PATENT f'-fUf' eei
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`8371 962
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`637196?
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`U.S. UTILITY PATENT APPLICATION
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`PREPARED AND APPROVED FOR ISSUE
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`ORIGINAL
`CLASS I SUnCLASS
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`INTERNATIONAL CLASSI FICATION
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`ISSTII NG CLASSI FICATION
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`Xl b) The term ot this patent shall
`not extend bevond the expiration date
`of U.S Patent. No.b,'lC-l6414
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`n c) The terminal
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`-months
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`Ll Continued on lssue Slip lnside File Jacket
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`DRAWINGS
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`Sheets Drwg.
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`CLAIMS ALLOWED
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`Print Fig.
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`TotalClaims
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`67
`
`Print Claim for O.G.
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`I
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`NOTICE OF ALI.OWANCE MAILED
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`(Assistant Examiner)
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`WARNING:
`The information disclosed herein may be restricted. Unauthorized disclosure may be prohibited by the United States Code Title 35, Sections 122, 181 and 368.
`Possession outside the U.S. Patent & Trademark Office is restricted to authorized employees and contractors only.
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 1
`
`

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`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 2
`
`

`

`filel / / c: / APP S/preexam/corr
`
`| flilril ililt lilll ilil| ilil| il||l ilil tilil ilil tilt |ilil ililil ilfiil
`Bib Data Sheet
`
`UNITED STATES DNPARTMENT OF COMMERC'
`Patent and Trademark Office
`Address: COMMSSIONER OF PATENTS AND TRADEMARKS
`Wmhingtorr D.C. 20231
`
`Louis g. ELLIS, ST. ANTHONY, MN ;
`ANDREWJ. DUSBABEK, DAYTON, MN ;
`CHRISTOPHER r. LARSON, ST. PAUL, MN ;
`TERRYV. BROWN, FRIDLEY, MN ;
`
`.
`
`coNTINUING DATA *************************
`. THIS APPLICATION tS A CON OF 08n02.150 08/2311996 PAT 6,007,543
`SiirffirPLrcAroNS
`Afe re
`REQUIR.ED, FOREIGN FILING LICENSE GRANTED --
`1 1/09/1999
`Priority claimed I y". $ no
`no E M","ft.,
`qsc 119 (a-d) conditions fl y""
`
`STATE OR
`COUNTRY
`MN
`
`SHEETS
`DRAWING
`4
`
`ATTORNEY
`DOCKET NO.
`s6.2-8619
`
`DEPENDT
`CLAIMf
`
`TOTAL
`
`CLAIMS4t
`
`f Arrett
`ARRETT & STEINKRAUS
`Second Avenue South
`uite 1.540\
`rinneapolid;MN 55402-401 4
`
`FILING FEE
`RECEIVED
`1142
`
`EES: Authori$ has been given in Paper
`to charge/credit DEPOQIT ACCOUNT
`
`H
`
`; ; :.::::.rn rn ::j.r::.::l:L):t;;:;.t.
`
`tl All Fees
`lJ 1.16 Fees ( Filing )
`Q I n Fees ( Processing Ext.
`Ilm" )
`f,l r.t 8 Fees ( lssue )
`u Other
`
`1of1
`
`3/r
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 3
`
`

`

`Page I of I
`
`Ulilrgp SrATns PATTNT AI'ID'TIrADEI'IARK OFFlcn
`
`----.------ --- ---
`
`UN|TED STATES PATENT rNoTnroEvrnr Orrlce
`WASHTNGrcN. O.C.2C23l
`wwwusdogov
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`iltilIl tilr illlr lllll llll llliil ||il rillll llil lill llil lffil illlil
`Bib Data Sheet
`
`SERIAL NUMBER
`09t420.249
`
`FILING DATE
`1 011 9/1 999
`
`RULE
`
`CLASS
`604
`
`GROUP ART UNIT
`3734
`
`ATTORNEY
`DOCKET NO.
`s6.2-8619
`
`IPPLICANTS
`Louis g. ELLIS, ST. ANTHONY, MN ;
`ANDREWJ, DUSBABEK, DAYTON, MN;
`CHRISTOPHER r. LARSON, ST. PAUL, MN ;
`TERRY V. BROWN, FRIDLEY, MN ;
`
`* coNTINUING DATA ************************r
`THIS APPLICATION lS A CON OF 08/702,150 0812311996 PAT 6,007,543
`
`- FOREIGN APPLICATIONS
`
`F REQUIRED, FOREIGN FILING LICENSE
`IRANTED .. 11/09/1999
`'eign Priority claimed E y". f,l no
`Usc 119 (a-d) conditions E u", fl no fl r", uo",
`t
`
`rified and
`knowledoed
`ADDRESS
`
`Allowance
`Examiner's Siqnature
`
`Initials
`
`STATE OR
`COUNTRY
`... MN
`
`SHEETS
`DRAWING
`4
`
`TOTAL
`CLAIMS
`34
`
`NDEPENDEN'I
`CLAIMS
`3
`
`Cliver f Arrett
`/IDAS ARRETT & STEINKRAUS
`i109 Blue Circle Drive
`Suite 2000
`N/linneaoolis .MN 55343-91 31
`
`rITLE
`
`STENT DELIVERY SYSTEM
`
`FILING FEE
`RECEIVED
`1142
`
`EES: Authority has been given in Paper
`\o.
`to charge/credit DEPOSIT ACCOUNT
`for following:
`No.
`
`u All Fees
`rJ 1.16 Feeq (!!!gl_
`E t.t7 Fees ( Processing Ext. of
`time )
`U t.t8 Fees
`E otner
`f,l Credit
`
`( lssuq )
`
`file ://C :\APP S\PreExam\correspondence\ I
`
`xml
`
`-A.
`
`912100
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 4
`
`

`

`Mail Label
`EM40581335US
`NEW UTILITY PATEIYT APPLICATION
`TRANSMITTAL
`(Large Entity)
`(Only for new nonprovisional applications under 37 C.F.R. 1.53(b))
`
`Docket No. 563.2-8619
`
`Total Pages in this Submission
`(including checks and postcard)
`
`ts
`\O
`
`*-=r
`
`-o
`
`si
`
`lar
`
`lor(,
`T'r
`
`Box Patent Application
`Assistant Commissioner for Patents
`Washington, D.C. 20231
`
`Transmittedherevfithforfilingunder35u.s.c. 111(a) and37 c.F.R. 1.53(b)isanewutilitypatent
`application for an invention entitled: Sfent Delivery System
`and invented by:
`
`Louis G. Ellis; Andrew J. Dusbabek; Christopher R. Larson; Terry V. Brown
`If a CONTINUATION APPLICATION, check appropriate box and suppty the requisite information;
`tr Continuation c Divisional tr Continuation-in-part (CIP) of piior application No.:
`08/702,1,50, filed August 23,1996
`
`Enclosed (in addition to the 4 pages of this transmittal) are:
`
`4 pages
`
`Applicafion Elements
`r. a Fi[ng fee as carculated berow:
`a. x filing fee is NOT ENCLOSED - i.. will be paid at the time of responding to the Notice
`of Missing Parts -- Do Nor CHARGE DEposrr AccouNT
`EI a check in the amount of $
`to cover the filing fee is enclosed. _ pages
`n charge to Deposit Account as authorized at Item 2(a) on next page.
`
`b.
`c.
`
`:t*
`
`r*'
`
`FNE CALCULATION AND C L A I I\{ S
`No. Filed
`
`For
`
`Total Claims
`
`Indep. Claims
`
`No. Allowed
`-20:
`- 3-
`
`34
`
`3
`
`&
`
`Fee
`
`$ 252.00
`
`$0
`
`No. Extra
`
`I4
`
`0
`
`Rate
`x $ 18.00
`x $78.00
`BASIC FEE
`
`$760.00
`TOTAL f,'ILING FEE $1,012.00
`continued on next page......
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 5
`
`

`

`ii rrrl
`ni
`
`t:i:
`
`Mail
`Label No. : EM40581335US
`NEW UTILITY PATENT APPLICATION
`TRANSMITTAL
`(Large Bntity)
`(Only for new nonprovisional applications under 37 C.F.R. 1.53(b))
`
`Docket No. 563,2-8619
`
`Total Pages in this Submission
`(including checks and postcard)
`?r\
`tA)
`
`11 pages
`
`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.
`tr Charge the amount of $_ as filing fee.
`^.
`b. B Credit any overpayment.
`c. tr Charge any additional filing fees required under 37 C.F.R. 1.16 and 1.17.
`d. tr Charge the issue fee set in 37 C.F.R. 1.18 at the mailing of the Notice of Allowance,
`pursuant to 37 C.F.R. 1.311(b).
`Specification having 11 pages and including the following:
`a Application Cover Sheet - 1 page
`E Descriptive Title of the Invention -
`F Cross References to Related Applications (if applicable)
`tr Statement Regarding Federally-sponsored Research/Development (if applicable)
`tr Reference to Microfiche Appendix (if applicable)
`B Background of the Invention
`a Brief Summary of the Invention
`a Brief Description of the Drawings (if applicable)
`E Detailed Description
`E Claim(s) as Classified Below - 3 pages
`E Abstract of the Disclosure -1 page
`
`3.a
`
`a.
`b.
`c.
`d.
`e.
`f.
`o|:'
`h.
`i.
`j.
`k.
`
`4.4
`
`5.4
`a.
`b.
`
`6.8
`
`Drawing(s) (when necessary as prescribed by 35 U.S.C. I 13) 4 sheets
`
`4 pages
`
`3 pages
`Oath or Declaration -
`tr Newly executed (original or copy) tr Unexecuted
`tr Copy from a prior application (37 C.F.R. 1.63(d) (or continuation/divisional application
`only)
`
`Separate Power of Attomey
`
`1 page
`
`37 C.F.R. 3.73(B) Statement (when there is an assignee and power of attorney 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 of the patent application identified
`herein and, to the best of undersigned's knowledge and belief, title is in the assignee
`identified in the.accompanying Power of Attorney.
`
`2
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 6
`
`

`

`ELr40581335US
`NEW UTILITY PATENT APPLICATION
`TRANSMITTAL
`(Large Entity)
`(Only for new nonprovisional applicatiow under 37 C.F.R. 1,53(b))
`
`Docket No. 563.2-8619
`
`Total Pages in this Submission
`
`a Power of Attorney filed in parent application.
`7. tr Incorporation by Reference (usable if Box 5b is checked)
`The entire disclosure of the prior application, from which a copy of the oath or declaration is
`supplied under Box 5b, is considered as being part of the disclosure of the accompanying
`application and is hereby incorporated by reference therein.
`E Computer Program in Microfiche (Appendix)
`tr Nucleotide and/or Amino Acid Sequence Submission
`(if applicable, all must be included)
`a. tr Paper Copy
`b. A Computer Readable Copy (identical to computer copy)
`c. n Statement Veriffing Identical Paper and Computer Readable Copy
`
`8.
`
`9.
`
`_ pages
`_ pages
`
`Accompanying Application Parts
`
`10.
`
`11.
`
`12.
`
`a Assignment Papers:
`a. tr Assignment Recordation Cover Sheet (Form PTO 1595)
`b. n Assignment
`c. tr A check in the amount of $_ to cover the Recordal Fee
`d. E Previously recorded on November 14,1996, Reel 8281, Frame 0720
`tr English Translation Document (f applicable)
`tr Information Disclosure Statement:
`a. E PTO Form 1449 b. tr Copies of IDS Citations
`13. x Preliminary Amendment
`14. x Acknowledgement Postcard
`15. x Form of Mailing - Express Mail (Specify Label No): EL440581335US
`16. n Certified Copy of Priority Document(s) (ifforeignpriority is claimed)
`
`3
`
`_ pages
`_ pages
`
`5 pages
`
`I page
`
`_ pages
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 7
`
`

`

`Etl40581335US
`NEW UTILITY PATENT APPLICATION
`TRANSN,IITTAL
`(Large Entity)
`(Only for new nonprovisional applications under 37 C.F.R. 1.53(b))
`
`Docket No. 563.2-8619
`
`Total Pages in this Submission
`
`17. x Additional Enclosures (please identifu below):
`1 page
`tr Constructive Petition for Extension of Time and Fee Authorization Pursuant to 37 C.F.R.
`$1.136(a)(3) - 1 page
`
`n
`
`Respectfully submitted,
`
`VIDAS, ARRETT & STEINKRAUS
`
`!'i i:
`
`Date: October 19,1,999
`
`By:
`
`William E. Anderson.
`Registration No. 37,7 66
`
`6109 Blue Circle Drive, Suite 2000
`Minnetonka, MN 55343-9131
`Telephone: (612) 563-3000
`Facsimile: (612) 563-3001
`F :\WPWORK\WEA\86 I 9-TRA.A I 9
`
`4
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 8
`
`

`

`DOCKET NO.563.2_8619
`
`rI\T rrrfrli! rrr.Yrrnnn
`IN TIIE UNITED STATES PATENT AND TRADEMARK OFFICE
`APPLICATION FOR TINITED STATES LETTERS PATENT
`
`I
`
`INVENTORS:
`
`\
`
`Loiris G. Ellis; Andrew J. Dusbabek; Christopher R. Larson;
`Terry V. Brown
`
`TITLE:
`STENT DELIVERY SYSTEM
`ATTORNEyS: William E. Anderson, II, Esq.
`VIDAS, ARRETT &.,STEINKRAUS
`Suite 2000
`109 Blue Circle Drive
`Minnetonka, Minneso ta 55343
`Tetephone: (612) 563_3000
`Facsimile: (612) 563-3001
`
`r 6
`
`ELqq[501335US
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 9
`
`

`

`-1-
`
`STENT DELTVERY SYSTEM
`
`(
`
`Backeround of the Invention
`Tr6'M fi-
`In typical PT.A procedures, a guiding catheter is percutaneousry
`5 introduced into the cardiovascular system oi a patient through a vessel and advanced
`through therein until the distal end thereof is at a desired location in the vasculature.
`A guidewire and a dilatation catheter having a balloon on the distal end thereof are
`introduced through the guiding catheter with the guidewire sliding through the
`dilatation catheter. The guidewire is first advanced out of the guiding catheter into
`10 the patient's coronary vasculature and the dilatation catheter is advanced over the
`previously advanced guidewire until the dilatation balloon is properly positioned
`ac.ross the lesion. Once in position across the lesion, the flexible, expandable,
`preformed balloon is inflated to a predetermined size with a liquid or gas at
`relatively high pressures, such as greater than about four atmospheres, to radially
`15, compress the arthrosclerotic plaque of the lesion against the inside of the artery wall
`and thereby dilate the lumen of the artery. The balloon is then deflated to a small
`profile so that the dilatation catheter may be withdrawn from the patients vasculature
`and blood flow resumed through the dilated artery.
`In angioplasty procedures of the kind described above, there may be
`20 restenosis of the artery, which either necessitates another angioplasty procedure, a
`surgical by-pass operation, or some method of repairing or strengthening the area.
`To prevent restenosis and strengthen the area, a physician can implant an
`intravascular prosthesis for maintaining vascular patency, called a stent, inside the
`artery at the lesion. The stent is expanded to a larger diameter for placement in the
`25 vasculature, often by the balloon portion of the catheter. Stents delivered to a
`restricted coronary artery, expanded to a larger diameter as by a balloon catheter,
`and left in place in the artery at the site of a dilated lesion are shown in U.S. patent
`4,740,207 to Kreamer; U.S. Patent 5,007,g26to Derbyshire; U.S. patent 4,733,665
`to Palmaz; U.S. Patent 5,026,377 to Burton et al.; U.S. patent 5,15g,54g to Lau et
`30 al.; u.s. patent 5,242,399 to Lau et al.; u.s. 5,344 ,426 to Lau et al.; u.s. patenr
`5,415,664 to pinbhuk; u.s. patent 5,453,090 to Martinez et al.; u.s. patent
`4,95a,227 to savin; u.s. patents,4o3,34l to solar; u.S. patent 5,10g,416 to Ryan
`et al. and European Patent Application No. 707 837 A1 to Sheiban, all of which are
`"l-
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 10
`
`

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`incorporated herein by reference. A stent particularly preferred for use with this
`invention is described in PCT Application No. 960 3092 A1, published 8 February
`L996, the content of which is also incorporated herein by reference.
`The present invention is particularly directed to improved
`5 alrangements for releasably attaching the stent to the catheter to facilitate delivery
`thereof.
`
`Summary of the Invention
`
`This invention concerns apparatus suitable for delivery of stents to
`10 body cavities. In general, stents are prosthetic devices which can be positioned
`within a body cavity, for example, a blood vessel of the body of a living human or
`in some other difficultly accessible place. The stent prosthesis is formed of a
`generally tubular body, the diameter of which can be decreased or increased. Stents
`are particularly useful for permanently widening a vessel which is either in a
`15' narrowed state, or internally supporting a vessel damaged by an aneurysm. Such
`stents are typically introduced into the body cavity by use of a catheter. The
`catheter is usually of the balloon catheter type in which the balloon is utilized to
`expand the stent, which is positioned over the balloon, to place it in a selected
`location in the body cavity. The present invention is particularly directed to
`20 improved alrangements for releasably attaching the stent to the catheter to facilitate
`delivery thereof. The stent is held in place on the catheter by means of an enlarged
`body canied by the catheter shaft within the balloon to which the stent and balloon
`are fitted, as by crimping.
`
`25 Brief Description of the Figures
`Figure 1 is an isometric view, a portion of which is enlarged and in
`longitudinal section, of a balloon catheter having a stent fixed to the catheter by
`being crimped thereto over the balloon;
`
`Figure 2 is an even more enlarged view in longitudinal cross-section
`30 of the distal end portion of the catheter of Figure 1;
`.
`Figure 3 is an enlarged cross-sectional view of the distal end portion
`of the catheter of Figure 1 similar to that of enlarged view Figure 2 but showing the
`balloon in an expanded condition along with the expanded stent;
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 11
`
`

`

`-3-
`
`Figure 4 is a schematic showing of a preferred mounting body carried
`by the catheter shaft within the balloon, the body being spirally cut to improve
`flexibility;
`
`Figure 5 is a schematic showing in cross-section of another
`embodiment of the invention with a stent not yet mounted;
`Figure 6 is a schematic showing of another embodiment of the
`
`invention;
`
`Figure 7 is a schematic showing of a means for conveniently crimping
`the stent on the embodiment shown in Figure 5, and
`Figure 8 is a schematic showing of yet another embodiment of the
`
`invention.
`
`Referring to Figures 1-3 a stent delivery system generally indicated at
`10 includes a balloon catheter 12 having a balloon 14 on a distal end portion
`generally indicated at 16. Figure 1 shows a proximal portion of the catheter at l2a
`and a distal portion 12b in enlarged view. Figure 2 shows the distal end portion 16
`in an even more enlarged view. The illustrative cathe ter 72 is of the type known as
`a rapid exchange or single operator catheter. However, other types of catheters may
`be used, such as over the wire and fixed wire types. The balloon 14 is fixed to the
`catheter 12 by standard means. The balloon is shown in its contracted state in
`Figures I and2. A stent 18 is fixed about the balloon by crimping it thereto. The
`stent has a larger expanded diameter which is obtained when the balloon is expanded
`in the known manner. That is, the stent is released from the catheter upon
`expansion of the balloon as shown in Figure 3 to be placed in a vessel. When the
`balloon is then deflated, removal of the balloon and catheter may be accomplished
`while leaving the stent in place.
`As ip known in the art the balloon is eitlleg bonded at its ends by
`F
`l,{
`adhesive 20 and,E, respectively to the outer member4 of the catheter and to the
`' E --- --J
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`inner member 26 of the catheter in the manner as shown, or is made one-piece with
`.the outer member as is known in the art. The catheter balloon may be inflated by
`fluid (gas or liquid) from an inflation port extending from a lumen 28 contained in
`the catheter shaft and opening into the balloon as shown, or by other known
`
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`30
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 12
`
`

`

`-4-
`
`arrangements, depending on the design of the catheter. The details and mechanics
`of balloon inflation and specific overall catheter construction will vary according to
`the particular design involved in any given instance, and are known in the art per se.
`All variations are acceptable for use with this invention.
`Any balloon expandable stent may be used with this invention. Many
`are known in the art including plastic and metal stents. Some are more well known
`such as the stainless steel stent shown in U.S. Patent 4,735,665; the wire stent
`shown in u.S. Patent 4,950,227; another metal stent shown in European patent
`Application EPO 707 837 A1 and that shown in U.S. Patenr 5,445,646. All of these
`patents are incorporated herein by reference. Also, shape memory metal stents may
`be used. As already indicated rhe stent of PCT Application 960 3092 A1 is
`particularly preferred.
`
`10
`
`15
`
`20
`
`The stent is typically about 16mm long, while the balloon may be
`20mm long. These dimensions, however, are merely representative for illustrative
`purposes only and are not meant to be limiting. The stent is positioned over the
`balloon portion of the dilatation catheter and gently crimped onto the balloon either
`by hand or with a tool such as a pliers or the like to be mounted for delivery as
`shown in Figures I and2. The crimping may be accomplished by either the
`manufacturer or the physician.
`In accordance with this invention, a mounting body 30, best seen in
`Figures 2 and 3, is included inside balloon 14 to provide a cushion and/or substrate
`of enlarged diameter relative to the stent shaft to support and hold the stent and
`secure it during crimping and the delivery procedure. The mounting body may be
`located only in ,tt. Uoay$rtion of the balloon or may extend into either or both of
`-==-'
`25 the cone portions of the balloon.
`In the embodiment shown, mounting body 30 is cylindrical in form
`and takes the shape of a sleeve canied on inner lumen 26, providing an enlarged
`area or portion for receiving the balloon and stent when the latter is crimped.
`Marker bands 32 and 34 may also be included on inner 26 as shown. Any
`30 radiopaque material such as gold is useful for this pu{pose. A stop member 36 of
`conical shape or any other shape may also be included on the distal marker
`.generally
`band 34 as shown to provide additional resistance to stent movement during delivery
`and to protect the leading edge of the stent during delivery. A proximal stop
`
`I
`
`;r
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 13
`
`

`

`i;
`
`ril
`
`-5-
`member similar to member 36 (not showrt) may be optionally included on marker
`band 32 if desired. Polyethylene or the like is suitable for the stop member(s).
`Although, the material of the mounting body may be hard, it is preferably of any
`deformable thermoplastic matrerial, preferably an elastomer material and more
`preferably of a relatively resilient elastomer material, e.g., lower durometer silicone.
`A preferred deformable thermoplastic material is high density polyethylene (HDpE).
`A preferred lower durorneter silicone is in the form of tubing. The deformation of
`resilient material of the mounting body when the stent/balloon is crimped to it causes
`a radial outward force on the stent/balloon increasing the friction therebetween
`despite a recoil of the stent.
`During delivery, the balloon catheter is advanced through and
`positioned in a patient's vasculature so that the stent is adjacent to the portion of the
`vessel where treatment is to take place. The balloon is inflated to expand the stent
`to an enlarged diameter. When the stent has reached the desired diameter, the
`balloon is deflated so that the catheter may be removed leaving the stent in place.
`Another embodiment of the invention is shown in Figure 4. In this
`embodiment the mounting body 30 is a spiral cut elastomer or other suitable
`material, such as a rigid or flexible plastic, to provide separation for flexibility in
`that portion of the catheter, allowing more easy movement or tracking around bends.
`The spiral cut may be only partly through the mounting body or may be all the way
`through as shown in Figure 4. Also, while stop members 36 are shown at both ends
`of mounting body 30 in this embodiment, one, or no stop members may be used.
`Another similar version is shown in Figure 5 which includes a
`cylindrical mounting body 30 made up of a plurality of separate adjacent rings 30a.
`Rings 30a may be individual bodies canied on the sheath or bodies cut from a
`cylinder partially separating them or fully separating them.
`The embodiment shown in Figure 6 includes another feature based on
`the geometry of the mounting body for further securing the stent upon crimping.
`This feature is referred to herein as interlocking. That is, the stent may be
`interlocked to the mount so that the stent cannot slide proximally or distally on the._.
`. balloon unless it is deformed, such as by expansion. This can be seen by perusing
`the structure shown in Figure 6 which includes the inner 26 having a two-piece
`mounting body made up of spaced mounting bodies 30a and 30b. The spacing
`
`,
`
`10
`
`15
`
`20
`
`25
`
`30
`
`f
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`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 14
`
`

`

`6-
`between bodies 30a and 30b allows portions of the stent 18 and balloon 14 to be
`depressed or inserted between the bodies upon crimping of the stent thus forming an
`interlock against sliding longitudinally before the stent is released.
`The interlock formation or crimping is readily accomplished by a two-
`5 piece die 40 as shown in Figure 7 or the like.
`Figure 8 demonstrates that more than a two-piece mounting body
`arrangement may be used if desired. In this embodiment, the mounting body is
`comprised of three spaced bodies 30a, 30b and 30c on the inner 26. preferably in
`the embodiments of Figures 6 and 8, the mounting bodies will be ring-like in shape
`10 or cylindrical in shape although other configurations will be readily apparent to those
`familiar with this art.
`The above Examples and disclosure are intended to be illustrative and
`not exhaustive. These examples and description will suggest many variations and
`alternatives to one of ordinary skill in this art. All these alternatives and variations
`15 are intended to be included within the scope of the attached claims. Those familiar
`with the art may recognize other equivalents to the specific embodiments described
`herein which equivalents are also intended to be encompassed by the claims attached
`hereto.
`
`20
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 15
`
`

`

`What is claimed is as follows:
`
`-7-
`
`therewith at a
`
`receiving the
`
`stent upon i
`
`including at least
`
`10
`
`inflatable means
`
`A stent delivery system comprising:
`radially expandable stent of generally cylindrical configuration, and
`catheter having a shaft and expandable inflatable means associated
`part of the shaft and including mounting and retaining means for
`on the expandable inflatable means for radial expansion of the
`n of the inflatable means, the mounting and retaining means
`mounting body carried on and surrounding the shaft inside the
`the diameter of the shaft and inflatable portion are
`part for facilitating the mounting and retaining of the stent.
`The stent delivery system of claim 1 wherein the mountins
`which resiliently deforms under radial pressure.
`
`increased at the di
`
`2.
`body is of a material
`aJ.
`
`15
`
`elastomeric.J4
`
`comprises HDPF.
`I
`
`The stent delivery system of claim 2 wherein the material is
`
`The stent delivery system of claim 2 wherein the material
`
`The stent delivery system of claim 2 wherein the material
`
`20
`
`25
`
`The stent delivery system of claim 1 wherein the mounting
`body configura{ion includes at least one separation whereby the flexibiliry of the
`body and cathetlr is increased.
`7.
`The stent delivery system of claim 6 wherein the separation is
`in the form of a spiral.
`8.
`The stent delivery system of claim 1 wherein the stent is
`crimped to the. mounting and retaining means for delivery
`0ll \
`IH6Y \.
`The stent delivery system of claim I including a pair of stops,
`I
`each of which i{ respectively positioned at opposite ends of the stent and canied by
`--
`t
`the shaft inside fie inflatable means.
`30
`10. The stent delivery system of claim 9 wherein the stops are
`. conical in shape.
`#9\.
`The stent delivery system of claim 1 including marker bands
`positioned pro*i\utty and distalty of the stenr.
`\
`
`\.
`
`,:{
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 16
`
`

`

`-8-
`12. The stent delivery system of claim
`a balloon.
`
`1 wherein the inflatable
`
`13:
`positidned at the
`
`The stent delivery systern of claim
`I end of the catheter and carried bv
`
`1 including a stop
`the shaft inside the
`
`therewith at a
`
`receiving a
`
`10
`
`mounting and
`
`inflatable
`
`that opposite
`
`the mounting
`
`15
`
`expansion of
`stent along the
`
`generally tubula
`
`1
`
`20
`
`spaced mountin
`
`diameter and
`&
`generally
`
`. ,, A stent delivery system comprising:
`catheter having a shaft and expandable inflatable means associated
`part of the shaft and including mounting and retaining means for
`to be delivered upon expansion of the inflatabre means, the
`ining means including at least one mounting body inside the
`and carried and/or surrounding the shaft, and
`stent crimped to the inflatable means and the mounting body such
`portions of'the stent are deformed to a diameter less than that of
`y whereby the stent is interlocked with the mounting body until
`stent and inflatable means to prevent accidental movement of the
`theter during delivery.
`. The stent delivery system of claim 14 wherein the stent is
`in shape and the mounting body is generaily cylindrical in shape.
`. The stent delivery system of claim 14 wherein at least two
`bodies are included and the stent is additionally crimped to a lesser
`between the mounting bodies.
`17. The stent delivery system of claim !6 wherein the stent is
`T$f: in shape and the mounring bodies ,r. ,ffi
`The stent delivery system of claim 14 wherein at least three
`ffi
`25 spaced mountin{ bodies are included and the stent is crimped to a lesser diameter
`between the bodl[s.
`19. The stent delivery system of claim 1g wherein the stent is
`r in shape and the mounting bodies are rinerffi
`A balloon catheter for intraluminal delivery of a stent, the
`a shaft, a balloon associated with a distal portion of the shaft for
`and means for inflating the balloon, the shaft including at least
`carried on the shaft inside the balloon whereby the diameter of
`
`fr
`
`generally tu
`
`30
`
`catheter com
`
`recelvlng a
`
`one, mounting
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 17
`
`

`

`-9-
`
`5
`
`the shaft is in\reased inside the balloon to facilitate mounting of a stent to the
`catheter ou.r,\ balloon.
`21. The catheter of claim 20 wherein the mounting body is of a
`material which resiliently deforms under radial pressure.
`22, The catheter of claim 21 wherein the material is elastomeric.
`-.V\
`The catheter of claim 21 wherein the material is HDPE. .
`,yn
`Y 24. The catheter of claim 21 wherein the material is silicone.
`25. The catheter of ;llim 20 wherein the mounting body is
`W->
`C:Scqfngored with at least one t"purfin whereby trackability of the catheter is
`10 improved.
`/
`26. The catheter of claim 25 wherein the separation is in a spiral
`
`confisuration.
`A.
`..;fr
`-r-
`The catheter of claim 20 including a pair of spaced stops.
`;7
`28. The catheter of claim 27 wherein the stops are conical in
`
`t;,
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`h
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`b"rf.l are included.'--
`"/
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`The catheter of cla{m 31 wherein the mounting bodies are
`32.
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`rins-p
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`+ike.w7nmountin'g bodies are
`
`_/-/
`The catfefer of claim 20 wherein at least three spaced
`"1"
`lncu0ed.
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`The catheter of claim 33 wherein the mounting bodies are ring-ff|Lu
`
`34.
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`30
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`F :\WPWORIOOFA\@5GAPP.722
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`lb
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 18
`
`

`

`-10-
`
`Abstract of the Disclosure
`
`STENT DELryERY SYSTEM
`A stent delivery system to facilitate introduction and placement of a
`stent, including a catheter having an expandable distal portion constructed and
`arranged for expanding the outer diameter of the catheter from a confiacted state to
`an expanded state: a stent positioned around the distal portion of the catheter having
`a contracted condition and being expandable to an expanded condition, and being
`sized in the contracted condition to closely surround the catheter in the contracted
`state, the expandable distal portion of the catheter including a balloon within which
`there is included on the catheter shaft at least one body of a diameter larger than the
`catheter shaft to which the stent and balloon are fitted, as by crimping, for holding
`the stent in place until it is released therefrom by expansion of the balloon.
`
`F:\WPWORK\OFA\605GApp.722
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 19
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 20
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 20
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 21
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 21
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 22
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 22
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`Petitioner Edwards Lifesciences
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`- Exhibit 1002 - P
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`age 23
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 23
`
`

`

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`Petitioner Edwards Lifesciences Corporation - Exhibit 1002 - Page 24
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