United States Patent [19]
`Ellis et al.
`
`[54] STENT DELIVERY SYSTEM WITH STENT
`SECUREMENT MEANS
`
`[75] Inventors: Louis G. Ellis, St. Anthony; Andrew J.
`Dusbabek, Dayton; Christopher R.
`Larson, St. Paul; Terry W. Brown,
`Fridley, all of Minn.
`[73] Assignee: SciMed Life Systems, Inc., Maple
`Grove, Minn.
`This patent is subject to a terminal dis
`claimer.
`
`[*] Notice:
`
`US006007543A
`[11] Patent Number:
`[45] Date of Patent:
`
`6,007,543
`*Dec. 28, 1999
`
`0.442 657 A2 9/1991 European Pat. Off. .
`O 259 091 B1 7/1993 European Pat. Off. .
`0.553 960 A1 8/1993 European Pat. Off. .
`0 627 201 A1 12/1994 European Pat. Off. .
`0.699 451 A2 3/1996 European Pat. Off. .
`0 707 837 A1 4/1996 European Pat. Off. .
`WO 93/19703 10/1993 WIPO .
`WO 96/03072 2/1996 WIPO .
`WO 96/03092
`A1 2/1996 WIPO .
`
`OTHER PUBLICATIONS
`
`Julio C. Palmaz et al., Expandable Intraluminal Graft: A
`Preliminary Study, Work in Progress, From the Departments
`of Radioloty (J.C.P., R.R.S., S.R.R.) and Pathology (F.O.T.)
`[21] Appl. No.: 08/702,150
`University of Texas Health Science Center at Samantonio
`and Memroial Medical Center (W.J.K.), Corpus Christi,
`[22] Filed:
`Aug. 23, 1996
`Texas, Radiology, vol. 356, No. 1, pp. 73–77.
`[51] Int. Cl." … A61F 11/00
`[52] U.S. Cl. ........................... 606/108; 606/195; 606/198
`Primary Examiner—Richard J. Apley
`[58] Field of Search ..................................... 606/108, 194,
`Assistant Examiner—Justine R. Yu
`606/195, 198; 604/96
`Attorney, Agent, or Firm—Vidas, Arrett & Steinkraus, PA.
`[57]
`ABSTRACT
`A stent delivery system to facilitate introduction and place
`ment of a stent, including a catheter having an expandable
`distal portion constructed and arranged for expanding the
`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
`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.
`
`[56]
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`5/1982 Snooks.
`4,328,056
`4,338,942 7/1982 Fogarty.
`4,423,725
`1/1984 Baran et al. .
`4,608,984 9/1986 Fogarty.
`4,733,665 3/1988 Palmaz.
`4,740,207 4/1988 Kreamer.
`4,744,366 5/1988 Jang .
`4,848,343
`7/1989 Walstein et al. .
`4,875,480 10/1989 Imbert .
`4,950,227 8/1990 Savin et al. .
`5,007,926
`4/1991 Derbyshire.
`(List continued on next page.)
`FOREIGN PATENT DOCUMENTS
`0 266 957 A2 5/1988 European Pat. Off. .
`
`| 20 - º
`
`33 Claims, 4 Drawing Sheets
`
`
`
`Page 1 of 9
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`EDWARDS LIFESCIENCES EX. 1226
`Edwards Lifesciences v. Boston Scientific Scimed
`U.S. Patent No. 6,915,560
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`

`

`6,007,543
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`5,415,664 5/1995 Pinchuk.
`5,441,515 8/1995 Khosravi et al. ....................... 606/194
`5,445,646 8/1995 Euteneuer et al. .
`§ º| H. | al. .
`5447,497 9/1995 Sogard et al.,
`soa5.132 º sºl.
`5,108,416 4/1992 Ryan et al. ............................. 606/194 sº ?º1995 Martinez et al. .
`5,116,318 5/1992 Hillstead .
`2 * ~ -->
`/1995 Klemm et al. .
`siassas 9/1992 Lau et al. .
`5,470,313 11/1995 Crocker et al. .
`5.226sso 7/1993 Martin .
`5,507,768 4/1996 Lau et al. .
`5,226,889
`7/1993 Sheiban .
`5,512,051 4/1996 Wang et al. .
`5,242,399 9/1993 Lau et al. .
`5,534,007 7/1996 St. Germain et al. .
`5,290,306 3/1994 Trotta et al. .
`5,536,252 7/1996 Imran et al. .
`5,304,198 4/1994 Samson ................................... 606/194
`5,571,086 11/1996 Kaplan et al. ............................ 604/96
`5,342,305 8/1994 Shonk.
`5,571,089 11/1996 Crocker ..................................... 604/96
`5,344,426 9/1994 Lau et al. .
`5,591,228
`1/1997 Edoga ......
`. 606/194
`5,358,487 10/1994 Miller.
`5,632,760 5/1997 Sheiban et al. .
`. 606/195
`5,403,341
`4/1995 Solar .
`5,653,691 8/1997 Rupp et al. .....
`... 604/96
`5,405,380 4/1995 Gianotti et al. .
`5,817,102 10/1998 Johnson et al. ......................... 606/108
`5,409,495 4/1995 Osborn .................................... 606/108
`B1 4,733,665
`1/1994 Palmaz.
`
`
`
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`Dec. 28, 1999
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`U.S. Patent
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`Dec. 28, 1999
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`1
`STENT DELIVERY SYSTEM WITH STENT
`SECUREMENT MEANS
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`BACKGROUND OF THE INVENTION
`In typical PTCA procedures, a guiding catheter is percu
`taneously introduced into the cardiovascular system of a
`patient through a vessel and advanced through therein until
`the distal end thereof is at a desired location in the vascu
`lature. Aguidewire 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 the patient’s coronary vasculature and the
`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
`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 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 restenosis of the artery, which either necessi
`tates 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 phy
`sician can implant an intravascular prosthesis for maintain
`ing vascular patency, called a stent, inside the artery at the
`lesion. The stent is expanded to a larger diameter for
`placement in the 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. 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. 707837A1 to Sheiban, all of which
`are incorporated herein by reference. A stent particularly
`preferred for use with this invention is described in PCT
`Application No. 960 3092 A1, published Feb. 8, 1996, the
`50
`content of which is also incorporated herein by reference.
`The present invention is particularly directed to improved
`arrangements for releasably attaching the stent to the cath
`eter to facilitate delivery thereof.
`SUMMARY OF THE INVENTION
`This invention concerns apparatus suitable for delivery of
`stents to 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
`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
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`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 improved arrangements
`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
`within the balloon to which the stent and balloon are fitted,
`as by crimping.
`
`BRIEF DESCRIPTION OF THE FIGURES
`FIG. 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;
`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
`body carried by the catheter shaft within the balloon, the
`body being spirally cut to improve flexibility;
`FIG. 5 is a schematic showing in cross-section of another
`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
`niently crimping the stent on the embodiment shown in FIG.
`5, and
`FIG. 8 is a schematic showing of yet another embodiment
`of the invention.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`Referring to FIGS. 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.
`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
`balloon is shown in its contracted state in FIGS. 1 and 2. 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 FIG. 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 is known in the art the balloon is either bonded at its
`ends by adhesive 20 and 24, respectively to the outer
`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
`extending from a lumen 28 contained in the catheter shaft
`and opening into the balloon as shown, or by other known
`arrangements, depending on the design of the catheter. The
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`3
`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. Pat. No. 4,735,665; the
`wire stent shown in U.S. Pat. No. 4,950,227; another metal
`stent shown in European Patent Application EP0707837A1
`and that shown in U.S. Pat. No. 5,445,646. All of these
`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 16 mm long, while the balloon
`may be 20 mm 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 FIGS. 1 and 2.
`The crimping may be accomplished by either the manufac
`turer or the physician.
`In accordance with this invention, a mounting body 30,
`best seen in FIGS. 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 the body ortion of the
`balloon or may extend into either or both of the cone
`portions of the balloon.
`In the embodiment shown, mounting body 30 is cylindri
`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.
`Any radiopaque material such as gold is useful for this
`purpose. Astop 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 resistance to stent move
`ment during delivery and to protect the leading edge of the
`stent during delivery. A proximal stop member similar to
`member 36 (not shown) 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 material, preferably an elastomer
`material and more preferably of a relatively resilient elas
`tomer material, e.g., lower durometer silicone. A preferred
`deformable thermoplastic material is high density polyeth
`ylene (HDPE). Apreferred lower durometer 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 FIG. 4.
`In this embodiment the mounting body 30 is a spiral cut
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`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 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
`partially separating them or fully separating them.
`The embodiment shown in FIG. 6 includes another fea
`ture 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 FIG. 6 which includes the inner 26 having a two-piece
`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
`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 accom
`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
`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 FIGS. 6 and 8, the mounting bodies
`will be ring-like in shape or cylindrical in shape although
`other configurations will be readily apparent to those famil
`iar with this art.
`The above Examples and disclosure are intended to be
`illustrative and not exhaustive. These examples and descrip
`tion will suggest many variations and alternatives to one of
`ordinary skill in this art. All these alternatives and variations
`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.
`What is claimed is as follows:
`1. A stent delivery system comprising:
`a radially expandable stent of generally cylindrical
`configuration, having a first end and a second end and
`a contracted state and an expanded state, and
`a catheter having a shaft having a diameter and expand
`able inflatable means associated therewith at a distal
`part of the shaft, wherein the inflatable means com
`prises a balloon, and including mounting and retaining
`means for receiving the stent on the expandable inflat
`able means for radial expansion of the stent upon
`inflation of the inflatable means, the mounting and
`retaining means including at least one mounting body
`carried on and surrounding the shaft inside the inflat
`able means, the at least one mounting body being
`substantially the same length as the stent and 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 and between the
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`first and second ends of the stent, whereby the diameter
`of the shaft and inflatable portion are increased at the
`distal part for facilitating the mounting and retaining of
`the stent.
`2. The stent delivery system of claim 1 wherein the
`mounting body is of a material which resiliently deforms
`under radial pressure.
`3. The stent delivery system of claim 2 wherein the
`material is elastomeric.
`4. The stent delivery system of claim 2 wherein the
`material comprises high density polyethylene.
`5. The stent delivery system of claim 2 wherein the
`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 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.
`9. The stent delivery system of claim 1, wherein the stent
`has two opposite ends, the stent delivery system further
`including a pair of stops, each of which is respectively
`positioned at the opposite ends of the stent and carried by the
`shaft inside the inflatable means.
`10. The stent delivery system of claim 9 wherein the stops
`are conical in shape.
`11. The stent delivery system of claim 1 further including
`marker bands positioned proximally and distally of the stent.
`12. The stent delivery system of claim 1 further including
`a stop carried by the shaft and positioned inside the inflatable
`means and axially spaced relative to the stent.
`13. A stent delivery system comprising:
`a catheter having a shaft and expandable inflatable means
`associated therewith at a distal part of the shaft, the
`expandable inflatable means comprising a balloon, and
`including mounting and retaining means for receiving
`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
`and retaining means including at least two axially
`spaced mounting bodies inside the balloon and radially
`carried on and surrounding the shaft, the at least two
`mounting bodies 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 each of the at least two mounting bodies are under
`the stent and between the first and second ends of the
`stent, and
`the stent crimped on the balloon and the at least two
`mounting bodies such that opposite end portions of the
`stent are deformed to a diameter less than that of the at
`least two mounting bodies whereby the stent is inter
`locked with the mounting bodies until expansion of the
`stent and inflatable means to prevent accidental move
`ment of the stent along the catheter during delivery.
`14. The stent delivery system of claim 13 wherein the
`stent is generally tubular in shape and the mounting bodies
`are generally cylindrical in shape.
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`15. The stent delivery system of claim 13 wherein a
`portion of the stent between the mounting bodies is crimped
`to a lesser diameter than that of the mounting bodies.
`16. The stent delivery system of claim 15 wherein the
`stent is generally tubular in shape and the mounting bodies
`are ring-like.
`17. The stent delivery system of claim 13 wherein three
`spaced mounting bodies are included and the stent is
`crimped to a lesser diameter between the bodies.
`18. The stent delivery system of claim 17 wherein the
`stent is generally tubular in shape and the mounting bodies
`are ring-like.
`19. 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
`contracted state and an expanded state, and means for
`inflating the balloon, the shaft including at least one mount
`ing body radially carried on the shaft inside the balloon, the
`at least one mounting body being substantially the same
`length as the stent, whereby the diameter of the shaft is
`increased inside the balloon to facilitate mounting of a stent
`to the catheter over the balloon, 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 and between the first and
`second ends of the stent.
`20. The catheter of claim 19 wherein the mounting body
`is of a material which resiliently deforms under radial
`pressure.
`21. The catheter of claim 20 wherein the material is
`elastomeric.
`22. The catheter of claim 20 wherein the material is high
`density polyethylene.
`23. The catheter of claim 20 wherein the material is
`silicone.
`24. The catheter of claim 19 wherein the mounting body
`is configured with at least one separation whereby track
`ability of the catheter is improved.
`25. The catheter of claim 24 wherein the separation is in
`a spiral configuration.
`26. The catheter of claim 19 further including a pair of
`spaced stops.
`27. The catheter of claim 26 wherein the stops are conical
`in shape.
`28. The catheter of claim 19 further including spaced
`marker bands.
`29. The catheter of claim 19 wherein the mounting body
`is cylindrical in shape.
`30. The catheter of claim 19 wherein at least two spaced
`mounting bodies are included.
`31. The catheter of claim 30 wherein the mounting bodies
`are ring-like.
`32. The catheter of claim 19 wherein at least three spaced
`mounting bodies are included.
`33. The catheter of claim 32 wherein the mounting bodies
`are ring-like.
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