UAEOA A
`US005437083A
`.
`[11] Patent Number:
`5,437,083
`[19]
`United States Patent
`
`
`Williamset al. Aug. 1, 1995 [45] Date of Patent:
`
`34]
`Al
`[75]
`
`[56]
`
`STENT-LOADING MECHANI
`
`SM
`Inventors: Michael S, Williams, Chapel Hill,
`N.C.; Lilip Lau, Sunnyvale, Calif.;
`Farhad Khosravi, Belmont, Calif.;
`William Hartigan, Fremont, Calif;
`Avegel Hernando, Union City, Calif.
`[73] Assignee: Advanced Cardiovascular Systems,
`.
`Inc., Santa Clara, Calif.
`[21] Appl. No.: 66,707
`;
`[22] Filed:
`May24,1993
`6
`.
`I me a seer B23P 19/wes Sor
`[58] Field of Search39/23.5. 234 382 793-
`ee ey
`:
`;
`.
`>
`269/164; 606/151, 201, 1
`References Cited
`U.S. PATENT DOCUMENTS
`696,289 3/1902 Williams... eeeeeesecennee 29/235
`5,189,786 3/1993 Ishikawa et al. oeeee 29/285
`
`FOREIGN PATENT DOCUMENTS
`159065
`2/1921 United Kingdom ............. 269/164
`.
`.
`Primary Examiner—Tamara L. Graysay
`Attorney, Agent, or Firm—Fulwider Patton Lee &
` Utecht
`.
`.
`B7
`.
`ABSTRACT
`57
`A stent-loading mechanism for loading a stent onto a
`balloon delivery catheter of the kind typically used in
`typical percutaneoustransluminal coronary angioplasty
`(PTCA)procedures.
`The device comprises a series of plates having substan-
`tially flat and parallel surfaces that movein a rectilinear
`fashion with respect to each another. A stent carrying
`catheter can be disposed between these surfacesto affix
`the stent onto the outside of the catheter by relative
`motion between the plates. The plates have multiple
`degrees of freedom and may have force-indicating
`3
`.
`transducers to measure and indicate the force applied to
`the catheter during affixation of the stent.
`
`13 Claims, 3 Drawing Sheets
`
`
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1028 - Page 1
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1028 - Page 1
`
`

`

`U.S. Patent
`
`Aug. 1, 1995
`
`Sheet 1 of 3
`
`5,437,083
`
`
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1028 - Page 2
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1028 - Page 2
`
`

`

`U.S. Patent
`
`Sheet 2 of 3
`
`Aug. 1, 1995
`
`5,437,083
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1028 - Page 3
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1028 - Page 3
`
`

`

`U.S. Patent
`
`Aug. 1, 1995
`
`Sheet 3 of 3
`
`5,437,083
`
`
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1028 - Page 4
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1028 - Page 4
`
`

`

`1
`
`5,437,083
`
`STENT-LOADING MECHANISM
`
`BACKGROUND OF THE INVENTION
`Field of the Invention
`
`This invention relates to a stent loading device that
`will automatically load a stent onto the distal end of a
`balloon dilatation catheter assembly, for example, of the
`kind used in typical percutaneous transluminal coronary
`angioplasty (PTCA) procedures.
`In typical PTCA procedures, a guiding catheter is
`percutaneously introduced into the cardiovascular sys-
`tem of a patient through the brachial or femoral arteries
`and advanced throughthe vasculature until the distal of
`the guiding catheter endis 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
`guidewireis first advanced out of the guiding catheter
`into the patient’s coronary vasculature and the dilata-
`tion catheter is advanced over the previously advanced
`guidewire until the dilatation balloon is properly posi-
`tioned across the lesion. Once in position across the
`lesion, a flexible, expandable, preformed balloon is in-
`flated to a predetermined size with a radiopaqueliquid
`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 bailoon 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. As should be appreciated by those
`skilled in the art, while the procedure just described is
`typical, it is not the only method used in angioplasty.
`In angioplasty procedures of the kind referenced
`above, there maybe restenosis of the artery, which may
`require another angioplasty procedure, a surgical by-
`pass operation, or some method of repairing or
`strengthening the area. To reduce the chanceofreste-
`nosis and strengthen the area, a physician can implant
`an intravascular prosthesis for maintaining vascular
`patency, typically called a stent, inside the artery at the
`lesion. The stent is typically expandedto a larger diame-
`ter, often by the balloon portion of the catheter. The
`stent may be ofthe self-expanding type.
`SUMMARY OF THE INVENTION
`
`This invention is directed to a vascular prosthesis
`loading device, which automatically loads a stent onto
`the distal end of a catheter assembly, with a minimum of
`human handling, to better secure the stent onto the
`catheter while the stent is being delivered through the
`patient’s vasculature.
`The present invention attempts to solve several prob-
`lems associated with placing stents onto balloon cathe-
`ters. In procedures where the stent is placed over the
`balloon portion of the catheter, one must crimpthe stent
`onto the balloon portion, to prevent the stent from
`sliding off the catheter when the catheter is advanced in
`a patient’s vasculature. In the past this crimping was
`often done by hand, which was found to be unsatisfac-
`tory due to uneven force being applied, resulting in
`non-uniform crimps. In addition, it is difficult to judge
`when a uniform and reliable crimp has been applied.
`Furthermore, the more the stent is handled, the greater
`the chance of human error in crimping the stent prop-
`erly. Though sometools, such as ordinary pliers, have
`been used to apply the stent, these tools have not been
`
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`2
`entirely adequate in achieving a satisfactory crimp.
`Further, some self-expanding stents are difficult to load
`by hand onto a delivery device such as a catheter.
`the
`In one embodiment of the present
`invention,
`stent-loading device includes a tubular member housing
`a bladder. The tubular member and bladder are de-
`signed to hold a stent that is to be loaded onto a balloon
`catheter assembly. Upon placementofthe stent over the
`balloon portion of the catheter, a valve in the loading
`device is activated to inflate the bladder. The bladder
`compresses the stent radially inwardly to a reduced
`diameter onto the balloon portion of the catheter, to
`achieve a snug fit. In this way the stent can be affixed
`onto the distal end of a balloon catheter with a mini-
`mum of human handling.
`In other embodiments of the present invention, the
`stent-loading device is madeofsliding plates having flat
`surfaces that allow a stent carrying catheter to be re-
`ceived in between them. The surfaces are movedrela-
`tive to one another to apply force uniformly to the
`outside of the stent disposed on the catheter, allowing
`the stent to be crimped onto the outside 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.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG.1 is a cross-sectional schematic of one embodi-
`ment of the stent-loading device depicting the bladder
`and chamberfor receiving the stent.
`FIG.2 is a cut-away. perspective view of the stent
`loading device of FIG.1.
`FIG. 3 is a cut-away perspective view of the stent
`loading device of FIG. 1, showing a balloon catheter
`assembly about to be inserted into the device, and a
`stent received by the device.
`FIG. 4 is a cut-away perspective view of the stent
`loading device of FIG. 1, whenit is operated to load a
`stent onto a balloon catheter assembly that has been
`placed inside the device.
`FIG.5 is a perspective view of a second embodiment
`of the present invention depicting sliding plates with a
`stent mounted to be placed between theplates.
`FIG.6 is a perspective view of the back of one ofthe
`blocks of the embodiment shown in FIG.5.
`FIG.7 is a side view of the second embodimentofthe
`present invention.
`FIG.8 is a perspective view of a third embodimentof
`the present invention.
`FIG. 9 showstheslider plate of the embodiment of
`FIG.8.
`FIG.10 showsthe spring-loaded plate of the embodi-
`ment of FIG.8.
`FIG. 11 shows the housing of the embodiment of
`FIG.8.
`.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`As shown by FIGS.1-4, the first embodiment of the
`stent-loading device 1 includes an elongated tubular
`member 5, having an open end 10 and a sealed-off end
`15. The tubular member houses an elastic bladder 20,
`which extends longitudinally along the inside of the
`tubular member. The bladder is secured to the tubular
`member by fastener ring 25, which clamps the bladder
`onto the tubular member. The bladder extends out of
`
`65
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1028 - Page 5
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1028 - Page 5
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`3
`the open end of the tubular memberandis folded over
`outside end 30 of the tubular member.
`The tubular member can be madeofa stainless steel
`or polytetrafluoroethylene (manufactured under the
`trademark TEFLON) lined hypotube. The bladder can
`be made of any flexible, elastic material, such as poly-
`ethylene material.
`The bladder is sealed at its end 35. The bladder end
`may be sealed by heat sealing, by an adhesive, bytying,
`or by clamping with a hemostat, depending onthe blad-
`der material used. As shown in the figures, the bladder
`seals from atmosphere an annular fluid chamber 40 in
`the tubular member. Chamber 40 can be placed under
`pressure by a pressurized fluid source 50, which is in
`fluid communication with the chamber via inflation
`port 55fitted with an inflation valve 66. In the preferred
`embodiment an adaptor with a male-threaded Luer
`fitting is used as an inflation port. A syringe, an infla-
`tion/deflation device commonlyreferred to as an “inde-
`flator,” a compressed fluid source or another pressuriz-
`ing means 50 is attached to the inflation port.
`Operation of the stent-loading device of FIGS. 1-4
`will now be described. Whenit is desired to load a stent
`65 onto a balloon catheter assembly 70, a stent is in-
`serted inside the open end 10 of the tubular member5.
`Thestent is confined inside the tubular member by the
`inner walls of the bladder, with the bladder being in a
`non-compressed state. The collapsed balloon portion
`85, adjacent distal end 90 of the balloon catheter 95, is
`inserted inside the stentso the stent overlies the balloon
`portion. At this point there is no pressure inside the
`sealed fluid chamber 40.
`Toload andattach the stent onto the balloon portion
`of the catheter assembly, the catheter is brought into
`operating engagement with the stent loading device.
`The catheter has been checked and prepped before this
`time, and the profile of the balloon portion 85 has been
`reduced to its minimum. Asillustrated in FIG.3, the
`catheteris inserted with its distal end first into open end
`10 of the tubular member. To achieve insertion, the
`balloon catheter assembly may be held stationary while
`the stent delivery device is movedrelative to the cathe-
`ter. The catheter distal end is inserted far enough into
`the tubular memberso the stent is positioned over the
`desired position on the catheter. At this point the stent
`is not fixed onto the balloon catheter assembly, because
`the stent has not been compressed.
`Thestent is attached onto the balloon 85 of catheter
`95 by first pressurizing chamber 40. As chamber 40 is
`pressurized,
`tubular member 5 becomes pressurized,
`and the pressure is transferred to the bladder, which
`causes it to compress radially inwardly the stent onto
`the balloon portion of the catheter, at a substantially
`uniform rate. The inflation of the chamber is depicted
`by dotted shading in FIG. 4. Pressurized fluid may be
`introduced into chamber 40 through inflation port 55
`controlled by a suitable valve 60 by way of a com-
`pressed fluid source 50, as shown in FIG. 1. The fluid
`may also be introduced by wayof a syringe or plunger
`atrangement, such as an indeflator. Other suitable pres-
`surizing gas or fluid sources are contemplated, as should
`be appreciated by one skilled in the art.
`After a predetermined pressure has been achieved
`and the stent has been affixed to the outside of the bal-
`loon portion of the balloon catheter assembly, the blad-
`der 10 is decompressed by releasing the pressurized
`fluid from inside the chamber through valve 60. Tubu-
`lar member5 is then withdrawn from over the catheter
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`assembly. The delivery catheter, now loaded with a
`stent, is ready to be inserted into the bodyof a patient
`for deployment.
`Furthermore, the stent-loading device of FIGS. 1-4
`may be used to compress andaffix a stent that has been
`first manually placed over a balloon catheter.
`Turning attention now to the embodiment of FIGS.
`5-7, there is shown a second embodimentof the present
`invention. In FIG. 5 there is shown an isometric per-
`spective view of the device. The device comprising a
`pair of plates, a lower support plate 100 and an upper
`support plate 120, that form flat surfaces or faces 125,
`130, in between which a stent-carrying catheter may be
`placed, as indicated by arrow 135. Uniform pressure
`may be applied to crimp the stent onto the catheter, by
`reciprocating surfaces 125, 130 relative to one another.
`Plates 100, 120 may be made of aluminum, and may be
`hollow. Thin rubber or elastomeric surfaces are lami-
`nated onto faces 125, 130 to better grip the stent and
`catheter and prevent them from sliding. The upper face
`130 has a thicker rubber or elastomeric surface, about 3”
`thick, and the lower face 125 has a thinner rubber sur-
`face, about 3”thick.
`Lower support plate 100 is fixed to base 140 while
`upper support plate 120 is movable, being affixed to flat
`rectangular surface 145 whichin turn is affixed to chan-
`nel-shaped block 150. Channel-shaped block 150 trans-
`lates in two directions. Channel-shaped block 150 has a
`horizontally-extending channel or groove 155 extend-
`ing alongits length through whichit slidably receives a
`guide-bearing surface 160. Guide-bearing surface 160 in
`turn has a vertically-extending channel or groove 165
`on its back side, as can be seen in FIG. 6, which receives
`a rail 170. Rail 170 is fixed to upright channel-shaped
`support 175. Upright channel support 175 in turn has a
`groove 180 that can slidably receive a fixed rail 185.
`Fixed rail 185 is immobile, fixed to a vertical post 1990,
`which is attached to base 140.
`Spring arms 172, 174 provide bias along the axial
`direction (the direction of arrow 135) to keep block 150,
`guide-bearing surface 160, and rail 170 together. In
`addition spring arms 172, 174 provide a vertical bias to
`keep faces 125, 130 separated.
`As can be appreciated from an examination of FIGS.
`5-7, guide bearing surface 160 allows two degrees of
`freedom forthetranslation ofplate 120, that is, allowing
`for movement along vertical and horizontal directions.
`Preferably these directions are substantially orthogonal
`directions, that is, at right angles to one another, as
`shown by the unmarked double headedarrowsin FIG.
`5.
`
`Furthermore, the use of several redundant sliding
`surfaces, such as guide-bearing surface 160 in conjunc-
`tion with channel-shaped support 175, both sliding
`along rails in the vertical direction, allows for reduced
`friction in the event there is excessive friction along one
`sliding surface. Multiple sliding surfaces may be em-
`ployed for horizontal travel as well.
`Furthermore, upper block 150 is spring biased up-
`wards from lower support plate 100 by spring arms 172,
`174. The arms provide for the upper block 150 to be
`spaced from lower support plate 100, and to give a
`resilient feel to an operator pressing down on upper
`block 150. The spring-biased arms may have spring
`tensioning means to adjust the spring tension in the
`arms, as well as dampening meansfor providing damp-
`ening.
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1028 - Page 6
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1028 - Page 6
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`

`5
`In addition, a force transducer 195, such as a strain
`gage or piezoelectric crystal, may be disposed in plate
`100 and/or plate 120, or in faces 125, 130, to measure
`the contact force applied to the stent disposed between
`the plates. Force transducer 195 may have a display 200,
`giving visual and/or audio output, to provide feedback
`to the operator and to indicate when either sufficient
`and/or excessive force has been imparted to the cathe-
`ter.
`Operation of the FIGS. 5-7 embodimentis achieved
`by placing a catheter that has a stent disposed aboutits
`stent-receiving portion, which in a balloon catheter
`would be the balloon portion ofthe catheter, in between
`the space formed betweenthe substantially flat surfaces
`of faces 125, 130. The operator then gently reciprocates
`plate 120 to move face 130, which contacts the stent-
`receiving catheter, with respect to face 125, which is
`fixed and also contacts the catheter, to apply a slight
`downward force and evenly crimp the stent onto the
`catheter. The gentle reciprocating motion of the two
`substantially flat rubberized faces 125, 130, together
`with the downward application of force,
`insures an
`even application of force to the outside of the stent and
`achieves a uniform crimping ofthe stent onto the cathe-
`ter.
`Turning attention now to FIGS.8-11, there is shown
`another embodiment of the present invention employ-
`ing sliding plates that operate in principle according to
`the embodiment of FIG. 5. A horizontally-sliding plate
`215 movesrelative to a vertically-sliding plate 220.
`Horizontally-sliding plate 215 slides along grooves 225
`in housing 230, via rails 235. Vertically-sliding plate 220
`is retained in U-shaped housing 230 by a ridge 240, but
`is free to travel upwards along the inside edge 245 of
`housing 230. Vertically-sliding plate 220 has a push
`plate 250 connected to it by springs 255. By pushing on
`push plate 250 the plates 215 and 220 can beresiliently
`biased together. In this way a user may apply pressure
`to the underside of vertically-sliding plate 220 by push-
`ing on push plate 250. As can be appreciated from
`FIGS.8-11, horizontally sliding plate 215 and vertical-
`ly-sliding plate 220 move along substantially orthogonal
`directions.
`In the operation of the device, a stent carrying cathe-
`ter 260 is placed in between plates 220 and 215, with
`catheter 260 entering through slot 265, and facing trans-
`verse to the direction of movement of horizontally-slid-
`ing plate 215. Thereinafter, horizontally-sliding plate
`215 is movedrelative to vertically-sliding plate 220, to
`compress the stent about the catheter. As can be seen
`from the drawings, horizontally-sliding plate 215 is
`constrained by grooves 225 to move along a single
`direction relative to vertically sliding plate 220.
`As before, a force measuring transducer and suitable
`output maybe placedin either or both of plates 215 and
`220 to measure the force imparted to the stent-carrying
`catheter and indicate the results.
`The embodiment of FIGS. 8-11 is sized to fit into a
`user’s palm. The horizontally-sliding plate 215 can be
`reciprocated with a thumb while housing 230 is held in
`the user’s palm, and the user’s fingers can apply pressure
`to push plate 250 affixed to the underside of vertically
`sliding plate 220. Springs 255 oppose the force of the
`user’s fingers. In this way feedback can be experienced
`by the user.
`While in the preferred embodiment the stent de-
`scribed is intended to be an intraluminal vascular pros-
`thesis for use within a blood vessel, and the balloon
`delivery catheteris of the kind used in therapeutic coro-
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`nary angioplasty, it will be appreciated by those skilled
`in the art that modifications may be madeto the present
`invention to allow the present invention to be used to
`load any type of prosthesis. The present inventionis not
`limited to stents that are deployedin a patient’s vascula-
`ture, but has wide applications to loading any type of
`graft, prosthesis,
`liner or similar structure. Further-
`more, the stent may be delivered not only into coronary
`arteries but into any body lumen. Other modifications
`can be madeto the present invention by those skilled in
`the art without departing from the scope thereof.
`Whatis claimedis:
`1. A stent-loading device for loading a stent onto a
`catheter comprising:
`a first substantially flat surface and a second substan-
`tially flat surface, said second flat surface being
`disposed substantially in parallel to said first flat
`surface and spaced therefrom a distance sufficient
`to allow a catheter having a stent disposed aboutits
`periphery to be received between said first and
`second surfaces; and
`means for allowing said surfaces to be forced toward
`one another while simultaneously allowing said
`surfaces to be shifted laterally relative one another
`for crimping the stent, disposed about the catheter
`and positioned between said first and second sur-
`faces, onto the outside of the catheter.
`2. The stent-loading device of claim 1, wherein said
`first and second substantially flat surfaces are formed
`from plates.
`3. The stent-loading device of claim 2, wherein said
`flat surfaces are elastomeric.
`4. The stent-loading device of claim 2, wherein said
`flat surfaces are spring biased towards one another.
`5. The stent-loading device of claim 2, wherein said
`first flat surface comprises a stationary plate, and said
`secondflat surface comprises a moveable plate, wherein
`said moveable plate is rigidly attached to a block ele-
`ment that is shiftably mounted to a support memberthat
`is in turn rigidly attached to said stationary plate.
`6. The stent-loading device of claim 5 wherein said
`block has a groove formed therein and further compris-
`ing a guide-bearing memberslideably received within
`said groove wherein said guide-bearing member has a
`groove formed therein which is perpendicularly ori-
`ented relative said groove formed in said block.
`7. The stent-loading device of claim 6, wherein said
`support member has a rail attached thereto, and
`wherein said rail
`is slideably received within said
`groove formed in said guide-bearing member.
`8. The stent loading device of claim 2, wherein said
`first and second surfacesare plates, and further compris-
`ing a housing supporting said plates.
`9. The stent loading device of claim 8, wherein said
`housingis sized to fit in a human hand.
`_
`10. The stent loading device of claim 8, wherein said
`plates are constrained by said housing to movein sub-
`stantially orthogonal directions.
`11. The stent loading device of claim 8, further com-
`prising a plurality of springs attached to one of said
`plates, and a push plate attached to said springs.
`12. The stent-loading device of claim 1, further com-
`prising a force transducer to measure the force applied
`to at ieast one of said flat surfaces.
`13. The stent-loading device of claim 12, further com-
`prising means for indicating the force measured by said
`transduceras said stent is crimped onto said catheter.
`*
`*
`*
`x
`*
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1028 - Page 7
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1028 - Page 7
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