Abstract:
An apparatus that allows a patient to blood let safely and automatically and which allows for the safe disposal of the withdrawn blood. The apparatus utilizes an intubator that couples to a blood vessel, a blood collector which contains a micro-biological inactivating agent and a blood conveyor which is coupled between the intubator and the blood collector for passing blood from the intubator to the blood collector.

Description:
FIELD OF THE INVENTION 
     The invention pertains to methods and apparatus for reducing blood viscosity of living beings, and more particularly, to methods and apparatus for the automatic and safe removal of blood from a living being. 
     BACKGROUND OF INVENTION 
     The concept of removal of blood from a living being, also known as blood letting, has been known for centuries. 
     However, the particular physiological benefits of removing blood from a living being, and thereby allowing new blood to be created, has not been appreciated in the medical community. For example, a healthy menstruating female removes “old blood” from her body on a monthly basis that is replenished with “fresh blood.” A male, on the other hand, does not experience such a cycle and his circulatory system re-circulates “old blood.” 
     Therefore, there remains a need to provide an individual with the ability to safely and automatically blood let while providing a safe and non-biohazardous way of disposing of the removed blood. 
     SUMMARY OF THE INVENTION 
     An apparatus for permitting automatic, self-blood letting of a living being of a predetermined amount of blood (e.g., approximately 1 pint) and which renders the removed blood non-biohazardous (e.g., using an internal micro-biological inactivating agent) for safe disposal. 
     A method of permitting automatic, self-blood letting of a living being of a predetermined amount of blood while rendering the removed blood non-biohazardous for safe disposal. The method comprises: (a) providing a blood collector that normally has an expanded state and which contains a micro-biological inactivating agent (e.g.,bromine, chlorine, Methylene blue (MB) and its derivatives azure A, B, C and thionine); (b) evacuating the blood collector of atmospheric pressure to form a compressed state of the blood collector; (c) coupling a releasable biasing member to the blood collector to maintain the blood collector in the compressed state until a desired time; (d) coupling the blood vessel of the living being to the blood collector; (e) activating the releasable biasing member to cause the blood collector to rapidly expand to draw the predetermined amount of blood into the blood collector; (f) de-coupling the blood collector from the blood vessel; and (g) discarding the blood collector. 
    
    
     DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a diagrammatic view of the blood letting system of the present invention coupled to a blood vessel of a human being at one end and including a blood collecting portion at another end before blood letting has begun; 
     FIG. 1A is an enlarged view of the portion indicated in FIG. 1; 
     FIG. 2 is a cross-sectional view of a blood collector of the blood letting system of the present invention during blood letting showing the automatic removal of the blood from the human being to the blood collecting portion; 
     FIG. 2A is an enlarged view of the portion indicated in FIG. 2; and 
     FIG. 3 is a cross-sectional view of the blood letting system of the present invention that is ready for safe disposal. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring now in detail to the various figures of the drawing wherein like reference characters refer to like parts, there is shown at  20  a non-biohazard blood letting system,  20  hereinafter “the system  20 .” The system  20  is a self-contained system that allows a patient, or a technician to assist a patient, to blood let safely and automatically. The system  20  basically comprises an intubation portion  22 , a blood conveyor  24  and a blood collector  26 . 
     The intubation portion  22  basically comprises a safety needle  34  having a safety cap  36  (FIG.  3 ). The safety needle  34  is coupled in fluid communication with the blood conveyor  24  via a housing  38 . The housing  38  is affixed to an attachment strap  40  that aids in holding the safety needle  34  in place once inserted into a blood vessel. The strap may include a hook/pile  42  (e.g., the fastener sold under the mark VELCRO®) configuration for permitting the strap  40  to be releasably secured to the limb of the living being. The housing  38  may also comprise, although not required, a manually-operable clamp  44  that the patient can use to control the flow of blood, as will be discussed later. 
     The blood conveyor  24  (e.g., a catheter, a pliable tube or any equivalent structure that can convey a fluid therein and that is pliable so that it can be stowed inside a bag or other similar structure ) is coupled at a first end  46  (FIG. 1A) to the safety needle  34  and to a one-way valve  48  adjacent its other end  50  (FIG.  2 ). 
     The blood collector  26  comprises two compartments: a blood collecting portion  30  and a resealable storage portion  28 . These two compartments are isolated from each other via an inner wall  52  having an aperture  53  in which is disposed the one-way valve  48 . The blood collecting portion  30  is formed by a durable material (e.g., plastic) having a memory that tends to maintain the blood collecting portion  30  in an expanded state (FIG.  2 ). An example of such a material is used in nose cleaners for infants, or other pliable bulbs used in medicine for creating a suction force (e.g., pipette pump, Cole-Parmer EW-24805-10 Pipette Filler). 
     On the exterior of the blood collecting portion  30  are a pair of molded pockets  54 A and  54 B on opposite sides of the blood collecting portion  30 . These molded pockets  54 A/ 54 B form sleeves into which the free ends  56 A and  56 B of an expandor, e.g., a leaf spring  58 , are captured. In particular, the leaf spring  58  may comprise a bent piece of spring steel having a memory or bias (which tends to move the free ends  56 A/ 56 B away from each other) and which is placed into a closed state (FIG. 1) at the factory whereby the free ends  56 A and  56 B are relatively close to each other. To hold this leaf spring  58  in the closed state, a frangible link  60  is also formed at the joined side  62  of the leaf spring  58 , at the factory. With the leaf spring  58  in the closed state, the free ends  56 A/ 56 B are positioned in their respective sleeves  54 A/ 54 B, resulting in the joined side  62  of the leaf spring  58  being exposed, or otherwise protruding away from the blood collecting portion  30 . As will be discussed in detail later, when an abrupt force is applied to the joined side  62 , the frangible link  60  breaks, thereby allowing the leak spring  58  to immediately open so that the free ends  56 A and  56 B move away from each other rapidly, thereby causing the respective pockets  54 A and  54 B to also move away from each other, resulting in the rapid expansion of the blood collecting portion  30 . 
     In addition, the interior of the blood collecting portion  30  comprises a micro-biological inactivating agent(s) (MBIA) which kill any micro-organisms, viruses, bacteria or the like to render any blood collected therein (as will be discussed in detail later) non-biohazardous; such agents may include bromine, chlorine, Methylene blue (MB) and its derivatives azure A, B, C and thionine. The inclusion of this agent, and/or other such agents, in the blood collecting portion  30  can be accomplished in several ways such as coating the interior surface of the blood collecting portion  30  with a coating of the MBIA; or, the material forming the blood collecting portion  30  may itself be formed of an MBIA; or, a tablet of bromine, or chlorine, etc., may be pre-disposed in the blood collecting portion  30  at the factory. In any case, the presence of the MBIA in the blood collecting portion  30  renders the collected blood non-biohazardous, thereby permitting the blood collector  26  to be discarded in a normal fashion. 
     The resealable storage portion  28  comprises the same material as the blood collecting portion  30 . The safety needle  34  (along with the cap  36 ), the blood conveyor  24 , the housing  38 , the attachment strap  40  (also referred to as the “contents”) are originally stored in this portion  28  at the factory and then the opening  32  is releasably sealed using, for example, a tongue  32 A and groove  32 B (also known as “pressure interlocking releasable rib and groove element closure”). When the patient or technician is ready to use the system  20 , the releasable seal is opened, e.g., the tongue  32 A is removed from the groove  32 B and the contents are pulled out. When the blood letting is completed, the original contents are stored back into the resealable storage portion  28  and the releasable seal is closed, e.g., the tongue  32 A is friction fitted into the groove  32 B. The resealable storage portion  28  also contains a MBIA(s) therein so that once the blood letting is complete, should any blood still in the blood conveyor  24 , or even in the needle  34  or in the housing  38  leak out, such leaking blood is also rendered non-biohazardous. Like the blood collecting portion  30 , there are many ways to include the MBIA in the releasable storage portion  28 . Once the blood letting is completed, the entire “used” system  20  can be disposed of in a conventional manner. 
     At the factory, the MBIA is disposed inside both the blood collecting portion  30  and the releasable storage portion  28  or, as discussed earlier, or is otherwise present inside both of these portions  28 / 30 . Next, a vacuum is applied to the aperture  53  to cause the blood collecting portion  30  to deflate and assume a substantially flat state, as shown in FIG.  1 . Then, the one way valve  48  is positioned in the aperture  53 , thereby maintaining the vacuum within the blood collecting portion  30 . Next, while in. the closed state, the free ends  56 A/ 56 B of the leaf spring  58  are positioned in their respective pockets  54 A/ 54 B, as shown in FIG.  1 . Finally, the contents (e.g., the safety needle  34  (along with the cap  36 ), the blood conveyor  24 , the housing  38 , the attachment strap  40 ) are placed inside the resealable storage portion  28  and the opening  32  is closed using the releasable seal (e.g., the tongue  32 A/groove  32 B). Thus, except for any packaging, the system  20  is ready for shipment to end users. 
     Upon receipt of the system  20 , the patient or technician opens the releasable seal and removes the contents through the opening  32 . The blood collector  26  may be placed on the ground, or some other lower level with respect to the patient, to have gravity assist in the withdrawal of blood; however, it should be understood that this placement is not required. The patient or technician (hereinafter, “the patient”) then operates the intubation portion  22  as follows: If the intubation portion  22  includes the manually-operable clamp  44 , the clamp  44  is placed in the closed position (FIG.  1 A). The cap  36  is removed and the safety needle  34  is coupled to a blood vessel of the patient, e.g., a vein in the arm  10  of the patient. Once intubation is completed, the patient then wraps the attachment strap  40  properly around the arm  10  to secure the needle  34  in place. 
     The patient then activates the system  20  by applying an abrupt force to the joined side  62  of the leaf spring  58 ; e.g., the patient can step strongly on the joined side  62  using his/her foot  12 . This action fractures the frangible link  60  of the leaf spring  58 , which causes the free ends  56 A/ 56 B of the leaf spring  58  to move away from each other suddenly. This movement causes the blood collecting portion  30  to expand suddenly, (FIG.  2 ), thereby creating a suction force to automatically draw a predetermined amount of blood  64  (e.g., approximately 550 cc or a pint) from the patient into the blood collecting portion  30 . Before the actual drawing begins, the patient needs to open the clamp  44  (FIG. 2A, if the clamp  44  is present) at which time the blood in the blood vessel is exposed to the suction force from expanding blood collecting portion  30  which draws out the blood. 
     The one-way valve  48  permits only the flow of blood from the blood conveyor  24  into the blood collecting portion  30 . There is no flow permitted from the blood collecting portion  30  into the blood conveyor  24 , thereby preventing any possibility of air or other gas making its way toward the blood vessel. Furthermore, the protruding or exposed joined side  62  of the leaf spring  58  permits the abrupt force to be applied to the expandor (e.g., leaf spring  58 ) only, rather than to the blood collecting portion  30  which could rupture if the abrupt force were applied thereto. 
     It should be further noted, where the manually-operable clamp  44  is not present in the system  20 , the activation of the system  20  would begin as soon as the abrupt force is applied to the joined side  62  of the leaf spring  58 . 
     Given the characteristics of the expandor  58  and the material of the blood receiving portion  30 , the system  20  generates the appropriate suction force for automatically drawing out the predetermined amount of blood (e.g., approximately 550 cc or a pint). Once the suction force is diminished and the predetermined amount of blood  64  is collected, the patient closes the clamp  44  (FIG. 1) and then disengages the intubation portion  22  by loosening the attachment strap  40 , removing the needle  34  and restoring the cap  36  onto the needle which renders the needle  34  unusable. Next, the intubation portion  22  and the blood conveyor  24  are placed into the resealable storage portion  28  and the opening  32  is closed using the releasable seal, as shown in FIG.  3 . The entire system  20  is now ready for safe disposal since all of the blood present in the blood collector  26  is rendered non-biohazardous due to the presence of the MBIA inside the blood collecting portion  30  and in the resealable storage portion  28 . 
     Without further elaboration, the foregoing will so fully illustrate my invention that others may, by applying current or future knowledge, readily adopt the same for use under various conditions of service.