United States Patent
`Fischell et al.
`
`[19]
`
`[54]
`
`[76]
`
`INTEGRATED CATHETER SYSTEM FOR
`BALLOON ANGIOPLASTY AND STENT
`DELIVERY
`
`Inventors: Robert E. Fischell, 14600 Viburnum
`Dr., Dayton, Md. 21036; TIm A.
`Fischell, 1018 Chancery La., Nashville,
`Tenn. 37215; David R. Fischell, 71
`Riverlawn Dr., Fair Haven, N.J. 07704
`
`[21] Appl. No.: 458,471
`Jun. 2, 1995
`[22] Filed:
`[51]
`Int. Cl. 6
`[52] U.S. CI
`
`A61M 29/00
`604/96; 604/104; 606/108;
`606/194
`604/96, 102, 104,
`[58] Field of Search
`6041160, 161, 171, 264, 280; 606/195,
`191, 198, 200, 108, 194; 623/1, 12, 11
`
`[56]
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`4,955,895
`4,969,890
`5,019,090
`5,092,877
`
`911990 Sugiyama
`1111990 Sugita et ai
`5/1991 Pinchuk
`3/1992 Pinchuk
`
`606/194
`6061192
`6061194
`623/1
`
`I11111111111111111111111111111111111111111111111111111111111111111111111111
`US005639274A
`5,639,274
`Patent Number:
`Jun. 17, 1997
`Date of Patent:
`
`[11]
`
`[45]
`
`3/1993 Hull
`5,192,297
`1111993 Hall
`5,266,073
`9/1994 Lau et ai
`5,344,426
`10/1995 Marin et ai
`5,456,694
`111996 Braunschwei1er et ai
`5,484,444
`4/1996 Lau et ai
`5,507,768
`Primary Examiner-Robert A. Hafer
`Assistant Examiner-Chalin Smith
`Attorney, Agent, or Firm-Morton
`Klein
`[57]
`
`ABSTRACT
`
`606/195
`623/1
`606/198
`606/198
`606/108
`606/198
`
`J. Rosenberg; David 1
`
`This invention is directed to an integrated catheter system
`(60) including a stent catheter (65) and a balloon angioplasty
`catheter (20). The balloon angioplasty catheter (20) has an
`inflatable balloon (23) mounted near the catheter's distal end
`which is initially used for dilation of a vessel at a low
`balloon pressure to partially inflate the balloon (23). The
`stent catheter
`(65) contains a stent (15) within a stent
`containment cavity (69) and the stent (15) is displaced over
`the balloon (23). The stent (15) is held in place over the
`partially inflated balloon (23) and an outer tube (62) of the
`stent catheter (65) is pulled back. The stent (15) is deployed
`and the balloon (23) is reinflated to a higher pressure to
`embed the stent (15) into the wall of the vessel.
`
`15 Claims, 9 Drawing Sheets
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1013 - Page 1
`
`

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`
`Jun. 17, 1997
`
`Sheet 1 of 9
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1013 - Page 2
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1013 - Page 4
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`

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`Jun. 17, 1997
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`Sheet 4 of 9
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`5,639,274
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`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1013 - Page 5
`
`

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`Jun. 17, 1997
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1013 - Page 6
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`

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`u.s. Patent
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`Jun. 17, 1997
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`Sheet 6 of 9
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`5,639,274
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`ARTERIAL WALL
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1013 - Page 7
`
`

`

`u.s. Patent
`
`Jun. 17, 1997
`
`Sheet 7 of 9
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1013 - Page 8
`
`

`

`u.s. Patent
`
`Jun. 17, 1997
`
`Sheet 8 of 9
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1013 - Page 9
`
`

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`u.s. Patent
`
`Jun. 17, 1997
`
`Sheet 9 of 9
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1013 - Page 10
`
`

`

`5,639,274
`
`1
`INTEGRATED CATHETER SYSTEM FOR
`BALLOON ANGIOPLASTY AND STENT
`DELIVERY
`
`This invention is generally in the field of devices for
`opening and maintaining patency within vessels of the
`human body with specific application to percutaneous trans-
`luminal coronary angioplasty (PTCA) and stent delivery into
`a dilated arterial stenosis.
`
`2
`to 100% of the length of the stent is placed over the stent
`catheter; but in that case, the balloon at the distal end of the
`balloon angioplasty catheter could not be used to expand the
`stent. If, on the other hand, most of the length of the stent is
`5 placed beyond the distal end of the catheter onto which it is
`mounted so that
`the balloon could be used (though not
`efficiently) to expand the stent, then in that case the stent, as
`previously described, could easily become dislodged from
`the distal end of its catheter. Still further, having a stent
`10 mounted on the exterior surface of a catheter can cause a
`great deal of abrasion of the endothelial tissue on the inside
`surface of the arteries which is highly disadvantageous.
`Furthennore,
`the Wall invention could not be used with a
`self-expanding stent which stent has several functional
`15 advantages. Still further, Wall does not teach either a means
`to prevent distal embolization of the stent beyond the end of
`the balloon, nor does he teach a means for accurately
`positioning the stent onto the balloon.
`SUMMARY OF THE INVENTION
`The present
`invention overcomes the disadvantages of
`prior art devices by integrating a balloon catheter and a
`single tube stent delivery catheter into an integrated catheter
`system which can perform both balloon angioplasty and
`stent delivery. Although this invention could be used for any
`vessel of the human body including but not limited to
`arteries, veins, vascular grafts, billiary ducts, urethras, fal-
`lopian tubes, bronchial tubes, etc., the descriptions herein
`will highlight
`the use of this device for arterial balloon
`angioplasty (and specifically PTCA)
`followed by intra-
`arterial stenting.
`No prior art known to the applicants teaches means for:
`(1) precisely positioning the stent located at the distal end
`of a stent delivery catheter onto the balloon prior to
`stent expansion,
`from being inadvertently
`(2) disallowing the stent
`released beyond the distal end of the balloon angio-
`plasty catheter thus resulting in a distal embolilzation
`of the stent,
`(3) using a tapered nose cone at the distal end of the stent
`catheter into which the stent
`is placed to assist in
`placement of the stent onto the balloon angioplasty
`catheter,
`(4) being capable of using either a balloon expandable
`stent or a self-expanding stent whichever
`is better
`suited for a particular vascular application, and
`(5) obtaining all the above listed advantages with the use
`of single tube, stent delivery catheter.
`Thus an object of this invention is to perform vessel
`dilatation, stent placement, and balloon enhanced embed-
`ding of the stent into the vessel wall all with a single
`integrated catheter.
`Another object of this invention is to allow the balloon to
`remain in one place in the artery during (1) balloon
`angioplasty, (2) stent placement, and finally (3) the further
`imbedding of the stent into the arterial wall.
`Still another object of this invention is to deploy a
`self-expanding stent by means of pulling back a slideable
`stent catheter while holding the stent onto the balloon which
`allows the stent to expand radially outward into a dilated
`stenosis.
`Still another object of this invention is to provide an
`improved apparatus and method for deploying balloon
`expandable stents.
`Still another object of this invention is to have the
`integrated catheter capable of being advanced over a flexible
`guide wire.
`
`25
`
`BACKGROUND OF THE INVENTION
`It is well known to use balloon angioplasty catheters for
`the dilatation of various vessels of the human body and most
`particularly for opening stenotic arteries. It is also well
`known to place stents into vessels to maintain patency of that
`vessel. It is also well known to use a balloon catheter for
`imbedding a stent into the wall of the vessel to prevent stent
`migration.
`It is typical to use separate catheters for vessel dilatation 20
`and for stent delivery. This requires one or more catheter
`exchanges which increases the time and cost for performing
`interventional procedures. Since the patient is typically in
`some discomfort during such procedures, it is also highly
`advantageous to the patient
`to make the interventional
`procedure as short as possible. Furthennore,
`removing a
`balloon angioplasty catheter after balloon dilatation can
`expose an intimal dissection that can make stent placement
`more difficult.
`In U.S. Pat. No. 5,019,090, L. Pinchukillustrates in FIGS. 30
`13 to 18 a method for mounting a self-deploying stent on a
`balloon angioplasty catheter. However, Pinchuk's method
`functions only for self-deploying stents and not balloon
`expandable stents, and furthermore, his method requires the
`balloon to be advanced at least 3 cm beyond the distal end 35
`of the stenosis that is treated. That is not possible in many
`coronary arteries because of restrictions in the distal length
`of the coronary arteries. Furthermore, Pinchuk's method
`requires two additional steps, i.e. one is a further advance-
`ment of the balloon after balloon angioplasty is perfonned,
`and later pulling the balloon back within the deployed stent.
`Pulling back of the balloon catheter can cause the stent to be
`moved away from its optimal location. Additional steps in
`such a procedure require additional time which is generally
`undesirable. Furthennore, Pinchuk does not teach a means 45
`or method for the use of a guide wire through the center of
`the integrated catheter so as to guide it through the typically
`tortuous coronary vasculatnre. Still further, Pinchuk teaches
`an outer sheath with a blunt end whose operability can be
`defeated because of intimal dissection which often occurs as 50
`a result of balloon angioplasty or atherectomy. Still further,
`Pinchuk does not describe any structure at the catheter's
`proximal end for the introduction of fluids and a guide wire
`and for disallowing inadvertent release of the stent. Still
`Further Pinchuk requires two separate tubes for stent place- 55
`ment which is more complex than the use of a single tube for
`stent placement.
`there is
`In U.S. Pat. No. 5,266,073 by W. H. Wall,
`described an "Angioplasty Stent" wherein a stent is mounted
`onto the exterior surface of a catheter, which catheter is 60
`placed coaxially over a conventional balloon angioplasty
`catheter. The Wall invention has several disadvantages and
`probably his design concept is not actually functional. By
`wrapping the stent around and onto the exterior surface at
`the distal end of the stent catheter, the stent can be easily 65
`dislodged as it is advanced through the tortuous coronary
`vasculatnre. Dislodgment would be less of a problem if close
`
`40
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1013 - Page 11
`
`

`

`5,639,274
`
`4
`tipped stent
`FIG. 8 illustrates how a prior art blunt
`catheter of an integrated stent and balloon angioplasty
`catheter system can be made dysfunctional because of an
`intimal flap formed in the plaque after balloon dilatation.
`FIG. 9 is a longitudinal cross section of a distal section of
`a "rapid exchange" embodiment of the integrated catheter
`system.
`
`5
`
`3
`Still another object of this invention is to provide a
`conically shaped distal section of the stent catheter which
`can accomplish proper placement of the stent even in cases
`of severe intimal dissection which could cause an intimal
`flap that could block the passage of a stent delivery catheter
`having a blunt end.
`Still another object of this invention is to initially position
`the non-deployed stent at least several centimeters proximal
`to the proximal end of the angioplasty balloon thus allowing
`better trackability of the catheter's distal end over a flexible 10
`guide wire and through tortuous coronary arteries and
`through a long tight stenosis.
`Still another object of this invention is to have an opti-
`mum means to limit the forward displacement of the stent so
`as to prevent
`the stent from being inadvertently released 15
`beyond the distal end of the balloon angioplasty catheter.
`Still another object of this invention is to provide a means
`to precisely position the stent onto the balloon after the
`integrated system has been placed in an artery.
`These and other objects and advantages of this invention 20
`will become apparent to a person of ordinary skill in this art
`upon careful reading of the detailed description of this
`invention including the drawings and claims as presented
`herein.
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a longitudinal cross section of a distal section of
`a simplified form of the integrated catheter system.
`FIG. 2Ais a longitudinal cross section of the distal section
`of a preferred embodiment of the integrated catheter system.
`FIG. 2B is a longitudinal cross section of the same
`embodiment as FIG. 2A with the stent catheter advanced to
`its most forward position over the balloon angioplasty
`catheter.
`FIG. 3 is longitudinal cross section of a distal section of
`an alternative embodiment of the stent delivery catheter.
`FIG. 4 is longitudinal cross section of a distal section of
`another alternative embodiment of the stent delivery cath-
`eter.
`FIG. 5 is a front view showing the nose cone of the
`integrated catheter system.
`FIG. 6 is longitudinal cross section of a proximal section
`of the integrated catheter system.
`FIG. 7A is a longitudinal cross section of a distal section 45
`of the integrated catheter system showing various sections of
`the balloon angioplasty catheter and the stent catheter and
`showing an unexpanded balloon placed within an arterial
`stenosis.
`FIG. 7B shows the balloon in its inflated state with the 50
`stent catheter advanced in a distal direction until its distal
`end is adjacent to the proximal end of the balloon.
`FIG. 7C shows the balloon deflated.
`FIG. 7D shows the stent catheter in its most forward 55
`position with the stent accurately positioned over the bal-
`loon.
`FIG. 7E' shows a balloon expandable stent as it is placed
`onto the deflated balloon with the stent catheter pulled back
`FIG. 7E shows the stent catheter pulled back thus releas-
`ing a self-expanding stent so that it deploys radially outward
`against the vessel wall.
`FIG. 7F shows the balloon inflated to high pressure to
`imbed a balloon expandable stent or a self-expanding stent
`into the arterial wall.
`FIG. 7G shows the stent in place with the catheter system
`being removed from the artery.
`
`35
`
`30
`
`DErAILED DESCRIPTION OF THE
`INVENTION
`Three prior U.S. patent applications (Ser. Nos. 08/273,
`459, 081298,214 and 08/351,498) by the same inventors
`(which are included herein by reference) describe various
`means for delivering self-expanding, shape memory metal
`stents or balloon expendable stents into a vessel of the
`human body. The invention described herein expands the
`concepts taught in those prior applications by teaching a
`simplified integrated catheter system that has an expandable
`balloon located near the catheter's distal end whose pur-
`poses are to initially dilate a vessel at a comparatively low
`balloon pressure, then hold the stent in place over a slightly
`inflated balloon while the stent delivery catheter is pulled
`back; then after the stent is deployed, reinflating the balloon
`to a higher pressure to imbed the stent into the wall of the
`25 vessel. The balloon can also be used to deploy a stent if the
`stent is not self-expandable. The present design is capable of
`performing these functions while retaining the balloon at
`one single longitudinal position within the artery, i.e., at no
`time is there a need to advance the balloon beyond the
`dilated stenosis.
`FIGS. 1 illustrates a simplified integrated catheter system
`10 consisting of a balloon angioplasty catheter 12, a stent
`catheter 30, a guide wire 50 and a stent 15 mounted within
`stent containment cavity 39. The "over-the wire" balloon
`angioplasty catheter U consists of an inner shaft 21, an outer
`shaft 22, a balloon 23 radiopaque markers 19A and 19B and
`an annular passageway 28 that lies between the inner shaft
`21 and the outer shaft 22. The markers 19A and 19B are
`40 situated to be at the proximal and distal extremities of the
`stent 15 after it has been placed over the balloon 23. A guide
`wire 50 is adapted to move slideably through the central
`lumen 26 of the balloon angioplasty catheter U. The stent
`catheter 30 has a pusher tube 32 and an outer tube 31 fixedly
`attached to the distal end of the pusher tube 32. The outer
`tube 31 encloses a self-expanding or balloon expandable
`stent 15. An annular passageway 38 is situated between the
`outer shaft 22 of the balloon angioplasty catheter U and the
`pusher tube 32 of the stent catheter 30.
`FIGS. 2A and 2B are longitudinal cross sections of the
`distal sections of an integrated catheter system 60 having a
`balloon angioplasty catheter 20 and a stent catheter 65. The
`balloon angioplasty catheter 20 has a first radiopaque marker
`19 centrally located inside the balloon 23 and a second
`radiopaque marker 18 mounted just proximal to the balloon
`23. The stent catheter 65 has a pusher tube 32 that is attached
`at its distal end to an outer tube 62 that encloses the stent 15,
`a spacer tube 68, a radiopaque stop marker 66 and has a nose
`cone 64 at its distal end. A stent containment cavity 69 is
`formed within the spacer tube 68, outer tube 62 and the nose
`cone 64. The central lumen 26 and annular passageways 28
`and 38 are identical to those same passageways shown in
`FIG. 1.
`FIG. 2B shows the stent catheter 65 advanced in a distal
`the first positioning mechanism or stop
`65 direction until
`marker 66 engages the second positioning mechanism or
`marker 18.As can be seen in FIG. 2B, the engagement of the
`
`60
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1013 - Page 12
`
`

`

`5,639,274
`
`6
`5
`pushed in a forward direction which, as described below,
`marker 18 with the marker 66: (1) prevents the stent from
`allows the balloon 23 to deploy the stent 15.
`being inadvertently released beyond the distal end of the
`The means for and method of using the integrated catheter
`balloon angioplasty catheter 20, (2) accurately centers the
`system 60 of FIGS. 2A, 2B and 6 is best explained with the
`stent 15 over the balloon 23, and (3) allows the operator to
`5 aid of FIGS. 7A to 7G inclusive.
`use the radiopacity of the markers 18 and 66 to indicate that
`(1) The integrated catheter 60 is advanced in a conven-
`items (1) and (2) above have been accomplished. The length
`tional manner until the balloon 23 lies within an arterial
`of the spacer tube 68 can be adjusted to assure that items (1)
`stenosis as shown FIG. 7A. The distance "L" would
`and (2) above can be accomplished.
`typically be set between 0.1 and 30 cm with optimum
`FIG. 3 is an alternative embodiment of a stent catheter 70
`values being between 5 and 10 em.
`showing a one-piece catheter 71 having a short, thin-walled 10
`1
`infl ted t
`.
`(2) A h
`. FIG 7B th ball
`distal section 72 and a thicker walled tube 73 for most of its
`0 a ow
`a
`,e
`oon IS
`s s own In
`.
`pressure which is just sufficient to allow dilatation of
`length having a stop marker 76 mounted as shown. The
`the stenosis to a large enough diameter to allow the
`distal section 72, the spacer tube 78 and the nose cone 74
`stent catheter 65 to pass through the pre-dilated steno-
`form a stent containment cavity 79 that encloses the stent 15.
`FIG. 4 is another alternative embodiment of a stent 15
`.SIS.
`(3) While the balloon is inflated, the stent catheter 65 is
`catheter 80 formed from an outer tube 81 fixedly attached to
`advanced over the outer shaft 22 of the balloon angio-
`the tube 85 which is fixedly attached to a thin-wailed metal
`plasty catheter 20 until the distal end of the nose cone
`tube 83 with a stop marker 86 mounted tlIerebetween. The
`64 contacts the marker band 18 as shown in FIG. 7B.
`outer tube 81, spacer tube 88 and the nose cone 84 form a
`Advancing the stent catheter 65 is easiest to accomplish
`stent containment cavity 89 that contains the stent 15. The 20
`when the balloon 23 is inflated.
`embodiments of FIGS. 3 and 4 would function in a manner
`identical to FIGS. 2A and 2B. One advantage of the embodi-
`(4) The balloon 23 is deflated as shown in FIG. 7C.
`ment of FIG. 4 is that most of the length of the integrated
`(5) The stent catheter is advanced over the balloon angio-
`catheter 80 would be of a smaller diameter.
`plasty catheter 20 until the stop marker 66 cannot be
`FIG. 5 is a front view of the nose cone 84 of the stent 25
`moved more distally because of engagement with the
`catheter 80, the nose cone having four slits 87. The nose
`balloon marker 18. In this position the stent 15 is
`cone 84 functions FIGS. 2A, 2B al manner to the nose cones
`centered over balloon 23. It can be clearly seen from
`64 and 74 of FIGS. 2A, 2B and 3. Although FIG. 5 shows
`FIGS. 2A and 7D that the stent cannot be advanced
`four slits in the nose cone 84, as few as 2 or as many as 24 30
`beyond the balloon 23. Therefore, it is not possible to
`slits could be used. The object of the nose cones 64, 74 or
`inadvertently release the stent beyond the distal end of
`84 is to retain the stent 15 within the catheters 65, 70 or 80
`the balloon angioplasty catheter 20. Thus distal embo-
`and to form a tapered front surface which can slide forward
`lization of the stent is precluded.
`with a tight sliding fit over the balloon 23. The purpose of
`(6) The balloon 23 is then inflated to a very low pressure
`the slits 87 is to allow the stent catheter 80 to be pulled back 35
`(typically less than 1 atmosphere) which causes the
`over the stent without exerting a large proximally directed
`stent 15 to be retained onto the balloon 23 when the
`force onto stent 15.
`stent catheter is pulled back as shown in FIG. 7E.
`FIG. 6 is a longitudinal cross section of a proxinlal section
`(7) If step 6 is accomplished with a self-erecting stent
`of the system 60. The proxinlal
`section of the balloon
`{such as those fabricated from a shape memory alloy
`angioplasty catheter 20 shows an outer shaft 22 and an inner 40
`such as Nitinol),
`the stent 15 will deploy radially
`shaft 21 having a lumen 26 through which tlIe guide wire 50
`outward against the inner surface of the dilated stenosis
`can be slideably moved. The inner shaft 21 has a female
`as shown in FIG. 7E'.
`Luer fitting 29 at its proxinlal end. The side arm 24 has
`(8) Irrespective of whether a balloon expandable or self-
`female Luer fitting 25 and a lumen 27 which is in fluid
`expanding stent 23 is used, FIG. 7F shows that the
`communication with the annular passageway 28 that lies 45
`balloon 23' is inflated to a high pressure to imbed either
`between the outer surface of the inner shaft 21 and the inner
`type of stent into the stenotic plaque.
`surface of the outer shaft 22. The Luer fitting 29 is used to
`(9) FIG. 7G shows the balloon 23 retracted and the
`flush tlIe lumen 26 prior to placement of the guide wire 50.
`integrated catheter system 60 being removed from the
`The Luer fitting 25 is attached to a source of pressurized
`artery.
`fluid for inflating and deflating the balloon 23.
`The material(s) selected for the tubes 21, 22, 32 and 62
`Also shown in FIG. 6 is the proximal section of the pusher
`can be Teflon or an elastomer such as polyurethane or
`tube 32 that is fixedly attached at its proxinlal end to a
`polyethylene. The Tuohy-Borst fittings are typically fabri-
`Tuohy-Borst fitting 33. The Tuohy-Borst
`fitting 33 has a
`cated from a harder plastic such as PVC or Nylon or a higher
`main body 34 and a side arm 35 having a female Luer fitting
`35. The side arm 35 has a lumen 37 that
`is in fluid 55 durometer of the same elastomer used for the pusher tube 32.
`communication with the annular passageway 38 that lies
`The stent 15 should be coated with a covalently bonded
`between the inner surface of the pusher tube 32 and the outer
`heparin coating, as is well known in the art of biomedical
`surface of the outer shaft 22 of the balloon angioplasty
`surfaces,
`to reduce thrombotic complications after stent
`catheter 20. The Luer fitting 36 makes it possible to flush out
`placement The stent 15 could also have a hydrophilic
`the passageway 38 with (typically) a normal saline solution 60 lubricious coating on at least its exterior surface to reduce
`prior to placing the system 10 into an artery of a human
`frictional forces when the outer sheath 62 is pulled back to
`body. The nut 40 is screwed onto a tlIreaded section of the
`release the stent. That is, the stent would optinIally have a
`main body 34. Tightening down on tlIe nut 40 causes the
`heparin coating that was also hydrophilic and lubricious.
`deformable elastomer gland 41 to be frictionally joined to
`The length of the integrated catheter 60 is typically 20 to
`the outer shaft 22. In this state, the pusher tube 32 will 65 150 cm depending on the vessel into which it is to be placed.
`remain in a fixed position relative to the outer shaft 22.
`The stent catheter 65 is typically considerably shorter than
`When the nut 40 is loosened, the pusher tube 32 can be
`the length of the balloon catheter 20. When the stent catheter
`
`50
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1013 - Page 13
`
`

`

`5,639,274
`
`5
`
`25
`
`7
`65 is pulled back to its most proximal position relative to the
`balloon catheter 20, the distal end of the nose cone 64 should
`be situated at least 3 cm proximal to the proximal end of the
`balloon 23 and typically 10 cm back When the distal end of
`the nose cone 64 is approximately 10 cm back from the
`proximal end of the balloon 23, the distal section of the
`balloon angioplasty catheter 20 can be advanced through an
`extended length of narrow stenosis and through tortuously
`curved arteries without the encumbrance and added stiffness
`of the stent catheter 65 and the stent 15 which otherwise
`could limit the catheter system's trackability over a guide
`wire. Once the balloon 23 is placed within a stenosis, and
`preferably when the balloon is inflated, the stent catheter 65
`can be advanced until the distal end of the nose cone is
`located at the proximal end of the balloon 23.
`The diameter of the catheter will typically vary from 1.0
`to 10.0 rnm depending on its use. The radiopaque marker
`bands 18, 19, 19A, 19B and 66 are typically made from a
`dense metal such as an alloy of tantalum, platinum or gold.
`A method for using the "over-the-wire" design, integrated
`catheter 60 for the treatment of an obstructed coronary artery
`would be as follows:
`1. By conventional means, an introducer sheath and a
`coronary guiding catheter are inserted at the groin and
`the guiding catheter's distal end is advanced until it is
`situated within the ostium of a coronary artery.
`2. Saline solution is flushed through each of the two
`annular passageways 28 and 38 and the central lumen
`26 of the catheter 20 by means of the three female Luer
`fittings 25, 29 and 36.
`3. A guide wire 50 that has been pre-loaded into the
`integrated catheter 60 is advanced with the catheter 65
`through the guiding catheter, and the guide wire 50 is
`then advanced through a coronary artery blockage.
`4. The catheter 20 is further advanced over the guide wire
`50 until the balloon 23 lies within a stenosis as shown
`in FIG. 7A. This is accomplished with the stent catheter
`65 in its most proximal position relative to the balloon
`20. The nut 40 of the Tuohy-Borst fitting 33 is initially 40
`screwed down tightly to frictionally join the stent
`catheter 65 to the balloon catheter 20.
`5. A fluid pressurization means is then joined to the Luer
`fitting 25 and the balloon 23 is initially inflated (as
`shown in FIG. 7B ) to an outside diameter between 2.0 45
`and 3.0 rnm depending on the nominal size of the
`coronary artery in which the blockage occurred. This
`inflation is to be done at a comparatively low pressure
`so that the balloon 23 is not inflated to its largest
`possible diameter.
`6. While the balloon 23' is inflated. the nut 40 of the
`Tuohy-Borst fitting 33 is loosened and the stent catheter
`65 is advanced forward in a distal direction thus
`decreasing the length L until the distal end of nose cone
`64 is in contact with the proximal end of the radiopaque 55
`marker 18 that is situated just proximal to balloon 23;
`i.e., L=O. This configuration is shown in FIG. 7B.
`7. The balloon 23 is then deflated as shown in FIG. 7C.
`8. The stent catheter 65 is then advanced over the deflated
`balloon as shown in FIG. 7D. It is important to note that 60
`any intimal dissection resulting in an intimal flap will
`be lifted away from, the surface of the deflated balloon
`23 by the pointed distal end of the nose cone 64. This
`is in contradistinction to all prior art integrated catheter
`devices which have outer sheaths whose ends are blunt 65
`and therefore could have their forward motion stopped
`by an intimal flap that was in contact with the outer
`
`8
`surface of either the balloon or the outer shaft of a
`balloon angioplasty catheter. This disadvantage of the
`prior art that can prevent proper functioning of an
`integrated catheter is shown in FIG. 8.
`It should be noted that the balloon angioplasty catheter 20
`could be pulled back from the pre-dilated stenosis and
`angioplasty could be performed once more at that point to
`provide assurance of an adequate stenotic dilatation. The
`catheter system 65 could then be advanced to the position
`10 shown in FIG. 7D. However, at no time is it required to
`advance the balloon 23 beyond the dilated stenosis.
`the stop
`It should be noted in FIGS. 2B and 7D that
`marker 66 has a smaller inside diameter as compared to the
`outside diameter of the radiopaque marker 18 that is situated
`15 just proximal to the balloon 23. Thus stent 15 cannot be
`advanced beyond the point where it is longitudinally cen-
`tered over the balloon 23 as shown in FIGS. 2B and 7D.
`Because the operator cannot advance the stent catheter 65
`distally relative to the balloon angioplasty catheter 20
`20 beyond the point where the radiopaque markers 18 and 66
`touch, at that point the stent will be automatically positioned
`at
`its precisely correct
`location over the balloon 23.
`Furthermore,
`the operator can confinn by fluoroscopy as
`well as by feel when the radiopaque markers 18 and 66 are
`in contact with each other. Still further, this simple distally
`located means prevents the stent from being advanced
`beyond the distal end of the balloon angioplasty catheter
`which would be extremely disadvantageous.
`9. The stent catheter 65 is then pulled back until the nose
`cone 64 lies proximal to the proximal end of the balloon
`23 as shown in FIG. 7E. The stent 15 will nonnally
`stick onto the deflated balloon 23 when the stent
`catheter 65 is pulled back because the deflated balloon
`23 forms "wings" that protrude radially outward even
`when the balloon 23 is fully deflated. That
`is,
`the
`deflated balloon 23 does not form itself into a tight
`cylinder around the inner shaft 21, but rather forms a
`flat shape wherein the "wings" of the deflated balloon
`are those parts that extend radially outward from the
`inner shaft 21.
`10. To enhance the ability of the balloon 23 to hold onto
`the stent 15 as the stent catheter 65 is pulled back the
`balloon 23 can be slightly inflated to a low pressure
`between 0.1 and 2 atmospheres prior to pulling back of
`the stent catheter 65.
`11. In the case of the self-expanding stent, (as shown
`partially expanded in FIG. 7E') the purpose of the
`balloon expansion is to push back the plaque to allow
`a comparatively fragile, shape memory metal stent to
`reach its final fully expanded shape. Until that final
`shape is achieved., shape memory stents do not exert a
`sufficiently strong outward radial force to outwardly
`deform hard plaque. However, once the fully expanded
`shape of the stent is achieved with the assistance of the
`balloon 23', shape memory metal stents are sufficiently
`strong to maintain considerable outward force on the
`dilated stenosis. At no time does the expanded balloon
`deform a shape memory metal by exceeding the elastic
`limit of the metal of the stent. On the other hand, the
`balloon expandable stent shown in FIGS. 7E and 7F is
`severely deformed by the expanded balloon 23', thus
`exceeding the elastic limit of the metal of the stent. This
`creates a plastic deformation of the stent so that it will
`retain its expanded shape as shown in FIG. 7G.
`12.The balloon 23 is then deflated (as shown in FIG. 7G)
`and the catheter 60 and the guide wire 50 are removed
`from the artery and the guiding catheter and introducer
`
`30
`
`35
`
`50
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1013 - Page 14