Abstract:
The present invention relates to a halo spray tip atomizer device primarily suited for the application of the fibrin glues. The device offers way to transition seamlessly between a static delivery device and an atomization device. The device is also so configured as to limit possible clogging.

Description:
CROSS REFERENCES TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit under 35 U.S.C. §119(e) of U.S. Non-Provisional application Ser. No. 12/258,076 filed on Oct. 24, 2008, and Provisional Application No. 61/887,359 filed on Oct. 5, 2013 the complete disclosure of which is incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to a Halo Tip Spray Head Atomizer Delivery Manifold Device. 
       INTRODUCTION 
       [0003]    Conventional atomizers work by delivering a fine spray. Specialized devices are used for dispensing a plurality of different, i.e., separate, fluid medications or agents as an admixed product. For example, specialized spray heads are used for delivering two biochemically reactive fluids, such as fibrinogen and thrombin to form fibrin in an admixed state, to a biological surface. The biochemically reactive fluids maybe delivered topically, in open-type surgeries such as laparotomic procedures, and in minimally invasive surgeries such as laparoscopic procedures. 
         [0004]    There exist many techniques for the application of fibrin glues or sealants. In one method, the fibrin sealant components are drawn into a syringe and ejected via an appropriate sized needle. In another method, a double barrel syringe is used. Other conventional techniques include a microdrop delivery system, and a spray application via a multi-channel catheter, which is fixed, to a pressurized air/gas source. These conventional atomizers work by delivering the fibrin glue in a fixed non-adjustable spray pattern. 
       BRIEF DESCRIPTION 
       [0005]    The Halo Tip Spray Head Atomizer Delivery Manifold Device in accordance with the present invention is especially useful with applications relating to the delivery of such admixtures as fibrin glues. It enables admixtures to be applied statically or through atomization to the specific site in a spray with use of the halo spray tip element or as a static delivery through its dual solution channels and deflectors. 
         [0006]    The present invention relates to a halo spray tip atomizer delivery manifold; collectively comprised of a halo spray tip, solution channel insert, and delivery manifold. There exist many techniques for the application of fibrin glues. Application of the fibrin glue can be accomplished in a number of ways. Since fibrin glues exhibit a short set time (time it takes the admixture to harden) once the two biochemically reactive fluid solutions are combine it tends to have the issue of clogging the application device and clogging is always a concern and can be experienced in many of the current application methods. In one method, with admixture with a longer set time and not as prone to clogging the admixture is drawn into a single syringe and ejected via an appropriate sized needle. In another method a double barrel syringe is used and the two solutions are combined in some type of mixing chamber. Other conventional techniques employ a microdrop delivery system, a spray application via a multi-channel catheter which is fixed to a pressurized gas source. Additionally, a number of special applicators are commercially available. Although the example of the use of this invention focuses on fibrin glues it should not be construed as limited to only such application. 
         [0007]    In one embodiment, the invention utilizes a halo spray tip atomizer delivery manifold which is connected to an air/gas source through the air channel of the manifold, thus utilizing the atomizer element of the invention. Additionally the air/gas exhaust apertures on the tip and apertures in the solution channel insert may also be varied in sixe and configuration to affect the particulate size being atomized. 
         [0008]    In another embodiment, the invention utilizes a halo spray tip atomizer delivery manifold which is not connected to an air/gas source and not to the air channel of the manifold, thus utilizing only the solution channel insert apertures and solution deflectors on the tip to dispense and combine the two biochemically reactive fluid solutions to create an admixture. 
         [0009]    In both afore mentioned, embodiments the fact that the two biochemically reactive fluid solutions are not combined until they are dispensed through the two solution channels and directed by the deflectors to converge into a single stream and finally combined. Depending on the admixture set time the device clogging issue is greatly reduced if not eliminated completely. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    The invention may be better understood and appreciated by reference to the detailed description of specific embodiments presented herein in conjunction with the accompanying drawings of which: 
           [0011]      FIG. 1  is an isometric view of the distal and proximal perspective of the halo tip spray head atomizer delivery manifold device, all in accordance with the invention; 
           [0012]      FIG. 2  is an isometric exploded view of the three components: halo tip, solution channel insert, and manifold of the halo tip spray head atomizer delivery manifold device, all in accordance with the invention; 
           [0013]      FIG. 3  is a side plan and cross section view of the, halo tip, solution channel insert and manifold components and their solution channels configuration of the halo tip spray head atomizer delivery manifold device, all in accordance with the invention; 
           [0014]      FIG. 4  is a top plan and cross section view of the, halo tip, solution channel insert and manifold components and their air/gas channels configuration of the halo tip spray head atomizer delivery manifold device, all in accordance with the invention; 
           [0015]      FIG. 5  is a front plan and isometric view of the atomizer manifold with the halo tip and solution channels insert removed, all in accordance with the invention; 
           [0016]      FIG. 6  is an isometric view of the distal and proximal perspective of the halo tip, all in accordance with the invention; 
           [0017]      FIG. 7  is a front plan view and cross section view of the halo tip, all in accordance with the invention; 
           [0018]      FIG. 8  is an isometric view of the distal and proximal perspective of the solution channel insert, all in accordance with the invention; 
           [0019]      FIG. 9  is an isometric view of the halo tip spray head atomizer delivery manifold device as combined in stages first with the solution source e.g. syringes then with a delivery system and air/gas source, all in accordance with the invention; 
       
    
    
     DETAILED DESCRIPTION 
       [0020]    A fibrin glue delivery halo tip spray head atomizer delivery manifold device embodying the principles of the invention is provided. The device includes a manifold, a solution channel insert, and a specialized halo spray tip with a radial aperture exhaust configuration, solution stream deflectors, and capable of delivery of an admixture comprised of two biochemically reactive fluid solutions either statically or atomized. 
         [0021]    Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of the structure and function set forth in the following description or illustrated in the appended drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “obround” herein is as defined per Merriam-Webster defines “obround” as having the form of a flattened cylinder with the sides parallel and the ends hemispherical. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. “Comprising” also encompasses the terms “consisting of” and “consisting essentially of.” The use of “consisting essentially of” means, e.g., that a method may include additional steps, but only if the additional steps do not materially alter the basic and novel characteristics of the claimed method. Unless specified or limited otherwise, the terms “joined”, “mounted,” “connected,” “supported,” and “coupled” and variations thereof herein are used broadly and encompass both direct and indirect mountings, connections, supports, and couplings. Further, “connected” and “coupled” are not restricted to physical or mechanical connections or couplings. 
         [0022]    No admission is made that any reference, including any patent or patent document, cited in this specification constitutes prior art. In particular, it will be understood that unless otherwise stated, reference to any document herein does not constitute an admission that any of these documents forms part of the common general knowledge in the art in the United States or in any other country. Any discussion of the references states what the author asserts and the applicant reserves the right to challenge the accuracy and pertinence of any of the documents cited herein. 
         [0023]    As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise. 
         [0024]    Unless otherwise noted, technical terms are used according to conventional usage. However, as used herein, the following definitions may be useful in aiding the skilled practitioner in understanding the invention. Such definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. 
         [0025]    In view of the foregoing disadvantages inherent in conventional fibrin glue application systems, the invention provides a novel system and method for application of fibrin glues. The invention provides a dual function device for use as a non-air/gas assist static delivery device for the dispensing of fibrin glue without atomization as well as the air/gas assist halo spray tip element capable of dispensing the fibrin glue in the form of atomization onto a biological surface. 
         [0026]    The full advantage of the combination of the static and halo tip atomization dispensing capabilities in accordance with the invention is realized when optimal spray area and particulate size are achieved through atomization, and additionally when atomization is not require then the static dispensing is utilized. Thus these two capabilities allows for the fibrin glue solution to be applied as effectively as possible while minimizing the device clogging issue communally associated with the application of fibrin glue. 
         [0027]    Reference is now made to  FIGS. 1-8  in which a halo tip spray head atomizer delivery manifold device, generally designated by reference numeral  10 , in accordance with the invention is shown. Device  10  includes a manifold  20  and a halo spray tip  30  and solution channel insert  40  for delivery of fibrin glues comprised of two biochemically reactive fluid solutions. In an illustrated embodiment, manifold  20  is defined by non-converging unvalved first solution channel  21   b  and an unvalved second solution channel  21   c  which are opposed to the isolated unvalved third air/gas channel  21   a.  Manifold  20  connects to two solution sources e.g. syringes each syringe containing a single component of the two biochemically reactive fluid solutions and one air/gas source e.g. low pressure compressed air via the three luer connector fittings  21   c . 2 ,  21   b . 2  and  21   a . 3  which are configured to ISO 594-1 and -2 standard for 6% taper luer fittings. As presented in this specification the configuration of one female locking luer fitting for the unvalved air/gas channel  21   a  and two female slip luer fittings of the unvalved solution channels  21   b  and  21   c  of the manifold  20  can optionally be configured in varying combinations depending on requirements or as all female locking luer fittings or all female slip luer fittings (not illustrated in specification). 
         [0028]    The manifold  20  includes a configuration  FIG. 5  for the mating and orienting of the halo spray tip. The mating configuration on the manifold located in the distal area  22  joins with the inner aperture surface  33  of the halo tip  30   FIG. 6 , the manifold distal area  22  also comprised of a proximal flange  22   a  and an orienting/anti-rotational protrusion element  22   b  which join with the recessed groove element  33   a  on the halo tip  30 . When joined the combined elements prevent relative rotation between the two parts, facilitating orientation of the tip  30  to the manifold  20  and aligns the obround aperture  31  and deflectors  31   a  and  31   b  of the halo tip  30  with the unvalved apertures  41   a  and  41   b  of the solution channel insert  40 . The manifold  20  distal area  22  has an aperture  22   c  which is proportioned to allow insertion and joining of the solution channel insert  40  with the manifold  20  a first rail channel  22   d  with an opposing second channel  22   e  located on the longitudinal center plane of manifold  20  that join with a first rail  42   a  and opposing second rail  42   b  of the solution channel insert  40 . The air/gas channel of  21   a   1  of the manifold  20  has an outer surface  22   a . 1  which is proportioned to pass within the groove  44  of the solution channel insert  40 . 
         [0029]    As shown in  FIG. 2 , the solution channel insert  40  first joins with the manifold  20  and then secondly the halo spray tip  30  joins with the manifold  20  collectively comprising the device  10 . 
         [0030]    As shown in  FIG. 3 . A cross section  2 - 2  of the halo tip spray head atomizer delivery manifold device  10 , illustrates the manifold  20  with its first  21   b  and second  21   c  unvalved solution channels with each channels having corresponding unvalved tapered channels  21   b . 1  and  21   c . 1  leading into the corresponding unvalved solution channels  41   a . 1  and  41   b . 1  which then leads into the corresponding unvalved channels  41   a  and  41   b  of the solution channel insert  40 . 
         [0031]    In a static method application the two biochemically reactive fluid solutions are introduced into the manifold  20  solution channels  21   b . 1  and  21   c . 1  via commonly actuable reservoirs then out though the corresponding solution channels  41   a . 1 ,  41   a , and  41   b . 1 ,  41   b  in the solution channel insert  40  then through the exhaust aperture  31  in the halo spray tip  30  as individual fluid streams where they come in fluid contact with the concave surfaces of the solution deflectors  31   a  and  31   b  of the exhaust aperture  31  in the halo spray tip  30 . The solution deflectors  31   a  and  31   b  facilitate the joining/directing resulting in convergence of the two solution fluid streams as they exit the exhaust aperture  31  which results in the creation of the admixture. 
         [0032]    In a atomization method application as in the use of pressured air/gas the introduction of the two biochemically reactive fluid solutions are as afore described wherein the two solution streams exiting through the exhaust aperture  31  are joined/directed by the deflectors  31   a  and  31   b  to converge and create the admixture which is then picked up by the air/gas exhaust which has entered through the isolated unvalved air channel  21   a . 2  and then through  21   a . 1  of the manifold  20  the air/gas is then diverter by the air/gas diverter  46  of the solution channel insert  40  and exhausted over surfaces  43   a  and  43   b  lastly through the apertures  32   a,    32   b,    32   c,  and  32   d  and in direct contact with the concave inner surfaces  3 . 2   a . 1 ,  32   b . 1 ,  32   c . 1 , and  32   d . 1  of the halo spray tip  30  which results in an atomization of the admixture in a halo effect. The pressure equalizing plenum chambers  50   a  and  50   b  created when the solution channel insert  40  and manifold  20  are joined acts to equalize and distribute the air/gas equally through the exhaust apertures  32   a,    32   b ,  32   c,  and  32   d  of halo spray tip  30 . 
         [0033]    As shown in  FIG. 4 , cross section  1 - 1  of the halo tip spray head atomizer delivery manifold device  10 , the manifold  20  has an isolated air/gas channel  21   a  leading into  21   a . 2  then  21   a . 1  which traverses along the groove  44  of the solution channel insert  40  and then terminating at the proximal tip  46   c  of the air/gas deflector  46  of the solution channel insert  40 . As air/gas pressure is applied during an atomization application the air/gas is deflected to either side  46   a  and  46   b  of the deflector  46  of the solution channel insert  40  and into the recessed area  45   a  and  45   b  which act to create the pressure equalizing plenum chambers  50   a  and  50   b  when joined with the manifold  20  as previously described. The equally pressurized air/gas then exhaust through the apertures  32   a,    32   b,    32   c,  and  32   d,  these apertures,  FIG. 7 , cross section  3 - 3  have concave inner surfaces  32   a . 1 ,  32   b . 1 ,  32   c . 1 , and  32   d . 1  ( 32   b . 1  and  32   d . 1  not shown in specification) the concave of the aperture inner surface acts to defect the air/gas as it is exhausted resulting in a halo effect. 
         [0034]    As shown in  FIG. 5 , further illustrates the distal portion  22  of the manifold  20  which corresponds with a matting orifice  33  of the halo spray tip  30 , a raised protrusion  22   b  of the distal portion  22  corresponds with the groove  33   a  of the halo spray tip  30  providing positioning of the exhaust aperture  31  in relationship to the solution channels apertures  41   a  and  41   b  of the solution channel insert  40  when the manifold  20 , solution channel insert  40  and halo spray tip  30  are joined together as shown in  FIG. 1 . 
         [0035]    As shown in  FIG. 6  isometric views of the distal and proximal perspective and  FIG. 7  front plan and cross section view  3 - 3  of the halo spray tip embodiment is further illustrated with the radially positioned air/gas exhaust apertures  32   a ,  32   b ,  32   c ,  32   d  and their inner concave surfaces  32   a . 1  and  32   c . 1  illustrated in cross section  3 - 3  along with the solution exhaust aperture  31  and solution stream deflectors  31   a  and  31   b  all lying about the longitudinal centerline; corresponding concave surfaces  32   b . 1  and  32   d . 1  relating to apertures  32   b  and  32   d  not shown in illustrations. 
         [0036]    As shown in  FIG. 8  isometric views of the distal and proximal perspective of the solution channel insert, is further illustrated with the two solution channels  41   a  and  41   b,  with their corresponding inlet apertures  41   a . 1 , and  41   b . 1  that interface with the solution channels of the manifold  21   b . 1  and  21   c   1 . Additionally illustrated are the two rails  42   a  and  42   b  which correspond with the rail channels  22   d  and  22   e  of the manifold  20 . Also further illustrated is the groove  44  which corresponds to the isolated air/gas channel outer surface  22   a . 1 . Although the presented embodiment illustrates the air/gas channel portion  21   a . 1  as sell-contained and joined to the manifold  20  it may also be configured and combined as part of the solution channel insert. The two recessed surfaces of the solution channel insert  40  with a first surface  43   a  and second surface  43   b  define the air/gas exhaust zones/apertures created between the inner surfaces of the distal aperture  22   c  of the manifold  20  the two apertures align with the radial apertures  32   a,    32   b ,  32   c,  and  32   d  of the tip  30 . Two angled surfaces  48   a  and  48   b  correspond to surfaces  23   a  and  23   b  of the manifold  20  to create a positive seal when the components are joined. The solution channel insert  40  has a proximal protrusion  47  which corresponds with a recess  23   c  of the manifold  20  which ensures proper positioning/alignment of the solution channel insert  40 . 
         [0037]    As shown in  FIG. 9  an isometric view of the embodiment is illustrated with the two stages of how the halo tip spray head atomizer device  10  would be applied first the device  10  is connected with the two solution source syringes  60  and then placed into a delivery system  70  and connected to an air/gas source  65  for application to a biological surface. 
         [0038]    In practice, the invention provides a method of dispensing fibrin glues to a biological surface. The method includes a halo tip spray head atomizer delivery manifold device capable of a static delivery method or accepting standard air/gas sources for an atomization method and with both methods capable of accepting solution delivery systems e.g. syringes or commonly actuable reservoirs. 
         [0039]    The foregoing description is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes may readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents are considered to fall within the scope of the invention. Various features and advantages of the invention are set forth in the following claims. 
         [0040]    All publications, patents and patent applications referenced in this specification are indicative of the level of ordinary skill in the art to which this invention pertains. Alt publications, patents and patent applications are herein expressly incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated by reference, in case of conflict between the present disclosure and the incorporated patents, publications and references, the present disclosure should control.