United States Patent
`
`[19]
`
`[11] Patent Number:
`
`5,061,273
`
`
`Yock
`[45] Date of Patent:
`Oct. 29, 1991
`
`[54] $231?1¥ifi:§ ARPQPP?DR‘E§UCISI iNGES
`
`[76]
`
`Inventor:
`
`Paul G. Yock, 1216 San Mateo Dr.,
`Menlo Park, Calif. 94025
`
`FOREIGN PATENT DOCUMENTS
`591963
`4/1925 France .
`.
`527323 10/1973 (1.5.5.11.
`OTHER PUBLICATIONS
`
`[21] APPL No‘ 548,200
`.
`‘
`[22] Filed‘
`
`Jul. 5’ 1990
`
`[63]
`
`.
`.
`Related US- Application Data
`Continuation of Ser. No. 361,676, Jun. 1, 1989, aban-
`doned, which is a continuation of Ser. No. 117,357,
`Oct. 27, 1987, abandoned, which is a continuation of
`Ser. No. 852,197, Apr. 15, 1986, abandoned.
`
`
`Int. C1.5 ............................................. A61M 25/00
`[51]
`[521 11.5.0. :----------
`605/194; 604/96
`[58] Field of Search ......................... 604/96, 101, 102;
`606/192, 193, 194
`
`[56]
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`[ZS/303.11
`6/1936 Wappler
`2,043,083
`
`.. 128/349
`2,687,131 8/ 1954 Raiche ........
`
`128/351
`2,883,986 4/1959 de Luca et 31.
`.. 128/349
`2,936,760 5/ 1960 Gants .....
`
`.. 128/351
`3,731,962
`5/1973 Goodyear ..
`
`1. 128/348
`3,769,981 11/1973 McWhot'ter
`
`3,882,852 5/ 1975 Sinnreich ................. 128/4
`
`4,195,637
`4/1980 Gruntzig et al.
`128/348] X
`
`...... 128/344
`4,198,981
`4/1980 Sinnreich
`4,289,128
`9/1981 Rusch .....
`.. 128/207
`4,299,226 11/1981 Banka.
`.. 128/344
`4,367,747
`1/1983 Witzel
`.. 128/344
`4,468,224 8/ 1984 Enzmann e a
`.. 604/247
`
`4,545,390 10/1985 Leary .....
`604/95
`.. 128/344
`4,569,347
`2/1986 Frisbie
`
`4,610,662 9/ 1986 Weikl et al.
`128/3481 X
`
`4,616,653 10/1986 Samson et a].
`...... 128/344
`
`
`4,619,263 10/1986 Frisbie et al
`.. 128/344
`
`4,652,258
`3/1987 Drach
`604/53
`
`
`
`A New PTCA System with Improved Steerability,
`Contrast Medium Application and Exchangeable In-
`tracoronary Catheters, Tassilo Bonzel, PTCA Proc.
`Abstract, Course 3, Center for Cardiology, University
`Hospital, Geneva, Switzerland, Mar. 24-26, 1986.
`Nordcnsmm: ACTA Radio‘ogy» V01- 57: N0“ 1952’
`PP- 411—416-
`.
`Nordenstrom, Radiology, vol, 85, pp. 256—259 (1965).
`Diseases of the Nose and Throat, at pp. 776—794—797 (S.
`Thomson) (6th Ed., 1955).
`Achalasia of the Esophagus, at pp. 122_147 (F. Ellis, Jr.
`et a1.) (1969) (vol. 1x in the Series Major Problems in
`Clinical Surgery, J_ Dunphy, M.D., Ed.)
`Primary Examiner—Michael H. Thaler
`Attorney, Agent, or Firm—Fulwider, Patton, Lee &
`Utecht
`
`ABSTRACT
`[57]
`Apparatus for introduction into the vessel of a patient
`comprising a guiding catheter adapted to be inserted
`into the vessel of the patient and a device adapted to be
`inserted into the guiding catheter. The device includes a
`flexible elongate member and a sleeve carried by the
`flexible elongate member near the distal extremity
`thereof and extending from a region near the distal
`extremity to a region spaced from the distal extremity of
`the flexible elongate element. The device also includes a
`guide wire adapted to extend through the sleeve so that
`the guide wire extends rearwardly of the sleeve extend-
`ing alongside of and exteriorally of the flexible elongate
`element into a region near the proximal extremity of the
`flexible elongate element.
`
`6 Claims, 3 Drawing Sheets
`
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`33
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`28
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`/7
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`Page 1
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`Medtronic Exhibit 1480
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`

`

`US. Patent
`
`Oct. 29, 1991
`
`Sheet 1 of 3
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`5,061,273
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`Page 2
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`Medtronic Exhibit 1480
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`Page 2
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`Medtronic Exhibit 1480
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`

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`US. Patent
`
`Oct. 29, 1991
`
`Sheet 2 of 3
`
`5,061,273
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`Page 3
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`Medtronic Exhibit 1480
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`Page 3
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`Medtronic Exhibit 1480
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`

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`US. Patent
`
`Oct. 29, 1991
`
`Sheet 3 of 3
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`5,061,273
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`5’ N 681
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`69
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`6‘6
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`67
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`68
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`5,061,273
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`FIG. SB is a cross sectional View taken along the line
`8B—SB of FIG. 8A.
`FIG. 10 is a side elevational view of a dedicated dye
`injection/pressure measurement catheter incorporating
`the present invention.
`FIG. 11 is a side elevational view of a fiber optic
`cable incorporating the present invention.
`FIG. 12 is a side elevational view of a dedicated dye
`injection/pressure measurement catheter incorporating
`the present invention and having specific guiding means
`for facilitating entering acute bends in arterial vessels.
`FIG. 13 is a side elevational view of a bail out cathe-
`ter incorporating the present invention.
`FIG. 14 is a plan view of a holder utilized in conned
`tion with the present invention.
`In general. the angioplasty apparatus of the present
`invention is designed for introduction into the vessel of
`a patient. It consists of a guiding catheter which is
`adapted to be inserted into the vessel of the patient. It
`also consists of a device which is adapted to be inserted
`into the guiding catheter. The device includes a flexible
`elongate member, a sleeve is secured to the flexible
`elongate member near the distal extremity thereof and
`extends from the distal extremity into a region spaced
`from the distal extremity of the flexible elongate mem-
`ber. The device also includes a guide wire which is
`adapted to extend through the sleeve from the distal
`extremity of the flexible elongate element, through the
`sleeve and rearwardly of the sleeve alongside of and
`exteriorally of the flexible elongate element.
`More particularly as shown in FIGS. 1—4. the angio-
`plasty apparatus 16 for facilitating rapid exchanges of
`dilatation catheters consists of a conventional guiding
`catheter 17 which is provided with a rotatable hemo-
`static adapter 18 mounted on a proximal end and a y or
`two-arm connector or adapter 19 which is mounted on
`the rotatable adapter 18. The y-connector 19 is pro-
`vided with a knurled knob 21 which carries a threaded
`valve member 22 that carries an O-ring 23 which is
`adapted to be urged into sealing engagement with a
`balloon dilatation catheter 26 and a guide wire 27 ex—
`tending through the y-adapter 19 and through the guid-
`ing catheter 17 as shown in FIG. 1.
`The balloon dilatation catheter 26 is of a single lumen
`type and is provided with a flexible elongate tubular
`member 29 which has a lumen 31 extending there-
`through. The flexible tubular member 29 can be formed
`of a suitable material such as plastic. A Luer-type fitting
`32 is mounted on the proximal extremity of the flexible
`tubular member 29 and is adapted to be connected to a
`syringe or other type of instrument for introducing a
`radiographic contrast liquid into the flexible tubular
`member 29. A balloon 33 is mounted on the distal ex—
`tremity of another flexible tubular member 36 which
`also is formed of a suitable material such as plastic. The
`distal extremity of the balloon 33 is bonded to the distal
`extremity of the flexible tubular member 36 to form an
`air-tight and liquid-tight seal with respect to the same.
`The balloon 33 is coaxial with the tubular member 36 or
`sleeve as shown in FIG. 4B. The flexible tubular mem-
`ber 36 is provided with a guide wire lumen 37 through
`which the guide wire 27 carrying its flexible tip 28 can
`extend.
`Means is provided for forming a balloon inflation
`lumen 41 substantially concentric with the flexible tubu-
`lar member 36 and extends toward the distal extremity
`of the flexible tubular member 36. As can be seen from
`FIGS. 38 and 4B.
`the balloon inflationlumen 41 is
`
`ANGIOPLASTY APPARATUS FACILITATING
`RAPID EXCHANGES
`
`This application is a continuation of application Ser.
`No. 361,676, filed June 1. 1989, now abandoned, which
`was a continuation of Ser. No. 117,357, filed Oct. 27,
`1987, now abandoned, which was a continuation of Ser.
`No. 852,197 filed Apr. 15, 1986, now abandoned.
`This invention relates to angioplasty apparatus facili-
`tating rapid exchanges and a method for making rapid
`exchanges of angioplasty devices.
`is
`it
`At the present time in practicing angioplasty,
`often necessary to exchange One dilatation catheter for
`another. In doing so,
`it has been necessary to utilize
`long exchange wires having a length of approximately
`300 centimeters which typically requires two operators
`to perform the procedure. During this procedure, it is
`necessary that the operators communicate with each
`other which makes the procedure time consuming. In
`addition, since the exchange wire is so long it often is
`awkward to handle and for that reason may come in
`contact with the floor or become contaminated which
`necessitates removing the entire apparatus being uti-
`lized for the angioplasty procedure. There is therefore a
`need for a new and improved angioplasty apparatus
`which overcomes such difficulties.
`In general, it is an object of the present invention to
`provide an angioplasty apparatus and a method which
`facilitates rapid exchanges of various types of devices.
`Another object of the invention is to provide an angi-
`oplasty apparatus and method of the above character
`which greatly facilitates exchanges of dilatation cathe-
`ters.
`Another object of the invention is to provide an angi-
`oplasty apparatus and method of the above character
`which can be utilized for the positioning of flexible
`elongate members.
`Another object of the invention is to provide an angi-
`oplasty apparatus and method of the above character
`which can be utilized with various types of devices
`utilizing flexible elongate members.
`Another object of the invention is to provide an angi-
`oplasty apparatus and method in which dye injection
`and pressure measurements can be made.
`Additional objects and features of the invention will
`appear from the following description in which the
`preferred embodiments are set forth in conjunction with
`the accompanying drawings.
`FIG. 1 is a side elevational view of an angioplasty
`apparatus incorporating the present invention.
`FIGS. 2A, 3A and 4A are partial cross sectional
`views of the shaft. transition and balloon regions of the
`balloon dilatation catheter utilized in the embodidment
`of the invention shown in FIG. 1.
`FIGS. 23, 3B and 4B are cross sectional views taken
`along the lines ZB—ZB, 33—33 and 4B——4B of FIGS.
`2A, 3A and 4A respectively.
`FIGS. 5A, 6A and 7A are cross sectional views cor—
`responding to FIGS. 2A, 3A and 4A of another embodi-
`ment of a balloon dilatation catheter incorporating the
`present invention.
`FIGS. SB, GB and 7B are cross sectional views taken
`along the lines SB~SB, 6B—6B and 7B——7B of FIGS.
`5A, 6A and 7A respectively.
`FIGS. 8A and 9 are cross sectional views of the tran-
`sition and balloon regions of another balloon dilatation
`catheter incorporating the present invention.
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`3
`formed by a flexible tubular member 42 which can be
`formed integral with the balloon 33. The flexible tubu-
`lar member 42 extends into a transition region 44 which
`overlies the distal extremity of the flexible tubular mem-
`ber 29 so that the lumen 31 therein is in communication
`with the balloon inflation lumen 41. As can be seen
`particularly from FIG. 3A, the flexible tubular member
`36 makes a transition and extends out of the tubular
`member 42 and provides an opening 43. The proximal
`extremity of the tubular member 36 overlies the flexible
`tubular member 31. The guide wire 27 exits through the
`opening 43 and extends alongside and exteriorally of the
`flexible tubular member 29 from the proximal extremity
`of the flexible tubular member 36 to the proximal ex—
`tremity of the flexible tubular member 29.
`The transition region 44 should be positioned at least
`approximately 10—15 centimeters from the distal ex-
`tremity of the balloon dilatation catheter 26. This is
`important for two reasons. One is that the transition
`region be kept at a point where when the balloon dilata-
`tion catheter 26 is utilized in a procedure, the transition
`region remains in the guiding catheter 17 and out of the
`coronary artery. The spacing from the distal extremity
`of the dilatation catheter for the transition region is also
`advantageous in that it permits the person performing
`the procedure to pull the balloon dilatation catheter 26
`out of the guiding catheter 17 until the transition region
`44 clears the y-connector 19 so that all of the portion of
`the guide wire 27 which is exterior of the balloon dilata-
`tion catheter 26 is proximal of the y-connector. While
`this is being done,
`the operator can then utilize the
`knurled nut 21 to again close the o—ring to form a hemo-
`static seal between the y-connector and the balloon
`dilatation catheter to minimize the loss of blood from
`the patient.
`The flexible tubular member 42 can be formed of a
`suitable material such as a heat shrinkable plastic so that
`it can be shrunk onto the distal extremity of the flexible
`tubular member 29 and onto the proximal extremity of
`the flexible tubular member 36 to form liquid-tight and
`air-tight seals with respect to the same. From the con‘
`struction shown it can be seen that the guide wire 27
`exits from the balloon dilatation catheter 26 in a region
`which is relatively close to the distal extremity of the
`balloon dilatation catheter 26 and extends exteriorally
`of the balloon dilatation catheter to the proximal ex—
`tremity of the same. As shown in FIG. 1, the guide wire
`27 and the balloon dilatation catheter 26 extend out-
`wardly from the y-connector 19.
`A torquer 46 of a conventional construction is se-
`cured to the guide wire 27 for rotating the guide wire as
`hereinafter described.
`Operation and use of the angioplasty apparatus
`shown in FIG. 1 may now be briefly described as fol-
`lows. The guiding catheter 17 is inserted into the coro-
`nary artery in a conventional manner. The balloon dila-
`tation catheter is prepared for insertion into the guiding
`catheter 17 in a conventional manner. The balloon 33
`can be inflated outside the body by the use ofa balloon
`flushing tube of the type described in U.S. Pat. No.
`4,323,071 and inflated by introducing a radiopaque liq-
`uid through the fitting 32 into the lumen 31 and through
`the lumen 41 into the balloon 33 to flush all of the air in
`the balloon 33 through the balloon flushing tube to fully
`inflate the balloon. After the balloon 33 has been in-
`flated,
`the balloon can be deflated by removing the
`radiopaque liquid from the balloon.
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`The guide wire 27 is then introduced into the balloon
`dilatation catheter 26 by a back loading technique.
`Without the torquer 46 on the guide wire, the proximal
`extremity of the guide wire 27 is inserted backwardly
`through the tip of the balloon dilatation catheter
`through the guide wire lumen 37. The guide wire is
`advanced rearwardly by holding the distal extremity of
`the balloon dilatation catheter in one hand and advanc~
`ing the guide wire 27 rearwardly with the other hand
`until the guide wire 27 exits through the opening 43 at
`the transition region 44 of the dilatation catheter. As
`soon as the guide wire has cleared the opening 43, the
`guide wire can be grasped by the hand and pulled rear-
`wardly paralleling the balloon dilatation catheter 26
`until its proximal extremity is near the proximal extrem-
`ity of the dilatation catheter and so that the distal ex-
`tremity of the guide wire 27 with its flexible or floppy
`tip 28 protrudes at least partially from the distal extrem-
`ity of the balloon dilatation catheter.
`At this point in time, the O-ring 23 in the y-connector
`19 is opened by operation of the knurled knob 21. The
`distal extremity of the balloon dilatation catheter 26
`having the flexible tip protruding therefrom is then
`introduced to the y-connector past the opened o-ring 23
`and slid down the guiding catheter 17. The balloon
`dilatation catheter 26 and the guide wire 27 are grasped
`between the fingers of a hand and are advanced parallel
`into the guiding catheter 17. This procedure is contin-
`ued until a substantial portion of the balloon dilatation
`catheter is disposed in the guiding catheter 17.
`The torquer 46 now can be attached to the guide wire
`27 near the proximal extremity of the same. The guide
`wire 27 is then advanced ahead of the balloon dilatation
`catheter until it enters the arterial vessel of the patient.
`The balloon dilatation catheter 26 is held stable by the
`fingers of the hand while the guide wire 27 is being
`advanced. The positioning of the guide wire 27 in the
`desired arterial vessel can be observed under a fluoro-
`scope by using x-ray techniques well known to those
`skilled in the art. As is well known to those skilled in the
`art, the torquer 46 can be utilized for rotating the guide
`wire 27 to facilitate positioning of the flexible tip 28 in
`the desired arterial vessel so that the distal extremity of
`the guide wire can be advanced into the stenosis which
`it is desired to open or enlarge.
`As soon as the guide wire 27 is in the desired location,
`it can be held stationary by two fingers of the hand and
`at this point in time, the balloon dilatation catheter 26 is
`advanced over the guide wire until the deflated balloon
`33 is across the desired lesion or stenosis. If any diffi-
`culty is encountered by the person conducting the pro-
`cedure in introducing the balloon dilatation catheter so
`that the balloon 33 resists crossing the lesion or stenosis,
`the guide wire 27 can be retracted slightly. The person
`then can observe under the fluoroscope to see that the
`tip 28 of the guide wire is wiggling in the blood stream
`indicating that it is free to move in the blood stream.
`Then the person can grasp both the guide wire and the
`dilatation catheter in one hand and advance them as a
`unit so that they can cross the stenosis as a unit. It has
`been found by utilizing such a procedure, greater pusha-
`bility can be obtained in advancing the balloon dilata-
`tion catheter across the stenosis. In other words, more
`force can be applied to the balloon to cause it to cross
`the stenosis or lesion in case the opening therein is very
`small.
`After the balloon 33 has crossed the stenosis or lesion.
`the balloon 33 can be inflated in a conventional manner
`
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`5
`by introducing a radiopaque contrast liquid through the
`lumen 31. After the inflation has occurred and the de-
`sired operation has been performed by enlarging the
`opening in the stenosis, the balloon dilatation catheter
`26 can be removed very rapidly by the person perform-
`ing the procedure by grasping the guide wire 27 by two
`fingers immediately proximal of the y-connector 19
`after the torquer 46 has been removed. The balloon
`dilatation catheter 26 can be removed in several seconds
`in comparison with the much longer time required for
`removing the balloon dilatation catheter utilizing prior
`art exchange wire procedures. As soon as the balloon
`dilatation catheter 26 has been removed from the guid-
`ing catheter 17, another injection of radiographic con-
`trast liquid can be introduced through the guiding cath-
`eter 17 to observe whether or not the balloon dilatation
`procedure which has been performed on the lesion or
`stenosis has in fact opened the lesion or stenosis to the
`satisfaction of the person performing the procedure.
`If it is ascertained by the person performing the pro-
`cedure that additional dilation of the stenosis is desired
`and that a larger balloon should be inserted into the
`stenosis, this can be accomplished very rapidly by se-
`lecting the desired size of balloon dilatation catheter.
`As the balloon dilatation catheter 26 is being re-
`tracted out of the guiding catheter 17 and as soon as the
`transition region 44 has cleared the y-adapter 19, the
`o-ring 23 can be tightened down to form a seal over the
`balloon dilatation catheter to minimize the loss of blood
`of the patient. Thereafter, if desired, the remainder of
`the balloon dilatation catheter 26 can be removed from
`the guiding catheter 17 until the proximal extremity of
`the guide wire passes through the opening 43 and passes
`through the end of the balloon dilatation catheter 26. As
`soon as this has been accomplished, a new balloon dila-
`tation catheter can be loaded onto the guide wire in a
`rearward direction by introducing the proximal extrem-
`ity of the guide wire 27 into the tip of the balloon dilata-
`tion catheter. As this is being done, the index finger of
`the hand performing the procedure can be utilized for
`opening the o-ring by adjusting the knurled knob 21.
`The guide wire 27 is grasped by the fingers of the hand
`and the balloon dilatation catheter 26 can be advanced
`rapidly over the guide wire into the guiding catheter 17
`and advanced across the lesion in a manner hereinbefore
`described with respect to the smaller balloon dilatation
`catheter which had been utilized. The balloon of the
`new dilatation catheter can be inflated in the same man-
`ner as hereinbefore described. If necessary even another
`exchange procedure can be readily accomplished in the
`same manner as hereinbefore described utilizing a still
`larger balloon dilatation catheter if that turns out to be
`necessary.
`It has been found that an exchange utilizing the pres-
`ent angioplasty apparatus can be performed in less than
`10 to 15 seconds whereas in the past utilizing a prior art
`guide wire exchange procedure required an average of
`approximately two minutes.
`After the desired amount of dilation of the stenosis or
`lesion has been accomplished,
`the balloon dilatation
`catheter 26 can be removed and thereafter, the guiding
`catheter 17 can be removed.
`Another embodiment of an angioplasty apparatus
`incorporating the present invention is shown in FIGS.
`5A and 5B, 6A and 68 and 7A and 7B in which an
`additional dye/pressure lumen has been incorporated
`into the apparatus in order to enable an injection of a
`distal dye through the balloon dilatation catheter and
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`also to enable the measurement of pressures at the tip of
`the balloon dilatation catheter. The construction which
`is utilized is very similar to that shown in the balloon
`dilatation catheter 26 shown in FIG. 1. The correspond-
`ing parts of the balloon dilatation catheter 26ashown in
`FIGS. 5—7 is very similar to that hereinbefore described
`and for that reason the corresponding parts have been
`given the same corresponding numbers with letters
`being added to the numerals where changes are present
`in the parts or components. Thus the tubular member
`290. rather than having a single lumen 31 is provided
`with dual lumens 31a and 31b disposed side by side in
`the shaft region of the balloon dilatation catheter as
`shown in FIGS. 5A and 5B. In the transition region 44a,
`the two lumens 31a and 31b are still disposed side by
`side with the lumen 37a for the guide wire being dis-
`posed above the lumens 31a and 3117. In the balloon
`region, the lumen 31a has been terminated and extends
`into the balloon lumen 41a. At the transition region 440,
`the guide wire lumen 37a inclines downwardly and
`sidewise and adjoins the lumen 311) through the distal
`extremity of the balloon dilatation catheter 26a. The
`lumen 31b extends to the distal extremity of the balloon
`dilatation catheter.
`The balloon dilatation catheter which is shown in
`FIGS. 5—7 can be utilized in the same manner as the
`balloon dilatation catheter shown in FIG. 1. It can be
`seen that the guide wire 27 extends out of the opening
`430 in the transition region 44c and parallels the balloon
`catheter to its proximal extremity. A balloon dilatation
`catheter of the type shown in FIGS. 5-7 can be utilized
`initially in an angioplasty procedure. However,
`it
`should be appreciated that if a very small opening is
`present in the stenosis or lesion, it may be desirable to
`utilize a balloon dilatation catheter of the type shown in
`FIG. 1 first because it can be constructed with a smaller
`diameter than a balloon dilatation catheter of the type
`shown in FIGS. 5—7 because of the additional lumen
`which is provided for dye injection and pressure mea-
`surements. After a smaller balloon dilatation catheter
`has been utilized, a balloon dilatation catheter of the
`type shown in FIGS. 5—7 can be used utilizing the ex-
`change procedure hereinbefore described to make dye
`injection and/or pressure measurements through the
`use of the additional lumen 311:. It is particularly desir~
`able to make such a pressure measurement before con-
`clusion of the angioplasty procedure to be sure that the
`proper dilation of the lesion or stenosis has occurred
`and that there is adequate blood flow through the lesion
`or stenosis.
`Still another embodiment of the angioplasty appara-
`tus incorporating the present
`invention is shown in
`FIGS. 8A and 8B and shows the transition region of a
`balloon dilatation catheter 26b which incorporates a
`vent tube 51 which is utilized for venting air from the .
`balloon during inflation of the balloon and before inser-
`tion into the patient with radiopaque liquid to ensure
`that all the air is exhausted from the balloon. As shown
`in the transition region 44b in FIG. 8A, the guide wire
`27 extends through an opening 4317 provided in the
`transition region and extends through a flexible tubular
`member 3617 out the end of the balloon dilatation cathe-
`ter as shown in FIG. 9. A balloon filling lumen 31c is
`provided by the flexible tubular member 29b and termi-
`nates in the transition region 44b where it opens into the
`balloon filling lumen 41b that opens into the interior of
`the balloon 3312. A relatively short sleeve 52 formed of
`a suitable material such as plastic is also provided in the
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`7
`transition region 44b and as shown in FIG. 8A underlies
`the flexible tubular member 29b and extends from a
`region forward of the flexible tubular member 42b and
`terminates distally within the balloon inflation lumen 41
`as shown in FIG. 8A.
`The sleeve 52 is provided with a lumen 53 through
`which the vent tube 51 extends. The vent tube 51 can be
`formed of a suitable material such as metal and is also
`provided with a lumen 54 of a size so that gas can escape
`therethrough. The proximal extremity of the vent tube
`51 is provided with a portion 510 which is bent at right
`angles to the main portion of the vent tube 51 to ensure
`that the vent tube will be removed from the balloon
`dilatation catheter 26b prior to insertion into the guiding
`catheter 17. As shown in FIG. 9, the vent tube 51 ex-
`tends into the balloon 33 into a region near the distal
`extremity of the same.
`Operation of the balloon dilatation catheter 261)
`shown in FIGS. 8A, 8B and 9 may now be briefly de-
`scribed as follows. With the vent tube 51 in place in the
`balloon dilatation catheter, radiopaque contrast liquid is
`introduced through the balloon inflation lumen 31 and
`through the balloon inflation lumen 41!) to introduce the
`liquid into the balloon. As the liquid is introduced into
`the balloon, any air in the balloon is discharged through
`the vent tube 51. Pressure is maintained on the radi-
`opaque contrast liquid introduced into the balloon until
`droplets 56 of the liquid exit from the proximal extrem-
`ity of the vent tube 51 which serves to indicate that the
`balloon has been completely filled with the radiopaque
`contrast liquid and that all of the air therein has been
`exhausted therefrom. As soon as this occurs, the vent
`tube 51 can be withdrawn completely from the balloon
`dilatation catheter. The sleeve 52 which carries the vent
`tube collapses upon withdrawal of the vent tube and
`will remain collapsed to provide a valve to prevent the
`escape of any additional radiopaque contrast
`liquid
`from the balloon 33b. The sleeve 52 remains collapsed
`because when a high pressure is being introduced
`through the balloon inflation lumen 31c.
`the flexible
`tubular member 2917 will force collapsing of the sleeve
`52. Alternatively, when a negative pressure is being
`applied to the balloon 33b as, for example, when the
`balloon is being deflated, the positive atmospheric pres-
`sure on the exterior of the flexible tubular member 421)
`will again cause collapsing of the sleeve 52. Thus in
`effect there is provided a double valve system in which
`positive pressures on the interior will collapse the sleeve
`and when there is negative internal pressure the positive
`exterior atmospheric pressure will collapse the sleeve.
`In all other respects, the balloon dilatation catheter
`26b can be utilized in the same manner as the balloon
`dilatation catheters hereinbefore described in connec-
`tion with exchanges on the guide wire 27.
`Still another embodiment .of an angioplasty apparatus
`incorporating the present invention is shown in FIG. 10
`in which there is disclosed a dedicated pressure/dye
`catheter 61. The pressure/dye catheter 61 consists of an
`elongate flexible tubular member 62 formed of a suitable
`material such as plastic which is provided with a pres-
`sure dye lumen 63 extending therethrough. The proxi-
`mal extremity of the tubular member 62 is provided
`with a Luer-type fitting 64 to which devices having
`Luer-type fittings can be attached. A sleeve 66 formed
`of a suitable material such as plastic is secured to the
`exterior of the flexible tubular member 62 by suitable
`means such as an adhesive. It is provided with a guide
`wire lumen 67 extending therethrough. It should be
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`5,061,273
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`8
`appreciated that the sleeve 66 can be formed integral
`with the flexible tubular member 62 if desired. The
`sleeve 66 extends for a distance of at least 10 to 15 centi-
`meters from the distal extremity of the catheter 61 so
`that the transition region where it terminates at its prox-
`imal extremity is be within the guiding catheter 17 so
`that the transition region does not enter into the arterial
`vessel of the patient. A guide wire 68 is provided which
`extends through the guide wire lumen 67. The guide
`wire 68 can be of the same type as the guide wire 27. It
`is inserted into the sleeve 66 by taking the proximal
`extremity of the guide wire which is relatively stiff and
`inserting it into the distal extremity of the sleeve and
`then pushing it backwardly or rearwardly through the
`sleeve until
`it clears the opening 69 at the proximal
`extremity of the sleeve 66. The guide wire 68 is then
`pulled so that it extends in a direction parallel to the
`flexible tubular member 62 into a region near the proxi-
`mal extremity of the tubular member 62.
`It can be readily seen from the foregoing description
`that the pressure/dye catheter 61 can be readily intro-
`duced into a guiding catheter 17 and that the distal
`extremity of the pressure/dye catheter can be posi-
`tioned in a desired location in the arterial vessel by
`utilizing the guide wire 68 to position the same. It also
`should be appreciated that a torquer of the type herein-
`before described such as the torquer 46 can be utilized
`on the proximal extremity of the guide wire 68 to cause
`rotational movement of the guide wire to facilitate posi-
`tioning of the guide wire in the desired arterial vessel
`and to thereafter have the tubular member 62 follow the
`same. The desired picture and/or dye measurements
`can then be made by utilizing the lumen 63 provided in
`the tubular member 62. As can be seen from FIG. 10 the
`distal extremity of the tubular member 62 can be slanted
`and rounded as shown to facilitate entry into the steno-
`sis in the arterial vessel. This is desirable because of the
`eccentricity created by the addition of the sleeve 66.
`Another embodiment of an angioplasty apparatus is
`shown in FIG. 11 and takes the form of a fiber optic
`device 71. An encased fiber optic bundle 72 which is
`generally circular in cross section is provided. A sleeve
`73 of the type hereinbefore described formed of a suit—
`able material such as plastic is secured to the distal
`extremity of the fiber optic bundle 72 which is adapted
`to receive a guide wire 74. As in the previous embodi-
`ments, the sleeve 73 extends from the distal extremity
`for a distance of approximately 10 to 15 centimeters
`after which the guide wire exits from the sleeve and
`extends alongside and exteriorally of the fiber optic
`bundle 72 for substantially the entire length of the fiber
`optic bundle. As with the previous devices. the guide
`wire 74 is threaded into the sleeve by taking the proxi-
`mal extremity or stiff end of the guide wire and inserting
`it at the distal extremity of the sleeve 73 and pushing it
`from the rear towards the forward extremity of the
`sleeve. The fiber optic device 71 can then be inserted
`into a guiding catheter 17 and advanced to the desired
`location through the use of the guide wire. The fi