Sealant applicator having a mixing spray assembly with a malleable section - Patents.com

Abstract

The mixed spray assembly for tissue sealant includes a mixing assembly, a spray tip assembly, and a malleable section having a proximal end connected to the mixing assembly and a distal end connected to the spray tip assembly to allow the spray tip assembly to be angled relative to the mixing assembly. The malleable section includes a flexible shaft having a length, a malleable wire conduit extending along the length of the flexible shaft, and a malleable wire disposed within the malleable wire conduit. The malleable wire is longer than the flexible shaft and has a proximal end connected to the mixing assembly and a distal end connected to the spray tip assembly. The first and second fluids are mixed in the mixing assembly to form a tissue sealant, which is delivered through the malleable section to be pumped out of the spray tip assembly.

Description

[Technical field]

[0001] This patent application relates to medical devices, and more particularly to systems, devices and methods for expressing tissue sealants and hemostatic agents during surgical procedures. [Background technology]

[0002] Mammals may experience bleeding due to a wound or during a surgical procedure. In some cases, the bleeding is minor and stops due to normal blood clotting function or by using simple first aid techniques. In other cases, however, excessive bleeding can occur, which requires the use of specialized equipment and materials, as well as the services of trained personnel to administer effective treatment.

[0003] To address the more challenging situations mentioned above, various materials have been developed to control excessive bleeding. For example, topical absorbable hemostats (TAHs) are widely used in surgical applications. TAHs include products based on oxidized cellulose (OC), oxidized regenerated cellulose (ORC), gelatin, collagen, chitin, chitosan, starch, etc. To improve hemostatic performance, scaffolds based on the above materials can be combined with biologically derived clotting factors such as thrombin and fibrinogen.

[0004] Controlling bleeding is essential and important in surgical procedures to minimize blood loss, shorten operation time, and reduce postoperative complications.

[0005] Recently, minimally invasive surgery (MIS) techniques have emerged as an alternative to traditional surgical techniques for performing a wide range of surgical procedures. MIS procedures differ from traditional surgical procedures in that multiple devices and / or surgical tools may be introduced into the body through cannulas and / or trocars that are inserted into small incisions made in the body. The use of MIS techniques results in less trauma to the body and shorter recovery times for patients.

[0006] One type of minimally invasive surgery includes laparoscopic surgical procedures, which are used to treat hernias, colonic dysfunction, gastroesophageal reflux disease, gallbladder disease, pulmonary disease, etc. Typically, patients undergoing laparoscopic surgical procedures are able to go home after a short recovery period (e.g., within a few hours of having surgery).

[0007] One challenge presented when performing MIS procedures relates to controlling bleeding at the surgical site. In contrast to traditional open surgical procedures, during laparoscopic procedures, the surgeon's access to the surgical site or cavity is greatly reduced.

[0008] In response, tissue sealants and other biological adhesive materials have been developed for use in closing incisions and wounds at surgical sites. Tissue sealants may include fibrin sealants, which include thrombin and fibrinogen materials, although other formulations are available. Typically, the individual components of the tissue sealant (e.g., thrombin and fibrinogen) are stored separately in separate reservoirs because these components react rapidly when they come into contact with each other. Often, the two separate components are not mixed until just before application to the tissue.

[0009] When mixed, these components solidify very quickly, resulting in an adhesive gel within a short period of time (eg, within 10-20 seconds).

[0010] Some developments have been made regarding systems for expressing tissue sealants. For example, US Patent No. 6,458,095 discloses a dispenser for simultaneously dispensing a first component and a second component of an adhesive tissue sealant, where at least the first component is stored in the dispenser as a dry powder that is dissolved before use by the introduction of a solvent. The dispenser includes a first container having a first septum at one end, an open end opposite the first septum, and a first movable plug disposed therein. The first container holds a quantity of the first component in the form of a dry powder stored between the first septum and the first movable plug. The dispenser includes a second container having a second septum at one end, an open end opposite the second septum, and a second movable plug disposed therein, where the second container contains a quantity of the second component.

[0011] U.S. Patent No. 10,183,132, assigned to Ethicon LLC, the disclosure of which is incorporated herein by reference, teaches an integrated delivery device that is operable with one hand and provides simultaneous delivery of liquid and powdered medicaments onto tissue or wounds from liquid and powdered medicament expression subunits, each having actuators for the liquid and powdered medicaments contained therein, disposed adjacent to each other at a proximal end of the expression subunit, and a delivery cannula for each of the expression subunits, disposed adjacent to each other at a distal end of the expression subunit.

[0012] U.S. Patent No. 10,507,293 to Goodman et al., assigned to Ethicon, Inc. of Somerville, New Jersey, the disclosure of which is incorporated herein by reference, teaches a device for the expression of hemostatic powder. The device has an elongated reservoir with a manual air pump, such as a bellows, at a proximal end and an expression port at a distal end. A porous filter is slidably disposed within the reservoir between the bellows, the plunger, and the expression port, and a spring is disposed within the reservoir between the air pump and the plunger. A device is described in which a powder is disposed within the reservoir between the porous filter and the expression port, and a pump is in fluid communication with the expression port through the porous filter and the powder.

[0013] U.S. Patent No. 2021 / 0101162, assigned to Ethicon, Inc., the disclosure of which is incorporated herein by reference, discloses a spraying device including a first spray tip having a first fluid path defining a first flow rate range and a second spray tip including a second fluid path defining a second flow rate range wider than the first flow rate range of the first spray tip. The first spray tip and the second spray tip are juxtaposed and spaced apart from one another at a distal end of the spraying device. When a first fluid having a volumetric flow rate is introduced into the first spray tip and a second fluid having the same volumetric flow rate is introduced into the second spray tip, the first fluid flows through the first fluid path at a rate greater than the rate at which the second fluid flows through the second fluid path. Summary of the Invention [Problem to be solved by the invention]

[0014] Despite the above advances, there remains a continuing need for improved systems, devices, and methods for delivering tissue sealants and hemostatic agents to a patient to control bleeding. Also needed is a sealant applicator for use in minimally invasive surgery that allows tissue sealants and hemostatic agents to be delivered to tight spaces and small surgical sites within a patient. [Means for solving the problem]

[0015] During minimally invasive surgery, it may be necessary to apply tissue sealants within small confined spaces. For example, the thoracic cavity is a small confined space, which makes it difficult for a conventional spray tip to fit inside the cavity and be far enough away from the lung surface to achieve good spray quality that effectively seals the lung tissue. In response to these issues, the present patent application discloses a short, malleable spray tip assembly that allows the spray tip to bend within a small confined space and still be far enough away from the lung surface to achieve good spray quality.

[0016] In one embodiment, a sealant applicator for expressing tissue sealant or hemostatic agent has a mixing spray assembly including a spray tip assembly that is preferably spaced from the mixing assembly by a malleable section that includes a flexible shaft that houses a malleable wire. The malleable section allows the spray tip assembly to be angled relative to the mixing assembly. The spray tip assembly has a shorter length and smaller outer diameter, which allows the spray tip assembly to be placed in smaller spaces and tighter body cavities to effectively express tissue sealant and hemostatic agent onto tissue.

[0017] In one embodiment, a mixing spray assembly for a tissue sealant preferably includes a mixing assembly located at a proximal end of the mixing spray assembly, a spray tip assembly located at a distal end of the mixing spray assembly, and a malleable section having a proximal end connected to the mixing assembly and a distal end connected to the spray tip assembly, allowing the spray tip assembly to be angled relative to the mixing assembly.

[0018] In one embodiment, the malleable section includes a flexible shaft having a proximal end, a distal end, and a length extending between the proximal and distal ends, a malleable wire conduit extending along the length of the flexible shaft, and a malleable wire disposed within the malleable wire conduit of the flexible shaft.

[0019] In one embodiment, the malleable wire has a length greater than the length of the flexible shaft, hi one embodiment, the malleable wire has a proximal end that extends beyond the proximal end of the flexible shaft and is connected to the mixing assembly, and a distal end that extends beyond the distal end of the flexible shaft and is connected to the spray tip assembly.

[0020] In one embodiment, the mixing assembly includes a mixer housing having a proximal end, a distal end, and a mixer housing conduit that extends along the length of the mixer housing from the proximal end to the distal end of the mixer housing.

[0021] In one embodiment, a mixing element is disposed within the mixer housing conduit. In one embodiment, a proximal end of a malleable wire that extends beyond the proximal end of the flexible shaft is secured to the mixing element.

[0022] In one embodiment, the mixing element preferably includes a static mixer having a central shaft extending along the length of the static mixer, the central shaft having a proximal end and a distal end. In one embodiment, a blind hole may be formed in the central shaft of the static mixer, extending from the distal end of the central shaft toward the proximal end of the central shaft. The blind hole may extend about 1 / 2 to 3 / 4 of the length of the central shaft of the static mixer.

[0023] In one embodiment, the proximal end of the malleable wire may be disposed within a blind hole formed in a central shaft of the static mixer to connect the proximal end of the malleable wire to the static mixer.

[0024] In one embodiment, the mixing assembly may include a proximal connector having a proximal end configured to be inserted into an opening at the distal end of the elongated cannula of the sealant applicator and a distal end having male threads.

[0025] In one embodiment, the mixer housing preferably has female threads located at a proximal end of the mixer housing that are configured to mate with male threads at a distal end of the proximal connector to secure the mixer housing to the proximal connector.

[0026] In one embodiment, the proximal connector may have a first fluid pathway extending from a proximal end to a distal end of the proximal connector, such that the first fluid pathway is in fluid communication with the proximal end of the static mixer.

[0027] In one embodiment, the proximal connector may have a second fluid pathway extending from the proximal end to the distal end of the proximal connector, such that the second fluid pathway is in fluid communication with the proximal end of the static mixer.

[0028] In one embodiment, the first and second fluid paths extending through the proximal connector are distinct and / or separate from one another.

[0029] In one embodiment, a first flexible tube may be disposed within a first fluid path of the proximal connector to supply a first fluid to a proximal end of the mixer housing.

[0030] In one embodiment, a second flexible tube may be disposed within the second fluid path of the proximal connector to supply a second fluid to the proximal end of the mixer housing.

[0031] In one embodiment, the static mixer is adapted to mix the first fluid and the second fluid such that the first fluid and the second fluid react with each other to form a tissue sealant that can be expelled from the spray tip assembly.

[0032] In one embodiment, the flexible shaft of the malleable section may have one or more tissue sealant conduits extending along its length to supply tissue sealant which preferably flows downstream through the tissue sealant conduits for delivery to the spray tip assembly.

[0033] In one embodiment, the malleable wire conduit extends along a central axis of the flexible shaft, and the one or more tissue sealant conduits of the flexible shaft include a first tissue sealant conduit and a second tissue sealant conduit extending along opposite sides of the malleable wire conduit.

[0034] In one embodiment, the spray tip assembly may include a distal connector having a proximal end and a distal end having male threads, hi one embodiment, the proximal end of the distal connector has a central opening that seats the distal end of the flexible shaft.

[0035] In one embodiment, the distal end of the malleable wire that extends beyond the distal end of the flexible shaft is connected to a distal connector.

[0036] In one embodiment, the spray tip assembly may include a spray cup having a spray opening for expelling tissue sealant delivered through the first and second tissue sealant conduits of the flexible shaft.

[0037] In one embodiment, the spray cup has a tubular proximal end having female threads configured to mate with male threads on the distal end of the distal connector to secure the spray cup to the distal connector.

[0038] In one embodiment, the distal end of the malleable wire that is secured to the distal connector of the spray tip assembly may have a paddle-shaped flange having a width greater than the diameter of the section of the malleable wire that extends to the proximal end of the malleable wire.

[0039] In one embodiment, a mixing spray assembly for expressing a tissue sealant preferably includes a mixing assembly configured to mix a first fluid and a second fluid that chemically react with each other to form the tissue sealant, a spray tip assembly configured to express the tissue sealant, and a malleable section having a proximal end connected to the mixing assembly and a distal end connected to the spray tip assembly to allow the spray tip assembly to be angled relative to the mixing assembly.

[0040] In one embodiment, the malleable section has one or more tissue sealant conduits extending along its length for delivering tissue sealant from the mixing assembly to the spray tip assembly.

[0041] In one embodiment, the malleable section desirably includes a flexible shaft having a malleable wire conduit extending from its proximal end to its distal end and a malleable wire disposed within the malleable wire conduit.

[0042] In one embodiment, the malleable wire preferably has a proximal end that extends beyond the proximal end of the flexible shaft to be connected to the mixing assembly and a distal end that extends beyond the distal end of the flexible shaft to be connected to the spray tip assembly.

[0043] In one embodiment, the mixing assembly desirably includes a mixer housing having a proximal end, a distal end, and a mixer housing conduit extending from the proximal end to the distal end of the mixer housing.

[0044] In one embodiment, the mixing assembly may include a mixing element disposed within a mixer housing conduit of the mixer housing.

[0045] In one embodiment, the spray tip assembly preferably includes a distal connector coupled to the distal end of the flexible shaft and a spray cup having a spray opening secured to the distal end of the distal connector.

[0046] In one embodiment, the proximal end of the malleable wire is preferably secured to a mixing element disposed within the mixer housing, and the distal end of the malleable wire is preferably secured to a distal connector of the spray tip assembly.

[0047] In one embodiment, the mixing element preferably includes a static mixer having a central shaft extending along the length of the static mixer. In one embodiment, the central shaft of the static mixer has a proximal end and a distal end. In one embodiment, a blind hole is formed in the central shaft of the static mixer, extending from the distal end of the central shaft toward the proximal end of the central shaft. In one embodiment, a proximal end of a malleable wire is disposed in a blind hole formed in the central shaft of the static mixer to connect the proximal end of the malleable wire to the static mixer.

[0048] In one embodiment, the mixer housing has a longitudinal axis that extends from a proximal end to a distal end of the mixer housing, hi one embodiment, the malleable section allows the spray tip assembly to be angled relative to the longitudinal axis of the mixer housing.

[0049] In one embodiment, the mixer housing has a first outer diameter and the spray tip assembly has a second outer diameter that is smaller than the first outer diameter of the mixer housing.

[0050] In one embodiment, a method of expressing tissue sealant includes obtaining a mixing spray assembly, preferably including a mixing assembly, a spray tip assembly, and a malleable section having a proximal end connected to the mixing assembly and a distal end connected to the spray tip assembly, the malleable section spacing the spray tip assembly from the mixing assembly and allowing the spray tip assembly to be angled relative to the mixing assembly.

[0051] In one embodiment, the method may include directing a first fluid and a second fluid toward a proximal end of a mixing assembly and mixing the first fluid and the second fluid in the mixing assembly such that the first fluid and the second fluid react with each other to form a tissue sealant.

[0052] In one embodiment, the method may include passing a tissue sealant through one or more tissue sealant conduits extending through the malleable section to supply the tissue sealant to a spray tip assembly, and expressing the tissue sealant from a distal end of the spray tip assembly.

[0053] In one embodiment, the first fluid may include fibrinogen and the second fluid may include thrombin, which reacts with the fibrinogen to form a tissue sealant.

[0054] In one embodiment, the malleable section of the mixing spray assembly desirably includes a flexible shaft having a malleable wire conduit extending from its proximal end to its distal end and a malleable wire disposed within the malleable wire conduit. In one embodiment, the malleable wire has a proximal end that extends beyond the proximal end of the flexible shaft and a distal end that extends beyond the distal end of the flexible shaft. In one embodiment, the proximal end of the malleable wire is connected to the mixing assembly and the distal end of the malleable wire is connected to the spray tip assembly.

[0055] The systems, devices, and methods disclosed herein are not limited to use within the thoracic cavity, but may be used anywhere on a patient's body to express tissue sealant and / or hemostatic agent.

[0056] These and other preferred embodiments of the present invention are described in more detail below. [Brief description of the drawings]

[0057] [Figure 1]FIG. 1 is a perspective view of a sealant applicator including a syringe assembly, a sealant delivery assembly, and a mixing and spraying assembly according to an embodiment of the present patent application. [Diagram 2] FIG. 2 is a perspective view of the syringe assembly shown in FIG. 1. [Diagram 3] 2 is an exploded view of the proximal end of the syringe assembly and sealant delivery assembly shown in FIG. 1. [Figure 4A] 2 is a cross-sectional view of the proximal end of the syringe assembly and sealant delivery assembly shown in FIG. 1. [Figure 4B] 4B is an enlarged view of the distal end of the syringe assembly and the proximal end of the sealant delivery assembly shown in FIG. 4A. [Diagram 5] 2 is a perspective view of the sealant delivery assembly and the mixing and spraying assembly shown in FIG. 1. [Figure 6] 2 is a perspective view of the proximal end of the syringe assembly and sealant delivery assembly shown in FIG. 1. [Figure 7] FIG. 2 is a perspective view of a mixing and spraying assembly located at a distal end of the sealant applicator shown in FIG. 1, the mixing and spraying assembly including a mixing assembly, a malleable section, and a spray tip assembly. [Figure 8] FIG. 8 is an exploded view of the mixing and spraying assembly shown in FIG. [Figure 9A] FIG. 8 is an exploded view of the spray tip assembly shown in FIG. 7, including the distal connector and spray cup. [Figure 9B] FIG. 9B is another exploded view of the spray tip assembly shown in FIG. 9A, including the distal connector and spray cup. [Figure 10] FIG. 9C is a proximal end view of the distal connector shown in FIGS. 9A and 9B. [Figure 11] FIG. 9C is a proximal end view of the spray cup shown in FIGS. 9A and 9B. [Figure 12] FIG. 9 is a partially assembled perspective view of the mixing and spraying assembly shown in FIGS. 7 and 8. [Figure 13A] FIG. 8 is a cross-sectional view of the mixing and spraying assembly shown in FIG. [Figure 13B] FIG. 8 is a perspective cross-sectional view of the mixing and spraying assembly shown in FIG. 7. [Figure 14A] FIG. 8 is a cross-sectional view of the mixing and spraying assembly shown in FIGS. 1 and 7. [Figure 14B] FIG. 8 is a perspective cross-sectional view of the mixing and spraying assembly shown in FIGS. 1 and 7. [Figure 15] FIG. 8 is a perspective view of the mixing and spraying assembly shown in FIGS. 1 and 7, the mixing and spraying assembly being in a straight configuration and including a mixing assembly, a malleable section, and a spray tip assembly. [Figure 16] FIG. 16 is a perspective view of the mixing spray assembly of FIG. 15 with the malleable section in a bent configuration such that the spray tip assembly is angled relative to the mixing assembly. [Figure 17] FIG. 17 is a juxtaposition of a conventional spray tip to the mixing spray assembly shown in FIG. [Figure 18] 3 illustrates a first step in a method for connecting a vial assembly to the distal end of the syringe assembly shown in FIGS. 1 and 2. [Figure 19] 19 shows the vial assembly and syringe assembly of FIG. 18 after the proximal end of the vial assembly has been connected with the distal end of the syringe assembly. [Figure 20] 20 illustrates a method of using the syringe assembly and vial assembly of FIG. 19 to mix a first fluid with a first powder and mix a second fluid with a second powder, according to one embodiment of the present patent application. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0058] 1, in one embodiment, a sealant applicator 100 for expressing tissue sealant and / or hemostatic agent during a surgical procedure preferably includes a syringe assembly 102, a sealant delivery assembly 104, and a mixing and spraying assembly 106. In one embodiment, the sealant delivery assembly 104 is secured to a distal end of the syringe assembly 102, and the mixing and spraying assembly 106 is secured to a distal end of the sealant delivery assembly 104.

[0059] In one embodiment, the mixing and spraying assembly 106 preferably includes a mixing assembly 108, a malleable section 110, and a spray tip assembly 112. The malleable section 110 preferably interconnects a distal end of the mixing assembly 108 and a proximal end of the spray tip assembly 112 such that the spray tip assembly 112 is aligned with a longitudinal axis A of the elongated cannula of the sealant delivery assembly 104. 1 This allows the projections to be angled and / or oriented at different angles relative to the projections.

[0060] 2, in one embodiment, the syringe assembly 102 of the sealant applicator 100 (FIG. 1) preferably includes a dual-barrel syringe 116 having a first syringe barrel 114A adapted to receive a first fluid and a second syringe barrel 116B adapted to receive a second fluid to be mixed with the first fluid to form the tissue sealant. In one embodiment, the syringe assembly 102 preferably includes a dual-barrel plunger 118 including a first plunger rod 120A insertable into the first syringe barrel 116A and a second plunger rod 120B insertable into the second syringe barrel 116B. The syringe assembly 102 preferably includes a tab 122 (e.g., a thumb tab) interconnecting proximal ends of the first plunger rod 120A and the second plunger rod 120B.

[0061] In one embodiment, the syringe assembly 102 preferably includes a first dispensing tip 124A located at the distal end of the first syringe barrel 116A and a second dispensing tip 124B located at the distal end of the second syringe barrel 116B.

[0062] In one embodiment, a first fluid (e.g., a first sealant precursor, an activation fluid, a buffer solution) may be disposed in a first fluid chamber of the first syringe barrel 116A, and a second fluid (e.g., a second sealant precursor, an activation fluid, a buffer solution) may be disposed in a second fluid chamber of the second syringe barrel 116B. In one embodiment, the tab 122 may be depressed in a distal direction DIR1 to cause the first and second fluids to be dispensed via first and second dispensing tips 124A and 124B, respectively, located at the distal ends of the first and second syringe barrels 116A and 116B.

[0063] In one embodiment, the first and second fluids may be first and second tissue sealant precursors that mix together to form a tissue sealant or hemostatic agent, which may be pumped out of the distal end of the sealant applicator 100. In one embodiment, the first and second fluids preferably react to form a tissue sealant or hemostatic agent when mixed together. In one embodiment, the first and second fluids are preferably separated from each other until they are mixed and directed into the spray tip assembly 106 (FIG. 1) so that the first and second fluids mix together and are pumped out of the spray tip assembly 112 (FIG. 1) located at the distal end of the sealant applicator.

[0064] 3, in one embodiment, the syringe assembly 102 preferably includes a first plunger 126A securable to a distal end of a first plunger rod 120A and a second plunger 126B securable to a distal end of a second plunger rod 120B. In one embodiment, the outer periphery of the first plunger 126B preferably forms a fluid-tight seal with an inner surface of the first syringe barrel 116A, and the outer periphery of the second plunger 126B preferably forms a fluid-tight seal with an inner surface of the second syringe barrel 116B. When the dual-barrel plunger 118 is moved in a distal direction DIR1 relative to the first syringe barrel 116A and the second syringe barrel 116B, the first plunger 126A pushes a first fluid out of the first dispensing tip 124A and the second plunger 126B pushes a second fluid out of the second dispensing tip 124B.

[0065] In one embodiment, the sealant delivery assembly 104 (FIG. 1) includes a sealant delivery housing 128, preferably having a first housing portion 130A and a second housing portion 130B. In one embodiment, the first housing portion 130A and the second housing portion 130B of the sealant delivery housing 128 may be snap-fitted together. In one embodiment, the sealant delivery housing is adapted to be secured to a distal end of the syringe assembly 102. In one embodiment, the distal end of the syringe assembly 102 desirably includes a latch mechanism 135 configured to engage a latch opening 135 formed in the first housing portion 130A of the sealant delivery housing 128. In one embodiment, the latch mechanism 135 is movable between a first position (e.g., an extended position) for locking the sealant delivery housing to the distal end of the syringe assembly and a second position (e.g., a depressed position) for releasing the sealant delivery housing from its attachment to the distal end of the syringe assembly 102.

[0066] In one embodiment, the sealant delivery assembly 104 preferably includes a connector 132 that interconnects a first hub 134A (e.g., a first fluid port) and a second hub 134B (e.g., a second fluid port). In one embodiment, when a proximal end of the sealant delivery assembly 104 is coupled to a distal end of the syringe assembly 102, a first dispensing tip 124A of the first syringe barrel 116A is preferably inserted into the first hub 134A and a second dispensing tip 124B of the second syringe barrel 116B is inserted into the second hub 134B to provide fluid communication between the first and second syringe barrels and the respective first and second hubs 134A, 134B.

[0067] In one embodiment, the sealant delivery assembly 104 preferably includes an elongated cannula 136 (e.g., an elongated tubular shaft) extending between a proximal end and a distal end of the sealant delivery assembly. The elongated cannula 136 may be rigid. In one embodiment, a first flexible tube 138A and a second flexible tube 138B are disposed within the elongated cannula 136 for delivering a first fluid and a second fluid to a mixing spray assembly 106 located at a distal end of the sealant applicator 100 (FIG. 1). In one embodiment, a proximal end 140A of the first flexible tube 138A is preferably in fluid communication with a distal end of the first hub 134A, and a proximal end 140B of the second flexible tube 138B is preferably in fluid communication with a distal end of the second hub 134B. In one embodiment, a first fluid supplied from the first syringe barrel 116A preferably passes through a first flexible tube 138A, and a second fluid supplied from the second syringe barrel 116B preferably passes through a second flexible tube 138B.

[0068] 4A and 4B, in one embodiment, the proximal end of the sealant delivery assembly 104 is configured to connect with the distal end of the syringe assembly 102. The syringe assembly 102 preferably includes a first syringe barrel 116A and a second syringe barrel 116B. The distal end of the first plunger 126A and the first plunger rod 120A are preferably inserted into the proximal end of the first fluid chamber 142A of the first syringe barrel 116A to force the first fluid out of the first dispensing tip 124A of the first syringe barrel 116A. The distal end of the second plunger 126B and the second plunger rod 120B is preferably inserted proximal to the second fluid chamber 142B of the second syringe barrel 116B to force the second fluid out of the second dispensing tip 124B of the second syringe barrel 116B.

[0069] In one embodiment, a first dispensing tip 124A located at the distal end of the first syringe barrel 116A is preferably inserted into the first hub 134A, and a second dispensing tip 124B located at the distal end of the second syringe barrel 116B is preferably inserted into the second hub 134B.

[0070] In one embodiment, a proximal end 140A of a first flexible tube 138A is inserted into a distal end of a first hub 134A to provide fluid communication between a first fluid chamber 142A of a first syringe barrel 116A and a first flexible tube 138A. In one embodiment, a proximal end 140B of a second flexible tube 138B is inserted into a distal end of a second hub 134B to provide fluid communication between a second fluid chamber 142B of a second syringe barrel 116B and a second flexible tube 138B.

[0071] The first flexible tube 138A and the second flexible tube 138B are disposed within an elongated cannula 136 that extends between the distal end of the sealant delivery housing 128 and the mixing spray assembly 106 located at the distal end of the sealant applicator 100 (FIG. 1).

[0072] 5, in one embodiment, the sealant applicator 100 preferably includes a sealant delivery assembly 104 and a mixing and spraying assembly 106 connected to a distal end of an elongated cannula 136 of the sealant delivery assembly 104. In one embodiment, the sealant delivery assembly 104 preferably includes a sealant delivery housing 128 having a first housing portion 130A and a second housing portion 130B that are preferably snap-fitted together. The elongated cannula 136 has a proximal end connected to the sealant delivery housing 128 and a distal end connected to the mixing and spraying assembly 106. The elongated cannula 136 is preferably rigid and extends along a longitudinal axis A. 1 In one embodiment, the elongated cannula 136 may be a hollow tube made from a biocompatible material, such as a metal (e.g., stainless steel) or a polymer.

[0073] In one embodiment, the mixing and spraying assembly 106 preferably includes a mixing assembly 108, a malleable section 110, and a spray tip assembly 112. In one embodiment, the malleable section 110 is configured such that the spray tip assembly 112 is aligned with the longitudinal axis A of the mixing assembly 108 and / or the elongated cannula 136. 1 The malleable section 110 may contain a malleable wire having shape memory properties to allow the spray tip assembly 112 to be angled relative to the longitudinal axis of the mixing assembly 108 and / or elongated cannula 136.

[0074] 6, in one embodiment, the proximal end of the sealant applicator 100 preferably includes a syringe assembly 102 and a sealant delivery assembly 104. In one embodiment, the syringe assembly 102 preferably includes a locking assembly 144 including a resilient latch 125 that engages with a latch opening 135 formed in a first portion 130A of the sealant delivery housing 128 to selectively lock the sealant assembly housing 128 to the distal end of the syringe assembly 102. In one embodiment, the locking assembly 144 may be depressed to separate the resilient latch 125 from the latch opening 135 such that the sealant delivery assembly 104 may be decoupled from its fixation to the distal end of the syringe assembly 102.

[0075] 7, in one embodiment, the mixing and spraying assembly 106 is preferably secured to the distal end of the elongated conduit 136 of the sealant delivery assembly 104. The mixing and spraying assembly 106 preferably includes a mixing assembly 108, a malleable section 110, and a spray tip assembly 112 connected to the distal end of the malleable section 110. In one embodiment, the first and second fluids delivered by the sealant delivery assembly 104 are directed into a proximal end 146 of the mixing assembly 108. The first and second fluids desirably mix together in the mixing assembly 108 as the first and second fluids flow downstream between the proximal and distal ends 146, 148 of the mixing assembly 108. The malleable section 110 is located distal (i.e., downstream) to the distal end 148 of the mixing assembly 108 and proximal (i.e., upstream) to the proximal end of the spray tip assembly 112. Thus, the malleable section 110 spaces the spray tip assembly 112 from the mixing assembly 108 .

[0076] 8, in one embodiment, the mixing and spraying assembly 106 preferably includes a mixing assembly 108, a malleable section 110, and a spray tip assembly 112. The mixing assembly 108 preferably includes a mixer housing 150 having an elongated conduit 152 extending from a proximal end 154 to a distal end 156 of the mixer housing 150. In one embodiment, the mixing assembly 108 preferably includes a mixing element 158 ​​(e.g., a static mixer) disposed within the elongated conduit 152 of the mixer housing 150. In one embodiment, the mixing element 158 ​​preferably includes a plurality of mixing fins 160 spaced apart from one another along a length of the mixing element 158. The mixing element 158 ​​is configured to mix the first and second fluids together as the first and second fluids flow through the mixer housing 150.

[0077] In one embodiment, the mixing assembly 108 preferably includes a proximal connector 162 (FIG. 7) having a proximal end 164 insertable into the distal end of the elongated cannula 136 (FIG. 7) and a distal end 166 having external threads 168 adapted to mate with internal threads (not shown) located at the proximal end 154 of the mixer housing 150. The proximal connector 162 has a first fluid path 170A in fluid communication with the first flexible tube 138A (FIG. 4B) and a second fluid path 170B in fluid communication with the second flexible tube 138B (FIG. 4B). The first and second fluid paths are preferably dispersed and / or separated from one another as they pass through the length of the proximal connector. The first fluid path 170A and the second fluid path 170B preferably direct the first fluid and the second fluid into the proximal end 154 of the mixer housing 150 so that the first fluid and the second fluid are mixed together by the mixing fins 160 of the mixing element 158.

[0078] In one embodiment, the malleable section 110 of the mixing spray assembly 106 preferably includes a flexible shaft 172 (e.g., flexible tube, flexible member) having a proximal end 174 and a distal end 176. The flexible shaft may be made of a polymeric material (e.g., rubber). The flexible shaft 172 desirably has a flexible wire opening 178 extending along the length of the flexible shaft 172, as well as first and second tissue sealant openings 180A and 180B. In one embodiment, the malleable section 110 preferably includes a malleable wire 182 configured to extend through the malleable wire opening 178 of the flexible shaft 172. The malleable wire 182 preferably has a proximal end 184 configured to be connected to the mixing element 158 ​​and a distal end 186 including a paddle-shaped flange 188 having a width greater than the outer diameter of the malleable wire 182 extending proximally therefrom.

[0079] 8 and 9A-9B, in one embodiment, the spray tip assembly 112 of the mixing spray assembly 106 includes a distal connector 190 preferably having a proximal end 192 and a distal end 194 having external threads 196. In one embodiment, the proximal end 192 of the distal connector 190 is preferably configured to receive the distal end 176 of the flexible shaft 172 and the distal end 186 of the malleable pin 182.

[0080] In one embodiment, the spray tip assembly 112 of the mixing spray assembly 106 desirably includes a spray cup 198 having a spray opening 200. The spray cup 198 preferably has female threads (not shown) that mate with male threads 196 on the distal end 194 of the distal connector 190 to secure the spray cup 198 to the distal connector 190.

[0081] 9B and 10, in one embodiment, the proximal end 192 of the distal connector 190 has a proximal opening 193 adapted to receive the distal end 176 of the flexible shaft 172. The distal connector 190 preferably includes a first tissue sealant opening 195A and a second tissue sealant opening 195B which direct the tissue sealant to the proximal end of the spray cup 198 for being expressed through the spray opening 200 of the spray cup 198.

[0082] 9B and 11, in one embodiment, the spray cup 198 has a proximal end with a proximal opening 207 that is preferably adapted to receive the male threads 196 located at the distal end of the distal connector 190. In one embodiment, the spray cup 198 preferably has a closed distal end wall 209 with a spray opening 200 formed therein for expressing tissue sealant passing through the distal connector 190. The distal end wall 209 is formed with grooves 211A, 211B that direct tissue sealant into a swirl chamber 215 surrounding the spray opening 200, as disclosed in commonly assigned U.S. Patent Application Serial No. 16 / 593,799, filed October 4, 2019, and published April 8, 2021 as U.S. Patent No. 2021 / 0101162 (Attorney Docket No. ETH6050USNP1), the disclosure of which is incorporated herein by reference.

[0083] 12, in one embodiment, the proximal connector 162 of the mixing and spraying assembly 106 is preferably inserted into an opening at the distal end of the elongated cannula 136 of the sealant delivery assembly. The distal end 166 of the proximal connector 162 preferably has male threads 168 that mate with female threads (not shown) located at the proximal end 154 of the mixer housing 150. The mixing element 158 ​​is located downstream of the first fluid conduit 170A and the second fluid conduit 170B accessible at the distal end 166 of the proximal connector 162. The proximal end 184 of the malleable wire 182 (FIG. 8) passing through the flexible shaft 172 is inserted into a blind hole 202 formed in the central shaft of the mixing element 158. The blind hole 202 of the mixing element 158 ​​preferably extends along the longitudinal axis of the central shaft of the mixing element 158. In one embodiment, the blind hole 202 may extend approximately ½ to ¾ of the length of the central shaft of the mixing element, and the proximal end of the malleable wire may be fully inserted into the blind hole 202 to ensure a tight connection between the mixing element and the proximal end of the malleable wire.

[0084] In one embodiment, the flexible shaft 172 of the malleable section 110 (FIG. 1) has a malleable wire conduit 178 adapted to receive a malleable wire 182. The malleable wire conduit 178 that receives the malleable wire preferably extends along the length of the flexible shaft between its proximal and distal ends 174, 176. The flexible shaft 172 preferably includes a first tissue sealant conduit 180A and a second tissue sealant conduit 180B that extend along the length of the flexible shaft 172. After the first and second fluids are mixed together within the mixer housing 150, the first tissue sealant conduit 180A and the second tissue sealant conduit 180B preferably deliver the mixture of the first and second fluids (i.e., a flowable tissue sealant) to the spray tip assembly 112 to be pumped out of the distal end of the mixed spray assembly 106 (FIG. 1).

[0085] In one embodiment, the mixer housing 150 preferably includes an elongated conduit 152 that extends along the length of the mixer housing 150. A mixing element 158 ​​(e.g., a static mixer) is preferably disposed within the elongated conduit 152 of the mixer housing 150. The proximal end 174B of the flexible shaft 172 and the proximal end of the malleable wire 182 are preferably disposed within the elongated conduit 152 at the proximal end 156 of the mixer housing 150.

[0086] A paddle-like flange 188 at the distal end 186 (FIG. 8) of the malleable wire 182 is preferably connected to a distal connector 190 for coupling the distal connector 190 with the malleable wire 182 and the flexible shaft 172. A spray cup 198 is preferably threaded onto male threads 196 (FIG. 9A) located at the distal end of the distal connector 190.

[0087] 13A and 13B, in one embodiment, the flexible shaft 172 of the malleable section 110 (FIG. 1) preferably includes a malleable wire conduit 178 that receives a malleable wire 182. The flexible shaft 172 desirably includes a first tissue sealant conduit 180A and a second tissue sealant conduit 180B that deliver a mixture of a first liquid and a second liquid (i.e., a flowable tissue sealant) to a spray tip assembly 112 (FIG. 7) located at the distal end of the sealant applicator 100 (FIG. 1). In one embodiment, when the tissue sealant flows through the first tissue sealant conduit 180A and the second tissue sealant conduit 180B, the first liquid and the second liquid are already mixed by a mixing element 158 ​​located within the mixer housing 150 (FIG. 12).

[0088] 14A and 14B, in one embodiment, the mixing and spraying assembly 106 is preferably secured to the distal end of the elongated cannula 136 of the sealant delivery assembly 104. In one embodiment, the proximal connector 162 has a proximal end 164 that is inserted into an opening at the distal end of the elongated cannula 136 of the sealant delivery assembly 104. The proximal connector 162 has a first fluid path 170A in fluid communication with the first flexible tube 138A. The proximal connector 162 also desirably includes a second fluid path 170B in fluid communication with the distal end of the second flexible tube 138B. The distal end of the proximal connector 162 desirably has male threads 168 that mate with the female threads of the proximal end 154 of the mixer housing 150 to secure the proximal end of the mixer housing to the distal end of the proximal connector 162. An O-ring 202 may be disposed between an outer surface of the proximal connector 162 and an inner surface of the mixer housing 154 to form a fluid-tight seal therebetween.

[0089] In one embodiment, the mixing element 158 ​​is disposed within the elongated conduit 152 of the mixer housing 150. The mixing element 158 ​​preferably has mixing fins 160 that protrude outwardly from the central shaft of the mixing element. The proximal end 184 of the malleable wire 182 is inserted into a blind hole 202 (FIG. 12) of the mixing element to secure the proximal end of the malleable wire to the mixing element 158. The malleable wire 182 extends through the malleable wire conduit 178 (FIG. 12) of the flexible shaft 172. In one embodiment, the blind hole formed in the central shaft of the mixing element 158 ​​extends approximately 1 / 2 to 3 / 4 of the length of the mixing element. In one embodiment, the proximal end of the malleable wire 182 is inserted completely into the blind hole in the central shaft of the mixing element to ensure a reliable connection between the malleable wire and the mixing element. The malleable wire 182 has a distal end 186 with a paddle-shaped attached flange 188 (e.g., a mounting tab) that connects with a distal connector 190 of the spray tip assembly 112. A spray cup 198 preferably threads onto external threads 196 (FIG. 9A) of the distal connector 190.

[0090] In one embodiment, the first fluid from the first syringe barrel 142A (FIG. 4B) is delivered to the mixing and spraying assembly 106 via the first flexible tube 138A, and the second fluid from the second syringe barrel 142B (FIG. 4B) is delivered to the mixing and spraying assembly 106 via the second flexible tube 138B. Upon reaching the proximal connector 162 of the mixing and spraying assembly 106, the first and second fluids are desirably directed through the first and second fluid paths 170A and 170B into an opening at the proximal end of the mixer housing 150. In one embodiment, the first and second fluids are preferably mixed together by the mixing fins 160 as the fluids flow in a distal direction DIR1 along the length of the mixing element 158. In one embodiment, after the first and second fluids are mixed together by the mixing element 158, the mixed solution is directed through first and second tissue sealant conduits 180A, 180B (FIG. 12) that extend along the length of the flexible shaft 172. The mixed tissue sealant flows downstream through the first and second tissue sealant conduits 180A, 180B, through the distal connector 190, and is directed into a spray cup 198 and expressed through a dispensing opening 200 located at the distal end of the spray cup 198. In other embodiments, the flexible shaft may have more than two tissue sealant conduits extending therethrough.

[0091] 15, in one embodiment, the spray tip assembly 112 of the mixing and spraying assembly 106 is aligned with the longitudinal axis A of the elongated cannula 136 of the sealant delivery assembly 104. 1 As a result, the surgeon can be oriented in a position parallel to the longitudinal axis A of the elongated cannula 136. 1The orientation of the spray tip 112 relative to the axis of the mixer housing 150 can be changed to access hard to reach locations within the surgical site. In one embodiment, the flexible shaft 172 allows the orientation of the spray tip 112 to be adjusted relative to the orientation or axis of the mixer housing 150 and elongated cannula 136. When the surgeon bends the flexible shaft to angle the spray tip assembly relative to the axis of the cannula, the malleable wire extending through the flexible shaft maintains the bent shape of the flexible shaft established by the surgeon.

[0092] 16, in one embodiment, the flexible shaft 172 is aligned with the longitudinal axis A of the mixer housing 150 and / or the elongated cannula 136. 1 Axis A forms an angle with 2 14A) to extend along the longitudinal axis A of the mixer housing 150 and / or elongated cannula 136. The flexible shaft 172 preferably includes a malleable wire 182 (FIG. 14A) that holds the spray tip assembly 112 in the angled orientation shown in FIG. 16. The malleable wire may have shape memory properties to maintain the orientation of the spray tip assembly selected by the surgeon. The orientation of the spray tip assembly 112 is determined by gripping the distal connector 190 and / or spray cup 198 to extend along the longitudinal axis A of the mixer housing 150 and / or elongated cannula 136. 1 16 by changing the orientation of the spray tip assembly 112 relative to the flexible shaft 172. Although this patent application is not limited by any particular theory of operation, it is believed that positioning the mixing element 158 ​​(FIG. 14A) within the mixer housing 150 and disposing the mixer housing 150 at a location proximal to the flexible shaft 172 allows the spray tip assembly 112 to have a shorter length and / or a smaller diameter (than the diameter of the mixer housing), which allows the surgeon to reach tighter locations and / or smaller cavities within the patient and to place the spray tip assembly 112 at a more acute angle relative to the elongated cannula than is possible when using conventional spray tip assemblies.

[0093] 17 shows a side-by-side comparison of the mixing and spraying assembly 106 of the present patent application with the conventional spray tip assembly 50. In the mixing and spraying assembly 106 of the present patent application, the flexible shaft 172 of the malleable section 110 is disposed between the mixer housing 150 and the spray tip assembly 112. As a result, the mixer housing 150, which contains the mixing element 158 ​​(FIG. 14A), is located upstream of the flexible shaft 172, and the spray tip assembly 112 has a shorter length L. 1 In one embodiment, the length L 1 is approximately 15 mm. In contrast, in the conventional spray device 40, the spray tip assembly 50 includes a mixer housing 56 that is located distally (i.e., downstream) relative to the distal end of the flexible shaft 54. Because the conventional spray tip 50 includes the mixer housing 56, the length L of the conventional spray tip assembly is approximately 15 mm. 2 is about 35 mm, which is the shorter length L of the spray tip assembly 112 disclosed in this patent application. 1 In addition, because the mixing assembly is not directly connected to the spray tip assembly, the spray tip assembly 112 disclosed in this patent application does not have to be directly connected to the mixer housing and the second outer diameter OD of the conventional spray tip 50. 2 First outer diameter OD smaller than 1 has.

[0094] A user may manipulate the conventional spray tip 50 to a desired angle for sealant application. As mentioned above, the spray tip 50 has a distal length L of about 35 mm. 2 , which may make the spray tip too long for use in tight spaces such as the chest cavity.

[0095] In this patent application, moving the mixing assembly 108 to the proximal end of the replaceable mixing and spraying tip assembly 106 preferably reduces the diameter of the distal end of the spray tip assembly 112 for improved intended use and reduces the length L of the spray tip assembly 112 for improved accessibility. 1to less than 15 mm.

[0096] Furthermore, due to its shorter length (i.e., 15 mm vs. 35 mm), the minimum critical distance requirement H of the spray tip assembly 112 disclosed in this patent application is 1 is the minimum critical distance requirement H for the conventional spray tip design 40 2 Smaller than.

[0097] 18, in one embodiment, the syringe assembly 102 may be assembled with a vial assembly 206 having a vial assembly housing 232, a first vial 238A containing a first powdered reaction component, a second vial 238B containing a second powdered reaction component, a first piercing element 240A, and a second piercing element 240A, as disclosed in commonly assigned U.S. patent application Ser. No. __________ (Attorney Docket No. ETH6118USNP1), filed on even date herewith, the disclosure of which is incorporated herein by reference. In one embodiment, the distal end of the syringe assembly 102 may be coupled with the proximal end 234 of the vial assembly housing 232 of the vial assembly 206 after the first and second end caps are removed from the distal end of the syringe assembly 102 to expose the first and second applicator tips 124A and 124B. The first dispensing tip 124A is preferably inserted into a first central opening (e.g., port) located at the proximal end of the first piercing element 240A, and the second dispensing tip 124B is preferably inserted into a second central opening (e.g., port) located at the proximal end of the second piercing element 240B.

[0098] 19, after vial assembly 206 is assembled with the distal end of syringe assembly 102, a first fluid disposed within first syringe barrel 116A of syringe assembly 102 is preferably in fluid communication with a first powder (e.g., powdered reaction component) disposed within first powder chamber 260A of first vial 238A. Similarly, a second fluid disposed within second syringe barrel 116B of syringe assembly 102 is preferably in fluid communication with a second powder (e.g., powdered reaction component) disposed within second powder chamber 260B of second vial 238B.

[0099] 20 shows the distal end of the syringe assembly 102 connected to the proximal end of the vial assembly 206. In one embodiment, the first piercing element 240A and the second piercing element 240B may be extended to pierce the sealing membranes 248A, 248B closing the vial openings at the proximal ends of the first and second vials 238A, 238B, respectively. The syringe assembly includes a first syringe barrel 116A having a first fluid chamber 142A that contains a first fluid used to reconstitute a first powder in the first powder chamber 260A of the first vial 238A. The syringe assembly 102 also desirably includes a second syringe barrel 116B having a second fluid chamber 142B that contains a second fluid used to reconstitute a second powder in the second powder chamber 260B of the second vial 238B. The first syringe barrel 116A is connected to the proximal end of the vial assembly 206 such that the first dispensing tip 124A of the first syringe barrel 116A is aligned with and in fluid communication with the first vial opening 246A of the first vial 238A. The first vial 238A has a first powder chamber 160A that contains a first powder that is reconstituted using a first fluid disposed in the first fluid chamber 142A of the first syringe barrel 116A. The second dispensing tip 124B at the distal end of the second syringe barrel 116B is preferably aligned with the second vial opening 246B of the second vial 238B. The second vial 238B preferably includes a second powder chamber 260B that contains a second powder to be reconstituted using a second fluid disposed in the second fluid chamber 142B of the second syringe barrel 116B.

[0100] During the stage shown in FIG. 20, the first fluid and first powder remain separated from the second fluid and second powder.

[0101] In one embodiment, the first fluid in the fluid chamber 142A of the first syringe 116A is mixed with the first powder in the first vial 238A by advancing and retracting the dual-barrel plunger 118 in a distal direction DIR1 and a proximal direction DIR2. When the first plunger rod 120A is advanced toward the distal end of the syringe assembly 114, the first fluid in the first fluid chamber 142A of the first syringe 116A is forced into the first powder chamber 260A of the first vial 238A to reconstitute the first powder into a first therapeutic solution. When the first plunger rod 120 is retracted away from the distal end of the syringe assembly 102, the first therapeutic solution (i.e., the mixture of the first powder and the first fluid) is drawn back into the first fluid chamber 142A of the first syringe 116A. The first plunger rod 120A may be repeatedly reciprocated back and forth between an extended position and a retracted position to thoroughly mix the first fluid and the first powder to form a first precursor solution (e.g., first fluid, first solution). In one embodiment, after the first precursor solution is formed, the first plunger rod 120A is preferably fully retracted to draw the entire volume of the first precursor solution back into the first fluid chamber 142A of the first syringe 116A.

[0102] In one embodiment, the second fluid in the second fluid chamber 142B of the second syringe 116B is mixed with the second powder in the second vial 238B by advancing and retracting the dual-barrel plunger 118 in a distal direction DIR1 and a proximal direction DIR2. As the second plunger rod 120B advances toward the distal end of the syringe assembly 102 (i.e., in the direction DIR1), the second fluid in the second fluid chamber 142B of the second syringe 116B is forced into the second powder chamber 260B of the second vial 238B to reconstitute the second powder into a second therapeutic solution. When the second plunger rod 120B is retracted away from the distal end of the syringe assembly 102 (i.e., in the direction DIR2), the second therapeutic solution (i.e., the mixture of the second powder and the second fluid) is drawn back into the second fluid chamber 142B of the second syringe 116B. The second plunger rod 120B may be repeatedly reciprocated back and forth between the extended and retracted positions to thoroughly mix the second fluid and the second powder to form a second precursor solution (e.g., a flowable fluid). In one embodiment, after the second precursor solution is formed, the second plunger rod 120B is preferably fully retracted to draw the entire volume of the second precursor solution into the second fluid chamber 142B of the second syringe 116B.

[0103] 1 and 20, in one embodiment, after the first and second precursor solutions are generated and withdrawn into the first and second fluid chambers 142A and 142B of the first and second syringes 116A and 116B, respectively, of the syringe assembly 102, the vial assembly 206 may be separated from the distal end of the syringe assembly 102, such that the sealant delivery assembly 104 may be secured to the distal end of the syringe assembly 102 to expel the mixture of the first and second precursor solutions (i.e., tissue sealant) from the spray tip assembly 112 located at the distal end of the sealant applicator 100. In one embodiment, the sealant delivery assembly housing 128 at the proximal end of the sealant delivery assembly 104 is preferably connected to the distal end of the syringe assembly 102. The cannula 136 preferably extends toward the distal end of the sealant delivery assembly 104 .

[0104] After the sealant delivery assembly 104 is secured to the distal end of the syringe assembly 102, the first fluid chamber 142A of the first syringe 116A containing the first precursor solution is in fluid communication with the mixing and spraying assembly 106, preferably via a first flexible tube 138A (FIG. 4B) extending through the elongated cannula 136. The second fluid chamber 142B of the second syringe 116B containing the second precursor solution is in fluid communication with the mixing and spraying assembly 106, preferably via a second flexible tube 138B (FIG. 4B) extending through the elongated cannula 136.

[0105] In one embodiment, when the dual barrel plunger 118 is depressed in a distal direction designated DIR1 to force the first and second precursor solutions out of the first and second fluid chambers 142A and 142B of the first and second syringes 116A and 116B, respectively, the first and second precursor solutions flow through the first and second flexible tubes 138A and 138B, respectively ( FIG. 4A ), until they reach the mixing and spraying assembly 106. Upon reaching the mixing and spraying assembly 106, the first precursor solution and the second precursor solution are mixed together by a mixing element 158 ​​(FIG. 14A) located within the mixer housing 108, such that the first precursor solution and the second precursor solution react with each other to form a tissue sealant or hemostatic agent that passes through the malleable section 110 to be pressed out of a dispensing opening 200 of a spray cup 198 (FIG. 14A) located at the distal end of the spray tip assembly 112 of the mixing and spraying assembly 106.

[0106] While the foregoing description is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope of the invention, the scope of which is limited only by the scope of the claims which follow. For example, it is contemplated that any of the features shown in any of the embodiments described herein or incorporated by reference herein may be incorporated with any of the features shown in any of the other embodiments described herein or incorporated by reference herein and still fall within the scope of the present invention.

[0107] [Embodiment] (1) A mixing and spraying assembly for a tissue sealant, comprising: a mixing assembly located at a proximal end of the mixing and spraying assembly; a spray tip assembly located at a distal end of the mixing and spraying assembly; a malleable section having a proximal end connected to the mixing assembly to allow the spray tip assembly to be angled relative to the mixing assembly and a distal end connected to the spray tip assembly. (2) The malleability classification is a flexible shaft having a proximal end, a distal end, and a length extending between said proximal end and said distal end; a malleable wire conduit extending along the length of the flexible shaft; 2. The mixing spray assembly of claim 1, comprising: a malleable wire disposed within the malleable wire conduit of the flexible shaft, the malleable wire having a length greater than the length of the flexible shaft, the malleable wire having a proximal end extending beyond the proximal end of the flexible shaft and connected to the mixing assembly, and a distal end extending beyond the distal end of the flexible shaft and connected to the spray tip assembly. (3) The mixing assembly comprises: a mixer housing having a proximal end, a distal end, and a mixer housing conduit extending along a length of the mixer housing from the proximal end to the distal end of the mixer housing; 3. The mixing and spraying assembly of claim 2, comprising: a mixing element disposed within the mixer housing conduit, the proximal end of the malleable wire extending beyond the proximal end of the flexible shaft being fixed to the mixing element. (4) The mixing element A static mixer having a central shaft extending along a length of the static mixer; a static mixer, the central shaft of the static mixer having a proximal end and a distal end; a blind bore formed in the central shaft of the static mixer and extending from the distal end of the central shaft toward the proximal end of the central shaft; 4. The mixing and spraying assembly of claim 3, wherein the proximal end of the malleable wire is disposed within the blind hole formed in the central shaft of the static mixer to connect the proximal end of the malleable wire to the static mixer. (5) The mixing assembly comprises: a proximal connector having a proximal end configured to be inserted into an opening at the distal end of the elongated cannula of the sealant applicator, the distal end having male threads; 5. The mixing and spraying assembly of claim 4, wherein the mixer housing has an internal thread located at the proximal end of the mixer housing, the internal thread configured to mate with the external thread at the distal end of the proximal connector to secure the mixer housing to the proximal connector.

[0108] (6) The proximal connector, a first fluid path extending from the proximal end to the distal end of the proximal connector, the first fluid path being in fluid communication with the proximal end of the static mixer; a second fluid path extending from the proximal end to the distal end of the proximal connector, the second fluid path being in fluid communication with the proximal end of the static mixer; and a first flexible tube disposed in the first fluid path of the proximal connector for supplying a first fluid to the proximal end of the mixer housing; A mixing and spraying assembly as described in embodiment 5, comprising: a second flexible tube disposed within the second fluid path of the proximal connector for supplying a second fluid to the proximal end of the mixer housing. (7) The mixing and spraying assembly of embodiment 6, wherein the static mixer is adapted to mix the first fluid and the second fluid such that the first fluid and the second fluid react with each other to form a tissue sealant. (8) The mixing spray assembly of embodiment 7, wherein the flexible shaft of the malleable section includes one or more tissue sealant conduits extending along the length thereof for supplying the tissue sealant to the spray tip assembly. (9) The mixing spray assembly of embodiment 8, wherein the malleable wire conduit extends along a central axis of the flexible shaft, and the one or more tissue sealant conduits of the flexible shaft include a first tissue sealant conduit and a second tissue sealant conduit extending along opposite sides of the malleable wire conduit. (10) The spray tip assembly, 1. A distal connector having a proximal end and a distal end having male threads, the proximal end of the distal connector has a central opening that seats the distal end of the flexible shaft; a distal connector, the distal end of the malleable wire extending beyond the distal end of the flexible shaft being connected to the distal connector; The mixing and spraying assembly of embodiment 9, comprising: a spray cup having a spray opening for expelling the tissue sealant supplied through the first tissue sealant conduit and the second tissue sealant conduit of the flexible shaft, the spray cup having a tubular proximal end having an internal thread configured to mate with the external thread at the distal end of the distal connector to secure the spray cup to the distal connector.

[0109] (11) The mixing spray assembly of claim 10, wherein the distal end of the malleable wire secured to the distal connector of the spray tip assembly comprises a paddle-shaped flange having a width greater than a diameter of a section of the malleable wire that extends to the proximal end of the malleable wire. (12) A mixing and spraying assembly for expressing a tissue sealant, comprising: a mixing assembly configured to mix a first fluid and a second fluid that chemically react with each other to form a tissue sealant; a spray tip assembly configured to expel the tissue sealant; a malleable section having a proximal end connected to the mixing assembly to allow the spray tip assembly to be angled relative to the mixing assembly and a distal end connected to the spray tip assembly, the malleable section having one or more tissue sealant conduits extending along its length for delivering the tissue sealant from the mixing assembly to the spray tip assembly. (13) The malleability classification is a flexible shaft having a malleable wire conduit extending from said proximal end to said distal end thereof; 13. The mixing spray assembly of claim 12, comprising: a malleable wire disposed within the malleable wire conduit, the malleable wire having a proximal end extending beyond the proximal end of the flexible shaft to be connected to the mixing assembly, and a distal end extending beyond the distal end of the flexible shaft to be connected to the spray tip assembly. (14) The mixing assembly includes a mixer housing having a proximal end, a distal end, and a mixer housing conduit extending from the proximal end to the distal end of the mixer housing; the mixing assembly including a mixing element disposed within the mixer housing conduit of the mixer housing; the spray tip assembly including a distal connector coupled to the distal end of the flexible shaft and a spray cup having a spray opening secured to a distal end of the distal connector; 14. The mixing spray assembly of claim 13, wherein the proximal end of the malleable wire is fixed to the mixing element disposed within the mixer housing, and the distal end of the malleable wire is fixed to the distal connector of the spray tip assembly. (15) The mixing element A static mixer having a central shaft extending along a length of the static mixer; a static mixer, the central shaft of the static mixer having a proximal end and a distal end; 16. The mixing and spraying assembly of claim 15, further comprising: a blind hole formed in the central shaft of the static mixer extending from the distal end of the central shaft toward the proximal end of the central shaft, the proximal end of the malleable wire being disposed within the blind hole formed in the central shaft of the static mixer to connect the proximal end of the malleable wire to the static mixer.

[0110] (16) The mixing spray assembly of claim 14, wherein the mixer housing has a longitudinal axis extending from the proximal end to the distal end of the mixer housing, and the malleable section enables the spray tip assembly to be angled relative to the longitudinal axis of the mixer housing. 17. The mixing and spraying assembly of claim 14, wherein the mixer housing has a first outer diameter and the spray tip assembly has a second outer diameter that is smaller than the first outer diameter of the mixer housing. (18) A method of expressing a tissue sealant, the method comprising: obtaining a mixing and spraying assembly including a mixing assembly, a spray tip assembly, and a malleable section having a proximal end connected to the mixing assembly and a distal end connected to the spray tip assembly, the malleable section spacing the spray tip assembly from the mixing assembly and allowing the spray tip assembly to be angled relative to the mixing assembly; Directing a first fluid and a second fluid into the proximal end of the mixing assembly; mixing the first fluid and the second fluid in the mixing assembly such that the first fluid and the second fluid react with each other to form a tissue sealant; passing the tissue sealant through one or more tissue sealant conduits extending through the malleable section to deliver the tissue sealant to the spray tip assembly; and expelling the tissue sealant from a distal end of the spray tip assembly. 19. The method of claim 18, wherein the first fluid comprises fibrinogen and the second fluid comprises thrombin that reacts with the fibrinogen to form the tissue sealant. (20) The malleable section of the mixing and spraying assembly comprises: a flexible shaft having a malleable wire conduit extending from its proximal end to its distal end; a malleable wire disposed within the malleable wire conduit, the malleable wire having a proximal end extending beyond the proximal end of the flexible shaft and a distal end extending beyond the distal end of the flexible shaft; 19. The method of claim 18, wherein the proximal end of the malleable wire is connected to the mixing assembly and the distal end of the malleable wire is connected to the spray tip assembly.

Claims

1. 1. A mixing spray assembly for a tissue sealant comprising: a mixing assembly located at a proximal end of the mixing and spraying assembly; a spray tip assembly located at a distal end of the mixing and spraying assembly; a malleable section having a proximal end connected to the mixing assembly to allow the spray tip assembly to be angled relative to the mixing assembly, and a distal end connected to the spray tip assembly.

2. The malleability classification is a flexible shaft having a proximal end, a distal end, and a length extending between said proximal end and said distal end; a malleable wire conduit extending along the length of the flexible shaft; 2. The mixing spray assembly of claim 1, comprising: a malleable wire disposed within the malleable wire conduit of the flexible shaft, the malleable wire having a length greater than the length of the flexible shaft, the malleable wire having a proximal end extending beyond the proximal end of the flexible shaft and connected to the mixing assembly, and a distal end extending beyond the distal end of the flexible shaft and connected to the spray tip assembly.

3. The mixing assembly comprises: a mixer housing having a proximal end, a distal end, and a mixer housing conduit extending along a length of the mixer housing from the proximal end to the distal end of the mixer housing; 3. The mixing and spraying assembly of claim 2, comprising: a mixing element disposed within the mixer housing conduit, the proximal end of the malleable wire extending beyond the proximal end of the flexible shaft being secured to the mixing element.

4. The mixing element comprises: A static mixer having a central shaft extending along a length of the static mixer; a static mixer, the central shaft of the static mixer having a proximal end and a distal end; a blind bore formed in the central shaft of the static mixer and extending from the distal end of the central shaft toward the proximal end of the central shaft; 4. The mixing and spraying assembly of claim 3, wherein the proximal end of the malleable wire is disposed within the blind hole formed in the central shaft of the static mixer for connecting the proximal end of the malleable wire to the static mixer.

5. The mixing assembly comprises: a proximal connector having a proximal end configured to be inserted into an opening at the distal end of the elongated cannula of the sealant applicator, the distal end having male threads; 5. The mixing and spraying assembly of claim 4, wherein the mixer housing has female threads located at the proximal end of the mixer housing configured to mate with the male threads at the distal end of the proximal connector to secure the mixer housing to the proximal connector.

6. The proximal connector comprises: a first fluid path extending from the proximal end to the distal end of the proximal connector, the first fluid path being in fluid communication with the proximal end of the static mixer; a second fluid path extending from the proximal end to the distal end of the proximal connector, the second fluid path being in fluid communication with the proximal end of the static mixer; and a first flexible tube disposed in the first fluid path of the proximal connector for supplying a first fluid to the proximal end of the mixer housing; 6. The mixing and spraying assembly of claim 5, comprising: a second flexible tube disposed within the second fluid path of the proximal connector for supplying a second fluid to the proximal end of the mixer housing.

7. 7. The mixing and spraying assembly of claim 6, wherein the static mixer is adapted to mix the first fluid and the second fluid such that the first fluid and the second fluid react with each other to form a tissue sealant.

8. 8. The mixing spraying assembly of claim 7, wherein the flexible shaft of the malleable section includes one or more tissue sealant conduits extending along the length thereof for supplying the tissue sealant to the spray tip assembly.

9. 9. The mixing and spraying assembly of claim 8, wherein the malleable wire conduit extends along a central axis of the flexible shaft, and the one or more tissue sealant conduits of the flexible shaft comprise first and second tissue sealant conduits extending along opposite sides of the malleable wire conduit.

10. the spray tip assembly comprising:

1. A distal connector having a proximal end and a distal end having male threads, the proximal end of the distal connector has a central opening that seats the distal end of the flexible shaft; a distal connector, the distal end of the malleable wire extending beyond the distal end of the flexible shaft being connected to the distal connector; 10. The mixing and spraying assembly of claim 9, comprising: a spray cup having a spray opening for expelling the tissue sealant delivered through the first and second tissue sealant conduits of the flexible shaft, the spray cup having a tubular proximal end having female threads configured to mate with the male threads on the distal end of the distal connector to secure the spray cup to the distal connector.

11. 11. The mixing spray assembly of claim 10, wherein the distal end of the malleable wire secured to the distal connector of the spray tip assembly comprises a paddle-shaped flange having a width greater than a diameter of a section of the malleable wire that extends to the proximal end of the malleable wire.

12. 1. A mixing and spraying assembly for expressing a tissue sealant, comprising: a mixing assembly configured to mix a first fluid and a second fluid that chemically react with each other to form a tissue sealant; a spray tip assembly configured to expel the tissue sealant; a malleable section having a proximal end connected to the mixing assembly to allow the spray tip assembly to be angled relative to the mixing assembly and a distal end connected to the spray tip assembly, the malleable section having one or more tissue sealant conduits extending along its length for delivering the tissue sealant from the mixing assembly to the spray tip assembly.

13. The malleability classification is a flexible shaft having a malleable wire conduit extending from said proximal end to said distal end thereof; 13. The mixing spray assembly of claim 12 comprising: a malleable wire disposed within the malleable wire conduit, the malleable wire having a proximal end extending beyond the proximal end of the flexible shaft to be connected to the mixing assembly and a distal end extending beyond the distal end of the flexible shaft to be connected to the spray tip assembly.

14. the mixing assembly including a mixer housing having a proximal end, a distal end, and a mixer housing conduit extending from the proximal end to the distal end of the mixer housing; the mixing assembly including a mixing element disposed within the mixer housing conduit of the mixer housing; the spray tip assembly including a distal connector coupled to the distal end of the flexible shaft and a spray cup having a spray opening secured to a distal end of the distal connector; 14. The mixing and spraying assembly of claim 13, wherein the proximal end of the malleable wire is secured to the mixing element disposed within the mixer housing and the distal end of the malleable wire is secured to the distal connector of the spray tip assembly.

15. The mixing element comprises: A static mixer having a central shaft extending along a length of the static mixer; a static mixer, the central shaft of the static mixer having a proximal end and a distal end; 15. The mixing and spraying assembly of claim 14, comprising: a blind hole formed in the central shaft of the static mixer extending from the distal end of the central shaft toward the proximal end of the central shaft, the proximal end of the malleable wire being disposed in the blind hole formed in the central shaft of the static mixer to connect the proximal end of the malleable wire to the static mixer.

16. 15. The mixing and spraying assembly of claim 14, wherein the mixer housing has a longitudinal axis extending from the proximal end to the distal end of the mixer housing, and the malleable section allows the spray tip assembly to be angled relative to the longitudinal axis of the mixer housing.

17. 15. The mixing and spraying assembly of claim 14, wherein the mixer housing has a first outer diameter and the spray tip assembly has a second outer diameter that is smaller than the first outer diameter of the mixer housing.

18. 1. A method of expressing a tissue sealant, the method comprising: obtaining a mixing and spraying assembly including a mixing assembly, a spray tip assembly, and a malleable section having a proximal end connected to the mixing assembly and a distal end connected to the spray tip assembly, the malleable section spacing the spray tip assembly from the mixing assembly and allowing the spray tip assembly to be angled relative to the mixing assembly; directing a first fluid and a second fluid into the proximal end of the mixing assembly; mixing the first fluid and the second fluid in the mixing assembly such that the first fluid and the second fluid react with each other to form a tissue sealant; passing the tissue sealant through one or more tissue sealant conduits extending through the malleable section to deliver the tissue sealant to the spray tip assembly; and expelling the tissue sealant from a distal end of the spray tip assembly.

19. 20. The method of claim 18, wherein the first fluid comprises fibrinogen and the second fluid comprises thrombin that reacts with the fibrinogen to form the tissue sealant.

20. The malleable section of the mixing and spraying assembly is a flexible shaft having a malleable wire conduit extending from its proximal end to its distal end; a malleable wire disposed within the malleable wire conduit, the malleable wire having a proximal end extending beyond the proximal end of the flexible shaft and a distal end extending beyond the distal end of the flexible shaft; 20. The method of claim 18, wherein the proximal end of the malleable wire is connected to the mixing assembly and the distal end of the malleable wire is connected to the spray tip assembly.

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