Surgery – Miscellaneous – Methods
Reexamination Certificate
1998-01-29
2001-05-15
Willse, David H. (Department: 3738)
Surgery
Miscellaneous
Methods
C514S170000
Reexamination Certificate
active
06230713
ABSTRACT:
BACKGROUND OF THE INVENTION
A thrombotic event occurs when a clot forms and lodges within a blood vessel. The clot may fully or partially block the blood vessel causing a thrombotic disorder such as a heart attack or stroke. Forms of a heart attack include angina and myocardial infarction. Often, a thrombolytic agent is used to dissolve the clot. Reperfusion occurs when the clot is dissolved and blood flow is restored.
Two phases of thrombotic events may exist, an ischemic stage and a necrotic stage. A patient may suffer from ischemia in which a decrease of blood flow may occur. This decrease in blood flow causes a decrease in tissue oxygenation. After prolonged ischemia, the tissue may undergo necrosis which is death of the tissue. Necrosis occurs in a time dependent fashion and can be prevented by the restoration of blood flow. Therefore, the ability to determine whether thrombolytic therapy will cause reperfusion prior to its administration is important. Accordingly, a need exists to predict whether a thrombolytic agent will induce reperfusion prior to its administration. Similarly, administering adequate therapy and reperfusing the patient in a timely fashion is important. Consequently, a need exists to determine the whether reperfusion has occurred within a reasonable time after a physician has administered therapy.
SUMMARY OF THE INVENTION
The present invention relates to methods, apparatuses and kits for determining and/or monitoring a treatment plan for patients suffering from a thrombotic event. This treatment plan allows a physician to determine the likelihood that a thrombolytic agent will induce reperfusion prior to its administration and, if administered, whether reperfusion has actually occurred. This method involves assessing the level of a sensitive marker for platelet activation and/or reperfusion called P-selectin.
Two forms of P-selectin exist. One form is soluble P-selectin and the other is membrane bound P-selectin. The claimed invention allows a physician to determine whether reperfusion has occurred by measuring the level of soluble P-selectin. Reperfusion can occur after thrombolytic therapy, coronary intervention, or by some other mechanism which induces reperfusion including spontaneous reperfusion. A spike, or an increase and subsequent decrease, of soluble P-selectin is indicative of successful reperfusion.
Similarly, a physician can determine whether thrombolytic therapy will induce reperfusion by assessing the level of membrane bound P-selectin. An increase in membrane bound P-selectin as compared with a standard indicates that a patient is less likely to reperfuse.
Accordingly, the claimed invention pertains to measuring both soluble and membrane bound P-selectin to allow the physician to determine a treatment plan for a patient suffering from a thrombotic event. Additionally, the claimed invention allows for determination of a clinical outcome or course based the levels of P-selectin assessed.
The claimed invention offers several advantages. The claimed invention allows a physician to monitor the patient and the efficacy of treatment. For example, the invention allows a physician to more efficiently and quickly determine a course of treatment to prevent necrosis or tissue death. Furthermore, the invention enables a physician to predict whether thrombolytic therapy will work and induce reperfusion. This information makes treatment more efficient because the physician can choose more effective methods of treatment and administer them in a timely manner.
REFERENCES:
patent: 5489581 (1996-02-01), Daynes et al.
patent: 5583126 (1996-12-01), Daynes et al.
patent: 5837689 (1998-11-01), Anderson et al.
Dalesandro Margaret R.
Gurbel Paul A.
Serebruany Victor L.
Hamilton Brook Smith & Reynolds P.C.
O'Hara Kelly
Willse David H.
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