pointed out in the claims. It will be ~ f~ tbat the particular devices c ~odyi lg the invention are shown by way of illllc~P~io" only and not as 1' " "~mc of the invention. The principles and features of this invention S may be employed in various and numerous ~lhb~ '' ' without departing from the scope of the invention.
RRTFF l ~F~(~RIlYrlON OF I~F DR~WINGS
Reference is made to the accù..l~all~ihg drawings in which are shown ill v~, el..~' of the invention, from which its novel 10 fedtures and ~Iv~ulL~s will be apparent.
In the drawings:
Fig. I is a ~la~,live view of one form of stent ilLIalldtive of an e ' ' of the invention;
Fig. 2 is a side cl.,v I view thereof;
Fig. 3 is a side clev I view of an alternative c.. ~, ' therecof;
Fig. 4 is a side el.,v ' view of a second r' ' v~
thereof;
Fig. S is a side el~,v I view of the stent shown in Fig. 1, but 20 shown in a CUI~1Caa~1 condition;
Fig. 6 is a side el~Ya~iul~l view of the stent shown in Figs. I and
2 with an e' ~ sleeve thereon;
Figs. 7A-7C are illustrative stylized ~ ;f views of one manner of use of the inventive devices of Figs. 1-6, as in the treatment of 25 an aneurysm of a large artery;
W 0 9513 2757 P ~, 1 / ~ ~. _ . 931
Figs. 7A-7C are illustrative stylized ~ ;f views of one manner of use of the inventive devices of Figs. 1-6, as in the treatment of 25 an aneurysm of a large artery;
W 0 9513 2757 P ~, 1 / ~ ~. _ . 931
3~7 . . .
6 ~ ' ~
Figs. 8A-8C are st,vlized ~ ;C views illustrdtive of another rnanner of use of the inventive device of Figs. 1-6, as in the trcatrnent of cu.u~l~ or narrowing of a vessel;
Figs. 9A-9E are stylized di~ ALic views illustrative of a manner Sof r~rnA;ti~ ~ the inventive device of Figs. 1-6;
Fig. 10 is a side cl.,vdlio--al view of a third ~IIIh~ ' of the stent of the present invention;
Fig. I1 is a side ~ v ' view of a fourth r~ of the stent of the present invention;
Fig. 12 is a side elevational view of a fifth ~ .. ~1.~1;.,- .. l of the stent of tbe present invention;
Fig. 13 is a block diagram showing the ~ used to r ' C the stent of the present invention;
Fig. 14 is a sectional exploded view of a stent delivery unit of the 15 present invention; and Fig. 15A-15E are sectional views ill,.c~ti~ the manner in which the stent delivery unit of Fig. 14 positions a stent.
DE.~CRTPrlON OF TT~F. PRFFERRFr) El\~RODlMFl~T
Referring to Figs. 1 and 2, it will be seen that an illustrative stent 20 includes a skeletal frame 2, l~lcf~,~dbl~ formed from a single wire 4. The wire 4 includes a plurality of abutting straight porlions 6 which are joined to each other, as by welding.
~ WO9513~757 r~ l"J.. _. I
~ 21~307 In Figs. 1 and 2, the ill ~ stent is shown in a first condition in which the frame 2 is expanded, relatively rigid, and ' - ~ly tubular in 5" Ends 8, 10 of the single wire 4 are disposed in one of the welded straight portions 6, such that there are no exposed wire free S ends, disposcd within or extending from the frame 2. Tne abutting and elongated straight portions 6 of the wire 4 facilitate the use of strong elongated welds to securely join the wire portions 6 together. The wire 4 preferably is round in cross-section, but may be formed of any desired cross-sectional shape. In the frame straight portions 6 the joined wire segments are disposed, relative to the tubular ~ - Of the frame, Cil-~ / thereof. The wire 4 abuts itself only at the straight portions 6 and does not CTOSS itself at any point. Acc~lJ~ly, the frame walls, that is, walls 12 of a tubular body portion 14 of the frame 2 have a thickness equal to the diameter of the wire 4.
The stent includes the body portion 14 and finger portions 16 extending generally axially from one, or both, ends of the body portion.
The fingers facilitate a gradual reduction in radiaUy outwardly extending pressure exerted by the stent on the wall of a vascular p ~,_way in which the stent is located. Such gradual reduction of pressure facilities - -r of the stent by the pà~ ,way and rcduces ~ reac~ons by the ~dS~ut~ way wall to the presence of the ste~t. Referring to Fig. 3, it will be seen that the finger portion 16 may be extendcd further axially to lessen the ~lolJdl/il;~y of adverse reaction by the ~a~a~way wall to the pressure exerted against the wall by the stent frame 2. Also, hooks or barbs 17 can be attached to project outwardly from some of the straight portions 6 to aid in anchoring the stent to the vessel in which it is . ' ' These hooks can be formed from Nitinol in either its memory W095132757 r~"
~!1913~7~ t ~ ~ `
form or s~ scti~ form, or they can be formed from other material such as ~ 'Iy ~ b~lc polymers.
The tubular body portion 14 comprises a mesh formed by the wire
6 ~ ' ~
Figs. 8A-8C are st,vlized ~ ;C views illustrdtive of another rnanner of use of the inventive device of Figs. 1-6, as in the trcatrnent of cu.u~l~ or narrowing of a vessel;
Figs. 9A-9E are stylized di~ ALic views illustrative of a manner Sof r~rnA;ti~ ~ the inventive device of Figs. 1-6;
Fig. 10 is a side cl.,vdlio--al view of a third ~IIIh~ ' of the stent of the present invention;
Fig. I1 is a side ~ v ' view of a fourth r~ of the stent of the present invention;
Fig. 12 is a side elevational view of a fifth ~ .. ~1.~1;.,- .. l of the stent of tbe present invention;
Fig. 13 is a block diagram showing the ~ used to r ' C the stent of the present invention;
Fig. 14 is a sectional exploded view of a stent delivery unit of the 15 present invention; and Fig. 15A-15E are sectional views ill,.c~ti~ the manner in which the stent delivery unit of Fig. 14 positions a stent.
DE.~CRTPrlON OF TT~F. PRFFERRFr) El\~RODlMFl~T
Referring to Figs. 1 and 2, it will be seen that an illustrative stent 20 includes a skeletal frame 2, l~lcf~,~dbl~ formed from a single wire 4. The wire 4 includes a plurality of abutting straight porlions 6 which are joined to each other, as by welding.
~ WO9513~757 r~ l"J.. _. I
~ 21~307 In Figs. 1 and 2, the ill ~ stent is shown in a first condition in which the frame 2 is expanded, relatively rigid, and ' - ~ly tubular in 5" Ends 8, 10 of the single wire 4 are disposed in one of the welded straight portions 6, such that there are no exposed wire free S ends, disposcd within or extending from the frame 2. Tne abutting and elongated straight portions 6 of the wire 4 facilitate the use of strong elongated welds to securely join the wire portions 6 together. The wire 4 preferably is round in cross-section, but may be formed of any desired cross-sectional shape. In the frame straight portions 6 the joined wire segments are disposed, relative to the tubular ~ - Of the frame, Cil-~ / thereof. The wire 4 abuts itself only at the straight portions 6 and does not CTOSS itself at any point. Acc~lJ~ly, the frame walls, that is, walls 12 of a tubular body portion 14 of the frame 2 have a thickness equal to the diameter of the wire 4.
The stent includes the body portion 14 and finger portions 16 extending generally axially from one, or both, ends of the body portion.
The fingers facilitate a gradual reduction in radiaUy outwardly extending pressure exerted by the stent on the wall of a vascular p ~,_way in which the stent is located. Such gradual reduction of pressure facilities - -r of the stent by the pà~ ,way and rcduces ~ reac~ons by the ~dS~ut~ way wall to the presence of the ste~t. Referring to Fig. 3, it will be seen that the finger portion 16 may be extendcd further axially to lessen the ~lolJdl/il;~y of adverse reaction by the ~a~a~way wall to the pressure exerted against the wall by the stent frame 2. Also, hooks or barbs 17 can be attached to project outwardly from some of the straight portions 6 to aid in anchoring the stent to the vessel in which it is . ' ' These hooks can be formed from Nitinol in either its memory W095132757 r~"
~!1913~7~ t ~ ~ `
form or s~ scti~ form, or they can be formed from other material such as ~ 'Iy ~ b~lc polymers.
The tubular body portion 14 comprises a mesh formed by the wire
4, the rnesh ~ a plurality of ~ cells 18 which are ~ fil~lJly of a polygonal c~. ~f.,, ~ when viewed in plan, providing spaced, ' "y parallel straight sides to form the ~ n.~A
straight portions 6. The cells 18, when polygonal, are preferably of a hexagonal 6~ n, which readily provides expansion and rigidity r~tl ;,;;-c desirable in the structure and operation of the device.
Preferably, the stent comprises six of the polygonal cells 18 C~l UU~I~ Uy and an even number of the polygonal cells along its length, thereby f~ilitstin~ formation of the stent by the single wire 4. The portion of the stent having the mesh - U,ti~JII exercises a ' 'Iy greater radial bias than do the finger portions 16. Thus, when it is desired to have more force near the ends of the stent than at its center, the c ulb~ 1 shown in Fig. 4 may be used. Referring to Fig. 4, it will be seen that in this; '~' t, the central portion of the tubular bc~dy portion 14 includes elongated cells 20 exercising less radial force tharl the cells 18.
It is important to note that each cell is formed by two straight portions 6 wbich are ' lly parallel to the central 1-~" ' ' axis of the stent or stent section of which the cell is a paTt. Each end of the cell is closed by an end waU or end waUs 21 which extend between adjacent ends of the straight portions 6; the end walls being disposed at an angle to the central 11 ,, ' ' axis of the stent or stent section containing the cell.
The stent preferably is made of an aUoy of nickel and titanium which provides the stent with a thermal memory. The unique . l., t~ .. IC~
.. _ _ _ _ _ _ _ _ _ _ .. _ _ .. ., ... ... _ ..... ,,,, _ . ,, _, _ . ,, ,, _,, .
~ WO 95132757 P~
2191307~
_ 9 _ of this alloy, known generally as '~itinol", is its therrnally triggered shape memory, which allows the stent co.~L, UL hd of the alloy to be cooled below a i r- ' G Ll~rul level and thereby softened for loading into a catheter in a relatively , ~,~sc~ and elongated state, and regain the S memoried shape when warmed to a selected ~ .-e, above the ~ t~G ~l~r~ n level, such as human body , c. The two il.b .~ ' ,, ' '~ shapes are possible because of the two distinct micro-crystalline structures that are ~ with a small variation in G. The i . G at which the stent assumes its first 10 ~ullrl.~ may be varied within wide limits by changing the of the alloy. Thus, while for human use the alloy may be focused on a , G of 98.6F for ~ of the first condition, the alloy readily may be modified for use in animals with clifferent body c Although the stents shown in Figs. 14 are preferably formed of wire, they could be formed from a sheet of Nitinol which has been stamped to form the cells 18. Once the cells are forrned, the opposed l.-..C;~
edges of the sheet would be joined to form the frarne 2 with the straight . portions 6 orierlted in parallel ' ' ,, to the 1,~ ~c;~ axis of the 20 stent.
Acculdil.~,ly, when the stents shown in Figs. 1-4 are subjected to a ~1~ -, c at or less than the transition ~ G, the relativity rigid stent changes to a second condition in which it is flexible, of reduced stress and c~ pQ;~IP The stent does not, of its own accord, collapse, or 25 compress, but the stent does become quite pliable, c-~ and , Gi.~;bl~. By ' ' means, the stent may be . , .,~1 to a point at which the walls 12 of the body portion 14 of the stent frame 2 are W095/32757 ~^~I.J.,,~. _l 10 ~ . .
positioned against each other, to form a stent diameter I 'ly equal to the combined thickness of the frame walls in abutting ~ v v with each other. In Fig. 5, the stent is shown a~ o~L;I~, but not yet having reached such rninimal stent diameter. In the c~ condition, the
straight portions 6. The cells 18, when polygonal, are preferably of a hexagonal 6~ n, which readily provides expansion and rigidity r~tl ;,;;-c desirable in the structure and operation of the device.
Preferably, the stent comprises six of the polygonal cells 18 C~l UU~I~ Uy and an even number of the polygonal cells along its length, thereby f~ilitstin~ formation of the stent by the single wire 4. The portion of the stent having the mesh - U,ti~JII exercises a ' 'Iy greater radial bias than do the finger portions 16. Thus, when it is desired to have more force near the ends of the stent than at its center, the c ulb~ 1 shown in Fig. 4 may be used. Referring to Fig. 4, it will be seen that in this; '~' t, the central portion of the tubular bc~dy portion 14 includes elongated cells 20 exercising less radial force tharl the cells 18.
It is important to note that each cell is formed by two straight portions 6 wbich are ' lly parallel to the central 1-~" ' ' axis of the stent or stent section of which the cell is a paTt. Each end of the cell is closed by an end waU or end waUs 21 which extend between adjacent ends of the straight portions 6; the end walls being disposed at an angle to the central 11 ,, ' ' axis of the stent or stent section containing the cell.
The stent preferably is made of an aUoy of nickel and titanium which provides the stent with a thermal memory. The unique . l., t~ .. IC~
.. _ _ _ _ _ _ _ _ _ _ .. _ _ .. ., ... ... _ ..... ,,,, _ . ,, _, _ . ,, ,, _,, .
~ WO 95132757 P~
2191307~
_ 9 _ of this alloy, known generally as '~itinol", is its therrnally triggered shape memory, which allows the stent co.~L, UL hd of the alloy to be cooled below a i r- ' G Ll~rul level and thereby softened for loading into a catheter in a relatively , ~,~sc~ and elongated state, and regain the S memoried shape when warmed to a selected ~ .-e, above the ~ t~G ~l~r~ n level, such as human body , c. The two il.b .~ ' ,, ' '~ shapes are possible because of the two distinct micro-crystalline structures that are ~ with a small variation in G. The i . G at which the stent assumes its first 10 ~ullrl.~ may be varied within wide limits by changing the of the alloy. Thus, while for human use the alloy may be focused on a , G of 98.6F for ~ of the first condition, the alloy readily may be modified for use in animals with clifferent body c Although the stents shown in Figs. 14 are preferably formed of wire, they could be formed from a sheet of Nitinol which has been stamped to form the cells 18. Once the cells are forrned, the opposed l.-..C;~
edges of the sheet would be joined to form the frarne 2 with the straight . portions 6 orierlted in parallel ' ' ,, to the 1,~ ~c;~ axis of the 20 stent.
Acculdil.~,ly, when the stents shown in Figs. 1-4 are subjected to a ~1~ -, c at or less than the transition ~ G, the relativity rigid stent changes to a second condition in which it is flexible, of reduced stress and c~ pQ;~IP The stent does not, of its own accord, collapse, or 25 compress, but the stent does become quite pliable, c-~ and , Gi.~;bl~. By ' ' means, the stent may be . , .,~1 to a point at which the walls 12 of the body portion 14 of the stent frame 2 are W095/32757 ~^~I.J.,,~. _l 10 ~ . .
positioned against each other, to form a stent diameter I 'ly equal to the combined thickness of the frame walls in abutting ~ v v with each other. In Fig. 5, the stent is shown a~ o~L;I~, but not yet having reached such rninimal stent diameter. In the c~ condition, the
5 stent is readily contained by a catheter C (Fig. 7B).
In Fig. 6, therG is shown an alternative ~ having still fi rther benefits. As noted above, in the second condition of the stent, the stent becomes flexible and cu~ Ga~ibl~, but does ~ot of its own accord compress. In the ~ I shown in Fig. 6, the stent body portion has 10 disposed thereon an i ' - - sleeve 22. The sleeve 22 is ~ . ' ' ' on the frarîle 2 as the frame expands to its enlarged c~ - However, as the sleeve expands. the sleGve exerts a: , Gaa;~ force on the frame.
Upon cooling of the stent to or below the transition t~ d~L G, the stent becomes flexible and the , G;~a;~G sleeve 22 urges the frame 2 to a 15 tbird configur~Ation of sma11er diameter than the first ~
Al~;uld;..~,ly, upon cooling of the sleeved; hl ' t, the flexible frame ~ ly reduces in si4e, thereby rendering any r~^P.^cifi~ v of the stent, as by a grasping tool or other hlJtl~ t, known in the art (not shown), a relatively simple matter. Again, upon rGmoval of the cooling 20 medium, the sleeved stent returns to its expanded condition.
The sleeved stent has an added benefit in that while an unsleeved stent will suffice in many instances, there are occasions when the affected wall is in such a weakened condition that the provision of a new wall, or a graft, is required. The sleeved stent is essentially a graft 25 and operates to provide a new pàaa~.~way wall when required.
In operation, the stent, sleeved or unsleeved, is carried through an affected vascular paaaa~way V (Fig. 7A) by the catheter C (Fig. 7B), wo ss/327s7 which is of a thermally insulative material. At room ~ 7 and wbile cooled by infusion of a cool solution within the catheter, the stent remains in the second condition, fleAible and of low stress. Being of low stress, the stent eAercises negligible radial force against the inside wall of S the catheter and is easily moved through the catheter at the a~lO~I -time.
As the catheter enters the pâ.~a~ a,~ V, the therrnal insulative properties of the catheter and the flow of cool solution maintain the stent at less than body ~ . When the distal end of the catheter is 10 properly disposed, as for example, in the vicinity of an aneurysm A (Fig.
7B), the stent is moved out of the end of the catheter C. As the stent contacts blood flow, and is subjected to body i , , the eAposed stent - ' 'y and rapidly assumes its first condition, eA~J~Li.dil~, against the walls of the pa~ a,~'. Upon total ejection of the stent, the catheter 15 is removed, leaving the stent in place to act as an internal wall graft (Fig. 7C).
Referring to Figs. 8A-8C, it will be seen that in treatment of ;v.l of a large vessel, such as a superior vene cava S, the catheter C (Fig. 8B) is moved through the vessel S to a point adjacent a stricture0 T. The stent 2 is moved from the catheter C, while the catheter is ~ .., to place the emerging stent witbin tbe vessel and in the area of the stricture (Fig. 8B). As the stent emerges from the catheter, the stent, as it is exposed to the blood stream, assumes its first condition. Upon total removal of the stent from the catheter, the stent in its entirety is expanded 25 against the wall of the vessel (Fig. 8C) to maintain the vessel in a free-flowing . ~ t)n WO95132757 I~,IIU.,~ I
~}~.~3~7 The cell structure and, - witbin the stent is very important to the proper expansion and . C~D;OII . 1 - ~ ,~, 1. . ;-1 ;~e of the stent. Since cell joinder is r . " ' ~ ~ solely at adjoining straight portions 6, the expansion of the stent radially and outwardly from the central 1-. ~,g,.~
axis or axes thereof places minimal stress on the . nnc between cells.
The straight portioDs 6, being parallel to the I 1~ ' ' axis of the stent or stent section, do not s:" ~ 'y change in c~-nfi~ ' as the stent is collapsed and expanded.
Since the sole . - between cells is along these straight 10 portions, the . is not subjected to tenDion or shear force during e~pansion and . . of the stent in a manner which would tend to stress and breal~ the . The end walls 21, which are inclined relative to the central 11 ,, ' ' axis of the stent or stent section, are the portions of the cell which provide the radial memory force during 15 ~p7 ~ and the r-, " 'Iy oriented ~ne between the cells causes the cells to distribute tbis radial memory force evenly around the stent. It is the pliability of the end walls at . ..~.CD below the '1 . 1~ C ,,,L .Cv l-l~on level whicb cause the cell straight portions 6 to . move together as tbe stent is CU.I.~ICDj7C~7 and it is these same end walls 20 wbich become relatively rigid but resiliently I- f~ to return the steDt to its tbermal mernory shape at i , above the i- -- ~ c level. As these end walls maintain the str7~ight portions 6 of the cells ~ y parallel to the l...~g~ axis of the stent iD all c~nfigr-- of tbe stent, these straight portions 7lre not ei~;, r;,s..~ly 25 biascd or stressed.
Once expanded in place within a body vessel, a stent is often subjected to forces which tend to crush the stent within Lhe vessel, and _ _ . _ _ . . .
WO 95/32757 P_I/~vv. _. . I
?~ 3~7 known stents, once crushed, are not self P~nrl;ng For example, a stent placed in the back of the leg is subjected to forces as the leg bends or is , ~ ~i in the seated position of a subject which tend to crush the stent. The stent of the present invention is self expanding if crushed due 5 to the inclined end walls 21. These end walls will fle~ to permit the straight portions 6 to move inwardly toward tne ~ t ~ l axis of the stent or stent section in response to a crushing force, but will spring outwardly to their original memory position once the crushing force is removed.
The ratio of expanded stent diameter to ~ stent diameter can be controlled within limits by selection of wire diameter. The diameter of the expanded stent generally is on the order of 6 to 10 times the diameter of the , .,~cd stent, but can be as great as 20 times that of the . , .,i~cd stent. In general, the ~greater the diameter of the wire 4, 15 tbe less the ratio of the stent collapsed/e~panded diameter. By selection of wire diameter, it is possible to vary tbe radial force which tbe expanded stent will exert on the interior walls of the ~ 6vw~.y in which the stent is set.
It is 5U 1II~ ' ~ the case tbat once tbe stent is in place and in part 20 expanded, it is l.,co6~ that tbe stent is somewhat off target (Figs. 9A
and 9B) and requires rep~;tir~ning To reposition the stent of the present invention, the operator ihlL~ into the pas~a6vw~ a cool medium M
(Figs. 9C and 9D), such as a saline solution, having a , c at or less than the transition t~ ;. When tbe cool solution ~ the 25 stent, the stent ih~ / t~vrns flexible and SUIIC~L~I~ radial force against the ~ .6~,w~ walls. In such rela~ed state, the stent, which has no free wire ends, is easily slid intû the proper position by , of wo ssl32757 the cathetGr C (Fig. 9D), ~h.,lG.I~,.. the flow of cool solution is stopped and the stent, upon returning to a body Ir...~ G, reassumes its expanded condition in the l~a~ way (Fig. 9E). The catheter C is then wilLdlawn from the stent and from the pà~ àg-,wa,~.
Thus, there is provided a stent which may be alloyed to have a selected i , a~ulc at which the stent assumes its first condition and a selected transition , G, at which the stent assumes its second condition, arld which includes a wire frame, wherein the diameter of the wire is selectable to provide a selected degree of expansion force. The 10 stent is ~ ;l,lc to less than a catheter-size diameter to facilitate delivery of the stent to a location within a body ~ ,w~ by a catheter.
The stent may be sleeved or unsleeved. The stent is self-expanding upon delivery from the catheter and I 'I ' Cm to a body i , G, to provide an internal graft or hold open a IJa~ ,wa,~. Even after such5 i ~ and ~ p~ the stent is rendered flexible and rcadily 7 ~I~lr merely by the flow of a cool medium through the stent.
And, finally, by t...~ A of the flow of cool fluid, the stent - ~Iy reassumes it~ pa~àS~,way ~ rigid condition. Any required ' , r ~rncitionin~ can be su , ' ~' in the same manner.
Although the stent of the present invention is generally tubular in r;g~Al;~m since the vessels in which the stent is normally placed are generally tubular, it must be IGCo~ ~ that different portions of these vessels may be sized .lilf~,l. ly, and therefore the stent must be sized and shaped accOIdil~gly. For example, above the renal arteries, the aorta changes size, and therefore a variable sizcd stent designcd to ~
these changes in shape is required. Referring to Figure 10, a stent 24 which is formed to fit within a vessel 26 having a variable diar~eter is , , . ... . .
W09S/3Z757 2tg~ r~ 3031 ~ ~i 7 ill ' In its e~panded condition, the diameter of the stent increases from a small diameter end 28 to a large diameter end 30. It is desirable to form a stent having a variable outer ~ n which will still apply ! ' ' ' lly equal outward radial force to the walls of the vessel 26 of 5 varying diameter. As lulcv;. u~ly indicated, a stent of this type can be formed in several different ways. First, the size of the cells 18 can be varied so that the cell size ~lùolc~;v~,ly increases from the small diameter end 28 to the large diameter end 30 as shown in Figure 10. Thus, the larger cells can be formed to expand the stent to a greater diameter than the 10 smaller cells.
In addition to varying cell size, it is possible to vary the outward radial force of expansion along the length of the stent either in C~ ir-~
with a variation in cell size or with cells of ' lly the same size.For example, referring to Figure 11, a stent 32 is illustrated in expanded 15 condition within a vessel, such as a renal artery 34. The cells 36 at the ends of the stent 32 are defined by Nitinol vire having a thickness or diameter which is much less than that of the cells 38 in the central portion of the stent. Therefore, when expanded, the cells 38, due to the heavier wire, wiU provide a greater radial force on a artery 34 then will the cells 20 36 at either end of the stent 32.
It should also be noted that the finger portions at one end of the stent are flared outwardly at 40 when the stent is expanded. This is a-lv O for a stent which, for example, is positioned within a renal artery 34, for the flared finger portions 40 will then engage the walls of the 25 aorta 42. When one end of the stent is so flared, the stent will not extend outwardly into the aorta, causing an ol,~uu-,Lu.., for this is p~L-,ul~ly d; ,.,~lv... :..o if a second stent, a catheter, or some other device is to be WO 95~32757 r~,l/L,~ q~l ~
~9~3~
, . ..
.- 16 -implanted or moved within the aorta. Secondly, the flared fingers 40 tend to draw back the wall of the aoTta as the stent expands opening both the aorta and the renal artery 34. Obviously, the end cells 36 of the stent could be formed to provide the flared portion 40 if no finger portions are 5 includcd in the stent design.
Another method for varying the radial outward force applied by the stent would be to anneal sections of the stent at different ~ 50 that the i , Ll~ru.~dlion level at which Yarious sectiorls of this stent fully expand will vary. For example, the central cells of the stent 32 10 could be annealed at a , c which would cause the central section of the stent to fully e~pand at normal body t ~ c. The end cells 36 of the stent could be annealed in such a manner that these end cells would fillly expand at h ~ slightly higber tharl normal body t~
and ~, ~y, at normal body i , c although these end cells 15 would expand, they would not expand to proYide full radial force on the vessel 34. Thus, the radial force proYided by the end cells 36 would be less than that provided by the center cells 38 at normal body i . c.
The cell e~pansion ~ Q of a stent may be altered by any of tbe methods described or by the ' of these methods. Thus, 20 cell size could be varied in . ' with either a variation in wire size or a variation in annealed , ~, or alt~ dli~.,ly, cell size could be ~ in.oA constant and a variation in wire size could be combined with the variation in annealed t~ f' ' ' C. Ideally, for most stent ~p~ tinn~
the central portion of the stent wiU provide a greater radial force on a 25 vessel than the end portions of the stent, altnough the end por~ons should expand sulrc;~ lly to anchor the stent in place as a catheter carrying the stent is removed.
~ WO 95132757 P~
~g~3~7 Referring now to Figure 12, the rl~ , polymeric sleeve 22 illustrated in Figure 6 may be formed to an extended length so that it can contain a plurality of separate stent sections, two of which are shown at 44 and 46 in Figure 12. The elongated ~' - sleeve may be cut apart S along cut lines, as indicated at 48, between the stent sections, so that a plurality of stents encased within a sleeYe as shown in Figure 6 may be obtained from the elongated unit of Figure 12. Al~llldli~,ly, a single elongated stent could be provided within the sleeve 22, and sections of the stent and sleeve could then be cut to various desired lengths.
In forming the stent of the present invention, it is important to provide a strong bond between cells along the straight portions 6. To P~- ,' ' this, the cells of the skeletal frame are first formed of thermal memory wire which has not yet been annealed to achieve its shape memory form and set the expansion shape of the device, and the straight portions
In Fig. 6, therG is shown an alternative ~ having still fi rther benefits. As noted above, in the second condition of the stent, the stent becomes flexible and cu~ Ga~ibl~, but does ~ot of its own accord compress. In the ~ I shown in Fig. 6, the stent body portion has 10 disposed thereon an i ' - - sleeve 22. The sleeve 22 is ~ . ' ' ' on the frarîle 2 as the frame expands to its enlarged c~ - However, as the sleeve expands. the sleGve exerts a: , Gaa;~ force on the frame.
Upon cooling of the stent to or below the transition t~ d~L G, the stent becomes flexible and the , G;~a;~G sleeve 22 urges the frame 2 to a 15 tbird configur~Ation of sma11er diameter than the first ~
Al~;uld;..~,ly, upon cooling of the sleeved; hl ' t, the flexible frame ~ ly reduces in si4e, thereby rendering any r~^P.^cifi~ v of the stent, as by a grasping tool or other hlJtl~ t, known in the art (not shown), a relatively simple matter. Again, upon rGmoval of the cooling 20 medium, the sleeved stent returns to its expanded condition.
The sleeved stent has an added benefit in that while an unsleeved stent will suffice in many instances, there are occasions when the affected wall is in such a weakened condition that the provision of a new wall, or a graft, is required. The sleeved stent is essentially a graft 25 and operates to provide a new pàaa~.~way wall when required.
In operation, the stent, sleeved or unsleeved, is carried through an affected vascular paaaa~way V (Fig. 7A) by the catheter C (Fig. 7B), wo ss/327s7 which is of a thermally insulative material. At room ~ 7 and wbile cooled by infusion of a cool solution within the catheter, the stent remains in the second condition, fleAible and of low stress. Being of low stress, the stent eAercises negligible radial force against the inside wall of S the catheter and is easily moved through the catheter at the a~lO~I -time.
As the catheter enters the pâ.~a~ a,~ V, the therrnal insulative properties of the catheter and the flow of cool solution maintain the stent at less than body ~ . When the distal end of the catheter is 10 properly disposed, as for example, in the vicinity of an aneurysm A (Fig.
7B), the stent is moved out of the end of the catheter C. As the stent contacts blood flow, and is subjected to body i , , the eAposed stent - ' 'y and rapidly assumes its first condition, eA~J~Li.dil~, against the walls of the pa~ a,~'. Upon total ejection of the stent, the catheter 15 is removed, leaving the stent in place to act as an internal wall graft (Fig. 7C).
Referring to Figs. 8A-8C, it will be seen that in treatment of ;v.l of a large vessel, such as a superior vene cava S, the catheter C (Fig. 8B) is moved through the vessel S to a point adjacent a stricture0 T. The stent 2 is moved from the catheter C, while the catheter is ~ .., to place the emerging stent witbin tbe vessel and in the area of the stricture (Fig. 8B). As the stent emerges from the catheter, the stent, as it is exposed to the blood stream, assumes its first condition. Upon total removal of the stent from the catheter, the stent in its entirety is expanded 25 against the wall of the vessel (Fig. 8C) to maintain the vessel in a free-flowing . ~ t)n WO95132757 I~,IIU.,~ I
~}~.~3~7 The cell structure and, - witbin the stent is very important to the proper expansion and . C~D;OII . 1 - ~ ,~, 1. . ;-1 ;~e of the stent. Since cell joinder is r . " ' ~ ~ solely at adjoining straight portions 6, the expansion of the stent radially and outwardly from the central 1-. ~,g,.~
axis or axes thereof places minimal stress on the . nnc between cells.
The straight portioDs 6, being parallel to the I 1~ ' ' axis of the stent or stent section, do not s:" ~ 'y change in c~-nfi~ ' as the stent is collapsed and expanded.
Since the sole . - between cells is along these straight 10 portions, the . is not subjected to tenDion or shear force during e~pansion and . . of the stent in a manner which would tend to stress and breal~ the . The end walls 21, which are inclined relative to the central 11 ,, ' ' axis of the stent or stent section, are the portions of the cell which provide the radial memory force during 15 ~p7 ~ and the r-, " 'Iy oriented ~ne between the cells causes the cells to distribute tbis radial memory force evenly around the stent. It is the pliability of the end walls at . ..~.CD below the '1 . 1~ C ,,,L .Cv l-l~on level whicb cause the cell straight portions 6 to . move together as tbe stent is CU.I.~ICDj7C~7 and it is these same end walls 20 wbich become relatively rigid but resiliently I- f~ to return the steDt to its tbermal mernory shape at i , above the i- -- ~ c level. As these end walls maintain the str7~ight portions 6 of the cells ~ y parallel to the l...~g~ axis of the stent iD all c~nfigr-- of tbe stent, these straight portions 7lre not ei~;, r;,s..~ly 25 biascd or stressed.
Once expanded in place within a body vessel, a stent is often subjected to forces which tend to crush the stent within Lhe vessel, and _ _ . _ _ . . .
WO 95/32757 P_I/~vv. _. . I
?~ 3~7 known stents, once crushed, are not self P~nrl;ng For example, a stent placed in the back of the leg is subjected to forces as the leg bends or is , ~ ~i in the seated position of a subject which tend to crush the stent. The stent of the present invention is self expanding if crushed due 5 to the inclined end walls 21. These end walls will fle~ to permit the straight portions 6 to move inwardly toward tne ~ t ~ l axis of the stent or stent section in response to a crushing force, but will spring outwardly to their original memory position once the crushing force is removed.
The ratio of expanded stent diameter to ~ stent diameter can be controlled within limits by selection of wire diameter. The diameter of the expanded stent generally is on the order of 6 to 10 times the diameter of the , .,~cd stent, but can be as great as 20 times that of the . , .,i~cd stent. In general, the ~greater the diameter of the wire 4, 15 tbe less the ratio of the stent collapsed/e~panded diameter. By selection of wire diameter, it is possible to vary tbe radial force which tbe expanded stent will exert on the interior walls of the ~ 6vw~.y in which the stent is set.
It is 5U 1II~ ' ~ the case tbat once tbe stent is in place and in part 20 expanded, it is l.,co6~ that tbe stent is somewhat off target (Figs. 9A
and 9B) and requires rep~;tir~ning To reposition the stent of the present invention, the operator ihlL~ into the pas~a6vw~ a cool medium M
(Figs. 9C and 9D), such as a saline solution, having a , c at or less than the transition t~ ;. When tbe cool solution ~ the 25 stent, the stent ih~ / t~vrns flexible and SUIIC~L~I~ radial force against the ~ .6~,w~ walls. In such rela~ed state, the stent, which has no free wire ends, is easily slid intû the proper position by , of wo ssl32757 the cathetGr C (Fig. 9D), ~h.,lG.I~,.. the flow of cool solution is stopped and the stent, upon returning to a body Ir...~ G, reassumes its expanded condition in the l~a~ way (Fig. 9E). The catheter C is then wilLdlawn from the stent and from the pà~ àg-,wa,~.
Thus, there is provided a stent which may be alloyed to have a selected i , a~ulc at which the stent assumes its first condition and a selected transition , G, at which the stent assumes its second condition, arld which includes a wire frame, wherein the diameter of the wire is selectable to provide a selected degree of expansion force. The 10 stent is ~ ;l,lc to less than a catheter-size diameter to facilitate delivery of the stent to a location within a body ~ ,w~ by a catheter.
The stent may be sleeved or unsleeved. The stent is self-expanding upon delivery from the catheter and I 'I ' Cm to a body i , G, to provide an internal graft or hold open a IJa~ ,wa,~. Even after such5 i ~ and ~ p~ the stent is rendered flexible and rcadily 7 ~I~lr merely by the flow of a cool medium through the stent.
And, finally, by t...~ A of the flow of cool fluid, the stent - ~Iy reassumes it~ pa~àS~,way ~ rigid condition. Any required ' , r ~rncitionin~ can be su , ' ~' in the same manner.
Although the stent of the present invention is generally tubular in r;g~Al;~m since the vessels in which the stent is normally placed are generally tubular, it must be IGCo~ ~ that different portions of these vessels may be sized .lilf~,l. ly, and therefore the stent must be sized and shaped accOIdil~gly. For example, above the renal arteries, the aorta changes size, and therefore a variable sizcd stent designcd to ~
these changes in shape is required. Referring to Figure 10, a stent 24 which is formed to fit within a vessel 26 having a variable diar~eter is , , . ... . .
W09S/3Z757 2tg~ r~ 3031 ~ ~i 7 ill ' In its e~panded condition, the diameter of the stent increases from a small diameter end 28 to a large diameter end 30. It is desirable to form a stent having a variable outer ~ n which will still apply ! ' ' ' lly equal outward radial force to the walls of the vessel 26 of 5 varying diameter. As lulcv;. u~ly indicated, a stent of this type can be formed in several different ways. First, the size of the cells 18 can be varied so that the cell size ~lùolc~;v~,ly increases from the small diameter end 28 to the large diameter end 30 as shown in Figure 10. Thus, the larger cells can be formed to expand the stent to a greater diameter than the 10 smaller cells.
In addition to varying cell size, it is possible to vary the outward radial force of expansion along the length of the stent either in C~ ir-~
with a variation in cell size or with cells of ' lly the same size.For example, referring to Figure 11, a stent 32 is illustrated in expanded 15 condition within a vessel, such as a renal artery 34. The cells 36 at the ends of the stent 32 are defined by Nitinol vire having a thickness or diameter which is much less than that of the cells 38 in the central portion of the stent. Therefore, when expanded, the cells 38, due to the heavier wire, wiU provide a greater radial force on a artery 34 then will the cells 20 36 at either end of the stent 32.
It should also be noted that the finger portions at one end of the stent are flared outwardly at 40 when the stent is expanded. This is a-lv O for a stent which, for example, is positioned within a renal artery 34, for the flared finger portions 40 will then engage the walls of the 25 aorta 42. When one end of the stent is so flared, the stent will not extend outwardly into the aorta, causing an ol,~uu-,Lu.., for this is p~L-,ul~ly d; ,.,~lv... :..o if a second stent, a catheter, or some other device is to be WO 95~32757 r~,l/L,~ q~l ~
~9~3~
, . ..
.- 16 -implanted or moved within the aorta. Secondly, the flared fingers 40 tend to draw back the wall of the aoTta as the stent expands opening both the aorta and the renal artery 34. Obviously, the end cells 36 of the stent could be formed to provide the flared portion 40 if no finger portions are 5 includcd in the stent design.
Another method for varying the radial outward force applied by the stent would be to anneal sections of the stent at different ~ 50 that the i , Ll~ru.~dlion level at which Yarious sectiorls of this stent fully expand will vary. For example, the central cells of the stent 32 10 could be annealed at a , c which would cause the central section of the stent to fully e~pand at normal body t ~ c. The end cells 36 of the stent could be annealed in such a manner that these end cells would fillly expand at h ~ slightly higber tharl normal body t~
and ~, ~y, at normal body i , c although these end cells 15 would expand, they would not expand to proYide full radial force on the vessel 34. Thus, the radial force proYided by the end cells 36 would be less than that provided by the center cells 38 at normal body i . c.
The cell e~pansion ~ Q of a stent may be altered by any of tbe methods described or by the ' of these methods. Thus, 20 cell size could be varied in . ' with either a variation in wire size or a variation in annealed , ~, or alt~ dli~.,ly, cell size could be ~ in.oA constant and a variation in wire size could be combined with the variation in annealed t~ f' ' ' C. Ideally, for most stent ~p~ tinn~
the central portion of the stent wiU provide a greater radial force on a 25 vessel than the end portions of the stent, altnough the end por~ons should expand sulrc;~ lly to anchor the stent in place as a catheter carrying the stent is removed.
~ WO 95132757 P~
~g~3~7 Referring now to Figure 12, the rl~ , polymeric sleeve 22 illustrated in Figure 6 may be formed to an extended length so that it can contain a plurality of separate stent sections, two of which are shown at 44 and 46 in Figure 12. The elongated ~' - sleeve may be cut apart S along cut lines, as indicated at 48, between the stent sections, so that a plurality of stents encased within a sleeYe as shown in Figure 6 may be obtained from the elongated unit of Figure 12. Al~llldli~,ly, a single elongated stent could be provided within the sleeve 22, and sections of the stent and sleeve could then be cut to various desired lengths.
In forming the stent of the present invention, it is important to provide a strong bond between cells along the straight portions 6. To P~- ,' ' this, the cells of the skeletal frame are first formed of thermal memory wire which has not yet been annealed to achieve its shape memory form and set the expansion shape of the device, and the straight portions
6 are joined by fusion welding, such as by laser welding, to melt together the metal of adjacent straight portions. These welds are initially quite brittle, and , l~, must be subjected to fuTther heat which provides grain growth and forms a ductal weld sufficient to bond the cells firmly together during the expansion of the stent against a vessel wall.
S ' 1 to the welding process, the stent in the expanded ~. 5, alion is annealed at a ~ which is sufficient both to set the shape of the stent which will be provided in response to thermal memory and also to render the welds ductal. After this heat treatment, the stent is quenched and is ready for use.
The l_ _ ' ' behavior of the Nitinol material used to form the stent of the present invention may be enhanced in ~ulda~, with the present invention by limiting the twenty three possible Illal L,l~it._ variants WO95132757 .~ 1/IJ...~ _I
for the material to a much smaUer number and ~l~f~ .L~lly orienting these varianis and/or the grain structure of the aUoy in a specific direction dependent on the design l~UIII of the ultimate device to be formed from the alloy. This ~ can be - - . ' ' - ' with the Nitinol in 5 either its shape memory- form or in its .,u~ l~sLc state. To orient the Illali ~ variants and/or the grain structure of Nitinol, either the wire or the stent being ' ~ is subjected to a magnetic field oriented to induce the Illcu - variants and/or grain structure to form along a path which will erlhance the mrrh ~;c~ r~ of the 10 unit. This process may be carried out at various i . ~ ;, depending on the desired effect, and is applicable to binary NiTi alloys but may be even more effective in ternary alloys such as Nitinol with iron ~NirFe).
For the stent of the present invention, the nlal i - variants and/or grain structure of the wire is oriented ~ ~ly at an angle to the l~ ~ v;~
15 axis of the wire with a preferred angle being ninety degrees. To achieve t'nis ~ . u..~, ' magnetic ~ processes and apparat~ls can be used, such as those used in Alinco ~l magnet t~ ' lcgy.
Referring to Figure 13, in 8ecoll' wit'n the method of the present invention, the thermal memory wire for the stent is wound about pins 50 20 which project from the surface of a metal heat ' g mandrel 52. It will be noted that for each cell 18, four pins ~0 are provided, with a pin being r ~ ~ at each end of a straight portion 6 for the cell where the straight portion meets the cell end wa'll 21. Thus, the pins define t'ne extent of the straight portions for each cell. When the stent includes finger 2~ portions 16, additional pins are positioned around the mandrel 52 at the e~ds of the stent to form these finger portions.
~ W0 9S132757 P~~ 31 In the formation of the mandrel 52, the mandrel is placed in a jig and tbe holes for tbe pins 50 are drilled in the mandrel in ac~l,' witb a position program in the central plu~a~6 unit 54 of a computer controlled driDing unit 56. The pins are then inserted in the mandrel, and once tbey receive the wire 4, the program in the central l)lU~a~6 unit controls a laser welder 58. Since the pins determine the extent of the straight portions 6 to be welded, the laser welder 58 may be controlled by tbe program in the central l"u.,.,~ ug unit which programs tbe location of the pins so that the welder creates a weld between the pins at the ends of the straight portions 6. It is possible to configure the jig to aDow for the laser beam to be focused through the jig on one side to tbe weld zone on the inside (luminal side) of the device. Thus fusion welds can be created on both the outer surface and the im~er surface of the device. Once all of the welds are formed, the mandrel is placed in an annealing oven which heats both the mandrel 52, the welds, and the wire 4 to set the expanded memory . ~., nn of the stent. Then the mandrel is removed and quenched, and this cooling of the mandrel and the wire 4 causes the stent to become flexible and e~pand ~urri~ y to be removed over the pins 50 of the mandrel 52.
Most stents are delivered following the insertion of a guide wire and catheter into the obstructed structure, such as an artery or other vessel.
The catheter serves to guide the insertion of the stent and p}otect the stent from being displaced as it is being pushed. Once the stent is properly pnciti~ ~, the catheter is usually pulled back over the top of the stent so that the stent can then be expanded. Normally, the distal end of the device is exposed first during the delivery procedure.
S ' 1 to the welding process, the stent in the expanded ~. 5, alion is annealed at a ~ which is sufficient both to set the shape of the stent which will be provided in response to thermal memory and also to render the welds ductal. After this heat treatment, the stent is quenched and is ready for use.
The l_ _ ' ' behavior of the Nitinol material used to form the stent of the present invention may be enhanced in ~ulda~, with the present invention by limiting the twenty three possible Illal L,l~it._ variants WO95132757 .~ 1/IJ...~ _I
for the material to a much smaUer number and ~l~f~ .L~lly orienting these varianis and/or the grain structure of the aUoy in a specific direction dependent on the design l~UIII of the ultimate device to be formed from the alloy. This ~ can be - - . ' ' - ' with the Nitinol in 5 either its shape memory- form or in its .,u~ l~sLc state. To orient the Illali ~ variants and/or the grain structure of Nitinol, either the wire or the stent being ' ~ is subjected to a magnetic field oriented to induce the Illcu - variants and/or grain structure to form along a path which will erlhance the mrrh ~;c~ r~ of the 10 unit. This process may be carried out at various i . ~ ;, depending on the desired effect, and is applicable to binary NiTi alloys but may be even more effective in ternary alloys such as Nitinol with iron ~NirFe).
For the stent of the present invention, the nlal i - variants and/or grain structure of the wire is oriented ~ ~ly at an angle to the l~ ~ v;~
15 axis of the wire with a preferred angle being ninety degrees. To achieve t'nis ~ . u..~, ' magnetic ~ processes and apparat~ls can be used, such as those used in Alinco ~l magnet t~ ' lcgy.
Referring to Figure 13, in 8ecoll' wit'n the method of the present invention, the thermal memory wire for the stent is wound about pins 50 20 which project from the surface of a metal heat ' g mandrel 52. It will be noted that for each cell 18, four pins ~0 are provided, with a pin being r ~ ~ at each end of a straight portion 6 for the cell where the straight portion meets the cell end wa'll 21. Thus, the pins define t'ne extent of the straight portions for each cell. When the stent includes finger 2~ portions 16, additional pins are positioned around the mandrel 52 at the e~ds of the stent to form these finger portions.
~ W0 9S132757 P~~ 31 In the formation of the mandrel 52, the mandrel is placed in a jig and tbe holes for tbe pins 50 are drilled in the mandrel in ac~l,' witb a position program in the central plu~a~6 unit 54 of a computer controlled driDing unit 56. The pins are then inserted in the mandrel, and once tbey receive the wire 4, the program in the central l)lU~a~6 unit controls a laser welder 58. Since the pins determine the extent of the straight portions 6 to be welded, the laser welder 58 may be controlled by tbe program in the central l"u.,.,~ ug unit which programs tbe location of the pins so that the welder creates a weld between the pins at the ends of the straight portions 6. It is possible to configure the jig to aDow for the laser beam to be focused through the jig on one side to tbe weld zone on the inside (luminal side) of the device. Thus fusion welds can be created on both the outer surface and the im~er surface of the device. Once all of the welds are formed, the mandrel is placed in an annealing oven which heats both the mandrel 52, the welds, and the wire 4 to set the expanded memory . ~., nn of the stent. Then the mandrel is removed and quenched, and this cooling of the mandrel and the wire 4 causes the stent to become flexible and e~pand ~urri~ y to be removed over the pins 50 of the mandrel 52.
Most stents are delivered following the insertion of a guide wire and catheter into the obstructed structure, such as an artery or other vessel.
The catheter serves to guide the insertion of the stent and p}otect the stent from being displaced as it is being pushed. Once the stent is properly pnciti~ ~, the catheter is usually pulled back over the top of the stent so that the stent can then be expanded. Normally, the distal end of the device is exposed first during the delivery procedure.
7 I _ 11 ~J ,.,~; 1 21~1307 3 ~
There are instances, however, where the preferred delivery of stent devices is proximal end first. This is especially true when a~ e to accurately place stents in the ostium or mouth of a tubular structure, e.g.
the renal artery at the aorta as shown in Fig. l l . If the proximal end of 5 the stent is flared outward and the proximal end of the stent can be delivered first, then it is possible to place the stent in perfect apposition tothe ostium where the proximal end of the device is anchored and the distal portion of the stent is delivered last. This eliminates the usual need to leave sorne portion of the stent device IJlUtl. " ,, into the lumen of the lO aorta.
Referring to Fig. 14, a novel two piece stent delivery unit indicated generally at 60 is shown for placing a stent within a vessel so that the proxirnal end of the stent is the first end to be expanded and anchored.
This delivery unit includes a dilator section 62 and a sheath section 64 15 which is an open ended, elongate tube that slides onto the dilator section.
The dilator section includes a central tubular body having ari enlarged portion 66 with an outer diameter that is sized to be slightly smaller tban the irmer diameter of the sheath section 64 so that tbe sheath section will slide relative to tbe central tubular body. This central tubular body also 20 includes a portion of reduced diameter 68 which extends outwardly from the enlarged por~ion to a tapered dilator tip 70. Extending l~ ~aldly from the dilator tip, spaced from and concentric with the porlion 68, is an Outer tube 72 which terminates in spaced r~loti-- ', to the enlarged portion 66.
The outer tube has an outer diameter which is ' -'1y equal to the 25 outer diameter of the erllarged portion 66 and is adapted to slidably receivethe sheath section 64. The outer tube defines an annular space 74 between the outer tube and the portion 68 of the central tubular body. A central .. . _ _ _ _ , ,, . , ,,, ,,,, ,, . ,, , , ,,, . . , _, . . .
~ WO95/32757 P~.11LV~V,. I
~gi3a7 1~ ;1".l-- 1 passage 76 which is open at both ends extends cullll~h,t~,ly through the dilator section 62.
In the operation of the stent delivery unit 60 as shown by Figs. 15A-15E, a stent, such the flanged stent 32 of Fig. 11 (shown in broken lines) 5 is inserted into the space 74 between the outer tube 72 and the reduced poriion 68 with the distal end of the stent ~ ~ ' adjaceDt to the dilator tip 70. The proximal end of the stent with the flanged portion 40 is positioned outside the space 74 between the outer tube 72 and the enlarged poriion 66 of the central tubular body. The sheath section 64 is then 10 moved into place over the enlarged portion 66 aDd the outer tube 72 to enclose the proximal end of the stent æ shown in Fig. 15A. With the stent so enclosed, a guidance wire 78 may be inserted through the central l" C ~ passage 76 to aid in g~uding the stent delivery unit into place in a vessel, such as the renal artery 34.
With the stent 32 properly located, the sheath section 64 is drawn back away from the outer tube 72 as shown in Fig. 15B to expose the proximal end of the stent. This proximal end, when subjected to normal body ~~ , now expands into contact with the vessel to anchor the stent in place. When a flared stent 32 is used for the trcatment of ostial 20 type lesions, the stent would be located at the ostium and held in place by contact between the flared portion 40 and a parent structure, such as the wall of the aoria 42.
Once the proximal end of the stent is anchored in place, the dilator section 62 is moved within the sheath section 64 into the vessel 34, as 25 shown in Figs. l5C and 15D, until the entire stent is exposed and the distal end is released from the space 74. The entire stcnt is now subjected to body i , c and is designed to expand against the vessel 34 to reach W0 95132757 r~
2~9I~
an inner diameter which is greater than the outer diameter of the stent delivery unit 60. Now, with the stent 32 expanded within the vessel 34, the stent delivery unit is WilL~ through the expanded stent as shown in Fig. 15E.
S It is to be, 1 d that the present invention is by no means limited to the par~cular constructio~s herein disclosed and/or shown in the orawings, but also comprises any ",o~ ;.."~ or c.luiv ' within the scope of the claims. For e~ample, while the use of the stent has been illustrated in with the vascular system, it will be apparent to 10 those skilled in the art that the stent herein shown and described finds equal utility in other bodily ~ _g~,,,~.
There are instances, however, where the preferred delivery of stent devices is proximal end first. This is especially true when a~ e to accurately place stents in the ostium or mouth of a tubular structure, e.g.
the renal artery at the aorta as shown in Fig. l l . If the proximal end of 5 the stent is flared outward and the proximal end of the stent can be delivered first, then it is possible to place the stent in perfect apposition tothe ostium where the proximal end of the device is anchored and the distal portion of the stent is delivered last. This eliminates the usual need to leave sorne portion of the stent device IJlUtl. " ,, into the lumen of the lO aorta.
Referring to Fig. 14, a novel two piece stent delivery unit indicated generally at 60 is shown for placing a stent within a vessel so that the proxirnal end of the stent is the first end to be expanded and anchored.
This delivery unit includes a dilator section 62 and a sheath section 64 15 which is an open ended, elongate tube that slides onto the dilator section.
The dilator section includes a central tubular body having ari enlarged portion 66 with an outer diameter that is sized to be slightly smaller tban the irmer diameter of the sheath section 64 so that tbe sheath section will slide relative to tbe central tubular body. This central tubular body also 20 includes a portion of reduced diameter 68 which extends outwardly from the enlarged por~ion to a tapered dilator tip 70. Extending l~ ~aldly from the dilator tip, spaced from and concentric with the porlion 68, is an Outer tube 72 which terminates in spaced r~loti-- ', to the enlarged portion 66.
The outer tube has an outer diameter which is ' -'1y equal to the 25 outer diameter of the erllarged portion 66 and is adapted to slidably receivethe sheath section 64. The outer tube defines an annular space 74 between the outer tube and the portion 68 of the central tubular body. A central .. . _ _ _ _ , ,, . , ,,, ,,,, ,, . ,, , , ,,, . . , _, . . .
~ WO95/32757 P~.11LV~V,. I
~gi3a7 1~ ;1".l-- 1 passage 76 which is open at both ends extends cullll~h,t~,ly through the dilator section 62.
In the operation of the stent delivery unit 60 as shown by Figs. 15A-15E, a stent, such the flanged stent 32 of Fig. 11 (shown in broken lines) 5 is inserted into the space 74 between the outer tube 72 and the reduced poriion 68 with the distal end of the stent ~ ~ ' adjaceDt to the dilator tip 70. The proximal end of the stent with the flanged portion 40 is positioned outside the space 74 between the outer tube 72 and the enlarged poriion 66 of the central tubular body. The sheath section 64 is then 10 moved into place over the enlarged portion 66 aDd the outer tube 72 to enclose the proximal end of the stent æ shown in Fig. 15A. With the stent so enclosed, a guidance wire 78 may be inserted through the central l" C ~ passage 76 to aid in g~uding the stent delivery unit into place in a vessel, such as the renal artery 34.
With the stent 32 properly located, the sheath section 64 is drawn back away from the outer tube 72 as shown in Fig. 15B to expose the proximal end of the stent. This proximal end, when subjected to normal body ~~ , now expands into contact with the vessel to anchor the stent in place. When a flared stent 32 is used for the trcatment of ostial 20 type lesions, the stent would be located at the ostium and held in place by contact between the flared portion 40 and a parent structure, such as the wall of the aoria 42.
Once the proximal end of the stent is anchored in place, the dilator section 62 is moved within the sheath section 64 into the vessel 34, as 25 shown in Figs. l5C and 15D, until the entire stent is exposed and the distal end is released from the space 74. The entire stcnt is now subjected to body i , c and is designed to expand against the vessel 34 to reach W0 95132757 r~
2~9I~
an inner diameter which is greater than the outer diameter of the stent delivery unit 60. Now, with the stent 32 expanded within the vessel 34, the stent delivery unit is WilL~ through the expanded stent as shown in Fig. 15E.
S It is to be, 1 d that the present invention is by no means limited to the par~cular constructio~s herein disclosed and/or shown in the orawings, but also comprises any ",o~ ;.."~ or c.luiv ' within the scope of the claims. For e~ample, while the use of the stent has been illustrated in with the vascular system, it will be apparent to 10 those skilled in the art that the stent herein shown and described finds equal utility in other bodily ~ _g~,,,~.
Claims (28)
1. A stent comprising an elongate body member having a longitudinal axis with a skeletal frame formed to define an elongate chamber which extends through said body member, the body member being formed of thermal shape memory material which has been annealed at a temperature sufficient to set a memory shape for said body member and impart to said shape memory material a temperature transformation level above which said skeletal frame assumes a first expanded configuration relative to said longitudinal axis and below which said skeletal frame will be collapsible toward said longitudinal axis to a second collapsed configuration, said thermal shape memory material being formed to define a plurality of interconnected open cells forming the skeletal frame of said body member with each of said cells including two substantially parallel, spaced straight side portions which are substantially parallel to said longitudinal axis in both the first expanded configuration and the second collapsed configuration of said skeletal frame and end wall means extending between said side portions at an angle to said longitudinal axis, said cells being joined together only along said straight side portions by fusion welds formed prior to the annealing of said shape memory material, said end wall means operating to maintain said cell straight side portions substantially parallel to said longitudinal axis in both said first expanded configuration and second collapsed configuration of said skeletal frame.
2. The stent of claim 1 wherein said cells are formed of at least one elongate strand of shape memory material and joined together only along the lengths of said straight side portions.
3. The stent of claim 1 wherein said shape memory material has a temperature transformation level above which said skeletal frame assumes a first expanded configuration relative to said longitudinal axis and below which said cell end wall means permit movement of said straight portions toward said longitudinal axis to collapse said skeletal frame to a second collapsed configuration, said cells being interconnected only at said straight side portions with no connection between the end wall means thereof.
4. The stent of claim 3 wherein said cell end wall means operate at a temperature above said temperature transformation level when said skeletal frame is in the second collapsed configuration to expand the skeletal frame to the first expanded configuration.
5. The stent of claim 4 wherein said end wall means operate to cause the space between the straight side portions of said cells to decrease in order to collapse said skeletal frame to the second collapsed configuration.
6. The stent of claim 5 wherein said end wall means operate to maintain said cell straight side portions 5 substantially parallel to said longitudinal axis as said cell moves between said first expanded configuration of said skeletal frame and said second collapsed configuration.
7. The stent of claim 5 wherein said cell end wall means are relatively pliable when said skeletal frame is subjected to temperatures below said temperature transformation level and are resiliently deformable but relatively rigid when said skeletal frame is subjected to temperatures above said temperature transformation level.
8. The stent of claim 5 wherein said cells are polygonal in shape.
9. The stent of claim 8 wherein said cells are hexagonal in shape.
10. The stent of claim 5 wherein said fusion welds extend substantially along the entire length of each of said straight side portions.
11. The stent of claim 5 wherein said cell end wall means each include first and second wall sections, each said wall section having a first end joined to one of the side portions of said cell and extending at an angle to the side portion to which the first end thereof is joined, and each said wall section having a second end opposite to said first end, the second ends of said first and second wall sections being joined.
12. The stent of claim 5 wherein said skeletal frame includes cells of different sizes.
13. The stent of claim 5 wherein the side portions and end wall means of some cells in said skeletal frame are formed to have a greater cross-sectional area than the side portions and end wall means of other cells in said skeletal frame.
14. The stent of claim 5 wherein the thermal shape memory material forming the side portions and end wall means of some cells in said skeletal frame has a temperature transformation level which differs from the temperature transformation level of the thermal shape memory material forming the side portions and end wall means of other cells in said skeletal frame.
15. The stent of claim 4 wherein said body member includes opposed open ends, said elongate chamber extending between said open ends, the skeletal frame adjacent to at least one of said open ends being formed to provide laterally extending means annularly of said open end in said first expanded configuration.
16. A stent for insertion in a body vessel comprising an elongate body means having a longitudinal axis, a first end, a second end, and an elongate chamber extending through said body means between said first and second ends, the body means being formed of thermal shape memory material which is relatively pliable at temperatures below a transition temperature to permit said body means to be collapsed toward said longitudinal axis to a collapsed configuration for insertion in said body vessel, said thermal shape memory material operating to expand said body means radially outward from said collapsed configuration toward an expanded memory configuration in response to said transition temperature to contact and apply force to said body vessel, said body means operating at said transition temperature to apply less force to said body vessel in the area of at least one of said first and second ends than the force applied by the remainder of said body means to said body vessel at the transition temperature.
17. A method for forming a stent of thermal shape memory material which becomes pliable to permit the stent to be collapsed at temperatures below a temperature transformation level and which expands the collapsed stent to a preset memory shape at temperatures above the temperature transformation level which includes the steps of forming a plurality of open cells from thermal shape memory material, fusion welding the thermal shape memory material to form a stent body member with an elongate chamber extending therethrough, and subsequently annealing said body member at a temperature sufficient to set the memory shape of said stent while rendering ductile the fusion welds.
18. The method of claim 17 which includes placing at least one elongate strand of thermal shape memory material on a heat conductive mandrel to form said plurality of open cells, joining said open cells on said heat conductive mandrel by fusion welding to form said stent body member, and subsequently annealing said stent body member on said heat conductive mandrel.
19. The method of claim 18 which includes forming a plurality of adjacent open cells which extend completely around said mandrel, each such cell being formed with two spaced, substantially parallel side walls arranged to extend substantially parallel to the longitudinal axis of said mandrel and joining said cells by fusion welding only along the sidewalls of adjacent cells.
20. The method of claim 17 which includes annealing first and second sections of said body members at different temperatures.
21. A delivery unit for a self expanding stent having a distal end section and a proximal end section comprising:
a dilator section including a stent mount for receiving and mounting a stent, and a stent enclosure means spaced from said stent mount for enclosing all but the proximal end section of said stent when said stent is mounted on said stent mount, and a sheath means slideably received on said dilator section and movable relative thereto, said sheath means being adapted to slide relative to said dilator section to selectively enclose or expose said stent proximal end section when said stent is mounted on said stent mount.
a dilator section including a stent mount for receiving and mounting a stent, and a stent enclosure means spaced from said stent mount for enclosing all but the proximal end section of said stent when said stent is mounted on said stent mount, and a sheath means slideably received on said dilator section and movable relative thereto, said sheath means being adapted to slide relative to said dilator section to selectively enclose or expose said stent proximal end section when said stent is mounted on said stent mount.
22. The delivery unit of claim 21 wherein said dilator section includes an enlarged end section spaced longitudinally from said stent enclosure means said enlarged end section having a cross sectional area greater than that of said stent mount, said sheath means operating to slide on said enlarged section and enclosure means to enclose said stent proximal end section.
23. The delivery unit of claim 22 wherein said enlarged end section and enclosure means each have a cylindrical outer surface, the cylindrical outer surface of said enlarged end section being aligned longitudinally with the cylindrical outer surface of said enclosure means and having a diameter substantially equal to the diameter of said enclosure means.
24. The delivery unit of claim 23 wherein said dilator section includes a central passage extending longitudinally therethrough.
25. A method for forming a stent from an elongate strand of a metallic thermal shape memory material having a longitudinal axis, said material including martensite variants and/or a metallic grain structure, said method including the steps of magnetically orienting said martensite variants and/or grain structure at an angle to the longitudinal axis of said elongate strand.
26. The method of claim 25 which includes orienting said martensite variants and/or grain structure at an angle of ninety degrees to said longitudinal axis.
27. The method of claim 25 wherein said metallic thermal shape memory material is Nitinol.
28. A stent comprising an elongate body member having a first section, a second section, a longitudinal axis and an elongate chamber which extends through said body member, the body member being formed of thermal shape memory material having a temperature transformation level above which said body member assumes an expanded configuration relative to said longitudinal axis and below which said body member may be collapsed to a collapsed configuration, the shape memory material in said first section of said body member having a temperature transformation level which differs from the temperature transformation level of the shape memory material in said second section of said body member.
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US08/252,198 US5540712A (en) | 1992-05-01 | 1994-06-01 | Stent and method and apparatus for forming and delivering the same |
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-
1994
- 1994-06-01 US US08/252,198 patent/US5540712A/en not_active Expired - Fee Related
-
1995
- 1995-04-21 CA CA002191307A patent/CA2191307A1/en not_active Abandoned
- 1995-04-21 EP EP95915454A patent/EP0788390A4/en not_active Withdrawn
- 1995-04-21 JP JP8500828A patent/JPH10504200A/en not_active Ceased
- 1995-04-21 WO PCT/US1995/003931 patent/WO1995032757A1/en not_active Application Discontinuation
-
1996
- 1996-05-17 US US08/649,289 patent/US5746765A/en not_active Expired - Fee Related
-
1997
- 1997-08-19 US US08/912,842 patent/US5902317A/en not_active Expired - Fee Related
Also Published As
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---|---|
US5902317A (en) | 1999-05-11 |
JPH10504200A (en) | 1998-04-28 |
EP0788390A1 (en) | 1997-08-13 |
US5746765A (en) | 1998-05-05 |
EP0788390A4 (en) | 1998-09-16 |
US5540712A (en) | 1996-07-30 |
WO1995032757A1 (en) | 1995-12-07 |
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Legal Events
Date | Code | Title | Description |
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EEER | Examination request | ||
FZDE | Discontinued |