(12)Un1ted States Patent
`(10) Patent N0.:
`US 6,202,272 B1
`
`Jackson
`(45) Date of Patent:
`Mar. 20, 2001
`
`USOO6202272B1
`
`(54) HAND-HELD STENT CRIMPING DEVICE
`.
`.
`(GUrSSgg A' JaCks‘m’ Mountam Vlew’ CA
`
`Inventor:
`
`(75)
`
`5,295,420 *
`5,920,975 *
`5,931,851 *
`
`3/1994 Grimes .................................. 81/3.43
`7/1999 Morales .....
`29/282
`
`8/1999 Morales ................................. 29/235
`
`(73) Assignee: Advanced Cardiovascular Systems,
`Inc., Santa Clara, CA (US)
`
`* cited by examiner
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`pjatsenct 1T5:)(bf)ngyc/% 3253]“th under 35
`'
`'
`'
`'
`
`Primary Examiner—Robert C. Watson
`(74) Attorney, Agent, or Firm—Fulwider Patton Lee &
`Utecht, LLP
`
`(21) Appl. N0.: 09/032,472
`
`(22)
`
`Filed:
`
`Feb. 26, 1998
`
`(57)
`
`ABSTRACT
`
`Int. Cl.7 ...................................................... B23P 19/02
`(51)
`(52) US. Cl.
`................................. 29/235, 29/234, 29/268;
`29/270; 29/282; 29/2835; 81/343; 81/64
`(58) Field Of Search .................................... 29/282, 283.5,
`29/268, 234, 235, 270, 751, 516, 280, 294/312,
`81/343, 64; 269/130—132; 606/139, 140,
`194, 108
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`AdeVice for enabling subStamiaHY uniform and tight “mp-
`ing of an intravascular stent onto a balloon catheter assem-
`bly. The stent crimping device includes at least one com-
`pressible and resiliently expandable 100p portion, that is
`expandable radially outwardly to enable supporting of the
`
`stent and catheter assembly thereon, and compressible radi-
`ally inwardly to substantially uniformly and tightly crimp
`the stent onto the balloon catheter assembly.
`
`698,492 *
`
`4/1902 Hart
`
`...................................... 81/343
`
`11 Claims: 3 DraWing Shem
`
`
`
`Edwards Lifesciences v. Boston Scientific
`
`US. Patent No. 6,915,560
`IPR2017-00444 EX. 2047
`
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`US 6,202,272 B1
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`1
`HAND-HELD STENT CRIMPING DEVICE
`
`BACKGROUND OF THE INVENTION
`
`1. Field of the Invention
`
`This invention relates to a stent crimping device of the
`type that will enable the user to crimp a stent onto the distal
`end of a balloon dilatation catheter assembly, for example of
`the kind used in a typical percutaneous transluminal coro-
`nary angioplasty (PTCA) procedure.
`2. Description of the Related Art
`In a typical PTCA procedure, for compressing lesion
`plaque against the artery wall to dilate the artery lumen, a
`guiding catheter is percutaneously introduced into the car-
`diovascular system of a patient
`through the brachial or
`femoral arteries and advanced through the vasculature until
`the distal end is in the ostium. A guidewire and a dilatation
`catheter having a balloon on the distal end are introduced
`through the guiding catheter with the guidewire sliding
`within 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, a flexible, expandable, preformed
`balloon is inflated to a predetermined size with radiopaque
`liquid at relatively high pressures to radially compress the
`atherosclerotic 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 can be withdrawn from the patient’s
`vasculature and blood flow resumed through the dilated
`artery. While this procedure is typical, it is not the only
`method used in angioplasty.
`In angioplasty procedures of the kind referenced above, a
`restenosis of the artery may develop over several months,
`which may require another angioplasty procedure, a surgical
`bypass operation, or some method of repairing or strength-
`ening the area. To reduce the chance of the development of
`restenosis and strengthen the area, a physician can implant
`an intravascular prosthesis for maintaining vascular patency,
`typically called a stent. Astent is a device used to hold tissue
`in place in a vessel or to provide a support for a vessel to
`hold it open so that blood flows freely. Avariety of devices
`are known in the art for use as stents, including expandable
`tubular members, in a variety of patterns, that are able to be
`crimped onto a balloon catheter, and expanded after being
`positioned intraluminally on the balloon catheter, and that
`retain their expanded form. Typically, the stent is loaded and
`crimped onto the balloon portion of the catheter, and
`advanced to a location inside the artery at the lesion. The
`stent is then expanded to a larger diameter, by the balloon
`portion of the catheter, to implant the stent in the artery at the
`lesion.
`
`tightly crimped onto the
`is not
`if the stent
`However,
`catheter balloon portion, when the catheter is advanced in
`the patient’s vasculature the stent may move or even slide off
`the catheter balloon portion in the coronary artery prior to
`expansion, and may block the flow of blood, requiring
`procedures to remove the stent.
`In procedures where the stent is placed over the balloon
`portion of the catheter, the stent must be crimped onto the
`balloon portion to prevent the stent from sliding off the
`catheter when the catheter is advanced in the patient’s
`vasculature. In the past this crimping was often done by
`hand, which does not provide optimum results due to the
`uneven force being applied,
`resulting in non-uniform
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`crimps. In addition, it was difficult to judge when a uniform
`and reliable crimp had been applied. Though some tools,
`such as ordinary pliers, have been used to apply the stent,
`these tools have not been entirely adequate in achieving a
`uniform crimp. Moreover, an unevenly crimped stent may
`result in an unevenly expanded stent in the vessel or artery,
`which is undesirable.
`
`SUMMARY OF THE INVENTION
`
`This invention is directed to a vascular prosthesis crimp-
`ing device which enables substantially uniform and tight
`crimping of a stent onto a catheter balloon portion, to better
`secure the stent onto the catheter for delivery of the stent
`through the patient’s vasculature.
`The present invention attempts to solve several problems
`associated with crimping stents onto balloon catheters.
`In an exemplary embodiment of the present invention, the
`stent crimping device includes a compressible and resiliently
`expandable loop portion (e.g., mylar, nylon, nickel-titanium
`(NiTi), polymide) in the tip of a hand tool (or mechanical
`device such a a pneumatic cylinder), connected to the distal
`end of jaw portions of the hand tool. The loop portion is
`compressible radially inwardly by the application of com-
`pressive force to the hand tool by the user, to substantially
`uniformly and tightly crimp the stent onto the balloon
`catheter assembly. The loop portion is further expandable
`upon release by the user of the compressive force applied to
`the hand tool, to enable the loop portion to resiliently expand
`for enabling another stent and balloon catheter assembly to
`be supported therein for crimping.
`The device enables the stent to be crimped onto the distal
`end of a balloon catheter substantially uniformly and tightly,
`reducing the risk that the stent may slide off the catheter
`balloon portion. It is further easy to use in performing the
`stent crimping procedure. It also enables the crimping pro-
`cedure to be repeatably performed on stent and balloon
`catheter assemblies with substantially repeatable crimping
`force applied thereto.
`These and other advantages of the invention will become
`more apparent from the following detailed description
`thereof when taken in conjunction with the accompanying
`drawings.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a side elevational view of an exemplary embodi-
`ment of the present invention, in which the loop portion of
`the hand tool is in expanded condition for supporting the
`stent positioned on the catheter balloon portion.
`FIG. 2 is an elevational view of the exemplary embodi-
`ment of the present invention in the expanded loop portion
`condition as shown in FIG. 1.
`
`FIG. 3 is a side elevational view of the exemplary
`embodiment of the present invention in which the loop
`portion of the hand tool is in compressed condition for
`substantially uniformly and tightly crimping the stent onto
`the catheter balloon portion.
`FIG. 4 is an elevational view of the exemplary embodi-
`ment of the present invention in compressed loop portion
`condition as shown in FIG. 3.
`
`FIG. 5 is an elevational partly-fragmentary end view of
`the stent and balloon catheter supporting member, prior to
`crimping the stent onto the balloon catheter, taken along line
`5—5 in FIG. 2.
`
`FIG. 6 is similar to the FIG. 5 view, after crimping the
`stent onto the balloon catheter.
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`US 6,202,272 B1
`
`3
`FIG. 7 is a partial cross-sectional view depicting another
`embodiment of the invention where a plurality of loops are
`tightened by a thumbscrew to compress the stent onto the
`distal end of the catheter.
`
`FIG. 8 is a cross-sectional view taken along lines 8—8
`depicting the wire loops of FIG. 7.
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`
`Device 10 comprises a tool 20 for enabling substantially
`uniform and tight crimping of an intravascular stent A onto
`the collapsed balloon portion B adjacent to the distal end C
`of a balloon catheter assembly D. In the exemplary embodi-
`ment of device 10, as shown in FIGS. 1—4, tool 20 is adapted
`to be held in the hand of the user, so as to enable stentA and
`catheter D to be supported in tool 20, and to enable the user
`to apply compressive force to tool 20 to substantially
`uniformly and tightly crimp stent A on catheter D.
`Tool 20 includes a pair of arms 22, each arm 22 having
`handle portions 24 and opposed jaw portions 26. The arms
`are pivotally interconnected by pivot pin 28, and normally
`held in expanded condition by coil spring 30. Spring 30
`extends between and biases handle portions 24 in normally
`expanded condition, biasing jaw portions 26 and connecting
`portions 34 in normally compressed condition and loop
`portion 36 in normally expanded condition. Spring 30 com-
`prises a compressed spring. In the expanded condition of
`handle portions 24, jaw portions 26 are compressed, and in
`a compressed condition of handle portions 24, jaw portions
`26 are expanded.
`Tool 20 further includes a crimping member 32, con-
`nected to the distal ends of jaw portions 26, for supporting
`stent A and catheter D therein. Member 32 includes portions
`34 for connecting supporting member 32 to jaw portions 26,
`and at least one compressible loop portion 36 wherein the
`portion of balloon catheter assembly D with stent A loaded
`thereon may be supported. Supporting member 32 is com-
`prised of compressible and resiliently expandable material,
`such that upon expansion of jaw portions 26 by compression
`of handle portions 24, jaw end portions 34 are expanded and
`loop portion 36 is compressed radially inwardly to substan-
`tially uniformly and tightly crimp stentA onto catheter D (or
`any stent delivery device). Upon compression of jaw por-
`tions 26, by releasable expansion of handle portions 24,
`distal jaw end portions 34 are drawn together and loop
`portion 36 is expanded radially outwardly to support stent A
`and balloon catheter portion B therein.
`In one embodiment as shown in FIGS. 2 and 4, loop
`portion 36 comprises a tubular sleeve including a plurality of
`discrete spaced apart interconnected loops 37, wherein the
`length of the sleeve is at least as long as the length of stent
`A and the diameter of the sleeve is greater than the diameter
`of stent A. Alternatively, the sleeve may comprise a con-
`tinuous tubular or cylindrical loop portion 36. FIGS. 2 and
`4 depict loops 37 having a rectangular cross-section such as
`in a ribbon. Alternatively, loop portion 36 may be formed
`from a wire having a round cross-sectional shape, or other
`cross-sectional shapes known in the art.
`The sleeve may also include a slotted mount, to enable
`tightening or loosening thereof dependent upon the size
`profiles of catheter D and stent A to be crimped thereon.
`Member 32 may comprise a threaded-capstan-sleeve
`configuration, or alternatively a wire loop or plurality of
`wire loops, such as a guitar-string-type mechanism for
`tightening or loosening the sleeve depending upon the
`profile and material of catheter balloon portion B on which
`stent A is to be crimped, for enabling tighter crimping.
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`to load stent A onto collapsed balloon
`In operation,
`portion B of balloon catheter assembly D, catheter balloon
`portion B is inserted in stent A so that stent A overlies
`balloon portion B. To enable stent A to be crimped onto
`catheter balloon portion B or other mechanism for delivering
`or deploying a stent, stent A and catheter balloon portion B
`may be inserted into and supported in the middle of loop
`portion 36 of tool supporting member 32. At this point, stent
`A is not crimped onto catheter assembly D, because stent A
`has not been compressed.
`To crimp stentA onto catheter balloon portion B, the user
`of tool 20 compresses handle portions 24 together against
`the biasing force of compressed spring 30. As handle por-
`tions 24 are compressed, jaw portions 26 and connecting
`portions 34 expand, and loop portion 36 compresses radially
`inwardly, compressing stent A radially inwardly and tightly
`onto catheter balloon portion B at a substantially uniform
`rate.
`
`If further crimping of stentAonto catheter balloon portion
`B is desired, the user may rotate the crimped stent A and
`catheter balloon portion B and/or move them forward or
`backward in loop portion 36, and repeat
`the crimping
`procedure until stent A is as tightly crimped on catheter
`balloon portion B as desired.
`After stent A has been crimped onto catheter balloon
`portion B, the user may release handle portions 24, which
`expand under the biasing force of compressed spring 30. As
`handle portions 24 expand, jaw portions 26 and connecting
`portions 34 compress, and loop portion 36 expands radially
`outwardly, enabling removal of the crimped stent and cath-
`eter balloon portion from loop portion 36. Balloon catheter
`assembly D, with stent A crimped thereon, may then be
`inserted into the body of the patient for deployment of stent
`A therein.
`
`In another embodiment of the invention, as depicted in
`FIGS. 7 and 8, a plurality of wire loops 40 are wound around
`thumbscrew 41. A thumbscrew 41 is tightened, for example
`by hand, wire loops 40 will become smaller. Support mem-
`ber 42 supports thumbscrew 41 and provides a basis for the
`thumbscrew threads to engage and tighten and draw down
`wire loops 40. As the diameter of wire loops 40 decrease, a
`stent mounted on the balloon portion of the catheter, as
`depicted in prior drawing figures, can be inserted in the
`loops and compressed onto the balloon portion of the
`catheter. The amount of force applied in crimping the stent
`is a matter of choice. The embodiment of FIGS. 7 and 8 can
`
`be incorporated into the device depicted in FIGS. 1—6.
`While in the preferred embodiment the stent described is
`intended to be an intraluminal vascular prosthesis for use
`within a blood vessel, and the balloon delivery catheter is of
`the same as or similar to that used in therapeutic coronary
`angioplasty, it will be appreciated by those skilled in the art
`that modifications may be made to the present invention to
`allow the present invention to be used to load any type of
`prosthesis. The present invention is not limited to stents that
`are deployed in a patient’s vasculature, but has wide appli-
`cations to loading any type of graft, prosthesis, liner or
`similar structure. Furthermore, the stent may be delivered
`not only into coronary arteries, but into any body lumen.
`Other modifications can be made to the present invention by
`those skilled in the art without departing from the scope
`thereof.
`What is claimed is:
`
`1. Adevice for crimping a stent onto a balloon catheter or
`other stent delivery assembly, comprising:
`means for supporting a portion of the balloon catheter
`assembly on which the stent may be loaded, including
`
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`US 6,202,272 B1
`
`5
`a compressible portion including a plurality of loops
`with opposed ends which loops are substantially uni-
`formly compressible radially inwardly upon the appli-
`cation of force thereto to substantially uniformly and
`tightly crimp the stent onto the catheter portion, and is
`resiliently expandable radially outwardly upon release
`of the applied force to support the stent and catheter
`portion therein; and
`means for enabling force to be applied to the supporting
`means including a pair of pivotally connected handles
`having jaws, wherein the opposed ends of the plurality
`of loops are attached to the jaws, adapted to be held in
`the hand of the user so as to enable the user to apply
`compressive force thereto to generate substantially
`uniform compression, radially inwardly, of the com-
`pressive portion of the supporting means, for substan-
`tially uniformly and tightly crimping the stent onto the
`catheter portion.
`2. A device as in claim 1, further comprising means for
`biasing the force applying means so as to bias the compress-
`ible portion of the supporting means in normally expanded
`condition.
`
`3. A device as in claim 1, wherein the supporting means
`comprise a wire, and the compressible portion comprises a
`plurality of loops supporting the stent and catheter portion
`and enabling substantially uniform and tight crimping of the
`stent onto the catheter portion.
`4. A device as in claim 1, wherein the force application
`enabling means comprise a pair of pivotally connected arms,
`each including a handle portion and an opposed jaw portion,
`means for pivotally connecting the pair of arms together
`such that upon expanding the handle portions the jaw
`portions compress, and upon releasing compression of the
`handle portions the jaw portions expand, and means for
`connecting the supporting means to the jaw portions such
`
`6
`that upon releasing compression of the jaw portions the
`compressible portion of the supporting means compress, and
`upon compressing the jaw portions the compressible portion
`of the supporting means expand.
`5. A device as in claim 2, wherein the biasing means
`comprise a compressed spring.
`6. A device as in claim 1, further comprising means for
`enabling adjustment of the size of the plurality of loops
`dependent upon the size of the stent and catheter portion to
`be supported therein.
`7. A device as in claim 4, wherein the supporting means
`further comprise portions for connecting the supporting
`means to the connecting means.
`8. A device as in claim 4, further comprising means for
`biasing the handle portions in normally expanded condition.
`9. A device as in claim 8, wherein the biasing means
`comprise a compressed spring.
`10. A device for crimping a stent onto the expandable
`portion of a catheter, comprising:
`a pair of handles pivotally connected at a common hinge
`to a pair of opposed jaws;
`a wire having a rectangular cross-section and having a
`plurality of loops and disposed between and attached to
`the opposed jaws;
`a spring disposed between the pair of handles for biasing
`the handles apart, whereby application of force to close
`the handles causes the opposed jaws to pivotally move
`apart so that the at least one wire loop becomes smaller
`in diameter.
`11. A device as in claim 10, wherein the diameter of the
`at least one wire loop is adjustable for receiving stents and
`catheters of various dimensions.
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENT NO.
`DATED
`
`INVENTOR(S)
`
`2 6,202,272 B1
`: March 20, 2001
`: Greg A. Jackson
`
`Page 1 of 1
`
`It is certified that error appears in the above-identified patent and that said Letters Patent is
`hereby corrected as shown below:
`
`Title p_age,
`Under ”U.S. PATENT DOCUMENTS", add the following:
`—— 2,452,857
`1 1/1948
`Mesaros
`4,907,336
`3/ 1 990
`Gianturco
`5,132,066
`7/1992
`Charlesworth, et a1.
`5,133,732
`7/1992
`Witkor
`5,183,085
`2/ 1993
`Timmerman
`5,209,143
`5/1993
`Swee --.
`
`Title page,
`After "5,931,851 * 8/1999 Morales", add -- FOREIGN PATENT DOCUMENTS
`0 873 371 A 10/1998 EP --.
`
`
`Column 5
`
`Lines 24 through 27, claim 3, delete four lines of text beginning with " and the
`compressible. . .".
`Line 29 and 30, claim 4, delete " a pair of pivotally connected arms each including
`a handle portion and an opposed jaw portion".
`Line 31, change "arms", to read -- handles --.
`Lines 32 and 33, change "handle portions the jaw portions", to read -— handles the jaws--
`Line 34, change "handle portions the jaw portions", to read —- handle the jaws --.
`Line 35, change, "jaw portions", to read -- jaws —-.
`
`
`Column 6
`
`Line 1, change "jaw portions", to read -- jaws -—.
`Line 3, change "jaw portions”, to read -— jaws ——.
`
`Arrest.-
`
`Signed and Sealed this
`
`Twenty-third Day of October, 2001
`
`77,64,124 P. Ma,
`
`Arresting Officer
`
`Acting Director of the United Slates Patent and Trudcnmrk Office
`
`NICHOLAS P. GODlCI
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`Page 8 of 8
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