(12) United States Patent
`Ellis et al.
`
`IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`US006371962B1
`(10) Patent No. :
`US 6, 371, 962 E1
`*Apr. 16, 2002
`(45) Date of Patent:
`
`(54) STENT DELIVERY SYSTEM WITH STENT
`SECUREMENT MEANS
`Inventors: Louis G. Ellis, St. Anthony; Andrew J.
`Dusbabek, Dayton; Christopher R.
`Larson, St. Paul; Terry V. Brown,
`Fridley, all of MN (US)
`
`(75)
`
`(73) Assignee: Scimed Life Systems, Inc. , Maple
`Grove, MN (US)
`
`( * ) Notice:
`
`the term of this
`Subject to any disclaimer,
`is extended or adjusted under 35
`patent
`U. S. C. 154(b) by 0 days.
`
`This patent
`claimer.
`
`is subject to a terminal dis-
`
`(21) Appl. No. : 09/420, 249
`Oct. 19, 1999
`(22) Filed:
`
`Related U. S. Application Data
`
`(63) Continuation of application No. 08/702, 150, filed on Aug.
`23, 1996, now Pat. No. 6, 007, 543.
`
`(51) Int. Cl.
`(52) U. S. Cl.
`(58) Field of Search
`
`. . .
`
`A61F 11/00
`. 606/108; 606/194
`. . . . . . . . . 606/194, 195,
`606/198, 108
`
`(56)
`
`References Cited
`U. S. PATENT DOCUMENTS
`
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`4, 950, 227
`5, 007, 926
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`A
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`Jang
`Walstein et al.
`Imbert
`Savin et al.
`Derbyshire
`
`5, 026, 377 A
`5, 037, 392 A
`
`6/1991 Burton et al.
`8/1991 Hillstead
`
`(List continued on next page. )
`FOREIGN PATENT DOCUMENTS
`
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`WO
`WO
`WO
`
`0 266 957 A2
`0 442 657 A2
`0 257 091 B1
`0 553 960 A1
`0 627 201 A1
`0 699 451 A2
`0 707 837 A1
`WO 93/19703
`WO 96/03072
`WO 96/03092 A1
`
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`12/1994
`3/1996
`4/1996
`10/1993
`2/1996
`2/1996
`
`OTHER PUBLICATIONS
`
`Intraluminal Graft: A
`Julio C. Palmaz et al. , Expandable
`Preliminary Study, Work in Progress, From the Departments
`of Radioloty (J. C. P. , R. R. S. , S. R. R. ) and Pathology (F. O. T. )
`Universtiy of Texax Health Science Center at Sanantonio
`and Memorial Medical Center (W. J. K. ), Corpus Christi,
`Texas, Radiology, vol. 356, No. 1, pp. 73 — 77.
`Primary Examiner — Justine R. Yu
`(74) Attorney, Agent, or Firm — Vidas, Arrett & Steinkraus
`
`(57)
`
`ABSTRACT
`
`A stent delivery system to facilitate introduction
`and place-
`ment of a stent, including a catheter having an expandable
`for expanding
`distal portion constructed
`the
`and arranged
`outer diameter of the catheter from a contracted state to an
`expanded state: a stent positioned around
`the distal portion
`of the catheter having
`a contracted condition
`and being
`to an expanded condition, and being sized in the
`expandable
`contracted condition
`the catheter
`to closely surround
`in the
`contracted state, the expandable distal portion of the catheter
`there is included on the
`a balloon within which
`including
`catheter shaft at least one body of a diameter
`larger than the
`catheter shaft to which the stent and balloon are fitted, as by
`it is released
`for holding
`the stent in place until
`crimping,
`therefrom by expansion of the balloon.
`
`606/192
`
`37 Claims, 4 Drawing Sheets
`
`I2a
`
`I2b
`
`g3
`
`20
`
`28
`
`I8 30
`
`36
`
`I6
`
`22
`
`I8
`
`C
`
`2
`
`26
`
`26
`
`26
`
`20
`
`32
`
`34
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1001 - Page 1
`
`

`

`US 6, 371, 962 B1
`Page 2
`
`U. S. PATENT DOCUMENTS
`
`5, 049, 132
`5, 108, 416
`5, 116, 318
`5, 158, 548
`5, 226, 880
`5, 226, 889
`5, 242, 399
`4, 733, 665
`5, 290, 306
`5, 304, 198
`5, 342, 305
`5, 344, 402
`5, 344, 426
`5, 358, 487
`5, 364, 354
`5, 378, 237
`5, 403, 341
`5, 405, 380
`5, 409, 495
`
`A
`A
`A
`A
`A
`A
`A
`C1
`A
`A
`A
`A
`A
`A
`A
`A
`A
`A
`A
`
`9/1991
`4/1992
`5/1992
`10/1992
`7/1993
`7/1993
`9/1993
`1/1994
`3/1994
`4/1994
`8/1994
`9/1994
`9/1994
`10/1994
`11/1994
`1/1995
`4/1995
`4/1995
`4/1995
`
`Shafter et al.
`Ryan et al.
`Hillstead
`Lau et al.
`Martin
`Sheiban
`Lau et al.
`Palmaz
`Trotta et al.
`. . . . . . . . . . . . . . .
`Samson
`Shonk
`Crocker
`Lau et al.
`Miller
`Walker et al.
`Boussignac et al.
`Solar
`Gianotti et al.
`. . . . . . . . . . . . . . . .
`Osborn
`
`606/194
`
`. 606/194
`
`. . . 604/96
`
`5, 415, 664 A
`5, 441, 515 A
`5, 445, 646 A
`5, 447, 497 A
`5, 453, 090 A
`5, 458, 615 A
`5, 470, 313 A
`5, 507, 768 A
`5, 512, 051 A
`5, 534, 007 A
`5, 536, 252 A
`5, 571, 086 A
`5, 571, 089 A
`5, 591, 228 A
`5, 632, 760 A
`5, 653, 691 A
`5, 817, 102 A
`5, 846, 246 A
`
`5/1995
`8/1995
`8/1995
`9/1995
`9/1995
`10/1995
`11/1995
`4/1996
`4/1996
`7/1996
`7/1996
`11/1996
`11/1996
`1/1997
`5/1997
`8/1997
`10/1998
`12/1998
`
`Pinchuk
`. . . . . . . . . . . 606/194
`Khosravi et al.
`Euteneuer et al. . . . . . . . . . . 606/198
`Sogard et al.
`Martinez et al.
`Klemm et al.
`Crocker et al.
`Lau et al.
`Wang et al.
`St. Germain et al.
`Imran et al.
`Kaplan et al.
`604/96
`. . . . . . . . . . . . . . . . . . . . . . .
`Crocker
`604/96
`606/194
`Edoga
`606/195
`Sheiban et al.
`Rupp et al. . . . . . . . . . . . . . . . . . . .
`604/96
`Johnson et al. . . . . . . . . . . . . .
`606/108
`Dirks et al. . . . . . . . . . . . . . . . . .
`606/108
`
`. 606/108
`
`* cited by examiner
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1001 - Page 2
`
`

`

`U. S. Patent
`
`Apr. 16, 2002
`
`Sheet 1 of 4
`
`US 6, 371, 962 E1
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1001 - Page 3
`
`

`

`U. S. Patent
`
`Apr. 16, 2002
`
`Sheet 2 of 4
`
`US 6, 371, 962 E1
`
`O
`O
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1001 - Page 4
`
`

`

`U. S. Patent
`
`Apr. 16, 2002
`
`Sheet 3 of 4
`
`US 6, 371, 962 E1
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1001 - Page 5
`
`

`

`U. S. Patent
`
`Apr. 16, 2002
`
`Sheet 4 of 4
`
`US 6, 371, 962 E1
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1001 - Page 6
`
`

`

`US 6, 371, 962 B1
`
`STENT DELIVERY SYSTEM WITH STENT
`SECUREMENT MEANS
`
`RELATED APPLICATIONS
`is a continuation of U. S. appli-
`The present application
`cation Ser. No. 08/702, 150, filed on Aug. 23, 1996, now U. S.
`Pat. No. 6, 007, 543, which
`is incorporated herein by refer-
`ence in its entirety.
`
`BACKGROUND OF THE INVENTION
`
`In typical PTCA procedures, a guiding catheter is percu-
`system of a
`the cardiovascular
`introduced
`taneously
`into
`through a vessel and advanced
`therein until
`patient
`through
`in the vascu-
`the distal end thereof is at a desired
`location
`lature. A guidewire and a dilatation catheter having a balloon
`on the distal end thereof are introduced
`the guiding
`through
`catheter with
`the dilatation
`the guidewire
`sliding
`through
`is first advanced out of the guiding
`catheter. The guidewire
`the patient's
`catheter
`coronary vasculature
`into
`the
`and
`dilatation catheter is advanced over the previously advanced
`guidewire until the dilatation balloon is properly positioned
`across the lesion. Once in position across the lesion,
`the
`is inflated
`flexible, expandable,
`balloon
`preformed
`to a
`size with a liquid or gas at relatively high
`predetermined
`to
`pressures, such as greater
`than about four atmospheres,
`the arthrosclerotic plaque of the lesion
`radially compress
`the inside of the artery wall and thereby dilate
`against
`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
`the
`through
`dilated artery.
`In angioplasty procedures of the kind described above,
`there may be restenosis of the artery, which either necessi-
`tates another
`a surgical by-pass
`procedure,
`angioplasty
`operation, or some method of repairing or strengthening
`the
`area. To prevent restenosis and strengthen
`the area, a phy-
`for maintain-
`sician can implant an intravascular prosthesis
`ing vascular patency, called a stent, inside
`the artery at the
`is expanded
`for
`lesion. The stent
`to a larger diameter
`in the vasculature, often by the balloon portion of
`placement
`the catheter. Stents delivered
`to a restricted coronary artery,
`to a larger diameter as by a balloon catheter, and
`expanded
`left in place in the artery at the site of a dilated
`lesion are
`shown in U. S. Pat. No. 4, 740, 207 to Kreamer; U. S. Pat. No.
`5, 007, 926 to Derbyshire; U. S. Pat. No. 4, 733, 665 to Palmaz;
`U. S. Pat. No. 5, 026, 377 to Burton et al. ; U. S. Pat. No.
`5, 158, 548 to Lau et al. ; U. S. Pat. No. 5, 242, 399 to Lau et al. ;
`U. S. Pat. No. 5, 344, 426 to Lau et al. ; U. S. Pat. No. 5, 415,
`664 to Pinchuk; U. S. Pat. No. 5, 453, 090 to Martinez et al. ;
`U. S. Pat. No. 4, 950, 227 to Savin; U. S. Pat. No. 5, 403, 341 to
`Solar; U. S. Pat. No. 5, 108, 416 to Ryan et al. and European
`Patent Application No. 707 837 A1 to Sheiban, all of which
`herein by reference. A stent particularly
`are incorporated
`in PCT
`is described
`for use with
`preferred
`this invention
`Application No. 960 3092 A1, published Feb. 8, 1996, the
`content of which is also incorporated herein by reference.
`is particularly directed to improved
`The present invention
`the stent to the cath-
`for releasably attaching
`arrangements
`thereof.
`eter to facilitate delivery
`
`SUMMARY OF THE INVENTION
`
`This invention concerns apparatus suitable for delivery of
`to body cavities.
`stents are prosthetic
`In general,
`stents
`devices which can be positioned within a body cavity, for
`example, a blood vessel of the body of a living human or in
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`some other dilficultly 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
`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
`is positioned over the balloon,
`the stent, which
`to
`expand
`place it in a selected location in the body cavity. The present
`is particularly directed to improved arrangements
`invention
`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 carried by the catheter shaft
`the balloon to which the stent and balloon are fitted,
`within
`as by crimping.
`
`BRIEF DESCRIPTION OF THE FIGURES
`FIG. 1 is an isometric view, a portion of which is enlarged
`section, of a balloon catheter having a
`and in longitudinal
`stent fixed to the catheter by being crimped
`thereto over the
`balloon;
`FIG. 2 is an even more enlarged view
`in longitudinal
`cross-section of the distal end portion of the catheter of FIG.
`1;
`FIG. 3 is an enlarged cross-sectional view of the distal end
`portion of the catheter of FIG. 1 similar
`to that of enlarged
`view FIG. 2 but showing
`the balloon
`in an expanded
`condition along with the expanded stent;
`FIG. 4 is a schematic showing of a preferred mounting
`the balloon,
`body carried by the catheter shaft within
`the
`body being spirally cut to improve
`flexibility;
`in cross-section of another
`FIG. 5 is a schematic showing
`embodiment of the invention with a stent not yet mounted;
`FIG. 6 is a schematic showing of another embodiment of
`the invention;
`FIG. 7 is a schematic showing of a means for conve-
`shown in FIG.
`the stent on the embodiment
`niently crimping
`5, and
`FIG. 8 is a schematic showing of yet another embodiment
`of the invention.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`to FIGS. 1 — 3 a stent delivery system generally
`Referring
`at 10 includes
`a balloon catheter 12 having
`indicated
`a
`indicated at 16.
`balloon 14 on a distal end portion generally
`FIG. 1 shows a proximal portion of the catheter at 12a and
`a distal portion 12b in enlarged view. FIG. 2 shows the distal
`end portion 16 in an even more enlarged view. The illustra-
`tive catheter 12 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
`in its contracted state in FIGS. 1 and 2. A
`balloon is shown
`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
`the catheter upon expansion of the
`stent is released
`from
`in FIG. 3 to be placed in a vessel. When
`balloon as shown
`removal of the balloon and
`the balloon
`is then deflated,
`catheter may be accomplished while
`the stent
`leaving
`in
`place.
`As is known
`is either bonded at its
`in the art the balloon
`ends by adhesive 20 and 24, respectively
`the outer
`to
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1001 - Page 7
`
`

`

`US 6, 371, 962 B1
`
`member 22 of the catheter and to the 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
`from a lumen 28 contained
`in the catheter shaft
`extending
`into the balloon as shown, or by other known
`and opening
`depending on the design of the catheter. The
`arrangements,
`and mechanics of balloon
`and specific
`details
`inflation
`overall catheter construction will vary according
`to
`the
`instance, and are
`particular design
`involved
`in any given
`known in the art per se. All variations are acceptable for use
`with this invention.
`stent may be used with
`Any balloon expandable
`this
`in the art including plastic and
`invention. Many are known
`stents. Some are more well known
`such as
`metal
`the
`in U. S. Pat. No. 4, 735, 665; the
`stainless steel stent shown
`in U. S. Pat. No. 4, 950, 227; another metal
`wire stent shown
`in European Patent Application EPO 707 837
`stent shown
`in U. S. Pat. No. 5, 445, 646. All of these
`A1 and that shown
`patents are incorporated herein by reference. Also, shape
`memory metal stents may be used. As already
`indicated
`the
`stent of PCT Application 960 3092 A1 is particularly pre-
`ferred.
`The stent is typically about 16mm long, while the balloon
`may be 20 mm long. These dimensions, however, are merely
`for illustrative
`representative
`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
`in FIGS. 1 and 2.
`like to be mounted
`for delivery as shown
`The crimping may be accomplished by either the manufac-
`turer or the physician.
`a mounting body 30,
`In accordance with this invention,
`inside balloon 14 to
`best seen in FIGS. 2 and 3, is included
`substrate of enlarged diameter
`a cushion
`provide
`and/or
`to the stent shaft to support and hold the stent and
`relative
`secure it during crimping and the delivery procedure. The
`mounting body may be located only in the body portion of
`into either or both of the cone
`the balloon or may extend
`portions of the balloon.
`shown, mounting body 30 is cylindri-
`In the embodiment
`cal in form and takes the shape of a sleeve carried on inner
`lumen 26, providing an enlarged area or portion for receiv-
`ing the balloon and stent when the latter is crimped. Marker
`bands 32 and 34 may also be included on inner 26 as shown.
`such as gold is useful for this
`Any radiopaque material
`purpose. A stop member 36 of generally conical shape or any
`other shape may also be included on the distal marker band
`34 as shown to provide additional
`to stent move-
`resistance
`ment during delivery and to protect the leading edge of the
`stent during delivery. A proximal
`to
`stop member similar
`member 36 (not shown) may be optionally
`included on
`marker band 32 if desired. Polyethylene
`is
`or the
`like
`the material of
`suitable for the stop member(s). Although,
`it is preferably of any
`the mounting body may be hard,
`thermoplastic material, preferably an elastomer
`deformable
`material and more preferably of a relatively
`resilient elas-
`tomer material, e. g. , lower durometer
`silicone. A preferred
`is high density polyeth-
`deformable
`thermoplastic material
`ylene (HDPE). Apreferred
`lower durometer silicone is in the
`form of tubing. The deformation of resilient material of the
`to it
`is crimped
`the stent/balloon
`body when
`mounting
`causes a radial outward force on the stent/balloon
`increasing
`the friction therebetween despite a recoil of the stent.
`the balloon catheter is advanced
`During delivery,
`through
`in a patient's vasculature
`so that the stent is
`and positioned
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`to the portion of the vessel where
`is to
`adjacent
`treatment
`take place. The balloon is inflated to expand
`the stent to an
`the stent has reached
`enlarged diameter. When
`the desired
`the balloon is deflated so that the catheter may be
`diameter,
`the stent in place.
`removed
`leaving
`is shown in FIG. 4.
`Another embodiment of the invention
`the mounting body 30 is a spiral cut
`In this embodiment
`elastomer or other suitable material,
`such as a rigid or
`for flexibility
`flexible plastic, to provide separation
`in that
`portion of the catheter, allowing more easy movement or
`tracking around bends. The spiral cut may be only partly
`the mounting body or may be all the way through as
`through
`shown in FIG. 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 FIG. 5 which includes
`a cylindrical mounting body 30 made up of a plurality of
`separate adjacent rings 30a. Rings 30a may be individual
`bodies carried on the sheath or bodies cut from a cylinder
`them or fully separating
`them.
`partially separating
`in FIG. 6 includes another fea-
`The embodiment
`shown
`ture based on the geometry of the mounting body for further
`the stent upon crimping. This feature is referred to
`securing
`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 FIG. 6 which
`the inner 26 having a two-piece
`includes
`mounting body made up of spaced mounting bodies 30a and
`30b. The spacing between bodies 30a and 30b allows
`portions of the stent 18 and balloon 14 to be depressed or
`the bodies upon crimping of the stent thus
`inserted between
`before
`forming an interlock against sliding
`longitudinally
`the stent is released.
`is readily accom-
`formation or crimping
`The interlock
`plished by a two-piece die 40 as shown in FIG. 7 or the like.
`FIG. 8 demonstrates
`that more than a two-piece mounting
`if desired.
`, body arrangement may be used
`this
`In
`is comprised of three
`embodiment,
`the mounting
`body
`spaced bodies 30a, 30b and 30c on the inner 26. Preferably
`in the embodiments of FIGS. 6 and 8, the mounting bodies
`in shape or cylindrical
`will be ring-like
`in shape although
`to those famil-
`other configurations will be readily apparent
`iar with this art.
`to be
`The above Examples and disclosure are intended
`and not exhaustive. These examples and descrip-
`illustrative
`to one of
`tion will suggest many variations and alternatives
`ordinary skill in this art. All these alternatives and variations
`the scope of the attached
`to be included within
`are intended
`claims. Those familiar with
`the art may recognize other
`to the specific embodiments
`described herein
`equivalents
`to be encompassed by
`are also intended
`which equivalents
`the claims attached hereto.
`What is claimed is as follows:
`1. A stent delivery system for carrying and delivering
`a
`stent having a first end and a second end and a contracted
`state and an expanded state, the system comprising:
`a catheter having a shaft having a diameter and expand-
`able inflatable means associated
`at a distal
`therewith
`part of the shaft and including mounting
`and retaining
`means for receiving
`inflat-
`the stent on the expandable
`the stent is radially expanded upon
`able means whereby
`inflation of the
`inflatable means,
`the mounting
`and
`retaining means including at least one mounting body,
`the at least one mounting body having a length and an
`outer surface diameter and being carried on and sur-
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1001 - Page 8
`
`

`

`US 6, 371, 962 B1
`
`system of claim 2 wherein
`
`the
`
`the
`
`the
`
`the
`
`the stops
`
`the shaft inside the inflatable means whereby
`rounding
`the diameter of the shaft is increased at the distal part
`and retaining of the stent
`for facilitating
`the mounting
`and wherein, when the stent is mounted on the catheter,
`the at least one mounting body is between
`the stent and
`the shaft, the outer surface diameter of the at least one
`its
`constant along
`mounting body being substantially
`length.
`system of claim 1 wherein
`2. The stent delivery
`the
`mounting body is of a material which resiliently deforms
`under radial pressure.
`3. The stent delivery
`is elastomeric.
`material
`4. The stent delivery
`system of claim 2 wherein
`material comprises high density polyethylene.
`5. The stent delivery
`system of claim 2 wherein
`material comprises silicone.
`6. The stent delivery system of claim 1 wherein
`the at least
`one mounting body includes at least one separation whereby
`the flexibility of the body and catheter
`is increased.
`7. The stent delivery
`system of claim 6 wherein
`is in the form of a spiral.
`separation
`8. The stent delivery system of claim 1 wherein
`the stent
`is crimped to the mounting and retaining means for delivery.
`9. The stent delivery system of claim 1, wherein
`the stent
`the stent delivery
`has
`further
`two opposite ends,
`system
`a pair of stops, each of which
`is respectively
`including
`positioned at the opposite ends of the stent and carried by the
`the inflatable means.
`shaft inside
`10. The stent delivery system of claim 9 wherein
`are conical in shape.
`11. The stent delivery system of claim 1 further
`including
`marker bands positioned proximally and distally of the stent.
`system of claim 1 wherein
`12. The stent delivery
`the
`inflatable means comprises a balloon.
`13. The stent delivery system of claim 1 further
`including
`a stop carried by the shaft and positioned
`inside the inflatable
`means.
`14. A stent delivery system comprising:
`a catheter having a shaft and expandable
`inflatable means
`at a distal part of the shaft and
`associated
`therewith
`and retaining means for receiving
`including mounting
`a stent, the stent having a first end and a second end and
`a contracted state and an expanded state, to be delivered
`upon expansion of the inflatable means,
`the mounting
`at least one mounting
`and retaining means
`including
`body, the at least one mounting body being inside the
`inflatable means and carried on the shaft, the at least
`one mounting body being positioned on the shaft such
`that, when the stent is loaded onto the inflatable means
`and the shaft in the stent's contracted state, at least a
`portion of the at least one mounting body is under
`the
`stent, the at least one mounting body having a length
`the outer sur-
`and an outer surface diameter, wherein
`face diameter is substantially constant along the length,
`and
`to the inflatable means and the at least
`the stent crimped
`one mounting body such that a portion of the stent is
`to a diameter less than that of the at least one
`deformed
`facilitating mounting
`thereby
`and
`mounting
`body,
`retaining of the stent.
`15. The stent delivery
`system of claim 14 wherein
`the
`is generally
`the at least one
`stent
`in shape and
`tubular
`mounting body is uniformly cylindrical
`in shape.
`16. The stent delivery system of claim 14 wherein at least
`spaced mounting bodies are included
`two
`longitudinally
`the stent and the shaft and a portion of
`positioned between
`
`is additionally
`bodies
`the stent between
`the mounting
`than that of the mounting bodies
`crimped to a lesser diameter
`the mounting bodies.
`and positioned between
`17. The stent delivery
`system of claim 16 wherein
`the
`in shape and the mounting bodies
`stent is generally
`tubular
`are ring-shaped.
`18. The stent delivery system of claim 14 wherein
`three
`spaced mounting bodies are included between
`longitudinally
`the stent and the shaft and the stent is crimped
`to a lesser
`the bodies.
`diameter between
`19. The stent delivery
`system of claim 18 wherein
`the
`in shape and the mounting bodies
`stent is generally
`tubular
`are ring-shaped.
`20. A balloon catheter for intraluminal delivery of a stent,
`the catheter comprising a shaft having a diameter, a balloon
`associated with a distal portion of the shaft for receiving a
`stent, the stent having a first end and a second end and a
`for
`contracted
`state and an expanded
`state, and means
`the balloon, the shaft including at least one mount-
`inflating
`the balloon,
`ing body radially carried on the shaft inside
`the diameter of the shaft
`is increased
`inside
`the
`whereby
`balloon to facilitate mounting and retaining of a stent to the
`catheter over the balloon,
`the at least one mounting body
`the stent is
`being positioned on the shaft such that when
`loaded onto the inflatable means and the shaft in the stent's
`contracted state at least a portion of the at least one mounting
`body is under the stent and between the first and second ends
`of the stent, the at least one mounting body having a length
`and an outer surface diameter, wherein
`the outer surface
`is substantially
`constant along the length.
`diameter
`21. The catheter of claim 20 wherein
`the mounting body
`is of a material which
`deforms under
`resiliently
`radial
`pressure.
`22. The catheter of claim 21 wherein
`elastomeric.
`23. The catheter of claim 21 wherein
`density polyethylene.
`24. The catheter of claim 21 wherein
`silicone.
`25. The catheter of claim 20 wherein
`the mounting body
`trackability of the
`comprises at least one separation whereby
`is improved.
`catheter
`26. The catheter of claim 25 wherein
`a spiral configuration.
`27. The catheter of claim 20 further
`spaced stops.
`28. The catheter of claim 27 wherein
`in shape.
`29. The catheter of claim 20 further
`marker bands.
`30. The catheter of claim 20 wherein
`is uniformly cylindrical
`in shape.
`31. The catheter of claim 20 wherein at least two longi-
`tudinally spaced mounting bodies are included, wherein
`the
`at least two mounting bodies are positioned between
`the
`stent and the shaft.
`32. The catheter of claim 31 wherein
`are ring-shaped.
`33. The catheter of claim 20 wherein
`at least
`three
`spaced mounting bodies are included posi-
`longitudinally
`the stent and the shaft.
`tioned between
`34. The catheter of claim 33 wherein
`are ring-shaped.
`35. A stent delivery system comprising:
`stent of generally
`cylindrical
`expandable
`a radially
`configuration, having a length, a first end and a second
`end and a contracted state and an expanded state, and
`
`the material
`
`is
`
`the material
`
`is high
`
`the material
`
`is
`
`the separation
`
`is in
`
`including
`
`a pair of
`
`the stops are conical
`
`including
`
`spaced
`
`the mounting body
`
`the mounting bodies
`
`the mounting bodies
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1001 - Page 9
`
`

`

`US 6, 371, 962 B1
`
`a catheter having a shaft having a diameter and expand-
`able inflatable means associated
`at a distal
`therewith
`part of the shaft, wherein
`the inflatable means com-
`prises a balloon, and including mounting and retaining
`means for receiving
`inflat-
`the stent on the expandable
`for radial expansion of the stent upon
`able means
`inflation of the inflatable means, the mounting
`retaining
`means including at least one mounting body carried on
`the shaft inside the inflatable means,
`and surrounding
`the at least one mounting body being at least '/~ the
`length of the stent and being positioned on the shaft
`the stent is loaded onto the inflatable
`such that when
`means and the shaft in the stent's contracted state at
`
`least a portion of the at least one mounting body is
`under the stent and between the first and second ends of
`the diameter of the shaft and inflat-
`the stent, whereby
`able portion are increased at the distal part for facili-
`and retaining of the stent.
`tating the mounting
`36. The stent delivery system of claim 35, the at least one
`layer of
`no more
`than one
`body comprising
`mounting
`material.
`37. The stent delivery system of claim 36, wherein
`material comprises high density polyethylene.
`
`the
`
`s
`
`to
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1001 - Page 10
`
`