Refrigeration
Reexamination Certificate
1998-12-17
2001-02-27
Kamm, William E. (Department: 3762)
Refrigeration
Reexamination Certificate
active
06193763
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to an apparatus and technique for treatment and fluoroscopic mapping of treated tissue by injection of radiographic contrast agent into the tissue and contemporaneous treatment of the same tissue to provide a radiographic visual map of treated locations. The invention also relates to use of such apparatus and technique to promote revascularization of heart muscle/tissue.
Recent research and investigation suggests that part of the process of healing wounds in human tissue is dependent on blood vessel growth, which is believed to be in turn dependent on release of angiogenesis or blood vessel growth factors by the ischemic (or injured) tissue. It has been suggested at a recent conference on angiogenesis and direct myocardial revascularization that any method, i.e., laser, radio frequency electromagnetic signals, or other technique that results in myocardial tissue ischemia (or injury) may result in release of angiogenesis growth factors and development of blood vessel growth and blood flow to the ischemhc/injured area. (As used herein, the term “ischemic” is intended to refer to reversible tissue damage and the term “injury” is intended to refer to irreversible tissue damage.)
While there are publications of references that disclose dyeing tissue of the heart during direct open heart surgery to mark lased or otherwise treated sites thereof, and although there are prior references disclosing introduction of radiographic contrast agent into various organs such as the chambers of the heart or coronary arteries for the purpose of radiographic imaging of the contractions of the heart, the prior art does not disclose use of needles or other means installed on distal ends of catheters to inject radiographic contrast agents into heart muscle or other tissue. In fact, in prior practice injection of radiographic contrast agent directly into tissue is deliberately avoided. However, angiogenesis factors alone have been injected into heart muscle tissue.
My U.S. Pat. No.4,976,710 entitled “WORKING WELL BALLOON METHOD”, issued Dec. 11, 1990, incorporated herein by reference, discloses a working well balloon catheter and method for visualizing and performing procedures on the inner myocardial wall.
There is an unmet need for an improved apparatus and technique for performing medical procedures on tissue within the body, especially within the heart, and repetitively radiographically marking contemporaneously treated sites so the physician can avoid multiple treatments of the same areas, to avoid complications such as perforation of the heart, to facilitate completion of a procedure to decrease radiation exposure of the patients, and to reduce overall costs by providing a more efficient method of treatment. In contrast, conventional radiography does not provide a way to determine if an internal area already has been subjected to contemporaneous treatment.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the invention to provide an apparatus and technique for repetitively effectively treating and effectively marking treated sites within an internal organ.
It is another object of the invention to provide an apparatus and technique to promote safe, rapid and effective marking and revascularization of internal organs such as the heart.
It is another object of the invention to provide an apparatus and technique to contemporaneously mark and reduce harmful vascularization in tumorous tissue.
It is another object of the invention to provide an apparatus and technique for reducing or avoiding the need to perform bypass surgery.
It is another object of the invention to provide an apparatus and method for reducing or avoiding the need to perform an angioplasty procedure.
Briefly described, and in accordance with one embodiment thereof, the invention provides an apparatus for contemporaneously treating a sequence of treatment sites in an internal organ and creating a viewable map of the treated sites, including a first catheter having a proximal end and a distal end for insertion through a body passage to tissue needing treatment. A needle assembly is attached to the distal end of the first catheter to permit injection of fluid into treatments sites of the tissue. A fluid injection assembly is connected to the proximal end of the first catheter and containing a predetermined fluid mixture of radiographic contrast agent and treatment substance for injection into the various treatment sites. A fluoroscopic visualization apparatus is aimed at the treatment sites, including a display screen for displaying the extent of radiographic contrast agent around each treatment site after injection. Radiographic markings appear on the display screen for a predetermined amount of time after each injection showing which treatment sites have been treated. In one embodiment a guide wire is introduced to extend through the body passage to effectuate introducing an outer or sheath catheter through which the first catheter then is passed to the desired treatment site. In one embodiment, a working well balloon is affixed to the distal end of a sheath catheter to abut a wall of the tissue. A second catheter having a distal end with a treatment element, such as a needle, laser lens, biopsy forceps, etc. attached to its distal end and a control apparatus attached to its proximal end can be used for controlling treatment of the tissue contemporaneously with injection of radiographic contrast agent into the tissue.
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Cahill Sutton & Thomas P.L.C.
Kamm William E.
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