Abstract:
A syringe has a sensor for sensing physical contact between a syringe needle and the syringe. As the sensor detects that a syringe needle has just been installed into the syringe, a counter is set to “zero”, indicating the number of injections given with the installed needle. The counter automatically and cumulatively counts each injection given to the animal during a period of continuous physical contact between the syringe and the syringe needle. When the number of cumulatively counted injections equals a predetermined maximum number of injections, a syringe needle change warning mechanism delivers a needle change warning to the operator of the syringe.

Description:
TECHNICAL FIELD 
     The present invention relates to medicine injection systems for animals. More particularly, the present invention relates to systems and methods for alerting the user of an automated animal injection system that the syringe needle should be changed. 
     BACKGROUND INFORMATION 
     Worldwide, the agribusiness industry is facing a public acceptance crisis. In the food animal industry, increased incidences of blemished, contaminated, diseased, or overmedicated meat products have resulted diminished consumer confidence in the wholesomeness of meat protein. Furthermore, the public outcry for safe meat is forcing a flurry of more stringent federal legislation relating to source and process verification during meat production, from animal conception to public consumption. 
     Numerous recent advances are revolutionizing meat safety systems and processes. Specifically, the commercially available VAC-MARC® and VAC-TRAC® products, both offered by AgEcom Inc. of Marietta, Ga. 1-800-793-1671 are creating new industry standards. VAC-MARC®, one embodiment of which is taught in U.S. Pat. No. 5,961,494 (incorporated by reference herein) provides a reliable, simultaneous method of marking an animal while delivering an injection to the animal, thus eliminating accidental multiple injections or non-injection of the animal. 
     VAC-TRAC®, one embodiment of which is taught in pending U.S. patent application Ser. No. 09/477,262, filed Jan. 4, 2000 (also incorporated herein by reference), provides a system whereby the unique identity of an animal and information relating to injections given to the animal are automatically and electronically linked, recorded, and maintained in a central database for analysis, review and reference. Thus, the system creates for each animal a body of data relating to each and every injection given the animal, which body of data can be used for a variety of comparative, scientific and commercial purposes. 
     While both of these inventions represent quantum leaps in the historically technology-starved agribusiness industry, they do not address every possible avenue by which contaminants or other undesirable agents could be introduced into food animal products. 
     For example, in the livestock vaccination process, a single needle, attached to a syringe such as the VAC-MARC® is typically used until it is no longer serviceable because it has either (a) become too dull to easily penetrate the animal&#39;s flesh, (b) is bent, or (c) has broken off in the animal. In each case, the needle has almost certainly been used far beyond the 15-20 injections per needle recommended by Beef Quality Assurance (BQA) programs. Consequently, the likelihood of introduction of unwanted contaminants and disease have been passed to a healthy animal are significantly increased. 
     Accordingly, there is a need for a system and related method for determining when the number of times a syringe needle has been used. 
     There is another need for a system and related method for alerting a person using the syringe needle that the predetermined, recommended number of syringe needle usages have occurred. 
     There is yet another need for a system and related method by which use of the syringe needle is disabled upon usage of the syringe needle exceeding a maximum predetermined number of usages. 
     BRIEF SUMMARY OF THE INVENTION 
     The foregoing needs and shortcomings in prior art systems are satisfied by the present invention, which is a system for automatic needle change warning. The system comprises, generally, a syringe having a syringe needle. The syringe has a sensor for sensing physical contact between the syringe needle and the syringe. As the sensor detects that a syringe needle has just been completely and properly installed into the syringe, a counter communicatively connected to the sensor re-sets to a value of “zero”, this value indicating the number of injections given with the needle which was just installed. 
     The counter automatically and cumulatively counts each injection given to the animal during a period of continuous physical contact between the syringe and the syringe needle. When the number of cumulatively counted injections given during the period of continuous physical contact between the syringe needle and the syringe equals a predetermined maximum number of injections, a syringe needle change warning mechanism delivers a needle change warning to the operator of the syringe. The needle change warning may be audible, visible, may disable the syringe, or may prevent any further information relating to subsequent injections from being recorded in a database. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 depicts exemplary steps of operation of the preferred method of the present invention. 
     FIG. 2 depicts an exemplary embodiment of the present invention in a preferred operating environment. 
     FIG. 3 depicts, in disassembled view, exemplary components for implementation of the present invention. 
     FIG. 4 depicts, in assembled view, exemplary components for implementation of the present invention. 
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
     FIG. 1 depicts exemplary steps of operation of the preferred method of the present invention. More specifically, the method depicted in FIG. 1 begins at step  10  and, at decision block  15 , a determination is made as to whether a syringe needle is detected attached to the syringe. As will be described in greater detail with reference to later figures, a syringe implementing the system and method of the present invention is enabled to detect the presence of a syringe needle which is properly attached to the syringe. 
     If the syringe needle is not properly attached to the syringe, a determination is made as to the length of time, t, that has elapsed since either the system has been turned on, or (b) a properly installed syringe needle was detected. If, as depicted in decision block  17 , time t exceeds a predetermined length, the method of the present invention terminates at step  60 . If time t does not exceed the predetermined length, the detecting step shown in decision block continues until either the predetermined period of time expires or a properly installed syringe needle is detected. 
     Once a properly installed syringe needle is detected, the injection counter is set to zero at step  20 . At step  25 , the syringe is enabled such as by applying power to an electrical version of the syringe, pneumatic or hydraulic pressure to air or fluid-driven versions of the syringe, or simply activating an interconnected database to accept data from the syringe. 
     It is significant to note that an underlying presupposition of the present invention is that its use, if proper, will ultimately provide additional guarantees of food safety to those purchasing food animal products derived from implementation of the present system and method. For a consumer to be able to recognize that such a system and method has been relied upon in production of an food animal product, an assurance must be given by the producer. Use of the present invention, in particular, use of the present invention in coordination with other systems such as the above-referenced VAC-TRAC® and VAC-MARC® systems allows a producer to make verifiable statements as to the processes used in production of the food product. Accordingly, the proper use of the present invention can be captured in a database such as those which capture information relating to the use of these other systems. In the alternative, improper use of the system and method of the present invention may be used by these other systems as a discriminator as to what data is included in the database and which data is not. In sum, it is contemplated that even if the improper utilization of the present invention (either by improper installation of a syringe needle or overuse of a syringe needle) doesn&#39;t physically disable the syringe, the data otherwise derived from its use may not be stored with data from compliant use, if stored at all. Thus, corruption of data relating to proper use of the present invention is not corrupted by data derived from improper use of the present invention. 
     Continuing now in the description of steps depicted in FIG. 1, after the syringe is enabled, an injection is delivered at step  30  and recorded at step  35 . In its simplest form, the present invention may merely record the occurrence of the injection and the number of injections given using a particular needle. On the other hand, if the present invention is used in conjunction with either the VAC-TRAC® and/or VAC-MARC® systems, the occurrence of the injection can be linked with data such as the identity of the animal, type of medicine, etc. 
     Once an injection is successfully given, the counter is changed to reflect this use of the needle by incrementing the counter from I to I+1 at step  40 . At decision block  45 , a comparison is done to determine whether I+1 is less than I(max) where I(max) is the maximum number of injections allowed with a single needle. If I+1 is less than I(max), the method of the present invention returns to step  25 , where the syringe is again enabled. If, on the other hand, I+1 is not less than I(max), the user is alerted as to the situation at step  50 . Optionally, the syringe may be disabled as described earlier. 
     At decision block  55 , an inquiry is made as to whether the syringe needle has been disconnected from the syringe. If so, the method returns to step  20 , where the counter is reset to zero and the above-described process is repeated. If not, the method concludes at step  60 . 
     FIG. 2 depicts an exemplary embodiment of the present invention in a preferred operating environment. More particularly, the system of the present invention is depicted as functionally integrated with an intelligent syringe  100 . The intelligent syringe  100  comprises, generally, a syringe handle  104  operatively connected to a medicine syringe  150  and an optional ink dispenser  170 . The syringe handle  104  comprises a first syringe handle  110  pivotally connected to a second syringe handle  130 . The first syringe handle  110  is elongated, having a first end  111  and a second end  113 . An ink dispenser interface  117  is located generally adjacent to the socket  115  on the handle  110 . The handle  110  has a pivot hole in its second end  113 . 
     The second syringe handle  130  of the intelligent syringe  100  is also elongated and has a first end  131  and a second end  133 . The first end  131  of the second syringe handle  130  may securely received a hook  190  for storage of the marking syringe  100  between uses. The second syringe handle  130  is configured to function as a finger grip for the user. The second end  133  of the second syringe handle  130  is sized to slidably straddle the second end  113  of the first handle  110  and has a pivot hole through its thickness. The second handle  130  includes an integral medicine syringe collar  132  and an integral ink dispenser collar  134 . 
     During assembly, the second end  133  of the second syringe handle  130  is positioned over the second end  113  of the first syringe handle  110  such that the pivot holes in the ends  113 ,  133  are axially aligned. Thereafter, a pivot pin  120  is inserted through the aligned holes and appropriately secured therein in any number of ways, including deforming distal ends of the pivot pin  120  so that the diameter of the pivot pin  120  is larger at the points of deformation than the diameter of the pivot pin receiving holes, thereby preventing withdrawal of the pivot pin  120  through the pivot receiving holes. After the pivot pin  120  is properly positioned and secured, the second syringe handle  130  rotates about the axis of the pivot pin  120  in a plane defined by the second syringe handle  130  and the first syringe handle  110 . In use, the first and second handles  110 ,  130  are initially in a spread position. The user can then grip the first and second handles  110 ,  130  and squeeze them into a closed position as the handles  110 ,  130  pivot about the pin  120 . 
     The medicine syringe  150  is mounted between the handles  110 ,  130  by means of the medicine syringe collar  132  on the second syringe handle  130  and the socket  115  on the first syringe handle  110 . The medicine syringe  150  comprises a medicine syringe head  152  with a ball  153 , an extendible medicine syringe shaft  151 , a medicine syringe biasing spring  168 , a medicine syringe plunger  160 , a medicine syringe dosage chamber  161 , a medicine syringe needle fastener  162 , and a needle  164  (also referred to herein as a “syringe needle”). In order to connect the medicine syringe  150  to the handle  104 , the dosage chamber  161  is threaded into the handle collar  132  of the handle  130 , and the medicine syringe head  152  is connected to the handle  110  by engaging the ball  153  of the head  152  into the socket  115  of the handle  110  in a well known manner. 
     The head  152  is hollow and further comprises a medicine syringe nipple  156  and a transmitting syringe stop flange  158 . The medicine syringe nipple  156  may be integral to the hollow medicine syringe head  152  and is sized to securely receive a syringe vaccine hose (not shown). Vaccine is delivered to the hollow interior cavity of the head  152  via the vaccine hose which is connected to a vaccine source (not shown). The medicine syringe stop flange  158  extends laterally about the periphery of the medicine syringe head  152 . 
     The extendible medicine syringe shaft  151  interconnects the syringe head  152  and the plunger  160 . The shaft  151  has an interior axial conduit (not shown) which communicates at one end with the interior cavity of the head  152  and at the other end with an interior axial conduit (not shown) through the plunger  160 . The syringe shaft  151  extends through a medicine syringe collar  132  of the second syringe handle  130  and into the vaccine dosage chamber  161 . In order to vary the amount of the dosage, the shaft  151  has a vaccine dosage adjust valve  166 . The dosage adjust valve  166  comprises a collar that engages the plunger  160  on one end and is threaded onto the syringe shaft  151 . 
     In the depicted syringe embodiment, a dosage signal is transmitted to the intelligent syringe  100  and the intelligent syringe  100  automatically varies the dosage amount depending on the size of the animal  40  (and possibly other factors, as well), a controller  198  is functionally connected to the dosage adjust valve  166 . More particularly, the controller  198  comprises a receiver  199  for receiving the dosage signal  61  from the transmitter  186 . The controller  198  possesses the requisite intelligence (by way of internal microprocessor) to convert the dosage signal  61  into an action command for the dosage adjust valve  166 . Thereafter, the controller  198  automatically adjusts the dosage adjust valve  166  to provide the proper dosage to the animal  40  via simple mechanical linkage such as that which is well known in the art. 
     The dosage receiver  199  and the controller  198  are powered by a power source such as power source  188 , illustrated as positioned within the intelligent syringe  100 . Alternately, the controller  198  and dosage receiver  199  may be powered by an external power source (not shown). 
     After automatic adjustment of the dosage adjust valve  166 , and actuation of the intelligent syringe  100 , the medicine syringe plunger  160  slides within the vaccine dosage chamber  161 . An O-ring  163  creates a liquid tight seal between the periphery of the plunger  160  and the interior wall of the dosage chamber  161 . The plunger  160  has a check valve (not shown) within its interior axial conduit that allows liquid to pass only in the direction toward the needle end of the syringe  150 . 
     The medicine dosage chamber  161  is formed of a translucent or transparent material and is secured at its first end to the medicine syringe collar  132 . The medicine dosage chamber  161  may be scored with incremental graduations to assist a user in dosage measurements. At its second end, the medicine dosage chamber  161  removably receives a syringe needle fastener  162 . The syringe needle fastener  162  is fitted to capture a needle  164 , as will be described in greater detail with reference to later figures. A check valve (not shown) is fitted within the syringe needle fastener  162  to allow liquid flow only out of the needle  164 . 
     A syringe biasing spring  168  is disposed around the medicine syringe shaft  151  between the medicine syringe stop flange  158  and the vaccine dosage adjust valve  166 . The biasing spring  168  is a compression spring which serves to return the syringe handles  110 ,  130  to their initial spread position after being squeezed closed by the user. 
     When the handles  110 ,  130  are squeezed together, the plunger  160  moves within the dosage chamber  161 . The movement of the plunger  160  closes the check valve within the plunger  160  to force vaccine in the dosage chamber  161  through the check valve within the needle fastener  162  and out through the needle  164 . When the handles  110 ,  130  are released by the user, the check valve within the needle fastener  162  closes to preclude fluid or air being drawn into the dosage chamber  161  through the needle  164 . Simultaneously, the check valve within the plunger  160  opens to that vaccine is drawn into the dosage chamber  161  through the nipple  156 , the hollow head  152 , the conduit within the shaft  151 , and the conduit within the plunger  160 . By turning the dosage adjust valve  166 , the length of the shaft  151  is changed. Changing the length of the shaft  151  changes the length of the plunger stroke, and the amount of medicine delivered through the needle  164  is correspondingly changed. 
     In a preferred embodiment, the optional ink dispenser  170  comprises a self contained storage unit  189 . It will be understood and appreciated that alternate embodiments may not implement this self contained storage unit  189 . Nonetheless, the self contained storage unit  189  may take any number of forms well known to those skilled in the art of marking substance apparatus, including, but not limited to, a canister, a jar, a tube, or the like. 
     Further, the specific form of self contained storage unit  189  is dependent upon the type of ink being utilized. For instance, a pressurized canister maybe used to store ink which is suspended in, or in the form of, a compressed gas. Alternatively, a structure such as that used to store household caulk may be used to store liquid ink. 
     To support and retain the self contained storage unit  189 , the second handle  130  may further comprise an integral retention cage  144  extending from the ink dispenser collar  134 . The retention cage  144  may take any number of forms well known to those skilled in the art of mechanical design. It will be appreciated that the form of the retention cage  144  is dependent upon the physical characteristics of the self contained storage unit  189  being used. 
     The self contained storage unit  189  may comprise a pressurized canister  191 , the ink dispenser interface  117  having a contact point  118 , a retention cage  144  having a body  145 , a valve actuator  146 , a tip opening  147 , and a can detent  148 . The pressurized canister  191  may contain ink in the form of an aerosol, a non-aerosol compressed gas, or the like. The pressurized canister may be mounted to the second handle  130  my means of the collar  134  and the retention cage  144 . The pressurized canister  191  comprises a canister body  192  having a bottom surface  193 , a valve trigger (not shown), and an ink discharge orifice  182 . In order to install the pressurized canister  191  into the handle  104 , the canister body is inserted into the handle collar  134  of the second syringe handle  130  and maneuvered into the retention cage  144  until the can detent  148  makes contact with the bottom surface  193  of the canister  191 , thereby securely capturing the pressurized canister  191  within the retention cage  144 . 
     After secure capture of the pressurized canister  191  within the retention cage  144 , the ink discharge orifice  182  extends through the tip opening  147 , and the valve trigger is positioned in contact with, or adjacent to, the valve actuator  146 . When fully inserted, the retention cage  144  assures that the bottom of the pressurized canister  191  is aligned with the radial path of rotation of the ink dispenser contact point  118  on the second syringe handle  130 , as defined by rotation of the second handle  130  about the pin  120 . 
     Importantly, it is specifically contemplated that the intelligent syringe could be pneumatic in design. More specifically, the syringe may be powered by a source of compressed air, liquid or electricity so that when the user activates a trigger, the functions previously described as effected by squeezing the handles together are accomplished. 
     Central to the preferred functionality of the intelligent syringe  100  is the transmitter circuitry integral to the intelligent syringe  100 . The transmitter circuitry may comprise a transmit trigger  184 , a transmitter  186 , and a power source  188 . As depicted, the transmit trigger  184  may be positioned within the handle  110  proximal to the ink dispenser contact point  117 . The transmit trigger  184  supports a transmit sensor  185  positioned such that actuation of the intelligent syringe  100  by squeezing handles  110 ,  130  places the transmit sensor  185  in contact with the pressurized canister  191 . The transmit trigger, powered by a power source  188  such as a battery, detects contact between the transmit sensor  185  and the pressurized canister  191  and relays an appropriate signal to the transmitter  186 . The specific characteristics of the transmitter  186  will vary depending on the particular embodiment of the present invention being practiced, but in all cases, the transmitter is of sufficient signal strength and signal complexity to transmit, at a minimum, the injection event to a receiver. 
     Optionally, the intelligent syringe  100  may include a flow meter in communication with the medicine syringe  150  for detecting the amount of medicine delivered in any given actuation. In such an optional embodiment, the transmitter  150  must be of a type to be able to transmit such data to a designated receiver. Similarly, it is within the spirit and scope of the present invention that the medicine syringe  150  is capable of transmitting and facilitating the recording of the time and date on which medical treatments were given, as well as specifics of the particular treatment, such as the manufacturer of the medicine, the batch number and the date of manufacture. 
     FIG. 3 depicts, in disassembled view, exemplary components for implementation of the present invention. In particular, FIG. 3 depicts a preferred configuration for implementation of the needle change warning aspect of the present invention. 
     The medicine syringe  150  and dosage chamber  161  are characterized, at one distal end, by a medicine discharge nozzle  210  connected at its first end to the medicine syringe  150  and further having, at its opposing end, a discharge nozzle tip  215 . Intermediate between opposing ends of the medicine discharge nozzle  210  are discharge nozzle screw threads  220 . Importantly, the medicine discharge nozzle  210  carries a syringe contact  225 . The syringe contact  225  can take a variety of forms, though its ultimate function is to detect, through either electrical connection or pressure detection, the presence of a needle such as syringe needle  164  in contact therewith. In the depicted embodiment, th e syringe contact  225  is an annular metallic member having an electrical connection (not shown) to the transmitter  186 . 
     In the depicted embodiment, the transmission of the injection event by the transmitter  186  to a receiver may contain information relating to the status of the connection between the syringe contact  225  and the needle  164 , as determined by monitoring the integrity of the connection between the syringe contact  225  and the needle  164 . 
     Continuing with the description of the embodiment depicted in FIG. 3, the needle fastener  162  is generally hollow so as to accommodate and interconnect the medicine syringe  150  to the needle  164 . The preferred configuration for accomplishing this interconnection calls for screw receiving threads on the inner annular surface of the “hollow” needle fastener. In particular, medicine syringe needle threads  230  are sized and positioned to securely interrelate with the discharge nozzle screw threads  220  on the medicine discharge nozzle  210 , thereby securely fastening the needle fastener  162  to the medicine syringe  150 . 
     The needle fastener  162  also defines, by inner molding, needle receiving threads  235 , which are sized and positioned to securely interrelate with needle screw threads  240  disposed about the needle head  245  of the needle  164 . 
     FIG. 4 depicts, in assembled view, exemplary components for implementation of the present invention. The needle fastener  162  has been secured to the medicine syringe  150  by rotating the needle fastener  162  in a well known manner such that the discharge nozzle screw threads  220  become securely engaged with corresponding medicine syringe receiving threads  230 . Thereafter, the syringe needle  164  is attached to the needle fastener  162  by rotating the needle about its longitudinal axis in a well known manner such that the needle screw threads  240  positioned about the needle head  245  become securely engaged with the needle receiving threads  235  within the needle fastener  162 . 
     A central aspect of the present invention relates to the positioning of the needle head end  250  and the syringe contact  225 . As previously described, and as currently illustrated, when the needle fastener is completely and properly mounted on the medicine syringe  150  and the needle  164  is completely and properly installed in the needle fastener  162 , the needle head end  250  is in substantial contact with at least a portion of the syringe contact  225 . Accordingly, the presence of (or absence of) a properly installed needle  164  as part of a syringe such as the intelligent syringe  100  can be detected by electrical means well known to one skilled in the art of electrical detection means. 
     An alternate (and somewhat less desirable) embodiment dispenses with the an electrical connection between the syringe contact  225  and the needle head end  250  being the system for detecting the proper and continuous presence of the needle  164 . More specifically, it is envisioned that a pressure-sensitive contact may serve as the syringe contact  225 . Such a pressure-sensitive contact would detect the urging force applied by a properly and completely installed syringe needle  164  and report, via electrical signal, to the transmitter  186  for transmission with other data to a database (not shown).