Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-12-30
2001-06-26
Seidel, Richard K. (Department: 3734)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S524000, C604S526000
Reexamination Certificate
active
06251092
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to the field of intraluminal catheters, and more particularly to a guiding catheter having a deflectable distal end.
Guiding catheters are used in many percutaneous intravascular procedures to guide diagnostic and therapeutic devices or fluids, and the like, to a desired location within the patient. For example, a guiding catheter is typically used in conjunction with balloon catheters used in angioplasty procedures and electrophysiology (EP) devices used for ablation or mapping of cardiac tissue. U.S. Pat. No. 5,509,411, incorporated by reference (Littmann et al.) is an example of an EP catheter.
In the design of guiding catheters, different and often competing considerations relating to catheter flexibility and strength must be balanced. The guiding catheter proximal section must have sufficient flexibility and strength to be advanceable and torqueable, and have sufficient column strength to limit shaft buckling. The distal end of the guiding catheter is typically more flexible than the proximal section, to provide maneuverability and to prevent trauma to the patient's vasculature. However, the distal end must have sufficient strength to prevent kinking during advancement.
While a large delivery lumen is desirable for delivering devices such as EP catheters, the outer diameter of the catheter must be minimized so that the catheter can be readily advanced within the patient. Therefore, when the catheter contains a large delivery lumen, the walls of the catheter are necessarily thin in order to minimize the outer diameter of the guiding catheter. Typically, a tubular or braided metal line reinforcement may be provided within a wall of the catheter. The line reinforcement stiffens the catheter and transmits torque to the catheter distal end as the proximal end of the catheter outside the patient is rotated .
The distal end of the guiding catheter frequently needs to be bent or shaped while within the patient. The bent shape is useful in guiding the catheter distal end into a desired body lumen or chamber. For example, during an EP ablation or mapping procedure, the guiding catheter must be maneuvered through a patient's branched vasculature to advance an EP device into a patient's coronary sinus. Moreover, the shaped or shapeable distal end of the guiding catheter is used to orient the distal tip of the EP device with respect to tissue, such as a patient's endocardium, to facilitate proper delivery of the device's RF or laser energy to the tissue. Consequently, the guiding catheter may be provided with a preformed distal tip which may be guided into the desired location in the patient by rotating the proximal end of the guiding catheter from outside the patient. Additionally, the guiding catheter may be provided with a deflection mechanism to reversibly deflect the distal tip while within the patient.
One difficulty has been providing a deflectable guiding catheter having sufficient column strength and torque transmission in combination with a relatively large lumen for delivering devices such as EP catheters. Moreover, many prior deflectable catheters are typically limited to uniplanar deflection, which requires the catheter shaft to be rotated from its proximal end located outside of the patient in order to place to deflected tip into a desired plane, as, for example, to place the distal tip of the catheter into a desired branched vessel or in contact with a desired tissue wall.
What has been needed is a catheter with a kink resistant, torqueable, and deflectable shaft which nonetheless defines a large unobstructed lumen for receiving a device therein. The present invention satisfies these and other needs.
SUMMARY OF THE INVENTION
The invention is directed to a catheter comprising an elongated shaft which has a deflectable distal section and an unobstructed delivery lumen, with kink resistance and torque transmission.
The guiding or delivery catheter of the invention generally has an elongated shaft with a deflectable distal section, a deflection line lumen, and a delivery lumen in fluid communication with a port in the distal end of the shaft. An elongated, preferably tapered, deflection line is disposed within the deflection line lumen. Preferably the wall of the shaft has reinforcing or stiffening strands or fibers which may be braided or wound. The longitudinal axes of the deflection line lumen and delivery lumen are axially aligned with respect to one another, and are eccentric to the central longitudinal axis of the shaft. The phrase “axially aligned” refers to the fact that the two lumens are aligned along a bisecting plane intersecting the central longitudinal axis of the shaft.
To selectively deflect the shaft distal section, the operator moves the deflection line longitudinally. From an undeflected position aligned with the shaft longitudinal axis, the distal shaft section is deflected away from the shaft longitudinal axis by pulling the line proximally out the proximal end of the shaft. In one embodiment, if the deflection line is stiff enough, the deflection line may be moved longitudinally toward the distal end of the shaft to deflect the shaft distal section in an opposite direction. In one example, the catheter is provided with a steering mechanism on the catheter proximal end, which facilitates the longitudinal movement of the deflection line by the operator.
The catheter of the invention is kink resistant and torqueable. The deflection line, which extends to the distal end of the deflection line lumen, provides column strength and is tapered to provide a smooth transition of stiffness from the catheter proximal shaft section to the deflectable distal shaft section. The distal end of the deflection line lumen extends into at least a portion of the deflectable distal shaft section to a location spaced proximally from the distal end of the deflectable distal shaft section. The deflection line generally extends in about 70% to about 95%, preferably about 85% to about 90%, of the total length of the deflectable distal shaft section. The distal end of the shaft is provided with improved flexibility due to the deflection line terminating proximal to the distal tip of the shaft.
The shaft is reinforced with suitable reinforcing strands or fibers, such as stiffening wire braids, which contribute to the shaft column strength and torque transmission. The reinforcement extends at least into a portion of the deflectable distal shaft section. Generally the reinforcement extends in about 15% to about 50%, preferably about 25% to about 45% of the total length of the deflectable distal shaft section. The reinforcements are preferably made of stainless steel, although other materials with similar stiffness are suitable, such as NITINOL, MP35N, Elginoy, and high strength polymer materials such as polyamide and Kevlar®.
The delivery lumen of the guiding catheter is independent from, or fluidly sealed from, the deflection line lumen, and thus provides an unobstructed passageway for slidably receiving an EP or other therapeutic or diagnostic agent or device. Because the guiding catheter of the invention provides superior control in accessing desired cardiovascular structure, it is particularly useful in supporting and delivering an EP mapping or ablation catheter to various locations in cardiac chambers for diagnosis or therapy. For example, the guiding catheter of the invention may be advanced into the right atrium of the heart from the inferior vena cava to position the operative distal end of an EP catheter within the right atrium above the tricuspid valve. The electrodes on the distal end of the EP catheter can then be put into operative contact with the cardiac tissue of the right atrium by torquing and/or deflecting the tip of the guiding catheter of the invention. Consequently, where a plurality of electrodes are on the EP device distal end, the range of movement and control of the guiding catheter of the invention allows for all the electrodes to be in contact with the cardiac tissue together, so t
Dickens Duane
Qin Jay J.
Schaller Laurent
McMahon Beth L.
Medtronic Inc.
Rodriguez Cris
Seidel Richard K.
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