Braid reinforced infusion catheter with inflatable membrane

Details Braid reinforced infusion catheter with inflatable membrane Braid reinforced infusion catheter with inflatable membrane

1997-07-31

2001-02-13

Bockelman, Mark (Department: 3762)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S525000, C604S527000, C606S194000, C606S195000

Reexamination Certificate

active

06186978

ABSTRACT:

FIELD OF THE INVENTION
This invention is a surgical device. In particular, the invention is a perfusion catheter having an inflatable membrane or balloon located at the distal end of the catheter shaft. The catheter shaft is comprised of an outer tubing assembly and an inner tubing assembly separated by an open annulus for inflating and deflating the inflatable membrane. The assembly may additionally comprise an inflatable membrane which is detachable. The outer tubing assembly is made up of at least one polymeric layer and a braid which may be polymeric or metallic, perhaps of a super-elastic alloy. At least a portion of the inner tubing assembly is made up of at least one polymeric layer and preferably a super-elastic metallic braid. The inner tubing assembly includes a lumen through which a guidewire may pass. It is further desirable that the inner tubing assembly include a coil member which generally is coextensive with the balloon along its axis. That lumen is preferably lined with a lubricious polymer. The outer tubing assembly allows the profile of the catheter to be minimized and yet provides significant kink-resistance to the inner tubing assembly. The structure of the inner tubing assembly provides resistance to premature inflation during introduction of infusate through the inner lumen.
BACKGROUND OF THE INVENTION
This invention relates generally to a catheter having an expandable membrane or balloon at its distal tip. It is constructed so that it has two lumens; one is central lumen for a guidewire or for the introduction of drugs or vaso-occlusive materials or devices, and the other is coaxial about the interior lumen and is used solely for the purpose of inflating or deflating the distal inflatable membrane. The device is designed is such a way that it has a very narrow overall diameter and it is preferably constructed using a compliant balloon as the membrane. This is to say that the balloon section located distally on the inventive catheter is of the same general diameter as is the catheter shaft in the near neighborhood of the inflatable membrane, and yet will expand to as much as four or five times the diameter of the device when so inflated. Because of the very narrow configuration of the device, it may be used in regions of the body where prior balloon catheters are not suitable. This is to say that it may be used in the vasculature of the brain and the periphery as well as in the soft organs, such as the liver. It is of significantly small enough diameter that it may be used in various genito-urinary passageways without undue hardship on the patient. Also central to the invention is the use of a braid in the outside tubing assembly, desirably either metallic or of polymeric filaments. At least a portion of the inner tubing assembly of the inventive catheter, generally the more proximal portion, comprises a metallic braid, often a metallic or super-elastic alloy ribbon braid. This super-elastic alloy braid provides exceptional kink resistance, not just to the tubing assembly in which it is placed, but more surprisingly to the inner tubing assembly. The inner braid prevents the balloon from expanding during introduction of fluids through the inner lumen or the inner lumen from collapsing when the balloon is inflated. The inner tubing asembly also preferably comprises a coil section in the region of the inflatable membrane to provide enhanced flexibility.
Catheters having a coaxial structure are known. Many of them are used in procedures such as percutaneous transluminal angioplasty (PTA). In such procedures, however, the balloon is a noncompliant one. That is to say, it is of a specific size which is set upon the time of its manufacture. The balloon itself is folded or collapsed into a somewhat bulky and stiff region which is difficult to maneuver, both through the guiding catheter by which it is placed and through the various vascular lumen to the site of treatment. In such a procedure, a guiding catheter typically having a pre-shaped distal tip, is introduced into the vasculature of the patient. The catheter is then advanced from the entry site in the femoral artery up into the aorta. Once the tip of the catheter reaches the aorta, the distal end of the catheter is twisted or “torqued” so to turn the preshaped distal tip of that guiding catheter into the ostium of the desired coronary artery. A balloon-bearing catheter is then advanced through the guiding catheter and out its distal tip until the dilatation catheter's balloon extends across the region to be treated. The balloon is then expanded to the predetermined size, often by the use of a radio-opaque liquid at relatively high pressures. Upon completion of the procedure, the balloon is then deflated so that the dilatation catheter may be removed and thereafter the blood flow is restored through the thus-treated artery.
In other procedures, a balloon-bearing catheter, typically of a somewhat smaller diameter than a catheter used in PTA procedures might be used. In a universal sense, the procedure might be considered to be similar, since a guiding catheter is initially placed so that its distal end is near the site to be treated or diagnosed. The balloon catheter would then be placed through the lumen of the guiding catheter to that site. The balloon-bearing catheter, perhaps with a guidewire extending through an existing central lumen, could then be extended from the distal side of the guiding catheter to the treatment or diagnostic site. The balloon would then be expanded, and once the procedure is complete, the balloon deflated and removed from the body. In some instances, the balloon might be of a compliant nature rather than of a fixed diameter configuration found in a typical PTA balloon.
The advent of interventional radiology and its sub-practice, interventional neuroradiology, as a viable treatment alternatives in various regions of the body having tortuous vasculature often surrounded by soft organs, has produced demands on catheterization equipment not placed on devices used in PTA. The need for significantly smaller diameter devices and particularly those which have variable flexibility and are able to resist kinking is significant.
U.S. Pat. No. 5,338,295, to Cornelius, et al., describes a dilatation balloon catheter having a shaft formed of a tubular braid of a stainless steel material. The proximal outer tube section is encased in a polyimide material. The distal outer tube section which forms a balloon is made of a polymeric material such as polyethylene.
Another similar device is shown in U.S. Pat. No. 5,451,209, to Ainsworth, et al. Ainsworth, et al., describes a composite tubular element useful in intravascular catheters. In particular, it is said to be useful as an element of a fixed wire dilatation catheter or in a guiding or angiographic catheter. The structure of the device is formed by braiding strands which are formed from a mixture of a polymeric matrix material (e.g., a fiber or powder) having a relatively low melting point in a high strength reinforcing fiber having a relatively high melting point. The fibers are woven into a tubular element, the resulting braided tubular element is heated to melt the matrix material so to permit it to flow around the high melting point reinforcing fibers. This procedure forms a matrix. Thermoplastic jackets or coatings are then extruded onto or otherwise applied to the exterior of the thus-produced braided tubular element.
U.S. Pat. No. 5,429,597, to DeMello, teaches a balloon catheter which is said to be kink resistant. In general, it appears to be made up of an outer polymeric covering over a “cross-wound multifilar (CWMF) coil in a nonfixed removable core wire.” The CWMF coil is a pair of helical coils which are wound in opposite directions so to provide torque transmission during use of the catheter. There appears to be no suggestion of weaving the CWMF materials into a braid.
PCT application to Pray, et al. (WO93-20881) assigned to SciMed Medical Systems suggests a dilatation catheter having a shaft with a proximal section which is

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