A DEVICE USEFUL FOR INTRAVENOUS BLOOD INFUSION
FIELD OF THE INVENTION
The present invention relates generally to a device useful for intervenous blood infusion, and more particularly to a novel medical device having electrical, chemical or biological means to indicate a successful puncturing of a vein.
BACKGROUND
The establishment of intervenous route for the administration of fluids (e.g., IN) is a common procedure, useful for both outflow of liquids from the body, such in the infusion of blood from patients, or for inflow, i.e., the administration of saline water, blood and medications to needed patients.
Aforementioned IN is a medical routine comprising the sequence of puncturing the wall of a vein by a hypodermic rigid needle and inserting a catheter (e.g., a flexible cannula) to said vein so blood flows through the passageway of the cannula and fills a translucent sample container (hereby denoted as flashback chamber), hence indicating that the cannula has entered the vessel. The use of intravenous and arterial cannula thus depends upon a visual observance of blood in flashback chamber. There is normally little difficulty in carrying out IV procedure. Nevertheless, in certain extreme situations, common in emergency medicine and in military medical care, conditions of subdue light are not providing the blood to be seen through the wall of the flashback chamber. In such cases, an auxiliary lamp should be used, decreasing the accuracy and the easiness of the procedure.
U.S. Pat No. 5,030,207 patent provides an indication when an intravenous needle has entered the vein by using a solid fiber optic mounted in the needle for showing visual instantaneous vein entry. The distal end of the fiber optic reflects color, such as red blood to the magnifying system at the end of the fiber optic. The user observes immediate vein entry without any blood flow or exposure to blood. According to said invention, the user is forced to look and focus at the proximal end
of the cannula instead of the puncture point. Moreover, devices manufactured according to this invention are respectively complicated and costly.
Another method for addressing the problem is approached by U.S. Pat. No. 5,314,410 and U.S. Pat. No. 5,954,701 that includes a pressure driven means, such as colored flexible membrane, disposed within a transparent body of a hypodermic needle that is stretched over the proximal end of the needle cannula. As the needle reaches the inside of the blood vessel, pressure within the vessel is transferred through the cannula to the membrane, which moves or inflates indicating entry has been achieve, or similarly, electronic pressure sensor buzzes at the very time of entering the blood vessel. Low blood pressure in the punctured vein, however, may avoid or disrupted the signal. Moreover, due to their complexity, the use of those devices requires some previously earned experience before handling.
It is thus the main object of the present invention to provide a cannula assembly, which is more reliable because it transduces the required signal for blood entering the flashback chamber and hence for successful intravenous blood infusion, without dependence on local blood pressure and without the requirement of any previous experience handing said device.
SUMMARY OF THE INVENTION
It is the object of the present invention to provide a device useful for intravenous infusion having means for the indication of successful puncturing of a vein, comprising (i) a double ended cannula open at both ends which have a passageway route throughout; (ii) a housing entrapping the cannula thereon so the distal end of said cannula is extending forwardly, adapted for puncturing a vein, and the proximate end is extending rearwardly, adapted for coupling with a blood sample, collected in a flashback chamber; (iii) a flashback chamber useful for containing blood; wherein said device comprising means to indicate signals for the presence of blood in said flashback chamber; wherein said means are selected from electrical, chemical or biological systems; and wherein said signal is selected for sound, vibration, luminescence, fluorescence, color change, visible light reflection or any other suitable light emitting systems.
In one preferred embodiment of the present invention is the device defined above, useful for intravenous infusion, having electrical means to indicate signals for the presence of blood in said flashback chamber comprising: (i) a power source, comprising one or more DC battery; (ii) at least one sensor, selected from a conductivity unit, a thermocouple, or any other suitable electrical driven apparatus capable sensing the presence of blood in the flashback chamber; (iii) signal transducer, selected from lumps, LEDs, buzzers, vibrators, loudspeakers any other sound forming units.
In another preferred embodiment of the present invention the device defined above, wherein said signals are introduced by transducers located on said housing; Similarly, preferred embodiment is said device, wherein said transducers introduce said signals from a remote unit.
In another preferred embodiment of the present invention is the device defined above, useful for intravenous infusion, having chemical means to indicate signals for the presence of blood in said flashback chamber, by means of exposure of chemical substances, effectively entrapped to said flashback chamber, with blood or with blood constituents.
In another preferred embodiment of the present invention is the device defined above, useful for intravenous infusion, wherein said chemical system comprising sufficient amount of resorcinol and phthalic anhydride, preheated with sulfuric acid, and NaOH so blood or blood constituents are reacted with said immobilized mixture to emit a noticeable fluorescent light at the flashback chamber.
Still another preferred embodiment of the present invention is the device defined above, useful for intravenous infusion, wherein said chemical system is located outside said flashback chamber and wherein blood is purged from said chamber to a separate compartment so signals are indicated outside the flashback chamber.
Lastly, in another preferred embodiment of the present invention is the device defined above, useful for intravenous infusion having biological means to indicate signals for the presence of blood in said flashback, wherein said biological means are selected from luciferin-luciferase based systems, antigen-antibody amplified systems or any suitable specific or non-specific enzymatic catalyzed reactions.
DETAILED DESCRIPTION OF THE INVENTION
In accordance with the present invention, a novel device useful for intravenous blood infusion has been developed and proved effective for the indication of successful intravenous puncturing.
The present invention deals with the general case of puncturing of liquid containing organs, including but not limited to blood vessels (e.g., vein or artery), members of the urinary system, and spinal fluids containing organs; denoted hereby for the particular case of 'intravenous puncturing'. Accordingly, for the purpose of simplicity, any body liquids will denote in the present invention for 'blood'. Said intravenous puncturing will hereby referred to a medical procedure suitable for the establishment of intervenous route in its generalized definition according to the present invention. The purpose of said procedure, in the scope of the present invention, is the administration of fluids and injectable materials from, and to a living body. Said procedure, comprising accordingly any outflow of materials from the body, such in the infusion of blood form patients, and any kind of inflow, i.e., for the administration of saline water, blood and medications to needed patients.
The successfulness of said infusion is referred in the present invention to a case in which fluid containing organs (preferably vein or artery) are punctured by a cannula, as hereby defined, so body fluids (preferably blood) are allowed to flow through the cannula and to be sensed in a flashback chamber of the cannula.
The device according to the present invention will hereby referred to the broad meaning of cannulas, infusion needles, trocars or any medical devices know in the art and in daily use, suitable for successful intravenous puncturing, which may comprise a needle, a cannula elastic sleeve, a flashback chamber, a sensor, a signal transducer etc.
In one preferred embodiment of the present invention is a device useful for the indication of successful intravenous puncturing as schematically described in Fig. 1 comprising a double ended cannula (la, lb) open at both ends which have a passageway route throughout, wherein furtherly a needle is located; a housing entrapping the cannula (bold lines, 2) thereon so the distal end of said cannula (la) is extending forwardly, adapted for vein puncture, and the proximate end (lb) is extending rearwardly, adapted for coupling with a blood sample, collected in a flashback chamber useful for containing a sample of blood (3), preferably made of
transparent materials; and means to indicate signals at the presence of blood in said flashback chamber, wherein said means are selected from sound, vibration or any suitable light emitting systems, comprising luminescence, fluorescence, color change or visible light reflection.
In another preferred embodiment of the present invention is the device useful for indicating successful intravenous blood infusion as schematically described in Fig. 2, as defined above, comprising a double ended cannula (1) open at both ends which have a passageway route throughout; a housing (2) entrapping the cannula (1) thereon so the distal end of said cannula (la) is extending forwardly, adapted for vein puncture, and the proximate end (lb) is extending rearwardly, adapted for coupling with a blood sample, collected in a flashback chamber; and a flashback chamber (3) useful for containing a sample of blood.
The device according to the present embodiment preferably comprising means for indicating the presence of blood is an electrical circuit (4) schematically and most generally comprising a power source (4a), preferably one or more DC batteries; at least one sensor (4b), which may be a conductivity unit, whereas blood fills the flashback chamber (3) closes or opens an electric circuit, a thermocouple sensing temperature or temperature difference, or any other suitable electrical driven apparatus capable sensing the presence of blood; and lastly, a signal transducer (4c), which may be selected from various lumps (i.e., including LED or an array of LEDs), buzzers, vibrators, loudspeakers or any other sound forming units. Said signal inducers may be single or multiplayer inducers of various types.
According to the present invention, said signal inducers are located in any place, preferably with a connection to the housing (2) of cannula assembly. In another embodiment of the invention, said inducers are located near the distal edge of the cannula (la), or at a remoter location. Additionally, the signal may be induced as a local light projection, as an RF or on-line transudation to a remqte receiver etc.
Another preferred embodiment of the present invention is aforementioned device as schematically described in Fig. 3, wherein said signal, which is indicated in the flashback chamber (3) when filled with blood, is driven from the exposure of chemical substance, immobilized to appropriate support (5), with blood or blood constituents.
Particularly preferred is a device, comprising means to prevent form immobilized chemical reactants to contaminate the infused blood. Such compartmentability is
achieved according to the present invention by means of a polymeric membrane (5b), characterized by sufficient porosivity or by ion-exchange characteristics. Most preferably, the pore diameter of said FAD approved membrane is less 0.2-micrometer. Another preferred embodiment of the present invention is aforementioned device, as schematically described in Fig. 4, wherein at least a portion of the infused blood is purged to a separate tunneling (5a), through a thin membranes as defined above (5b) and reacting with said immobilized reactants (5). In this example system, signs driven from the presence of blood in the flashback chamber are not indicated in the very same location.
Said signal may a product of a specific or non-specific chemical reaction between blood driven substances or diluents, yielding with the emittion of light. Resorcinol is used in the tanning and dyeing industries; in the manufacture of resins and resin adhesives. Accordingly, one preferred embodiment for aforementioned chemically driven light emittion is an immobilized system comprising resorcinol and sufficient amount of phthalic anhydride preheated with sulfuric acid. In the presence of blood, and more specifically, water diluent of the blood, NaOH is released from said matrix to react with said resorcinol mixture to yield a noticeable fluorescent light.
When expressed in mammalian cells, luciferase molecules produce luminescence in direct proportion to their number, provided that the substrate luciferin, and ATP are present:
ATP + D-luciferin + O2 -» oxyluciferin + AMP + PPi + CO2 + light Further more, luciferase is expressed in mammalian cells without the need for post transcriptional modification and is catalytically active immediately after release from ribosome. This allows an almost instantaneous detection of transcription activity.
It hence another preferred embodiment of the present invention is aforementioned device wherein the means to indicate the presence of blood in the flashback chamber is chosen from biologically driven systems, preferably luciferin-luciferase based systems or any other suitable specific or non-specific enzymatically catalyzed reactions, antigen-antibody amplified interaction etc.