Surgery – Instruments – Electrical application
Reexamination Certificate
1999-01-20
2001-06-26
Leubecker, John P. (Department: 3739)
Surgery
Instruments
Electrical application
C606S049000, C607S101000, C607S122000
Reexamination Certificate
active
06251109
ABSTRACT:
BACKGROUND OF INVENTION
This invention relates to medical devices and processes useful for the treatment of atrial arrhythmia. In particular, it relates to a preferred process and medical device used for ablation procedures in vessels of the human body, namely the pulmonary veins.
Introducers and catheters have been in use for medical procedures for many years. For example, one procedure utilizes a catheter to convey an electrical stimulus to a selected location within the human body. Another procedure utilizes a catheter to monitor activity in various locations in the body for diagnostic tests. Thus, catheters may examine, diagnose and treat while positioned at specific locations within the body which are otherwise inaccessible without more invasive procedures. In use, catheters may be inserted into a major vein or artery which is near the body surface. These catheters are then guided to a specific location for examination, diagnosis and treatment by manipulating the catheter through the artery or vein of the human body, frequently with the assistance of other medical devices, such as introducers or guidewires.
One common medical procedure utilizing specialized catheters is the treatment of vessels located within the human body, frequently vessels associated with the human heart. Those procedures, most notably angioplasty procedures, utilize a catheter which often contains an inflatable balloon secured to the catheter. In some of these medical procedures, the catheter contains a pair of inflatable balloons used to limit the portion of the vessel that is treated or to assure that the catheter remains at a fixed location within the vessel throughout the medical procedure or to assist in the performance of the medical procedure.
Multiple balloon catheters are utilized throughout the body. For example, U.S. Pat. No. 5,468,239 discloses a device for circumferential laser burning of tissue in a urethral canal. This device utilizes a pair of cuffs or balloons (
60
) with a laser probe (
12
) located between those balloons. U.S. Pat. No. 5,588,961 discloses an infusion catheter for delivery of medication to a vessel and contains a pair of balloons (
16
,
17
) and an electrode (
35
) secured to the catheter. Ports are provided in the catheter to introduce the medication into the space between the two balloons within the vessel. Energy may also be introduced into the electrode to encourage the movement of the medication away from the catheter toward the walls of the vessel. U.S. Pat. No. 5,256,141 discloses a pair of balloons (
14
,
18
) with an electrode secured to a catheter to apply a controlled electric charge to material introduced into the space in the vessel between the two balloons.
Biological material may also be introduced into this space for medical treatment of the vessel. U.S. Pat. No. 5,366,490 discloses a pair of balloons (
30
,
32
) secured to a catheter and a stylette (
36
). Radio frequency energy is supplied to the catheter to destroy tissue. U.S. Pat. No. 5,599,307 discloses a pair of balloons (
41
,
42
) secured to a catheter designed to occlude a vessel. U.S. Pat. No. 5,002,532 discloses a pair of balloons (
21
,
22
) secured to a catheter (
12
) for use in a dilation procedure within a vessel, whereby the two balloons may be inflated to different extents. U.S. Pat. No. 5,792,105 discloses a multichannel balloon catheter for delivering fluids which utilizes an inner and an outer balloons. See also U.S. Pat. No. 4,445,892.
In addition to the use of multiple balloons on a single catheter for medical procedures, U.S. Pat. No. 5,462,529 discloses a medical device containing a pair of catheters (
12
,
28
), each containing a balloon (
20
,
48
) secured at or near its distal end, which device is utilized to perform a medical procedure within a vessel. U.S. Pat. No. 5,484,412 also discloses a pair of catheters (
18
,
22
) utilized to perform a medical procedure within a vessel, each containing an inflatable balloon (
36
,
38
). U.S. Pat. No. 4,911,163 discloses a pair of balloons (
2
,
8
) secured to a pair of catheters (
1
,
7
) for introduction of medicine or diagnostic fluids into the space between the two balloons.
Atrial fibrillation is the most common sustained heart arrhythmia. It is estimated to occur in upwards of 0.4 percent of the adult population and perhaps as many as 10 percent of the population who are 60 years or older. Cox, J. L., et al.,
Electrophysiology, Pacing and Arrhythmia,
“Operations for Atrial Fibrillation,” Clin. Cardiol. 14, 827-834 (1991).
Atrial arrhythmia may be transient or persistent. While most atrial arrhythmia occur in individuals having other forms of underlying heart disease, some atrial arrhythmia occur independently. While atrial arrhythmia do not directly cause death as frequently as ventricular arrhythmia, they increase the risk factors for a number of other diseases such as systemic and cerebral embolism and may cause a number of additional medical problems.
In the treatment of atrial arrhythmia, antiarrhythmic drugs sometimes provide relief. Other treatments for atrial arrhythmia or fibrillation involve the use of an implanted atrial defibrillator or cardioversion. See, for example, U.S. Pat. Nos. 5,282,836, 5,271,392 and 5,209,229 and Martin, D., et al.,
Atrial Fibrillation,
pgs. 42-59 (1994).
Certain patients with symptomatic or life threatening atrial arrhythmia, however, cannot be adequately treated by drugs or these types of medical devices. Other forms of aggressive treatment are sometimes mandated, which have in the past included surgery. For example, a surgical procedure for the treatment of atrial arrhythmia known as the “Maze” procedure is discussed in Cox, J. L. et al.,
Electrophysiology, Pacing and Arrhythmia,
“Operations for Atrial Fibrillation,” Clin. Cardiol. Vol. 14, pgs. 827-834 (1991).
Another procedure increasingly used within the last 10 to 15 years for the treatment of certain types of cardiac arrhythmia involves ablation of cardiac tissue. For example, this procedure has been commonly used to interrupt or modify existing conduction pathways associated with arrhythmia within the heart. The particular area for ablation depends on the type of underlying arrhythmia. The use of radio frequency catheter ablation for the treatment of paroxysmal atrial fibrillation is disclosed in Haissaguerre, M., et al., “Right and Left Atrial Radiofrequency Catheter Therapy of Paroxysmal Atrial Fibrillation”
J. Cardiovascular Electrophysiology,
V.7, pgs. 1132-1144 (December 1996). Ablation procedures have also been used for the treatment of atrioventricular (AV) nodal reentrant tachycardia. With this condition, ablation of the fast or slow AV nodal pathways has become an accepted treatment. Singer, I., et al., “Catheter Ablation for Arrhythmias”
Clinical Manual of Electrophysiology,
pgs. 421-431 (1993); Falk, R. H., et al.,
Atrial Fibrillation Mechanisms in Management,
pgs. 359-374 (1992); Horowitz, L. N.,
Current Management of Arrhythmias,
pgs. 373-378 (1991); and Martin, D., et al.,
Atrial Fibrillation,
pgs. 42-59 (1994). In addition, the use of ablation catheters for ablating locations within the heart has been disclosed, for example in U.S. Pat. Nos. 4,641,649, 5,263,493, 5,231,995, 5,228,442 and 5,281,217.
The sources of energy used for catheter ablation vary. Initially, high voltage, direct current (DC) ablation techniques were commonly used. However, because of problems associated with the use of DC current, radio frequency (Rf) energy has become the preferred source of energy for ablation procedures. The use of Rf energy for ablation has been disclosed, for example, in U.S. Pat. Nos. 4,945,912, 5,209,229, 5,281,218, 5,242,441, 5,246,438, 5,281,213 and 5,293,868. Other energy sources which are being used currently or are being considered for ablation of heart tissue include laser, ultrasound, microwave and fulgutronization.
Ablation of a precise location within the heart requires the precise placement of the ablation catheter within the heart. Precise positioning of the ablation catheter is es
Bednarek Michael C.
Hassett James A.
Swartz John F.
Cox Scott R.
Daig Corporation
Gibson Roy
Leubecker John P.
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