Abstract:
The present invention provides systems for the injection delivery of at least two fluid doses to a small bird by penetrating the skin of the recipient bird with at least two injection needles. It is then possible to simultaneously inject drugs, or other fluid vaccines that do not mix well or whose mixture would be detrimental to the stability or efficacy of the active ingredients therein. The present invention provides a novel injection needle support for connecting the injection needles to dose distributors and fluid supply containers while maintaining the injection ends of the injection needles in a substantially parallel arrangement. 
     The injection needle support typically is attached to a carrier connected to an actuator, an actuator power source and a switch mechanism wherein the actuator, when activated, can reciprocally move the carrier and injection support toward and away from an injection position. The injection delivery system may further include one or more dose distributors and fluid supply containers for delivering fluid doses to the injection needles for injection into a recipient bird held against an aperture in a retaining plate.

Description:
The present application claims the benefit of priority from a provisional application filed Nov. 16, 2001 and having U.S. Serial No. 60/331,468. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to a device for the injection delivery of drugs or vaccines to birds. More particularly, the present invention allows the subcutaneous or intramuscular injection of one or two doses of drugs or vaccines into bird. 
     BACKGROUND OF THE INVENTION 
     Inoculation of one-day old chicks or other small birds using automatic vaccine injection devices is known in the poultry industry. Automatic bird injection devices, including devices suitable for injecting small bird such as one-day chicks, are described, for example, in U.S. Pat. Nos. 5,312,353, 4,863,443, 4,758,227, 4,681,565, 4,515,590, 4,276,879, 4,177,810, 4,108,176, 3,964,481, 3,641,998. Such automated devices can allow one person to inoculate a multitude of birds with the significant economic benefit of reduced labor costs. 
     These automatic injection devices generally provide a movable reciprocating carrier that supports a single injection needle assembly connected to a fluid supply container. The carrier may be actuated relative to a support surface against which the chick is maintained by the operator. Once the needle reaches its extended position, and when it has penetrated into the tissue of the bird, a syringe or other dose delivery means is actuated to deliver the required dose from the supply container to the recipient bird. 
     It may also be desirable to separately administer different drugs or vaccines. U.S. Pat. No. 4,758,227, for example, provides two injection needles configured to be simultaneously introduced into the bird&#39;s breast muscle tissue. This automatic injection system can to inject two doses at the same time. However, the diminutive size of intended recipient birds, such as one-day chicks, has limited available automatic injectors to delivering the separate doses to the breast muscle tissue on opposite sides of the keel bone. 
     Many therapeutic compositions are not stable or otherwise incompatible when co-mingled. Such combinations must be either injected consecutively and/or injected into different localities in the recipient bird. Further, for vaccines or drugs that need to be administered subcutaneously into the necks of one-day chicks, a procedure that requires more precise and limited penetration of the bird than generally is practiced by available automatic injection delivery systems is necessary. Manual injections of the drugs or vaccines is still the only procedure available, with the main drawback of reduced production. Moreover, to inject a second dose of a drug or vaccine, the birds must be rehandled, inducing undue stress in the bird and significant increases in costs. 
     Thus, there exists a need for an automatic inoculating system for small birds, especially for one-day chicks, that can automatically deliver two or more separate doses of therapeutic fluids such as drugs or vaccines via a subcutaneous route. 
     SUMMARY OF THE INVENTION 
     The present invention provides systems for the injection delivery of at least two fluid doses to a small bird by penetrating the skin of the recipient bird with at least two injection needles. It is possible with the injection delivery system of the present invention to simultaneously inject drugs, or other fluid vaccines that do not mix well or whose mixture would be detrimental to the stability or efficacy of the active ingredients therein. Preferably, the injection ends of the injection needles will penetrate the skin of the recipient bird concurrently and deliver the fluid doses to a small target tissue area. The present invention provides a injection needle support for connecting the injection needles to dose distributors and fluid supply containers while maintaining the injection ends of the injection needles in a substantially parallel arrangement to allow for penetration of the bird&#39;s skin by both needles. 
     The injection needle support typically is attached to a carrier operably connected to an actuator, an actuator power source and a switch mechanism wherein the actuator, when activated, can reciprocally move the carrier and injection support toward and away from an injection position. The injection delivery system may further includes one or more dose distributors and fluid supply containers for delivering fluid doses to the injection needles for injection into a recipient bird held against an aperture in a retaining plate. When the carrier and injection needle support are in an extended position, the injection needles attached project through the apertures of the needle support and penetrate a selected area of the skin of the recipient bird. The fluid dose(s) is then delivered through the injection needles to the bird. The injection needle support of the present invention generally comprises a base, a base plate having recesses for receiving hubs of the injection needles, and an end plate having bores for receiving the shank portions of the injection needles. The needle support further comprises fluid connections for delivering fluid doses to the needles and which communicate with the recesses and the hubs of injection needles inserted therein. The shank portions of the needles also may be curved and not bent so that their internal canula sections are substantially maintained and fluid flow is not restricted. The injection ends of the needles generally project from the injection needle support in a substantially parallel configuration and in close proximity to each other to allow the substantially simultaneous penetration of the skin of a recipient bird, but with sufficient separation such that the fluids being administered do not substantially mix or interfere with each other once subcutaneously administered. 
     The injection ends of the needles also may be beveled. In one embodiment of the present invention, the needles are oriented about their longitudinal axes to face the bevels away from each other, thereby directing the two fluid flows exiting from the injection ends into opposite directions. 
     In another embodiment of the injection delivery system of the present invention, the injection needles each are operably connected via a fluid connection to a dose distributor, such as a multidose syringe, attached to the injection needle support. Alternatively, the dose distributor(s) may be a large volume multidose syringe that simultaneously provides a fluid supply container. The multidose syringe can be stepwise actuated to deliver a series of consecutive fluid doses. A pump also may be used to deliver the injectable fluid from a fluid supply container, and to expel the required dose from the injection needle. Additionally, the fluid connections can include substantially rigid piping, or can include flexible fluid ducts. The flexible fluid ducts allow the dose distributors to be located on the movable carrier but separate from the injection needle support, or on a fixed part of the system. 
     In still another embodiment of the present invention, a single dose distributor can be operably connected to both injection needles to deliver the same fluid to both injection needles. Each injection needle also can be operably connected to a separate dose distributor which allows the injection of at least two doses of different fluids, wherein the volume of each fluid dose may be identical or different, and the two fluid doses may be delivered to the recipient bird simultaneously or consecutively. 
     The reciprocating carrier further typically is driven by a hydraulic or electric actuator mechanism and the dose distributor(s) also will be operably connected to multidirectional flow valve to alternatively draw liquid from the fluid supply container and to expel a desired dose through the respective needle. 
     Additional objects and aspects of the present invention will become more apparent upon review of the detailed description set forth below when taken in conjunction with the accompanying figures, which are briefly described as follows. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The present invention will now be exemplified with reference to the following drawings where: 
     FIG. 1 is a perspective view of the needles assembly of the present invention. 
     FIG. 2 is a schematic view of the injection delivery system according to the present invention. 
     FIG. 3 is a schematic view of an additional embodiment of the injection delivery system according to the present invention 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Reference now will be made in detail to presently preferred embodiments of the invention, one or more examples of which are illustrated in the accompanying drawings. Each example is provided by way of explanation of the invention, not limitation of the invention. In fact, it will be apparent to those skilled in the art that various modifications, combination, additions, deletions and variations can be made in the present invention without departing from the scope or spirit of the invention. For instance, features illustrated or described as part of one embodiment can be used in another embodiment to yield a still further embodiment. It is intended that the present invention covers such modifications, combinations, additions, deletions and variations as come within the scope of the appended claims and their equivalents. 
     The injection delivery devices and systems according to the present invention are useful to deliver substantially simultaneously multiple fluid doses to a recipient such as small birds. The devices and systems of the present invention are particularly useful for delivering fluids that cannot be stably stored or mixed together. The injection delivery systems of the present invention also allow the co-delivery of vaccines such as herpes virus of turkey (HVT) vaccine with compositions such as antibiotics that may otherwise reduce the therapeutic efficacy of a live virus vaccine. 
     Referring now to FIG. 1, the present invention provides an injection needle support  10  adapted to receive at least two injection needles  14 ,  15 . The injection needle support  10  comprises a base  38  having a base plate  30  and an end plate  11  disposed thereon. The base  38  may be any geometric shape, such as square, rectangular, circular or the like, that will rigidly hold the base plate  30  and the end plate  11  in a fixed spatial relationship. The base  38  may be a solid plate or a frame defining a hole as shown, for example, in FIG.  1 . In preferred embodiments, the base  38  is triangular or trapezoidal, with the end of the base  38  having the end plate  11  thereon being narrower than the end having the base plate  30 , as shown in FIG.  1 . The end plate  11  has at least two substantially parallel bores  21 ,  22 , each bore capable of receiving a shank  23 ,  24  of one of the injection needles  14 ,  15 . Suitable injection needles  14 ,  15  for use in the system of the present invention each generally will comprise a hub or distal end  17 ,  18  and an injection or proximal end  25 ,  26  disposed at the opposite end of the shank  23 ,  24 . Preferably, the injection end  25 ,  26  of each needle is sharpened to ease penetration of the skin of a recipient bird, and further is typically beveled. 
     The injection needle support  10  of the present invention further comprises recesses  27 ,  28  in the base plate  30 . The recesses  27 ,  28  are configured to receive the hubs  17 ,  18  of the injection needles  14 ,  15  and which may be held in position in the recesses  27 ,  28  by a releasable or backing plate clamp  12 . The claim generally will be secured with a set screw or similar fastener  13  to prevent the needle hubs  17 ,  18  from disengaging from the recesses  27 ,  28 . Fluid connections  19 ,  20  provided, and generally are mounted in communication with the recesses  27 ,  28  and are also able to engage with the hubs  17 ,  18  held in the recesses  27 ,  28 , thereby allowing fluids to pass into the injection needles  14 ,  15  from a fluid supply source (not shown). 
     The injection needles  14 ,  15  may be attached to the injection needle support  10  by passing the injection end  25 ,  26  of a injection needle  14 ,  15  through a bore  21 ,  22  and placing a hub  17 ,  18  in a recess  27 ,  28  of the base plate  30 . The clamp  12  is then positioned on the base plate  30  and secured over the needle hubs to prevent the hubs  17 ,  18  from being displaced from the recesses  27 ,  28  and the injection needle support  10 . In one embodiment of the present invention, the clamp  12  is a detachable plate. In another embodiment, the clamp  12  can be connected to the injection needle support  10  along a hinge mechanism that allows the clamp to the be displaced, but not removed from, the injection needle support  10 . Exemplary fasteners for securing the clamp  12  in a closed configuration and which can be easily released to allow the injection needles  14 ,  15  to be easily replaced when blunted, blocked or otherwise becomes unsuitable for injecting birds include, but are not limited to, a screw means or opposed polarity magnets, and the like. 
     The injection needles  14 ,  15  can be replaced by releasing fasteners  13  of the clamp  12 , lifting the hub  17 ,  18  from the recess  27 ,  28 , disconnecting the needles  14 ,  15  from fluid connectors  19 ,  20 , and extracting the respective needle  14 ,  15  from the end plate  11  of the needle support. Substitute injection needles  14 ,  15  may then be introduced to the injection needle support  10  by reversing this order of operation. 
     In one embodiment of the present invention, the distance separating the recesses  27 ,  28  from one another exceeds the distance between the bores  21 ,  22 . In such an embodiment, the injection ends  25 ,  26  of injection needles  14 ,  15 , once placed into position in the injection needle holder  10 , generally will remain substantially parallel while the shanks  23 ,  24  between the hubs  17 ,  18  and the end plate  11  are curved. However, the shanks  23 ,  24  preferably are not bent, so as to thus maintain unimpeded fluid flows through the cannula of the needles  14 ,  15 . 
     Alternatively, the distance separating the recesses  27 ,  28  can be about, or substantially the same as the distance between the bores  21 ,  22  of the plate  11  so that the needle shanks  23 ,  24  are substantially parallel. 
     In the various embodiments of the injection delivery systems of the present invention, the injection ends  25 ,  26  of the injection needles  14 ,  15 , when inserted into the injection needle support  10 , will project beyond the end plate  11 . The extent to which the injection ends  25 ,  26  project beyond the end plate  11  may be selected manually or automatically according to the type or size of the recipient birds. The selected length of the injection ends  25 ,  26  of the needles and the degree of the extension movement of the carrier  4  imparted by the actuator  6  also determines whether the injection of fluid(s) into the recipient bird is subcutaneous or intramuscularly by affecting the depth of penetration of the needles. Injection needles  14 ,  15  suitable for use in the present invention may be from 2-20 gauge. Preferably, the injection ends  25 ,  26  are sharpened and beveled. For example, beveled injection ends  25 ,  26  orientated in substantially opposite directions are shown in FIG.  1 . This substantially opposed orientation of beveled injection ends  25 ,  26  can direct injected fluids in divergent directions to reduce potential co-mingling of incompatible fluids within the tissues of the recipient bird. 
     As illustrated in FIGS. 2A and 3, the present invention provides an injection needle support  10  connected to a carrier  4  slidably disposed in a guide  5 . The carrier  4  is operably connected to an actuator  6  configured to reciprocally move the carrier  4  and injection needle support  10  from a retracted position to an extended injection position. Suitable actuators  6  include, but are not limited to, a solenoid, electric motor or driver, or a hydraulic actuator, the selected actuator  6  further comprising a power source. The actuator  6  is also operably connected to a switch  35  that may include, but is not limited to, a manually activated switch, or an automatic switch such as a pressure switch or sensor, or a photoelectric switch. It is contemplated that the switch will be reversible so that in a first position the carrier  4  and injection needle support  10  are extended by the actuator  6 , and in a second position the carrier  4  and the injection needle support  10  may be retracted away from the injected recipient bird. It is further contemplated that the carrier  4  and the injection needle support  10  may be automatically retracted, for example, by a spring-biased device, for example, once the actuator  6  is deactivated. 
     The injection delivery system of the present invention further comprises one or more dose distributors  31 ,  32  communicating with the fluid connectors  19 ,  20  for the needles  14 ,  15 . Suitable fluid distributors  31 ,  32  for use in the present invention include, but are not limited to, pumps or syringes, such as a multi-dose syringe and the like that are capable of receiving a fluid dose from fluid containers or supplies  33 ,  34  and delivering the fluid dose to an injection needle  14 ,  15 . Each fluid container  33 ,  34  is preferably connected to a dose distributor  31 ,  32  by a two-way valve  36 ,  37  that allows a fluid dose to be withdrawn from the fluid container  33 ,  34  and delivered to the injection needle  14 ,  15  without back-flow to the fluid container  33 ,  34 . 
     In one embodiment of the injection delivery system of the present invention, each dose distributor  31 ,  32  is attached to the carrier  4  or to injection needle support  10  such that the dose distributor  31 ,  32  will move with the carrier  4  and injection needle support  10 . In another embodiment, dose distributors  31 ,  32  may be separate from the carrier  4  and the injection needle support  10  and connected to the fluid connectors  19 ,  20  by flexible fluid ducts or lines  8 ,  9 . In these embodiments of the present invention, the fluid container  33 ,  34  also may be optionally attached to the carrier  4  or injection needles support  10 , or attached to a fixed structure such as a housing (FIG.  3 ). The fluid container  33 ,  34  likewise can communicate with the dose distributor  31 ,  32  by a flexible or rigid fluid duct  8 ,  9 . The injection delivery system further generally includes a control means and power source to activate the dose distributors  31 ,  32  to deliver at least two fluid doses to a bird maintained against the retaining plate  2 , and cause movement of the needle support to its operative injection position. 
     The needle injection device of the present invention further generally includes a retaining plate  2  having an aperture  3  therein. The retaining plate  2  and the aperture  3  are positioned so that when the carrier  4  and the injection needle support  10  are in an extended position, the injection ends  25 ,  26  project through and beyond the aperture  3  to a selected distance that allows injection of a fluid dose into a recipient bird. The chick or other small bird can be slightly pressed against the retaining plate  2  by the operator or otherwise restrained in a desired position for injection. The retention means also may be sloped with regard to the travel axis of the needles. 
     In operation of the injection delivery systems of the present invention, a chick or other small bird is maintained against the retaining plate  2  with the area of the bird to receive the fluid dose(s) positioned over the aperture  3  in the retaining plate  2 . Generally, the neck of the bird is the targeted area, but any other areas of the bird, including the breast, thigh, wing and the like may be selected to receive the delivered fluid dose. An optional restraint may be used to prevent escape of the bird. Pressure of the bird against the retaining plate  2  can engage and actuate a switch to activate the actuator  6  to move the carrier  4  and the injection needle support  10  attached thereto, to a predetermined extended operative injection position. The injection ends  25 ,  26  of the needles  14 ,  15  project through the retaining plate  2  and the aperture  3  therein, to penetrate the skin overlying the selected injection point of the bird. 
     When the carrier  10  and the needles  14 ,  15  thereon are in the extended position with the injection  25 ,  26  ends, in the bird, the dose distributors  31 ,  32  are actuated by a switch means activated automatically, as described in U.S. Pat. No. 5,312,353 incorporated herein by reference in its entirety, or by a system operator to deliver the fluid doses through their respective needles  14 ,  15 . The volumes for the delivered doses are selected depending on the treatment protocol administered to the birds. A suitable adjustment means, for example, as taught in U.S. Pat. No. 5,312,353 can administer doses from 0.05 to 4 ml per dose. The volumes can be identical or different between needles. It is contemplated to be within the scope of the present invention for the fluid doses delivered to a recipient bird to be the same therapeutic fluids or different. The delivery systems of the present invention can deliver the same fluid to two different positions in the bird or two different fluids that may be incompatible or unstable when mixed.