Method for avoiding mistakes during plasmapheresis

• US 4,678,458 A
• Filed: 06/09/1986
• Issued: 07/07/1987
• Est. Priority Date: 06/09/1986
• Status: Expired due to Fees

• Current Assignee: Terry M. Fredeking
• Original Assignee: Terry M. Fredeking
• Inventors: Fredeking, Terry M.
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US06/872,030
• Time in Patent Office: 393 Days
• Field of Search: 128/771, 604/6, 604/110, 604/111, 604/189, 604/408-410, 604/404
• US Class Current: 604/6.04
• CPC Class Codes: A61J 1/1437 Locking means requiring key or combination to open the container
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 2205/60 with identification means

Abstract

An apparatus and method are shown for eliminating mistakes during plasmapheresis procedures in returning red blood cells to a correct donor. In the procedure, a portion of the return blood flow line is rendered inoperative by a lock device. A key, unique to the donor, is attached to the blood collection bag prior to the centrifuging operation which separates the blood into plasma and red blood cells. After the centrifuge operation, flow between the collection bag and the donor can only be established by utilizing the unique key in the correct lock box.

Claims

1. A method for avoiding mistakes in returning red blood cells to the correct donor during plasmapheresis, the method comprising the steps of:

collecting a quantity of the donor'"'"'s whole blood in a whole blood collection container, the whole blood collection container being provided with a collecting port, a plasma removal port and a reinfusion port, and wherein the reinfusion port is sealed with a seal means bearing identifying indicia, the identifying indicia being unique to the donor;

separating the whole blood in the blood collection container into plasma and red cells;

removing the plasma from the blood collection container through the plasma removal port and sealing the plasma removal port;

removing the seal means from the reinfusion port after verifying the identifying indicia with the correct donor;

reinfusing the donor with the red cells; and

wherein the identifying indica comprise a key and lock.

2. The method of claim 1, wherein the key is attached to the reinfusion port as a part of the seal means.

3. The method of claim 2, wherein the key is encapsulated in a protective coating, and wherein the key and protective coating are provided with a transverse opening, the key being attached to the reinfusion port by means of a tie strap which passes through the transverse opening.

4. A method for avoiding mistakes in returning red blood cells to the correct donor during plasmapheresis, the method comprising the steps of:

collecting a quantity of the donor'"'"'s whole blood in a whole blood collection container, the whole blood collection container being provided with a collecting port, a plasma removal port and a reinfusion port, and wherein the reinfusion port is sealed with a seal means including a key which is unique to the donor;

installing flow control means at some point in the return flow line used to return red blood cells to the donor, the flow control means including a lock adapted to receive the unique key;

separating the whole blood in the blood collection container into plasma and red cells;

removing the plasma from the blood collection container through the plasma removal port and sealing the plasma removal port;

removing the seal means from the reinfusion port and connecting the return flow line to the reinfusion port;

unlocking the flow control means with the key; and

reinfusing the donor with the red cells.

5. The method of claim 4, wherein the flow control means includes a roller clamp in the return flow line, the roller clamp being received within lock box which is opened and closed by means of the unique key.

6. The method of claim 4, wherein the flow control means is a spiked end portion of the return flow line which is received within a lock box, the lock box being opened and closed by means of the unique key.

7. The method of claim 4, wherein the flow control means is a constricted region in the return flow line which is received within a lock box, the lock box being opened and closed by means of the unique key.

8. A method for avoiding mistakes in returning red blood cells to the correct donor during plasmapheresis, the method comprising the steps of:

collecting a quantity of the donor'"'"'s whole blood in a whole blood collection container, the whole blood collection container being provided with a collecting port, a plasma removal port and a reinfusion port, and wherein the reinfusion port is sealed with a seal means including a key which is unique to the donor;

installing flow control means at some point in the return flow line used to return red blood cells to the donor, the flow control means including a roller clamp in the return flow line which is initially positioned to restrict flow through the return flow line, the roller clamp being received within a lock box mounted on an I.V. pole in the vicinity of the donor, and the lock box being provided with a swing arm movable by means of the unique key between a locked position in which the roller clamp is secured within the lock box and an unlocked position;

separating the whole blood in the blood collection container into plasma and red cells;

removing the plasma from the blood collection container through the plasma removal port and sealing the plasma removal port;

removing the seal means from the reinfusion port and connecting the return flow line to the reinfusion port;

unlocking the lock box with the key;

changing the position of the roller clamp to allow flow through the return flow line; and

reinfusing the donor with the red cells.

9. A method for avoiding mistakes in returning red blood cells to the correct donor during plasmapheresis, the method comprising the steps of:

collecting a quantity of the donor'"'"'s whole blood in a whole blood collection container, the whole blood being comprised of plasma and red blood cells;

associating a key with the collection container, the key being unique to the donor;

installing flow control means at some point in the return flow line used to return red blood cells to the donor, the flow control means including a lock adapted to receive the unique key;

separating the whole blood in the blood collection container into plasma and red cells;

removing the plasma from the blood collection container and connecting the return flow line to the container;

unlocking the flow control means with the key; and

reinfusing the donor with the red blood cells.

10. The method of claim 9, wherein the key is attached to the whole blood collection container prior to separating the whole blood into plasma and red blood cells.

11. The method of claim 10, wherein the blood collection container is provided with a reinfusion port and wherein the key is attached to the collecting container by a strap which also seals the reinfusion port.

12. An apparatus used to avoid mistakes in returning red blood cells to the correct donor during plasmapheresis, comprising:

a stand for supporting a blood collection container containing red blood cells to be returned to the donor;

a return blood flow line for connecting the blood collection container to the donor;

flow restricting means located at some point in the return blood flow line for temporarily interrupting the flow of fluid through the return blood flow line; and

a lock box installed on the stand, the lock box having an opening for receiving the flow restricting means and having a key operated lock movable by means of a unique key between a locked position denying access to the flow restricting means and an unlocked position.

13. The apparatus of claim 12, wherein the flow restricting means is a roller clamp.