Surgery – Miscellaneous – Methods
Reexamination Certificate
2002-06-18
2004-07-20
Peffley, Michael (Department: 3739)
Surgery
Miscellaneous
Methods
C606S041000
Reexamination Certificate
active
06763836
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to the field of electrosurgery and, more particularly, to surgical devices and methods that employ high frequency electrical energy to increase the flow of blood to a target tissue.
Coronary artery disease, the build up of atherosclerotic plaque on the inner walls of the coronary arteries, causes the narrowing or complete closure of these arteries resulting in insufficient blood flow to the heart. A number of approaches have been developed for treating coronary artery disease. In less severe cases, it is often sufficient to treat the symptoms with pharmaceuticals and lifestyle modification to lessen the underlying causes of the disease. In more severe cases a coronary artery blockage can often be treated using endovascular techniques, such as balloon angioplasty, laser recanalization, placement of stents, and the like.
In cases where pharmaceutical treatment and endovascular approaches have failed or are likely to fail, it is often necessary to perform a coronary artery bypass graft (CABG) procedure using open or thoracoscopic surgical methods. For example, many patients still require bypass surgery due to such conditions as the presence of extremely diffuse stenotic lesions, the presence of total occlusions and the presence of stenotic lesions in extremely tortuous vessels. However, some patients are too sick to successfully undergo bypass surgery. For other patients, previous endovascular and/or bypass surgery attempts have failed to provide adequate revascularization of the heart muscle.
Laser myocardial revascularization (LMR) is a recent procedure developed with the recognition that myocardial circulation occurs through arterioluminal channels and myocardial sinusoids in the heart wall, as well as through the coronary arteries. In LMR procedures, artificial channels are formed in the myocardium with laser energy to provide blood flow to ischemic heart muscles by utilizing the heart's ability to perfuse itself from these artificial channels through the arterioluminal channels and myocardial sinusoids. In one such procedure, a CO2 laser is utilized to vaporize tissue and produce channels in the heart wall from the epicardium through the endocardium to promote direct communication between blood within the ventricular cavity and that of existing myocardial vasculature. The laser energy is typically transmitted from the laser to the epicardium by an articulated arm device. Recently, a percutaneous method of LMR has been developed in which an elongated flexible laser apparatus is attached to a catheter and guided endoluminally into the patient's heart. The inner wall of the heart is irradiated with laser energy to form a channel from the endocardium into the myocardium for a desired distance.
While recent techniques in LMR have been promising, they also suffer from a number of drawbacks inherent with laser technology. One such drawback is that the laser energy must be sufficiently concentrated to form channels through the heart tissue, which reduces the diameter of the channels formed by LMR. In addition, free beam lasers generally must completely form each artificial lumen or revascularizing channel during the still or quiescent period of the heart beat. Otherwise, the laser beam will damage surrounding portions of the heart as the heart beats and thus moves relative to the laser beam. Consequently, the surgeon must typically form the channel in less than about 0.08 seconds, which requires a relatively large amount of energy. This further reduces the size of the channels that may be formed with a given amount of laser energy. Applicant has found that the diameter or minimum lateral dimension of these artificial channels may have an effect on their ability to remain open. Thus, the relatively small diameter channels formed by existing LMR procedures (typically on the order of about 1 mm or less) may begin to close after a brief period of time, which reduces the blood flow to the heart tissue.
Another drawback with current LMR techniques is that it is difficult to precisely control the location and depth of the channels formed by lasers. For example, the speed in which the revascularizing channels are formed often makes it difficult to determine when a given channel has pierced the opposite side of the heart wall. In addition, the distance to which the laser beam extends into the heart tissue is difficult to control, which can lead to laser irradiation with heating or vaporization of blood or heart tissue within the ventricular cavity. For example, when using the LMR technique in a pericardial approach (i.e., from the outside surface of the heart to the inside surface), the laser beam may not only pierce through the entire wall of the heart but may also irradiate blood within the heart cavity. As a result, one or more blood thromboses or clots may be formed which can lead to vascular blockages elsewhere in the circulatory system. Alternatively, when using the LMR technique in an endocardial approach (i.e., from the inside surface of the heart toward the outside surface), the laser beam may not only pierce the entire wall of the heart but may also irradiate and damage tissue surrounding the outer boundary of the heart.
The promotion of blood flow to tissue, e.g., via canalization, vascularization or revascularization, is desirable in areas of the body other than the heart. The degenerative changes in the musculoskeletal system can be attributed to aging, trauma, overuse, and diminished focal blood supply. Degenerative changes of the musculoskeletal system are ubiquitous, particularly in the shoulder, knee, elbow, or the like. Conditions such as rotator cuff tendinitis, patellar tendinitis, tennis elbow, and plantar fasciitis are extremely common, and yet have no well-defined minimally invasive treatment protocol. Typically, the treatment consists of physical therapy, non-steroidal anti-inflammatories, and occasionally surgery. Recently in Europe, surgeons have begun using lithotrypsy, receiving only equivocal results.
One example of an area of the body that would benefit from vascularization is the meniscus tissue. The meniscus tissue, a C-shaped piece of fibrocartilage located at the peripheral aspect of the joint, typically has very little blood supply (particularly the inner portions of the meniscus). For that reason, when damaged, the meniscus is unable to undergo the normal healing process that occurs in most other tissues of the body. In addition, with age, the meniscus begins to deteriorate, often developing degenerative tears. Typically, when the meniscus is damaged, the torn pieces begins to move in an abnormal fashion inside the joint. Because the space between the bones of the joint is very small, as the abnormally mobile piece of meniscal tissue (meniscal fragment) moves, it may become caught between the bones of the joint (femur and tibia). When this happens, the knee becomes painful, swollen and difficult to move.
Another example of an area of the body that would benefit from vascularization is the tendons. When a tendon is damaged, the tendon usually forms tiny tears which allow collagen to leak from the injured areas. The collagen leakage causes inflammation of the tendon that can cut off the flow of blood and pinch the surrounding nerves. Because tendons are inherently poorly vascularized, and receive less oxygen, nutrients, and blood flow, as compared with other tissues and organs, tendons tend to heal much more slowly than other tissues of the body. Accordingly, there is a need for apparatus and methods to canalize, vascularize, revascularize, and/or increase blood flow to tendons that have been torn or otherwise damaged, so as to stimulate, expedite, or facilitate the healing process.
SUMMARY OF THE INVENTION
The present invention provides systems, apparatus and methods for selectively applying electrical energy to structures within or on the surface of a patient's body. The systems, apparatus, and methods of the present invention are particularly useful for treating acute and
Baker Michael A.
Eggers Philip E.
Pacek James L.
Tasto James P.
Thapliyal Hira V.
Arthrocare Corporation
Batt Richard R.
Peffley Michael
Raffle John T.
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