Abstract:
An applicator assembly for mixing at least a first and second component is provided. The applicator assembly includes a manifold configured for operable engagement with at least a first and second source of component, the manifold including at least a first and second component channel therethrough, an elongated shaft extending distally from the manifold, the elongated shaft including at least a first and second component lumen extending the length thereof, the at least first and second component channels in fluid communication with the at least first and second component channels, a tip assembly defining a first chamber, an intermediate chamber and a final chamber.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. application Ser. No. 12/427,965 filed Apr. 22, 2009, now U.S. Pat. No. 8,033,483, which claims benefit of application No. 61/047,826 filed Apr. 25, 2008, and the disclosures of each of the above-identified applications are hereby incorporated by reference in their entirety. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present disclosure relates to assemblies for mixing and applying two or more components. More particularly, the present disclosure relates to a spray tip for use with an applicator assembly for mixing two or more components. 
     2. Background of Related Art 
     Applicator assemblies for dispensing two or more components are known. In the field of medical devices, such assemblies are used for applying bioadhesives, polymers and other synthetic material used in wound closure. Because of the reactant nature of the components used to form the bioadhesive, mixing of the components does not occur until the solution is ready to be applied. Mixing of the components too soon before application may result in premature hardening of the mixture, thereby making application of the solution impossible. Thus, in known applicator assemblies, the two or more components are maintained separately until just prior to application. The applicator assemblies include one or more mixing means for mixing the two or more solutions prior to application. The mixing means may be passive, e.g. spiral configuration in the tubing, or instead may be active, e.g. mixing blade or impeller. Once mixed, the solution may be applied through a needle-like output or may instead be ejected through a spray assembly. Thorough mixing of the two or more components prior to application is important to ensure the solution will perform as intended. 
     SUMMARY 
     Accordingly, an applicator assembly for mixing at least a first and second component is provided. The applicator assembly includes a manifold configured for operable engagement with at least a first and second source of component, the manifold including at least a first and second component channel therethrough, an elongated shaft extending distally from the manifold, the elongated shaft including at least a first and second component lumen extending the length thereof, the at least first and second component channels in fluid communication with the at least first and second component channels, a tip assembly defining a first chamber, an intermediate chamber and a final chamber, wherein the first chamber is configured to receive a distal end of the elongated shaft, the second chamber is configured to receive an insert, and the final chamber is configured to receive the at least partially mixed at least first and second components prior to the mixture being ejected from an outlet defined in the distal end of the tip assembly. 
     The elongated shaft may include a flexible wire extending the length thereof. The manifold and elongated member may be integrally formed. The intermediate chamber may include ribs for maintaining the insert in a space relationship from a wall of the chamber. The outlet may be configured to eject the mixture from the tip assembly as a spray. The applicator assembly may further include at least a first slot formed between the intermediate chamber and the final chamber configured to direct the at least first and second components radially inward. In one embodiment, the tip assembly includes three or more slots. The at least first slot may be configured to cause the swirling of the at least first and second components within the final chamber. The insert may include a substantially cylindrical body configured to be received within the intermediate chamber. The manifold may include a substantially Y-shaped member. The elongated shaft and/or the insert may be composed of silicone. The elongated shaft may be flexible. 
     Also provided is a system for mixing at least a first and second component. The system includes at least a first and second source of component, a manifold configured for operable engagement with the at least first and second source of component, the manifold including at least a first and second component channel therethrough, an elongated shaft extending distally from the manifold, the elongated shaft including at least a first and second component lumen extending the length thereof, the at least first and second component channels in fluid communication with the at least first and second component channels, a tip assembly defining a first chamber, an intermediate chamber and a final chamber, wherein the first chamber is configured to receive a distal end of the elongated shaft, the second chamber is configured to receive an insert, and the final chamber is configured to receive the at least partially mixed at least first and second components prior to the mixture being ejected from an outlet defined in the distal end of the tip assembly. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with a general description of the disclosure given above, and the detailed description of the embodiment(s) given below, serve to explain the principles of the disclosure, wherein: 
         FIG. 1  is an exploded perspective view of an applicator assembly including a spray tip assembly according to an embodiment of the present disclosure; 
         FIG. 2  is a cross-sectional side view of a manifold of the applicator assembly of  FIG. 1 ; 
         FIG. 3  is a cross-sectional side view of the spray tip assembly of the applicator assembly of  FIG. 1 ; 
         FIG. 3A  is a cross-sectional side view of an alternative embodiment of the insert of the applicator assembly of  FIG. 3 ; 
         FIG. 4  is an enlarged cross-sectional view of the distal end of the spray tip assembly of  FIG. 3 ; 
         FIG. 5  is a side view of the spray tip assembly of  FIGS. 3 and 4 ; 
         FIG. 6  is a cross-sectional view of the spray tip assembly of  FIG. 5  taken along line  6 - 6 ; 
         FIG. 6A  is a cross-sectional view of an alternate embodiment of the spray tip of  FIG. 6 ; 
         FIG. 7  is an exploded perspective view of an applicator assembly according to another embodiment of the present disclosure; 
         FIG. 8  is a top plan view of the applicator assembly of  FIG. 7 ; 
         FIG. 9  is a cross-sectional side view of the applicator assembly of  FIGS. 7 and 8 , taken along line  9 - 9  of  FIG. 8 ; and 
         FIG. 10  is an enlarged cross-sectional view of section  10  of  FIG. 9 ; and 
         FIG. 11  is a cross-sectional view of the spray tip assembly of  FIG. 9  taken along line  11 - 11  of  FIG. 10 . 
     
    
    
     DETAILED DESCRIPTION 
     Referring initially to  FIG. 1 , an applicator assembly including a spray tip assembly according the present disclosure is shown generally as applicator assembly  10 . Applicator assembly  10  includes a manifold or base  20 , an elongated shaft  30  extending from manifold  20 , and a spray tip assembly  50  positioned on a distal end  30   b  of elongated shaft  30 . Applicator assembly  10  further includes an insert  40  configured to be received within spray tip assembly  50  and distal of elongated shaft  30 . 
     With reference now to  FIG. 2 , manifold  20  includes a substantially Y-shaped member having first and second proximal extension  22 ,  24  and a distal extension  26 . Proximal extensions  22 ,  24  are configured for operable engagement with a first and second source of component (not show), e.g. syringe. Distal extension  26  is configured for operable engagement with elongated shaft  30 , as will be discussed in further detail below. Manifold  20  further includes first and second component channels  23 ,  25 . First and second component channels  23 ,  25  fluidly communicate the first and second sources of component with a first and second lumen  33 ,  35  formed in elongated shaft  30 . While manifold  20 , as shown, is configured to receive only two sources of component, it is envisioned that manifold  20  may be configured to receive more than two sources of component. 
     Referring back to  FIG. 1 , elongated shaft  30  defines a substantially solid body of silicone, plastic, polymer or other flexible material. As noted above, elongated shaft  30  includes first and second component lumen  33 ,  35  extending the length thereof. A wire  36  composed of a malleable material also extends the length of elongated shaft  30 . Wire  36  is configured to maintain elongated shaft  30  in a bent or flexed configuration after elongated shaft  30  has been bent or flexed to accommodate a given procedure. Elongated shaft  30  is secured to distal extension  26  of manifold  20  such that first and second component lumen  33 ,  35  align with first and second component channels  23 ,  25 , respectively. Alternatively, elongated shaft  30  may be integrally formed with manifold  20 . Elongated shaft  30  may further include grooves, detents or otherwise be configured for secure engagement with spray tip assembly  50 . 
     With reference now to  FIGS. 3-6 , spray tip assembly  50  defines a substantially cylindrical body  52  having an open proximal end  52   a  and a substantially closed distal end  52   b . Open proximal end  52   a  is configured to receive distal end  30   b  of elongated shaft  30  ( FIG. 3 ). As will be discussed in further detail below, distal end  52   b  includes an outlet  59  configured to eject a thoroughly mixed solution. Spray tip assembly  50  may be composed of silicone or other suitable biocompatible materials. 
     In one embodiment, spray tip assembly  50  is composed of a silicone elastomer, for example, TUFEL® II 94706, a silicone rubber compound or LIM®6071, a liquid silicone rubber, available from Momentive Performance Materials, Waterford, N.Y. Through testing, it has been found that a spray tip assembly  50  composed of silicone having a  70  durometer, spray tip assembly  50  is capable of unclogging itself during operation. The flexible nature of silicone permits spray tip assembly  50  to flex under the increased pressure experienced during a clog of spray tip assembly  50 . The flexion of spray tip assembly  50  dislodges any clog that may form therein. Additionally, the non-wetting surface characteristic (hydrophobicity) of silicone may assist in preventing the clogging of spray tip assembly  50 . The ability of spray tip assembly  50  to unclog itself during operations permits the continuous use of applicator assembly  10  without the need to repeatedly change spray tip assembly  50 . In this manner, the length of the procedure may be reduced and the expense of using multiple spray tip assemblies is eliminated. 
     Still referring to  FIGS. 3-6 , spray tip assembly  50  includes a first chamber  54 , an intermediate chamber  56  and a final chamber  58 . First chamber  54  defines a substantially cylindrical cavity for receiving distal end  30   b  of elongated shaft  30 . As will be discussed in further detail below, first chamber  54  is configured such that distal end  30   b  of elongated shaft  30  is received pressed flush against insert  40 . It is envisioned, however, that first chamber  54  may be configured such that distal end  30   b  of elongated shaft  30  is proximally spaced from insert  40  so as to form an initial mixing space for the first and second components. Intermediate chamber  56  defines a substantially cylindrical cavity configured to receive insert  40 . Intermediate chamber  56  includes ribs or spacers  56   a  for maintaining insert  40  (shown in phantom in  FIG. 6 ) centered within intermediate chamber  56 . Insert  40  includes a solid, substantially cylindrical member positioned within intermediate chamber  56  to force the first and second components to flow around insert  40  in the space recreated by ribs  56   a . In an alternative embodiment ( FIG. 3A ), insert  40 ′ may extend proximally from intermediate chamber  56  into first chamber  54 , thereby creating an initial mixing space  41 ′ between distal end  30   b  of elongated shaft  30  and intermediate chamber  56  about a proximal end  40   a ′ of insert  40 ′. In this manner, the first and second components flowing from first and second component lumen  33 ,  35  may initially mix prior to entering intermediate chamber  56 . Inserts  40 ,  40 ′ may be composed of silicone or other suitable biocompatible material. 
     With reference still to  FIGS. 3-6 , final chamber  58  defines a substantially cylindrical cavity having a tapered distal portion  58   a . Spray tip assembly  50  includes slots  57  formed therein fluidly communicating intermediate chamber  56  and final chamber  58 . Slots  57  define opposed openings angling outwardly from final chamber  58  between a line tangent to final chamber  58  and about twenty degrees (20°) counter-clockwise from the tangent line. As will be discussed in further detail below, slots  57  direct the partially mixed first and second components from within intermediate chamber  56  into final chamber  58 . Although shown as a pair of opposed openings, it is envisioned that spray tip assembly  50  may include only a single slot  57  ( FIG. 6A ), or may alternatively include three or more slots  57  (shown in phantom,  FIG. 6A ). Outlet  59  is configured to atomize the thoroughly mixed solution into a cone-shaped spray. As shown, from proximal to distal, outlet  59  includes a first cylindrical portion  59   a , a second cylindrical portion  59   b , and a recessed portion  59   c . It is envisioned, however, that outlet  59  may be formed without second cylindrical portion  59   b.    
     The operation of applicator assembly  10  will now be described as relates to the figures. Prior to use, insert  40  is received within intermediate chamber  56  of spray tip assembly  50 . As discussed above, insert  40  is positioned such that fluid passing through intermediate chamber  56  is forced around insert  40  in the space created by ribs  56   a . Spray tip assembly  50  is selectively received on distal end  30   b  of elongated shaft  30 . As discussed above, manifold  20  may be integrally formed with elongated shaft  30 , or instead it may be necessary to secure elongated shaft  30  to manifold  20  manually prior to use, making sure that first and second component channels  23 ,  25  are aligned with first and second component lumen  33 ,  35 . First and second source of component (not shown) are next connected to first and second proximal extensions  22 ,  24 , respectively. Once secured to manifold  20 , first and second source of components may be activated, e.g. depression of syringe plungers (not shown), to initiate the flow of first and second components within first and second component channels  23 ,  25 , respectively. The first and second components flow through first and second component channels  23 ,  25 , through first and second component lumen  33 ,  35 , respectively, and into spray tip assembly  50 . 
     The first and second components flowing from first and second component lumen  33 ,  35  encounter insert  40  retained with intermediate chamber  56 . First and second component lumen  33 ,  35  are spaced such that the first and second components may flow around insert  40  in the space created by ribs  56   a  in between insert  40  and spray tip assembly  50 . The initially mixed first and second components are then forced into slots  57  where they are directed radially inward toward final chamber  58 . The flow of the mixture through slots  57  imparts a swirling motion to the mixture as the mixture enters final chamber  58 . Thereafter, the thoroughly mixed solution is atomized as it is ejected through outlet  59  in a cone-shaped spray. 
     Turning to  FIGS. 7-10 , an alternate embodiment of the present disclosure is shown generally as applicator assembly  110 . Applicator assembly  110  is substantially similar to applicator assembly  10 , and will therefore only be described as relates to the differences therebetween. With reference initially to  FIGS. 7 and 8 , applicator assembly  110  includes a manifold or base  120  configured to receive a pair of check valves  105 , an elongated shaft  130  extending from manifold  120 , and a spray tip assembly  150  positioned on a distal end of elongated shaft  130 . An insert  140  is received within spray tip assembly  150  and a shrink tube  160  is received about spray tip assembly  150 . 
     Referring to  FIG. 7 , first and second component channels  123 ,  125  extend from a distal end of manifold  120 . First and second component channels  123 ,  125  are configured to fluidly communicate with first and second component lumen  133 ,  135  extending through elongated shaft  130 . This configuration permits for a more secure fluid seal between manifold  120  and elongated shaft  130 . 
     With reference now to  FIGS. 9 and 10 , insert  140  is substantially similar to insert  40 , including a substantially cylindrical member configured to be received within spray tip assembly  150 . As shown, insert  140  includes hemispherical recess  141  on both a first and second end thereof, however, it is envisioned that hemispherical recess  141  may be formed on a single end thereof. Recess  141  is configured to create turbulence in the flow of the first and second components as they encounter insert  140 , thereby assisting in the mixing of the components. 
     Still referring to  FIGS. 9 and 10 , shrink tube  160  is received about spray tip assembly  150  to prevent the excess radial expansion/flexion of spray tip assembly  150  during operation. Shrink tube  160  may also assist in securing spray tip assembly  150  to elongated shaft  130 . 
     With reference now to  FIG. 11 , spray tip assembly  150  is substantially similar to spray tip assembly  50 , described hereinabove, including radially extending slots  157 . A gutter or annular recess  157   a  is formed about slots  157 . Gutter  157   a  is configured to direct the partially mixed first and second components into slots  157 . 
     Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings, it is to be understood that the disclosure is not limited to those precise embodiments, and that various other changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the disclosure.