Automatic whole blood collection system

• US 6,113,554 A
• Filed: 10/16/1998
• Issued: 09/05/2000
• Est. Priority Date: 10/16/1998
• Status: Expired due to Term

• Current Assignee: Haemonetics Corporation
• Original Assignee: Haemonetics Corporation
• Inventors: Chammas, Jacques, Gilcher, Ronald O., Stacey, Gary R., Medberry, Joseph M.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US09/174,495
• Time in Patent Office: 690 Days
• Field of Search: 600/562, 604/27, 604/3, 604/30, 604/4, 604/43, 604/65-67, 604/93, 604/122, 604/151
• US Class Current: 600/573
• CPC Class Codes: A61M 1/0272 Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/303 having a reservoir for treated blood to be returned
• CPC Class Codes: A61M 1/308 Volume control, e.g. with open or flexible containers, by counting the number of pump revolutions, weighing
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 60/279 Peristaltic pumps, e.g. roller pumps
• CPC Class Codes: F04B 43/1292 Pumps specially adapted for several tubular flexible members

Abstract

A whole blood collection system includes an automated pump/control unit and an accompanying disposable blood set. When combined and connected to a source of anticoagulant, these elements allow automatic priming of the blood set with anticoagulant and automatic collection of anticoagulated blood product according to three different collection modes. The unit'"'"'s pump and the blood set are specially designed to cooperate during the collection process to assure that the collected product has a precise blood to anticoagulant ratio. During the collection procedure, the pump/control unit automatically collects data relating to the procedure. Additional data specifically identifying components of the blood set, such as the blood collection bag, along with identification data on the donor'"'"'s registration form may be scanned into the pump/controller unit by a scanner associated with the unit; this facilitates positive sample identification and tracking. At the end of the procedure, a printer in the pump/controller unit automatically prints out this information so that a detailed record is immediately available about the collected blood product, the procedure for collecting it and the source of the product, i.e., the donor.

Claims

1. Blood collection apparatus comprising

a pump unit, said unit including

a first pump head;

a second pump head;

a gear reducer rotatably coupling the first and second pump heads so that when one of said pump heads is rotated, both pump heads rotate with a selected speed ratio;

motive means for rotating one of the pump heads, and

means for releasably joining first and second tubes of a blood collection set in pumping relation with said first and second pump heads, respectively, so that when the tubes are joined with the pump heads and said motive means rotate said first pump head, fluid will flow through the first and second tubes at a volumetric ratio substantially equal to said speed ratio.

2. The apparatus defined in claim 1 wherein each pump head comprises a peristaltic pump which includes a plurality of rollers.

3. The apparatus defined in claim 2 wherein the joining means comprise a platen movable between a closed position wherein the platen is close to and opposite said pump heads and an open position wherein the platen is situated away from and exposes said pump heads.

4. The apparatus defined in claim 2 wherein the speed ratio is in excess of 5:

1.

5. The apparatus defined in claim 2 wherein the gear reducer includes means for rotating the second pump head in a direction opposite to that of the first pump head.

6. The apparatus defined in claim 5 wherein said first and second pump heads are collinear.

7. The apparatus defined in claim 1 and further comprising a disposable blood collection set, said set including

a phlebotomy needle;

a first flexible tube in fluid communication with said needle and having a segment thereof joined by said joining means with said first pump head, and

a second flexible tube in fluid communication with said needle and having a segment thereof joined by said joining means with said second pump head.

8. The apparatus defined in claim 7 wherein the blood collection set also includes a tubing tray supporting said segments of said first and second tubes in spaced parallel relation opposite said first and second pump heads, respectively.

9. The apparatus defined in claim 8 wherein said tray is a card-like member having a relatively large opening which is bridged by said first and second tube segments.

10. The apparatus defined in claim 9 wherein

said tray includes a window which is bridged by said second tube, and

said pump unit includes a fluid flow detection means for detecting the presence or absence of fluid flowing through the second tube and producing a corresponding signal.

11. The apparatus defined in claim 10 wherein said unit further includes control means responsive to said signal for disabling said motive means when the detection means detects the absence of fluid for a selected number of revolutions of one of said pump heads.

12. Blood collection apparatus comprising

a housing having a top wall with an opening therein;

first and second roller pump heads rotatably mounted in said housing, said pump heads being exposed in said opening;

a speed reducer coupling the first pump head to the second pump head so that when one of the pump heads is rotated, the two heads rotate with a selected speed ratio;

a platen movably mounted to said top wall adjacent to the opening therein, said platen being movable between a closed position wherein the platen is spaced opposite the pump heads and closes said opening and an open position wherein the platen is swung away from said opening thereby exposing said pump heads;

means for releasably maintaining the platen in its said closed position;

motive means in the housing for rotating one of the pump heads, and

a programmable controller in the housing for controlling the motive means so that said one pump head is rotated at a selected speed within a selected speed range.

13. The apparatus defined in claim 12 wherein the first and second pump heads rotate in opposite directions.

14. The apparatus defined in claim 12 and further including a one-way clutch coupled to one of the pump heads so that said one pump head can only rotate in one direction.

15. The apparatus defined in claim 12 and further including a pressure transducer having a pressure inlet and positioned in the housing, said transducer producing an output indication to said controller indicative of the pressure at said inlet, said controller being programmed to control said motive means so that the speed of said first pump head varies within said range according to the pressure at said inlet.

16. The apparatus defined in claim 12 and further including means in said housing for sensing that the platen is in said closed position and providing an electrical indication to said controller in response thereto, said controller being programmed to disable said motive means in the absence of said indication.

17. The apparatus defined in claim 12 and further including fluid detection means mounted in said housing near said opening therein, said detection means producing an indication to said controller when it fails to detect fluid, said controller being programmed to disable said motive mean s when said fluid detector fails to detect fluid after a selected number of revolutions of said second pump head.

18. The apparatus defined in claim 17

where in the detection means comprises a first sonic emitter/detector, and

further including a second sonic emitter/detector positioned in said platen which, when said platen is in its said closed position, is located directly opposite said first emitter detector.

19. The apparatus defined in claim 12 and further including a weigher associated with said housing and for supporting a blood collection bag, said weigher providing an output indication to said controller indicative of the bag weight, said controller being programmed to convert the weight indication to a bag contents volume indication and to turn off the motor when said volume indication reaches a target volume.

20. The apparatus defined in claim 19 and further including means for inputting data to said controller for changing said target volume.

21. The apparatus defined in claim 12 and further comprising a disposable blood collection set, said set including

a blood collection bag;

a first tube leading to said bag;

a second tube having one end in fluid communication with the first tube and having a second end adapted to be connected to a source of anticoagulant;

a tubing tray, said tray having an opening therethrough;

means for securing said first and second tubes to the tray so that segments of said tubes are maintained in spaced relation opposite said opening, said tray being positioned on the top wall of said housing when said platen is in its open position so that said tray opening is located opposite the wall opening and so that when the platen is moved to its closed position, the tube segments are captured between the platen and the first and second pump heads.

22. The apparatus defined in claim 21 and further including

fluid detection means mounted in the housing top wall adjacent to the opening therein, and

a window in said tray opposite said detection means which exposes a portion of the second tube to said detection means.

23. The apparatus defined in claim 21 and further including a coded label affixed to said blood collection bag for being correlated with a coded sticker affixed to a donor registration form for tracking purposes.

24. The apparatus defined in claim 23 and further including

a database associated with the controller for storing data including identifiers, and

means for acquiring a donor identifier corresponding to a particular blood donor and adding it to the database, and means for scanning said set identifier and inputting the scanned data into the database whereby said blood collection set can be correlated with that particular blood donor.

25. The apparatus defined in claim 24 and further including a printer in the housing for printing out data stored in said database.

26. The apparatus defined in claim 12 and further including a one-way clutch coupled to each of said pump heads so that each of said pump heads can only rotate in a selected direction.