.
`USOOS690613A
`5,690,613
`[11] Patent Number:
`[19]
`Unlted States Patent
`Verbeek
`[45] Date of Patent:
`Nov. 25, 1997
`
`
`l|||||llllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllll
`
`[54] RAPID EXCHANGE HIGH PRESSURE
`TRANSITION FOR HIGH PRESSURE
`CATHETER WITH NON-COMPLIANT
`BALLOON
`
`[75]
`
`Inventor: Maurice T.Y. Verbeek, Geleen,
`Netherlands
`
`[73] Assignee: Medtronic, Inc, Minneapolis, Minn.
`
`[21] Appl. No.: 759,696
`
`[22] Filed:
`
`Dec. 6, 1996
`
`Int. Cl.6 .................................................... A61M 29/00
`[51]
`[52] US. Cl.
`............................. 604/103; 604/96; 606/194
`[5 8] Field of Search .............................. 604/96—104, 282;
`128/898; 606/191—200, 108; 600/201, 204,
`207
`
`[56]
`
`References Cited
`
`U'S- PATENT DOCUMENTS
`4/1987 Daniels et a1. ............................ 604/53
`4,655,746
`5/1933 Homewskj et 31.
`.
`4,743,932
`8/1988 Bonzel .
`4,762,129
`9/1988 Homewski et al. .
`4,771,777
`3/1991 YOCk -
`5,040,543
`5,061,273 10/1991 Yock ....................................... 606/194
`
`54807367
`“1993 Kontos et 31'
`604/101
`9/1993 Eyard .................... 604/96
`5,242,396
`
`..... 604/96
`5,279,562
`1/1994 Suhan et a1.
`4,1994 Wantink ________________ 604/96
`5,300,025
`
`5,328,472
`7/1994 Steinke et a1.
`504/102
`5,364,376
`11/1994 Homewski et a1.
`.................... 604/280
`5,410,797
`5/1995 Steinke et al. .
`5,451,233
`9/1995 Yock ....................................... 604/194
`
`5,496,346
`5,545,134
`5,549,556
`5,549,557
`5,567,203
`
`.................... 604/194
`3/1996 Homewski et a1.
`8/1996 Hilaire et a1. ...........
`.. 604/96
`8/1996 Ndondo—Lay et a].
`.
`604/102
`8/1996 Steinke eta]. ......
`604/l03
`10/1996 Euteneuer et a1.
`........................ 604/96
`
`
`
`FOREIGN PATENT DOCUMENTS
`9217236 10/1992 WIPO .
`
`Primary Examiner—Glenn K. Dawson
`Attorney, Agent, or Firm—Dianne M.F. Plunkett; Harold R.
`Patton
`
`[57]
`
`ABSTRACT
`
`A medical catheter is provided which includes a core wire
`extending longitudinally through inflation tubing. The infla—
`tion tubing defines an inflation lumen- The distal end of the
`inflation tubing extends longitudinally through a tubular first
`reinforcement band which terminates distal to the distal end
`of the inflation tubing. An inner lumen tube defines a
`guidewire lumen, the inner lumen tube being biaxial with the
`inflation tubing and running longitudinally along the outer
`diameter of the inflation tubing. The inner lumen tube
`extends longitudinally through a Shim tube which has 3
`longitudinal slit running along its top side. The inner lumen
`tubing which has the shim coaxially bonded thereon extends
`longitudinally through a shaft tube. The inflation tube with
`the first reinforcement band coaxially bonded thereon also
`extends longitudinally through the shaft 11le. The shaft tube
`is bonded to the inner lumen tube and to the inflation tube.
`A
`tal
`.
`be b
`d d t
`th infl ti
`be An
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`P1606 may
`on e
`0
`F
`a 0“ t“
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`inflatable balloon IS mounted at the distal end of the shaft
`tube, the balloon is in fluid communication with the inflation
`lumen.
`
`22 Claims, 3 Drawing Sheets
`
`
`
`
`
`BSC USP 8,142,413
`Exhle 1018
`Page 1 of 10
`
`BSC USP 8,142,413
`Exhibit 1018
`
`Page 1 of 10
`
`

`

`US. Patent
`
`Nov. 25, 1997
`
`Sheet 1 of 3
`
`5,690,613
`
`
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`Page 2 of 10
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`
`

`

`US. Patent
`
`Nov. 25, 1997
`
`Sheet 2 of 3
`
`5,690,613
`
` 0..
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`
`Pageaof10
`
`Page 3 of 10
`
`
`

`

`U.S. Patent
`
`Nov. 25, 1997
`
`Sheet 3 of 3
`
`5,690,613
`
`
`
`Page4of10
`
`Page 4 of 10
`
`

`

`5,690,613
`
`1
`RAPID EXCHANGE HIGH PRESSURE
`TRANSITION FOR HIGH PRESSURE
`CATHETER WITH NON-COMPLIANT
`BALLOON
`
`FIELD OF THE INVENTION
`
`The present invention relates to angioplasty catheters, and
`more particularly, to a shaft transition section for a rapid
`exchange high pressure balloon catheter.
`BACKGROUND OF THE INVENTION
`
`One of the therapeutic procedures applicable to the
`present invention is known as percutaneous transluminal
`coronary angioplasty (P'I‘CA). This procedure can be used,
`for example, to reduce arterial build-up of .cholesterol fats
`or atherosclerotic plaque. Typically a first guidewire of
`about 0.038 inches in diameter is steered through the vas-
`cular system to the site of therapy. A guiding catheter, for
`example, can then be advanced over the first guidewire to a
`point just proximal of the stenosis. The first guidewire is
`then removed. A balloon catheter on a smaller 0.014 inch
`diameter second guidewire is advanced within the guiding
`catheter to a point just proximal of the stenosis. The second
`guidewire is advanced into the stenosis, followed by the
`balloon on the distal end of the catheter. The balloon is
`inflated causing the site of the stenosis to widen. The original
`catheter can then be withdrawn and a catheter of a diiferent
`size or another device such as an atherectomy device can be
`inserted.
`
`into high,
`Conventional angioplasty balloons fall
`medium, and low pressure ranges. Low pressure balloons
`are those that have burst pressures below 6 atmospheres
`(6.1x105 Pascals). Medium pressure balloons are those that
`have burst pressures between 6 and 12 atm (6.1)(105 and
`1.2><106 Pa). High pressure balloons are those that have
`burst pressures above 12 atm (1.2)(10‘5 Pa). Burst pressure is
`determined by such factors as wall thickness and tensile
`strength, for example.
`High pressure balloons are desirable because they have
`the ability to exert more force and crack hard lesions. High
`pressure balloons are also useful in stent deployment. A
`biocompatible metal stent props open blocked coronary
`arteries, keeping them from reclosing after balloon angio-
`plasty. Aballoon of appropriate size and pressure is first used
`to open the lesion. The process is repeated with a stent
`crimped on a high pressure balloon. The stent is deployed
`when the balloon is inflated. A high pressure balloon is
`useful for stent deployment because the stent must be forced
`against the artery’s interior wall so that it will fully expand
`thereby precluding the ends of the stent from hanging down
`into the channel encouraging the formation of thrombus.
`Rapid exchange catheters are those which have shorter
`guidewire lumens passing from the distal end of the catheter
`through the balloon and opening to the exterior of the
`catheter somewhere proximal
`to the balloon. Catheter
`exchanges over the guidewire are easier to accomplish
`because they can be done with a single operator rather than
`two operators as required by over—the—wire catheters.
`The catheter shaft area where the proximal end of the
`guidewire lumen begins is lmown as the transition area.
`Maintaining flexibility, a low profile and a strong bond in the
`transition area is diflicult when high pressures of greater than
`450 psi (31 bar) are used. With such pressures, parts could
`delarninate and separate. Typically, the area having the least
`bond strength, with the exception of the balloon area, is at
`the transition section where components meet and the tubing
`is necked down and/or weakened by heat.
`
`10
`
`15
`
`20
`
`25
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`30
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`35
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`45
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`50
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`55
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`65
`
`2
`U.S. Pat. Nos. 5,328,472 and 5,410,797 to Steinke et at.
`disclose flexible biaxial tubes which form the transition
`region. The rated burst pressure for this product is 10 bar
`with a transition area capable of 14 bar.
`U.S. Pat. No. 5,545,134 to Hilaire et a1. discloses a tube
`which comprises in its upper part a channel with a substan-
`tially circular cross-section which, once drawn, constitutes
`the second inner duct for the passage of a guide-wire, and in
`its lower part a second channel with a cross-section having
`substantially the shape of a crescent or kidney, which
`progressively disappears by stretching.
`U.S. Pat. No. 5,549,556 to Ndondo-Lay et al in FIG. 6 and
`U.S. Pat. No. 5,549,557 to Steinke et al in FIG. 2 disclose
`a biaxial guidewire and inflation lumen. The inflation lumen
`being defined by a spring coil and an inflation lumen jacket
`with a central core wire. Such a transition construction
`withstands pressures of up to 400 psi.
`What is needed is a rapid exchange catheter with a shaft
`transition that can reliably withstand internal pressure of at
`least 450 psi (31 bar) without leaking or rupturing which is
`relatively easy, consistent and reliable to manufacture.
`
`SUNIMARY OF THE INVENTION
`
`The above features and advantages of the present
`invention, as well as others, are accomplished by providing
`a medical catheter comprising a core wire extending longi-
`tudinally through inflation tubing. The inflation tubing
`defines an inflation lumen. The distal end of the inflation
`tubing extends longitudinally through a tubular first rein—
`forcement band which terminates distal to the distal end of
`
`the inflation tubing. An inner lumen tube defines a guidewire
`lumen, the inner tureen tube being biaxial with the inflation
`tubing and running longitudinally along the outer diameter
`of the inflation tubing. The inner lumen tube extends lon-
`gitudinally through a shim tube which has a longitudinal slit
`running along its top side. The inner lumen tubing which has
`the shim coaxially bonded thereon extends longitudinally
`through a shaft tube. The inflation tube with the first
`reinforcement band coaxially bonded thereon also extends
`longitudinally through the shaft tube. The shaft tube is
`bonded to the inner lumen tube and to the inflation tube. A
`metal piece may be bonded to the inflation tube. An inflat—
`able balloon is mounted at the distal end of the shaft tube,
`the balloon is in fluid communication with the inflation
`lumen.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1Ais a longitudinal cross section of the proximal end
`of the shaft of the present invention;
`FIG. 1B is a longitudinal cross-section of the transition
`section;
`
`FIG. 1C is a longitudinal cross-section of the balloon;
`FIG. 2 is a cross-section taken along the lines 2—2 of
`FIG. 1B before heat shrinldng;
`FIG. 3 is a cross-section taken along the lines 3—3 of
`FIG. 1B before heat shrinking;
`FIG. 4 is a cross-section taken along the lines 4—4 of
`FIG. 1B before heat shrinking; and
`FIG. 5 is a cross-section taken along the lines 5—5 of
`FIG. 1C.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`
`The present invention provides a 6 French compatible,
`rapid exchange catheter with a transition that can reliably
`
`Page5of10
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`Page 5 of 10
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`

`5,690,613
`
`3
`withstand internal pressure of at least 450 psi (31 bar)
`pressure without leaking or rupturing which is relatively
`easy, consistent and reliable to manufacture. FIG. 1A—1C are
`longitudinal cross—sectional views of a high pressure balloon
`catheter adapted for use in percutaneous transluminal coro—
`nary angioplasty (PTCA). FIG. 1A represents the proximal
`section 65. FIG. 13 represents the transition section 75. FIG.
`1C represents the balloon section 85. With the addition of a
`metal piece such as a marker band 22, an irradiated rein-
`forcement band of at least 8 mm in length and a shim 14 with
`a longitudinal slit 90 along the top side, the transition section
`75 can withstand 2.44 Lbf or 10.8 N, which is over twice the
`typical catheter 5N minimum requirement.
`The proximal section 65 of the shaft seen in FIG. 1A is
`made of a stainless steel 0.0232 inch (0.58 mm) outer
`diameter hypotube 20, a stainless steel core wire 30 tapering
`down from a 0.305 mm proximal end to a 0.102 mm distal
`end for flexibility, a 0.026 inch (0.66 mm) outer diameter
`clear laminate irradiated shaft tubing 21 and polyirnide
`tubing 50 with essentially the same outer diameter as the
`shaft 21, or a minimal variance such as an 0.029 inch (0.74
`mm) outer diameter. The distal end of the irradiated shaft
`tubing 21 is adhesively bonded to the proximal end of the
`polyirnide tubing 50 using polyirnide shaft adhesive 16.
`The transition section 75 shown in FIG. 1B is designed to
`handle at least 450 psi (31 bar) pressure and still remain
`flexible enough to navigate torturous paths. The transition
`section 75 of the shaft seen in FIG. 1B adds the following
`components to the assembly, an exit marker band 22 made
`of radiopaque metal such as Pt/Ir or stainless steel, a
`reinforcement band 13 of a clear material such as irradiated
`Linear Low Density Polyethylene (LDPE), inner lumen
`tubing 70 defining a guidewire lumen made of High Density
`Polyethylene (HDPE), and an inner lumen shim 14 made of
`LDPE.
`
`The balloon section 85 seen in FIG. 1C comprises distal
`shaft tubing 80 made of 50% HDPE/50% LDPE, a balloon
`35 made of any material suitable for high pressures above 12
`atm such as PET, PET blends or Nylon, and a balloon marker
`band 45 made of any suitable radiopaque metals such as
`platinum/iridium.
`Begin the assembly process by preparing the polyirnide
`tubing 50. Neck and trim the polyirnide tubing 50 by
`inserting the distal end of polyirnide tubing 50 having an
`outer diameter of 0.029 inches (0.74 mm) and an inner
`diameter of 0.0249 inches (0.63 mm) into the 0.022 inch
`diameter of the stepped mandrel. The stepped mandrel
`consists of a 0.022 inch outside diameter hypotube having an
`internal diameter to allow insertion of a 0.012 inch mandrel,
`which after insertion forms the stepped mandrel. Locate 9
`mm of the tubing 50 onto the 0.012 inch section of the
`stepped mandrel.
`Bonding a metal piece such as a marker band 22 into the
`transition section 75, and preferably to the inner diameter of
`the polyirnide tubing 50 increases the pull strength of the
`transition section 75 thereby reducing the likelihood of
`separation under high inflation pressures. Greater force can
`be applied in the proximal direction without the polyirnide
`tubing 50 separating from the reinforcement band 13. A
`radiopaque metal can be used for the marker band 22. This
`permits the marker band 22 to perform the function of
`allowing the physician to visualize with fluoroscopy the
`location of the guidewire exit at the proximal end of the
`inner lumen tubing 70. To accomplish the dual purpose of
`visualization and greater pull strength. slide an marker band
`22 with an outside diameter of 0.56 mm and an inside
`
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`20
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`4
`diameter of 0.43 mm inside the polyirnide tubing 50 and
`onto the 0.012 inch section of the stepped mandrel 5 mm
`distal from the distal end of the 0.022 inch section of the
`stepped mandrel. Pull back the 0.012 inch section mandrel
`far enough to be able to grasp the distal end of the tubing 50
`with needle nose pliers. To anchor the marker band 22 within
`the transition section 75, perform necking by locating the
`tubing 50 which is over the 0.012 portion of the mandrel,
`over a heat source. Neck the distal end of the tubing 50 down
`to a 0.012 inch inner diameter for a trim length of 11.0 mm.
`This length is just long enough for anchoring and bonding.
`Trim the polyirnide tubing 50 on the proximal side to a 20
`cm length while inserted into a 0.022 inch mandrel.
`Without a metal piece such as a marker band 22 in the
`transition section 75, the polyirnide tubing 50 can be pulled
`out of the reinforcement band 13 with less elfort because the
`weakest part of the bonding is between the polyirnide tubing
`50 and the reinforcement band 13. Adding the metal marker
`band 22 means that the marker band 22 must push aside all
`the material in the transition section 75 much like pulling a
`Ping-Pong ball through a tube with a smaller diameter than
`the diameter of the Ping-Pong ball.
`Expand a 30 mm section of reinforcement band 13 to a
`diameter which is suitable for fitting over the polyirnide
`tubing 50. The reinforcement band 13 must be irradiated to
`prevent
`the walls from melting and thinning. The wall
`formed by the reinforcement band 13 must be preserved
`because the wall from the inner lumen tubing 70 melts away
`and the reinforcement band 13 wall is then the last barrier for
`the pressure. For optimal pull strength the portion of the
`polyirnide tubing 50 beyond the neck 125 where the rein-
`forcement band 13 is crimped onto must be at least 10 mm.
`Testing showed reinforcement band 13 lengths of 6 mm was
`too short while a length of more than 12 mm was unneces—
`sary. Locate the reinforcement band 13 over the distal end of
`the polyirnide tubing 50 subassembly. Verify that the proxi—
`mal end of the reinforcement band 13 is aligned with the
`polyirnide tubing necking 125. The reinforcement band 13
`will overlap the 0.433 inch (11 mm) length of the necked
`down distal end of the polyirnide tubing 125, and will extend
`distally from the tubing 50 for a minimum length of 3 mm.
`The distal end of the reinforcement band 13 will extend
`
`0.315 inches (8 mm preferably with a range of 7 mm to 9
`mm) beyond the distal end of the polyirnide tubing 50. The
`proximal end of the reinforcement band 13 terminates at the
`neck 125 of the polyirnide tubing so as to maintain a
`minimum profile. Using a heat source, shrink the reinforce—
`ment band 13 onto the polyirnide tubing 50. The shim 14
`length may range between approximately 9 mm and 11 mm.
`The distance between the polyirnide tubing neck 125 and the
`distal end of the inner lumen shim 14 is approximately 0.748
`inches (19.00 mm). The purpose of the inner lumen shim 14
`is to fill the gap between the reinforcement band 13, inner
`lumen tubing 70 and distal shaft 80 distally from the exit
`marker band 22 and proximally from the distal shaft neck
`120 with a material which has a melt compatibility with the
`material in both the LDPE reinforcement band 13 and the
`HDPE inner lumen tubing 70 so as to bond the pieces
`together and prevent leakage at high pressures.
`Slit and trim the shim 14 into 10 mm lengths and cut a
`straight slit 90 from one end to the other. When positioned
`in the transition prior to melting, it is important that the slit
`90 in shim 14 is on top. This is because melting shrinkage
`occurs in the opposite direction of the slit, i.e., downwards.
`The top of the distal shaft tubing 80 will shrink onto and
`bond with the top of the inner lumen tubing 70. The ends of
`the inner shim 14 (left and right from the slit 90) will pull
`
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`5
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`5,690,613
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`down and fill in the cavities between the distal shaft tubing
`80 and the inner tureen 70 and the reinforcement band 13.
`A mandrel in the guidewire lumen 55 and also in the
`inflation tureen 25 prevents these lumens from collapsing
`during heat shrinking and bonding of the transition section
`75. The inflation/core wire lumen 25 empties into the
`inflation lumen 40 which is defined by the shaft 80. The
`inner lumen tubing 70 defines the guidewire lumen 55 and
`should have an inner diameter suitable for passing a standard
`0.014 inch guidewire, as for example, 0.017 inches (0.43
`mm). Neck the inner lumen tubing 70 within a 3 rnm section
`to an outside diameter of approximately 0.457 mm to 0.559
`rmn. Cut the inner lumen tubing 70 to approximately
`208—212 mm and preferably to 210 mm.
`When no marker band 22 is used but adhesive is used to
`bond the polyirnide tubing 50 to the reinforcement band 13
`it is important that all surfaces are clean so as to reduce
`impurities contributing to separation failures. Clean and
`activate the surfaces with plasma treating. Ultraviolet (UV)
`curable adhesive could be used to bond the polyimide tubing
`50 and reinforcement band 13 together. Put UV—curable
`adhesive on the polyimide tubing neck 125 and shrink the
`reinforcement band 13 around it. Cure the UV adhesive.
`As seen in FIG. 1B. an optional second reinforcement
`band 17 with a length of 1.5 mm (0.06 inch) and a preshrunk
`wall thiclmess of 0.03 mm (0.001 inch), could also be placed
`proximal to the marker band 22 and coaxially over the
`proximal end of the reinforcement band 13. The second
`reinforcement band 17 would be placed proximal to the
`marker band 22 so that circumferential rigidity is increased.
`To increase the pull strength still further in the transition
`section 75, the material proximal to the marker band 22
`could be made even more rigid. This can be done by using
`polyester tubing for the second reinforcement band 17.
`Polyester is more rigid than the LDPE. The second rein—
`forcement band 17 could be used in conjunction with the
`marker band 22 or without the marker band 22. Pull strength
`is greatest with both the marker band 22 and the second
`reinforcement band 17. Pull strength is less with the marker
`band 22 only. Having the second reinforcement band 17
`without the marker band 22 would not significantly increase
`pull strength. Omitting the marker band 22 simplifies manu-
`factming and reduces cost.
`Assemble the distal shaft tubing 80 and the inner lumen
`tubing 70 as follows. Expand the proximal end of the distal
`shaft tubing 80 such that it will fit over the many layers of
`tubing within, including the inner lumen tubing 70, inner
`lumen shim 14, polyimide tubing 50, reinforcement band 13
`and exit marker band 22. Assemble the shim 14 slit 90 face
`up onto the inner lumen tubing 70 such that the distal end of
`the shim 14 is 21.5 mm to-22.5 mm (0.846 inch to 0.886
`inch) away from the proximal end of the inner lumen tubing
`70. A mandrel with 0.0165 inch (0.42 mm) diameter is
`inserted in the inner lumen tubing 70. Locate the shim 14
`assembly in the proximal end of the distal shaft 80 such that
`the distal end of the shim 14 is aligned with the distal shaft
`neck 120. Insert the two stepped mandrel of 0.022/0.012
`inch inside the polyirnide tubing 50 in such a way that the
`0.012 section of the mandrel will extend from the distal end
`of the reinforcement band 13 with 5.0 to 10.0 mm (0.20
`inch—0.39 inch). Insert the distal end of the polyimide tubing
`50 into the proximal end of the distal shaft tubing 80. The
`distal end of the clear reinforcement band 13 preferably
`extends past the polyirnide tubing 50 by 8 mm. Locate the
`distal end of the clear reinforcement band 13, in alignment
`with the distal end of the shim 14. After fitting the expanded
`distal shaft tubing 80 over these layers, heat shrink the distal
`
`shaft tubing 80 tightly down using a conventional heat
`source. The resulting distal shaft tubing 80in the transition
`section 75 will have a major outer diameter of 0.048 inches
`(1.22 mm) and a minor outer diameter of 0.038 inches (0.97
`mm).
`
`Trim the excess proximal end of the distal shaft tubing 80
`to just proximal to the proximal end of the inner lumen 70
`tubing. Remove the 0.0163 inch mandrel from the transition
`section 75. Skive 95 the proximal end of the inner lumen
`tubing 70 at an angle of approximately 10 degrees for a
`length of 2 mm. Use a suitable medical grade cyanoacrylate
`adhesive such as Loctite® 420 preferably or 421
`(manufactured by Loctite Corp. in Hartford Conn.) to create
`a polyimide shaft adhesive 100 fillet at the proximal end of
`the trimmed area of the inner lumen tubing 70 on the distal
`shaft tubing 80 perimeter. The purpose of the adhesive fillet
`100 is to smooth the transition from the polyimide tubing 50
`to the larger outer diameter of the distal shaft tubing 80 and
`to provide a secondary pressure seal for the inflation lumen
`25. Remove the 0.022/0.012 inch stepped mandrel from the
`polyimide tubing 50.
`
`Various visual markers can be applied onto the hypotube
`20 and the polyirnide shaft tubing 50. The markers can be
`used for physician end marks without the need for angiog—
`raphy; such end marks include the brachial approach or the
`femoral approach and the guidewire exit marker band 22.
`Markers should be approximately 2 mm to 4 mm wide
`around the polyirnide tubing 50. Bond the balloon marker
`band 45 to the inner lumen tubing 70 using conventional
`adhesives.
`
`Trim the balloon 35 tails to 2 mm at the distal neck end
`and to 4.5 mm at the proximal neck end. Neck down a 2 mm
`length of the distal end of the distal shaft tubing 80 for 1.5
`mm diameter balloons. Balloons larger than a 1.5 mm
`diameter need not be necked down. Bonding surfaces may
`be treated to facilitate bonding. Bond the proximal balloon
`tall to the distal end of the distal shaft tubing 80 with any
`conventional manner such as adhesive 105. Bond the distal
`balloon tail to the distal end of the inner lumen tubing 70
`with any conventional manner such as adhesive 110.
`
`Prepare the hypotube assembly. Cut a hypotube 20 with
`an outer diameter of 0.0232 inches and an inner diameter of
`0.010 to 0.012 inches to 42.13 inches in length. Braze the
`core wire 30 to the hypotube 20. The core wire 30 provides
`push and prevents the polyimide tubing 50 and transition
`area 75 from kinking when bent. Place the proximal end of
`the core wire 30 into the distal end of the hypotube 20 such
`that there is about a 7.0 mm to 9.0 mm overlap, and braze.
`Heat shrink the clear laminate irradiated shaft tubing 21 onto
`the hypotube and trim such that approximately 1.575 inches
`(40.0 mm) of the distal end of the hypotube 20 extends
`beyond the irradiated shaft tubing 21 on the distal end and
`approximately 50.0 mm extends on the proximal end. Insert
`the polyirnide tubing 50 assembly onto the hypotube Align
`the core wire 30 through the transition section 75. Apply a
`suitable medical grade cyanoacrylate adhesive such as Loc-
`tite® 420 (manufactured by Loctite Corp.
`in Hartford
`Conn.) to the hypotube 20 and abut the proximal end of the
`polyirnide tubing 50 with the distal end of the irradiated
`shaft tubing 21.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`45
`
`50
`
`55
`
`65
`
`The preceding specific embodiments are illustrative of the
`practice of the invention. It is to be understood, however,
`that other expedients known to those skilled in the art or
`disclosed herein, may be employed without departing from
`the appended claims.
`
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`
`Page 7 of 10
`
`

`

`5,690,613
`
`7
`
`
`No.
`Component
`
`13
`First Reinforcement Band
`14
`Inner Lumen Shim
`16
`Polyimide Shafi Adhesive
`17
`Second Reinforcement Band
`20
`Hypotube
`21
`Irradiated Shaft Tubing
`22
`Marker Band
`25
`Core Wire Lumen] Inflation Lumen
`30
`Core Wire
`35
`Balloon
`40
`Inflation Lumen
`4S
`Balloon Marker Band
`50
`Polyimide Tubing
`55
`Guidewire Lumen
`65
`Proximal Section
`70
`Inner Ltunen Tubing
`75
`Transition Section
`80
`Distal Shafi Tubing
`85
`Balloon Section
`90
`Slit
`95
`Skive
`100
`Adhesive Fillet
`105
`Proximal Bond Adhesive
`110
`Distal Bond Adhesive
`120
`Distal Shaft Neck
`
`125 Polyimide Tubing Neck
`
`What is claimed is:
`1. A medical catheter comprising:
`a proximal section having a proximal end and a distal end;
`a transition section having a proximal end and a distal
`end;
`a balloon section having a proximal end and a distal end,
`the distal end of the proximal section being affixed to
`the proximal end of the transition section, the distal end
`of the transition section being aflixed to the proximal
`end of the balloon section, the balloon section having
`a balloon mounted at the distal end,
`the transition
`section further comprising:
`an inflation tube defining an inflation lumen, the inflation
`tubing having an inner diameter, an outer diameter, a
`proximal end and a distal end, the balloon being in fluid
`communication with the inflation lumen;
`a first reinforcement band having a distal end and a
`proximal end.
`the distal end of the inflation tube
`extending longitudinally through the first reinforce-
`ment band, the distal end of the first reinforcement band
`terminating distal to the distal end of the inflation tube;
`an inner lumen tube defining a guidewire lumen, the inner
`lumen tube being biaxial with the inflation tubing and
`running longitudinally along the outer diameter of the
`inflation tubing;
`a shim tube, the inner lumen tube extending longitudi-
`nally through the shim tube, the shim tube having a
`proximal end and a distal end;
`a shaft tube defining a shaft lumen; and
`the inner lumen tube having the shim tube coaxially
`bonded thereon extending longitudinally through the
`lumen of the shaft tube, the inflation tube with the first
`reinforcement band coaxially bonded thereon also
`extending longitudinally through the lumen of the shaft
`tube, the shaft tube being bonded to the inner lumen
`tube and to the inflation tube.
`2. A catheter according to claim 1 wherein the inflation
`tube has a core wire extending longitudinally therethrough.
`3. A catheter according to claim 1 wherein the shim tube
`has a longitudinal slit running along a top portion of the shim
`tube.
`
`.10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`4o
`
`45
`
`50
`
`55
`
`65
`
`8
`4. A catheter section according to claim 1 wherein the first
`reinforcement band is necked down over the distal end of the
`inflation tube such that the distal end of the shim tube is
`aligned with the distal end of the first reinforcement band.
`5. A catheter according to claim 1 wherein the inflation
`tube is necked down proximal to the proximal end of the first
`reinforcement band, the necked down portion of the inflation
`tube abuts the proximal end of the first reinforcement band.
`6. A catheter according to claim 1 wherein the shaft is
`necked down distal to and abutting the distal end of the shim.
`7. A catheter according to claim 1 wherein a metal piece
`having a proximal end and a distal end is bonded to an inner
`surface of the inflation tube.
`8. A catheter according to claim 7 wherein the proximal
`end of the shim tube is distal to the distal end of the metal
`piece.
`9. A catheter according to claim 7 wherein the metal piece
`is made of a radiopaque material.
`10. A catheter according to claim 1 wherein the first
`reinforcement band extends beyond the inflation tube by at
`least 5 mm.
`
`11. A catheter according to claim 1 wherein the first
`reinforcement band is made of irradiated LDPE.
`
`12. A catheter according to claim 1 wherein the shim tube
`is at least about 10 mm long.
`13. A catheter according to claim 1 having a second
`reinforcement band, the second reinforcement band having
`a distal end and a proximal end, the inflation tube extending
`longitudinally through the second reinforcement band, the
`second reinforcement band distal end being proximal to the
`first reinforcement band proximal end.
`14. A medical catheter comprising:
`a proximal section having a proximal end and a distal end;
`a transition section having the proximal end and a distal
`end;
`a balloon section having a proximal end and a distal end,
`the distal end of the proximal section being affixed to
`the proximal end of the transition section, the distal end
`of the transition section being aflixed to the proximal
`end of the balloon section, the balloon section having
`a balloon mounted at the distal end,
`the transition
`section further comprising:
`an inflation tube, the inflation tube defining an inflation
`lumen, the inflation tube having an inner diameter, an
`outer diameter, a proximal end and a distal end, the
`balloon being in fluid communication with the inflation
`tube;
`a first reinforcement band having a distal end and a
`proximal end,
`the distal end of the inflation tube
`extending longitudinally through a first reinforcement
`band, the distal end of the first reinforcement band
`terminating distal to the distal end of the inflation tube,
`the first reinforcement band being necked down over
`the distal end of the inflation tube, the inflation tube
`being necked down proximal to the proximal end of the
`first reinforcement band, the necked down portion of
`the inflation tube abutting the proximal end of the first
`reinforcement band;
`an inner lumen tube defining a guidewire lumen, the inner
`lumen tube being biaxial with the inflation tubing and
`running longitudinally along the outer diameter of the
`inflation tubing;
`a shim tube, the inner lumen tube extending longitudi-
`nally through the shim tube, the shim tube having a
`proximal end and a distal end, the distal end of the shim
`tube being aligned with the distal end of the first
`
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`

`5,690,613
`
`9
`
`reinforcement band, the shim tube having a longitudi—
`nal slit running along a top portion of the shim tube;
`a shaft tube defining a shaft lumen; and
`the inner lumen tube having the shim tube coaxially bonded
`thereon extending longitudinally through the shaft tube, the
`inflation tube with the first reinforcement band coaxially
`bonded thereon also extending longitudinally through the
`shaft tube, the shaft tube being bonded to the inner lumen
`tube and to the inflation tube, the shaft being necked down
`distal to and abutting the distal end of the shim tube.
`15. A transition section according to claim 14 wherein a
`core wire extends longitudinally through the inflation lumen.
`16. A transition section according to claim 14 wherein the
`first reinforcement band and the shim tube are made of
`LDPE.
`
`17. A transition section according to claim 14 wherein the
`inner lumen tube is made of HDPE.
`18. A transition section according to claim 14 wherein a
`metal piece is bonded to the inflation tube.
`19. A transition section according to claim 14 wherein the
`proximal end