APPARATUS FOR TAKING BLOOD SAMPLES

Abstract: The blood drawing device (10) includes a holding element (14) for securing a blood collecting assembly (A), and a clamping mechanism (20) for clamping a blood sampling tube (C). A sliding mechanism (56) is provided for sliding the blood sampling tube (C) into engagement with the blood collecting assembly (A).

Description: Title of the Invention APPARATUS FOR TAKING BLOOD SAMPLES Background of the Invention The present invention is directed to the field of obtaining blood samples from a living patient and more particularly to apparatus suitable for use with conventional blood receptacle assemblies and double-ended needles. Various devices and methods have been developed for withdrawing blood from a patient. One commercial blood receptacle assembly used for drawing blood is a "NACUTAINER." Fig. 1 shows one such blood receptacle assembly A, along with a first embodiment of the present invention to be described below. Assembly A includes two parts: blood collecting assembly B and blood sampling tube C. Tube C is a standard blood sampling tube, and has a rubber stopper D in the opening E of tube C. Blood collecting assembly B includes a first housing F including a hollow needle G. Housing F is attached by flexible tubing H to a second housing I having a second needle J. First needle G punctures the skin and underlying vein of the patient (not shown). Rubber stopper D is inserted into housing I so that second needle J extends through stopper D into the tube B. (As shown in Fig. 1, tube C is in a retracted position relative to housing I in which needle J does not penetrate stopper D). One such device for withdrawing blood is known as a "NACUTAINER," and is available from Becton-Dickenson, although others are also available. In use, blood travels from the patient to the tube C via needle G, flexible tubing H, and needle J. Often, more than one sample of blood is required, each sample being placed in a separate blood sampling tube C which may contain one of a variety of preparations to facilitate a particular analytical procedure. Such preparations may include, for example, preservatives, anti¬ coagulants, and the like. Using conventional blood sampling devices, a venipuncturist must stabilize the first needle puncturing the vein while simultaneously manipulating the blood sampling tube or tubes into the housing and into engagement with the second needle. Often the process of engaging blood sampling tube C with hollow needle F causes first needle G, in contact with the patient's vein, to dislodge or puncture the other side of the patient's vein. In addition to increasing the painfulness of the procedure and possibly contributing to hematoma formation, dislodging the needle or puncturing the other side of the vein may necessitate re-sticking the patient. To ensure sterility, resticking the patient requires the use of a new blood receptacle assembly, therefore increasing the initial cost the blood drawing procedure. Additionally, many patients who undergo multiple blood drawings have poor veins, increasing the difficulty of finding a suitable vein to use for blood sampling. There is therefore a need for an improved blood sampling device which will permit blood samples to be taken with a conventional blood receptacle assembly, such as a "NACUTAINER," while providing increased stability, ease of use, safety and convenience for the blood drawing procedure. Further, there is a need for automating the blood taking procedure to permit multiple blood samples to be taken from a patient with increased stability, safety and convenience. Summary and Objects of the Invention It is an object of the present invention to provide a simple, effective, and efficient apparatus for taking a blood sample or multiple blood samples from a patient. In accordance with the present invention, a blood drawing device is provided for use with a blood receptacle assembly including a first part and second part, blood from a patient passing through the first part into the second part for collection therein, the device including a base, a mechanism secured to a base for securing the first part of the blood receptacle assembly, a mechanism for grasping the second part of the blood receptacle assembly, and a mechanism for moving the second part into engagement with the first part for collection of blood within the second part. Fig. 1 illustrates one embodiment of a blood drawing device 10 according to the present invention, along with conventional blood receptacle assembly A, as described below. The mechanism for securing the first part of the blood receptacle assembly is preferably a holding element, the holding element being u-shaped and having two oppositely situated pieces. The mechanism for grasping the second part of the blood receptacle assembly preferably includes a clamping mechanism having two clamping elements, at least one of the clamping elements being configured for movement in a clamping direction to clamp the second part there between. Preferably, the mechanism for moving the second part into engagement with the first part includes a connecting arm attached to a slide mechanism, which connecting arm is moved by means of a lever attached to the connecting arm. In accordance with another aspect of the invention, a blood drawing device is provided for use with a blood receptacle assembly including a first part and a second part, blood from a patient passing through the first part into the second part for collection therein, the device including a base having a surface, a holding element extending from the surface for securing the first part, a first grasping member extending from the surface, and a second grasping member and extending from the surface adjacent to the first grasping member. At least one of the first and second grasping members is movable in a grasping direction for grasping the second part of the blood drawing assembly between the first and second grasping members, both of the first and second grasping members being simultaneously movable toward the holding element to place the second part into engagement with the first part for collection of blood within the second part. In accordance with yet another aspect of the invention, a blood drawing device is provided for use with a blood receptacle assembly including a first part and a second part, blood from a patient passing through the first part into the second part for collection therein, the blood drawing device including a base, a carriage assembly moveably attached to the base and defining an opening for receiving the second part, a holding element fixed to the base and having an extending portion configured to receive the first part and secure the first part in a fixed location relative to the base, a mechanism for moving the carriage assembly relative to the base, and a mechanism for reciprocating the second part between a first and a second position relative to the carriage assembly within the opening, movement of the second part from the first position to the second position causing the second part to engage the first part to thereby permit collection of blood within the second part. Preferably, the carriage assembly is a carousel, and the carousel rotates relative to the base. The blood drawing device is preferably for use with a blood receptacle assembly including one first part and a plurality of second parts, the carriage defining a plurality of openings, each opening for receiving a given one of the second parts. Optionally, a sensor for detecting a blood fill level within the second part may be provided, along with a valve operative responsive to the sensor detecting the blood fill level to preclude flow of blood to the first part. Also, responsive to the sensor detecting the blood fill level, the mechanism for reciprocating retracts the second part into the opening. Further, responsive to the sensor detecting the blood fill level, a moving mechanism moves the carriage assembly relative to the base. Preferably, the reciprocating mechanism includes a plurality of roller elements driven by a servo motor, and the roller elements include a first set of roller guides and a second set of roller guides spaced from the first set. Additional objects and advantages of the invention will be set forth in part in the following description, or may be learned from practice of the invention. Brief Description of the Drawings Fig. 1 is a perspective view of one embodiment of a blood sampling device according to the present invention. Fig. 2a is a top, cut-away view of the blood sampling device in Fig. 1. Fig. 2b is a partial cut-away view as in Fig. 2a showing the positioning of the device as the second part of the blood receptacle assembly engages the first part of the blood receptacle assembly. Fig. 2c is a partial cut-away view as in Fig. 2a showing positioning of the device as the second part of the blood receptacle assembly is disengaged from the first part of the blood receptacle assembly. Fig. 3 is a partial cross-sectional view of the device of Fig. 1 taken along line 3 - 3 in Fig. 2a, showing a mechanism for grasping the second part of the blood receptacle assembly. Fig. 4 is a partial cross-sectional view as in Fig. 3, showing the mechanism for grasping in a receiving position for receiving the second part of the blood receptacle assembly. Fig. 5 is a partial cross-sectional view of the device of Fig. 1 taken along line 5 - 5 in Fig. 2a, showing the mechanism for moving the second part of the blood receptacle assembly into engagement with the first part of the blood receptacle assembly. Fig. 6 is a partial cross-sectional view of the device of Fig. 1 taken along line 6 - 6 in Fig. 2a. Fig. 7 is a schematic cross-sectional side view of a second embodiment of a blood sampling device according to the present invention. Fig. 8 is an enlarged view of the rollers shown in Fig. 7. Fig. 9 is a top view of the embodiment of Fig. 7. Description of the Preferred Embodiments Reference will now be made in detail to the presently preferred embodiments of the invention, one or more examples of which are illustrated in the drawings. Each example is provided by way of explanation of the invention, and not meant as a limitation of the invention. For example, features illustrated or described as part of one embodiment can be used on another embodiment to yield yet another embodiment. It is intended that the present invention include such modifications and variations. Fig. 1 illustrates one embodiment of a blood drawing device 10 according to the present invention, along with conventional blood receptacle assembly A, as described above. Device 10 includes a base 12 and, a means for securing a first part of the blood receptacle assembly A, namely blood collecting assembly B, to base 12. Base 12 may consist of metal, wood, plastic or any other suitable material and may further comprise a weighted base for increased stability. As broadly embodied in Fig. 1, the means for securing includes a holding element such as u-shaped holder 14. The holding element may have various shapes in accordance with the invention, and such shapes are to a large part dependent on the design of the blood collecting assembly B. As shown, second housing I slides into slots 14a in the holder 14, thereby allowing for placement into and removal from holder 14. As shown in Fig. 1, u-shaped holder 14 may include two unitary, oppositely situated u-shaped pieces, first holder piece 14b and second holder piece 14c, such that housing I of the blood collection assembly B is secured between holder piece 14b and holder piece 14c. In accordance with the invention, device 10 further includes means for grasping the second part of the blood receptacle assembly A, namely tube C. As broadly embodied in Figs. 1, 3, and 4, the means for grasping includes a clamping mechanism 20 including a first clamping element 23 and a second clamping element 25. Preferably, at least one of clamping elements 23 and 25 is moveable in a clamping direction to clamp tube C between clamping elements 23 and 25. More preferably, both of clamping elements 23 and 25 are moveable. Figs. 3 and 4 provide a cross-sectional view of clamping mechanism 20 in which both clamping elements 23 and 25 are pivotable about an axle 48. A compression spring 46 urges both of clamping elements 23 and 25 in the clamping direction, although it should be understood that only one of the clamping elements may be so moveable. Alternately, one or both of clamping elements 23 and 25 could be made flexible enough to permit insertion and removal of tube C, but firm enough to move tube C into engagement with housing I, as will be described below. Fig. 4 shows clamping element 23 and 25 in an open position permitting blood sampling tube C to be inserted or removed as indicated by arrow 16. In the open position, compression spring 46 is compressed as leg 50 of clamping element 23 is moved closer to leg 51 of clamping element 25. Fig. 3 shows clamping elements 23 and 25 in a clamped position in which they are grasping tube C. In such position, compression spring 46 causes tube C to be grasped securely between clamping elements 23 and 25. According to the present invention, blood drawing device 10 further comprises a means for moving tube B of blood receptacle assembly A into engagement with blood collecting assembly C for collection of blood within tube B. Fig. 1 shows device 10 and tube B in position prior to such movement, and Fig. 2a shows device 10 and tube B after such movement. As indicated in Fig. 2a, such movement causes such that second needle H to puncture rubber stopper I of blood sampling tube B. One such means for moving tube B into engagement with assembly C is broadly illustrated in Fig. 2a. As shown, the means for moving includes a means for manipulating, including a connecting arm 34 attached to a slide mechanism 56 slidable along a track 54. Connecting arm 34 pivots on pin 40 between a first position 36 (in Fig. 2a and 2c) and a second position 38 (in Fig. 2a and 2b), as slide mechanism 56 slides along track 54. Preferably, device 10 further includes a means for manipulating the means for grasping and the means for moving. As broadly embodied in Fig. 5, the means for manipulating includes a lever 28 mounted to base 12 via a ball joint 52. Lever 28 is movable between first position 30 and second position 32 to thereby move connecting arm 34 between first position 36 and second position 38. Arm 34 defines an elongated opening 42 for receiving a pin 44 extending from slide mechanism 56. Slide mechanism 56 slides back and forth within base 12 on track 54. A clamp opening mechanism 58 is disposed at one end of track 54, as shown in Fig. 2b. Clamp mechanism 58 includes at least one gate 60 mounted with a torsion spring 62. Clamping members 23 and 25 are mounted by an axle 24 to slide mechanism 56. When slide mechanism is slid from position shown in Fig. 2b to the position shown in Fig. 2c, gate(s) 60 contacts clamping members 23 and/or 25 to thereby open clamping mechanism 20. As shown in Figs. 2b and 2c, two such gates and springs are provided. Spring 62 may be tensioned against a spring base 64 within base 12, as shown. Thus, when lever 28 is in first position 30 and arm 34 is in first position 36, clamping members 23 and 25 are in the position shown in Fig. 4, and a tube may by readily placed into or removed from clamping mechanism 20. As lever 28 is moved toward position 32, arm 34 is moved toward position 38. Accordingly, clamping members 23 and 25 move out of engagement with gates 60, thereby clamping the clamping members around tube B to thereby firmly grasp the tube. As lever 28 is moved further toward position 32, clamping members 23 and 25 slide tube C until stopper D moves into housing F to be pierced by needle G. When lever 28 is moved in the opposite direction, slide mechanism 56 slides along track 54 in the opposite direction with clamping members 23 and 25 grasping tube C until clamping members 23 and 25 encounter gate 60. At that point, clamping members 23 and 25 open to the position shown in Fig. 4 allowing for removal of tube C and replacement if necessary. This operation of device 10 provides a steady and reliable insertion and removal of tube C into blood collecting assembly B that can be done with one hand grasping lever 28 as long as base 12 is mounted in a steady location. Thus, the possibility of having movement of needle G in the patient's vein is much less than with use of blood receptacle assembly A alone. Fig. 7 shows an alternative embodiment of the present invention wherein the blood drawing device may hold more than one blood sampling tube 16 in carriage assembly 80. Further, carriage assembly 80 may move in relation to base 12 to provide a first blood sampling tube 16 for filling, after which carriage assembly 80 is again moved to permit second tube 16 to come into place for filling. In the alternative embodiment illustrated in Figs. 7 and 8, the inventive entity comprises a base 12; carriage assembly 18, movably attached to base 12 and defining at least one opening 81 for receiving at least one blood sampling tube 16; securing element 14, for securing first part 18 of a blood receptacle assembly; a moving means for moving carriage 80 relative to base 12; and a means for reciprocating blood sampling tube 16 between first reciprocating position 90 and second reciprocating position 92, such that when blood sampling tubelό is in first reciprocating position 90, blood sampling tubelό is engaged with first needle 24 via stopper 22 to permit the collection of blood. When blood sampling tubelό is in second reciprocating position 92, blood sampling tubelό disengages second needle 24. As broadly embodied in Fig. 9, carriage assembly 80 preferably is a carousel, and more preferably, carriage assembly 80 rotates relative to base 12. In an alternative embodiment, carriage assembly 80 may be configured in a linear arrangement such that movement of blood sampling tube 16 occurs in a linear fashion. " Fig. 7 illustrates roller assembly 68, compromising a plurality of rollers 69 arranged circumferentially around opening 88. An exploded view of roller assembly 68 is shown in Fig. 8. Roller assemble 68 comprises first gear 70 and second gear 72; slotted opening 74; and spring 62, such that blood sampling tubelό is moved from first reciprocating position 90 to second reciprocating position 92 by means of gear teeth 76. The interaction between first gear 70 and second gear 72 moves blood sampling tubelό from first reciprocating position 90 to second reciprocating position 92 permitting blood sampling tube 16 to engage second needle 24. In yet another embodiment, sensor 82 may be incorporated in the blood sampling device of the present invention, as illustrated in Fig. 7, to detect the blood fill level in blood sampling tubelό and permit blood sampling tubelό to move from first reciprocating position 90 to second reciprocating position 92 to disengage blood sampling tubelό from second first needle 24. This sensor may further comprise a moving means such that carriage assembly 80 is moved relative to base 12 once the blood fill level is detected. As will be obvious to one of skill in the art, the moving means may include a servo motor or other known means by which carriage assembly 80 may be moved relative to base 12. The operation of blood sampling device in Fig. 7 is as follows: Initially, blood sampling tubes 16 are in first reciprocating position 90. Upon activation the roller assembly 68, blood sampling tubelό is moved into second reciprocating position 92 engaging blood sampling tubelό with the first part 18 of blood receptacle assembly 19 such that second needle 24 punctures stopper 22 and permits blood flowing from the patient through flexible tubing 26 and first needle 24 to enter blood sampling tubelό. When the blood fill level is detected, sensor 82 interrupts blood flow from the patient. The interruption may be accomplished by a variety of means well known to those of skill in the art, including clams, stopcocks and the like. Sensor 82 may simultaneously permit blood sampling tubelό to move into first reciprocal position 90 to disengage blood sampling tubelό from second needle 24. Once blood sampling tubelό is moved into first position 90, carriage assembly 80 is advanced to next tube opening 88 by movement means. Second blood sampling tubelό is subsequently moved into first reciprocating position 90 engaging blood sampling tubelό with second needle 24. In this manner, any number of blood sampling tubes may be automatically filled, while permitting the venipuncturist to stabilize the needle in contact with patient's vein. Once the blood sampling is completed, the needle in contact with the patient's vein may be withdrawn and multiple blood sampling tubes removed from the carriage assembly for processing and analysis. Although preferred embodiments of the invention have been described using specific terms, devices, and methods, such description is for illustrative purposes only. The words used are words of description rather than of limitation. It is to be understood the changes in variations may be made by those of ordinary skill in the art without departing from the spirit of the scope of the present invention, which is set forth in the following claims. In addition, it should be understood that aspects of the various embodiments may be interchanged both in whole or in part. Therefore, the spirit and scope of the impended claim should not be limited to the description of the preferred embodiments contained therein.

Claims: We claim: 1. A blood drawing device for use with a blood receptacle assembly including a first part and a second part, blood from a patient passing through the first part into the second part for collection therein, the blood drawing device comprising: a base; a means secured to the base for securing the first part of the blood receptacle assembly; a means secured to the base for grasping the second part of the blood receptacle assembly; and a means secured to the base for moving the second part into engagement with the first part for collection of blood within the second part. 2. The blood drawing device of claim 1, wherein said base further comprises a weighted base. 3. The blood drawing device of claim 1, further including a means for manipulating the means for grasping and for manipulating the means for moving. 4. The blood drawing device of claim 3, wherein the means for manipulating includes a lever actuatable between a first position and a second position, movement of the manipulating means from the first position to the second position causing the means for grasping to clamp the second part of the blood receptacle assembly. 5. The blood drawing device of claim 3, wherein the means for manipulating includes a lever actuatable between a first position and a second position, movement of the manipulating means from the first position to the second position causing the means for moving to move the second part into engagement with the first part. 6. The blood drawing device of claim 3, wherein the means for manipulating includes a switch actuatable between a first position and a second position, movement of the manipulating means from the first position to the second position causing the means for moving to move the second part into engagement with the first part. 7. The blood drawing device of claim 1, wherein the means for grasping includes a clamping mechanism having two clamping elements, at least one of the clamping elements being configured for movement in a clamping direction to clamp the second part between the clamping elements. 8. The blood drawing device of claim 7, wherein the clamping mechanism further includes a compression spring for the urging at least one of the clamping elements in the clamping direction. 9. The blood drawing device of claim 1, wherein the means for securing the first part of the blood receptacle assembly includes a u-shaped holding element. 10. The blood drawing device of claim 9, wherein the u-shaped holding element further comprises two oppositely situated pieces. 11. A blood drawing device for use with a blood receptacle assembly including a first part and a second part, blood from a patient passing through the first part into the second part for collection therein, the blood drawing device comprising: a base; a holding element extending from the base for securing the first part; a first grasping member unitary with and extending from the base; and a second grasping member unitary with and extending from the base adjacent to the first grasping member, at least one of the first and second grasping members being movable in a grasping direction for grasping the second part of the blood drawing assembly between the first and second grasping members, both of the first and second grasping members being simultaneously movable toward the holding element to place the second part into engagement with the first part for collection of blood within the second part. 12. The blood drawing device of claim 11, wherein the means for grasping further includes a clamping mechanism for engaging the second part of the blood receptacle assembly, the clamping mechanism defined by two clamping elements and the clamping mechanism including means for moving at least one of the clamping elements toward and away from the other. 13. The blood drawing device of claim 12, wherein said clamping mechanism further includes a compression spring for urging at least one of the clamping elements away from the other. 14. The blood drawing device of claim 11 , wherein the holding element further comprises a u-shaped holder. 15. The blood drawing device of claim 14, wherein the u-shaped holder further comprises two oppositely situated pieces. 16. A blood drawing device for use with a blood receptacle assembly including a first part and a second part, blood from a patient passing through the first part into the second part for collection therein, the blood drawing device comprising: a base; a carriage assembly moveably attached to said base and defining an opening for receiving the second part; a securing element fixed to said base and having an extending portion configured to receive the first part and secure the first part in a fixed location relative to said base; a moving means for moving said carriage assembly relative to said base; and a means for reciprocating said second part between a first and a second position relative to said carriage assembly within said opening, movement of the second part from the first position to the second position causing the second part to engage the first part to thereby permit collection of blood within the second part. 17. A blood drawing device as in claim 16, wherein said carriage assembly is a carousel. 18. A blood drawing device as in claim 17, wherein said carousel rotates relative to said base. 19. A blood drawing device as in claim 16, wherein said blood drawing device is for use with a blood receptacle assembly including one first part and a plurality of second parts, said carriage defining a plurality of openings, each said opening for receiving a given one of said second parts. 20. A blood drawing device as in claim 16, further comprising a sensor for detecting a blood fill level within said second part. 21. A blood drawing device as in claim 20, comprising a valve operative responsive to said sensor detecting said blood fill level to preclude flow of blood to said first part. 22. A blood drawing device as in claim 21 , wherein responsive to said sensor detecting said blood fill level, said means for reciprocating retracts said second part onto said opening. 23. A blood drawing device as in claim 21, wherein responsive to said sensor detecting said blood fill level, said moving means moves said carriage assembly relative to said base. 24. A blood drawing device as in claim 17, wherein said moving means includes a servo motor. 25. A blood drawing device as in claim 16, wherein said reciprocating means includes a plurality of roller elements driven by a servo motor. 26. A blood drawing device as in claim 25, wherein said roller elements include a first set of roller guides and a second set of roller guides spaced from said first set.

Inventors: KEITH HUNT, RUMPH SCOTT W III, KEITH, HUNT, RUMPH, SCOTT, W., III
Applicants: KEITH & RUMPH INVENTORS INC, KEITH & RUMPH INVENTORS, INC.
Application year: 1999
Main classification: A61B5
IPC codes: A61B5