Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-03-06
2001-08-07
Sykes, Angela D. (Department: 3762)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S097010, C604S102010, C604S527000, C606S192000
Reexamination Certificate
active
06270477
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention generally relates to medical devices, and in particular, to catheters which can be used in an emboli containment system.
Balloon angioplasty, and other transluminal medical treatments, are well-known, and have been proven efficacious in the treatment of stenotic lesions in blood vessels. The application of such medical procedures to certain blood vessels, however, has been limited, due to the risks associated with creation of emboli during the procedure. For example, angioplasty is not the currently preferred treatment for lesions in the carotid artery, because of the possibility of dislodging plaque from the lesion, which can enter the various arterial vessels of the brain and cause permanent brain damage. Instead, surgical procedures are currently used, but these procedures present substantial risks.
One solution to this problem is the use of a multi-catheter emboli containment system, as disclosed in the above-referenced application Ser. No. 08/650,464. As disclosed therein, a treatment chamber within a blood vessel is formed by two occlusion balloons on opposite sides of a stenotic lesion, thereby preventing emboli migration during the treatment procedure. The chamber is created by two occlusion balloon catheters which are slidably disposed with respect to one another.
Emboli containment procedures of this type are advantageous, because they permit the clinician to utilize the benefits of transluminal treatment in a wider variety of blood vessels. However, the procedures require the complex coordination of multiple catheters. Consequently, it is desirable to have catheters which make it easier for the clinician to utilize an emboli containment system. It is also desirable that the catheters used in the emboli containment system have a high degree of flexibility, to navigate tortuous blood vessel networks.
Consequently, there exists a need for improved emboli containment catheters. This is especially true in the context of the “main” catheter, through which other catheters are inserted and controlled to form the emboli containment system.
SUMMARY OF THE INVENTION
The present invention advantageously provides as a main catheter an occlusive device adapted for use in a multi-catheter emboli containment system. In one aspect of the present invention, there is provided a catheter, comprising an elongate flexible tubular body having a proximal end and a distal end. The tubular body incorporates a metallic member, which may comprise a braid or a coil. A main lumen and an inflation lumen extend through the tubular body, and are in a side-by-side configuration. The main lumen is sized to receive a therapeutic and/or diagnostic device such as a balloon angioplasty catheter or an atherectomy catheter. The tubular body is provided with a manifold. The manifold has an aspiration port which is in fluid communication with the main lumen. The distal end of the tubular body also has a tip formed of a more flexible material than that used to form the tubular body.
In one preferred embodiment, an inflatable balloon is mounted on the distal end of the tubular body. An inflation port is also provided on the manifold in this embodiment. The inflation port is in fluid communication with the inflation lumen. In this embodiment, the inflatable balloon is formed of a block copolymer of styrene-ethylene-butylene-styrene.
In another preferred embodiment, the metallic braid or coil is formed of a metal selected from the group consisting of
304
,
316
, or
400
series stainless steel, nitinol, platinum, gold, Elgiloy (TM), or combinations thereof. Where a metallic braid is used, it may optionally have a braid density at a first point on the tubular body that is greater than the braid density of the metallic braid at a second point on the tubular body by at least
20
picks per inch. Similarly, where a metallic coil is used, it may optionally have a coil density at a first point on the tubular body that is greater than the coil density at a second point on the tubular body.
In another aspect of the present invention, there is provided a catheter comprising an elongate flexible tubular body having a proximal end and a distal end. Alternatively, there may be provided a circular cross-sectional configuration at the proximal end which is continuous with a distal end having a reduced internal and outer tubular body diameters. A first and second lumen extend through the tubular body from the proximal end to the distal end in a side-by-side configuration. The first lumen has a generally circular cross-sectional configuration at the proximal end and a generally oval cross-sectional -configuration at the distal end. The second lumen has a diameter no smaller than 0.05 inches, preferably no smaller than 0.08 inches, and is adapted to slidably accommodate a therapeutic or diagnostic device.
In one preferred embodiment, an inflatable balloon is mounted on the distal end of the tubular body. The inflatable balloon is in fluid communication with the first lumen, such that fluid passing through the first lumen may be used to inflate or deflate the inflatable balloon. The second lumen size may vary in certain embodiments, such that in one embodiment, the second lumen has a diameter no smaller than about 0.05 inches, and is preferably no less than 0.080 inches.
In another aspect of the present invention, there is provided a catheter with variable stiffness, comprising a tubular body having a proximal end and a distal end. A metallic braid or metallic coil is within the tubular body. In one embodiment, the proximal end of the tubular body has a lower braid or coil density than the distal end. In another embodiment, the braid or coil density is kept constant along the length of the tubular body, and the tubular body is formed of materials with greater stiffness at the proximal end. In another embodiment, a combination of braids and coils of varying density can be used at various points along the tubular body, to create a catheter tubular body having a more flexible distal end.
In another aspect of the present invention, there is provided a method of making a catheter tubular body. The method comprises providing a first polymeric tube formed of a first material having a first melting point. The first polymeric tube is then inserted into a second polymeric tube to form a combined tube. The second polymeric tube is formed of a second material having a second melting point which is less than the first melting point. The combined tube is then placed adjacent to a third tube. The third tube is formed in part of the second material. The tubes are then heated to a temperature greater than the second melting point but less than the first melting point, such that the combined tube melt fuses with third tube to form a catheter tubular body having two lumen extending therethrough in a side-by-side configuration. The first material may be selected from the group comprising polyimide, polyamide, PET and PEEK, blends thereof and the second material may be selected from the group comprising Pebax (TM), polyethylene, nylon, or Hytrel (TM) or blends thereof Preferably, the temperature of the heating step is from about 250° to 600° F. It is also preferred that the third tube incorporate a metallic member, such as a braid or coil.
REFERENCES:
patent: 3144868 (1964-08-01), Jascalevich
patent: 4405313 (1983-09-01), Sisley et al.
patent: 4445892 (1984-05-01), Hussein et al.
patent: 4468216 (1984-08-01), Muto
patent: 4481323 (1984-11-01), Sterling
patent: 4511354 (1985-04-01), Sterling
patent: 4573966 (1986-03-01), Weikl et al.
patent: 4619643 (1986-10-01), Bai
patent: 4782834 (1988-11-01), Maguire et al.
patent: 4790812 (1988-12-01), Hawkins, Jr. et al.
patent: 4790813 (1988-12-01), Kensey
patent: 4921483 (1990-05-01), Wijay et al.
patent: 4946466 (1990-08-01), Pinchuk et al.
patent: 4950238 (1990-08-01), Sullivan
patent: 4964409 (1990-10-01), Tremulis
patent: 5019057 (1991-05-01), Truckai
patent: 5027812 (1991-07-01), Shapiro et al.
patent: 5059178 (1991-10-01), Ya
patent: 5071405 (1991-12
Bagaoisan Celso J.
Ha Hung V.
Patel Mukund R.
Zadno-Azizi Gholam-Reza
Bianco Patricia
Knobbe Martens Olson & Bear LLP
PercuSurge, Inc.
Sykes Angela D.
LandOfFree
Catheter for emboli containment does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Catheter for emboli containment, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Catheter for emboli containment will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2451996