USOO615.

6005A
United States Patent (19) 11 Patent Number: 6,156,005
Theron (45) Date of Patent: *Dec. 5, 2000
54) BALLON CATHETER FOR STENT 5,599,307 2/1997 Bacher et al. .......................... 604/101
IMPLANTATION 5,603,721 2/1997 Lau et al......... . 606/195
5,607,466 3/1997 Imbert et al. ............................... 623/1
75 Inventor: Jacques Théron, Fleury Sur Orne, 5,632,760 5/1997 Sheiban et al. ......................... 606/191
France 5,645,529 7/1997 Fagan et al. ............................ 604/101
5,695,498 12/1997 Tower ...... ... 606/108
rr. A 5,709,701 1/1998 Parodi ...... ... 606/194
(73) Assignee: Schneider (Europe) GmbH, 5,728,068 3/1998 Leone et al. ... . 604/101
Switzerland 5,782.909 7/1998 Quiachon et al. .......................... 623/1
5,807,330 9/1998 Teitelbaum ................................ 604/96
* Notice: This patent issued on a continued pros
ecution application filed under 37 CFR FOREIGN PATENT DOCUMENTS
1.53(d), and is subject to the twenty year 0277367A1 8/1988 European Pat. Off..
patent term provisions of 35 U.S.C. 0650740A1 5/1995 European Pat. Off..
154(a)(2). 0747088A1 12/1996 European Pat. Off..
0775470A1 5/1997 European Pat. Off..
21 Appl. No.: 08/991,848 WO 97/44082 11/1997 WIPO.
WO 97/44085 11/1997 WIPO.
22 Filed: Dec. 16, 1997 WO 98/38930 9/1998 WIPO.
30 Foreign Application Priority Data Primary Examiner Sharon Kennedy
Oct. 23, 1997 EP European Pat. Off. .............. 972O328O Attorney, Agent, or Firm-Crompton, Seager & Tufte, LLC
(51) Int. Cl. ............................................... A61M 29/00 57 ABSTRACT
52 U.S. Cl. ................................ 604/96; 604/101; 604/99 A catheter device for the treatment of a vessel carrying body
58 Field of Search ................................ 604/96, 97, 101, fluid, comprising an inner first occlusion catheter, having a
604/93, 99,915,917,919,920, 921; 606/194, first tubular shaft with a proximal end and a distal end, a
195, 198, 108 distal occlusion balloon disposed at the distal end of the first
56) References Cited tubular shaft and an inflation lumen extending through the
first tubular shaft between a proximal entry at the proximal
U.S. PATENT DOCUMENTS end and a distal exit inside the distal occlusion balloon, and
3,173,418 3/1965 Baran ...................................... 604/920
an outer treatment catheter, having a second tubular shaft
3,982.544 9/1976 Dyck. ... 128/349 R with a central lumen extending therethrough for coaxial
4,333,452 6/1982 Au ................. ... 128/205.24 reception of the first occlusion catheter, and being longitu
4,655,746 4/1987 Daniels et al. ............................ 604/53 dinally displaceable with respect to the first occlusion
4,697.574 10/1987 Karcher et al. ... ... 604/118 catheter, further comprises a Seal for the proximal entry of
4,733,665 3/1988 Palmaz .............. ... 606/108 the inflation lumen, having an outside dimension Small
4,771,777 9/1988 Horzewski et al. ... 128/344 enough to fit within the central lumen for advancing, resp.
5,152.277 10/1992 Honda et al. ..... ... 604/101 withdrawing, a treatment catheter proximally onto, resp.
5,158,553 10/1992 Berry et al. ............................. 604/248 from, the Sealed first occlusion catheter, treatment catheters
5,334,153 8/1994 McIntyre et al. ......................... 604/99 are exchangeable while the distal occlusion balloon is main
5,397.307 3/1995 Goodin .......... ... 604/96 tained in its inflated condition.
5,403.274 4/1995 Cannon . ... 604/9
5,423,742 6/1995 Théron ...................................... 604/28
5,462,529 10/1995 Simpson et al. ........................ 604/101 11 Claims, 3 Drawing Sheets
U.S. Patent Dec. 5, 2000 Sheet 1 of 3 6,156,005
U.S. Patent Dec. 5, 2000 Sheet 2 of 3 6,156,005

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U.S. Patent Dec. 5, 2000 Sheet 3 of 3 6,156,005

FIG-5
 6,156,005
1 2
BALLON CATHETER FOR STENT All documents cited herein, including the foregoing, are
IMPLANTATION incorporated herein by reference in their entireties for all
BACKGROUND OF THE INVENTION purposes.
This application claims priority under 35 U.S.C. S 119 of 5 SUMMARY OF THE INVENTION
European Patent Application No. 972032809, filed in the
European Patent Office on Oct. 23, 1997. It is therefor an object of the invention to provide a
The invention relates to a catheter device for the treatment catheter device as described above which allows the
of a vessel carrying body fluid, comprising an inner first eXchange of a treatment catheter by another one while the
occlusion catheter, having a first tubular shaft with a proxi occlusion catheter remains in place maintaining the occlu
mal end and a distal end, a distal occlusion balloon disposed Sions ballon in its inflated condition for Sealing the vessel
at the distal end of the first tubular shaft and an inflation distal of the portion to be treated.
lumen extending through the first tubular Shaft between a Where the catheter device comprises a seal for the proxi
proximal entry at the proximal end and a distal exit inside mal entry of the inflation lumen, having an outside dimen
the distal occlusion balloon, and an Outer treatment catheter, Sion Small enough to fit within the central lumen for
having a Second tubular Shaft with a central lumen extending 15
advancing, resp. Withdrawing, a treatment catheter proxi
therethrough for coaxial reception of the first occlusion mally onto, resp. from, the Sealed first occlusion catheter, it
catheter, and being longitudinally displaceable with respect is possible to exchange treatment catheters over the posi
to the first occlusion catheter.
A catheter device of the kind mentioned in the introduc tioned occlusion catheter. During replacement the Seal keeps
tion is known for example from U.S. Pat. No. 5,423,742 maintaining the occlusion balloon in its inflated State and
which is used for percutaneous transluminal angioplasty of does not form a stopping obstacle.
arteriosclerotic deposits or atheroma in the carotid artery. In a preferred embodiment of the invention the treatment
For this treatment an outermost guide catheter is pushed catheter is a dilatation catheter further having a non
through an opening in the inguinal region of the patient into compliant dilatation balloon whereby Subsequent treatment
the vessel, until its front opening is situated directly in front 25 of a stenosis with dilatation balloons of different diameters
of the Stenosis. An innermost occlusion catheter is then or lengths is possible. Such ballon dilatation catheters are
inserted into the guide catheter and placed in a way that the well known in the art, see for example EPO 650 740 A1, and
occlusion balloon can be stabilized in the inflated State distal have to be adapted in their central lumen which is usually
of the Stenosis. A central dilation catheter is then pushed sized for the reception of a guidewire. Thus, known balloon
over the occlusion catheter, and the dilatation balloon is catheter technology can be used with a slight change in a
positioned in the middle of the Stenosis which is now dilated lumen diameter. In a further embodiment of the invention a
in a known manner. Vessel parts which might be detached balloon-expandable Stent is mounted on the dilatation bal
during angioplasty are prevented by the occlusion balloon loon taking advantage of the fact that dilatation catheter are
from getting into the narrow and tortuous cerebral vessel commonly used instruments for the deployment of balloon
System reducing thereby the risk of embolism. 35 expandable stents, it is referred to U.S. Pat. No. 4,733,665
After treatment of the Stenosis the dilatation balloon is as an example. Accordingly, Such a treatment catheter allows
emptied and the dilation catheter is retracted. With the Scaffolding of a predilated Stenosis by implanting a balloon
occlusion catheter Simultaneously inflated, vessel fluid and expandable Stent immediately after having widened the
any detached particles present are removed by Suction Stricture and while the downstream vessel System is still
through the guide catheter by means of a Syringe. As a result 40 protected by the filled occlusion balloon.
of pressure exerted by means of the Syringe, vessel fluid with In another preferred embodiment of the invention the
Small particles can be washed out reaching areas of the treatment catheter is a Stent delivery instrument loaded with
vessel where there is no danger of embolism. Finally, the a Self-expanding Stent. Self-expanding Stents are also well
occlusion balloon is also returned to the emptied State and known in the art and are special in that they comprise an
the catheter device is removed from the vessel. 45 unconstrained large diameter State which is taken by Self
For inflating and deflating the occlusion balloon a Syringe expansion upon removing the constraint which keeps the
is connected to the proximal end of the occlusion catheter. tubular Stent in a compressed Small diameter condition. For
The latter must have a length greater than the length of the insertion into the vessel System Such a Stent can be loaded
guide catheter plus the length of the dilation catheter, for distally into the lumen of an outer shaft of a delivery
example between 250 and 300 cm, to allow the dilation 50 instrument, Such as it is disclosed in EP 0 775 470 A1.
catheter being withdrawn over the occlusion catheter com Having reached the treatment site the outer shaft is with
pletely out of the guide catheter, while the occlusion balloon drawn relative to an inner Shaft which works as a plunger
remains in its inflated condition. The Syringe connector keeping the axial position of the Stent while the constraint
which might be a stop cock combines the occlusion catheter applied by the outer shaft is removed from the stent to
and the dilation catheter to a unit which shows disadvan 55 release it. Delivery instruments for Self-expanding Stents are
tages if further treatment, Such as Stenting or post-dilating of also usually inserted over a guide wire which is passed
the widened Stenosis, is necessary. The catheter unit does not through a central lumen of the instrument. By adaption of
allow the eXchange of the dilation catheter by another the central guide wire lumen the deployment of Self
catheter during the protective occlusion balloon is kept in its expanding Stents following balloon angioplasty is possible.
inflated condition, Since the connector forms an obstacle 60 In a further preferred embodiment of the invention the
which cannot be passed through the central lumen of the treatment catheter is a Second occlusion catheter further
dilation catheter. Thus, in Such a case the whole catheter unit having a proximal occlusion balloon for Sealing a vessel
must be replaced. On one hand this might be a rather time portion between the proximal and distal occlusion balloon.
consuming procedure putting a lot of StreSS to the patient. On Due to the fact that the occlusion catheters are displaceable
the other hand it raises the risk of embolism since the 65 with respect to each other the length of the vessel portion to
protective downstream occlusion of the vessel has to be be sealed is adjustable. U.S. Pat. No. 4,655,746 is incorpo
interrupted. rated here with as a reference. The Sealing can provide for a
 6,156,005
3 4
well visible access to this protion in a Surgical intervention. DETAILED DESCRIPTION OF THE
Moreover, if according to a further preferred embodiment an INVENTION
annular lumen is disposed between the first and Second FIGS. 1 and 4-6 show a portion . of a blood vessel 1
occlusion catheter and extends between a proximal inlet and which, downstream from a lateral branch 2, was partially
a distal outlet for infusion, resp. aspiration, of a liquid into, closed by a Stenosis formed by arterial plaque deposit 3. The
resp. from, the Sealed vessel portion, drugs can be delivered inserted catheter device comprises an inner first occlusion
locally to a vessel portion, i.e., without affecting the rest of catheter 4 having a first tubular shaft 5 with a proximal end
the vessel System, and any reaction products or particles can 6 (not shown) and a distal end 7, a distal occlusion balloon
be aspirated through said annular lumen. 8 and an inflation lumen 9 extending through the first tubular
In a further preferred embodiment of the invention the shaft 5 between a proximal entry 10 (not shown) and a distal
exit 11 inside the distal occlusion balloon 8. The distal
catheter device futher comprises an outer insertion catheter occlusion balloon 8 is disposed at the distal end 7 of the first
having a third tubular shaft with a through lumen for tubular shaft 5 and is positioned in its inflated condition
insertion, resp. retraction, of the first occlusion catheter and distally of the area affected by plaque deposit 3. This is to
of a treatment catheter into, resp. from, the vessel to be establish a protective Seal for particles detached from the
treated. This catheter Serves as a guide for the occlusion and 15
treatment catheters finding their way from the puncture vessel wall during the treatment. The first occlusion catheter
which is usually placed in the inguinal region through the 4 and treatment catheters 5, 22, 15' are inserted and retracted
vessel System having a larger diameter to the portion to be through an insertion catheter 12 having a third tubular shaft
treated. It is kept in place during all manipulations and can 13 with a through lumen 14.
finally be used to rinse off Small particles detached from the According to FIG. 1 the plaque deposit 3 is forced into the
vessel wall during the treatment before the protective distal wall of the vessel portion 1 by known balloon dilatation
occlusion is removed. technique performed with a dilatation catheter 15 having a
In Sum, the present invention relates to a catheter device
second tubular shaft 6 with a central lumen 17 (not shown)
extending therethrough for coaxial reception of the first
for the treatment of a vessel carrying body fluid. The catheter 25 occlusion catheter 4 and being longitudinally displaceable
has an inner first occlusion catheter, having a first tubular with respect to the first occlusion catheter 4. After dilation
shaft with a proximal end and a distal end, a distal occlusion the dilatation balloon 18 is emptied and withdrawn through
balloon disposed at the distal end of the first tubular shaft the insertion catheter 12 over the first occlusion catheter 4.
and an inflation lumen extending through the first tubular FIG. 2 shows the proximal end 6 of the first occlusion
shaft between a proximal entry at the proximal end and a catheter 4 which is connected to a stop cock 19. Before
distal exit inside the distal occlusion balloon, and an outer balloon dilatation the distal occlusion balloon 8 was filled
treatment catheter, having a Second tubular shaft with a with an inflation medium Such as physiological Saline or
central lumen extending therethrough for coaxial reception fluoroscopic contrast which is set under pressure for
of the first occlusion catheter, and being longitudinally example by a Syringe (not shown) placed into the proximal
displaceable with respect to the first occlusion catheter. The 35 opening 20 of the stop cock 19. The pressurized condition is
device has a Seal for the proximal entry of the inflation maintained during the treatment procedure by Switching the
lumen, having an outside dimension Small enough to fit Stop cock 19 into its locking position. After balloon dilata
within the central lumen for advancing, resp. withdrawing, tion the dilatation catheter 15 can only be withdrawn until it
a treatment catheter proximally onto, resp. from, the Sealed reaches the Stop cock 19 as it was in the prior art Situation.
first occlusion catheter. The catheter may be a dilatation 40 In order to remove the dilatation catheter 15 completely
catheter further having a non-compliant dilatation balloon from the first occlusion catheter 4 the inflation lumen 9 is
and a balloon-expandable Stent mounted on the dilatation occluded by clamping or kinking the first tubular shaft 5
balloon. The catheter may be a stent delivery instrument distal of the stop cock 19. In this state the stop cock 19 is
loaded with a Self-expanding Stent. The catheter may be a replaced by a Seal 21 which is plugged into the proximal
Second occlusion catheter further having a proximal occlu 45 entry 10 of the inflation lumen 9. According to FIG. 3 the
Sion balloon, for Sealing a vessel portion between the Seal 21 has an outside dimension Small enough to fit within
proximal and distal occlusion balloon, optionally with an the central lumen 17 of the dilatation catheter 15 which
annular lumen disposed between the first and Second occlu therefor can be withdrawn proximally from the sealed first
Sion catheter and extending between a proximal inlet and a occlusion catheter 4. The occlusion catheter 4 still fulfills its
distal outlet for the infusion, resp. aspiration, of a liquid into, 50 function of occluding the vessel 1 downstream of the
resp. from, the Sealed vessel portion. The catheter device treatment portion and is ready to receive another treatment
may further have an outer insertion catheter having a third catheter if indicated.
tubular shaft with a through lumen for insertion, resp. In case the widened Stenosis requires Stenting, i.e. Scaf
retraction, of the first occlusion catheter and of a treatment folding the treated vessel portion 1 by implanting a vessel
catheter into, resp. from, the vessel. 55 Supporting tubular member to prevent restenosis, a Stent
BRIEF DESCRIPTION OF THE DRAWINGS delivery instrument 22, as shown in FIG. 4, loaded with a
Further advantages are readily apparent from an exem Self-expanding Stent 23 is introduced over the first occlusion
plary embodiment of the invention described with reference catheter 4. For insertion the Self-expanding Stent 23 is
to the drawings in which: radially compressed and kept in a Small diameter State
60 between an inner shaft 24 and an outer shaft 25 which are
FIGS. 1 and 4-6 show schematic representations of a axially shiftable relative to each other. The stent 23 is
vessel Section with an inserted catheter device according to released by retraction of the outer shaft 25 so that the stent
the invention, 23 can expand and conformingly Support the inner wall of
FIG. 2 shows the proximal end of the first occlusion vessel portion 1. After the self-expandingstent 23 is fully set
catheter according to the invention connected to a stop cock, 65 free the stent delivery instrument 22 is withdrawn through
FIG. 3 shows a longitudinal section through the sealed the insertion catheter 12 and can be removed completely
proximal end of the catheter device. from the first occlusion catheter 4.
 6,156,005
S 6
According to FIG. 5, again a dilatation catheter 15" is 7. The catheter device of claim 1 further comprising an
introduced which may have different diametral and/or lon outer insertion catheter having a third tubular shaft with a
gitudinal sizes in its dilatation balloon 18'. It is used to through lumen for insertion and retraction, of the occlusion
perform a post-dilation if the treated Stenosis has not yet catheter and of the treatment catheter into and from, the
reached the required patency and it further anchors the vessel.
implanted stent 23 within the wall of the vessel portion 1.
In FIG. 6 the dilatation catheter 15" is retracted and the 8. A catheter System comprising:
Stent 23 is engaged with the vessel portion 1 as desired. a first catheter including a first tubular shaft having a
Before emptying the distal occlusion balloon 8 any particles proximal region, a distal region, and an inflation lumen
which may have been detached from the vessel wall during 1O with a proximal entry disposed in the proximal region;
the treatment are removed by Suction via the through lumen
14 of the insertion catheter 12 as it is known from the state an inflatable balloon having an interior and being dis
of the art. posed at the first tubular shaft distal region, the inflation
The above-described embodiments of the invention are lumen extending through the first tubular shaft between
merely descriptive of its principles and are not to be con 15
the proximal entry and the balloon interior and being in
sidered limiting. Further modifications of the invention fluid communication with the proximal entry and the
herein disclosed will occur to those skilled in the respective balloon interior;
arts and all Such modifications are deemed to be within the
Scope of the invention as defined by the following claims. a proximal entry Seal for Sealing the proximal entry; and
I claim: a Second catheter including a Second tubular shaft having
1. A catheter device for the treatment of a vessel carrying a proximal region, a distal region, and a lumen extend
body fluid, comprising an inner occlusion catheter, having a ing within the second tubular shaft between the proxi
first tubular shaft with a proximal end and a distal end, a mal and distal regions, wherein the Second tubular Shaft
distal occlusion balloon disposed at the distal end of the first lumen is sized to receive the first tubular shaft proximal
tubular shaft and an inflation lumen extending through the region therein and the first tubular shaft proximal entry
first tubular shaft between a proximal entry at the proximal 25
seal is sized to be slideably received within the second
end and a distal exit inside the distal occlusion balloon, and tubular shaft lumen.
an outer treatment catheter, having a Second tubular shaft
with a central lumen extending therethrough for coaxial 9. A catheter system as recited in claim 8 wherein the
reception of the first occlusion catheter, and being longitu Second catheter includes a distal inflatable balloon.
dinally displaceable with respect to the first occlusion 10. A catheter system as recited in claim 8 wherein the
catheter, the first tubular shaft inflation lumen having a Second tubular shaft lumen includes an annular lumen
proximal entry Seal having an outside dimension Small defined by the second tubular shaft and the first tubular shaft
enough to fit within the central lumen for advancing and disposed therein, and the annular lumen has a distal outlet
withdrawing the treatment catheter onto and from, the inner for infusing fluid through the Second tubular shaft lumen and
occlusion catheter.
2. The catheter device of claim 1 wherein the treatment 35 through the annular lumen distal outlet.
catheter is a dilatation catheter further having a non 11. A catheter System comprising:
compliant dilatation balloon. a first balloon catheter including a first tubular shaft, a
3. The catheter device of claim 2 wherein the dilatation proximal region, a distal region, a distal inflatable
catheter further comprises a balloon-expandable Stent 40
balloon having an interior, an inflation lumen extending
mounted on the dilatation balloon. through the first tubular shaft between a proximal entry
4. The catheter of claim 1 wherein the treatment catheter in the proximal region and the distal region and being
is a Stent delivery instrument loaded with a Self-expanding in fluid communication with the balloon interior;
Stent. a Second catheter having a Second tubular shaft, a proxi
5. The catheter of claim 1 wherein the treatment catheter mal region, a distal region, a lumen therethrough, the
45
comprises a Second occlusion catheter further having a lumen sized to receive the first tubular shaft proximal
proximal occlusion balloon for Sealing a vessel portion region therein;
between the proximal and distal occlusion balloon. means for Sealing the first catheter proximal entry; and
6. The catheter device of claim 5 having an annular lumen
disposed between the first and second tubular shafts and 50
means for proximally removing the Second catheter over
extending between a proximal inlet and a distal outlet for the the first catheter while the first catheter is sealed.
infusion and aspiration, of a liquid into and from, the Sealed
vessel portion.