Patent Description:
Recently, minimally invasive surgery (MIS) techniques have emerged as an alternative to conventional surgical techniques for performing a wide range of surgical procedures. MIS procedures differ from conventional surgical procedures in that a plurality of devices and/or surgical tools may be introduced into the body through cannulas and trocars that are inserted into small incisions. As a result, trauma to the body is greatly reduced, thereby decreasing the recovery time for patients.

One type of minimally invasive surgery involves laparoscopic surgical procedures, which are used to treat hernias, colon dysfunctions, gastroesophageal reflux disease, gallbladder disorders, etc. Typically, a patient undergoing a laparoscopic surgical procedure is able to return home within hours after undergoing surgery.

One challenge presented when performing minimally invasive surgical procedures relates to controlling bleeding at the surgical site. In contrast to conventional open surgical procedures, during a laparoscopic procedure a surgeon's access to a surgical site or surgical cavity is greatly reduced.

In response, the use of tissue sealants and other biological adhesive materials has emerged as a technique for closing incisions at surgical sites. Tissue sealants may include fibrin sealants, which is comprised of thrombin, and a fibrinogen material, although other formulations are also available. Typically, the individual components of the tissue sealants are stored separately in isolated reservoirs. The components are mixed together for the first time immediately prior to being applied to tissue. Once mixed, the components coagulate very quickly, yielding an adhesive gel within a short period of time (e.g., within <NUM>-<NUM> seconds). When considerable access to the application site is possible, the rapid coagulative properties of the tissue sealant are advantageous. However, the fast-acting properties of tissue sealants often clog the spray tips that are used for dispensing the components.

In addition, it is difficult to manufacture flexible accessories for delivering a two component material to a location in vivo. The components of the material are stored separately in and expressed out of a dual syringe, which requires a minimum distance between the exit orifices of the dual syringe. To be functional, the flexible cannula must be significantly smaller than the minimum distance between the exit orifices of the dual syringe, which results in two physically separated fluid paths coming together to fit through a cannula or trocar.

Various devices for spraying fluids are disclosed in <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>.

Medical devices for spraying at least two fluid components that react together rapidly are disclosed in <CIT>, and <CIT>. The above-identified documents, however, are silent regarding the performance of the medical devices when spraying is carried out in close proximity to the target location.

Commercially available spray tips that are used to atomize tissue sealants typically operate by mixing the components of the tissue sealant inside the spray tip and prior to spraying. Due to the quick acting nature of the biologics, the spray tips typically clog as soon as the flow of fluid through the spray tip stops (e.g., typically within one to two seconds). Once the spray tips become clogged, they can no longer be used to atomize biologics and must be replaced with new spray tips.

In view of the above-noted deficiencies, there is a need for dispensing devices having spray tips that provide surgeons with the ability to spray biologics and quick-acting tissue sealants, evaluate the results of the spray (e.g., has hemostasis occurred?), and then continue spraying without the need for changing spray tips. Satisfying this need is particularly valuable in minimally invasive/robotic surgery where removing the device to change the spray tip and reposition the device for spraying is a more time-consuming procedure.

Moreover, there is a need for improved anti-clogging spray tips for dispensing tissue sealants onto tissue.

In addition, there is a need for a medical device for spraying two components, which react together rapidly, in close proximity to a target surface.

There is also a need for a device capable of effectively delivering a multiple component tissue sealant to a location in vivo from a remote location, whereby the device may be easily and reproducibly manufactured.

<CIT> discusses a medical device for delivering volumetric quantities of a first and a second biochemically reactive fluid in which separate mechanical breakup units atomize the fluids. This device includes a fluid delivery device for laparoscopically delivering fluids having two feed conduits for delivering fluid to feed ports of the mechanical breakup units, the mechanical breakup units having two feed ports for receiving fluid from the feed conduits and directing such fluid into spin chambers and funneling portions having a sloped sidewall for directing fluid from the spin chambers through an exit port. This device is suitably dimensioned for creating a spray of two fluids with different viscosities such as fibrinogen and thrombin in such a manner that the thrombin spray cone encompasses the fibrinogen spray cone at a distance of about one inch from the exit port with a <NUM> cc/second flow rate to avoid depositing unreacted fibrinogen on a surface.

<CIT> discusses a spraying device having a spray head for spraying, at least one component comprises at least one substance component duct , the component outlet of which leads out of a spray head tip. An annular duct for a pressurized gas surrounds the at least one component duct at least partially in the longitudinal direction and leads out of the spray head at the spray head tip. A pressurized gas supply duct is provided for introducing pressurized gas at the annular duct. The annular duct has a plurality of ribs, which divide the annular duct at least in the region of the spray head tip into pressurized gas outlet ducts that are separated from each other.

The invention is defined by the independent claim with further embodiments defined by the dependent claims.

Referring to <FIG>, in one embodiment, a dispensing device <NUM> for spraying fluids may include one or more of the features disclosed in one or more embodiments of <CIT>, assigned to Ethicon LLC. In one embodiment, the dispensing device <NUM> preferably includes a device housing <NUM> that contains a manifold (not shown) and two Luer-type connections <NUM>, <NUM> that extend proximally from the device housing. In one embodiment, the two Luer-type connectors <NUM>, <NUM> may be connected to two syringes that contain respective fluids that react with one another. The dispensing device <NUM> desirably includes a brace <NUM> that is configured to connect the device housing <NUM> with a structure containing the two syringes. A first syringe may contain a first fluid and a second syringe may include a second fluid that reacts with the first fluid upon being sprayed from the dispensing device <NUM>.

In one embodiment, the dispensing device <NUM> preferably includes an elongated shaft <NUM> (e.g., an elongated flexible or rigid tube) having a proximal end that is connected to the device housing <NUM>. The elongated shaft <NUM> preferably extends distally from the device housing. In one embodiment, the elongated shaft <NUM> contains two cannulas, which are desirably side-by-side and used to deliver two fluids to a connector <NUM> secured to a distal end <NUM> of the elongated shaft <NUM>. A first fluid may be delivered through the first cannula and a second fluid may be delivered through the second cannula. In one embodiment, the dispensing device <NUM> preferably includes an anti-clogging spray tip <NUM> that is secured to the distal end <NUM> of the elongated shaft <NUM> via a connector <NUM> (<FIG>). Upon being sprayed from the anti-clogging spray tip <NUM>, the two fluids preferably react with one another.

In one embodiment, the anti-clogging spray tip <NUM> may be permanently secured to the distal end <NUM> of the elongated shaft <NUM>. In one embodiment, the anti-clogging spray tip <NUM> may be releasably secured to the distal end <NUM> of the elongated shaft <NUM> so that a first spray tip (e.g., a used spray tip) may be detached and replaced by a second spray tip (e.g., a new spray tip) that may be releasably secured to the distal end of the shaft.

Referring to <FIG>, in one embodiment, the anti-clogging spray tip <NUM> (<FIG>) preferably includes various components that are assembled together for use in spraying two fluids from the distal end of the dispensing device <NUM> (<FIG>). In one embodiment, the anti-clogging spray tip <NUM> preferably includes a gasket <NUM>, a tip housing <NUM>, an inner manifold <NUM>, and a dispensing cap <NUM>. In one embodiment, the above-listed components of the anti-clogging spray tip <NUM> (<FIG>) are assembled together and the fully assembled anti-clogging spray tip <NUM> is secured to the distal end <NUM> of the tubular shaft <NUM> of the dispensing device <NUM> (<FIG>) via the connector <NUM>. In one embodiment, the connector <NUM> is not part of the anti-clogging spray tip <NUM>, but is used for connecting the spray tip to a distal end of a shaft of a dispensing device. In one embodiment, an anti-clogging spray tip may include a connector that is used for securing the spray tip to the distal end of a shaft of a dispensing device.

Referring to <FIG>, in one embodiment, the connector <NUM> preferably includes a tube-shaped body <NUM> that is secured to the distal end <NUM> of the elongated shaft <NUM> of the dispensing device (<FIG>). In one embodiment, the connector <NUM> preferably includes a proximal end <NUM>, a distal end <NUM>, an inlet opening <NUM> at the proximal end <NUM> that is adapted to receive the distal end <NUM> of the elongated shaft <NUM> of the dispensing device <NUM> (<FIG>), and a connector flow chamber <NUM> that extends between the inlet opening <NUM> and an end wall <NUM> that defines an end of the connector flow chamber <NUM>.

In one embodiment, the connector <NUM> preferably includes a first lumen <NUM> that extends between the connector flow chamber <NUM> and the distal end <NUM> of the connector. The first lumen <NUM> is adapted to receive a first cannula for a first fluid. The connector <NUM> preferably includes a second lumen <NUM> that extends between the connector flow chamber <NUM> and the distal end <NUM> of the connector. The second lumen <NUM> is adapted to receive a second cannula for a second fluid that reacts with the first fluid. In one embodiment, the first and second fluids are preferably separated from one another as they pass through the connector <NUM>. The first and second lumens <NUM>, <NUM> are preferably side-by-side and are adapted to receive and seat respective first and second cannulas that extend through the tubular shaft <NUM> of the dispensing device <NUM> (<FIG>).

In one embodiment, the distal end <NUM> of the connector <NUM> preferably has external threads <NUM> that are adapted to be threaded into internal threads provided inside the tip housing <NUM> (<FIG>) for assembling the proximal end of the tip housing with the connector <NUM>, as will be described in more detail herein.

Referring to <FIG> and <FIG>, in one embodiment, the distal end <NUM> of the connector <NUM> preferably includes a first D-shaped exit port <NUM> that is aligned with a distal end of the first lumen <NUM>, and a second D-shaped exit port <NUM> that is aligned with the distal end of the second lumen <NUM>. The connector <NUM> desirably includes a connector dividing wall <NUM> that divides and spaces the first and second D-shaped exit ports <NUM>, <NUM> from one another. As will be described in more detail herein, the first and second D-shaped exit ports <NUM>, <NUM> are adapted to receive first and second D-shaped attachment plugs projecting from a proximal face of the gasket <NUM> (<FIG>) for assembling the gasket <NUM> with the distal end <NUM> of the connector <NUM>. In one embodiment, the two fluids are preferably maintained separate and apart from one another until they are sprayed from the dispensing cap <NUM> (<FIG>) located at the distal end of the anti-clogging spray tip <NUM> (<FIG>), whereupon the two fluids are mixed together for reacting with one another.

Referring to <FIG>, in one embodiment, the inlet opening <NUM> of the connector <NUM> provides access to the proximal end <NUM> (<FIG>) of the connector flow chamber <NUM>, which is located at the proximal end of the tubular member <NUM> of the connector <NUM>. The connector flow chamber <NUM> desirably terminates at the distal end wall <NUM>. The first and second lumens <NUM>, <NUM> are preferably formed in the distal end wall <NUM> and extend distally toward the respective D-shaped exits ports <NUM>, <NUM> located at the distal end <NUM> of the connector <NUM>. The first lumen <NUM> is adapted to receive a first cannula that contains a first fluid of a multiple component material and the second lumen <NUM> is adapted to receive a second cannula that contains a second fluid of the multiple component material.

Referring to <FIG>, in one embodiment, the gasket <NUM> preferably includes an annular plate <NUM> having a proximal face <NUM> that faces toward a proximal end of the anti-clogging spray tip <NUM> (<FIG>) and a distal face <NUM> that extends toward the distal end of the anti-clogging spray tip. The gasket <NUM> desirably includes a first D-shaped attachment plug <NUM> that is configured to be inserted into the first D-shaped exit port <NUM> at the distal end <NUM> of the connector <NUM> (<FIG>). The gasket <NUM> desirably includes a second D-shaped attachment plug <NUM> that is adapted to be inserted into the second D-shaped exit port <NUM> located at the distal end <NUM> of the connector <NUM> (<FIG>). The first and second D-shaped attachment plugs <NUM>, <NUM> preferably have an outer dimension and configuration that closely matches the shape of the respective D-shaped exit ports <NUM>, <NUM> located at the distal end <NUM> of the connector <NUM> for forming a press fit between the gasket <NUM> and the distal end of the connector <NUM>.

In one embodiment, the gasket <NUM> preferably includes a first lumen <NUM>' that extends through the first D-shaped plug <NUM> to the distal end face <NUM> of the annular plate <NUM>. The gasket <NUM> desirably includes a second lumen <NUM>' that extends through the second D-shaped plug <NUM> to the distal end face <NUM> of the annular plate <NUM>.

In one embodiment, when the gasket <NUM> is assembled with the distal end <NUM> of the connector <NUM> (<FIG>), the first D-shaped attachment plug <NUM> is preferably inserted into the first D-shaped exit port <NUM> of the connector and the second D-shaped attachment plug <NUM> is inserted into the second D-shaped exit port <NUM> of the connector. After the gasket <NUM> has been assembled with the distal end of the connector <NUM>, the first lumen <NUM> extending through the connector is preferably in alignment with the first lumen <NUM>' of the gasket <NUM> and the second lumen <NUM> extending through the connector <NUM> is preferably in alignment with the second lumen <NUM>' of the gasket <NUM>.

Referring to <FIG>, in one embodiment, the gasket <NUM> desirably includes a first pair of lateral struts 160A, 160B that extend across the first lumen <NUM>'. The lateral struts 160A, 160B are preferably positioned between the proximal end of the D-shaped attachment plug <NUM> and the distal face <NUM> of the annular plate <NUM>. The gasket <NUM> desirably includes a second pair of laterally extending struts 162A, 162B that extend across the second lumen <NUM>' of the gasket <NUM>. The second pair of laterally extending struts 162A, 162B is preferably positioned between the proximal end of the second D-shaped attachment plug <NUM> and the distal face <NUM> of the annular plug <NUM>. As will be described in more detail herein, the laterally extending struts 160A-160B and 162A-162B preferably seat the free ends of butterfly-shaped connectors that extend proximally from a proximal end of the inner manifold <NUM> (<FIG>).

In one embodiment, the distal face <NUM> of the annular plate <NUM> of the gasket <NUM> includes a first butterfly-shaped opening <NUM> that is aligned with the first lumen <NUM>'. The first butterfly-shaped opening <NUM> is configured to receive a first butterfly-shaped connector that extends proximally from the inner manifold <NUM> (<FIG>). In one embodiment, the distal face <NUM> of the annular plate <NUM> of the gasket <NUM> includes a second butterfly-shaped opening <NUM> that is aligned with the second lumen <NUM>'. The second butterfly-shaped opening <NUM> is configured to receive a second butterfly-shaped connector that extends proximally from the inner manifold <NUM> (<FIG>).

Referring to <FIG>, in one embodiment, the tip housing <NUM> (<FIG>) of the anti-clogging spray tip preferably includes a tubular-shaped body <NUM> having a proximal end <NUM> and a distal end <NUM>. The tubular-shaped body <NUM> of the tip housing <NUM> desirably includes an elongated conduit <NUM> that extends from a first opening <NUM> located at the proximal end <NUM> of the tubular member <NUM> and a second opening <NUM> located at the distal end <NUM> of the tubular member <NUM>.

Referring to <FIG>, in one embodiment, the tubular member <NUM> has an inner surface <NUM> that surrounds the elongated conduit <NUM> and that extends from the proximal end <NUM> to the distal end <NUM> of the tubular member <NUM>. In one embodiment, the tip housing <NUM> preferably has internal threads <NUM> that are formed in the inner surface <NUM> of the tubular member <NUM>. In one embodiment, the internal threads <NUM> are preferably adjacent the proximal end <NUM> of the tubular member <NUM>. The internal threads <NUM> are adapted to receive the external threads <NUM> at the distal end of the connector <NUM> (<FIG>) for securing the distal end of the connector <NUM> with the proximal end of the tip housing <NUM>, with the gasket <NUM> (<FIG>) being positioned between the distal end of the connector <NUM> and the tip housing <NUM>.

Referring to <FIG>, in one embodiment, the inner manifold <NUM> (<FIG>) preferably includes a tubular member <NUM> having a proximal end <NUM> and a distal end <NUM>. The inner manifold <NUM> desirably includes an annular sealing flange <NUM> that is secured to the proximal end <NUM> of the tubular member <NUM>. In one embodiment, the annular sealing flange <NUM> desirably includes a proximal face <NUM> that is adapted to abut against the distal face <NUM> of the gasket <NUM> (<FIG>) when the components of the anti-clogging spray tip are assembled together. In one embodiment, the inner manifold <NUM> desirably includes a first butterfly-shaped connector <NUM> that projects proximally from the proximal face <NUM> of the annular sealing flange <NUM>. The inner manifold <NUM> desirably includes a second butterfly-shaped connector <NUM> that also projects proximally from the proximal face <NUM> of the annular sealing flange <NUM> of the inner manifold <NUM>. In one embodiment, the first and second butterfly-shaped connectors <NUM>, <NUM> are adapted to be inserted into the respective butterfly-shaped openings <NUM>, <NUM> formed in the distal face <NUM> of the annular plate <NUM> of the gasket <NUM> (<FIG>).

In one embodiment, the first butterfly-shaped connector <NUM> desirably includes a first lumen <NUM>" that is adapted to be aligned with the first lumen <NUM>' (<FIG>) of the gasket <NUM> and the first lumen <NUM> of the connector <NUM> (<FIG>). In one embodiment, the second butterfly-shaped connector <NUM> desirably includes a second lumen <NUM>" that is adapted to be aligned with the second lumen <NUM>' of the gasket <NUM> (<FIG>) and the second lumen <NUM> of the connector (<FIG>). When the connector, the gasket, the tip housing and the inner manifold are assembled together, a first cannula for a first fluid preferably passes through the first lumen <NUM> of the connector <NUM> (<FIG>), the first lumen <NUM>' of the gasket <NUM> (<FIG>), and the first lumen <NUM>" of the first butterfly-shaped connector <NUM> (<FIG>), and a second cannula for a second fluid preferably passes through the second lumen <NUM> of the connector <NUM> (<FIG>), the second lumen <NUM>' of the gasket <NUM> (<FIG>), and the second lumen <NUM>" of the second butterfly-shaped connector <NUM> (<FIG>).

In one embodiment, the distal end <NUM> of the tubular member <NUM> of the inner manifold <NUM> is bifurcated into a first terminal chamber <NUM> for a first fluid of a multiple component material and a second terminal chamber <NUM> for a second fluid of the multiple component material. The distal end <NUM> of the tubular member <NUM> preferably includes a space <NUM> that extends between the first and second terminal chambers <NUM>, <NUM> for spacing the first and second terminal chambers from one another. In one embodiment, the first fluid of a multiple component material is passed through the first lumen <NUM>" for being directed into the first terminal chamber <NUM>, and the second fluid of the multiple component material is passed through the second lumen <NUM>" for being directed into the second terminal chamber <NUM>. In one embodiment, the first and second terminal chambers <NUM>, <NUM> maintain the first and second fluids away from one another.

In one embodiment, the first terminal chamber <NUM> desirably has an outer wall with radial openings 200A, 200B formed therein that enable the first fluid of the multiple component material to exit radially from the first terminal chamber. In one embodiment, the second terminal chamber <NUM> desirably has an outer wall with radial openings 202A, 202B formed therein that enable the second fluid of the multiple component material to exit radially the second terminal chamber.

Referring to <FIG>, in one embodiment, the inner manifold <NUM> preferably includes the first lumen <NUM>" that extends through the first butterfly-shaped connector <NUM> and the annular seal <NUM> to an end wall at the distal end of the first terminal chamber <NUM>. In one embodiment, the inner manifold <NUM> preferably includes first radial openings 200A, 200B (<FIG>) formed in the outer wall of the first terminal chamber <NUM> for enabling a first fluid of a multiple component material that flows through the first lumen <NUM>" to exit radially from distal end of the first terminal chamber <NUM>.

The inner manifold <NUM> preferably includes the second lumen <NUM>" that extends through the second butterfly-shaped connector <NUM> and the annular seal <NUM> to an end wall at the distal end of the second terminal chamber <NUM>. In one embodiment, the inner manifold <NUM> preferably includes second radial openings 202A, 202B (<FIG>) formed in the outer wall of the second terminal chamber <NUM> for enabling a second fluid of the multiple component material that flows through the second lumen <NUM>" to exit radially from the distal end of the second terminal chamber <NUM>.

Referring to <FIG>, in one embodiment, the first lumen <NUM>" terminates at an end wall of the first terminal chamber <NUM>. The first terminal chamber <NUM> preferably includes the first radial openings 200A, 200B that are formed in the outer wall of the first terminal chamber <NUM>. The inner manifold <NUM> preferably includes first radially-extending flutes <NUM>, <NUM> that extend outwardly from the first lumen <NUM>" to the respective first radial openings 200A, 200B. In one embodiment, when the first fluid of the multiple component material reaches the distal end of the first lumen <NUM>" it is directed radially outward through the first radially-extending flutes <NUM>, <NUM> whereupon it exits the distal end of the first terminal chamber <NUM> via the first radial openings 200A, 200B.

In one embodiment, the second lumen <NUM>" terminates at an end wall of the second terminal chamber <NUM>. The second terminal chamber <NUM> preferably includes the second radial openings 202A, 202B that are formed in the outer wall of the second terminal chamber <NUM>. The inner manifold <NUM> preferably includes second radially-extending flutes <NUM>, <NUM> that extend outwardly from the second lumen <NUM>" to the respective second radial openings 202A, 202B. In one embodiment, when the second fluid of the multiple component material reaches the distal end of the second lumen <NUM>" it is directed radially outward through the second radially-extending flutes <NUM>, <NUM> whereupon it exits the distal end of the second terminal chamber <NUM> via the second radial openings 202A, 202B.

In one embodiment, the first and second terminal chambers <NUM>, <NUM> are spaced from one another via a space <NUM> that extends therebetween. In one embodiment, opposing walls of the first and second terminal chambers define the space <NUM>. As will be described in more detail herein, the space <NUM> extending between the first and second terminal chambers <NUM>, <NUM> may receive a securing flange provided on a proximal side of the dispensing cap <NUM> (<FIG>) for securing the dispensing cap to the distal end of the inner manifold <NUM>.

Referring to <FIG>, in one embodiment, the dispensing cap <NUM> of the anti-clogging spray tip preferably includes a tubular shaped body <NUM> having a proximal end <NUM> and distal end <NUM>. The distal end <NUM> of the dispensing cap <NUM> preferably has a distal end wall <NUM> having an outer surface <NUM>. In one embodiment, the dispensing cap <NUM> preferably includes a first raised orifice <NUM> having a first raised mound <NUM> and a first spray opening <NUM> formed in the first raised mound <NUM>. In one embodiment, the dispensing cap <NUM> preferably includes a second raised orifice <NUM> having a second raised mound <NUM> and a second spray opening <NUM> formed in the second raised mound <NUM>. In one embodiment, the first and second raised orifices <NUM>, <NUM> preferably project distally from the outer surface <NUM> of the distal end wall <NUM>.

In one embodiment, the first fluid of the multiple component material is discharged through the first radial openings 200A, 200B of the first terminal chamber <NUM> (<FIG>), whereupon the first fluid is further directed through the first raised orifice <NUM> of the dispensing cap <NUM>. In one embodiment, the second fluid of the multiple component material that flows out of the radial openings 202A, 202B of the second terminal chamber <NUM> (<FIG>) is further directed through the second raised orifice <NUM> of the dispensing cap <NUM>.

In one embodiment, the dispensing cap <NUM> desirably includes an external dividing wall <NUM> that projects distally from the outer surface <NUM> of the distal end wall <NUM> of the dispensing cap. In one embodiment, the external dividing wall <NUM> has a height H<NUM> that projects beyond the outer surface <NUM> of the distal end wall <NUM> of the dispensing cap <NUM>. In one embodiment, the external dividing wall <NUM> functions as a barrier between the first and second raised orifices <NUM>, <NUM> to prevent the first and second fluids that are sprayed from the respective first and second raised orifices from contacting one another and reacting together over the outer surface <NUM> of the distal end wall <NUM> of the end cap. Thus, the external dividing wall <NUM> serves to minimize clogging of one or more of the first and second spray openings <NUM>, <NUM> of the respective first and second raised orifices <NUM>, <NUM>.

Referring to <FIG>, in one embodiment, the proximal end <NUM> of the tubular body <NUM> of the dispensing cap <NUM> preferably includes a first D-shaped chamber <NUM> that is configured to receive the first terminal chamber <NUM> located at the distal end <NUM> of the inner manifold <NUM> (<FIG>). In one embodiment, the dispensing cap <NUM> desirably includes a second D-shaped chamber <NUM> that is configured to receive the second terminal chamber <NUM> located at the distal end <NUM> of the inner manifold <NUM>. The dispensing cap <NUM> desirably includes an interior dividing wall <NUM> that separates the first D-shaped chamber <NUM> of the inner manifold <NUM> from the second D-shaped chamber <NUM> of the inner manifold <NUM>. In one embodiment, when the dispensing cap <NUM> is assembled with the distal end of the inner manifold <NUM>, the interior dividing wall <NUM> accessible at the proximal end <NUM> of the tubular member <NUM> is preferably inserted into the space <NUM> extending between the first and second terminal chambers <NUM>, <NUM> of the inner manifold <NUM> (<FIG>) for securing the dispensing cap <NUM> to the distal end of the inner manifold <NUM> (<FIG>).

Referring to <FIG>, in one embodiment, the dispensing cap <NUM> preferably includes the tubular body <NUM> having a proximal end <NUM> and a distal end <NUM>. The dispensing cap <NUM> preferably includes the first raised orifice <NUM> having a first raised mound <NUM> and a first spray opening <NUM> formed in the first raised mound <NUM>, which is in fluid communication with the first D-shaped chamber <NUM> of the dispensing cap. The dispensing cap <NUM> desirably includes a second raised orifice <NUM> having a second raised mound <NUM> with a second spray opening <NUM> formed in the second raised mound <NUM>, which is in fluid communication with the second D-shaped chamber <NUM> of the dispensing cap. The interior dividing wall <NUM> divides the first D-shaped chamber <NUM> from the second D-shaped chamber <NUM> for insuring that the first and second fluids of the multiple component material remain separated from one another until they are discharged via the first and second spray openings <NUM>, <NUM> of the respective first and second raised orifices <NUM>, <NUM>.

The exterior dividing wall <NUM> of the dispensing cap <NUM> preferably projects distally from the outer surface <NUM> of the distal end wall <NUM> of the dispensing cap <NUM>. The exterior dividing wall <NUM> divides the first and second raised orifices <NUM>, <NUM> from one another. The exterior dividing wall <NUM> preferably defines a height H<NUM> that extends above and/or beyond the outer surface <NUM> of the distal end wall <NUM> of the dispensing cap <NUM>.

In one embodiment, the first D-shaped chamber <NUM> includes a first inner surface <NUM> of the distal end wall <NUM> having a first fluid pathway <NUM> formed therein that is in fluid communication with the first spray opening <NUM> of the first raised orifice <NUM>. In one embodiment, the first fluid of the multiple component material that is directed into the first D-shaped chamber <NUM> is advanced into the first fluid pathway <NUM> for being rapidly rotated within the first swirl chamber <NUM> prior to being dispensed from the first spray opening <NUM> of the first raised orifice <NUM> of the dispensing cap <NUM>.

In one embodiment, the second D-shaped chamber <NUM> includes a second inner surface <NUM> of the distal end wall having a second fluid pathway <NUM> formed therein that is in fluid communication with the second spray opening <NUM> of the second raised orifice <NUM>. In one embodiment, the second fluid of the multiple component material that is directed into the second D-shaped chamber <NUM> is advanced into the second fluid pathway <NUM> for being rapidly rotated within the second swirl chamber <NUM> prior to being dispensed from the second spray opening <NUM> of the second raised orifice <NUM> of the dispensing cap <NUM>.

Referring to <FIG>, in one embodiment, the dispensing cap <NUM> preferably includes the interior dividing wall <NUM> that divides the first D-shaped chamber <NUM> and the second D-shaped chamber <NUM> from one another. The first D-shaped chamber <NUM> preferably includes an outer peripheral wall <NUM> having an inner surface <NUM> that is spaced away from the interior dividing wall <NUM>. The first fluid pathway <NUM> preferably includes the first swirl chamber <NUM> that surrounds the first spray opening <NUM> and a pair of first flutes 250A, 250B that extend inwardly from the inner surface <NUM> of the peripheral wall <NUM> toward the first swirl chamber <NUM>. In one embodiment, the first flutes 250A, 250B may have respective widths that narrow between the inner surface <NUM> and the first swirl chamber <NUM> for increasing the speed of the first fluid as it passes through the first flutes 250A, 250B toward the first swirl chamber <NUM>. In one embodiment, the configuration of the first flutes 250A, 250B relative to the first swirl chamber <NUM> preferably rotates the first fluid in a counterclockwise direction designated R1 as it enters into the first swirl chamber <NUM>. In one embodiment, the first fluid is rotated in the counterclockwise direction R1 prior to being dispensed/sprayed through the first spray opening <NUM>.

In one embodiment, the second D-shaped chamber <NUM> preferably includes an outer peripheral wall <NUM> having an inner surface <NUM> that is spaced away from the interior dividing wall <NUM>. The second fluid pathway <NUM> preferably includes the second swirl chamber <NUM> that surrounds the second spray opening <NUM> and a pair of second flutes 258A, 258B that extend inwardly from the inner surface <NUM> of the peripheral wall <NUM> toward the second swirl chamber <NUM>. In one embodiment, the second flutes 258A, 258B may have widths that narrow between the inner surface <NUM> of the peripheral wall <NUM> and the second swirl chamber <NUM> for increasing the speed of the first fluid as it passes through the second flutes 258A, 258B toward the second swirl chamber <NUM>. The configuration of the second flutes 258A, 258B relative to the second swirl chamber <NUM> preferably rotates the second fluid in a clockwise direction designated R2 as it enters into the second swirl chamber <NUM>. In one embodiment, the second fluid is rotated in the clockwise direction R2 prior to being dispensed through the second spray opening <NUM>.

In one embodiment, when the first fluid of the multiple component material enters into the first D-shaped chamber <NUM> of the dispensing cap <NUM>, the first fluid preferably flows into the outer ends of the first flutes 250A, 250B, whereupon the first flutes direct the first fluid into the outer periphery of the first swirl chamber <NUM> for rotating the first fluid in the counterclockwise direction R1 as it is sprayed from the first spray opening <NUM>. Similarly, when the second fluid of the multiple component material enters into the second D-shaped chamber <NUM> of the dispensing cap <NUM>, the second fluid preferably flows into the outer ends of the second flutes 258A, 258B, whereupon the second flutes direct the second fluid into the outer perimeter of the second swirl chamber <NUM> for rotating the second fluid in the clockwise direction R2 as it is sprayed from the second spray opening <NUM>.

Referring to <FIG> and <FIG>, in one embodiment, the first spray opening <NUM> of the first fluid pathway <NUM> preferably defines a first diameter D<NUM> and the first swirl chamber <NUM> preferably defines a second diameter D<NUM> that is greater than the first diameter D<NUM> of the first spray opening <NUM>. In one embodiment, the first spray opening <NUM> may be located in the center of the first swirl chamber <NUM>. In one embodiment, a first one 250A of the first flutes desirably has an outer end 260A that is located adjacent the inner surface <NUM> of the outer peripheral wall <NUM> and an inner end 260B that is located adjacent the outer periphery of the first swirl chamber <NUM>. In one embodiment, the first one 250A of the first flutes preferably has a width W<NUM> of about <NUM>-<NUM> (<NUM>-<NUM> inches) that narrows between the outer end 260A and the inner end 260B thereof. In one embodiment, the narrowing of the first one 250A of the first flutes preferably increases the speed of the first fluid as it passes from the outer end 260A toward the inner end 260B of the first one 250A of the first flutes.

In one embodiment, a second one 250B of the first flutes desirably has an outer end 262A that is located adjacent the inner surface <NUM> of the outer peripheral wall <NUM> and an inner end 262B that is located adjacent the outer periphery of the first swirl chamber <NUM>. In one embodiment, the first one 250B of the first flutes preferably has a width W<NUM> that narrows between the outer end 262A and the inner end 262B thereof. In one embodiment, the narrowing of the second one 250B of the first flutes preferably increases the speed of the first fluid as it passes from the outer end 262A toward the inner end 262B of the second one 250B of the first flutes.

Referring to <FIG> through <FIG>, in one embodiment, the first fluid pathway <NUM> is formed in the inner surface <NUM> of the distal end wall <NUM> of the first D-shaped chamber <NUM> of the dispensing cap <NUM>. In one embodiment, the first fluid pathway <NUM> including the first swirl chamber <NUM> and the first flutes 250A, 250B (<FIG>) define a height H1 of about <NUM>-<NUM> (<NUM>-<NUM> inches).

In one embodiment, the first spray opening <NUM> preferably has a diameter D1 that is less than the diameter D2 of the first swirl chamber <NUM>. In one embodiment, the first spray opening preferably has a length L1.

Referring to <FIG>, in one embodiment, the dimensions of the first fluid pathway <NUM> may be modified to control the speed and/or the rate of rotation of the first fluid flowing through the first fluid pathway <NUM>. Thus, one or more of the width and the height of the first flutes 250A, 250B may be modified to control the speed of the first fluid flowing through the first flutes. Moreover, the degree of narrowing of the first flutes 250A. 250B between the respective outer and inner ends thereof may be modified to control the speed of the first fluid flowing through the first flutes. In addition, the diameter D1, the height H1, and/or the chamfer of the first swirl chamber <NUM> may be modified to control the speed and/or the rate of rotation of the first fluid that is directed into the first spray opening <NUM>. In one embodiment, the diameter D1 and the length L1 of the first spray opening <NUM> may be modified to control the speed and/or the dispensing angle of the first fluid as it is dispensed from the first spray opening.

Referring to <FIG>, in one embodiment, the anti-clogging spray tip <NUM> may be assembled together by overmolding the gasket <NUM> onto the proximal end of the inner manifold <NUM>. In one embodiment, after the gasket <NUM> is assembled to the proximal end of the inner manifold <NUM>, the distal end of the gasket <NUM>/inner manifold <NUM> subassembly may be inserted into the first opening <NUM> at the proximal end <NUM> of the tip housing <NUM> for assembling the gasket <NUM>/inner manifold <NUM>/tip housing <NUM> subassembly.

In one embodiment, the external threads <NUM> at the distal end <NUM> of the connector <NUM> are preferably threaded into the internal threads <NUM> located inside the proximal end of the tip housing <NUM> for securing the connector <NUM> with the tip housing <NUM>.

In one embodiment, in order to assembly the anti-clogging spray tip <NUM> to the connector <NUM>, the first and second D-shaped attachment plugs <NUM>, <NUM> of the gasket <NUM> are desirably inserted into the respective D-shaped exit chambers <NUM>, <NUM> at the distal end <NUM> of the connector <NUM>. In one embodiment, the outer surfaces of the D-shaped attachment plugs <NUM>, <NUM> preferably form a friction fit with the inner surfaces of the respective D-shaped exit chambers <NUM>, <NUM>.

Referring to <FIG>, in one embodiment, the inner manifold <NUM> may be assembled with the tip housing <NUM> by inserting the first and second butterfly-shaped connectors <NUM>, <NUM> and the annular sealing flange <NUM> located at the proximal end <NUM> of the inner manifold <NUM> into the second opening <NUM> at the distal end <NUM> of the tip housing <NUM>. In one embodiment, the inner manifold <NUM> is advanced in a proximal direction designated DIR1 until the first and second butterfly-shaped connectors <NUM>, <NUM> are inserted into the respective butterfly-shaped openings <NUM>, <NUM> formed in the distal end face <NUM> of the gasket <NUM> (<FIG>). In one embodiment, the outer surfaces of the first and second butterfly-shaped connectors <NUM>, <NUM> preferably form a friction fit with the respective butterfly-shaped openings <NUM>, <NUM> (<FIG>) of the gasket <NUM> for securing the proximal end of the inner manifold <NUM> with the connector <NUM>/gasket <NUM>/tip housing <NUM> subassembly (<FIG>).

In one embodiment, the dispensing cap <NUM> is preferably assembled with the distal end <NUM> of the inner manifold <NUM> by juxtaposing and/or aligning the interior dividing wall <NUM> of the dispensing cap <NUM> with the space <NUM> that extends between opposing inner walls of the first and second terminal chambers <NUM>, <NUM> of the inner manifold <NUM>.

In one embodiment, in order to assemble the dispensing cap <NUM> with the inner manifold <NUM>, the first and second D-shaped chambers <NUM>, <NUM> accessible on the proximal side of the dispensing cap <NUM> are juxtaposed with the respective first and second terminal chambers <NUM>, <NUM> located at the distal end <NUM> of the inner manifold <NUM>. In one embodiment, the dispensing cap <NUM> is advanced in the proximal direction DIR1 so that the interior dividing wall <NUM> of the dispensing cap <NUM> advances into the space <NUM> between the first and second terminal chambers <NUM>, <NUM> of the inner manifold <NUM>. The dispensing cap <NUM> is preferably advanced proximally until the end walls <NUM>, <NUM> of the respective D-shaped chambers <NUM>, <NUM> of the dispensing cap (<FIG>) abut against a distal face <NUM> (<FIG>) of the inner manifold <NUM>.

In one embodiment, when the dispensing cap <NUM> is secured over the first and second terminal chambers <NUM>, <NUM>, the first radial openings 200A, 200B (<FIG>) of the first terminal chamber <NUM> (<FIG>) are preferably aligned with the outer ends of the first flutes 250A, 250B (<FIG>) of the dispensing cap <NUM>, and the second radial openings 202A, 202B of the second terminal chamber <NUM> (<FIG>) are preferably aligned with the outer ends of the second flutes 256A, 256B (<FIG>) of the dispensing cap <NUM>. In one embodiment, the first fluid of the multiple component material exits from the first terminal chamber via the first radial openings 200A, 200B (<FIG>) whereupon it is directed into the outer ends of the first flutes 250A, 250B (<FIG>). In one embodiment, the second fluid of the multiple component material exits from the second terminal chamber via the second radial openings 202A, 202B (<FIG>) whereupon it is directed into the outer ends of the second flutes 254A, 254B (<FIG>).

Referring to <FIG>, in one embodiment, the fully assembled anti-clogging spray tip <NUM> preferably includes the connector <NUM>, which has a distal end with external threads that mesh with internal threads located at the proximal end of the tip housing <NUM>. The gasket <NUM> (<FIG>) is preferably disposed between the distal end of the connector <NUM> and the tip housing <NUM>. In one embodiment, the proximal end <NUM> of the tip housing <NUM> preferably surrounds the gasket. The anti-clogging spray tip <NUM> desirably includes the dispensing cap <NUM> that is accessible at the distal-most end of the anti-clogging spray tip <NUM>. The inner manifold <NUM> (<FIG>) is preferably disposed within the tip housing <NUM> and extends between the distal end of the connector <NUM> and the dispensing cap <NUM>. The exterior dividing wall <NUM> of the dispensing cap <NUM>, which projects distally from the distal end face <NUM> of the dispensing cap <NUM>, provides a barrier that separates the first raised mound <NUM> from the second raised mound <NUM> so that the first and second fluids that are sprayed from the respective first and second raised mounds do not mix with one another over the distal end face <NUM>, which minimizes the likelihood of the first and second raised mounds becoming clogged during a spraying operation.

Referring to <FIG> and <FIG>, in one embodiment, the anti-clogging spray tip <NUM> preferably includes the distal end <NUM> of the connector <NUM> inserted into the opening at the proximal end <NUM> of the tip housing <NUM>. The external threads <NUM> (<FIG>) at the distal end <NUM> of the connector <NUM> are desirably threaded into the internal threads <NUM> located inside the proximal end <NUM> of the tip housing <NUM> for securing the connector <NUM> and the tip housing <NUM> to one another. The gasket <NUM> is desirably juxtaposed between the distal end <NUM> of the connector <NUM> and the annular sealing flange <NUM> of the inner manifold <NUM>. The D-shaped attachment plugs <NUM>, <NUM> of the gasket <NUM>, which preferably project proximally from a proximal end face of the annular plate <NUM> of the gasket <NUM>, are inserted into the respective D-shaped exit chambers <NUM>, <NUM> (<FIG>) located at the distal end <NUM> of the connector <NUM> for securing the gasket <NUM> to the distal end of the connector. In one embodiment, the annular plate <NUM> of the gasket <NUM> is preferably juxtaposed between the distal end <NUM> of the connector <NUM> and the annular sealing flange <NUM> located at the proximal end <NUM> of the inner manifold <NUM>. The first and second butterfly-shaped connectors <NUM>, <NUM>, projecting proximally from the proximal end of the inner manifold <NUM>, are preferably inserted into the butterfly shaped openings formed in the distal end face <NUM> (<FIG>) of the gasket <NUM> for assembling the proximal end of the inner manifold <NUM> with the gasket <NUM>.

Referring to <FIG>, in one embodiment, in order to secure the gasket <NUM> (<FIG>) with the connector <NUM>, the D-shaped attachment plugs <NUM>, <NUM> of the gasket <NUM> (<FIG>) are preferably inserted into the respective D-shaped exit chambers <NUM>, <NUM> of the connector <NUM> (<FIG>), whereupon the outer surfaces of the D-shaped attachment plugs <NUM>, <NUM> of the gasket <NUM> preferably form a friction fit with the inner surfaces of the respective D-shaped exit chambers <NUM>, <NUM> of the connector <NUM>. The first butterfly-shaped connector <NUM> of the inner manifold <NUM> (<FIG>) preferably includes a first lumen <NUM>" that is adapted to receive a first cannula that contains a first fluid of a multiple component material. The second butterfly-shaped connector <NUM> of the inner manifold <NUM> (<FIG>) preferably includes a second lumen <NUM>" that is adapted to receive a second cannula that contains a second fluid of a multiple component material.

Referring to <FIG>, in one embodiment, in order to secure the proximal end of the inner manifold <NUM> with the gasket <NUM> (<FIG>), the outer surfaces of the first and second butterfly-shaped connectors <NUM>, <NUM> of the inner manifold are preferably inserted into the butterfly-shaped openings <NUM>, <NUM> (<FIG>) formed in the distal face of the gasket <NUM>, whereupon the outer surfaces of the first and second butterfly-shaped connectors <NUM>, <NUM> form a friction fit with the respective butterfly-shaped openings of the gasket <NUM>. The first butterfly-shaped connector <NUM> preferably includes a first lumen <NUM>" that is adapted to receive a first cannula that contains a first fluid of a multiple component material. The second butterfly-shaped connector <NUM> preferably includes a second lumen <NUM>" that is adapted to receive a second cannula that contains a second fluid of a multiple component material.

Referring to <FIG> and <FIG>, in one embodiment, the internal dividing wall <NUM> of the dispensing cap <NUM> is preferably inserted into the space <NUM> that divides the first and second terminal chambers <NUM>, <NUM> of the inner manifold <NUM> from one another. In one embodiment, the internal dividing wall <NUM> preferably forms a friction fit with the distal end <NUM> of the inner manifold <NUM> for securing the dispensing cap <NUM> and the inner manifold <NUM> together. In one embodiment, the inner surfaces <NUM>, <NUM> (<FIG>) of the distal end wall <NUM> of the respective first and second D-shaped chambers <NUM>, <NUM> (<FIG>) of the dispensing cap preferably engage the distal end wall <NUM> (<FIG>) of the inner manifold <NUM>. The tubular member <NUM> of the dispensing cap <NUM> preferably surrounds the outer surfaces of the respective first and second terminal chambers <NUM>, <NUM> of the inner manifold <NUM>. The exterior dividing wall <NUM> of the dispensing cap <NUM> preferably projects distally from the distal face <NUM> of the distal end wall <NUM> of the dispensing cap <NUM> for acting as a barrier that separates the respective first and second raised orifices <NUM>, <NUM> from one another.

Referring to <FIG>, in one embodiment, the first terminal chamber <NUM> of the inner manifold <NUM> preferably includes first radial openings 200A, 200B (<FIG>) that directs the first fluid of the multi-component material out of the first terminal chamber <NUM> and into the first fluid pathway <NUM> of the dispensing cap <NUM> (<FIG>) whereupon the first fluid is swirled within the first fluid pathway prior to being sprayed from the first spray opening <NUM> of the first raised orifice <NUM> of the dispensing cap <NUM>. The second terminal chamber <NUM> of the inner manifold <NUM> preferably includes second radial openings 202A, 202B (<FIG>) that direct the second fluid of the multi-component material out of the second terminal chamber <NUM> and into the second fluid pathway <NUM> of the dispensing cap <NUM> (<FIG>) whereupon the second fluid is swirled within the second fluid pathway prior to being sprayed from the second spray opening <NUM> of the second raised orifice <NUM> of the dispensing cap <NUM>.

The external dividing wall <NUM> of the dispensing cap <NUM> projects distally from the distal surface <NUM> of the distal end wall <NUM> of the dispensing cap <NUM> to insure that the first and second fluids of the multi-component material do not mix on the distal surface <NUM> of the distal end wall <NUM>, which may result in clogging of the first spray opening <NUM> of the first raised orifice <NUM> and/or the second spray opening <NUM> of the second raised orifice <NUM>.

Referring to <FIG>, in one embodiment, a dispensing device <NUM> preferably includes a manifold <NUM> that directs the first and second fluids of a multi-component material through first and second cannulas <NUM>, <NUM>, respectively, toward an anti-clogging spray tip <NUM> that is constructed as disclosed herein. The anti-clogging spray tip <NUM> has a distally extending exterior dividing wall <NUM> that preferably divides and separates first and second raised mounds <NUM>, <NUM> from one another. The first and second fluids may be sprayed from the respective first and second raised orifices <NUM>, <NUM> whereupon the first and second fluids mix together for reacting with one another.

Referring to <FIG>, in one embodiment, a dispensing device <NUM> may be similar to that shown and described herein and preferably includes first and second one way check valves <NUM>, <NUM> associated with each of the first and second fluids of a multiple component material to prevent back flow of the first and second fluids, which could result in clogging of the anti-clogging spray tip <NUM>.

Claim 1:
A spray tip (<NUM>) for dispensing fluids that react together comprising:
a first lumen (<NUM>);
a second lumen (<NUM>);
a dispensing cap (<NUM>) located at distal ends of said respective first and second lumens (<NUM>, <NUM>) and defining a distal end of said spray tip (<NUM>), said dispensing cap (<NUM>) comprising
a distal end wall (<NUM>) defining a closed end of said dispensing cap (<NUM>);
a first spray orifice (<NUM>) formed in said distal end wall (<NUM>) that is in fluid communication with said first lumen (<NUM>), wherein said first spray orifice (<NUM>) includes a first raised mound (<NUM>) that projects distally from an outer surface of said distal end wall (<NUM>) of said dispensing cap (<NUM>),
a second spray orifice (<NUM>) formed in said distal end wall (<NUM>) that is in fluid communication with said second lumen (<NUM>), wherein said second spray orifice (<NUM>) includes a second raised mound (<NUM>) that projects distally from the outer surface of said distal end wall (<NUM>) of said dispensing cap (<NUM>), and
an external dividing wall (<NUM>) that projects distally from said distal end wall (<NUM>) of said dispensing cap (<NUM>) and that extends between said first and second spray orifices (<NUM>, <NUM>) for forming a barrier between said first and second spray orifices (<NUM>, <NUM>).