SEPARABLE INTEGRAL DONOR CONNECTOR WITH MANUAL CLAMPING MEANS

Abstract: Separable integral donor connector (15) with an improved clamping mechanism for use with flexible blood collection tubing (16). The device is positioned in line with the blood tubing (16) between a phlebotomy needle and the collection bag (10). Separation of the device is accomplished by manipulation and breaking of a thin frangible ring area (26) and drawing the sections (18 and 24) of the device apart. This separation exposes an internally-mounted needle (36) that may be used for penetration of sample collection tube closures and subsequent collection of blood samples. The present embodiment of this invention includes improved manually-operated clamping means that are flexibly biased away from the blood tubing. Clamping jaws (28 and 30) of differing lengths are disclosed which, when engaged, overlap and cause an area of tubing to be collapsed into a distinctive, S-shaped configuration which crimps and more effectively seals the tubing against blood flow. The clamping device is free from restraints permitting simple, one-handed operation, as well as the broadest control over the blood flow.

Description: SEPARABLE INTEGRAL DONOR CONNECTOR WITH MANUAL CLAMPING MEANS FIELD OF THE INVENTION AND DESCRIPTION OF THE PRIOR ART The basic concept of one form of a separable integral donor connector has been previously described in U.S. Patent 3,127-892 to Kuehn, issued January 3, 1979 and assigned to the same assignee as the subject applica¬ tion. Separable integral donor (SID) connectors are used during blood collection to separate the donor tube from the blood collection bag and collect samples of the donor's blood without the necessity of removing the phlebotomy " needle from the arm of the donor. After filling the blood collection bag, the separable integral donor connector is separated, exposing a hollow needle which is then inserted through the closure of a sample tube, permitting the col¬ lection of one or more samples of blood through the same donor tubing. The present invention provides an improved ver¬ sion of a separable integral donor connector which has integral with it means for manually clamping the tubing so that the flow of the blood through the separable integral donor connector and into the sample tubes can be regulated and/or cut off when it is undesirable. SUMMARY OF THE INVENTION This application relates to a separable integral donor connector for use in collection tubing in a blood collection system, including a flexible plastic blood bag. The connector includes means for separating the device such that a hollow needle is exposed for the insertion of blood into sample collectors by puncturing of the closure of said sample collector tubes with the needle. In accordance with this invention, the connector includes flexible blood tubing internally mounted within the device and positioned to permit flow through an inter- nally-mounted needle. Also included in the device is a thin-walled frangible area which may be easily broken by manual manipulation, separating the tubing which leads to the blood bag from the donor tubing and exposing the needle for use. Overlapping crimping jaws of differing lengths are provided. When engaged, the jaws do not oppose each other; rather, protruding arms on the ends of the jaws overlap and collapse the blood flow tubing twisting it and forcing it into an S-shaped configuration. This con¬ figuration results in the- sealing of a broader area of flow tubing than would be accomplished if the crimping jaws met directly opposite each other, and a more effective regulation of blood flow. The jaws are made of flexible, ' resilient material and are free from clamps or restraints. The jaws are biase away from the flow tubing so that when the jaws are manuall released by the operator they disengage from the tubing and allow blood to flow through the flexible tubing. This feature permits the operator to have increased control and regulation over the blood flow during operation. The device is also manufactured from flexible material to facilitate its breaking apart and separation, to expose the needle more smoothly, and to prevent the introduction- of small pieces of plastic from the frangible area which are occasioned by the use of harder or more hrit/fcle plastics. DESCRIPTION OF THE DRAWINGS FIGURE 1 is a plan view of a double blood. bag collection system with blood donor tubing incorporating a preferred embodiment of the invention of this application. FIGURE 2 is a perspective view of the embodiment of the invention separate from the tubing. FIGURE 3 is a side view of the embodiment of the invention. FIGURE * is a cross-sectional view of the embodi- ment of the invention showing the internally-mounted needle FIGURE 5 is a longitudinal view of the embodi¬ ment of the invention with the blood donor tubing incor¬ porated. FIGURE 6 is a view similar to FIGURE 5 , but show- ing the embodiment of the invention with the crimping jaws activated, sealing the donor tubing. FIGURE 7 is a longitudinal view of the embodi¬ ment of the invention showing the device separated. DESCRIPTION OF THE PREFERRED EMBODIMENT In FIGURE 1 a multiple ' blood bag system is shown comprising flexible plastic blood bags 10, 12, connected by standard flexible blood transfer tubing 1*4. These are stand¬ ard commercially available blood collection products such as those manufactured by the Fenwal Division of Baxter Travenol Laboratories, Deerfield, Illinois. Donor tubing 16 connects blood collection bag 10 to a donor phlebotomy needle (not shown) and contains a separable integral donor connector 15 in line with the tubing 16. As more specifically shown in FIGURES 2 through 5j the separable integral donor connector 15 contains two separable sections 18 and 2*4 connected by a thin, frangible flexible annular ring 26 which is manually manipulated and broken at the time of use. Second section 2*4 contains a set of crimping jaws 28, 30 one of which, 28, is longer than the other 30. The jaws 28, 30 are further defined by per¬ pendicular protruding arms 32, 33- When engaged by manually compressing jaws 28, 30, arms 32, 33 overlap and collapse a section of. tubing iβ. As shown in FIGURE 6, by this collapsing, tubing 16 is twisted and crimped into an S-shaped configuration. This configuration more effectively blocks or controls the flow of blood through tubing 16 and hollow needle 36 by sealing a wider area of tubing 16 than would occur if the arms 32, 33 of jaws 28, 30 engaged directly opposite to each other. - J ~ \E. ~ Blood tubing 16 is integral with the separable integral donor connector 15 and internally secured at in¬ let port 20. The inlet port 20 is further defined by an internal bevelled area 3 which leads from tubing 16 to the inlet 38 of needle 36, providing a smooth and efficient blood flow path, and alleviating eddy currents in the blood flow at the juncture of the tubing 16 and the needle inlet 38. The prevention of eddy currents is important to avoid hemolysis caused by such currents at the juncture of the needle inlet 38 and the tubing 16. Gripper ridges 40 are provided external to the crimping jaws 32, 33 to facilitate the grip of the operator on the separable integral donor connector 15 during manual operation. Ribs *41 are also provided on integral member 18 to facilitate the oppositely directed twisting of sections 18 and 2*4 and the breaking of frangible ring 26. A protective sheath *42 surrounds and protects the tip *4*4 and bottom section of needle 36. The protective sheath *42 is constructed from material such that when the separable integral donor connector 15 is autoclaved for sterilization, the sheath *42 shrinks around and becomes integral with needle 36. This shrinking provides a unified blood flow path through the separable integral donor con¬ nector 15 and an uninterrupted sterile connection from dono to blood collection bag 10. The sheath 42 is internal of plastic member 18 and is integral with plug 46 which abuts and seals the lower end of member 18 and communicates mem¬ ber lδ with flexible tubing 16. In operation, a unit of whole blood is collected from the donor in blood collection bag 10. After collectio the tubing 16 betv/een the separable integral donor connecto 15 and blood bag 10 is heat-sealed, clipped, or sealed in some other conventional manner, to prevent blood loss from the blood collection bag 10 and preserve sterility, and the blood unit is removed for storage or processing. ^u E Clamping jaws 28, 30 are manually compressed together in such a manner that extension arms 32 and 33 collapsibly crimp a section of flexible tubing 16, forcing tubing 16 into an S-shaped configuration, and 5 cutting off the flow of blood. As illustrated in FIGURE 7, the two sections 18, 24 of the separable integral donor connector 15 are then manually manipulated such that frangible ring 26 is broken and needle 3 is drawn back from member 18 and ex- 10 posed. Needle 3 " may then be inserted in sample collection tubes (not shown) by puncturing a latex or rubber closure on such tubes. To permit blood to flow for sample collection, clamping jaws 28, 30 are manually released allowing them 15 to flexibly bias away from the blood tubing 16. The blood ϊ. ' tubing 16 uncrimps, straightening from its S-shape, and blood flows through tubing 16 into a sample collection tube at a desired rate and until a desired quantity of blood is collected. Said clamping jaws 28, 30 are then re-engaged 0 to cut off the blood flow and the needle 36 is withdrawn from the sample collection tube. Jaws 28, 30 are free of any restraints or clamps of their own and can be used to regulate the rate of flow of blood through the tubing in addition to simply permitting 5 or not permitting its flow. Reliability is promoted by the lack of restraint as well as ease of operation and control. The needle 3 may be reinserted in other sample collection tubes, the jaws 28, 30 released, and another sample taken. After taking the desired number of samples, 0 the tubing 16 is again crimped and the donor phlebotomy needle (not shown) is withdrawn from the arm of the donor. The separable integral donor connector 15 and the remaining tubing 16 may then be conveniently disposed of. The above has been offered for illustrative pur- 5 poses only and is not intended to limit the scope of the invention of this application, which is as defined in the claims below. ?. P N £

Claims: CLAIMS 1. In a blood handling apparatus, a flexible blood tube communicating with a blood collection means, a separating means joined to said flexible tubing to per- mit convenient separation by manual manipulation, said separating means including an inlet member and an outlet member, a thin, frangible area intermediate said inlet member and said outlet member at which separation of said separating means can occur, a hollow needle internal of said separating means and -in line with said flexible tubing For the insertion of blood samples into sample collectors after the separation of said separating means, the improve¬ ment comprising: manual crimping means extending from said separating means and positioned proximate to said flexible tubing, said crimping means comprising jaws of different lengths positioned opposite each other such that, when compressed against said tubing, the jaw ends overlap side by side, crimping said flexible tubing and prohibiting or regulating blood flow, said crimping means being free of restraining means, permitting said crimping means to flex away from said tubing when manually released. 2. A blood handling apparatus as claimed in Clai 1 wherein said separating means is composed of flexible material, such as vinyl plastic, to facilitate removal of said needle and prevent the chipping or scouring of said outlet member by said needle. 3. A blood handling apparatus as claimed in Claim 2 in which the portion of said hollo needle internal of said outlet member is surrounded by a protective sheath, said protective sheath being integral with a connective plug sealing said outlet member and connecting said separating means to said flexible tubing. 4. A blood handling apparatus as claimed in Claim 3 wherein gripping ridges are external to said crimping means to facilitate manual operation of said crimping means. 5. A blood handling apparatus as claimed in Claim 4 in which ribs are provided external to said outlet member to facilitate twisting and separation of said separating means. 6. In a blood handling apparatus, a flexible blood tube communicating with a blood collection bag, a means for separating said flexible tubing comprising an inlet port, a body member joined to said inlet port, an outlet port joined to said body member by a thin-walled, frangible element, said frangible element permitting the separation of said separating means by twisting of said separating means and breaking said frangible element, a pointed cannula internal of said separating means, com¬ municating with said inlet port, passing through said body member and said frangible element and exiting in said out- let port, said cannula being exposed by the separation of said separating means for the deposit- of blood in blood collection containers, the improvement comprising: flexibly biased sealing means including flexible members extending from said body member for manually collapsing said flexible tubing into an S-shaped configuration and preventing or regulating blood flow through said tubing, said sealing means being free of restraint and free to bias away from said flexible tubing at the release of said sealing means. 7- A blood handling apparatus as claimed in Claim 6 wherein said separating means is composed of flexible material, such as vinyl plastic to facilitate removal of said cannula and prevent the chipping or scouring of said outlet port by said cannula. 8. A blood handling apparatus as claimed in Claim 7 in which the portion of said pointed cannula in¬ ternal of said outlet port is surrounded by a protective sheath, said protective sheath being integral with a con- nective plug sealing said outlet port and connecting said separating means to said flexible tubing. 9. A blood handling apparatus as claimed in Claim 8 wherein gripping ridges are external to said seal¬ ing means to facilitate manual operation of said sealing means. 10. A blood handling apparatus as claimed in Claim 9 in which ribs are provided external to said out¬ let port to facilitate twisting and separation of said separating means. 11. In a blood handling apparatus, flexible tubing connective of a blood bag and a blood donor, a means for separating said tubing, integral with said tubing to permit the collection of blood samples subsequent to donor collection, said separating means including two body halves, each of said halves integrally connected to said flexible tubing, a frangible section between said body halves, which can be broken by manual manipulation to effect the separation of said separating means, an inser¬ tion means internally located within said separating means, and in line with said tubing, said insertion means being exposed upon separation to permit the insertion of said insertion means in a collection container for the col¬ lection of blood samples, the improvement comprising: flexible crimping means projecting from the upper body half, said crimping means including flexible L-shaped jaws of differing lengths positioned to be biased away from said flexible tubing, said crimping means when man¬ ually engaged against said flexible tubing collapse said tubing into an S-shaped configuration, preventing or reg¬ ulating the flow of blood through said tubing, said crimping means being free of clamps or other restraints to permit said crimping means to bias back away from said tubing when released. 12. A blood handling apparatus as claimed in Claim 11 wherein said separating means is composed of flexible material, such as vinyl plastic, to facilitate removal of said cannula and prevent the chipping or scour¬ ing of said outlet port by said insertion means. 13- A blood handling apparatus as claimed in Claim 12 in which the portion of said insertion means in¬ ternal of said lower body half is surrounded by a pro¬ tective sheath, said protective sheath being integral with a connective plug sealing said lower body half and connect- ing said separating means to said flexible tubing. 14. A blood handling apparatus as claimed in Claim 13 in which said insertion means include a pointed cannula. - ?*tA~ 15. A blood handling apparatus as claimed in Claim 14 wherein gripping ridges are external to said crimping means to facilitate manual operation of said crimping means. 16. A blood handling apparatus as claimed in Claim 15 in which ribs are provided external to said lower body half to facilitate twisting and separation of said separating means.

Inventors: WILLIAMS R
Applicants: BAXTER TRAVENOL LAB, BAXTER TRAVENOL LAB INC
Application year: 1981
Main classification: A61M5
IPC codes: A61M1, A61M39