Ulllted States Patent [19]
`Morales
`
`[54] STENT CRIMPING DEVICE AND METHOD
`OF USE
`
`[75] Inventor: Stephen A. Morales, Mountain View,
`Calif
`
`[73] Assignee; Advanced Cardiovascular Systems,
`Inc., Santa Clara, Calif.
`
`21 A l. N .: 09 169 270
`[
`1
`pp
`0
`/
`’
`[22] Filed:
`Oct. 9, 1998
`
`[51] Int. cl.7 .................................................... .. A61F 11/00
`
`[52] US‘ Cl‘ ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' '
`' ' ' ' ' ' ' ' " 606/108
`[58] Field of Search ................................... .. 606/108, 194,
`606/198; 623/1, 11, 12
`
`[56]
`
`References CIted
`
`US' PATENT DOCUMENTS
`3/1902 Williams .
`696,289
`8/1984 Enlmann et a1- -
`4,468,224
`3/1986 Schiff .
`4,576,142
`2/1987 Schiff .
`4,644,936
`7/1987 Cho et a1‘ '
`476817092
`.
`4 697 573 10 1987 S h ff.
`4Z9OIZ7O7 22990 szhifp
`
`4,907,336
`5,189,786
`
`3/1990 Gianturco.
`3/1993 IShikaWa et 8.1..
`.
`.
`8/1995 Wllllams et a1. .
`5,437,083
`8/1996 Williams et a1. '
`5,546,646
`5/1997 Cottone, 11..
`5,626,604
`8/1997 Rupp et a1. .
`5,653,691
`9/1997 Verbeek.
`5,672,169
`4/1998 Williams et a1. .
`5,738,674
`5/1998 Green et a1. .
`5,746,764
`7/1998 Dunham.
`5,783,227
`7/1998 Schatz _
`577857715
`5,836,952 11/1998 Davis et a1_ _
`
`FOREIGN PATENT DOCUMENTS
`159065 2/1921 United Kingdom _
`WO 98/14120 4/1998 WIPO .
`WO 98/19633
`5/1998 WIPO .
`
`US006051002A
`[11] Patent Number:
`[45] Date of Patent:
`
`6,051,002
`Apr. 18, 2000
`
`OTHER PUBLICATIONS
`
`US. Patent Application Serial No. 08/795,335 ?led Feb. 4,
`1997 NO Drawlngs 2}“: enclosed
`US. Patent Application Serial No. 08/837,771 ?led Apr. 22,
`1997.
`US. Patent Application Serial No. 08/893,936 ?led Jul. 15,
`1997~
`US. Patent Application Serial No. 08/962,632 ?led Nov. 3,
`1997.
`US. Patent Application Serial No. 09/024,910 ?led Feb. 17,
`1998.
`S ~lN .09030261?l dF b.25
`t'
`U.S.P t tA l'
`19% a 6“ pp lea 10H em 0
`/
`’
`e
`e
`’
`
`US. Patent Application Serial No. 09/063,905 ?led Apr. 21,
`1998'
`US. Patent Application Serial No. 09/063,587 ?led Apr. 21,
`1998.
`US. Patent Application Serial No. 09/069,010 ?led Apr. 28,
`1998.
`US. Patent Application Serial No. 09/069,011 ?led Apr. 28,
`1998.
`US. Patent Application Serial No. 09/072,925 ?led May 5,
`1998_
`
`.
`.
`.
`US. Patent Application Serial No. 09/123,844 ?led Jul. 28,
`1998 Lost? Not available.
`.
`The eXTraordlnary Stent, C.R. Bard Brochure (Undated).
`
`-
`.
`-
`.
`Primary Exammer MlchaelBulZ
`Assistant Examiner—Vy Q. Bui
`_
`_
`Attorney, Agent, or Ftrm—FulWlder Patton Lee & Utecht
`
`ABSTRACT
`[57]
`A pivotally-engageable device for enabling uniform and
`tight crimping of an intravascular stent onto a balloon
`catheter assembly. The stent crimping device includes at
`least one releasable loop portion that enables the stent and
`catheter assembly to be supported therein. The ends of the
`loop portion are moved in opposite directions thereby reduc
`ing the siZe of loop radially inWardly to uniformly and
`tightly crimp the stent onto the balloon catheter assembly.
`
`12 Claims, 7 Drawing Sheets
`
`Page 1 of 13
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`

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`U.S. Patent
`US. Patent
`
`Apr. 18,2000
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`Sheet 1 0f 7
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`Page 2 of 13
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`U.S. Patent
`US. Patent
`
`Apr. 18,2000
`Apr. 18, 2000
`
`Sheet 2 0f 7
`Sheet 2 0f 7
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`6,051,002
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`Page 3 of 13
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`Page 3 of 13
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`U.S. Patent
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`Apr. 18,2000
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`Sheet 3 0f 7
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`Page 4 of 13
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`U.S. Patent
`US. Patent
`
`Apr. 18,2000
`Apr. 18, 2000
`
`Sheet 4 0f 7
`Sheet 4 0f 7
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`6,051,002
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`Page 5 of 13
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`Apr. 18, 2000
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`Page 7 of 13
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`Page 7 of 13
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`U.S. Patent
`US. Patent
`
`Apr. 18,2000
`Apr. 18, 2000
`
`Sheet 7 0f 7
`Sheet 7 0f 7
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`6,051,002
`6,051,002
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`Page 8 of 13
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`Page 8 of 13
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`

`

`1
`STENT CRIMPING DEVICE AND METHOD
`OF USE
`
`6,05 1,002
`
`2
`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
`crimps. In addition, it Was dif?cult to judge When a uniform
`and reliable crimp had been applied. Though some tools,
`such as ordinary pliers, have been used to crimp the stent,
`these tools have not been entirely adequate in achieving an
`effective crimp. Moreover, an ineffectively crimped stent
`may result in an ineffectively expanded stent in the vessel or
`artery, Which is undesirable.
`
`SUMMARY OF THE INVENTION
`
`The invention is directed to a crimping tool and method
`of use for enabling effective crimping of a stent onto the
`balloon portion of a catheter in order to better secure a stent
`onto the catheter for loW-pro?le delivery of the stent through
`the patient’s vascular system. The present invention
`attempts to solve several problems associated With crimping
`stents onto balloon catheters.
`In an exemplary embodiment ofthe present invention, the
`stent crimping tool includes a pair of handles pivotally
`engaged such that a ?rst handle member receives Within it a
`second handle member. The invention further includes a
`cylindrical loop crimping member comprising a ?exible
`sheet or ?lm of material, such as a thin piece of Mylar
`material, in the form of a loop. The ends of the loop are
`attached respectively to the ?rst handle and the second
`handle. An application of force on the handles causes the
`prospective ends of the cylindrical loop to move in opposite
`directions thereby providing a tension force Which results in
`reducing the opening of the cylindrical loop.
`The invention further provides for mounting a stent on the
`balloon portion of a catheter, and positioning the stent and
`balloon portion of the catheter Within the cylindrical loop.
`As the handles of the stent crimping tool are compressed, the
`ends of the cylindrical loop are pulled in opposite directions
`thereby reducing the siZe of the loop and tightly compress
`ing the stent in a uniform manner on the balloon portion of
`the catheter.
`By releasing the handles, Which are biased open, the
`cylindrical loop returns to its original siZe, thereby permit
`ting the stent and balloon portion of the catheter to be
`removed from the cylindrical loop.
`In one embodiment of the invention, the cylindrical loop
`is formed from a substantially non-stretchable plastic mate
`rial having a high tensile strength and a loW modulus.
`One of the handles of the stent crimping tool includes
`reference indicia relative to the other handle member so that
`the reference indicia correspond to the crimping diameter of
`the cylindrical loop. As the tWo handles are compressed one
`into the other, the reference indicia Will indicate the siZe or
`diameter of the cylindrical loop, and thereby determine the
`ultimate travel and thus, the resultant crimped diameter of
`the stent onto the balloon portion of the catheter.
`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.
`
`BACKGROUND OF THE INVENTION
`
`This invention relates to a stent crimping device of the
`type that Will enable the user to uniformly and tightly crimp
`a stent onto the distal end of a catheter assembly, for
`example of the kind used in a typical percutaneous translu
`minal coronary angioplasty (PTCA) procedure or percuta
`neous transluminal angioplasty (PTA) procedure.
`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 guide Wire and a dilatation
`catheter having a balloon on the distal end are introduced
`through the guiding catheter With the guide Wire sliding
`Within the dilatation catheter. The guide Wire is ?rst
`advanced out of the guiding catheter into the patient’s
`coronary vasculature, and the dilatation catheter is advanced
`over the previously advanced guide Wire until the dilatation
`balloon is properly positioned across the lesion. Once in
`position across the lesion, a ?exible, expandable, preformed
`balloon is in?ated to a predetermined siZe 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 de?ated to
`a small pro?le, so that the dilatation catheter can be With
`draWn from the patient’s vasculature and blood ?oW
`resumed through the dilated artery. While this procedure is
`typical, it is not the only method used in angioplasty. Other
`methods for compressing plaque or removing it are knoWn,
`such as atherectomies or use of plaque dissolving drugs.
`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 likelihood of the development
`of restenosis and strengthen the area, a physician can
`implant an intravascular prosthesis for maintaining vascular
`patency, typically called a stent. A stent 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 ?oWs freely. Avariety of
`devices are knoWn in the art for use as stents, including
`expandable tubular members, in a variety of con?gurations,
`that are able to be crimped onto a balloon catheter, and
`expanded after being positioned intraluminally on the bal
`loon 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. Examples of stents and delivery
`catheters of the type described herein are disclosed in more
`detail in US. Pat. No. 5,102,417 (PalmaZ); US. Pat. No.
`5,569,295 (Lam); and US. Pat. No. 5,514,154 (Lau et al.).
`If the stent is not effectively crimped onto the catheter
`balloon portion When the catheter is advanced in the
`patient’s vasculature, the stent may move or possibly slide
`off the catheter balloon portion in the coronary artery prior
`to expansion, and may block the ?oW 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 compressed or
`crimped onto the balloon portion to prevent the stent from
`
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`BRIEF DESCRIPTION OF THE DRAWINGS
`
`65
`
`FIG. 1 is a perspective vieW of an exemplary embodiment
`of the present invention, in Which the pivotally-engaging
`member is pivoted into engagement With the receiving
`member.
`
`Page 9 of 13
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`

`

`6,05 1,002
`
`3
`FIG. 2 is a plan vieW of the ?rst handle member of the
`crimping tool.
`FIG. 3 is a plan vieW depicting the second handle member
`of the crimping tool, Which is con?gured for slidably engag
`ing the ?rst handle member of FIG. 2.
`FIG. 4 is a plan vieW depicting the ?rst and second handle
`members pivotally engaged so that the cylindrical loop is
`positioned for receiving a stent for crimping onto the balloon
`portion of a catheter.
`FIG. 5 is a plan vieW depicting the second handle member
`squeezed into the ?rst handle member thereby restricting the
`diameter of the cylindrical loop Which provides the crimping
`force on the stent.
`FIGS. 6—9 are side elevational vieWs depicting a series of
`crimping steps Wherein the cylindrical loop gradually tight
`ens onto the stent thereby crimping it onto the balloon
`portion of the catheter as the loop ends are moved in
`opposite directions.
`FIG. 10 is a perspective vieW of the cylindrical loop With
`the stent and the balloon portion of the catheter positioned
`Within the loop.
`FIG. 11 is a plan vieW depicting one preferred embodi
`ment of the cylindrical loop in an uncoiled and ?attened
`con?guration.
`FIGS. 12A—12C are perspective vieWs depicting various
`embodiments of protective sheaths.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`
`The present invention provides for a crimping tool Which
`uniformly and tightly crimps an expandable stent onto a
`catheter, such as a balloon catheter, so that the stent remains
`removably attached to the catheter until the stent and cath
`eter are positioned in a body lumen. In keeping With the
`invention, device 10 comprises crimping tool 20 for
`enabling effective crimping of an intravascular stent 11 onto
`the collapsed balloon portion 12 adjacent the distal end 13
`of a balloon catheter assembly 14. In the exemplary embodi
`ment of device 10, as shoWn in FIGS. 1—5, crimping tool 20
`is adapted to be held in the hand of the user, so as to enable
`stent 11 and catheter 14 to be supported in tool 20, and to
`enable the user to apply compressive force to tool 20 to
`crimp stent 11 on catheter 14.
`Crimping tool 20 includes ?rst handle member 22, second
`handle member 24 pivotally movable into engagement With
`?rst handle member 22 in a generally pendulum-like
`movement, and pin 26 pivotally connecting the upper por
`tions of ?rst handle member 22 and second handle member
`24. First handle member 22 and second handle member 24
`are engageable and generally complementary and preferably
`someWhat triangular in shape to ergonomically ?t the hand,
`and include slots 28 and 30 therein Which are preferably
`someWhat arcuate-shaped. Preferably, ?rst handle member
`22 is con?gured to receive second handle member 24.
`Crimping tool 20 further includes crimping member 32
`Which is disposed Within slots 28,30 Which is adapted to
`receive stent 11 mounted on balloon portion 12 of the
`catheter assembly 14. Crimping member 32 includes cylin
`drical loop 34 having ?rst end 36 and second end 38. First
`end 36 of cylindrical loop 34 is attached to ?rst attachment
`member 40 on ?rst handle member 22. Second end 38 of
`cylindrical loop 34 is attached by second attachment mem
`ber 42 to second handle member 24. First attachment
`member 40 and second attachment member 42 can be of any
`design Which can removably attach ?rst end 36 and second
`
`4
`end 38 respectively to the ?rst and second handle members.
`As an example, ?rst attachment member 40 and second
`attachment member 42 can include a snap or jaW-like
`member Which grips ?rst end 36 and second end 38 of
`cylindrical loop 34. It is intended, for example, that cylin
`drical loop 34 be replaceable When it Wears out.
`While cylindrical loop 34 can have various con?gurations
`to suit particular needs, a preferred embodiment is shoWn in
`FIG. 11. Thus, ?rst end 36 of the cylindrical loop is attached
`to ?rst attachment member 40 on ?rst handle member 22 and
`second end 38 is attached by second attachment member 42
`to second handle member 24. As indicated, the ?rst and
`second attachment members can be of any design Which can
`removably attach the ?rst and second ends of the cylindrical
`loop to the handle members. In the FIG. 11 embodiment,
`apertures 44,46 are provided as convenient attachment
`means to correspond With a snap or jaW-like member on the
`handle members to help grip and removably attach ?rst and
`second ends 36,38. A slot 48 is provided in the cylindrical
`loop to receive ?rst end 36 to form the loop. Flanges 49 are
`provided to prevent the loop overtravel. The Width 45 of the
`cylindrical loop should coincide With the length of the stent
`Which typically is from about 6 mm to 30 mm. The Width
`can be selected to accommodate either shorter or longer
`stents as necessary. Preferably, Width 45 is selected so that
`the full length of the stent is covered by the cylindrical loop
`since it generally is undesirable to crimp less than the entire
`stent length at one time. The cylindrical loop can be formed
`of any non-stretchable material, and preferably is formed of
`Mylar or a similar ?exible, but non-stretchable plastic mate
`rial.
`In a manufacturing context, the crimping tool can be used
`repeatedly to crimp stents onto the balloon portion of
`catheters. Repeated use Will result in the cylindrical loop
`Wearing out, Whereby it should be replaced. Thus, it is
`contemplated that ?rst attachment member 40 second attach
`ment member 42 provide means for releasing the ends of the
`cylindrical loop and accepting ends of a replacement cylin
`drical loop for further use. Additionally, an adhesive may be
`used to permanently attach ?rst end 36 and second end 38 to
`the handle members, for use in those situations Where the
`crimping tool 20 is designed for a single-use application, as
`Will be described.
`Crimping tool 20 also is adapted for a single-use
`application, for example, by a cath lab physician or cath lab
`personnel. In that situation, crimping tool 20 can be dis
`carded after the stent is crimped onto the balloon portion of
`the catheter. Further, ?rst attachment member 40 and second
`attachment member 42 can be a permanent attachment, as
`opposed to a removable attachment to attach the ends of the
`cylindrical loop to the handle members.
`In the preferred method of use, as shoWn in FIGS. 6—10,
`stent 11 is ?rst positioned over balloon portion 12 by hand,
`and then catheter assembly 14 is moved Within cylindrical
`loop 34 to receive the crimping procedure. For ease of
`illustration, FIGS. 6—10 depict loop 34 as having no or very
`little Width, hoWever, loop 34 should preferably have a Width
`that approximates the length of the stent, Which typically
`may be 20 mm or more as previously described for thc FIG.
`11 embodiment. First handle member 22 and second handle
`member 24 are compressed together thereby moving ends
`36, 38 in opposite directions as depicted in FIGS. 6—9. As the
`opening of cylindrical loop 34 becomes smaller, the loop
`tightens around stent 11 thereby crimping it onto the balloon
`portion of the catheter. Reference indicia 50 on second
`handle member 24 corresponds to the siZe or diameter of
`cylindrical loop 34. Thus, one using the crimping tool can
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`6,05 1,002
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`easily determine the crimping force, and importantly, the
`crimped diameter of the stent on the balloon portion of the
`catheter. Thus, the reference indicia correspond to the ?nal
`diameter, or crimped diameter of the stent, thereby taking
`the guesswork out of the crimping procedure as it relates to
`the amount of force applied to the stent and the ?nal crimped
`diameter.
`The ?rst and second handle members are biased open,
`such as by a coil spring or other biasing means, so that When
`the compressive force of the user’s hand is released, the
`handles Will move open and aWay from each other. When the
`handles move open, cylindrical loop 34 has enough resil
`iency in the material that it naturally Will open, alloWing the
`crimped stent and balloon catheter assembly to be With
`draWn.
`In each of the embodiments of the crimping tool, sheath
`60 can be positioned over the stent, preferably prior to
`crimping the stent. The sheath can have various con?gura
`tions such as those shoWn in FIGS. 12A—12C, and prefer
`ably has sufficient length and Wall thickness to cover the
`stent and uniformly distribute the crimping forces applied to
`the stent by crimping tool 20. As the crimping tool applies
`force to the sheath, the force is evenly distributed over the
`sheath and hence to the stent. The sheath can be left on the
`stent after crimping and provide a cover to protect the stent
`in a safe manner until just before the stent is implanted in the
`patient.
`In one preferred embodiment of sheath 60, slots 61 are
`formed in the sheath so that strips 62 in betWeen the slots
`cover speci?c portions of the stent to prevent ?sh scaling
`during the crimping process. Fish scaling, Which results
`from portions of the stent moving radially outWardly due to
`uneven crimping forces, can occur during the crimping
`process With some stent con?gurations. Thus, strips 62 are
`positioned over portions of the stent susceptible to ?sh
`scaling to counteract the effect and maintain a cylindrical
`geometry in the stent.
`The sheath can be formed from an elastic material knoWn
`in the art and can have various thicknesses depending on the
`particular stent con?guration. Slots 51 or other apertures 54
`are formed in the sheath using a laser or by other means
`knoWn in the art. The sheath is removed prior to implanting
`the stent in the patient.
`It is contemplated that the present invention crimping tool
`20 can be used in a manufacturing facility having a sterile
`environment to be used multiple times to crimp multiple
`stents on catheter assemblies. It is also contemplated that the
`crimping tool 20 Will be used for single use applications by
`cath lab personnel, Where a stent is crimped onto the balloon
`portion of a catheter, and the tool is then discarded, since
`there is no assurance that the tool can be steriliZed after the
`single use application in the cath lab.
`While certain dimensions and materials of manufacture
`have been described herein, modi?cations can be made
`Without departing from the scope and spirit of the invention.
`While in the preferred embodiment the stent described is
`intended to be an intraluminal vascular prosthesis for use
`Within a blood vessel, such as a saphenous vein, coronary
`artery, carotid artery, etc., and the balloon delivery catheter
`is of the same or similar to that used in therapeutic coronary
`angioplasty, it Will be appreciated by those skilled in the art
`that modi?cations may be made to the present invention to
`alloW the present invention to be used to crimp any type of
`stent onto any catheter. The present invention is not limited
`to stents that are deployed in a patient’s vasculature, but has
`Wide applications to loading any type of graft, prosthesis,
`
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`6
`liner or similar structure. Furthermore, the stent may be
`delivered and implemented not only into coronary arteries,
`but into any body lumen. Other modi?cations can be made
`to the present invention by those skilled in the art Without
`departing from the scope thereof.
`What is claimed is:
`1. A device for crimping a stent onto a balloon catheter
`assembly, comprising:
`a pair of handles including a ?rst handle member con?g
`ured for pivotable engagement With a second handle
`member and a pivot pin extending through each of the
`handle members;
`a crimping member including a strip that is looped and
`having a ?rst end and a second end, the ?rst end being
`attached to the ?rst handle member and the second end
`being attached to the second handle member;
`the looped strip forming a substantially cylindrical loop
`for receiving the stent and balloon catheter assembly,
`Whereby the stent and balloon catheter assembly are
`positioned Within the cylindrical loop and the ?rst and
`second handle members are squeeZed together so that
`the ?rst and second ends of the crimping member move
`in opposite directions thereby constricting the cylindri
`cal loop to a smaller diameter and forcibly compressing
`the stent onto the balloon catheter assembly.
`2. A device as in claim 1, Wherein the second handle
`member is con?gured to receive the ?rst handle member
`When the handle members are squeeZed together.
`3. A device as in claim 1, Wherein the ?rst and second
`handles are ergonomically shaped in a substantially
`triangular-shaped con?guration to ?t the hand.
`4. A device as in claim 1, Wherein the crimping member
`is formed from a non-stretchable plastic material.
`5. A device as in claim 4, Wherein the non-stretchable
`plastic material includes material having a high tensile
`strength and a loW elastic modulus.
`6. A device as in claim 1, Wherein the handles are formed
`from a rigid plastic.
`7. Adevice as in claim 1, Wherein the ?rst handle member
`includes reference indicia relative to the second handle
`member so that the reference indicia correspond to the
`crimping diameter of the cylindrical loop.
`8. Adevice as in claim 1, Wherein the ?rst handle member
`and the second handle member include a ?rst attachment
`member and a second attachment member respectively
`associated thereWith for attaching the ?rst end and the
`second end of the crimping member to the ?rst handle
`member and the second handle member.
`9. A device for crimping a stent onto a balloon catheter
`assembly, comprising:
`?rst and second handles pivotably connected at a common
`location;
`a strip curved into a loop and having ?rst and second ends,
`Wherein the ?rst end is attached to the ?rst handle and
`the second end is attached to the second handle;
`Wherein the stent and balloon assembly are positioned
`Within the loop, and squeeZing the handles pulls the
`?rst and second ends in opposite directions collapsing
`the loop and crimping the stent onto the balloon assem
`bly.
`10. The crimping device of claim 9, Wherein the ?rst and
`second handles each includes opposite ends and the handles
`are pivotably connected at a common end, and Wherein each
`handle includes a slot formed adjacent to the hinged ends
`and the loop is disposed in the slot.
`11. The crimping device of claim 9, Wherein the strip
`includes a slot and the ?rst end of the strip passes through
`the slot.
`
`Page 11 of 13
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`

`

`7
`12. A method of crimping an intravascular stent onto a
`balloon catheter assembly, comprising:
`positioning an intravascular stent over the balloon portion
`of the catheter assembly;
`placing the stent and balloon portion of the catheter
`assembly in a radially compressible device;
`disposing the stent and balloon portion of the catheter
`Within a strip curved into a cylindrical loop having a
`pair of ends, the pair of ends being attached to a pair of
`handle members hinged for pivotal movement;
`
`6,05 1,002
`
`8
`applying leveraged pivotably-engageable compressive
`force to the pair of handle members to pull the ends and
`collapse the loop to crimp the stent onto the balloon
`portion of the catheter; and
`releasing the compressive force, to enable removal of the
`crimped stent and the balloon portion of the catheter
`together from the radially compressible device.
`
`Page 12 of 13
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENTNO. 16,051,002
`DATED
`:Apr. 18, 2000
`'NVENT0H($) 1 Stephen A. Morales
`
`it is certified that error appears in the above-identified pateni and that said Letters Patent is hereby
`corrected as shown below:
`
`Title page, under “U.S. PATENT DOCUMENTS", add the following:
`--1,966,543
`7/1934
`O'Russa—-.
`
`Title page, under "FOREIGN PATENT DOCUMENTS" add the following:
`--0 938 880
`9/1999
`European Pat. Off.,
`297 14 857U
`10/1997
`Germany,
`0 303 889
`2/1989
`European Pat. Off.,
`975 797 A
`3/1951
`France--.
`
`Title page, under "OTHER PUBLICATIONS", line 2, after "1977",
`delete "No Drawings are enclosed", and delete the
`duplication at lines 19 & 20, and line 24, after "1998",
`delete "Lost? Not available."
`
`Signed and Sealed this
`
`Third Day of April, 2001
`
`Arresting Of?CEr
`
`Acting Director ofrhe Uniled Slams Patent and Trademark Offire
`
`NICHOLAS P. GODIC]
`
`Page 13 of 13
`
`