Page 1 of 212
`
`Edwards Lifesciences v. Boston Scientific Scimed
`U.S. Patent No. 6,915,560
`IPR2017-00072 EX. 2010
`
`

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`BSC-EDW0012021
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`Page 5 of 212
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`PATENT APPLICATION SERIAL NO.
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`U.S. DEPARTMENT OF COMMERCE
`PATENT AND TRADEMARK OFFICE
`FEE RECORD SHEET
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`W
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`10/05/1999 WIVES
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`00000029 09401210
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`:‘s'Iz1ii Labczi Nu: 122€}6£}2US
`ljmimai No. S£33.2w7~105
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`Express Mail Label No.: EI_451220602US
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`Respectfully submitted,
`
`VIDAS, ARRETT & STEINKRAUS
`
`Date: September 22, 1999
`
`By:
`
`/ M
`
`Jon
`
`an Grad
`
`Registration No. 41,795
`
`6109 Blue Circle Drive, Suite 2000
`Minnetonka, MN 55343-9131
`Telephone:
`(612)563-3000
`Facsimile:
`(612) 563-3001
`l’:\WPWORK\.lG‘.740S-'l'RA.92l
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`BSC-EDW0012026
`
`Page 10 of 212
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`[jI[f."(:12c'zws?::z2’,3: //‘:e:r¢2wiri’<z_,}
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`A METHOD FOR CQNTRACHNG, LOADING OR
`CRRVWING SELF-EX.P.AN.¥§}}‘NCi AND ,BA1J.,(){3N
`ELI’{P‘AN[)A,J3 S’YF,NT DEVICES
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`Rcspestfully stxbmiited,
`V1DA$. .«‘\§{i'3'.F,£‘1”T’ & STEINKRAUS
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`By:
`
`3/7:
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`.Ic»22z1’Ehzm Grad
`Registratian NL>,41,‘E’9S
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`WW
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`
`Sep%:m1%3c:r?.2,E99E?
`
`M89 Biue Circle Drive, Suite 2030
`Minneicml-:a§ sV[?\‘ 55343-9E3!
`'I‘eiephm1e: {6} 2) 563-3900
`Fac~",‘:ra1iie:: (512) 553--3081
`
`BSC-EDW0012027
`
`Page 11 of 212
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`DOCKET NO. S63 . 2-7405
`
`IN THE UNITED STATES PAT\ENT AND TRADEMARK OFFICE
`APPLICATION FOR UNITED\SC[‘ATES LETTERS PATENT
`
`INVENTOR(S):
`
`Michael Austin
`
`TITLE:
`
`ATTORNEYS:
`
`A METHOD FOR CONTRACTING, LOADING OR
`CRIMPING
`SELF—EXPAND1NG
`AND
`BALLOON
`EXPANDABLE STENT DEVICES
`
`Jonathan Grad
`VIDAS, ARRETT & STEINKRAUS
`Suite 2000
`6109 Blue Circle Drive
`Minnctonka, MN 55343-9131
`Phone: (612) 563-3000
`Facsimile: (612) 563-3001
`
`BSC-EDW0012028
`
`Page 12 of 212
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`Page 12 of 212
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`-1-
`
`A METHOD FOR CONTRACTING,
`EXPANDING AND BALLOON
`
`ADING OR CRIMPING SELF-
`PANDABLE STENT DEVICES
`
`BACKGROUND OF THE INVENTION
`
`5
`
`This invention relates to an apparatus and a method for reducing in size a
`
`medical device such as a stent, stent-graft, graft, or vena eava filter. The apparatus may
`
`be used in particular for fastening a medical device onto a catheter.
`
`Medical devices such as stents, stent-grafts, grafts, or vena cava filters
`
`and catheters for their delivery are utilized in a number of medical procedures and
`
`10
`
`situations, and as such their structure and function are well known.
`
`A stent, for example, is a generally cylindrical prosthesis introduced via a
`
`catheter into a lumen of a body vessel ina configuration having a generally reduced
`diameter and then expanded to the diaxnetiegof the vessel. In its expanded configuration,
`the stent supports and reinforces the vessel walls while maintaining the vessel in an
`open, unobstructed condition.
`
`15
`
`Stents are typically inflation expandable or self-expanding. Self
`
`expanding stents which are constrained by a sheath or other restraining means, must be
`
`provided in a reduced diameter.
`
`V
`
`An example ofa stent described in PCT Application No. 960 3092 Al,
`
`20
`
`published 8 Februaiy 1996.
`
`In advancing a stent through a body vessel to the deployment site, the
`
`stent must be able to securely maintain its axial position on the delivery catheter,
`
`without translocating proximally or distally, and especially without becoming separated
`
`from the catheter. Stents that are not properly secured or retained to the catheter may
`
`25
`
`slip and either be lost or be deployed in the wrong location. The stem must be crimped
`
`in such a way as to minimize or prevent altogether distortion of the stent and to thereby
`
`prevent abrasion and/or reduce trauma of the vessel walls.
`
`In the past, this crimping or size reduction has been done by hand often
`
`resulting in the application of undesired uneven forces to the stent. Such a stent must
`
`30
`
`either be discarded or re-crimped. Stents which have been crimped or otherwise
`
`reduced in size multiple times can suffer from fatigue and may be scored or otherwise
`
`marked which can cause thrombosis. A poorly crimped stent can also damage the
`
`underlying balloon.
`
`
`
`
`
`/54;;
`
`ELHSLEEDEDEUS
`
`BSC-EDW0012029
`
`Page 13 of 212
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`Page 13 of 212
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`

`

`-2-
`
`Recently, stent crimping devices have been disclosed in US 5,546,646 to
`
`Williams et al, US 5,183,085 to Timmermans et al._. US 5,626,604 to Cottone, Jr., US
`
`5,725,519, US 5,810,873 to Morales, W0 97/20593 and W0 98/19633.
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`A cam actuated stent crimper, shown in Figure 1, employs a plurality of
`
`arc-shaped or curved slots with semi-circular ends, disposed such that each slot or cam
`
`engages a cam follower bearing 22. The arc-shaped or curved surfaces of the slots are
`inclined to be non-concentric relative to the axis of rotation 26, and therefore rotation of
`
`the cam plate 28 transmits equal radial displacements to the cam follower bearings 22,
`
`to simultaneously actuate a like number of linear bearings 24, which have their
`
`corresponding linear tracks or rails mounted on a fixed plate. As shown in Fig.1 the
`
`cam plate rotary drive 29 comprises a pneumatic cylinder mounted on a pivot or
`trunnion. arranged with the cylinder rod\connected rotatably to a short arm fixed rigidly
`to the cam plate. Accordingly, linear motioitproduced by the pneumatic cylinder
`translates into controllable arcs of motion of the circular cam plate, which has a
`
`projecting V»shaped profile on its outer edge in rolling engagement with three equally
`
`spaced rollers with mating inverse V-shaped profiles to provide precise rotatable
`
`support to the cam plate. Depending on the direction of rotation, the linear slides which
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`each carry a radially disposed crimping blade, are either moved inwards to apply a
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`crimping force to the stem, or outwards to release the stent. Also when crimping,
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`depending on the degree of rotation ofthe cam plate, a specific radial crimping
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`displacement may be obtained to match the diametral reduction required for any
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`particular stent.
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`All US patents and applications and all other published documents
`
`mentioned anywhere in this application are incorporated herein by reference in their
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`entirety.
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`BRIEF SUMMARY OF THE INVENTION
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`It would be desirable to produce a device capable of crimping a stent
`
`uniformly while minimizing the distortion of and scoring and marking of the stent due
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`30
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`to the crimping. The present invention is directed to that end.
`
`The present invention is particularly concerned with the crimping and
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`otherwise reducing in size of inflation expandable stents, self—expanding stents and
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`other expandable medical devices. For the purpose of this disclosure, it is understood
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`that the term ‘stent‘ includes stems, stent-grafts, grafts and vena cava filters.
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`It is also
`
`understood that the term ‘crimping’ refers to a reduction in size or profile of a stent.
`
`In the description that follows it is understood that the invention
`
`contemplates crimping a medical device either directly to a catheter tube or to a catheter
`
`balloon which is disposed about a catheter tube. When reference is made to crimping a
`
`medical device to a catheter, a balloon may be situated between the medical device and
`
`the catheter tube or the medical device may be crimped to a region of a catheter tube
`
`directly. The invention also contemplates crimping a stent in the absence of a catheter
`to reduce the stent in size.
`
`The present invention is directed, in one embodiment, to an apparatus for
`
`reducing a medical device in size. Desirably, the medical device is a stent, a stent—graft,
`a graft or a vena cava filter, whether self‘-eitpandable, balloon expandable or otherwise
`expandable, although the inventive apparatus may also be employed with any other
`suitable, generally tubular medical device which must be reduced in size.
`
`The inventive apparatus comprises at least three coupled movable blades
`
`disposed about a reference circle to form an aperture whose size may be varied. Each
`
`blade is in communication with an actuation device which is capable of moving the
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`blade to alter the size ofthe aperture. Each bladeincludes a single radial point on the
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`surface of the blade which a) lies on the circumference of the reference circle prior to
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`movement of the blade, and b) may be moved only along a radius of the reference circle
`on movement of the blade.
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`The apparatus further includes an actuation device which comprises a
`
`cam and a plurality of linear slide devices. Each linear slide device is in communication
`
`with a blade. Each of the linear slide devices is also in mechanical communication with
`
`the cam. Rotation of the cam results in linear translation of the slide device and blade,
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`such that the slide device moves along an axis parallel to the radius on which the radial
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`point of the blade lies or along the radius itself.
`
`The invention is also directed to an apparatus similar to that described
`
`above, with blades disposed about a reference tube to form a tubular aperture whose size
`
`may be varied. Each blade is in communication with an actuation device which is
`
`capable of moving the blade to alter the size of the tubular aperture. Each blade
`
`includes a single line which a) lies on the surface of the reference tube prior to
`x
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`I
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`movement of the blade, and b) may be moved only along a radial plane of the reference
`tube on movement of the blade.
`
`The inventive apparatus finds particular utility in crimping a medical
`
`device such as those mentioned above to a catheter or to a balloon disposed about a
`catheter.
`
`The inventive apparatus also finds utility in reducing the diameter of a
`
`medical device such as those mentioned above prior to crimping.
`
`The invention is also directed to a method of manipulating a medical
`
`device which comprises the steps of providing the medical device and providing at least
`
`three blades capable of applying a radial inward force. The blades are disposed about a
`reference circle to form a shrinkable aperture. A medical device such as a stent is
`placed into the shrinkable aperture andifhe blades simultaneously moved inward to
`apply a radial inward force to the medical device. The blades are constructed and
`
`arranged such that each blade has a single point which a) lies on the circumference of
`
`the reference circle prior to movement of the blade, and b) is moved along a radius of
`the reference circle on movement of the blade.
`
`The inventive apparatus may also be used as a variable size balloon
`
`mold. To that end, the invention is further directed to a method of molding a medical
`
`balloon.
`
`In the practice of the method, a balloon preform prepared through any suitable
`
`technique known in the art is provided. The preform is placed in an apparatus which
`
`has a shrinkable tubular aperture formed by at least three movable blades disposed about
`
`a reference tube. The blades are constructed and arranged such that each blade has a
`
`single line which a) lies on the surface of the reference tube prior to movement of the
`
`blade, and b) is moved along a radial plane of the reference tube on movement of the
`
`blade. The aperture may be set to a predetermined size prior to placement of the
`
`preform therein or after placement of the preform therein. An inflation fluid is supplied
`
`to the balloon preform to expand the balloon preform until it contacts the blades. The
`
`preform may optionally be heated prior to, during or after the blowing step. The thus
`
`formed balloon is then pressure relieved and removed from the apparatus.
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`BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)
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`Figure 1 shows a perspective view of a stent crimper;
`/'
`. X’/I
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`Figtirc 2.1 is 21 sc:}1u:mat§c frctn View afar: embcsdimzznt Qffixe Sim.-‘.nE§\.=c
`
`appa1'»:§i1:5:
`
`Wm;
`§9ig:..:m 4.
`.> .5 9:1 schematic :f:'r<:m View Qftha eztibmditneni of Pig. 2:: 23116:-
`111:: mm: hag been. rzsducmzd in size;
`
`5
`
`Figures
`
`2:31:21 3%: are s~:.}'1en1aims af blades:
`
`E-‘figure 3:; is a partial. schemmirc. fmnz View of an vsmbodimzsni csfthe:
`
`inmmtiw: appsemtus erxupiaayizag the curved ‘n}.aCic:2s afflgure 38;
`
`Ifigum 4.2: is 22 partiai fiom View {fan embodimcnt sf aha: §.zm:r1tiw2
`
`apparatus:
`
`10
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`"Figure 4%:
`
`:2 partiafi fr<:.\m View of an embodiment cf the 111*».-'c:r;i'ive
`
`eappzmmzsz
`
`Eirzcs 4-C~4L’~;
`
`Ifigtarc 4:: shcsws a side wzisw cf the embc2<iin1entafF‘igur<: rib tiaiazezw am
`L
`
`RE
`
`ifigme 5a skews a partiai ii"on*; viaw of‘azm1:h;2r embtzdixneni Qfthe
`
`1S
`
`im-=e::1m-a: apgraaratusg
`
`.§?ign.m: 51> shm-vs. a iink. cannecteci is) a biadcg
`
`1'-’§;gure 6 ix 3 scmmmic! pe.:2‘spec:ive View of an atmbmciimem (‘if Linc:
`
`inwzniivc apparattsza;
`
`Ifigurrs 7 skews 2: partial View an" the ::m§3<3d.im«3m mi’ Figurs: 6;
`
`30
`
`Figures
`
`and 8b are panéal side eievationai views :'>.f‘an azmbcsciimem
`
`the i1wc:m§,vr:: apparatus; takten aiming a ‘radial piane aiming the size: wsiuciima pr€>ce:'s:::
`Figure 8:: is a partial $ide eiszvaticmxi view of an ernbaciimmit of me
`
`§i'W€:i1'Li‘»«’€§
`aathcier;
`
`ap1:«amms ta?-ecu almg a radiai pfanc: fibllowing crfimgzrmg of :2 stem. to a
`
`25
`
`Figure: 9 ‘E3 22 cfiagzazmzaatis; side e.!m'z:tioz1al View nfan embmiinwm 0?"
`
`in\=€::'11'iv<: apparatazs;
`
`i'*’3gm'e ED is a paniai sicie izlevatimxai view of an cxnfimdimezzi ofthe
`
`irxvezytive appamtus taken zzimlg 2: radiai pizme sf an embodiment cafthe invzmtiam
`
`c<3r2:s:ism"x1;;5g <)1'iI1m:2 indiviéual a§pparaiu.ses: arrzmgexzi seqtzclfiiaiiy;
`
`30
`
`Figure IE is a schematic: ghawing a stem being reciuced in sfize arid
`Eazuied mm :1 slzcathg
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`0%‘
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`the
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`Figure 12 is a partial side elevational view of an embodiment of the
`
`inventive apparatus taken along a radial plane showing a balloon that has been molded
`with the inventive device; and
`
`Figure 13 is a partial side elevational view taken along a radial plane
`
`showing a stepped balloon that has been molded with the inventive device.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`While this invention may be embodied in many different forms, there are
`
`described in detail herein specific preferred embodiments of the invention. This
`
`description is an exemplification of the principles of the invention and is not intended to
`
`limit the invention to the particular embodiments illustrated.
`As shown generally at 100\:ln Figures 2a and 2b, the inventive apparatus
`comprises eight coupled blades 106 disposed‘about a reference circle 114 to form an
`aperture 1 18 whose size may be varied. The apparatus may comprise as few as three
`
`blades and as many as sixteen or more blades. Desirably, the apparatus will have four or
`
`more blades and more desirably, eight or more blades. The maximum number of blades
`
`is limited only by how many blades can physically be coupled together under the
`relevant size constraints. As the number of blades is increased, the profile of the
`
`aperture and hence of the medical device following reduction in size, becomes
`
`smoother. Figure 2b shows the apparatus of Figure 2a after the stent has been reduced
`in size.
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`Blades 106 as shown in Figure 3a have an inner end 108 which is
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`desirably beveled 11 1 so as to mesh with adjacent blades and an outer end 110 which is
`
`displaced from aperture 118. Aperture 118 is polygonal. Blades 106 may also be shaped
`with a curved end 1 12, as shown in Figures 3b and 3c so as to form a substantially
`
`25
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`circular shaped aperture, when the aperture is fully closed.
`
`Each blade 106 includes a single radial point 122 which lies on a radial
`
`line 126 of reference circle 114 prior to movement of blade 106 and which may be
`
`moved only along the radius 126 of reference circle 114 on movement of blade 106.
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`30
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`Desirably, the single radial point 122 will be disposed at the tip of the blade adjacent to
`beveled end 1 1 1.
`
`1n the embodiment shown in Figure 4a, radial point 122 lies at the tip of
`
`blade 106. Each blade 106 has a connecting link 130 extending from second end 1 10.
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`
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`Connecting link 130 ends in mounting means 134, typically a mounting flange adapted
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`for attachment to a linear bearing block, for interfacing with an actuation device, shown
`
`generally at 138. Actuation device 138 is capable ofsimultaneously moving blades 106
`to alter the size of aperture 118.
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`Actuation device 138 includes actuation plate 142 which is coaxial with
`
`reference circle 1 14.. Actuation plate 142 has eight equi-spaced radial slots 146. More
`
`generally, for every blade there will be a corresponding radial slot on actuation plate
`
`142. Each radial slot 146 overlaps a mounting means 134 for a linear bearing block at
`
`the end ofa connecting link 130. Each blade 106 is engaged to actuation plate 142 via a
`
`cam follower bearing 150 disposed in radial slot 146 and attached to mounting means in
`slotted end 134.
`
`Each bearing 150 extendsfrom a linear slide 154. Linear slide 154 is
`mounted on a non—rotating plate 156 (showiiin Figure 8). Linear slide 154 is
`
`constructed and arranged to slide along a line 158 which is parallel to the radius 126 on
`
`which radial point 122 of blade 106 lies.
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`For the purposes of this disclosure, the term ‘cam follower bearing’
`
`includes cam follower bearings, low friction rollers, roller bearings, needle roller
`
`bearings and a slipper block pivot mounted on abearing and stub shalt. Figure 4b is a
`
`partial front view of an embodiment in which a slipper block is used. A side view of the
`
`embodiment of Figure 4b taken along lines 4c-4c is shown in Figure 4c. Slipper block
`
`150 resides in slot 146 of actuation plate 142. Slipper block 150 is mounted on stub
`
`shaft 151 which extends from connecting link 130. Desirably, bearings 153 will be
`
`present between shaft 151 and slipper block 150. Connecting link 130, in turn, is
`
`fastened to linear bearing block 212 via fasteners 214. Bearing block 212 is linearly
`
`mounted on linear slide which is mounted on fixed plate 156. Linear motion is
`
`facilitated by the presence of bearings 216.
`
`Cam follower bearing 150 may be replaced by any other suitable
`
`connecting member which can connect the slide and the link.
`
`In use, as actuation plate 142 is rotated in a clockwise direction, the
`
`clockwise motion of the actuation plate is translated into linear motion of each of linear
`
`slide 154 and blade 106 via bearing 150. Each blade 106 moves outward in a direction
`
`parallel tothe radius 126 on which the radial point 122 of the blade 106 lies, resulting in
`
`the opening of aperture 118. As actuation plate 142 is rotated in a counterclockwise
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`direction, each blade 106 moves inward in a direction parallel to the radius 126 on
`
`which the radial point 122 of the blade 106 lies, resulting in the closing of aperture 1 18.
`
`As aperture 118 closes, a radially inward force is applied to a medical device disposed
`
`in the aperture. The actuation plate is rotated until the desired size reduction of the
`
`aperture and medical device has been achieved. Following the reduction, the actuation
`
`plate is rotated in the opposite direction to allow for removal of the medical device from
`
`the aperture.
`
`The apparatus may be used to reduce the diameter of a suitable medical
`
`device such as those disclosed above or may be used to crimp a medical device to a
`catheter,
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`10
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`Another embodiment of the invention is shown in Figure 521. Each blade
`
`106, as shown in Figure 5a, has a conne‘et\ing link 130 extending therefrom. Connecting
`link 130 is rigidly attached to blade 106. C\onnecting link 130 ends in an angled end 134
`for interfacing with an actuation device, shown generally at 138. Actuation device 138
`
`is capable of simultaneously moving blades 106 to alter the size of aperture 118.
`
`tuation device 138 includes a rotatable actuation plate 142 which is
`
`
`
`' l with refere
`ich are not concentri wtih the axis of rotation, arcing inward. Each connecting link
`
`e circle 114. Rotatable actuation plate includes cam slots 146
`
`130 is engaged to actuation
`
`ate 146 via a cam follower bearing 150 disposed in slot
`
`146 and attached to both angle
`
`nd 134 of connecting link 130 and to a linear slide
`
`154. Linear slide 154 is mounted o a non-rotating plate similar to that shown in Figure
`8. Linear slide 154 is constructed and
`
`radial point 122 of blade 106 lies.
`
`Connecting link 130 may be bonded adhesively, welded, joined with a
`
`fastener or otherwise joined to blade 106. As shown in Figure 5a, a single screw 131 is
`
`used to connect link 130 to blade 106. Figure 5b shows a connecting link 130 including
`
`a right angle portion which is fastened to a blade 106 using two screws 131. Connecting
`
`link 130 and blade 106 may optionally be formed ofa single piece of material.
`
`Regardless of how the connecting member is joined to the blade, no movement of the
`
`blade relative to the connecting link is permitted.
`
`1n use, as actuation plate 142 is rotated in a clockwise direction, the
`
`clockwise motion of the actuation plate is translated into a linear outward motion of
`
`each of linear slides 154 and blades 106 via bearings 150 resulting in the opening of
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`/5
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`ix?
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`ezpemms E E
`
`"flue ::»utwarc§ mmicm rcaults ffmxn that racgiially outwarri arcing sf cam 5201‘
`
`145. As aciuaiim pfauz 142 is rntatazi it) 21 munterciociswise dtiriiittififi, each Eaéagie 136,
`
`because cx§‘t§*.e radizxiiy inward
`
`of cam séats M6, moves inward in a direction paraéicl
`
`‘:0 ma: radius; 126 cm which the radial point 222 cafthe blade :06 Iiaas, reszzfitmg in this
`
`5
`
`clusing ofapertaw 118) A5 niiscuszed abcwcz,
`
`the apemzre is decrssasexé in sizes, :2
`
`racéial imavani farce is bnaught to bear against :1 meciixzai den/ice disposed in the apcrmm
`fl‘zGt‘i'3b}‘ reciucing flu: size ofthe meatiical dcvica.
`
`The embodiment of Figure 5:: differs mm 3116 ccmbzadiment 0? Figure:
`
`in that in 1116 e121b0dim:mtm£’F§gure 53, zhes1ir.:¥:: nmws along the radial am: am whieh
`
`ii}
`
`the razdial pain: cf thaz attacheé blade lies w§:<—:r<:as in Figure 42:: the shale meves garailctfi
`
`to {he radéafi line:
`
`In both afthe: em.bodima°:nts;, each of the inlades is cm1szra§ned‘w§:h
`
`two degrees cf i7re::cf:cam tic» satisfy the céngiiion that {he mmzemem of the tip be mdia.l in
`accor:ia.nc:e wiih2hainv{::1tim1.
`
`
`
`In the embudimzznts at” Efigures; 4a and 53‘ the slots in the actuaticrn plate
`
`15
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`are: c(mst1"u<:1::d and arranged to aiicsw far a sufficiezzt radustinn. in size 0?‘ the. aperture 59
`
`ma‘: a zmeciicai dervicaa can be raéticed in sizzc: to a dcgired diam-ate; These sf Qrdizxary
`
`in that am; wili recognize v;3th:3.r zsuiiablsz acmaziori de