United States Patent
`[19]
`[11] Patent Number:
`5,972,016
`
`Morales
`[45] Date of Patent:
`Oct. 26, 1999
`
`U8005972016A
`
`[54]
`
`STENT CRIMPING DEVICE AND METHOD
`OF USE
`
`[75]
`
`Inventor: Stephen A. Morales, Mountain View,
`Calif
`.
`[73] Assignee: Advanced Cardiovascular Systems,
`1110-, Santa Clara, Calif
`
`5,630,830
`5,653,691
`5,672,169
`
`5/1997 Verbeek .
`8/1997 Rupp et a1.
`9/1997 Verbeek .
`
`.
`
`4/1998 Williams et a1~ ~
`577389674
`5/1998 Green et a1.
`.
`5,746,764
`7/1998 Dunham .
`5,783,227
`7/1998 SChatZ '
`5’785’715
`FOREIGN PATENT DOCUMENTS
`
`.
`[21] Appl‘ No" 08/837,771
`[22]
`Filed:
`Apr. 22, 1997
`51
`I t. C].6 .................................................... A61M 29 00
`{52]
`618 C]
`606/198’ 60/6/1
`
`[58] Field Of Search ................................ 606/1, 108, 191,
`606/194> 195> 198> 200; 623/1> 12; 128/898>
`899; 29/234, 235, 282, 283
`
`0 630 623
`0 826 346
`
`.
`12/1994 European Pat. Off.
`.
`3/1998 European Pat. Off.
`OTHER PUBLICATIONS
`The eXTraordinary Stem, C.R. Bard Brochure (Undated).
`Primary Examiner—William Lewis
`Attorney, Agent, or Firm—Fulwider Patton Lee & Utecht,
`LLP
`
`[56]
`
`References Cited
`
`[57]
`
`ABSTRACT
`
`.
`
`U.S. PATENT DOCUMENTS
`8/1984 Enzmann et a1.
`.
`3/1986 Schiff .
`2/1987 Schiff .
`7/1987 Cho et a1.
`10/1987 Schiff .
`2/1990 Schiff .
`3/1990 GianturCO .
`7/1992 Charlesworth 6t a1~ -
`3/133;
`:Mktor.
`41993 Dlgfiere?:ils ‘
`8/1996 Williams et 211..
`5/1997 Cottone, Jr.
`.
`
`4,468,224
`4,576,142
`4,644,936
`4,681,092
`4,697,573
`4,901,707
`4,907,336
`571329066
`zigzag?
`5’195’539
`5:546:646
`5,626,604
`
`Adevice and method for enabling substantially uniform and
`tight crimping of an intravascular stent onto a balloon
`catheter assembly. The dev1ce has a base portion haVing an
`intermediate portion and pivoting arm portions attached
`thereto. A loop portion is attached at its end portions to the
`pivoting handle portions. The loop portion has a compress-
`ible and generally cylindrical opening which is substantially
`uniformly compressible radially inwardly upon pivoting the
`arm portions downwardly from the intermediate portion.
`This substantially uniformly and tightly crimps the stent
`onto the catheter portion which is inserted therein.
`
`10 Claims, 5 Drawing Sheets
`
`
`
`Edwards Lifesciences v. Boston Scientific
`
`IPR2017-00444 EX. 2041 Page 1 of11
`
`US. Patent No. 6,915,560
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`Page 1 of 11
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`US. Patent
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`Oct. 26, 1999
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`Sheet 1 0f 5
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`5,972,016
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`US. Patent
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`Oct. 26, 1999
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`US. Patent
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`Oct. 26, 1999
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`Sheet 3 0f5
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`F/G. 6
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`33
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`.38
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`FIG. 7
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`US. Patent
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`Oct. 26, 1999
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`Sheet 4 0f5
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`5,972,016
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`FIG. 8
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`LIA-WAY
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`US. Patent
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`Oct. 26, 1999
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`Sheet 5 0f5
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`5,972,016
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`Page6of11
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`5,972,016
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`1
`STENT CRIMPING DEVICE AND METHOD
`OF USE
`
`BACKGROUND OF THE INVENTION
`
`1. Field of the Invention
`
`This invention relates to a stent crimping device and
`method of use of the type that will enable an end user to
`firmly crimp a stent onto the distal end of a catheter
`assembly.
`
`2. Description of the Related Art
`
`In a typical percutaneous transluminal coronary angio-
`plasty (PTCA) procedure, for compressing lesion plaque
`against the artery wall to dilate the arterial lumen, a guiding
`catheter is percutaneously introduced into the cardiovascular
`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 dila-
`tation 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 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. Further, other methods are
`well known in opening a stenosed artery such as atherec-
`tomy devices, plaque dissolving drugs, and the like.
`
`In angioplasty procedures of the kind referenced above,
`there may be restenosis of the artery, which may require
`another angioplasty procedure, a surgical bypass operation,
`or some method of repairing or strengthening the area. To
`reduce the chance of restenosis and strengthen the area, a
`physician can implant an intravascular prosthesis for main-
`taining vascular patency, typically called a stent. A stent is
`a device used to hold tissue in place or to provide a support
`for a graft or tissue joined together while healing is taking
`place. A variety of devices are known in the art for use as
`stents, including coiled wires and wire mesh sleeves, 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 mounted 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. 5,514,154 (Lau et al.); and US. Pat. No. 5,56,295
`(Lam), incorporated herein by reference.
`
`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 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.
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`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, the crimping procedure was often
`done by hand, which may result in uneven force being
`applied, resulting in non-uniform crimps. In addition, it was
`difficult to judge when a uniform and reliable crimp had
`been applied or if the stent had damaged the balloon. Though
`some tools, such as ordinary pliers, have been used to crimp
`the stent, these tools have not been entirely adequate in
`achieving a uniform crimp.
`There accordingly remains a need for improved tools and
`methods to secure stents on the balloon portions of catheters.
`
`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, while at the same time
`permitting uniform expansion of the stent in a patient’s
`artery, vein, duct, or other vessel or lumen. 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 radially compressible and
`resiliently radially expandable cylindrical loop portion hav-
`ing opposed side edges extending from the loop portion.
`These side edges are secured to pivoting arm portions of the
`device. The inner diameter of the loop portion is compress-
`ible radially inwardly by the user moving the pivoting arm
`portions downwardly to substantially uniformly and tightly
`crimp the stent onto the balloon catheter assembly inserted
`within the loop portion. The loop portion is returned to its
`expanded state upon bringing the pivoting arm portions back
`to their un-pivoted position thereby allowing the stent
`crimped onto the catheter balloon to be withdrawn by the
`user.
`
`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 inadvertently shift or
`slide off the catheter balloon portion. Further, it is easy to use
`in performing the stent crimping procedure. The device, due
`to its simplicity, low manufacturing and assembly cost, and
`adaptability to compressing stents of different length and
`diameter, is particularly well suited for use in compressing
`stents onto balloon catheters of different manufacturers, and
`ideally suited as a one-time use disposable device, thereby
`eliminating the need for sterilization of the device between
`uses.
`
`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 perspective view of an exemplary embodiment
`of the present invention, in its open position, in which the
`loop portion of the device is fully expanded for receipt of a
`stent to be compressed onto a balloon catheter.
`FIG. 2 is a top plan view of the main body portion of the
`present invention as shown in FIG. 1.
`FIG. 3 is a cross-sectional view through view lines 3—3
`of FIG. 2.
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`5,972,016
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`3
`FIG. 4 is a perspective side view of a preferred embodi-
`ment of the loop portion of the device in its threaded
`orientation.
`
`FIG. 5 is a plan view of the sheet of material forming the
`loop portion prior to being threaded.
`FIG. 6 is a bottom view of securing clips of the device
`used to secure the loop portion to the main body portion.
`FIG. 7 is a side view of the securing clips of the device
`of FIG. 6.
`
`FIG. 8 is a side view of the device packaged to maintain
`its loop portion,
`in its open position, wherein the loop
`portion cannot be radially compressed.
`FIG. 9 is an exploded side view of the parts of the device
`and its packaging prior to being assembled.
`FIG. 10 is a side view of the device with packaging
`removed, in its open position prior to radial compression of
`the loop portion.
`FIG. 11 is a side view of the device with the arm portions
`of the main body portion pivoted downwardly away from
`the intermediate portion to cause the loop portion to con-
`strict in diameter, to thereby crimp a stent around the balloon
`portion of the catheter which has been positioned within the
`loop portion.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`
`The invention comprises a tool 10 and method for use in
`uniformly and tightly crimping an intravascular stent A onto
`the collapsed balloon portion B adjacent the distal end C of
`a balloon catheter assembly D. In the exemplary embodi-
`ment of device 10, as shown in FIGS. 1 and 10, tool 10 is
`adapted to be held in the hand of the user. The user will insert
`stent A, previously placed over the collapsed balloon B, into
`the loop portion 12 to enable stent A and catheter D to be
`supported in tool 10, and to enable the user to apply
`compressive force to tool 10 to substantially uniformly and
`tightly crimp stentAonto collapsed balloon B of catheter D.
`Tool 10 includes a loop portion 12 affixed to a base
`portion 14 wherein the circumference of loop portion 12 is
`variable. Base portion 14 has an intermediate portion 16
`which is pivotally connected to two pivoting arm portions 18
`and 20. Base portion 14 has a top surface 22 on which loop
`12 rests. Base portion 14 ideally comprises a single flat piece
`of material, such as plastic, with a pair of parallel longitu-
`dinal V—shaped slits 26 and 28 extending from the top
`surface 22 almost all the way to the bottom surface 24, the
`slits 26 and 28 terminating in lower parallel edges 30, 31,
`each forming hinges 30A and 31A to permit pivoting arm
`portions 18 and 20 to swing downwardly away from inter-
`mediate portion 16. When base portion 14 is formed from a
`single piece of plastic (or metal), then hinges 30A and 30B
`can be said to be living hinges formed in base portion 14.
`Alternatively, base portion 14 and pivoting arm portions
`18,20 can be formed separately and connected by hinges
`30A,30B which can be added and include conventional
`hinge designs. Referring to FIGS. 2 and 3, pivoting arm
`portions 18 and 20 have first engagement means,
`for
`example slots 32, formed in their top surface 22. Recesses 34
`are formed on side edges 36 of pivoting arms 18 and 20, as
`best shown in FIG. 2. Clip portions 38 are used to secure
`loop portion 12 to base portion 10.
`Referring to FIGS. 4 and 5, a preferred embodiment of
`loop portion 12 is shown in greater detail. Loop portion 12
`comprises a sheet of thin and flexible yet strong material,
`such as the polyester film Mylar® and has a plurality of
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`elongate straps 40 extending from a first end 42 of sheet 44
`and extending opposite a second end 46 of sheet 44. Other
`known flexible materials can be used. Apertures 48 formed
`in sheet 44 are adapted to receive straps 40 when threaded
`therethrough, as shown in FIGS. 1 and 4, thereby forming a
`generally cylindrical opening 50 for receiving stent Aplaced
`on the distal end C of balloon catheter B. Straps 40 have
`terminal end regions 52. By pulling terminal end regions 52
`of straps 40 and the second end 46 away from each other, the
`generally cylindrical opening 50 will constrict in size, from
`its larger size shown in FIGS. 1, 4, 8 and 9, to the constricted
`size shown in FIG. 10.
`
`As seen in FIG. 5, the distance X between aperture 48 and
`first end 42 of straps 40 will determine the smallest diameter
`of loop portion 12. Those skilled in the art will appreciate
`that distance X can be varied depending upon the diameter
`of the stent and balloon, and ultimately the crimped diameter
`of the stent on the balloon. The thickness of the polyester
`film forming loop portion 12 is an important consideration
`in the ability of the loop to rebound open after the stent is
`crimped. Thus, the polymer film preferably has a thickness
`in the range of 0.002 to 0.008 inches. With this range of
`thickness for the polymer film of loop 12, it is flexible and
`durable, and will readily rebound open to form open loop 12
`after the stent is crimped on the balloon and removed from
`within loop 12.
`In a preferred embodiment of the invention, straps 40 can
`be about 5 mm wide (0.2 inches), with about 2.5 mm (0.1
`inches) of open space between the straps 40. The entire
`length of sheet 44, the length of straps 40 and spacing of
`apertures 48 from first end 42, can be chosen depending on
`the size of loop portion 12 desired. In lieu of a sheet of
`Mylar® or other sheet material, a plurality of wires or cords
`can be utilized to form loop portion 12.
`The end regions 52 and end 46 of loop portion 12 are
`secured to tool 10 for radially compressible and expandable
`movement as follows. Referring to FIGS. 2, 3, 6 and 7, slots
`32 formed on upper surface 22 of pivoting arm portions 18
`and 20 (FIGS. 2 and 3), are adapted to receive a comple-
`mentary engagement portion, for example, bar portion 54
`extending from a bottom surface 56 of clip portion 38. Clip
`ends 58 are formed on ends of clip portions 38 (FIGS. 6 and
`7). After placing loop portion 12 on top surface 22 of
`intermediate portion 16 and extending terminal end regions
`52 of finger portions 40 and second end 46 over slots 32 in
`pivoting arms 18 and 20, clip portions 38 are snapped onto
`pivoting arms 18 and 29 with complementary bar portions
`54 fitting into slots 32 and clip ends 58 fitting into recesses
`34. This secures terminal end regions 52 of elongate straps
`40 and second end 46 of loop portion, yet allows the portion
`of loop portion defining generally cylindrical opening 50 to
`ride on intermediate portion 16. In addition to this mechani-
`cal affixation, adhesives and other means can be utilized to
`secure elongate straps 40 and 52 of loop portion 12 to base
`portion 14. An advantage of device 10 is that its components,
`viz., base portion 14, loop portion 12 and clip portions 38 are
`all relatively low in cost, and base portion 14 and clip
`portions 38 will accommodate a loop portion 12 of desired
`diameter and length, to accept a balloon catheter D and stent
`A of desired diameter and length.
`Referring to FIG. 8, upper surface 22 of base portion 14,
`clip portions 38, and loop portion 12 are covered with
`protective layer 60 which cushions upper surface 22 and
`loop portion 12, and prevents loop portion 12 from being
`inadvertently crushed. The protective layer 60 can comprise
`bubble pack material, a vacuum formed plastic cover, or
`other known materials. To prevent arms 18 and 20 and
`
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`5,972,016
`
`5
`intermediate portion 16 of base portion 14 from being
`pivoted, a rigid support sheet 62 is preferably positioned on
`lower surface 24 of base portion 14. Other means can be
`provided to protect the device 10 such as a case or box to
`surround the device in a sterile environment. FIG. 9 is an
`
`exploded side view of the device 10 and its packaging. FIG.
`10 shows device 10 after being removed from its packaging
`60 and 62 and ready for use.
`Referring to FIGS. 1 and 11, in a preferred method of
`operation, a user will load stent A onto a deflated (unused)
`balloon portion B of balloon catheter assembly D. Catheter
`balloon portion B are then inserted in stent A so that stent A
`overlies balloon portion B. To enable stent A to be crimped
`onto catheter balloon portion B, stent A and catheter balloon
`portion B is inserted within loop portion 12 and supported in
`the middle of loop portion 12 which is carried on interme-
`diate portion 16 of base portion 14. At this point, stent A is
`not fixed onto catheter assembly D, because stent A has not
`been compressed.
`To crimp stentA onto catheter balloon portion B, the user
`of tool 10 simultaneously swings arm portions 18 and 20
`downwardly together relative to intermediate portion 16.
`Swinging arm portions 18 and 20 downwardly causes ends
`52 of straps 40 and sheet portion 46 to be pulled in opposite
`directions in a noose-like manner. Elongate straps 40 and
`sheet portion 44 on the sides of loop portion 12 will extend
`between opposite edges 64 and 66 of intermediate portion 16
`and pivoting arm portions (18 and 20), respectively. As
`swinging arm portions 18 and 20 are swung down from
`intermediate portion 16, generally cylindrical opening 50 in
`loop portion 14 will constrict to a smaller inner diameter,
`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 12, 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 will swing arm portions 18 and 20 back
`up, thereby enlarging the generally cylindrical opening 50,
`enabling removal of crimped stent A and catheter balloon
`portion B from generally cylindrical opening 50. Balloon
`catheter assembly D, with stentAcrimped thereon, may then
`be inserted into the body of the patient for deployment of
`stent A therein, (not shown).
`As will be appreciated by those skilled in the art, the stent
`crimping assembly of the present invention is designed both
`for single use applications in a cath lab for use by a
`physician, or
`for multiple use applications in a sterile
`environment in a high volume manufacturing facility. Refer-
`ring to the latter, where sterile conditions exist, the stent
`crimping assembly can be used to repeatedly crimp stents on
`balloons until the polyester film wears out and has to be
`replaced. Thus, repeated uses are contemplated for con-
`trolled sterile environments, however, single use applica-
`tions are required when used by cath lab personnel.
`While in the preferred embodiments the stent described
`herein is intended to be an intraluminal vascular prosthesis
`for use within a blood vessel, and the balloon delivery
`catheter is of the kind used in therapeutic coronary angio-
`plasty or similar thereto,
`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
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`limited to stents that are deployed in a patient’s vasculature
`but has wide applications 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 substantially uniform and tight crimping of
`an intravascular stent loaded onto a portion of a catheter of
`a catheter assembly by a user, so as to enable the user to
`apply compressive force thereto to substantially uniformly
`and tightly crimp the stent onto the catheter assembly, the
`crimping device comprising:
`a base portion having an intermediate portion and pivot-
`ing arm portions pivotally attached to the intermediate
`portion; and
`a loop portion attached to the pivoting arm portions, for
`use in supporting the stent and catheter portion, the
`loop portion having a compressible and generally cylin-
`drical opening portion which is substantially uniformly
`compressible radially inwardly upon the application of
`force to said pivoting arm portions to substantially
`uniformly and tightly crimp the stent onto the catheter
`portion.
`2. The device as in claim 1, wherein the loop portion of
`the device comprises a sheet of flexible material having end
`portions, the end portions including a plurality of elongate
`straps extending from a first side edge of the sheet and a
`second side edge of the sheet, the sheet having apertures
`formed therethrough, wherein the elongate straps are
`threaded through the apertures formed in the sheet to form
`a generally cylindrical opening portion, the opening being
`adapted to constrict when the elongate straps and the second
`side edge of the sheet are pulled in opposite directions.
`3. The device as in claim 2, further comprising a pair of
`clips for affixing portions of the elongate straps and a portion
`of the second side edge of the loop portion to the pivoting
`arm portions, with the generally cylindrical opening portion
`placed on the intermediate portion.
`4. The device as in claim 3, wherein each pivoting arm
`portion has an engagement portion formed thereon and
`wherein the clips have complementary engagement portions
`adapted for engagement with the pivoting arm engagement
`portions to retain end portions of the loop portion positioned
`thereon.
`
`5. The device as in claim 4, wherein the engagement
`portion on the pivoting arm portions comprise slots formed
`on an upper surface and side edges thereof, the complemen-
`tary engagement portion of the clips comprise a bar on an
`underside of each of the clips and a plurality of clip ends
`adapted to firmly attach to the slots on side edges of the
`pivoting arm portions.
`6. The device as in claim 1, further comprising a protec-
`tive layer which covers the loop portion and which prevents
`the arm portions from being prematurely pivoted down-
`wardly from the intermediate portion.
`7. The device as in claim 1, wherein the base portion is
`formed from a single block of generally rigid material,
`wherein the arm portions and intermediate portions are
`formed by longitudinal slots formed in the rigid material
`extending from a top surface to near a bottom surface of the
`single block of material, leaving unslotted areas of material
`defining a pair of hinges so that in use the arm positions can
`be pivoted on the pair of hinges.
`8. Amethod of substantially uniformly and tightly crimp-
`ing an intravascular stent onto a catheter assembly, com-
`prising:
`
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`5,972,016
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`7
`providing a device comprising a base portion having an
`intermediate portion and pivoting arm portions
`attached to the intermediate portion, and a loop portion
`for use in supporting a portion of the catheter assembly
`on which the stent may be positioned, the loop portion 5
`having a compressible and generally cylindrical open-
`ing portion which is substantially uniformly compress-
`ible radially inwardly upon the application of force
`thereto to substantially uniformly and tightly crimp the
`stent onto the catheter portion, the loop portion having 10
`end portions attached to the pivoting handle portions;
`placing a portion of the catheter assembly, on which the
`stent is positioned, within the loop portion;
`pivotally moving the arm portions relative to the inter-
`mediate portion to move the end portions of the loop
`portion in opposite directions thereby reducing the
`diameter of the generally cylindrical opening portion to
`apply compressive force to compress the stent radially
`inwardly, to substantially uniformly and tightly crimp
`the stent onto the catheter portion; and
`
`15
`
`8
`releasing the compressive force to enable radially outward
`expansion of the generally cylindrical opening portion
`to enable the stent and catheter portion to be with-
`drawn.
`
`9. The method as in claim 8, wherein the loop portion
`comprises a sheet of flexible material,
`the end portions
`having a plurality of elongate straps extending from a first
`side edge of the sheet and a second side edge of the sheet,
`the sheet having apertures formed therethrough, wherein the
`elongate straps are threaded through the apertures formed in
`the sheet to establish the generally cylindrical loop opening
`portion, which loop opening is configured to constrict when
`the elongate straps and the second side edge of the sheet are
`pulled in opposite directions.
`10. The method as in claim 8, wherein the device is
`covered with a removable protective layer to protect the loop
`portion and to prevent the arm portions from prematurely
`pivoting from the intermediate portion.
`*
`*
`*
`*
`*
`
`Page100f11
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`Page 10 of 11
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`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`CERTIFICATE OF CORRECTION
`
`PATENTNO.: 5,972,016
`
`DATED
`
`1 Oct. 25, 1999
`
`INVENTOFKS): Stephen A. Morales
`
`It is certified that error appears in the above-identified patent and that said Letters Patent is hereby
`corrected as shown below:
`
`Title page, under ”FOREIGN PATENT DOCUMENTS", add
`the following:
`
`——W098/14120
`WO98/19633
`
`4/1998
`5/1998
`
`PCT.
`PCT—-.
`
`
`
`Signed and Sealed this
`
`Twenty-third Day of May, 2000
`
`M Q
`
`. TODD DICKINSON
`
`Arresting Ofi‘icer
`
`Director of Parents and Trademarks
`
`Page110f11
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`Page 11 of 11
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`