Surgery – Blood drawn and replaced or treated and returned to body – Constituent removed from blood and remainder returned to body
Reexamination Certificate
1999-04-08
2002-11-05
Sykes, Angela D. (Department: 3762)
Surgery
Blood drawn and replaced or treated and returned to body
Constituent removed from blood and remainder returned to body
C494S043000, C494S037000, C604S004010, C604S006110, C604S006010, C422S044000, C210S782000
Reexamination Certificate
active
06475175
ABSTRACT:
TECHNICAL FIELD
The present invention relates to blood separation devices and methods in general and more particularly to blood separation devices and methods suitable for autotransfusion.
BACKGROUND ART
Surgical operations, including more complex operations where a substantial amount of bleeding may occur, may require transfusions during the course of the surgery to maintain a sufficient blood volume and blood pressure. Since many blood-borne diseases may exist including hepatitis, cancer and HIV, it is desirable to not require transfusion from another person. Also, if blood or blood components from the same person can be used, the necessity to match blood factors can be eliminated.
These disadvantages of receiving transfusions from donors are overcome by self-donation prior to operations. However, operations involving transfusions are not always identified in advance and few patients take the time and effort to go through the procedure. Additionally, a patient may be weakened by removal of blood prior to an operation.
Autotransfusion, whereby blood retrieved from the patient during the operation is separated so that reusable portions can be reinserted into the patient, is an effective method of overcoming the problems with transfusions. Various autotransfusion type systems currently exist but are somewhat complex to operate. For example, some autotransfusion systems require the operator to memorize a series of system steps to insure that the operator performs operations in the proper sequential order. Failure to perform the step or to perform the step in the proper sequence may cause the system to shut down or may cause morbidity in the patient.
Additionally, it is highly useful to have a blood separation system that can efficiently separate platelet and plasma from waste products in the blood. A high degree of efficiency in obtaining platelets has not been previously achieved.
It is therefore desirable to have a blood separation system that is highly efficient in extracting platelets from the blood, extracting waste products from the blood, allowing performance of operations in a simple and easy manner that does not require extensive knowledge of the system and processes, and preventing inadvertent or accidental operation of the blood separation device.
DISCLOSURE OF THE INVENTION
The present invention provides a blood separation system suitable for autotransfusion that displays instructions to guide the operator of the autotranfusion system to perform predetermined operation at predetermined times. In this manner, the operator of the system can be assured that the proper sequence of operations is being performed without a great degree of experience and knowledge of the system.
The present invention additionally requires confirmation of each operational step that is entered in the blood separation system by the operator to prevent the system from inadvertently being activated or performing an unintended operation that would necessitate the system being shut down or cause harm to the patient.
The present invention also is capable of separating blood platelets in a highly efficient manner from the blood sample by spinning the blood sample at a hard rate of approximately 5,600 rpm until the solid cells are separated from the blood sample, and then slowing the spin rate to a soft rate of about 2,400 rpm to allow the platelets to elute from the solid cells. The spin rate of 2,400 rpm is maintained for a period of approximately 60 seconds which allows the platelets to elute in a highly efficient manner.
REFERENCES:
patent: 4241866 (1980-12-01), Giesbert et al.
patent: 4708712 (1987-11-01), Mulzet
patent: 5281342 (1994-01-01), Biesel
patent: 5370802 (1994-12-01), Brown
patent: 5505685 (1996-04-01), Antwiler
patent: 5951877 (1999-09-01), Langley et al.
Blood Conservation Update; Electromedics, Inc./ University of Colorado Health Sciences Center Certificate Program; Spring-Summer 92; vol. 6:No. 2; pp. 16-19.
Cheek Daniel
Kaminski Roger P.
Le Son
Matt Richard
Rivera John
Bianco Patricia
Lewis, Jr. Ancel W.
Sykes Angela D.
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