Catheter with distal-end engaging means

Details Catheter with distal-end engaging means Catheter with distal-end engaging means

1999-07-12

2002-02-19

Nguyen, Anhtuan T. (Department: 3763)

Surgery

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

Treating material introduced into or removed from body...

C604S103040

Reexamination Certificate

active

06348045

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to catheterization. More particularly it relates to a catheter suitable for guidance and positioning within the patient's body using the monorail positioning method or similar methods involving the engagement of the distal end of the catheter to a guide-wire and guiding it by advancing the catheter's distal end along the guide-wire.
BACKGROUND OF THE INVENTION
Catheterization is a well-known regular procedure, employed as a part of various medical treatments, such as intravascular catheterization, urinary catheterization, endotracheal catheterization, brain catheterization (shunt), and other types of catheterization.
In particular, cardiac pacemaker implant procedure had become a standard procedure in cardiology in the past few decades. Cardiac pacemaker implant procedure generally includes implanting the body of the pacemaker itself and one or two pacing electrode leads, usually inserted in the right chamber or atrium of the heart, and providing electric stimuli to the cardiac muscle through the electrodes.
Excitable tissue control (ETC) devices are devices which modulate the activity of excitable tissues by application of non-excitatory electrical field signals to the excitable tissue through suitable electrodes in contact with the tissue. For example, ETC devices may be used, inter alia, to increase or decrease the contractility of cardiac muscle in vitro, in vivo and in situ., as disclosed in detail in PCT application PCT/IL97/00012 (International Publication Number WO 97/25098) to Ben-Haim et al., titled “ELECTRICAL MUSCLE CONTROLLER”, incorporated herein by reference. Other methods and applications of ETC devices are disclosed in PCT application PCT/IL97/00231 (International Publication Number WO 98/10828) titled “APPARATUS AND METHOD FOR CONTROLLING THE CONTRACTILITY OF MUSCLES” to Ben Haim et al., incorporated herein by reference, PCT application PCT/IL97/00232 (International Publication Number WO 98/10829) titled “DRUG-DEVICE COMBINATION FOR CONTROLLING THE CONTRACTILITY OF MUSCLES” to Ben Haim et al., incorporated herein by reference and PCT application PCT/IL97/00233 (International Publication Number WO 98/10830) titled “FENCING OF CARDIAC MUSCLES” to Ben Haim et al., incorporated herein by reference, PCT application PCT/IL97/00235 (International Publications Number WO 98/10831) to Ben Haim et al., titled “CARDIAC OUTPUT CONTROLLER”, incorporated herein by reference.
There also are known sensing electrodes such as the BIPOLAR SENSOR FOR MUSCLE TISSUE ACTION POTENTIAL DURATION ESTIMATION (Mika et al.) disclosed in U.S. patent application Ser. No. 09/280,486, filed Mar. 30, 1999, incorporated herein by reference.
Other catheters such as drug administration catheters, feeding catheters etc also exist.
The above mentioned devices, as well as other electro-cardiac devices employ electrode leads to transfer the electric signal from the electric device to the muscle tissue (in the case of signal providing devices, such as ETC in its active modality, pacemaker etc.) and/or in the opposite direction (such as the ETC in its passive modality, the action potential duration estimation sensor etc.)
Inserting the electrode leads into the desired location is quite an intricate task and a skilful hand is needed to guide the lead through the blood vessels, and especially through the coronary venous system of the patient, to the final destination in the heart. The complexity of this procedure lies in the problem of navigating the lead safely to its desired target position, passing through vascular junctions and bends, successfully using the right exits en route, and entering the desired path.
The problem arises from the physical and mechanical characteristics of the pacing lead: an electrode lead comprises an elongated body with one or more electrodes exposed at the lead's distal end, electrically connected via electric wiring to a connector at the lead's proximal end (designated to be connected to the pacemaker, ETC device or the like). The body of the lead is tubular, and is relatively soft, collapsible, and flexible, to increase its fatigue resistance and durability.
A common method of catheterization of a pacing lead in position inside the heart's atrium or ventricle is to use a stiffening stylet, inserted inside and threaded through a lumen passing through the lead. When fully inserted through the lead, and advanced forward by pushing its proximal end, the distal tip of the stylet presses against the distal end of the lead, thus the pushing force at the proximal end of the stylet is transferred to the distal end of the lead, pulling the rest of the lead, trailed behind, through the desired route and into the atrium. For the lead to reach the ventricle, it is further passed through the valve separating the atrium from the ventricle.
Navigation of the lead is generally monitored using simultaneous “on-line” fluoroscopic imaging, allowing the medical staff performing the catheterization to observe the advancement of the catheter to the desired location.
But if navigating the lead to the atrium or ventricle is an intricate task, navigating a lead into position inside the coronary veins is an even more a complex job. This is due to the fact that while the lead follows a path into the heart's atrium that is relatively a straight one, with no substantial bends en route, in order to position the distal end of the lead inside the coronary veins, it must pass the coronary sinus and follow a multiple of bends along the way. In this case, the use of a stiffening stylet would prove problematic, as it is not suitable for maneuvering the lead around bends, and may also inflict damage to the blood vessel walls.
Several methods for the positioning of electrode leads inside coronary veins were developed and described in the art.
A known method of catheterization introducing a CS (coronary sinus) lead uses a lead pre-shaped to present a bent tip at its distal end, and incorporated with the use of a stiffening stylet. The bent-tip shape allows navigation of the stylet-driven lead around bends and junctions as the surgeon or technician advances the stylet and rotates the stylet to point the bent tip of the lead in the direction of the bend or desired exit. The pushing force applied on the proximal end of the stylet is transferred to the lead's distal end along the stylet body. When the distal end of the lead reaches the atrium, its bent tip is designed to be easily maneuvered into the coronary sinus. Once the lead tip is inside the coronary sinus further pushing of the stylet advances the lead within the coronary sinus to its end, and into the great cardiac vein. See U.S. Pat. No. 5,683,445 (Swoyer), titled MEDICAL ELECTRICAL LEAD, filed Apr. 29, 1996.
Another known method of catheterization is referred to as over-the-wire catheterization. Mainly used in conjunction with mapping catheters, a guide-wire comprises a stiff but relatively flexible axially, long, thin wire. The guide-wire is pushed forward through the vein until the distal tip reaches a junction. The operator of the guide-wire jiggles with it until the tip enters the desired branch, and then resumes pushing the guide-wire forward. Once the guide-wire has reached the desired location, a catheter or a soft lead is threaded over the guide-wire and advanced to its designated location, and then the guide-wire is removed. An example for the over-the-wire guidance method is described in U.S. Pat. No. 5,389,087 (Miraki), titled FULLY EXCHANGEABLE OVER-THE-WIRE CATHETER WITH RIP SEAM AND GATED SIDE PORT, filed Jun. 29, 1992.
Mapping catheters, such as these used in electro-physiology laboratories (see for example U.S. Pat. No. 5,711,298, titled HIGH RESOLUTION INTRAVASCULAR SIGNAL DETECTION to Littmann et al.), have a semi-stiff lead body and thus the pushing force exerted on the proximal end is transmitted along the catheter's body to its distal tip. The tip itself is more flexible than the rest of the body, and the catheterzation method is carried out i

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