United States Patent
`Rupp et al.
`
`[19]
`
`[54] THICKENED INNER LUMEN FOR
`UNIFORM STENT EXPANSION AND
`METHOD OF MAKING
`
`[76]
`
`Inventors: Garry Eugene Rupp, 10777-B Andrea
`Ter. , Santee, Calif. 92071; Randell L.
`Werneth. 11315 Affinity Ct. . 1145, San
`Diego, Calif. 92131; Perfecta P. Tiios,
`8277 Calle Fino, San Diego, Calif.
`92126
`
`[21] Appl. No. : 637/59
`Apr. 25, 1996
`[22] Filed:
`[51] Int. Cl. e .
`A61M 29/00
`[52] U. S. Cl. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 604/96; 606/194
`[58] Field of Search . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 604/96, 103, 171,
`604/280, 282, 273, 104; 128/658; 606/192,
`194, 195, 108
`
`[56]
`
`References Cited
`U. S. PATENT DOCUMENTS
`4, 886, 062 12/1989 Wiktor . . . . . . . . . . .
`1/1991 Evard et al. . . .
`4, 981, 478
`7/1992 Wiktor . . . . . . . . . . .
`5, 133, 732
`5/56, 143 10/1993 Miller et al. . . .
`
`. . . 128/343
`. . . 604/282
`. . . 606/195
`. . . . . 604/96
`
`INIIIINlllllllllllllllllllllIIIIIIIIIIIIIIIIIIIlIIIIIIIIIIIIIIIIIIIIII
`US005653691A
`[11] Patent Number:
`[45] Date of Patent:
`
`5, 653, 691
`Aug. 5, 1997
`
`606/198
`606/108
`
`4/1995 Solar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`5, 403, 341
`4/1995 Osborn . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`5, 409, 495
`FOREIGN PATENT DOCUMENTS
`4/1993 European Pat. Off. . . . . . . . . . . A61F 2/06
`Primary Examiner — Corrine M. McDermott
`Assistant Examiner — Cris L. Rodriguez
`Attorney, Agent, or Firm — Dianne M. F. Plunkett; Harold R.
`
`0553960
`
`inff
`
`Patton
`
`[57]
`
`ABSTRACT
`
`catheter system for implanting
`a radially
`An intravascular
`stent within a body vessel including a catheter
`expandable
`atio lumen tube, an
`comprising an inner lumen tube, an
`inflatable balloon and at least one free standing built-up
`layer af5xed to the outer diameter of the inner lumen
`tube,
`to the balloon. A stent is
`the built-up
`layer being internal
`coaxially upon
`the balloon,
`the built-up
`mounted
`layer
`extends coaxially within
`the stent but does not extend
`and distal ends of the steat. The
`the proximal
`beyond
`layer is sufficiently
`thick as to cause the balloon to
`built-up
`to deploy uniformly. The
`the stent
`expand evenly and
`method of manufacturing
`the built-up layer includes forming
`the layer from shrink wrap tubing or alternatively
`forming
`the layer from molded ultraviolet
`light curing adhesive.
`
`17 Claims, 5 Drawing Sheets
`
`4
`
`l00
`45
`
`'
`
`'
`
`50
`
`"60
`
`50
`
`55
`
`6
`
`7
`
`8
`
`20
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1023 - Page 1
`
`

`

`U. S. Patent
`
`Aug. 5, 1997
`
`Sheet 1 of 5
`
`5, 653, 691
`
`4
`
`(
`'
`
`45
`
`50
`
`60
`
`30
`
`Flg. 2
`55
`
`135
`
`140
`
`30
`135
`
`5
`
`6
`
`7
`
`8
`
`20
`Fig. 3
`
`Fig. 4
`
`140
`
`30
`
`135
`
`35
`
`140
`40
`
`135
`
`35
`
`140
`
`135
`
`35
`140
`
`30
`
`60
`
`Fig 7.
`
`Fig. 8
`
`135
`50
`
`45
`30
`
`140
`
`40
`135
`
`30
`
`30
`
`35
`
`140
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1023 - Page 2
`
`

`

`U. S. Patent
`
`Aug. 5, 1997
`
`Sheet 2 of 5
`
`5, 653, 691
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1023 - Page 3
`
`

`

`U. S. Patent
`
`Aug. 5, 1997
`
`Sheet 3 of 5
`
`5, 653, 691
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1023 - Page 4
`
`

`

`U. S. Patent
`
`Aug. 5, 1997
`
`Sheet 4 of 5
`
`5, 653, 691
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1023 - Page 5
`
`

`

`U. S. Patent
`
`Aug. 5, 1997
`
`Sheet 5 of 5
`
`5, 653, 691
`
`Fig. 16
`
`235
`
`240
`
`255
`
`245
`
`I
`
`210
`
`236
`
`I
`
`200
`
`230
`
`220
`
`Fig. X7
`235
`240
`
`2IO
`
`245
`
`Fig. 18
`
`PRIOR ART
`
`3I5
`
`3I5c
`
`3I58
`
`335
`
`305
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1023 - Page 6
`
`

`

`5, 653. , 691
`
`1
`THICKENED INNER LUMEN FOR
`UNIFORM STENT EXPANSION AND
`METHOD OF MAKING
`
`FIELD OF THE INVENIION
`
`to an intravascular
`The present
`relates
`stent
`invention
`system and method of manufacture
`and more
`deployment
`to a balloon catheter for stent delivery with the
`particularly
`catheter inner lumen tube having a greater outer diameter for
`a central portion of the area covered by the steat thereby
`permitting more uniform expansion of the stent.
`
`BACKGROUND OF THE INVENTION
`
`(PI'CA)
`coronary angioplasty
`Percutaneous
`transluminal
`is used to reduce arterial build-up of cholesterol
`fats or
`atherosclerotic plaque. Typically a first guidewire of about
`0. 038 inches
`is steered
`the vascular
`in diameter
`through
`to the site of therapy. A guiding
`for
`catheter,
`system
`example, can then be advanced over the first guidewire. The
`is then removed. A balloon catheter on a
`first guidewire
`smaller 0. 014 inch diameter guidewire
`is advanced within
`the guiding catheter to a point just proximal to the stenosis.
`into the stenosis, fol-
`is advanced
`The second guidewire
`lowed by the balloon at the distal end of the catheter. The
`the site of the stenosis
`to
`is then inflated causing
`balloon
`the arterial wall. The dilatation of the
`into
`compress
`occlusion, however, can form fiaps, fissures and dissections
`re-closure of the dilated vessel or even
`which
`threaten
`in the vessel wall. Implantation of a metal stent
`perforations
`for such flaps and dissections
`and
`can provide
`support
`thereby prevent reclosure of the vessel or provide a patch
`repair for a perforated vessel wall until corrective surgery
`the possibility of restenosis
`can be performed. Reducing
`that a secondary
`the likelihood
`reduces
`after angioplasty
`angioplasty procedure or a surgical bypass operation will be
`necessary.
`such as a stent can preclude
`An implanted prosthesis
`and maintain vascular patency by
`additional procedures
`supporting dilated vessels to prevent vessel
`mechanically
`collapse. Stents can also be used to repair aneurysms,
`to
`support artificial vessels as liners of vessels or to repair
`dissections. Stents are suited to the treatment of any body
`the vas deferens, ducts of the gallbladder,
`including
`lumen,
`prostate gland, trachea, bronchus and liver. The body lumens
`range in size from the small coronary vessels to the 28 mm
`to acute and chronic
`aortic vessel. The invention
`applies
`closure or reclosure of body lumens.
`A typical stent is a cylindrically
`shaped wire formed
`device intended to act as a permanent prosthesis. A stent is
`in a body
`from a radially compressed
`lumen
`deployed
`into a radially expanded configuration which
`configuration
`allows it to contact and support a body lumen. The stent can
`be made to be radially self-expanding or expandable by the
`use of an expansion device. The self expanding stent is made
`from a resilient springy material while the device expand-
`able stent is made from a material which
`is plastically
`deformable. A plastically deformable stent can be implanted
`during a single angioplasty procedure by using a balloon
`catheter bearing a stent which has been crimped onto the
`is inflated,
`balloon. Stents radially expand as the balloon
`forcing the steat into contact with the body lumen
`thereby
`relationship with the vessel walls.
`forming a supporting
`The biocompatable metal stent props open blocked coro-
`them from reclosing after balloon
`nary arteries. keeping
`angioplasty. A balloon of appropriate
`is
`size and pressure
`first used to open the lesion. The process is repeated with a
`
`stent crimped on a balloon. The stent is deployed when the
`balloon is infiatetL The stent remains as a permanent scafFold
`after the balloon is withdrawn.
`U. S. Pat. No. 4, 886, 062 to Wiktor for 'Intravascular
`Radially Expandable Stent and Method of Implant" dis-
`closes a two-dimensional
`zig-zag form, typically a sinusoi-
`dal form.
`U. S. Pat. No. 5, 409, 495 to Osborn for "Apparatus
`for
`Implanting a Stent" discloses elastic restraining
`Uniformly
`bands which exert a force at the proximal and distal ends of
`to that generated by the
`the balloon equal and opposite
`combined resistance of the sleeve and the stent tending
`to
`deform the balloon. In this way, the uneven expansion (end
`effects) are limited when the balloon is expanded which, in
`turn, inhibits a "dog boning" deformation at the proximal
`and distal regions of the balloon. FIGS. 3 — 6 show a balloon
`of complex manufacture.
`As stent metal mass increases in stents having elements
`in the longitudinal direction,
`that can expand independently
`compression at the
`there is a tendency
`towards
`longitudinal
`center of the stent when expanded. The increased metal mass
`creates more radial hoop strength which in turn increases the
`mount of force required to expand the stent. The center of
`than the ends of the
`the stent has more radial hoop strength
`steat. As a result, the balloon expands first at the distal and
`proximal ends before expanding at the center. This creates a
`shaped balloon. With the steat ends expanding
`dumbbell
`first, the stent slides down the expanded balloon ends toward
`the center of the balloon which is as yet unexpanded because
`of the stent' s greater radial hoop strength in the center. When
`the stent has
`the balloon ends have expanded completely,
`one-half of its original
`to approximately
`been compressed
`crimped length. Because the steat is compressed
`toward the
`center of the balloon, complete balloon expansion may not
`be possible. What is needed is a method of stent deployment
`which results in uniform stent expansion.
`
`SUMMARY OF THE INVENTION
`It is an object of the invention to provide a means for steat
`deployment which reduces longitudinal
`stent slippage dur-
`ing stent expansion and permits uniform radial stent expan-
`sion. A further object of the invention
`is to provide a method
`of molding parts which reduces costs, reduces the possibility
`of damage
`and produces a precision part. The present
`is accomplished by providing
`an intravascular
`invention
`a radially expandable
`catheter system for implanting
`stent
`within a body vessel including
`a catheter comprising
`an
`tube, an irdlatable
`tube, an inflation
`inner
`lumen
`lumen
`balloon and at least one free standing built-up
`layer affixed
`to the outer diameter of the inner lumen
`tube, the built-up
`to the balloon. A stent
`is mounted
`layer being
`internal
`layer extends coaxi-
`coaxially upon the balloon, the built-up
`ally within the stent but does not extend beyond the proximal
`and distal ends of the stent. The built-up layer is sufficiently
`thick as to cause the balloon to expand evenly and the stent
`to deploy uniformly. The method of manufacturing
`the
`the layer from shrink wrap
`layer includes forming
`built-up
`tubing or alternatively
`forming the layer from molded ultra-
`violet light curing adhesive.
`
`BRIEF DESCRIPriON OF THE DRAWINGS
`cross-section of a stent on a
`FIG. 1 is a longitudinal
`layers accord-
`deployment device having multiple built-up
`ing to the invention;
`
`FIG. 2 is a cross-section along the lines 2 — 2 of FIG. 1;
`FIG. 3 is a cross-section along the lines 3 — 3 of FIG. 1;
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1023 - Page 7
`
`

`

`5, 653, 691
`FIG. 4 is a cross-section along the lines 4 — 4 of FIG. 1;
`FIG. 5 is a cross-section along the lines 5 — 5 of FIG. 1;
`FIG. 6 is a cross-section along the lines 6 — 6 of FIG. 1;
`FIG. 7 is a cross-section along the lines 7 — 7 of FIG. 1;
`FIG. 8 is a cross-section along the lines 8 — 8 of FIG. 1;
`FIG. 9 is a cross-section along the lines 9 — 9 of FIG. 1;
`FIG. 10 is a longitudinal
`cross-sectional view of a mold
`containing
`inner lumen tubing having marker bands affixed;
`FIG. 11 is a perspective view of a pair of molds of FIG.
`10;
`FIG. 12 is a longitudinal
`cross-sectional view of a mold
`for a catheter strain relief with the catheter therein;
`FIG. 13 is a perspective view of a pair of molds of FIG.
`12;
`FIG. 14 is a longitudinal
`cross-sectional view of the
`catheter and alternative mold to FIG. 12 including a mold
`fixture;
`alignment
`FIG. 15 is a perspective view of a pair of mold alignment
`fixtures of FIG. 14;
`FIG. 16 is a longitudinal
`cross-section of a stent on a
`deployment device having a molded built-up layer according
`to the invention; and
`FIG. 17 is a cross-section along the lines 17 — 17 of FIG.
`16.
`FIG. 18 is a side elevation overall view of a Wiktor stent
`fitted over a defiated balloon.
`
`20
`
`25
`
`DETAILED DESCRIPHON OF THE
`PRFSSRED EMBODIMENTS
`in U. S. Pat.
`A typical Wiktor coronary stent is described
`No. 4. 886, 062 herein
`incorporated by reference. Refer to
`FIG. 18 showing a side elevation overall view of a Wiktor
`stent 300 fitted over a defiated balloon 335. The Wiktor stent
`300 is formed with a wire which is formed into zig-zags such
`the length of the
`as a sinusoidal wave form helix pattern
`stent by a means such as passing the wire through gears such
`in U. S. Pat. No. 2, 153, 936 issued
`to
`as those disclosed
`Owens et al. The zig-zags are formed by alternate peaks 305
`and valleys 310. The zig-zags are canted toward the proxi-
`mal and distal ends of the stent 300. The zig-zags form a
`plurality of spaced-apart elements 315a — e each extending
`the hollow cylinder. Each of the ele-
`360 degrees around
`ments 315a — e has a plurality of extendible portions such as
`the wire elements 315a-e to be
`the zig-zags which permit
`to a second,
`from an unexpanded
`diameter
`expanded
`expanded diameter.
`A wire having formed zig-zags is wound around a form-
`to create the cylindrical stent shape. After the
`ing mandrel
`stent has been reduced
`to the objective outer diameter by
`it on successively smaller mandrels,
`the proxi-
`compressing
`mal and distal ends of the wire segment are attached. The
`means of attachment may include looping the end segments
`together, twisting, biocompatible adhesive, brazing, welding
`or stamping.
`The stent wire can have a diameter of about 0. 001 inches
`to about 0. 015 inches. Around wire is shown in the phantom
`stent 100 in FIG. 1. The balloon expandable
`stent can be
`made of an inert, biocompatible material with high corrosion
`resistance that can be plastically deformed at low-moderate
`the preferred embodiment.
`stress levels such as tantalum,
`Other acceptable materials
`include stainless steel, titanium
`ASTM F63-83 Grade 1, niobium or high carat gold K 19-22.
`A self-expanding device can be made by the use of super-
`elastic nickel titanium
`(NiTi) such as Nitinol manufactured
`by Raychem or Forukawa.
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`65
`
`5
`
`10
`
`15
`
`The preferred form of the sinusoidal wave of the stent
`wire is a length of about 0. 150 inches to about 0. 090 inches
`and a wave amplitude of between about 0. 050 inches and
`about 0. 080 inches. Any wave length and amplitude com-
`that would provide adequate vessel hoop strength
`bination
`and vessel coverage is appropriate. The stent of this inven-
`tion and balloon can be transported via a standard ¹7 French
`guiding catheter of 0. 092 inches (2. 3 mm) outer diameter or
`8 French guiding catheter of 0. 105 inches (2. 7 mm) outer
`the stent can be expanded
`diameter. Once on location,
`radially by the expansion of the balloon 35; a ratio of 2. 75:1
`can be achieved with a wire diameter of approximately
`0. 005 inches and an initial steat diameter of 0. 060 approxi-
`mately inches.
`As seen in FIG. 18, the stent 300 is centrally located and
`positioned with respect to the length of balloon 335. The
`stent 300 turns are evenly spaced so that when the stent 300
`the stent 300 will provide even support
`is expanded
`inside
`loading. The stent 300 must
`the vessel and resist external
`expand evenly and permit the balloon 335 to expand evenly.
`The Wiktor stent is formed of a hollow cylindrical wire
`winding having a plurality of spaced-apart circumferential
`elements 315a — e. Each element 315a-e extends 360
`the hollow cylinder such that the elements
`degrees around
`315a — e can move
`as the stent 300 is
`longitudinally
`expanded. Each of the elements 315a-e has a plurality of
`extendible portions 305, 310 which permit the wire elements
`315a — e to be expanded. Each peak 305 and valley 310 pair
`comprises a wave. To achieve greater coverage, metal mass
`in a sinusoidal wave form stent 300 by
`can be increased
`having more waves per revolution, as for example, increas-
`ing from four waves to six waves. Stents such as that shown
`in FIG. 18 having elements 315a-e can expand
`indepen-
`dently in the longitudinal direction and can present special
`problems not presented by stents formed of a solid cylinder.
`there is a tendency
`As stent metal mass increases
`towards
`compression at the center of the stent when
`longitudinal
`expanded. The increased metal mass creates more radial
`the amount of force
`hoop strength which in turn increases
`required to expand the stent 300. The center of the stent has
`than the ends of the stent 300. The
`more radial hoop strength
`balloon expands first at the distal and proximal ends before
`is covered by the stem. This
`the center which
`expanding
`creates a dumbbell
`shaped baIIoon. With
`the stent ends
`first, the stent slides down the expanded balloon
`expanding
`the center of the balloon which
`is as yet
`toward
`ends
`unexpanded because of the stent's
`increased radial hoop
`in the center. As the proximal and distal ends of the
`strength
`two-thirds of normal
`to approximately
`balloon expand
`expansion diameter, the mid-section of the balloon begins to
`expand. When the balloon ends have expanded completely,
`to approximately
`the stent may have been compressed
`one-half of its original crimped length. Because the stent is
`the center of the balloon, complete
`compressed
`toward
`balloon expansion may not be possible.
`the dumbbell effect, a section of inner lumen
`To prevent
`tubing under the area of the stent can be built up as seen in
`FIGS. 1, or 16. Refer to FIG. 1. Since the portion of the stent
`100 situated over the built up section 20 is already partially
`the center of the stent 100 will begin to expand to
`expanded,
`its full diameter at the same time as the balloon 35 ends
`to expand. The built up section 20 in the central
`begin
`portion of the stent 100 improves stent expansion by reduc-
`ing radial hoop strength at the center of the stent 100 and
`this area of the stem 100 a head start on
`also by giving
`expansion so as to have the effect of pre-dilating
`the central
`portion of the stent.
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1023 - Page 8
`
`

`

`5, 653, 691
`
`5
`The length of the built up section 20 varies with the length
`of the stent 100 being deployeL Stents can range from 0. 197
`to 1. 97 inches (50 mm)
`in length. The
`inches (5 mm)
`length of the built up section 20 is equal
`to
`preferred
`one-third of the length of the steat 100. The built up section
`20 should be centered between the proximal and distal ends
`of stent 100. The built up section 20 has a tapering profile at
`either end to direct the stent elements slightly away from the
`center of the stent as the stent starts to expand. In particular,
`to be canted slightly
`the taper would cause the zig-zags
`toward the ends to give them that initial direction as the stent
`begins to expand.
`A typical catheter has inner lumen tubing 30 which may
`be made of High Density Polyethylene
`(HDPE) or polya-
`mide. The inner lumen tubing 30 defines an inner lumen 135
`for a guidewire. The inner
`which provides a passageway
`tubing 30 may be either coaxial or biaxial with the
`lumen
`tubing 55. The infiation
`tubing 55
`lumen
`inflation
`lumen
`lumen 140. In FIG. 1, the inner lumen
`defines an inflation
`lumen tubing 55 and
`tubing 30 is coaxial with the inflation
`therethrough. The inflation
`lumen may
`runs longitudinally
`be made from polyimide, polyamide, polyester, Low Den-
`(LDPE) or a jacketed spring coil. The
`sity Polyethylene
`distal end of the balloon 35 may be sealed to the distal end
`tubing 30. The proximal end of the
`of the inner
`lumen
`balloon 35 may be sealed to the distal end of the inflation
`tubing 55. The balloon may be made from LDPE,
`lumen
`(LLDPE). polyethylene
`Linear Low Density Polyethylene
`(PET) or Nylon. One metal marker band 45, in
`terephthalate
`FIG. 10 or two metal marker bands 65, or more than 2 metal
`the balloon on the
`marker bands may be positioned within
`outer surface of the inner lumen tubing FIG. 1 ¹30, FIG. 10
`¹130, FIG. 16 ¹230 to enable the physician
`to observe the
`advancement of the balloon under fluoroscopy.
`is 0. 014 inches. The inner diameter of
`Atypical guidewire
`the inner lumen tubing 30, 130, 230 is typically 0. 017 inches
`to allow approximately 0. 003 inches for clearance. The outer
`diameter of the inner lumen tubing 30, 130, 230 is typically
`0. 021 inches.
`When a steat 100 is crimped upon a balloon 35, the plastic
`two pieces of metal,
`is compressed between
`the
`balloon
`marker band 45 and the stent 100. This could cause pin hole
`leaks if not properly crimped. To avoid such
`leaks and
`provide a built up section 20 of sufficient thickness to avoid
`effect, one or more free standing built-up
`the dumbbell
`layers can be afiixed to the inner lumen tubing 30, 130, 230.
`FIGS. 1-9 show 3 such built-up
`layers, 40, 50 and 60.
`The total increase in thickness of all the built-up
`layers
`within the outer diameter of the inner lumen tubing 30, 130,
`230 over the built up section 20, 120, 220 can range from
`about 0. 001 inches to about 0. 060 inches at its thickest point.
`The built up section 20, 120, 220 proximal and distal ends
`taper down. The thickness of each individual built-up
`layer
`0. 001 inches and 0. 010
`ranges between
`approximately
`inches and should more preferably should range from about
`0. 002 inches to about 0. 008 inches in thickness, but not less
`than about 0. 002 inches in thickness. If a built-up layer is too
`the stent and
`thin it may puncture when crimped between
`to insufficiently
`building up the
`marker band in addition
`section to uniformly deploy the stent. If the built up section
`20 becomes too thick, the distal end of the catheter will
`too stiff and will fail to track properly within
`become
`thickness of a single
`tortuous vessels. The most preferable
`built-up layer is about 0. 003 inches. When shaft stock tubing
`is heat shrunk about the built up section 20, the typical
`layer ranges between 0. 003 to
`thickness of an individual
`layer 40, 50, 60 can be made
`0. 004 inches. Each built-up
`from polyethylene or nylon or other suitable biocompatable
`materials.
`
`tubing 30 can be built up by adding
`The inner
`lumen
`layers 40, 50, 60 of a polymer material or by
`built-up
`tubing 30 by adding
`molding. To build up the inner lumen
`one or more layers of a polymer material such as polyeth-
`5 ylene (PE) as seen in FIG. 1. one can heat shrink layers of
`tubing 30. This can be accom-
`PE onto the inner
`lumen
`plished by using a hot air torch box or a heat lamp from
`about 230 degrees to about 300 degrees for about 5 to about
`60 seconds. One layer of thick material or several layers of
`io thinner material can be used to achieve the desired increase
`layers may be more iiexible then a
`in diameter. Multiple
`single larger layer. The proximal and distal ends of the PE
`to form a smooth
`material are then shaved and tapered
`transition edge. The preferred number of built-up
`layers is
`i5 not more than 3 because of the amount of time each layer
`for each layer, a shrink wrap tube
`adds to manufacturing;
`will have to be cut to length, shrunk and shaved.
`tubing or any other material which
`Using shrink wrap
`to the inner
`requires heat in the process can cause damage
`&o lumen tubing 30. Shrinkable
`tubing also may have variabil-
`ity in tubing wall thickness and would pass that variability
`tapering would
`into the product. With shrinkable
`tubing,
`have to be performed, as for example, manually. This adds
`the potential for damage as well as the additional costs of
`~5 manufacture. The assembly
`steps associated with shrink
`wrap tubing are labor intensive.
`Refer to FIG. 10. Molding
`to the use of
`is an alternative
`to build up a section 120 of the inner
`shrink wrap tubing
`tubing 130. Molding can be done with silicon parts
`lumen
`but the tooling costs for producing such a mold can be high.
`instead a cast-in-place
`iiexible adhesive
`Applicant uses
`into a
`is formed by dispensing a flexible adhesive
`which
`molL After the adhesive is dispensed. the adhesive is cured.
`The advantage of a cast-in-place adhesive part is that it
`an accurate and precise profile which does not
`maintains
`need to be shaved. Less labor is involved
`in the molding
`process. The part is adhered to the catheter body at the same
`time the part is cast and cured. The resulting assembly forms
`~ a bond between the catheter body and the part. Cast-in-place
`to any assembly which may
`adhesive parts are applicable
`to be bonded
`as for
`two components
`together
`require
`example, strain relief parts or an inner lumen tubing built-up
`layer. Molds 75, 80 used for building up the inner lumen
`tubing 130 are seen in FIGS. 10 and 11. Molds 90, 95 for
`creating a strain relief are seen in FIGS. 12 and 13. An
`to strain relief molds 90, 95 is seen in FIG. 14.
`alternative
`In FIG. 14 the adhesive is dispensed into molding tubing 25
`to fashion
`the strain relief. The related mold
`in order
`fixtures 105, 110 are seen in FIGS. 14 and 15.
`alignment
`The molds 75, 80, 90, 95, 25 which are used for cast-in-
`place adhesive parts should be made of, or lined/coated with
`a material which will not adhere to the flexible adhesive.
`for the mold/liner
`include silicone and
`Suitable materials
`such as TEFLON™ from E.
`55 polyurethane. A fiuoropolymer
`I. Du Pont de Nemours Er. Company, Wilmington, Del. could
`also be used among others. If an ultraviolet
`light cured
`is used, the mold must be transparent. Suitable
`adhesive
`include polycarbonate or
`for transparent molds
`materials
`so acrylic.
`Refer to FIGS. 16 and 17. To create a molded built up
`section 220 the following procedure may be employed. The
`inner lumen tubing 230 is placed in the build up cavity 125
`of the inner lumen tubing mold side one 75. The inner lumen
`65 tubing mold side two 80 seen in FIG. 11 is then closed.
`Suitable iiexible adhesive is injected into the built up cavity
`layer 210
`125 and cured. The resulting adhesive built-up
`
`35
`
`5
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1023 - Page 9
`
`

`

`5, 653, 691
`
`-continued
`
`No. Component
`
`105
`110
`115
`120
`125
`130
`135
`140
`145
`200
`210
`220
`230
`235
`236
`240
`245
`255
`300
`305
`310
`315a-e
`335
`
`Mold Alignment Fixture Side One
`Mold Alignment Fixture Side Two
`Strain Relief Cavity
`Built Up Section
`Built Up Cavity
`Inner Lumen Tubing
`Inner Lumen
`lntlation Lumen
`Manifold
`Stent
`Adhesive Built-up Layer
`Built Up Section
`Inner Lumen Tubing
`Balloon
`Inner Lumen
`Intlation Lumen
`Marker Bank
`InQation Lumen Tubing
`Wrktor Stent
`Peak
`Valley
`Elements
`Balloon
`
`10
`
`15
`
`20
`
`30
`
`35
`
`forms a built up section 220 is shown in FIG. 16. Once the
`tubing 230 is built up, the distal end of the
`lumen
`inner
`balloon 235 is attached to the distal end of the inner lumen
`the proximal end of the balloon 235 is
`tubing 230 and
`attached to the distal end of the infiation
`tubing 255
`lumen
`as seen in FIG. 16. The inner lumen tubing 230 defines the
`inner lumen 236. After the balloon 235 is wrapped and heat
`set, the stent 200 is crimped down onto the balloon 235. The
`layer 210 keeps
`the balloon 235 fi'om
`adhesive built-up
`the metal stent 200 and the
`becoming punctured between
`metal marker band 245. The built up section 220 causes the
`middle of the stent 200 to be slightly
`expanded,
`thus
`the radial hoop strength and reducing
`the amount
`reducing
`of force required to expand the middle of the stent 200. This
`the stent 200 to be expanded uniformly
`simulta-
`allows
`neously.
`To mold a strain relief, refer to FIG. 12. A catheter shaft
`85 is placed in the strain relief cavity 115 of the strain relief
`mold side one 90. The strain relief mold side two 95 seen in
`FIG. 13 is then closed. A strain relief can also be formed with
`a section of molding
`tubing 25 and an alignment fixture 105,
`110 as seen in FIGS. 14 and 15. Use of an alignment
`fixture
`105, 110 results in the proper centering of the catheter shaft
`tubing 25. The alignment
`fixture 105
`S5 within the molding
`when placed next to its mirror image counterpart 110, forms
`a passage therethrough. The passage has a larger aperture 70
`at the proximal end than the aperture at the distal end 72. The
`apertures are sized to fit the particular catheter manifold 145.
`Flexible adhesive
`is then injected into either the molding
`tubing 25 or the strain relief cavity 115 and cured. The
`from mold 25 or molds 90/95 and
`is removed
`assembly
`further processed.
`(UV) light curing adhesives
`Ultraviolet
`are preferable
`because heat which may damage the catheter is not requiretL
`
`Furthermore, ~ curing time, generally under 20 sec-
`
`onds are required. A suitable light source is required for UV
`curing adhesives. The preferred material for UV/Light cur-
`includes 1-20270 Dymax Ultra Light
`ing adhesive
`WeldrM from Dymax Corp. of Torrington Conn. Loctite
`manufactured by Loctite Corp. in Hartford Conn. could also
`to room
`be used. UV/light
`are superior
`cured adhesives
`curing adhesives which take longer.
`temperature
`The preceding specific embodiments are illustrative of the
`practice of the invention. It is to be understood, however,
`to those skilled in the art or
`that other expedients known
`disclosed herein, may be employed without departing
`the
`scope of the appended claims.
`
`No. Component
`
`20 Built Up Section
`25 Molding
`'Tubing
`30 Inner Lumen Tubing
`35 Balloon
`40 First Built-up Layer
`45 Marker Band
`50 Second Built-up Layer
`55 Intlation Lumen Tubing
`60 Third Built-up Layer
`65 Marker Band Pair
`70 Molding Tubing Proximal Aperture
`72 Molding Tubing Distal Aperture
`75 Inner Lumen Tubing Mold Side One
`80 Inner Lumen Tubing Mode Side Two
`85 Catheter Shaft
`90 Strain Relief Mold Side One
`95 Strain Relief Mode Side Two
`ICO Stent
`
`what is claimed is:
`1. An
`for implanting
`a
`catheter
`intravascular
`system
`stent within a body vessel the combi-
`radially expandable
`nation comprising:
`a catheter comprising:
`an inner lumen tube defining an inner lumen,
`the inner
`tube having a proximal end, a distal end and
`lumen
`an outer diameter;
`an inflation lumen tube defining an infiation lumen, the
`tube having a proximal end and a
`inffation
`lumen
`tube extending distal to
`distal end, the inner lumen
`the inflation
`lumen
`tube;
`an inflatable balloon having a proximal end and a distal
`end, the balloon distal end being sealingly affixed to
`the distal end of the inner lumen
`tube, the balloon
`proximal end being sealingly affixed to the distal end
`of the infiation lumen tube, the balloon being in fiuid
`communication with the inffation
`lumen; and
`at least one free standing built-up
`layer affixed to the
`outer diameter of the inner lumen tube, the built-up
`layer being internal to the balloon, the built-up
`layer
`having proximal and distal ends;
`a stent having a proximal end and a distal end, the steat
`mounted coaxially upon the balloon, the built-up
`layer
`extending coaxially within the stent, the built-up
`layer
`not extending beyond the proximal and distal ends of
`the stent and with the built-up
`layer being sufiiciently
`thick as to cause the balloon to expand evenly and the
`stent to deploy uniformly.
`2. A catheter system according
`to claim 1 wherein
`the
`length of the built-up layer is approximately one-third of the
`length of the stent.
`3. A catheter system according
`to claim 1 wherein
`the
`layer is formed of at least one heat shrunk
`built-up
`layer.
`4. A catheter system according
`to claim 1 wherein
`the
`layer is formed from molded adhesive.
`built-up
`5. A catheter system according
`to claim 4 wherein
`6o adhesive
`light cured adhesive.
`is an Ultraviolet
`6. A catheter system according
`to claim 1 wherein
`the
`built-up layer ranges between 0. 001 inches and 0. 060 inches
`in thickness at its thickest point, the thickest point being
`central to the stent.
`7. A catheter system according
`to claim 1 wherein
`the
`inner lumen tube is coaxial with and extends longitudinally
`the infiation
`tube.
`within
`lumen
`
`50
`
`ss
`
`6s
`
`the
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1023 - Page 10
`
`

`

`5, 653, 691
`
`8. A catheter system according
`to claim 1 wherein
`the
`stent is formed of a hollow cylindrical wire winding having
`a pl