Sampling in blood collection

• US 6,626,884 B1
• Filed: 04/09/2001
• Issued: 09/30/2003
• Est. Priority Date: 10/26/1998
• Status: Expired due to Fees

• Current Assignee: Noble House Hotels & Resorts Limited
• Original Assignee: Noble House Hotels & Resorts Limited
• Inventors: Mobbs, William Leonard, Dillon, Jagmohanbir Singh
• Primary Examiner(s): Basichas, Alfred
• Application Number:
  US09/807,068
• Time in Patent Office: 904 Days
• Field of Search: 604/409, 604/7, 604/323, 604/248, 604/249, 600/573
• US Class Current: 604/409
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150366 Blood collection bags, e.g. connected to the patient by a catheter comprising means for removing a small sample of collected blood from the bag collection bags as such A61J1/05, A61M1/0209
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61M 1/02 Blood transfusion apparatus blood infusion by syringes A61M5/14
• CPC Class Codes: A61M 1/0236 with sampling means, e.g. sample bag or sampling port
• CPC Class Codes: A61M 39/223 Multiway valves
• CPC Class Codes: A61M 39/286 Wedge clamps, e.g. roller clamps with inclined guides

Abstract

Methods and apparatus are disclosed whereby the initial flow of blood during blood collection is diverted to a sample pouch to trap the skin plug and to allow samples to be taken during subsequent blood collection to a normal blood bag. This is effected by connecting the needle line (106), the sample line (118) to the sample pouch (116) and the bag line (114) to the blood bag to a multi-port valve (110) that includes an actuator (120). During the procedure, the valve (110) may be attached to the arm (100) of the donor by means of a wrist-strap (112).

Claims

1. A blood collection method wherein blood is drawn from a donor via a needle line and is conveyed to a collection bag via a bag line, the method comprising the steps of:

moving an actuator in valve means connected between the needle line and the bag line to open a first connection causing initial blood flow to be directed from the needle line to a sample line while preventing access by blood in the needle line to the bag line, the sample line comprising or being connected to sample collection means,

moving said actuator to close said first connection stopping said initial blood flow while continuing to prevent access to blood to the bag line, after a blood sample has been collected in said sample collection means, and

moving said actuator to open a second connection between the needle line and the bag line to allow blood flow to the bag line while continuing to keep said first connection closed so as to prevent access by blood in the sample line to the needle line and to the bag line.

2. A method according to claim 1 including the further step of moving said actuator to close said second connection while continuing to keep said first connection closed, thereby preventing access by blood between the needle line, the bag line and the sample line, after blood has been collected in the collection bag.

3. A method according to claim 1 wherein said sample collection means comprises a sample pouch connected to the sample line, the method including the steps of:

allowing said initial blood flow through the sample line to continue until sufficient blood for at least one blood sample has been collected in said sample pouch for use in subsequent analysis, and

drawing off said blood sample while said second connection is open, blood is flowing from the needle line to the bag line and the first connection between the needle line and the sample line is closed.

4. A method according to claim 1 including the step of securing the valve means to the arm of the donor at the outset of the blood collection procedure and removing said valve means from the arm of the donor at the end of the procedure.

5. Apparatus suitable for use in taking a blood sample during a blood collection procedure in which blood is collected from a donor via a needle line and delivered to a collection bag via a bag line, the apparatus comprising:

sample collection means,

a sample line comprising said sample collection means or connected thereto,

valve means having an inlet connected to the needle line for receiving blood from the donor, a first outlet connected to said sample line for conveying blood from the inlet to said sample collection means during sample collection, and a second outlet connected to the bag line for conveying blood from said inlet to the collection bag during blood collection, and

valve actuator means having a first position for directing initial blood flow from the inlet to the first outlet to effect sample collection while preventing blood flow through said second outlet to the collection bag, and having a second position for directing initial blood flow from the inlet to the second outlet to effect blood collection while preventing blood flow through the first outlet.

6. Apparatus according to claim 5 wherein said valve actuator means can be positioned intermediate between said first and second positions, to prevent blood flow through both the first and the second outlet.

7. Apparatus according to claim 6 wherein:

said valve actuator means can be in a third position to prevent blood flow through both the first and the second outlets,

said first, intermediate, second and third positions are reached sequentially by moving said actuator means in one direction, and

said valve means includes non-return means adapted to prevent said actuator means from moving said actuator through said positions in reverse sequence from a higher number position to a lower number position.

8. Apparatus according to claim 5 wherein:

the valve means includes a body having a cylindrical chamber incorporating said inlet and said first and said second outlet, the inlet and outlets being in fluid connection with said chamber,

the actuator means includes a cylindrical rotor located within said chamber for rotation therein, the rotor having a cylindrical periphery,

said rotor includes a first and second channel each extending through the rotor and each having ends that open into said periphery, there being no connection between said first and second channels within the rotor, and

the arrangement of said channels is such that, when the actuator means is in said first position, the rotor is arranged in the chamber so that the first channel connects the inlet with the first outlet and, when the actuator means is said second position, the rotor is arranged within the chamber so as that the second channel connects the inlet to the second outlet.

9. Apparatus according to claim 8 wherein:

said rotor has an end face, a sampling port on said end face and a third channel connected to said port and opening into said periphery,

the arrangement of said third channel is such that, when the actuator is in the second position, the third channel connects the first outlet with the sampling port so that blood contained in the sample line is accessible via the sampling port while blood is flowing from the inlet through the second channel to the second outlet, when the apparatus is in use.

10. Apparatus according to claim 5 wherein:

the valve means includes body having a longitudinally extending cylindrical bore therein

said second outlet and said inlet extend laterally into said body so as to connect with said bore,

the actuator means comprises a cylindrical member fitted within the bore for longitudinal and rotary movement relative to the body, said member comprising the aforesaid actuator and having a cylindrical side face and an end face,

said member has a first channel therein that extends axially and opens into said end face to form said first outlet, said first channel also opening into said side face of the member,

said member has a second channel formed therein that extends laterally across the member but is not in fluid connection with said first channel, and

the arrangement of the first and second channels is such that, when the actuator is in said first position, the inlet is connected by the first channel to the first outlet and, when the actuator is in the second position, the inlet is connected by the second channel to the second outlet.

11. Apparatus according to claim 10 wherein:

movement of the actuator from the first to the second position is effected by both axial and rotational movement of the member to align the second channel with the inlet and the second outlet, and

a sample port is provided in the body so that, when the actuator is in the second position, said port is connected by the first channel with the first outlet so that blood in the sample line can be conveyed to the sample port for sampling while blood collection is taking place via the second outlet and the bag line.

12. Apparatus according to claim 5, wherein:

said sample and bag lines are connected directly to the needle line at a junction of said lines,

said valve means includes a body through which part of the sample line and a part of the bag line pass through and exit from said valve means, said needle line at or near said junction forming the inlet of the valve means,

said part of the sample line is formed from resilient tubing that can be collapsed to effect closure of said sample line, and said part of the sample line includes a portion that exits from the body thus forming said first outlet of said valve means,

said part of the bag line is formed from resilient tubing that can be collapsed to effect closure of said bag line, and said part of the bag line includes a portion that exits the body thus forming said second outlet of the valve means,

said actuator means can be in said first position to collapse the tubing of the bag line but not the tubing of the sample line so that blood can flow from the needle line to said sample line, and

said actuator means can be in said second position to collapse the tubing of the sample line but not the tubing of the bag line so that blood can flow from the needle line to the bag line.

13. Apparatus according to claim 12 wherein said valve actuator means can be positioned intermediate between said first and said second positions to collapse both said part of the sample line and said part of the bag line to prevent blood flow through the sample line and blood flow through the bag line.

14. Apparatus according to claim 13 wherein:

said valve actuator means can be in a third position, to prevent blood flow through both the first and second outlets,

said first, intermediate, second and third positions are reached sequentially by moving said actuator means in one direction, and

said valve means includes non-return means that can prevent the actuator means from moving the actuator through said positions in reverse sequence from a higher number position to a lower number position.

15. Apparatus according to claims 14 wherein:

said part of the sample line and said part of the bag line are arranged in substantially parallel spaced relation within said valve means, and

the actuator means comprises rollers arranged to move linearly within said valve means with said rollers rolling on said part of said sample line and on said part of said bag line to selectively collapse said lines to effect operation of said valve means.

16. Apparatus according to claim 12 wherein:

said part of the sample line and said part of the bag line are arranged in spaced coplanar relation on opposite sides of a circle formed on a platten or base in said valve means, the circle having a center, and

the actuator comprising a carriage mounted for rotation about said center and in a plane substantially parallel to said coplanar parts of said sample and bag lines, and

said actuator having rollers to selectively bear upon said parts of said sample and bag lines to. effect the operation of said valve means by rotation of the carriage and by selective compression of said parts of said sample and bag lines.

17. A multi-position valve for blood collection, comprising:

a body having an inlet, a first outlet and a second outlet, and

actuator means moveable in sequence to (i) a first position wherein said first outlet is connected to said inlet but said second outlet is not connected to said inlet, (ii) an intermediate position wherein neither said first nor said second outlet is connected to said inlet, (iii) a second position wherein said second outlet is connected to said inlet but said first outlet is not connected to said inlet, and (iv) a third position wherein neither said first nor said second outlet is connected to the inlet.

18. A multi-position valve according to claim 17 having non-return means that can be positioned between said actuator means and said body to constrain said actuator means to move only in the aforesaid sequence and not in a reverse sequence.

19. A multi-position valve according to claim 17 having stop means that can be positioned between said actuator and said body to prevent said actuator means from moving beyond said third position.

20. A multi-position valve according to claim 17 having a sample port through which samples of blood may be drawn through said first outlet from said sample collection means, when said actuator is in said second position and said valve is in use.

21. A multi-position valve according to claim 17 further comprising an attachment means whereby said valve can be releasably attached to said arm of a donor during a blood collection procedure.