Catheter with flexible and rigid reinforcements

Details Catheter with flexible and rigid reinforcements Catheter with flexible and rigid reinforcements

1999-03-16

2001-11-20

Nguyen, Anhtuan T. (Department: 3763)

Surgery

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

Treating material introduced into or removed from body...

C604S526000, C604S530000

Reexamination Certificate

active

06319244

ABSTRACT:

FIELD OF THE INVENTION
The present invention is generally related to medical catheters, and more particularly to catheters subject to high insertion and manipulation forces such as aortic perfusion catheters and the like.
BACKGROUND OF THE INVENTION
One of the challenges surgeons face during surgery while connecting catheters to body vessels, such as arteries, is the difficulty of inserting and manipulating the catheters within the body vessels. It is preferred to have the catheter body comprised of a softer material so that the catheter body does not create trauma to the body vessels. However, softer catheter bodies are more difficult to insert and manipulate within the body vessels, because they have reduced body strength. One way to stiffen the softer catheter body is to place the catheter in an ice slush before inserting it into the body vessel. By lowering the temperature of the catheter body, the surgeon is able to temporarily stiffen the catheter body, which is typically made of a material such as polyvinylchloride (PVC), polyurethane, polyethylene and the like.
The problems presented by soft catheter bodies during insertion and manipulation are more apparent when the catheter bodies are made of elastomeric materials. Elastomeric materials, such as silicone, are quite desirable for inflatable balloons and catheter bodies since they are atraumatic, but suffer in that these materials cannot be bonded to other conventional non-similar materials such as PVC, polyurethane and polyethylene.
Silicone catheter bodies usually need to be structurally reinforced to provide body strength and kink resistance to avoid collapsing during use. One conventional form of reinforcement is to provide a coil integrally formed in the catheter body outerwall. This coil reinforcement gives flexibility to the catheter while at the same time providing kink resistance. Flexibility of the catheter at all times is desired because the surgeon would like to clear the catheter body out from a surgical site once he secures the catheter in the body vessel. However, a coil may not provide sufficient body strength for inserting and manipulating the catheter within a body vessel.
There is desired an improved catheter preferably comprised of an atraumatic elastomeric material, such as silicone, which has improved resistance from collapsing and kinking, and also has sufficient body strength to facilitate insertion and maneuvering within a body vessel, such as the aorta.
SUMMARY OF THE INVENTION
The present invention achieves technical advantages as a catheter comprised of an elastomeric material and reinforced with two different reinforcement elements. The distal tip portion of the catheter is reinforced with a rigid tubular member, while the proximal portion of the catheter is reinforced with a more flexible member such as a coil or spring. The rigid tubular member is preferably malleable to allow custom shaping, and to provide body strength during insertion and manipulation. The spring and rigid tubular member preferably extend within a common lumen.
In one embodiment, the diameter of the coil or spring is about the same as the outer diameter of the tubular member, and the coil or spring is securely disposed about the rigid tubular member within a common lumen of the catheter body. In another embodiment, the outer diameter of the spring is about the same as the inner diameter of the rigid tubular member, and the spring securely resides within the tubular member. In yet another embodiment, the support members are slightly spaced from one another. In all embodiments, the coil or spring extends within one of the lumens of the catheter body, whereby a thin layer of polymeric material coats the lumen wall to encapsulate the coil or spring reinforcing member and provide a smooth surface in the flow lumen.
An elastomeric balloon may be sealingly attached about the catheter body and may be comprised of a material compatible with the catheter body, both preferably being comprised of silicone. A hinge is preferably provided in the catheter body proximal to the rigid tubular member to allow hinging the catheter body distal portion within a body vessel after insertion. The hinge allows the balloon and catheter distal portion to self-align within the center of the body vessel.
Also disclosed is a method of manipulating a catheter within a body vessel including the steps of inserting the catheter into the vessel and advancing the catheter in the vessel such that the catheter distal portion is positioned along the length of the vessel. The catheter has a lumen extending between a proximal portion and a distal portion, and has a resilient support member extending about the lumen from the catheter proximal portion to a location short of the distal portion. The catheter also has a tubular rigid support member extending about the lumen from proximate the resilient member distal portion to the catheter distal portion. Optional steps include holding the rigid support member of the catheter during advancement, infusing a fluid into the body vessel, aspirating a fluid from the body vessel, and inflating an optional elastomeric balloon to occlude a portion of the body vessel. Preferably, the distal portion of the catheter remains positioned parallel to the length of the vessel during the steps of advancing and manipulating the catheter to avoid damage to the inner walls of the body vessel.
The rigid reinforced section at the distal tip of the catheter body allows the surgeon to hold the catheter tip more firmly during insertion and manipulation within a body vessel. Because the tip is rigid, the catheter tip is more controllable within the body vessel, such as the aorta. Because the catheter section proximal the rigid tip is reinforced by the spring or coil member, this portion of the catheter is flexible and resists kinking. This more flexible section, however, allows the surgeon to move the catheter proximal portion out of the surgical site without kinking.


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