Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-08-27
2004-01-06
Mendez, Manuel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S509000, C604S101030, C604S101050, C604S102020, C604S919000, C606S194000
Reexamination Certificate
active
06673040
ABSTRACT:
FIELD OF INVENTION
The present invention relates generally to cardiovascular catheters and also to circulatory support systems. More particularly, it relates to a system and method for performing catheter based medical procedures, such as balloon angioplasty, stent placement, atherectomy, valvuloplasty and other therapeutic procedures, with protective circulatory support in order to minimize the risk to the patient from such procedures. The system and methods of the present invention serve to expand the patient population treatable by catheter based procedures to include patients who might otherwise require open chest surgery with cardiopulmonary bypass and also to high risk patients who might not be acceptable candidates for these surgical alternatives.
BACKGROUND OF THE INVENTION
Many catheter based diagnostic and therapeutic procedures have been developed in the areas of interventional cardiology, interventional radiology, interventional neuroradiology and electrophysiology. Examples of such procedures include balloon angioplasty, stent placement, atherectomy and valvuloplasty. These and many other catheter based diagnostic and therapeutic procedures can benefit from the system and methods of the present invention, particularly in high risk patients.
Balloon angioplasty is a procedure in which a small, cylindrical balloon is mounted on an elongated catheter which is inserted into a stenosis or a narrowing in a blood vessel and inflated to dilate the stenosis and improve blood flow. Balloon angioplasty can be applied to coronary arteries, carotid arteries and peripheral arteries, as well as other body passages. Patents which describe apparatus and methods for performing balloon angioplasty include U.S. Pat. Nos. 4,195,637; 4,323,071; 4,545,390; 4,545,390; 4,538,622; 5,055,024; 4,490,421; 4,616,653; 5,133,364; 5,060,660; 5,031,636; 4,922,923; 4,917,103; 4,875,489; 4,827,941; 4,762,129; 4,988,356; 4;748;982; 5,040,548 and 5,061,2,73. The specifications of these patents and all other patents and patent applications mentioned herein are hereby incorporated by reference in their entirety.
Valvuloplasty is a closely related procedure in which a somewhat larger balloon or balloons are inserted into a stenosis in a heart valve and inflated to open the stenosis and improve blood flow through the valve. Valvuloplasty can be applied to the aortic valve, mitral valve, tricuspid valve or pulmonic valve. Patents which describe apparatus and methods for performing valvuloplasty include U.S. Pat. Nos. 4,787,388; 4,796,629; 4,909,252; 5,295,958.
Atherectomy is an alternative procedure to balloon angioplasty in which, rather than simply dilating the stenosis, some or all of the stenotic material is removed to debulk the stenosis and improve blood flow. Atherectomy includes both rotational atherectomy in which stenotic material is removed symmetrically about the catheter and directional atherectomy in which stenotic material is selectively removed from certain parts of the blood vessel. Patents which describe apparatus and methods for performing atherectomy include. U.S. Pat. Nos. 4,323,071; 5,071,425; 4,781,186; RE 33,569; 4,290,427; 4,315,511; 4,574,781; 4,621,636; 4,890,611; 5,368,603; 3,730,183; 5,071,424; 5,156,610; 5,282,484; 5,211,651; 5,267,955; 5,195,956; 5,178,625; 4,589,412; 4,854,325; 4,883,460; 4,273,128.
Stent placement, is a procedure often very closely associated with balloon angioplasty and also sometimes with atherectomy. Vascular stents, also known as endovascular prostheses, are small, generally cylindrical, metallic or polymeric scaffolds that are implanted within the lumen of a blood vessel to maintain patency of the lumen. Elective stent placement may be done as an adjunct to balloon angioplasty or atherectomy or emergency stent placement may be done in the case of a failed angoplas or atherectoiny. Stents can be applied to coronary arteries, carotid arteries and peripheral arteries, as well as other body passages. Stent grafts or covered stents resemble standard vascular stents with the addition of a prosthetic vascular wall over the metallic or polymeric scaffold of the stent. Patents which describe apparatus and methods for performing stent placement include. U.S. Pat. Nos. 5,041,126; 4,856516; 5,037,392; 5,683,452; 5,578,072; 5,571,171; 5,522,880; 5,360,443; 5,102,417; 4,776,337; 4,739,762; 4,733,665; 55674,278; 5,782,855; 5,780,807; 5,766,710; 5,766,239; 5,766,238; 5,759,192; 5,738,674; 5,735,893; 5,733,330; 5,728,158; 5,725,572; 5,725,549; 5,707,385; 5,700,286; 5,681,346; 5,649,977; 5,649,952; 5,637,113; 5,632,840; 5,629,077; 5,618,299; 5,607,444; 5,605,696; 5,603,721; 5,593,434; 5,591,197; 5,569,295; 5,556,413; 5,546,646; 5;514,154; 5,507,768; 5,498,240; 5,476,505; 5,458,615; 5,458,605; 5,456,667; 5,443,500; 5,443,458; 5,441,515; 5,437,083; 5,423,885; 5,421,955; 5,415,637; 5,409,495; 5,391,172; 5,360,401; 5,344,426; 5,242,399; 5,158,548.
Electrophysiology diagnostic studies and therapeutic ablation procedures are used for diagnosis and treatment of various cardiac arrhythmias. Patents that describe apparatus and methods for performing electrophysiology procedures include U.S. Pat. Nos. 4,699,147; 5,327,889; 4,960,134; 5,140,987; 4,522,212; 4,660,571; 4,664,120; 5,125,896; 5,104,393.
Other catheter based procedures will also benefit from the system and methods of the present invention, particularly in high risk patients. For example: transmyocardial revascularization, U.S. Pat. Nos. 4,658,817; 5,125,924; 5,125,926, patent ductus arteriosus closure, septal defect repair, U.S. Pat. Nos. 3,874,388; 4,874,089, intravascular ultrasonic imaging, U.S. Pat. Nos. 5,000,185; 4,794,931; 5,029,588; 4,024,234; 4,917,097; 5,167,233; 5,368,037; 5,190,046; WO 94/16625, laser angioplasty or ablation, U.S. Pat. Nos. 5,354,294; 5,366,456; 5,163,935; 4,740,047; 5,242,438; 5,147,353; 5,242,437; 5,188,634; 5,026,366; 4,788,975.
The system and methods of the present invention find particular use in performing catheter based medical procedures, such as balloon angioplasty, stent placement, atherectomy, valvuloplasty and other therapeutic procedures, on high risk patients. High risk patients in this context include extremely young or extremely elderly patients and patients whose cardiopulmonary functions are severely compromised.
In addition to the above examples, patients with severe cardiovascular disease or other complicating factors, such as patients requiring balloon angioplasty, stent placement or atherectomy in highly critical portions of the vasculature will particularly benefit from these procedures. Examples of highly critical portions of the vasculature may include: lesions in the ostia of the coronary arteries, the left main coronary artery, diseased saphenous vein grafts and totally occluded coronary arteries or the carotid arteries.
Because of the risks to the patient, the aforementioned catheter procedures are usually performed while a surgical backup team stands by on call with a surgical suite reserved for emergency surgery in the event that the procedure fails or if dangerous complications arise. This gives rise to two specific problems, surgical backup may not always be logistically possible and surgical backup is costly. One example of where surgical backup is not logistically possible, is when the catheter procedure is being performed in an emergency situation.
Surgical backup is also a significant economic burden for the patient, the hospital and the entire medical system. The timing for emergency surgery is very critical, although the surgical backup team only needs to be relied upon in a very small percentage of cases, it is necessary to have the surgical team and the operating room ready immediately. In particular, where a failed procedure results in severe complications, such as cardiac arrest, myocardial infarction or cerebral ischemia or embolization, there is only a narrow window of response time available to perform emergency surgery in order to save the patient.
Therefore, because of the conflicting pressures of economics and of patient safety, it would be e
Macoviak John A.
Samson Wilfred J.
Cardeon Corporation
Mendez Manuel
Rodriguez Cris L.
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