Balloon catheter for occluding aneurysms of branch vessels

21 Pages·2013·2.25 MB·English

US00579533 IA
United States Patent [191 [11] Patent Number: 5,795,331
Cragg et a1. [45] Date of Patent: Aug. 18, 1998
[54] BALLOON CATHETER FOR OCCLUDING T. Terada et al.. “Embolization of arteriovenous malforma
ANEURYSMS OF BRANCH VESSELS tions With peripheral aneurysms using ethylene vinyl alcohol
copolymer” appearing in J. Neurosurg 75:655-660. 1991.
[75] Inventors: Andrew H. Cragg. Edina: Jonathan
Kagan. Minneapolis. both of Minn. (List continued on next page.)
Primary Examiner—Manuel Mendez
[73] Assignee: Micro Therapeutics, Inc.
Attorney, Agent, or Firm-Burns. Doane. Swecker &
Mathis. LLP
[2]] Appl. No.: 148,374
[57] ABSTRACT
[22] Filed: Jan. 24, 1994
A method and apparatus for delivering occluding agents
[51] Int. Cl.6 ........................ .. A61M 29/00; A61M 31/00 through an opening in a blood vessel wall and into an
aneurysm chamber or a branch vessel by introducing a
[52] US. Cl. . . . . . . . . . . . . .. 604/96: 604/53
balloon catheter. in?ating the balloon to seal the blood vessel
[58] Field of Search ................................ .. 604/48. 49. 53.
604/96. 101; 606/191. 192. 194. 195. 198 lumen around the vessel opening. and delivering the occlud
ing agent through the opening. The in?ation of the balloon
positions an exit port laterally in the vessel in alignment with
[56] References Cited
the vessel opening for delivering of the occluding agent
therethrough. In one embodiment. the balloon encircles the
U.S. PATENT DOCUMENTS
distal end segment of the catheter body. and the delivery exit
4,207,891 6/1980 Bolduc .................................. .. 128/235 port is supported on the in?ated surface of the balloon. In a
4,323,071 4/1982 Simpson et a]. . 128/343 second embodiment. the balloon is formed and extends
4,351,342 9/1982 Wiita et a]. .. l28/349B around a major circumferential section of the distal end
4,582,181 4/1986 Samson 128/3481 segment. and the delivery exit port is formed in the remain
4,636,195 1/1987 Wolinsky . . . . . . . . . .. 604/53 ing minor circumferential section for lateral movement into
4,655,746 4/1987 Daniels et a1. .... .. 604/53 alignment with the vessel opening as the balloon ?lls the
4,661,094 4/1987 Simpson ................................. .. 604/53
blood vessel on in?ation. The in?ated balloon maintains the
occluding agent therein until it forms an occluding cast. and
(List continued on next page.)
the balloon wall shapes the occluding cast into conformance
FOREIGN PATENT DOCUMENTS with the blood vessel lumen. The catheter body is formed
with lumens for balloon in?ation/de?ation. the passage over
32 27 575 2/1984 Germany ..................... .. A6113 17/12 a guide wire. the delivery of the occluding agent and the
WO 95108289 3/1995 WIPO . venting during delivery or aspiration prior to delivery. More
than one delivery exit port and associated lumen may be
OF HER PUBLICATIONS
provided for venting during delivery and/or for the delivery
of a two component occluding agent. The catheter body and
Mandai et al.. “Direct thrombosis of aneurysms with cellu
the balloon are preferably formed integrally of coaxial tubes
lose acetate polymer. Part I: Preliminary animal experi
with delivery/venting lumens formed in the outer tube and a
ence”. J. Neurosurg 77:497-500. 1992.
common inner lumen for in?ation/de?ation of the balloon.
K. Kingugasa et al.. “Direct thrombosis of aneurysms with terminating in a self sealing distal valve for receiving the
cellulose acetate polymer. Part 11: Results of thrombosis in guide wire. Liquid occluding agents or mechanical thrombus
experimental aneurysms”. J. Neurosurg 77:501-507. 1992. forming devices my be delivered thereby into the aneurysm
W. Taki et al. “A New Liquid Material for Embolization of chamber or branch vessel to occlude it.
Arteriovenous Malformations” appearing in AJNR
11:163-168. jan./Feb.. 1990. 43 Claims, 7 Drawing Sheets
5,795,331
Page 2
US. PATENT DOCUMENTS 5.242.397 9/1993 Barath eta]. .......................... .. 604/96
5.295.962 3/1994 Crocker eta]. ....................... .. 604/101
4.693.243 9/1987 Burns ............................... .. 128/207.15 5313531 6/1994 Leone __________________________________ ” 604/101
4,708,718 11/1987 Daniels . 604/53
4,763,653 8/1988 Rockey ..... .. 128/344 OTHER PUBLICATIONS
4.832.688 5/1939 Sag-ac eta]. .. 604/53 _ , _
4994033 2/1991 Schockey at a], _ " 604/96 Gugllelmi. G. C1 31.. “EICCH‘OlhIOIIlbOSlS Of S?CUl?l' aneu
5,041_090 3/1991 Scheglov er a1, _, __ 604/101 rysms via endovascular approach". J. Neurasurg, 75:1-7.
5,049,132 9/1991 Shaffer et a1. 604/101 1991.
5,087 .244 2/1992 Wolinslry et a1. . 604/53 Higashida. R. et aL. “Advances in the Treatment of Complex
5990960 2/1992 Don Michael 604/101 Cerebrovascular Disorders by Interventional Neurovascular
1112502 5/1992 Bari/‘£11 6W1 -~ 694/96 Techniques”. Circulation, 1991;83 Isupp 11: I-196-I-206.
5’l22’l3 6/1992 Sub?“ 8131' ‘ 606/32 Purdy P. et a.1.. “Preoperative Embolization of Cerebral
5,188,595 2/1993 Jaco. bi .. 604/53 Arteri. ovenous Malformati. ons wi.t h Polyvi. nyl Alcohol Par
5,213,576 5/1993 AblllSO et a1. 604/96 . ,,
5,222,941 6/1993 Don Miccth ael m“ n" 604/101 RtloCsle?nS th. al. D. et a1.. “Endovascular infrainguinal in situ
5,232,444 8/1993 Just e: a], 604/96 saphenous vein bypass: Amulticenter preliminary report". .1.
5,234,437 8/1993 Sepelka ................................. .. 606/108 Vasc. Surg., 1992: 16:453-8.
US. Patent Aug. 18, 1998 Sheet 1 0f 7 5,795,331

US. Patent Aug. 18, 1998 Sheet 3 0f 7 5,795,331
M441,;/ k :
_I
1\11| { ?
1
mvg
mm,
US. Patent Aug. 18, 1998 Sheet 4 0f 7 5,795,331
5:...6
2mamm
~kQ®vi l
US. Patent Aug. 18, 1998 Sheet 5 of 7 5,795,331
GmE2
US. Patent Aug. 18, 1998 Sheet 6 0f 7 5,795,331
m6m.E“
G<E9
GmE1
Wm,
G<E3
US. Patent Aug. 18, 1998 Sheet 7 0f 7 5,795,331
lllll'_
,ml3m11i l.l,
vm»!
5.795.331
l 2
BALLOON CATHETER FOR OCCLUDING retained there. The in?ated balloon or balloons may protrude
ANEURYSMS OF BRANCH VESSELS out through the opening of the aneurysm and interfere with
blood ?ow through the vessel lumen. Material emitted from
BACKGROUND OF THE INVENTION
holes in a balloon in the aneurysm chamber may be forced
1. Field of the Invention out the opening and block the vessel lumen. Moreover. the
The present invention relates to a method and apparatus introduction of the balloon catheter or catheters into the
for delivering occluding agents through the opening in a aneurysm chamber itself poses the risk that the aneurysm
wall will be punctured.
blood vessel wall and into the aneurysm chamber or into a
peripheral vessel. and in particular by introducing a balloon Further approaches to encouraging thrombus formation in
catheter. in?ating the balloon to seal the blood vessel lumen 10 aneurysm chambers are described in U.S. Pat. No. 5.234.437
around the vessel opening. and delivering the occluding wherein a plurality of metallic vaso-occlusion coils are
agent through the opening to prevent loss of occluding agent placed in the chamber by positioning a pusher catheter into
into the blood vessel during such delivery and until in situ the opening and detaching the coils. Detachment is proposed
stabilization of the occluding agent as an occluding cast by applying current of electrically sever the connection or by
shaped to retain the patency of the blood vessel at the 15 threading the coil out of engagement with the pusher mecha
occluded opening. nism. See also. for example. “Electro Thrombosis of Aneu
2. Description of the Background Art rysms” .I. Neurosurgery, 75:1-7. January. 1991 by
Guglielmo. where electric current is employed as well.
The occurrence of aneurysms in weakened blood vessel
These approaches require the proper introduction of a cath
Walls. particularly in arterial blood vessels. often presents a
eter into the opening. and the positioning of such catheters
life threatening risk to a patient. This is particularly true in
is di?icult and presents the risk of perforating the aneurysm
blood vessels serving the heart. brain and other vital organs.
wall.
In both venous and arterial blood vessels. such aneurysms
may rupture. causing internal bleeding and loss of blood In a still further approach described in U.S. Pat. No.
pressure or become the source of clots that may become 5.219.355. a catheter borne sleeve is proposed to be placed
dislodged and are borne by moving blood to other sites 25 across and within the depicted wide mouth opening of an
where they restrict blood ?ow. In major arteries. the rupture aneurysm to block the mouth and serve as an alternative.
may lead to severe loss of pressure and rapid death. In the intralurninal blood vessel. The sleeve is attached at either
brain. the pooling of blood may lead to pressure on brain end to a pair of expandable stents which are introduced by
cells and result in a stroke. a double balloon catheter and expanded upon in?ation of the
balloons. Presumably. the expanded stents stabilize the
The invasive. surgical removal of aneurysms and closure
sleeve ends against patent blood vessel walls. In this
of the opening in the vessel wall itself presents a grave risk
to the patient and poses severe post-operative complications. approach. an apparent risk lies in detachment of one or both
Conventional vascular surgery or micro-surgery may be of the stents from contact with the blood vessel walls over
employed successfully to correct aneurysms of vessels time. Alternatively. as the stents ?brose in. the ?brosis may
35 resn'ict blood ?ow and lead to further complications. Many
accessible to such surgical approach. However. the most
blood vessels would appear to be too small to bene?t from
threatening aneurysms are often deep within a vital organ or
this approach due to the necessary size of the components
large in size and having a wide neck where the trauma of
and introducing apparatus.
surgical treatment presents a great risk.
One surgical treatment for dealing with such aneurysms Spaced apart. double balloon catheters are also proposed
involves closing off the blood vessel and thereby sacri?cing for use in temporarily occluding blood vessels to introduce
it and tissue that it serves to ischemia. This type of occlusion a therapeutic agent in treating blood vessel intima injured in
balloon angioplasty procedures. as disclosed in U.S. Pat. No.
may be employed as a last resort in cases where the induced
trauma presents the lesser evil. 4.832.688.
It is therefore often either impossible to proceed surgi 45 Further spaced apart balloon catheters have been pro
cally or preferable to avoid such surgical procedures. Less posed for isolating a network of small branch blood vessels
invasive approaches have been proposed and tested either in collaterally supplying a tumor and injecting a contrast
animals or clinically for closing off the aneurysm opening material or a small vessel occlusive collagen material into
and/or ?lling the aneurysm sac. For example. as described in the network. as disclosed in U.S. Pat. Nos. 4.655.746 and
U.S. Pat. No. 5.041.090. a number of approaches have been 4.708.718. The injected material is delivered directly into
undertaken employing catheters for positioning detachable the vessel between the two in?ated balloons and described
balloons either in the aneurysm sac or in the adjacent vessel. as being drawn into the small diameter branch blood vessels
?lling the balloon with a quick setting polymer and detach and remaining there over a period of time to occlude them.
ing the balloon in attempts to either ?ll and displace blood The disposal of the collagen material remaining in the main
in the aneurysm sac or e?iect stationary occlusion of the 55 vessel is apparently not explained. To the extent that the
vessel. In the ’090 patent. a pair of catheter borne. detach solidi?ed collagen remains in the secondary and tertiary
able balloons are provided that are intended to be placed in vessels after withdrawal of the catheter. it may protrude out
the aneurysm sac. in?atable with one balloon inside the of these minor branch vessels into the lumen of the main
other. and in?ated to fill with one material or polymerize vessel and provide sites for the development of thrombi or
another material in the outer balloon in a shape conforming stenosis.
to the aneurysm sac. so that the catheters may be detached In addition. single or co-axially disposed double balloon
with the balloons remaining in place. In one embodiment. catheters of the type disclosed in U.S. Pat. Nos. 5.049.132.
polymerizable material appears to be directed out of mul 5.087.244. 5.112.305. and 5.213.576 are described for dis
tiple holes in the outer balloon and into contact with the wall tributing therapeutic agents through side wall holes in the
of the aneurysm to bond the balloons and wall together. 65 outermost balloon to vessel walls to treat an atherosclerotic
In all of these procedures. it is necessary to get a balloon plaque or to induce penetration of the agent into the vessel
or balloons directed through the neck of the aneurysm and wall to treat a vessel wall tumor or for applying heparin