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`Page 5 of 212
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`Page 5 of 212
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`

`

`PATENT APPLICATION SERIAL NO.
`
`US. DEPARTMENT OF COMMERCE
`PATENT AND TRADEMARK OFFICE
`FEB RECORD SHEET
`
`37
`/
`
`10/05/1999 “WES
`
`00000029 09401218
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`01 FCIWI
`02 H3103
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`“0.00 N
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`PTO-1556
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`(5/87)
`'l! S GPO" 1995—433-214/50404
`
`BSC-EDW0012022
`
`Page 6 of 212
`
`Page 6 of 212
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`

`

`
`
`Mai} Labei Nu: 122(36Q2US
`Dmkai No, 3&323405
`NEW UTILITY PATENT A?PLICATION
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`Transmitteé herewith for filing under 35$ 1.3.3.0 1] Ma} and 37 CFR, 153%) is a new 2,1151in patent
`appficaticn far am imamion entitlefi: A METHOD FER CON?RAC'WNG, LOADING {3R CRIMPENG
`SELEEXFANDMG AN}? BADMOON EXPANDABLE SYSNI'
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`and Wanted by:
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`1 pages
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` FEE CALCULATIUN AMI} C L A I M 3
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`BSC-EDW0012023
`
`Page 7 of 212
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`Page 7 of 212
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`

`
`
`
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`‘
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`
`Express Mail Label No: EL451220602US
`
`NEW UTILITY PATENT APPLICATION
`TRANSMITTAL
`
`
` Docket No. S63 .2~7405
`
`
`
`
`(Large Entity)
`
`Total Pages in this Submission
`(Only for new nonprnvisional application: under 37 C. F.R. 1.53(b))
`(including checks and postcard)
`
`
`
`5 3
`
`
`2. The Commissioner is hereby authorized to charge and credit Deposit Account No. 22—0350 as
`described below. A duplicate copy of this sheet is enclosed.
`a. D Charge the amount of $___ as filing fee.
`
`
`b. E Credit any overpayment.
`
`
`c.
`Charge any additional filing fees required under 37 C.F.R. 1.16 and 1.17.
`d. D Charge the issue fee set in 37
`1.18 at the mailing of the Notice of Allowance,
`pursuant to 37 C.F.R. 1.311(b).
`.\
`
`L
`
`3.
`
`a:
`
`Specification having QQ pages and including the lbllowing:
`a. E Application Cover Sheet - 1 page
`b. E Descriptive Title ofthe Invention ~
`
`20 pages
`
`
`
`c. D Cross References to Related Applications (ifapplicable)
`d. D Statement Regarding Federally—sponsored Research/Development (ifapplicable)
`e. D Reference to Microfiche Appendix (ifapplicable)
`f.
`E Background of the Invention
`g. E Brief Summary of the Invention
`h. E Brief Description of the Drawings (ifapplicable)
`i.
`E Detailed Description
`j.
`E Claim(s) as Classified Below — 4 pages
`k. E Abstract of the Disclosure —1 page
`
`4. E Drawing(s) (when necessary as prescribed by 35 US. C. 113) 18 sheets
`
`18 pages
`
`5. E Oath or Declaration ~
`D Unexecuted
`a. E Newly executed (original or copy)
`b. D Copy from a prior application (37 CPR. l.63(d)) Her continuation/divisional application
`only)
`
`3 pages
`
`6. E Separate Power of Attorney
`
`1 pages
`
`D
`
`37 CPR. 3.73(B) Statement (when there is an assignee andpower ofatrorney is from
`assignee). It is hereby certified that the undersigned has authority to make this certification
`and has reviewed all the documents in the chain of title ofthe patent application identified
`herein and, to the best of undersigned's knowledge and belief, title is in the assignee
`identified in the accompanying Power ofAttorney.
`
`BSC-EDW0012024
`
`Page 8 of 212
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`Page 8 of 212
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`

`

`NEW UTILITY PATENT APPLICATION
`TRANSMITTAL
`
`
`
`Docket No. S63 .2-7405
`
`
`
`
`(Large Entity)
`
`Total Pages in this Submission
`
`(Only for new nonprovisional applications under 37 C.F.R. 1.53 (b))
`(including checks and postcard)
`
`
`53
`
`
`Exress Mail Label No.: ELA51220602US
`
`
`
`
`
`
`
`
`Cl Power of Attorney filed in parent application.
`
`Incorporation by Reference (usable ifBox 517 is checked)
`The entire disclosure ofthe prior application, from which a copy ofthe oath or declaration is
`supplied under Box 5b, is considered as being part of the disclosure ofthe accompanying
`application and is hereby incorporated by reference therein.
`\.
`
`Computer Program in Microfiche (Appendix)
`
`Nucleotide and/or Amino Acid Sequence Submission
`(ifapplicablel all must be included)
`:1 Paper Copy
`
`
`El Computer Readable Copy (identical to compuler copy)
`Statement Verifying Identical Paper and Computer Readable Copy
`
`Accompanying Application Parts
`
`Assignment Papers:
`81 Assignment Recordation Cover Sheet (Form PTO 1595)
`El Assignment
`
`
`
`8 A check in the amount of $49.00 to cover the Recordal Fee
`Previously recorded on
`, Reel *, Frame *
`
`English Translation Document (ifapplicable)
`
`
`Information Disclosure Statement:
`
`
`13 PTO Form 1449
`b.
`Copies of IDS Citations
`
`Preliminary Amendment
`
`Acknowledgement Postcard
`
`_ pages
`
`_ Pages
`
`3 pages
`
`_ pages
`
`_ pages
`
`5 pages
`
`1 page
`
`Form of Mailing - Express Mail (Specify Label N01): EL451220§02US
`
`Certified Copy of Priority Document(s) (ifforeign priority is claimed)
`
`,7 d7 pages
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`BSC-EDW0012025
`
`Page 9 of 212
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`Page 9 of 212
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`

`

`
`
`Express Mail Label No.: EL451220602US
`
`
`Docket No. S63 ,2—7405
`NEW UTILITY PATENT APPLICATION
`
`
`TRANSMITTAL
`
`
`
`Total Pages in this Submission
`
`
`(including checks and parlwru')
`53
`
`
`(Large Entity)
`(Only for new nonprovisional applications under 37 C. ER. 1.530)»
`
`2 pages
`17. E Additional Enclosures (please identijj) below):
`E Constructive Petition for Extension of Time and Fee Authorization Pursuant to 37 CPR.
`
`§l.l36(a)(3) - 1 page
`8 Limited Authorization to Act of Behalf of Assignee Regarding Certain Patent Matters
`Effective Through: December 31, 1999 — 1 page
`\
`
`\\
`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
`r:\WPwoRK‘JGW405-‘I‘RA92i
`
`
`
`BSC-EDW0012026
`
`Page 10 of 212
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`Page 10 of 212
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`

`

`
`
`Applaeaénmz ML:
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`[ICtuzczwesazf/y herewith
`
`A METHOD FOR CGNTRACTENG, LOADING OR
`CREMWNG SELF«EXI’AMLHNG ANDBALLOON
`EXPANDAB S?ENT DEVICES
`
`Filed:
`
`Far:
`
`
`
`Backet Non: $63,3~’f€3(}5
`
`(ICNSTRUCTI'VE PETITION FOR EXTENSZUN OF TIME AND FEE
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`
`Applicant hereby requests that the {mixed 8mm Paiem waif 'I‘mdemark Office {mat
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`required extensiofl oftime
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`that haw: amt otharwjae men paid to Diagram Acwum Me, 22433:).
`
`Respestfully submiited,
`VlDAS. ARRE‘IVT‘ 3: STBINKRAUS
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`8);:
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`: fl:
`
`Jazzmhau Grad
`Registratian N0,41,?95
`
`mate:
`
`gepmmbcr22, 2‘99?
`
`{SEW {31an Circle Drive, Suite 2030
`MinnemnkaS MN 55343-9E31
`'I‘eifiphmm: {6f 2) 563—3fl00
`Faca‘maiie: (512} 563-3081
`
`BSC-EDW0012027
`
`Page 11 of 212
`
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`Page 11 of 212
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`

`

`DOCKET NO‘ S63 . 2—7405
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`APPLICATION FOR UNITED\SC[‘ATES LETTERS PATENT
`
`INVENTOR(S):
`
`Michael Austin
`
`TITLE:
`
`ATTORNEYS:
`
`A METHOD FOR CONTRACTING, LOADING OR
`CRIMPING
`SELF—EXPANDING
`AND
`BALLOON
`EXPANDABLE STENT DEVICES
`
`Jonathan Grad
`VIDAS, ARRETT & STEINKRAUS
`Suite 2000
`6109 Blue Circle Drive
`Minnetonka, MN 55343-9131
`Phone: (612) 563—3000
`Facsimile: (612) 563—3001
`
`BSC-EDW0012028
`
`Page 12 of 212
`
`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 cava 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 in a configuration having a generally reduced
`diameter and then expanded to the diameterpf 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.
`
`An example ofa stent described in PCT Application No. 960 3092 Al,
`
`20
`
`published 8 February 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 stent 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-c-rimped. 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.
`
`75»;
`
`ELHSLEEDEDEUS
`
`BSC-EDW0012029
`
`Page 13 of 212
`
`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 ah. US 5,626,604 to Cottone, Jr., US
`
`5,725,519, US 5,810,873 to Morales, WO 97/20593 and WO 98/19633.
`
`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
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`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
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`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 motiditzproduced 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 stent, or outwards to release the stent. Also when crimping,
`
`depending on the degree of rotation ofthe cam plate, a specific radial crimping
`
`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
`
`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
`
`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 stents, 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.
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`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
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`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
`
`blade to alter the size ofthe aperture. Each blade'includes a single radial point on the
`
`surface of the blade which a) lies on the circumference of the reference circle prior to
`
`movement of the blade, and b) may be moved only along a radius of the reference circle
`on movement of the blade.
`
`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,
`
`such that the slide device moves along an axis parallel to the radius on which the radial
`
`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
`r
`l
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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 andilhe 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.
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`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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`3O
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`BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)
`
`Figure 1 shows a perspective view of a stent crimper;
`/. iaz
`/'
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`Figure 2a is a schematic from View Man embadimgm Qi’ihe hummiw
`
`apparams:
`
`Figure 2b is a schemaiic fmm View Qi‘iha embmdimfim m” Fig, 22: MR:-
`111:: mm have been mdumd in six;
`
`5
`
`Figures
`
`and 3h are sahemaims 8f blades:
`
`Figure 3:: i3 a partial. sashemmic {mm View Of an embodizmm oi‘the
`
`inventive appm'mus empiaying the curved blacks 0fF£gure 38;
`
`Figure 4;: is 22 partied fiem View {fan embodimth {3f aha: inventive
`
`apparatug:
`
`10
`
`Figure 4b
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`a partiafi mum View of an embodiment 0f the invenfive
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`appexmms:
`
`firms 4046;
`
`Figure 4c shmws a side flaw 9f the embadiment cf Figu‘m rib taken 310
`L
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`2m
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`Figure 5a skews a paniai {hm viaw of‘azmther embadimam Q'fthr:
`
`13
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`imsemi's-c apgamtus;
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`Fig.2)? 5b ShUWS a fink. semester} :9 21 Made;
`
`Figure 6 £5; a SC-hfimmim pm‘spmtive S‘iBW of an smbadimem (if [Em
`
`invcmivc app'gmm;
`
`Figure 7 shaws a partial View an" the amhydimcm m" Figum 6;
`
`30
`
`Figures
`
`and 8b are partial side ciamtionai views afar) ambeéimem
`
`the invmtive apparatus takan aiming a radial piam: during the size: {educ‘iinn processs:
`Figure 8:: is: a partial Side eiévat‘immi View of an, embmiiment at" me
`
`inventive apparatus Kai-ecu almg a radiai pfanc: finllowing crimping at" a stem. 30 a
`mthcier;
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`25
`
`Figure 9 {3 a éiagmmmafic side aicvational View nf’an cmbndimem a?"
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`invemive apparatazs;
`
`Figure £0 is; a pammi sick: film‘afimzzi View of an embadimeni ofthe
`
`inventive apparatus taken aimg a mafia; plaza 01“ an ambodimem fifths invmtim
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`cansigting Qi'ihme indiviéua] appayaiuses arrmgexzi sequcmiafiy;
`
`3C!
`
`Figure: H is a schematic skewing a stem being reduced in sfiza arid
`Emde mm a Sheath;
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`01‘
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`{ha
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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 1003;} 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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`10
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`Blades 106 as shown in Figure 3a have an inner end 108 which is
`
`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
`
`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.
`
`3O
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`Desirably. the single radial point 122 will be disposed at the tip of the blade adjacent to
`beveled end 1 11.
`
`1n the embodiment shovm 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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`Connecting link 130 ends in mounting means 134, typically a mounting flange adapted
`
`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.
`
`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 extends‘from 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.
`
`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 tum, 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.
`
`10
`
`Another embodiment of the invention is shown in Figure 521. Each blade
`
`106, as shown in Figure 5a, has a connecting 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
`
`
`
`'
`'1 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
`
`
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`20
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`
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`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.
`
`in 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
`[i,.
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`apemlm l l
`
`The autwazé mmlcm maulls l‘mm the radially outwarri arcing 53f cam 5201‘
`
`145‘ As actualler plan: M2 is mii‘fifid it) a uzmmerclockwlse dimmer}, each Mafia 1%,
`
`because Offlit‘, radially inward
`
`of cam slats. liléi, moves inward in a dirmtion parallel
`
`w Illa radius; 126 cm which the radial palm £22 gfthe Made {06 Hess, resultlng in {Em
`
`5 musing Ufapeflm’e US) As fiisgusmd abcwcz,
`
`the apemma is dscmaseul in sizes, a
`
`racéial inwanl {mes Es brwght {D bear against a medlml device disposed in the aperture?
`thereby reducing {lug size affine meeziical clcvlca.
`
`The embvdimem of Figure 5a differs fmm lhe embudlm‘em cal" Figure
`
`in that in 1116 embodiment ml’Flgure 53, aha filial»: mews along the radial Elm: cm whleh
`
`10
`
`the razfilal pain: at“ tlm attachetl blade lies whereas in Figure 421 the slick: mm‘ex garallcl
`
`to file radial ling In both Ui‘the: smbodlmems, each (if the inlades is mnslraimd with
`
`two degrees of frag:de m satisfy the cS‘ngliiiQn that {he mavemem of the tip be radial in
`accortlance wiih {ha invamian.
`
`
`
`In the embudimzzms (:xf Figures; Ila and 5a the slats in the: actuaticm plate
`
`15
`
`are: constructed and arranged in allaw far a sufficiem reductinn in size 0? lhc: apartm'e 59
`
`ma? :1 medical device can be reéticed in $122610 a {haired diam-ate;
`
`'3?th 9f ardizlary
`
`Ekili in this art will recognize mm zsuiiablsz acmmlm devlcsfi that may be: 136:6 in film
`practice Qi‘llflls imcntian
`
`Dasirablfi in the aim“: czmiimdlmgms, the blades will he as 2011;; as m“
`
`