Systems, devices and methods for reconstituting therapeutic powders, mixing precursor solutions and expressing sealants to control bleeding and seal fluid and air leaks - Patents.com

Abstract

The sealant delivery system includes a syringe assembly having a juxtaposed syringe and a vial assembly having a juxtaposed vial. The first vial is aligned with the distal end of the first syringe and has a vial opening at its proximal end, the vial opening being closed by a first sealing membrane. The second vial is aligned with the distal end of the second syringe and has a second vial opening at its proximal end, the vial opening being closed by a second sealing membrane. The vial assembly includes a first piercing element movable between a retracted position and an extended position to pierce the first sealing membrane to provide fluid communication between the first fluid chamber and the first vial, and a second piercing element movable between a retracted position and an extended position to pierce the second sealing membrane to provide fluid communication between the second fluid chamber and the second vial.

Description

[Technical field]

[0001] This patent application relates generally to systems, devices, and methods for dispensing therapeutic fluids during surgical procedures, and more specifically to systems, devices, and methods for dispensing therapeutic fluids used to control bleeding, seal wounds, seal air leaks during pulmonary surgery, seal fluid leaks, and for graft fixation. [Background technology]

[0002] In a wide variety of situations, mammals may experience bleeding due to wounds or during surgical procedures. In some cases, the bleeding is relatively minor and stops due to normal blood clotting function or by using simple first aid techniques. In other cases, however, substantial bleeding may occur. These latter instances require the use of specialized equipment and materials, and the services of trained personnel, to provide effective assistance in controlling the excessive bleeding.

[0003] To address the more challenging situations 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 (e.g., thoracic surgery) 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 significantly 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 are composed of thrombin and fibrinogen materials, although other formulations are also available. Typically, the individual components of the tissue sealant (e.g., thrombin and fibrinogen) are stored separately in separate reservoirs, since 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 rapidly, resulting in an adhesive gel within a short period of time (eg, within 10-20 seconds).

[0010] There have been some developments in systems for reconstituting a therapeutic powder to form a therapeutic solution and delivering the therapeutic solution to a patient. For example, U.S. Patent No. 4,723,691 discloses a hand-held, manually operated powder dispenser having a container including a handle / nozzle portion terminating at its discharge end at an unobstructed powder dispensing opening, a hand grip portion, and a central, flexible bellows portion connected between the handle / nozzle portion and the hand grip portion. The bellows portion is adapted to contract and expand axially to function as a pump. The inner diameter of the handle / nozzle portion decreases substantially linearly and continuously as a function of the length of the handle / nozzle portion in a direction toward the powder dispensing opening.

[0011] US 2003 / 0040701 discloses a dual chamber syringe in which a dual function piston divides the syringe into two compartments, one compartment containing a powder or fluid and the other compartment containing a fluid. To mix the two substances, a passage is opened between the two compartments before or during retraction of the piston, forcing the substances to mix in the front compartment. During forward movement of the piston, the passage between the two compartments is closed, forcing the mixture of substances out of the discharge opening of the syringe.

[0012] 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 prior to use by the introduction of a solvent. The dispenser includes a first container having a first partition at one end, an open end opposite the first partition, 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 partition and the first movable plug. The dispenser includes a second container having a second partition at one end, an open end opposite the second partition, and a second movable plug disposed therein, where the second container contains a quantity of the second component.

[0013] No. 6,699,229 discloses a fluid transfer and mixing device for use in the sterile mixing of powdered and fluid components. The device includes a first adapter that may be connected to a container holding the powdered components, and a second adapter that may be removably interconnected to the first adapter and may be readily connected to a container containing a fluid, such as a diluent, to also allow for sterile mixing of the diluent and the powder. In use, a syringe is connected to the first adapter, whereby a mixture of powder and diluent may be aseptically drawn from the first container and delivered to a patient.

[0014] US Patent Application Publication No. 2010 / 0219200 discloses a device and method for mixing two components and delivering the mixture to a patient. The device includes a mixing chamber for mixing a liquid component and a powder component. The liquid and powder components are mixed in the mixing chamber by rotation of a collapsible mixing element. A plunger is advanced through the mixing chamber to force the mixture out of the mixing chamber and deliver the mixture to the patient.

[0015] No. 7,923,031 discloses a powder delivery system including a chamber for storing a hemostatic composition including dry gelatin powder having an average particle size in the range of 30 to 250 micrometers and hyaluronic acid. The system includes a chamber having at least one discharge opening sized for dispensing the composition.

[0016] U.S. Patent No. 7,946,417 discloses a device and method for mixing two components and delivering the mixture to a patient. The device includes a mixing chamber for mixing a liquid component and a powder component. The liquid and powder components are mixed in the mixing chamber by rotation of a collapsible mixing element. A plunger is then advanced through the mixing chamber to force the mixture out of the mixing chamber and deliver the mixture to the patient.

[0017] US Patent Application Publication No. 2011 / 0178495 discloses a powder delivery device including a gas powder mixer providing a gas powder mixing chamber and a powder dispenser (bellows) screwed onto the gas powder mixer and in communication with the gas powder mixing chamber therein. A hemostatic agent powder is adapted to be loaded into the powder dispenser (bellows) and delivered to a bleeding site via a powder delivery catheter.

[0018] US Patent No. 7,967,779 discloses a mixing syringe having a first sealed chamber (powder housing) that contains a powder and a second sealed chamber (liquid housing) that contains a liquid. When a user needs to inject a patient, the device is held approximately upright while pressing the plunger, causing the piercing element to pierce the foil seal that separates the two chambers. The liquid then drips into the powder housing. The liquid flows through a passage in a piston located in the powder housing, where it comes into contact with the powder. As the user continues to press the plunger downward, the perforator comes to rest in the piston, sealing the passage through the piston, thereby locking the perforator and piston together. The device is then ready for injection. As the plunger is pressed further down, the piston expels the mixture of powder and liquid through the needle.

[0019] 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.

[0020] 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 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.

[0021] U.S. Patent Application Publication 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 range and a second spray tip including a second fluid path defining a second flow range greater than the first flow 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.

[0022] Several efforts have been made aimed at controlling intra- and post-operative bleeding, fluid leakage, and air leakage that occurs during thoracic surgery, such as during organ resection.

[0023] Resection is a surgical procedure that involves the removal of portions of tissue or organs. Resections performed on a wide variety of organs, including the liver, lungs, and gastrointestinal system, present the surgeon with many unique challenges related to effectively managing post-operative bleeding, as well as fluid and air leaks.

[0024] During organ resection procedures, surgeons manage heavy bleeding at the resection surface by using tourniquets, extensive sutures, etc. Some surgeons use adhesive fluids (e.g., synthetic glues, fibrin glue gels), but these are limited because they may run off the resection surface before fully curing, or may easily peel off after curing due to lack of sufficient adhesion to the underlying tissue or appropriate elastic properties.

[0025] Liver resection. Surgical procedures involving the removal of all or part of the liver are generally referred to as hepatectomy. Partial hepatectomy is the preferred approach for removing solid tumors from the liver. During liver resection, tissue boundaries within the resected area are destroyed, and the internal parenchyma and flow system are exposed. Re-establishment of proper boundaries does not occur immediately, but requires a prolonged tissue healing process that may last for days to weeks. During the tissue healing process, the resected tissue may exude blood and / or leak organ-specific fluids (e.g., bile), which may cause postoperative complications. One study found that after liver resection procedures, the bile leakage rate is about 5%, which dramatically increases the chances of postoperative complications for patients.

[0026] Pulmonary resection. Pulmonary resection procedures typically require a significant amount of tissue manipulation and processing, resulting in a high incidence of postoperative air leaks. Standardized techniques used to address air leaks involve suturing or stapling the lung tissue. However, these techniques are often ineffective at creating an airtight seal due to the inherent friability of the lung parenchyma, especially in emphysematous patients. In some cases, topical adhesives are applied either directly over the pleural strip or over the staple line, but these techniques are often insufficient to prevent air leaks.

[0027] GI Resection. Gastrointestinal (GI) procedures often involve resecting a large portion of a patient's intestinal anatomy to effectively treat disease. After removing the GI tissue, the surgeon must reconstruct the patient's digestive system. GI reconstruction is complex due to the delicate structure of the intestine, the limited blood supply to the lower colon, the limited surgeon's access to the complex anatomy, and medical conditions that typically affect the surrounding tissues. However, even when surgeons exercise great care during GI reconstruction procedures, there is a percentage of patients who have complications resulting from leaks at the surgically created anastomosis sites. GI leaks can have devastating consequences, requiring additional surgeries and treatments that often fail to manage the leak.

[0028] In view of the above, many efforts have been made aimed at effectively managing intraoperative and postoperative bleeding, as well as fluid and air leakage. For example, when resecting solid organs, surgeons typically manage heavy bleeding at the resection surface by using tourniquets and extensive sutures. Small amounts of bleeding and fluid leakage are often managed by using adhesive fluids (e.g., synthetic glues, fibrin glues) to coat the resection surface, but these methodologies have achieved limited success because the adhesive fluids tend to run off the resection surface before curing and / or peel off after curing because the cured adhesive lacks sufficient adhesion to the underlying tissue or suitable elastic properties.

[0029] Covidien sells the VERISET® hemostatic patch for sealing resected tissue surfaces. The VERISET® hemostatic patch is composed of an oxidized regenerated cellulose (ORC) layer and a reactive polyethylene glycol (PEG) layer. The patch is applied to the tissue surface by applying pressure to the surface. Due to the fact that the OR® matrix is ​​opaque, the surgeon cannot see through the VERISET® hemostatic patch to assess the condition of the resected surface while applying pressure on the resected surface. The patch is also stiff with low flexibility and therefore may not achieve good tissue conformability or remain compliant to tissue movement. Summary of the Invention [Problem to be solved by the invention]

[0030] Despite the above developments, there remains a need for improved systems, devices, and methods that enable surgeons to effectively seal organ and tissue surfaces and prevent and / or successfully manage intra- and post-operative bleeding, fluid leakage, and / or air leakage from organ and tissue surfaces (e.g., resected surfaces). [Means for solving the problem]

[0031] In one embodiment, a sealant applicator system for mixing and delivering a sealant or hemostatic agent during a surgical procedure preferably includes two syringes for mixing and reconstituting powdered reactive components, in one embodiment, the two syringes are preferably held side-by-side by a syringe holder.

[0032] In one embodiment, the syringe holder may be formed by joining two syringe holder parts, each having two hollow cavities configured to accommodate at least a portion of two syringes.

[0033] In one embodiment, each syringe contains a liquid (e.g., a diluent, a buffer solution, a catalyst, an initiator, an activating fluid, etc.) that may be mixed with a powdered reaction component to reconstitute the powdered reaction component.

[0034] In one embodiment, the sealant applicator system preferably includes two vials, each configured to hold a powdered reaction component, and in one embodiment, each vial is closed by a pierceable sealing membrane (e.g., septum, bung) that seals the vial opening and keeps the powdered reaction component dry during shipping and storage.

[0035] In one embodiment, two vials are held in juxtaposition within the vial holder. In one embodiment, the vial holder includes two piercing elements, each having a proximal end with a central opening or hub and a distal end having a spike, each spike having a sharp tip capable of piercing one of the sealing membranes. In one embodiment, the piercing elements are held in juxtaposition within the vial holder, with the sharp tips of the spikes pointing toward the sealing membrane.

[0036] In one embodiment, the vial holder may be formed by joining two vial holder parts, each vial holder part having two hollow cavities configured to accommodate a vial and at least a portion of the piercing element.

[0037] In one embodiment, the juxtaposed piercing elements are slidably movable within the vial holder, and the sharp tips of the spikes are configured to pierce the sealing membrane when moved toward the sealing membrane.

[0038] In one embodiment, the proximal end of each piercing element preferably includes a port connectable to the distal end of one of the syringes. Each piercing element preferably has an elongate conduit extending along the length of the piercing element between the port at the proximal end of the piercing element and a sharp point at the distal end of the piercing element.

[0039] In one embodiment, the piercing element has a proximal end that couples with a distal end of the syringe to establish fluid communication between the syringe and the respective vial.

[0040] In one embodiment, the sealant applicator system may include an elongated extrusion tip having a mixing tip at a distal end and a housing at a proximal end adapted to connect to the syringe.

[0041] In one embodiment, the elongated extrusion tip may include a cannula with two lumens for transporting the two components of the sealant from the syringe towards the mixing tip.

[0042] In one embodiment, the elongated extrusion tip is bendable at the distal end, hi one embodiment, the bendable portion of the elongated extrusion tip may include a malleable component having shape memory properties to maintain the orientation of the mixing tip after the distal end of the elongated extrusion tip is bent into a particular shape.

[0043] In one embodiment, the sealant applicator system may include a single piece syringe housing with side-by-side dual barrel cavities for holding the liquids used for reconstitution and mixing.

[0044] In one embodiment, the sealant delivery system preferably includes a syringe assembly including a first syringe and a second syringe arranged side by side, the first syringe having a first fluid chamber and the second syringe having a second fluid chamber.

[0045] In one embodiment, the sealant delivery system preferably includes a vial assembly coupled to a distal end of a syringe assembly, the vial assembly including a first vial and a second vial in juxtaposition.

[0046] In one embodiment, the vial assembly and the syringe assembly preferably have structural features that ensure that the first syringe can only be connected to the first vial and the second syringe can only be connected to the second vial. Thus, the design of the vial assembly and the syringe assembly desirably ensures that the first syringe always matches the first vial and the second syringe always matches the second vial. In one embodiment, when a medical practitioner attempts to connect the first syringe to the second vial and the second syringe to the first vial, the structural features of the syringe assembly and the vial assembly prevent the distal end of the syringe assembly from connecting with the proximal end of the vial assembly.

[0047] In one embodiment, the first vial has a proximal end aligned with the distal end of the first syringe.

[0048] In one embodiment, the first vial includes a first vial opening at its proximal end that is closed by a first sealing membrane.

[0049] In one embodiment, the second vial has a proximal end aligned with the distal end of the second syringe.

[0050] In one embodiment, the second vial includes a second vial opening at its proximal end that is closed by a second sealing membrane.

[0051] In one embodiment, the vial assembly preferably includes a first piercing element located between the distal end of the first syringe and the proximal end of the first vial. The first piercing element may have a first piercing spike protruding from its distal end.

[0052] In one embodiment, the first piercing element is movable between a retracted position in which the first piercing spike is positioned proximal to the first sealing membrane and an extended position in which the first piercing spike passes through the first sealing element to pierce the first sealing membrane and provide fluid communication between the first fluid chamber of the first syringe and the first vial.

[0053] In one embodiment, the vial assembly includes a second piercing element located between the distal end of the second syringe and the proximal end of the second vial. The second piercing element may have a second piercing spike protruding from its distal end.

[0054] In one embodiment, the second piercing element is movable between a retracted position in which the second piercing spike is positioned proximal to the second sealing membrane and an extended position in which the second piercing spike passes through the second sealing element to pierce the second sealing membrane and provide fluid communication between the second fluid chamber of the second syringe and the second vial.

[0055] In one embodiment, the first piercing element defines a first fluid pathway extending along a length of the first piercing element to provide a first fluid communication between a first fluid chamber of the first syringe and the first vial.

[0056] In one embodiment, the second piercing element defines a second fluid pathway extending along the length of the second piercing element to provide a second fluid communication between a second fluid chamber of the second syringe and the second vial.

[0057] In one embodiment, the first fluid path and the second fluid path are isolated from each other.

[0058] In one embodiment, a first liquid may be disposed in a first fluid chamber of a first syringe and a first powdered reaction component may be disposed in a first vial. In one embodiment, the first liquid and the first powdered reaction component are configured to be mixed together to form a first solution (e.g., a first precursor, a first therapeutic solution, etc.) to reconstitute the first powdered reaction component.

[0059] In one embodiment, a second liquid may be disposed in a second fluid chamber of a second syringe and a second powdered reaction component may be disposed in a second vial. In one embodiment, the second liquid and the second powdered reaction component are configured to be mixed together to form a second solution (e.g., a second precursor, a second therapeutic solution, etc.) to reconstitute the second powdered reaction component.

[0060] In one embodiment, the vial assembly housing may include a first guide channel (e.g., a cavity) extending between a proximal end and a distal end of the vial assembly housing. In one embodiment, the first piercing element is disposed within the first guide channel and configured to move (e.g., slide) between a retracted position and an extended position.

[0061] In one embodiment, the vial assembly housing may include a second guide channel (e.g., a cavity) extending between the proximal and distal ends of the vial assembly housing. In one embodiment, the second piercing element is disposed within the second guide channel and configured to move (e.g., slide) between a retracted position and an extended position.

[0062] In one embodiment, the vial assembly housing may include a first proximal projection extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the retracted position, and a first distal projection extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the extended position. Thus, in one embodiment, the first piercing element may be fixed (e.g., locked) in either the retracted position or the extended position.

[0063] In one embodiment, the vial assembly housing may include a second proximal projection extending into the second guide channel adapted to contact the second piercing element to retain the second piercing element in the retracted position, and a second distal projection extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the extended position. Thus, in one embodiment, the second piercing element may be fixed (e.g., locked) in either the retracted position or the extended position.

[0064] In one embodiment, the first piercing element may include a first resilient flange adapted to sequentially engage a first proximal protrusion and a first distal protrusion of the vial assembly housing when moving the first piercing element from a retracted position to an extended position within the first guide channel. When a force is applied to the proximal end of the first piercing element to slide the first piercing element toward the distal end of the vial housing, the first resilient element can deflect to allow the first piercing element to slide from the retracted position to the extended position. In one embodiment, when the first piercing element is moved to the extended position, the first resilient element preferably holds the first piercing element in the extended position.

[0065] In one embodiment, the second piercing element may include a second resilient flange adapted to sequentially engage the second proximal protrusion and the second distal protrusion of the vial assembly housing when moving the second piercing element from the retracted position to the extended position within the second guide channel. When a force is applied to the proximal end of the second piercing element to slide the second piercing element toward the distal end of the vial housing, the second resilient element can deflect to allow the second piercing element to slide from the retracted position to the extended position. In one embodiment, when the second piercing element is moved to the extended position, the second resilient element preferably holds the second piercing element in the extended position.

[0066] In one embodiment, the first piercing element may have a central opening at its proximal end, and the first syringe may have a first dispensing tip protruding from its distal end and inserted into the central opening at the proximal end of the first piercing element.

[0067] In one embodiment, the second piercing element may have a central opening at its proximal end, and the second syringe may have a second dispensing tip protruding from its distal end and inserted into the central opening at the proximal end of the second piercing element.

[0068] In one embodiment, the syringe assembly may include a dual barrel plunger including a first plunger rod inserted into a proximal end of the first syringe and a second plunger rod inserted into a proximal end of the second syringe. A tab (e.g., a thumb tab) may interconnect the proximal ends of the first and second plunger rods.

[0069] In one embodiment, the dual-barrel plunger is movable toward a distal end of the syringe assembly to force a first liquid into a first vial and a second liquid into a second vial.

[0070] In one embodiment, a vial assembly for a sealant delivery system may include a vial assembly housing having a proximal end and a distal end, the vial assembly housing having juxtaposed first and second guide channels extending between the proximal and distal ends of the vial assembly housing.

[0071] In one embodiment, a first vial is secured to the vial assembly housing. In one embodiment, the first vial has a proximal end aligned with the first guide channel and a first vial opening at the proximal end of the first vial closed by a first sealing membrane.

[0072] In one embodiment, the vial assembly includes a first piercing element disposed in the first guide channel, the first piercing element movable between a retracted position in which the first piercing element is located proximal to the first sealing membrane and an extended position in which the first piercing element passes through the first sealing element to pierce the first sealing membrane.

[0073] In one embodiment, a second vial is secured to the vial assembly housing. In one embodiment, the second vial has a proximal end aligned with the second guide channel and a second vial opening at the proximal end of the second vial closed by a second sealing membrane.

[0074] In one embodiment, the vial assembly includes a second piercing element disposed in the second guide channel, the second piercing element movable between a retracted position in which the second piercing element is located proximal to the second sealing membrane and an extended position in which the second piercing element passes through the second sealing element to pierce the second sealing membrane.

[0075] In one embodiment, the first piercing element has a proximal end and a distal end, hi one embodiment, the first piercing element includes a central opening at its proximal end that defines a first fluid pathway extending along a length of the first piercing element.

[0076] In one embodiment, the first piercing element includes a first piercing spike protruding from a distal end of the first piercing element.

[0077] In one embodiment, the second piercing element has a proximal end and a distal end, hi one embodiment, the second piercing element has a central opening located at its proximal end and defining a second fluid pathway extending along the length of the second piercing element.

[0078] In one embodiment, the second piercing element includes a second piercing spike protruding from a distal end of the second piercing element.

[0079] In one embodiment, the first and second fluid paths extending through the respective first and second piercing elements are isolated from one another.

[0080] In one embodiment, the vial assembly housing preferably includes a first proximal projection extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the retracted position, and a first distal projection extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the extended position.

[0081] In one embodiment, the vial assembly housing preferably includes a second proximal projection extending into the second guide channel adapted to contact the second piercing element to retain the second piercing element in the retracted position, and a second distal projection extending into the second guide channel adapted to contact the second piercing element to retain the second piercing element in the extended position.

[0082] In one embodiment, the first piercing element may include a first resilient flange adapted to sequentially engage a first proximal projection and a first distal projection of the vial assembly housing when the first piercing element is moved from a retracted position to an extended position within the first guide channel.

[0083] In one embodiment, the second piercing element may include a second resilient flange adapted to sequentially engage with the second proximal projection and the second distal projection of the vial assembly housing when the second piercing element is moved from a retracted position to an extended position within the second guide channel.

[0084] In one embodiment, the sealant delivery system may include a vial assembly. In one embodiment, the sealant delivery system may include a syringe assembly including a first syringe and a second syringe arranged side by side, the first syringe having a first fluid chamber and the second syringe having a second fluid chamber.

[0085] In one embodiment, the distal end of the syringe assembly may be coupled to the proximal end of the vial assembly housing such that the distal end of the first syringe is aligned with the central opening of the proximal end of the first piercing element and the distal end of the second syringe is aligned with the central opening of the proximal end of the second piercing element.

[0086] In one embodiment, the first syringe has a first dispensing tip protruding from its distal end, the first dispensing tip being in fluid communication with a first fluid compartment of the first syringe. In one embodiment, the first dispensing tip is inserted into a central opening in the proximal end of the first piercing element to provide fluid communication between the first fluid chamber and a first fluid pathway extending along the length of the first piercing element.

[0087] In one embodiment, the second syringe has a second dispensing tip protruding from its distal end, the second dispensing tip being in fluid communication with a second fluid compartment of the second syringe. In one embodiment, the second dispensing tip is inserted into a central opening in the proximal end of the second piercing element to provide fluid communication between the second fluid chamber and a second fluid pathway extending along the length of the second piercing element.

[0088] In one embodiment, a first liquid is disposed in a first fluid chamber of a first syringe and a first powdered reaction component is disposed in a first vial of a vial assembly.

[0089] In one embodiment, the first fluid pathway provides fluid communication between the first fluid chamber and the first vial when the first piercing element is moved to the extended position.

[0090] In one embodiment, a second liquid is disposed in a second fluid chamber of a second syringe and a second powdered reaction component is disposed in a second vial of the vial assembly.

[0091] In one embodiment, the second piercing element is moved to an extended position and the second fluid pathway provides fluid communication between the second fluid chamber and the second vial.

[0092] In one embodiment, the sealant delivery system preferably includes a syringe assembly including a first syringe and a second syringe arranged side by side, the first syringe having a first fluid chamber containing a first liquid and the second syringe having a second fluid chamber containing a second fluid.

[0093] In one embodiment, the sealant delivery system may include a vial assembly coupled to a distal end of a syringe assembly, the vial assembly including a first vial and a second vial in juxtaposition.

[0094] In one embodiment, the first vial contains a first powdered reaction component. In one embodiment, the first vial has a proximal end aligned with the distal end of the first syringe and a first vial opening at the proximal end of the first vial closed by a first sealing membrane.

[0095] In one embodiment, the second vial contains a second powdered reaction component. In one embodiment, the second vial has a proximal end aligned with the distal end of the second syringe and a second vial opening at the proximal end of the first vial closed by a second sealing membrane.

[0096] In one embodiment, the vial assembly preferably includes a first piercing element located between the distal end of the first syringe and the first sealing membrane. In one embodiment, the first piercing element is movable between a retracted position in which the first piercing element is located proximal to the first sealing membrane and an extended position in which the first piercing element pierces the first sealing membrane to provide fluid communication between the first fluid chamber and the first vial.

[0097] In one embodiment, the vial assembly preferably includes a second piercing element located between the distal end of the second syringe and the second sealing membrane. In one embodiment, the second piercing element is movable between a retracted position in which the second piercing element is located proximal to the second sealing membrane and an extended position in which the second piercing element pierces the second sealing membrane to provide fluid communication between the second fluid chamber and the second vial.

[0098] In one embodiment, the syringe assembly may include a dual-barrel plunger including a first plunger rod inserted into a proximal end of the first syringe and a second plunger rod inserted into a proximal end of the second syringe.

[0099] In one embodiment, a tab interconnects the proximal ends of the first plunger rod and the second plunger rod.

[0100] In one embodiment, the dual-barrel plunger is movable toward a distal end of the syringe assembly to force a first liquid into a first vial to reconstitute a first powdered reaction component to produce a first solution, and to force a second liquid into a second vial to reconstitute a second powdered reaction component to produce a second solution.

[0101] The first and second solutions may be mixed together to form a sealant or hemostatic agent that may be applied onto tissue.

[0102] In one embodiment, the dual barrel plunger may be repeatedly reciprocated in a distal and proximal direction (e.g., back and forth) to facilitate the solution mixing process (e.g., reconstitution of the powdered reaction components). In one embodiment, the dual barrel plunger may be repeatedly reciprocated in a proximal and distal direction for about 20, 30, 40, or more cycles. The dual barrel plunger is preferably reciprocated back and forth until the first liquid is thoroughly mixed with the first powdered reaction component and the second liquid is thoroughly mixed with the second powdered reaction component.

[0103] In one embodiment, after the first reactive powdered component and the second reactive powdered component are reconstituted, the dual-barrel plunger may be retracted to draw the first solution into the first syringe and the second solution into the second syringe. At this stage, the first and second solutions preferably remain separated from each other.

[0104] In one embodiment, the vial assembly housing may include juxtaposed first and second guide channels (e.g., cavities) extending between the proximal and distal ends of the vial assembly housing.

[0105] In one embodiment, the vial assembly housing includes a first proximal projection extending into the first guide channel adapted to contact the first piercing element to hold the first piercing element in a retracted position, and a first distal projection extending into the first guide channel adapted to contact the first piercing element to hold the first piercing element in an extended position.

[0106] In one embodiment, the vial assembly housing includes a second proximal projection extending into the second guide channel adapted to contact the second piercing element to retain the second piercing element in the retracted position, and a second distal projection extending into the second guide channel adapted to contact the second piercing element to retain the second piercing element in the extended position.

[0107] In one embodiment, the powder vial may contain about 0.1 to 2 grams of powder. In one embodiment, the powder vial may contain about 0.4 to 0.5 grams, more preferably about 0.408 grams of powdered reactive component.

[0108] In one embodiment, the vial may have a size of about 2-10 ml, more preferably about 3-5 ml, and even more preferably about 4 ml.

[0109] In one embodiment, the vial may be made of glass or a polymeric material (eg, plastic).

[0110] These and other preferred embodiments of the present invention are described in more detail below. [Brief description of the drawings]

[0111] [Figure 1] FIG. 1 is a perspective view of components of a sealant delivery system, including a syringe assembly, a sealant delivery assembly, and a vial assembly, according to one embodiment of the present patent application. [Diagram 2] FIG. 2 is a perspective view of the syringe assembly shown in FIG. 1. [Diagram 3] FIG. 3 is an exploded view of the syringe assembly shown in FIG. 2. [Figure 4A] FIG. 3 is a top cross-sectional view of the syringe assembly shown in FIG. 2. [Figure 4B] FIG. 3 is a cross-sectional view of the syringe assembly shown in FIG. 2. [Figure 5A] FIG. 3 is a perspective view of the vial assembly shown in FIG. 2. [Figure 5B] FIG. 5B is a front view of the vial assembly shown in FIG. 5A. [Figure 6] FIG. 5C is an exploded view of the vial assembly shown in FIGS. 5A and 5B. [Figure 7] FIG. 5C is a cross-sectional view of the vial assembly shown in FIGS. 5A and 5B. [Figure 8A] 8 illustrates the vial assembly of FIG. 7 with the first piercing element and the second piercing element in a retracted position according to one embodiment of the present patent application. [Figure 8B] FIG. 8A shows the vial assembly with the first and second piercing elements in an extended position to pierce the first and second sealing membranes that seal the vial openings of the respective first and second vials, according to one embodiment of the present patent application. [Figure 9] FIG. 2 is a perspective view of the sealant delivery assembly shown in FIG. 1. [Figure 10] FIG. 10 is an exploded view of the sealant delivery assembly shown in FIG. [Figure 11] FIG. 10 is a top cross-sectional view of the proximal end of the sealant delivery assembly shown in FIG. [Figure 12] FIG. 10 is a cross-sectional view of the distal end of the sealant delivery system shown in FIG. 9, including a spray tip. [Figure 13A] 8B shows a side view of the vial assembly of FIG. 8A with the first and second piercing elements in a retracted position. [Figure 13B] 8C shows a side view of the vial assembly of FIG. 8B with the first and second piercing elements in the extended position. [Figure 14] FIG. 2 is a plan view of the syringe assembly shown in FIG. 1. [Figure 15A] 1 illustrates steps in a method for joining a distal end of a syringe assembly and a proximal end of a vial assembly according to one embodiment of the present patent application. [Figure 15B] 15B shows the syringe assembly and vial assembly of FIG. 15A after the distal end of the syringe assembly has been coupled with the proximal end of the vial assembly. [Figure 15C]15B illustrates a method of using the syringe assembly and vial assembly of FIG. 15B to mix a first liquid with a first powder and mix a second liquid with a second powder according to one embodiment of the present patent application. [Figure 16] 10 is a cross-sectional view of a sealant applicator including the sealant delivery assembly of FIG. 9 secured to a distal end of the syringe assembly of FIG. 2 according to an embodiment of the present patent application. [Figure 17] FIG. 1 is a perspective view of components of a sealant delivery system including a syringe assembly, a vial assembly, and a sealant delivery system having a spray tip, according to one embodiment of the present patent application. [Figure 18] FIG. 18 is a perspective view of the syringe assembly shown in FIG. 17. [Figure 19] FIG. 19 is an exploded view of the syringe assembly shown in FIG. [Figure 20] FIG. 20 is a perspective cross-sectional view of the syringe assembly shown in FIG. 18 according to one embodiment of the present patent application, in which the syringe assembly has an end cap secured to the distal end of the syringe assembly housing. [Figure 21] 21 illustrates a perspective cross-sectional view of the syringe assembly shown in FIG. 20 after the end cap has been removed to expose the distal end of the syringe assembly housing. [Figure 22A] 17A-17C illustrate steps in a method for connecting the distal end of the syringe assembly of FIG. 18 with the proximal end of the vial assembly of FIG. 17 according to one embodiment of the present patent application. [Figure 22B] 22B shows the syringe assembly and vial assembly of FIG. 22A after the distal end of the syringe assembly has been coupled with the proximal end of the vial assembly. [Figure 22C] 22B illustrates a method of using the syringe assembly and vial assembly of FIG. 22B to mix a first liquid with a first powder and mix a second liquid with a second powder according to one embodiment of the present patent application. [Figure 23A] FIG. 18 is a perspective view of the sealant delivery assembly shown in FIG. 17. [Figure 23B]FIG. 23B is a perspective view of the proximal end of the sealant delivery assembly shown in FIG. 23A. [Figure 24] 23A and 23B and the syringe assembly of FIG. 21. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0112] 1, in one embodiment, a sealant delivery system 100 for dispensing tissue sealant (e.g., a sealant for sealing air leaks during lung surgery) is shown, which preferably includes a syringe assembly 102, a vial assembly 104, and a sealant delivery assembly 106. In one embodiment, the syringe assembly 102 may include a first syringe and a second syringe, whereby each syringe contains a liquid (e.g., a diluent, a buffer solution, a catalyst, a reaction initiator, an activation fluid, etc.). In one embodiment, the vial assembly 104 may include a first vial and a second vial, whereby each vial contains a reactive powder component (e.g., fibrinogen powder, thrombin powder, reactive synthesis powder, crosslinker, etc.), which will be described in more detail herein.

[0113] 2 and 3, in one embodiment, the syringe assembly 102 preferably has a proximal end 108 and a distal end 110. In one embodiment, the syringe assembly 102 includes a dual barrel plunger 112 having a first plunger rod 114A and a second plunger rod 114B. In one embodiment, the proximal ends of the first plunger rod 114A and the second plunger rod 114B are connected to a depressible thumb tab 116 that may be utilized by a surgical practitioner (e.g., a surgeon) to depress the plunger rods 114A, 114B in a direction DIR1 toward the distal end 110 of the syringe assembly 102 (e.g., to expel one or more sealant precursors from the distal end of the syringe assembly).

[0114] In one embodiment, the syringe assembly 102 preferably includes a first plunger 118A secured to a distal end of a first plunger rod 114A and a second plunger 118B secured to a distal end of a second plunger rod 114B. The first plunger 118A and the second plunger 118B preferably have outer peripheries that form a fluid-tight seal with the inner surfaces of the first and second syringe barrels, as described in more detail herein.

[0115] In one embodiment, the syringe assembly 102 preferably includes a syringe assembly housing 122 including a first housing portion 120A and a second housing portion 122B configured to be connected to one another. In one embodiment, the first housing portion 122A and the second housing portion 122B may be snap-fit ​​together.

[0116] In one embodiment, syringe assembly housing 120 is preferably adapted to hold a first syringe 124A and a second syringe 124B. First syringe 124A and second syringe 124B are preferably configured to contain a fluid (e.g., a diluent, a buffer solution, a catalyst, an initiator, an activating fluid, etc.) that is to be mixed with reactive powder components disposed within respective first and second vials of vial assembly 104 (FIG. 1).

[0117] In one embodiment, the first syringe 124A is configured to receive a distal end of the first plunger rod 114A and a first plunger 118A secured to the distal end of the first plunger rod. In one embodiment, the second syringe 124B is configured to receive a distal end of the second plunger rod 114B and a second plunger 118B secured to the distal end of the second plunger rod.

[0118] Referring to FIG. 3, in one embodiment, the distal end of the first syringe 124A has a first dispensing tip 126A with an opening for dispensing a first fluid contained in a first fluid chamber (not shown) of the first syringe, and the distal end of the second syringe 124B has a second dispensing tip 126B with an opening for dispensing a second fluid contained in a second fluid chamber (not shown) of the second syringe.

[0119] In one embodiment, the syringe assembly 102 preferably includes a first end cap 128A and a second end cap 128B adapted to be releasably secured over a first dispensing tip 126A and a second dispensing tip 126B located at the distal ends of the first syringe 124A and the second syringe 124B, respectively.

[0120] In one embodiment, after the first end cap 128A and the second end cap 128B are removed from the first and second dispensing tips 126A and 126B of the first and second syringes 124A and 124B, respectively, the thumb tab 116 may be pressed down in the direction DIR1 (FIG. 2) toward the distal end of the syringe assembly, such that the first and second fluids (e.g., diluents, buffer solutions, catalysts, reaction initiators, activating fluids, etc.) are contained within the respective fluid chambers of the first and second syringes 124A and 124B and dispensed from the first and second dispensing tips 126A and 126B.

[0121] 4A and 4B, in one embodiment, the syringe assembly 102 includes a first syringe 124A and a second syringe 124B that are preferably positioned in juxtaposition between a first housing part 122A and a second housing part 122B of the syringe assembly housing 120. The first syringe 124A preferably has a first fluid chamber 130A that is configured to receive a first liquid (e.g., a diluent, a buffer solution, a catalyst, a reaction initiator, an activation fluid, etc.). The second syringe 124B preferably includes a second fluid chamber 130B that is configured to receive a second liquid (e.g., a diluent, a buffer solution, a catalyst, a reaction initiator, an activation fluid, etc.). In one embodiment, the first and second fluids contained within the respective first and second fluid chambers 130A and 130B may have the same or different properties.

[0122] In one embodiment, the distal end of the dual barrel plunger 112 is preferably assembled with the proximal ends of the first and second syringes 124A, 124B, respectively, such that the distal ends of the first plunger 118A and first plunger rod 114A are inserted into the proximal end of the first syringe 124A, and the distal ends of the second plunger 118B and second plunger rod 114B are inserted into the proximal end of the second syringe 124B.

[0123] In one embodiment, a first end cap 128A is preferably secured over a first dispensing tip 126A of a first syringe 124A, and a second end cap 128B is preferably secured over a second dispensing tip 126B of a second syringe 124B. The end caps may remain on the dispensing tips during storage and prior to use, or may be removed from covering the end caps immediately prior to use during a surgical procedure.

[0124] In one embodiment, the first and second end caps 128A, 128B may be removed from the distal end 110 of the syringe assembly 102 to expose the dispensing tips 126A, 126B located at the distal ends of the first and second syringes 124A, 124B, respectively. In one embodiment, the thumb tab 116 of the dual-barrel plunger 112 may be depressed in a distal direction DIR1 toward the distal end 110 of the syringe assembly 102 to dispense and / or express the first and second liquids (e.g., diluents, buffer solutions, catalysts, initiators, activating fluids, etc.) contained within the first and second fluid chambers 130A, 130B of the first and second syringes 124A, 124B, respectively. In one embodiment, the first liquid and the second liquid are utilized to reconstitute and mix powder components contained within the first and second vials of vial assembly 104 (FIG. 1).

[0125] As described in more detail herein, in one embodiment, after the activation fluid is initially forced into the vial of the vial assembly, the thumb tab 116 and dual-barrel plunger 112 may be retracted in a proximal direction designated DIR2 to draw the solution and / or mixture of activation fluid and powdered reaction components back into the fluid chambers 130A, 130B of the first and second syringes 124A, 124B, respectively, to further mix the activation fluid and powdered reaction components.

[0126] Certain therapeutic components must be stored in powder form because they react and / or lose their effectiveness rapidly when mixed with a liquid or solution. These therapeutic components must be reconstituted with a liquid (e.g., a diluent, a buffer solution, a catalyst, a reaction initiator, an activating fluid, etc.) before being used on a patient. The first liquid and the second liquid in the syringe may be used to activate the reactive powdered components contained in the vial assembly to form a tissue sealant or hemostatic agent that can be sprayed and / or pressed onto tissue. In one embodiment, the first liquid is used to reconstitute the first reactive powdered component (e.g., fibrinogen in powder form, reactive synthetic powder, crosslinker, etc.) and the second liquid is used to reconstitute the second reactive powdered component (e.g., thrombin in powder form, reactive synthetic powder, crosslinker, etc.).

[0127] 5A and 5B, in one embodiment, the vial assembly 104 (FIG. 1) of the sealant delivery system preferably includes a vial assembly housing 132 having a proximal end 134 and a distal end 136. In one embodiment, the vial assembly 104 includes a first vial 138A and a second vial 138B, which are desirably configured to contain powdered reaction components that are mixed together using a liquid (e.g., a diluent, a buffer solution, a catalyst, a reaction initiator, an activation fluid, etc.), contained within a first syringe and a second syringe of a syringe assembly. In one embodiment, the first vial 138A and the second vial 138B are preferably secured to the distal end 136 of the vial assembly housing 132. In one embodiment, the first vial 138A may contain a first reactive powder component (e.g., fibrinogen powder, reactive synthesis powder, cross-linking agent, etc.) and the second vial 138B may contain a second reactive powder component (e.g., thrombin powder, reactive synthesis powder, cross-linking agent, etc.). In one embodiment, the vial assembly 104 preferably includes a first piercing element 140A having a first piercing spike (not shown) aligned with a first vial opening at a proximal end of the first vial 138A, and a second piercing element 140B having a second piercing spike (not shown) aligned with a second vial opening at a proximal end of the second vial 138B.

[0128] In one embodiment, the first piercing element 140A and the second piercing element 140B are movable between a retracted position and an extended position. In one embodiment, the first piercing element and the second piercing element move independently of one another. In one embodiment, the first piercing element and the second piercing element move simultaneously with one another.

[0129] The vial assembly 104 is designed to keep the first reactive powder component and the second reactive powder component separated from each other during storage of the vial assembly and prior to use of the powder components to form a therapeutic solution (e.g., a tissue sealant, a hemostatic agent, a sealant for sealing air leaks during pulmonary surgery).

[0130] 6, in one embodiment, the vial assembly 104 desirably includes a vial assembly housing 142 having a first housing portion 132A and a second housing portion 142B. In one embodiment, the first housing portion 142A and the second housing portion 142B are adapted to be snap-fit ​​together to form the vial assembly housing. In one embodiment, when the first housing portion 142A and the second housing portion 142B are assembled together, the vial assembly housing 132 is adapted to receive the first piercing element 140A and the second piercing element 140B, whereby the first piercing element and the second piercing element may slide relative to the vial assembly housing between a retracted position and an extended position, as described in more detail herein.

[0131] In one embodiment, the vial assembly 104 preferably includes a first powder vial 138A having a proximal end 144A with a first vial opening 146A, and a first sealing membrane 148A covering and / or sealing the first vial opening 146A. During storage and prior to use, the first sealing membrane 148A preferably maintains a first powder (e.g., a first powdered reaction component) disposed within the first powder vial 138A in a dry state. The vial assembly 104 preferably includes a first sealing ring 150A having a central opening 152A configured to receive a first piercing spike 154A protruding from a distal end of the first piercing element 140A. In one embodiment, the vial assembly 104 includes a first O-ring 156A that is inserted into an opening at the proximal end of the first piercing element 140A and preferably a first O-ring retainer 158A that holds the first O-ring 156A within the opening at the proximal end of the first piercing element 140A.

[0132] In one embodiment, the vial assembly 104 preferably includes a second powder vial 138B having a proximal end 144B with a second vial opening 146B, and a second sealing membrane 148B covering and / or sealing the second vial opening 146B. During storage and prior to use, the second sealing membrane 148B preferably maintains a second powder (e.g., a second powdered reaction component) disposed within the second powder vial 138B in a dry state. The vial assembly 104 preferably includes a second sealing ring 150B having a central opening 152B configured to receive a second septum piercing spike 154B protruding from a distal end of the second piercing element 140B. In one embodiment, the vial assembly 104 includes a second O-ring 156B that is inserted into an opening at the proximal end of the second piercing element 140B and preferably a second O-ring retainer 158B that holds the second O-ring 156B within the opening at the proximal end of the second piercing element 140B.

[0133] In one embodiment, the first housing portion 142A and the second housing portion 142B of the vial housing 132 are molded components having guide channels 145A, 145B juxtaposed and extending between the proximal and distal ends of the vial housing 132. The guide channels 145A, 145B are preferably configured to receive the first and second piercing elements 140A, 140B, respectively, to guide the sliding movement of the first and second piercing elements between the retracted and extended positions. When the first and second piercing elements 140A, 140B are disposed within the vial housing 132, the first and second piercing elements 140A, 140B may slide and / or move between the retracted and extended positions. In one embodiment, when the first piercing element and the second piercing element are in the extended position, the first piercing spike 154A and the second piercing spike 154B pierce the first sealing membrane 140A and the second sealing membrane 140B, respectively, which seal the first vial opening 146A and the second vial opening 146B of the first vial 138A and the second vial 138B, respectively.

[0134] 7, in one embodiment, the vial assembly 104 preferably includes a first vial 138A secured to a distal end 136 of the vial assembly housing 132. A first sealing membrane 148A covers and / or seals a first vial opening 146A located at a proximal end 144A of the first vial 138A. A first piercing element 140A is assembled with the vial assembly housing 132 such that a first piercing spike 154A of the first piercing element 140A is aligned with the first sealing membrane 148A that covers and / or seals the first vial opening 146A of the first vial 138A.

[0135] In one embodiment, the vial assembly 104 preferably includes a second vial 138B secured to the distal end 136 of the vial assembly housing 132. A second sealing membrane 148B covers and / or seals a second vial opening 146B located at the proximal end 144B of the second vial 138B. The second piercing element 140B is assembled with the vial assembly housing 132 such that the second piercing spike 154B of the second piercing element 140B is aligned with the second sealing membrane 148B covering and / or sealing the second vial opening 146B of the second vial 138B.

[0136] In one embodiment, the vial assembly housing 132 preferably includes a first proximal projection 162A for locking and / or retaining the first piercing element 140A in the retracted position and a first distal projection 163A for locking and / or retaining the first piercing element in the extended position. In one embodiment, the first piercing element 140A preferably includes a first resilient flange 164A adapted to selectively engage the first proximal projection 162A and the first distal projection 163A. In one embodiment, when the first piercing element 140A is in the retracted position shown in FIG. 7, the first resilient flange 164A desirably engages the first proximal projection 162A to retain the first piercing element 140A in the retracted position. In one embodiment, the first piercing element 140A may be slid and / or pushed in the distal direction DIR1 such that the first elastic flange 164A is released from the first proximal projection 162A and slides into engagement with the first distal projection 163A to lock and / or retain the first piercing element 140A in the extended position (FIG. 8B).

[0137] In one embodiment, the vial assembly housing 132 preferably includes a second proximal protrusion 162B for locking and / or retaining the second piercing element 140B in the retracted position and a second distal protrusion 163B for locking and / or retaining the second piercing element 140B in the extended position. In one embodiment, the second piercing element 140B preferably includes a second resilient flange 164B adapted to selectively engage the second proximal protrusion 162B and the second distal protrusion 163B. In one embodiment, when the second piercing element 140B is in the retracted position shown in FIG. 7, the second resilient flange 164B engages the second proximal protrusion 162B to retain the second piercing element 140B in the retracted position. In one embodiment, the second piercing element 140B may be slid and / or pushed in the distal direction DIR1 such that the second elastic flange 164B is released from the second proximal projection 162B and slides into engagement with the second distal projection 163B to lock and / or retain the second piercing element 140B in the extended position (FIG. 8B).

[0138] In one embodiment, when the first piercing element 140A is assembled with the vial assembly housing 132, the first piercing spike 154A is aligned with the first sealing membrane 148A that seals the first vial opening 146A of the first vial 138A. When the first piercing element 140A is advanced to the extended position (FIG. 8B), the first piercing spike 154A pierces the first sealing membrane 148A to provide fluid communication between a first liquid contained within a first fluid chamber of the first syringe 124A (FIG. 4A) and a first powder (e.g., a first powdered reaction component) contained within a first powder chamber 160A of the first vial 138A.

[0139] In one embodiment, when the second piercing element 140B is assembled with the vial assembly housing 132, the second piercing spike 154B is aligned with the second sealing membrane 148B that seals the second vial opening 146B of the second vial 138B. When the second piercing element 140B is advanced to the extended position (FIG. 8B), the second piercing spike 154B pierces the second sealing membrane 148B to provide fluid communication between a second liquid contained within a second fluid chamber of the second syringe 124B (FIG. 4A) and a second powder (e.g., a second powdered reaction component) contained within a second powder chamber 160B of the second vial 138B.

[0140] In one embodiment, the first piercing element 140A has an elongated conduit defining a first fluid path extending through both the first piercing element and the first piercing spike 154A to provide fluid communication between the first fluid chamber of the first syringe and the powder chamber 160A of the first vial 138A, thereby allowing a first liquid to be used to reconstitute a first powder disposed in the first vial. In one embodiment, a first O-ring 156A is inserted into an opening in the proximal end of the first piercing element 140A, and a first O-ring retainer 158A retains the first O-ring 156A in the proximal opening of the first piercing element 140A.

[0141] In one embodiment, the second piercing element 140B has an elongated conduit defining a second fluid path extending through both the second piercing element and the second piercing spike 154B to provide fluid communication between the second fluid chamber of the second syringe and the second powder chamber 160B of the second vial 138B, thereby allowing a second liquid to be used to reconstitute a second powder (e.g., a second powdered reaction component) disposed in the second vial. In one embodiment, a second O-ring 156B is inserted into an opening in the proximal end of the second piercing element 140B, and a second O-ring retainer 158B retains the second O-ring 156B in the proximal opening of the second piercing element 140B.

[0142] 8A, in one embodiment, the vial assembly 104 preferably includes a first vial 138A and a second vial 138B secured to the distal end 136 of the vial assembly housing 132. In one embodiment, the first vial 138A includes a first powder chamber 160A configured to accommodate a first powder (e.g., a first powdered reactive component, fibrinogen powder, thrombin powder, cross-linking agent, etc.) and the second vial 138B includes a second powder chamber 160B configured to accommodate a second powder (e.g., a second reactive powder, fibrinogen powder, thrombin powder, cross-linking agent, etc.). In FIG. 8A, the first piercing element 140A is in a retracted position and the first piercing spike 154A is located proximal to the first sealing membrane 148A. The first piercing element 140A includes a first resilient flange 164A that engages a first proximal projection 162A of the vial housing 132 to retain the first piercing element 140A in a retracted position. The vial assembly 104 includes a first distal projection 163A adapted to engage a distal end of the first resilient flange 164A to retain the first piercing element 140A in an extended configuration, as described in more detail herein.

[0143] In one embodiment, the second piercing element 140B is in a retracted position and the second piercing spike 154B is disposed proximal to the second sealing membrane 148B. The second piercing element 140B includes a second resilient flange 164B that engages a second proximal projection 162B of the vial housing 132 to hold the second piercing element 140B in the retracted position. The vial assembly 104 includes a second distal projection 163B adapted to engage a distal end of the second resilient flange 164B to hold the second piercing element 140B in an extended configuration, as described in more detail herein.

[0144] 8B, in one embodiment, first piercing element 140A and second piercing element 140A may be advanced in a distal direction DIR1 toward distal end 136 of vial assembly housing 132 to move the first piercing element and second piercing element to an extended position. In the extended position shown in FIG. 8B, first piercing spike 154A pierces first sealing membrane 148A and second piercing spike 154B pierces second sealing membrane 148B. The first elastic flange 162A of the first piercing element 140A engages with the first distal protrusion 163A of the vial assembly housing 132 to hold and / or lock the first piercing element 140A in the extended position, and the second elastic flange 162B of the second piercing element 140B engages with the second distal protrusion 163B of the vial assembly housing 132 to hold and / or lock the second piercing element 140B in the extended position.

[0145] 9 and 10, in one embodiment, the sealant delivery assembly 106 of the sealant delivery system 100 (FIG. 1) preferably includes a proximal end 168 configured to connect with the distal end of the syringe assembly 102 (FIG. 1) and a distal end 170 adapted to squeeze and / or spray a tissue sealant (e.g., a hemostatic agent). The proximal end 168 of the sealant delivery assembly 106 is designed to keep the first reactive powder component and the second reactive powder component separated from each other prior to use of the powder components to form a sealant (e.g., a sealant for sealing air leaks during lung surgery). In one embodiment, the proximal end 168 of the sealant delivery assembly 106 desirably includes a sealant delivery assembly housing 172 having a first housing portion 172A and a second housing portion 172B, which may be snap-fit ​​together.

[0146] In one embodiment, the housing 172 includes an H-connector 174 having a first hub 176A adapted to receive a first O-ring 178A and a first O-ring retainer 180A. In one embodiment, the first hub 176A, the first O-ring 178A, and the first O-ring retainer 180A are preferably aligned with a first fluid pathway that provides fluid communication between the first fluid compartment 130A of the first syringe 124A (FIG. 4A) and the distal end of the sealant delivery assembly 106.

[0147] In one embodiment, the H-connector 174 preferably includes a second hub 176B adapted to receive a second O-ring 178B and a second O-ring retainer 180B. In one embodiment, the second hub 176B, the second O-ring 178B, and the second O-ring retainer 180B preferably align with a second fluid pathway that provides fluid communication between the second fluid compartment 130B of the second syringe 124B (FIG. 4A) and the distal end of the sealant delivery assembly 106.

[0148] In one embodiment, the sealant delivery assembly 106 preferably includes a cannula 182 (e.g., a rigid tube) adapted to receive a first flexible tube 184A and a second flexible tube 184B. The cannula may be rigid and may be made from a biocompatible material such as metals and polymers. The first flexible tube 184A preferably has a proximal end in fluid communication with a first hub 174A of the H connector 176. The second flexible tube 184B preferably has a proximal end in fluid communication with a second hub 174B of the H connector 176.

[0149] In one embodiment, the sealant delivery assembly 106 desirably includes a malleable connector 186 secured to the distal end of the cannula 182. The sealant delivery assembly 106 preferably includes a spray tip 188 secured to the distal end of the malleable connector 186. The spray tip 188 may include a static mixer for mixing together the first and second precursor solutions directed into the spray tip 188.

[0150] 11, in one embodiment, a proximal end of an elongated cannula 182 is assembled with a distal end of the sealant delivery assembly housing 172. A first flexible tube 184A and a second flexible tube 184B extend through the elongated conduit of the cannula 182. The proximal end of the first flexible tube 184A is in fluid communication with the first hub 176A. The proximal end of the second flexible tube 184B is in fluid communication with the second hub 176B. A first O-ring 178A is inserted into the first hub 176A and held in place by a first O-ring retainer 180A. A second O-ring 178B is inserted into the second hub 176B and held in place by a second O-ring retainer 180B.

[0151] 12, in one embodiment, a malleable connector 186 at the distal end of sealant delivery assembly 106 preferably connects spray tip 188 with the distal end of cannula 182. Malleable connector 186 desirably includes a malleable component 190 (e.g., a malleable metal rod, a malleable pin) disposed therein that allows spray tip 188 to be positioned and held at different angles relative to longitudinal axis A1 of cannula 182.

[0152] In one embodiment, the spray tip 188 preferably includes a spray tip housing 192 that houses a static mixer 194 having mixing fins 195. The first and second precursor solutions delivered to the spray tip 188 via the first and second flexible tubes 184A, 184B are preferably mixed together within the spray tip housing 194 by the mixing fins 195 of the static mixer 192. The mixed precursor solutions may be pumped and / or sprayed out of the distal end of the sealant applicator via a pumping opening 196 in a spray cap 197 located at the distal end 170 of the sealant delivery assembly 106. In one embodiment, the sealant delivery assembly 106 and spray cap may include one or more structural features (e.g., a swirl chamber) disclosed in commonly assigned U.S. Patent Application Publication No. 2021 / 0101162 to Trezza II et al. (Attorney Docket No. ETH6050USNP1), the disclosure of which is incorporated herein by reference.

[0153] 13A, in one embodiment, vial assembly 104 includes a vial assembly housing 132 with a first vial 138A and a second vial 138B secured to a distal end 136 of vial assembly housing 132. First vial 138A contains a first reactive powder component (e.g., fibrinogen powder, reactive synthesis powder, cross-linking agent, etc.) and second vial 138B contains a second reactive powder component (e.g., thrombin powder, reactive synthesis powder, cross-linking agent, etc.).

[0154] 13B, in one embodiment, the first and second piercing elements 140A and 140A may be advanced in a distal direction DIR1 toward the distal end 136 of the vial assembly housing 132 to move the first and second piercing elements to the extended position shown in FIG 8B. In the extended position, the first and second piercing spikes 154A and 154B of the respective first and second piercing elements pierce the respective first and second sealing membranes 148A and 148B (FIG 8B) that seal the vial openings at the proximal ends of the respective first and second vials 138A and 138B.

[0155] 14, in one embodiment, a syringe assembly 102 containing first and second liquids used to reconstitute reactive powder components may be prepared for connection to a proximal end of a vial assembly housing 132 (FIG. 13B) by removing first and second end caps 128A, 128B. Removal of first and second end caps 128A, 128B exposes respective first and second dispensing tips 126, 126B accessible at a distal end of the syringe assembly housing 120.

[0156] 15A, in one embodiment, after the first end cap 128A and the second end cap 128B (FIG. 14) are removed from the distal end of the syringe assembly housing 120 of the syringe assembly 102, the distal end of the syringe assembly housing 120 is preferably coupled with the proximal end 134 of the vial assembly housing 132. The first dispensing tip 126A is preferably inserted into an opening in the proximal end of the first piercing element 140A, and the second dispensing tip 126B is preferably inserted into an opening in the proximal end of the second piercing element 140B.

[0157] 15B, after vial assembly 104 is assembled with the distal end of syringe assembly 102, a first liquid disposed within first syringe 124A (FIG. 4A) of the syringe assembly is preferably in fluid communication with a first powder (e.g., powdered reaction component) disposed within first powder chamber 160A of first vial 138A. Similarly, a second liquid disposed within second syringe 124B (FIG. 4A) of the syringe assembly is preferably in fluid communication with a second powder (e.g., powdered reaction component) disposed within second powder chamber 160B of second vial 138B.

[0158] 15C shows the distal end of the syringe assembly 102 connected to the proximal end of the vial assembly 104. The syringe assembly includes a first syringe 124A having a first fluid chamber 130A that contains a first activation fluid (e.g., a diluent, a buffer solution, a catalyst, a reaction initiator, an activation fluid for activating a first powder, etc.). The syringe assembly 102 also includes a second syringe barrel 124B having a second fluid chamber 130B that desirably contains a second activation fluid (e.g., a diluent, a buffer solution, a catalyst, a reaction initiator, an activation fluid for activating a second powder, etc.). The first syringe barrel 124A is connected to the proximal end of the vial assembly 104 such that a first dispensing tip 128A of the first syringe barrel 124A is aligned with and in fluid communication with a first vial opening 146A of a first vial 138A. The first vial 138A has a first powder chamber 160A that contains a first powder that is reconstituted using a first activation fluid disposed in a first fluid chamber 130A of the first syringe barrel 124A. A second dispensing tip 128B at the distal end of the second syringe 124B is preferably aligned with a second vial opening 146B of the second vial 138B. The second vial 138B preferably includes a second powder chamber 160B that contains a second powder that is reconstituted using a second activation fluid disposed in the second fluid chamber 130B of the second syringe 124B.

[0159] During the stage shown in FIG. 15C, the first liquid and first powder remain separated from the second liquid and second powder.

[0160] In one embodiment, the first activation fluid in the first syringe 124A is mixed with the first powder in the first vial 138A by advancing and retracting the dual-barrel plunger 112 in a distal and proximal direction. As the first plunger rod 114A advances toward the distal end of the syringe housing 120, the first activation fluid in the first fluid chamber 130A of the first syringe 124A is forced into the first powder chamber 160A of the first vial 138A to reconstitute the first powder into a first therapeutic solution. When the first plunger rod 114A is retracted away from the distal end of the syringe housing 120, the first therapeutic solution of the first powder and the first activation fluid is drawn back into the first fluid chamber 130A of the first syringe 124A. The first plunger rod 114A may be repeatedly reciprocated back and forth between an extended position and a retracted position to thoroughly mix the first activation fluid and the first powder to form a first precursor solution (e.g., a flowable liquid). In one embodiment, after the first precursor solution is formed, the first plunger rod 114A is preferably fully retracted to draw the entire volume of the first precursor solution into the first fluid chamber 130A of the first syringe 124A.

[0161] In one embodiment, the second activation fluid in the second syringe 124B is mixed with the second powder in the second vial 138B by advancing and retracting the dual-barrel plunger 112 in a distal and proximal direction. As the second plunger rod 114B advances toward the distal end of the syringe assembly housing 120, the second activation fluid in the second fluid chamber 130B of the second syringe 124B is forced into the second powder chamber 160B of the second vial 138B to reconstitute the second powder into a second therapeutic solution. When the second plunger rod 114B is retracted from the distal end of the syringe assembly housing 120, the second therapeutic solution of the second powder and the second activation fluid is drawn back into the second fluid chamber 130B of the second syringe 124B. The second plunger rod 114B may be repeatedly reciprocated back and forth between the extended and retracted positions to thoroughly mix the second activator and the second powder to form a second precursor solution (e.g., a flowable liquid). In one embodiment, after the second precursor solution is formed, the second plunger rod 114B is preferably fully retracted to draw the entire volume of the second precursor solution into the second fluid chamber 130B of the second syringe 124B.

[0162] 15C and 16, in one embodiment, after the first and second precursor solutions are generated and withdrawn into the first and second fluid chambers 130A and 130B of the first and second syringes 124A and 124B of the syringe assembly 120, respectively, the vial assembly 104 may be separated from the distal end of the syringe assembly housing 120, and the sealant delivery assembly 106 may be secured to the distal end of the syringe assembly housing 102 to pump the first and second precursor solutions out of the distal end of the sealant applicator. In one embodiment, the sealant delivery assembly housing 172 at the proximal end of the sealant delivery assembly 106 is preferably connected to the distal end of the syringe assembly housing 120. The cannula 182 and the spray tip 188 preferably extend toward the distal end 170 of the sealant delivery assembly 106.

[0163] After the sealant delivery assembly is secured to the distal end of the syringe assembly housing, the first fluid chamber 130A of the first syringe 124A containing the first precursor is preferably in fluid communication with the spray tip 188 via the first flexible tube 184A. The second fluid chamber 130B of the second syringe 124B containing the second precursor is preferably in fluid communication with the spray tip 188 via the second flexible tube 184B.

[0164] In one embodiment, when the dual barrel plunger 112 is depressed in a distal direction designated DIR1 to force the first and second precursor solutions out of the first and second fluid chambers 130A and 130B of the first and second syringes 124A and 124B, respectively, the first and second precursor solutions flow through the first and second flexible tubes 184A and 184B, respectively, to the spray tip 188. Upon reaching the spray tip, the first and second precursor solutions are mixed together by a static mixer 194 (FIG. 12), after which the first and second precursor solutions react with each other to form a tissue sealant or hemostatic agent, which is forced out of a dispensing opening 196 of a spray cup 197 (FIG. 12) located at the distal end 170 of the sealant delivery assembly 106.

[0165] Referring to FIG. 17, in one embodiment, a sealant delivery system 200 preferably includes a syringe assembly 202 containing one or more liquids or fluids for reconstituting a therapeutic powder, a vial assembly 204 having a first vial 238A and a second vial 238B containing powdered reactive components, and a sealant delivery assembly 206 for expressing a sealant or hemostatic agent. In one embodiment, the syringe assembly 202 may be a molded component having juxtaposed dual barrel cavities configured to hold liquids used to reconstitute the reactive powdered components. In one embodiment, the vial assembly 204 may be similar to the vial assembly 104 disclosed above in the embodiments shown in FIGS. 5A-5B, 6, 7, and 8A-8B. In one embodiment, the sealant delivery assembly 206 may be similar to the sealant delivery assembly 106 shown in FIGS. 9-12 and described above.

[0166] 18 , in one embodiment, the syringe assembly 202 preferably includes a syringe assembly housing 220 adapted to receive a distal end of a dual-barrel plunger 212. The dual-barrel plunger 212 preferably includes a first plunger rod 214A insertable into a first syringe barrel cavity formed in the syringe assembly housing 220 of the syringe assembly 202 and a second plunger rod 214B insertable into a second syringe barrel cavity of the syringe assembly housing 220 of the syringe assembly 202. In one embodiment, the proximal ends of the first syringe plunger rod 214A and the second syringe plunger rod 214B are interconnected by a thumb tab 216 that defines the proximal end of the dual-barrel plunger 212.

[0167] In one embodiment, the syringe assembly 202 preferably includes a syringe end cap 228 releasably secured to a distal end of the syringe assembly housing 220 of the syringe assembly 202 to cover a syringe dispensing tip that is in fluid communication with a respective syringe barrel cavity formed within the syringe assembly housing 220, as described in more detail herein.

[0168] 19, the syringe assembly 202 preferably includes a syringe assembly housing 220 having a proximal end adapted to receive the dual barrel plunger 212 and a distal end adapted to be connected to a syringe end cap 228. The syringe assembly housing 220 preferably includes a first dispensing tip 226A protruding from the distal end of the syringe housing 220 and in fluid communication with a first fluid chamber of a first syringe barrel cavity integrally formed within the syringe assembly housing 220. The syringe assembly housing 220 preferably includes a second dispensing tip 226B protruding from the distal end of the syringe housing 220 and in fluid communication with a second fluid chamber of a second syringe barrel cavity integrally formed within the syringe assembly housing 220.

[0169] In one embodiment, syringe end cap 228 may be removed from the distal end of syringe assembly housing 220 to expose first and second dispensing tips 226A, 226B. After syringe end cap 228 is removed to expose dispensing tips 226A, 226B, the distal end of the syringe assembly housing may be assembled with a vial assembly or a sealant delivery assembly.

[0170] In one embodiment, the dual barrel plunger 212 preferably includes a first plunger rod 214A having a distal end adapted to be connected with a first plunger 218A. The dual barrel plunger 212 also includes a second plunger rod 214B having a distal end adapted to be connected with a second plunger 218B. In one embodiment, the distal end of the first plunger rod 214A to which the first plunger 218A is secured is insertable into a first fluid chamber defined by a first syringe barrel cavity of the syringe assembly housing, and the distal end of the second plunger rod 214B to which the second plunger 218B is secured is inserted into a second fluid chamber defined by a second syringe barrel cavity of the syringe assembly housing.

[0171] 20, in one embodiment, the distal end of the first plunger 218A and the first plunger rod 214A are inserted into a first fluid chamber 230A of a first syringe barrel cavity 224A integrally formed within the syringe assembly housing 220 of the syringe assembly 202. Similarly, the distal end of the second plunger 218B and the second plunger rod 214B are inserted into a second fluid chamber 230B of a second syringe barrel cavity integrally formed within the syringe assembly housing 220 of the syringe assembly 202. In one embodiment, a first liquid (e.g., a diluent, a buffer solution, a catalyst, a reaction initiator, an activation fluid, etc.) is disposed within the first fluid chamber 230A of the first syringe barrel cavity 224B. In one embodiment, a second liquid (e.g., a diluent, a buffer solution, a catalyst, an initiator, an activation fluid, etc.) is disposed in the second fluid chamber 230B of the second syringe barrel cavity 224B. The first and second activation fluids may have the same properties or may have different properties.

[0172] In one embodiment, during storage, a syringe assembly end cap 228 is preferably connected to the distal end of the syringe assembly housing 220 of the syringe assembly 202 to cover the first and second dispensing tips 226A, 226B, which are in fluid communication with the respective first and second fluid chambers 230A, 230B.

[0173] Referring to FIG. 21, in one embodiment, the syringe assembly end cap 228 (FIG. 20) may be removed from the distal end of the syringe assembly housing 220 to expose the syringe dispensing tips 226A, 226B, which are in fluid communication with the first and second fluid chambers 230A, 230B of the respective first and second syringe barrel cavities 224A, 224B.

[0174] 22A, in one embodiment, after a syringe end cap 228 (FIG. 20) is removed from the distal end of the syringe assembly housing 220 of the syringe assembly 204, the distal end of the syringe assembly housing 220 may be coupled to a proximal end 234 of a vial assembly housing 232 of the vial assembly 202. A first syringe dispensing tip 226A is preferably inserted into an opening at a proximal end of a first piercing element 240A to provide fluid communication between a first fluid chamber 230A (FIG. 21) and a first vial 238A. A second syringe dispensing tip 226B is preferably inserted into an opening at a proximal end of a second piercing element 240B to provide fluid communication between a second fluid chamber 230B (FIG. 21) and a second vial 238B.

[0175] Referring to FIG. 22B, after vial assembly 204 is assembled with the distal end of syringe assembly housing 220 of syringe assembly 202, a first liquid (e.g., a diluent, a buffer solution, a catalyst, a reaction initiator, an activation fluid, a reconstitution fluid, etc.) is disposed within first fluid chamber 230A of first syringe barrel cavity 224A ( FIG. 21 ) of syringe assembly housing 220 of syringe assembly 202, preferably in communication with a first powder disposed within first powder chamber 260A of first vial 238A of vial assembly 204. Similarly, a second liquid (e.g., a diluent, buffer solution, catalyst, reaction initiator, activation fluid, reconstitution fluid, etc.) is disposed within a second fluid chamber 230B of a second syringe barrel cavity 224B (FIG. 21) of the syringe assembly housing 220 of the syringe assembly 202, and is preferably in communication with a second powder disposed within a second powder chamber 260B of a second vial 238B of the vial assembly 204.

[0176] 22C, in one embodiment, the distal end of the syringe assembly 202 is connected to the proximal end of the vial assembly 204. The syringe assembly includes a first syringe barrel cavity 224A having a first fluid chamber 230A that contains a first liquid for reconstituting a first powder. The first syringe barrel cavity 224A is connected to the proximal end of the vial assembly 204 such that a first dispensing tip 226A of the first syringe barrel cavity 224A is aligned with and in fluid communication with a first vial opening 246A of a first vial 238A. The first vial 238A has a first powder chamber 260A that contains a first powder to be reconstituted with a first liquid disposed in the first fluid chamber 230A of the first syringe barrel cavity 224A.

[0177] In one embodiment, the syringe assembly 202 desirably includes a second syringe barrel cavity 224B having a second fluid chamber 230B that contains a second liquid used to reconstitute a second powder. A second dispensing tip 226B at a distal end of the second syringe barrel cavity 224B preferably aligns with a second vial opening 246B of a 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 liquid disposed in the second fluid chamber 230B of the second syringe barrel cavity 224B.

[0178] In one embodiment, a first liquid in the first fluid chamber 230A of the first syringe barrel cavity 224A is mixed with a first powder disposed in the first powder compartment 260A of the first vial 138A by advancing and retracting the dual-barrel plunger 112 in a distal direction DIR1 and a proximal direction DIR2. As the first plunger rod 114A advances distally in the direction DIR1 toward the distal end of the syringe assembly housing 220, the first liquid in the first fluid chamber 230A of the first syringe barrel cavity 224A is forced into the first powder chamber 260A of the first vial 238A. When the first plunger rod 214A is retracted from the distal end of the syringe assembly housing 220, the first precursor solution, including the first powder and the first liquid, is drawn back into the first fluid chamber 230A of the first syringe barrel cavity 224A. The first plunger rod 214A may be repeatedly reciprocated back and forth between the extended position and the retracted position to thoroughly mix the first liquid and the first powder components to form the first precursor solution (e.g., a flowable liquid). In one embodiment, after the first precursor solution is generated, the first plunger rod 214A is preferably fully retracted to draw the entire volume of the first precursor solution back into the first fluid chamber 230A of the first syringe barrel cavity 224A.

[0179] In one embodiment, the second liquid contained within the second syringe barrel cavity 224B may be mixed with the second powder disposed within the second powder component 260B of the second vial 138B by advancing and retracting the dual-barrel plunger 112 in a distal direction (DIR1) and a proximal direction (DIR2). As the second plunger rod 114B advances toward the distal end of the syringe assembly housing 220, the second liquid within the second fluid chamber 230B of the second syringe barrel cavity 224B is forced into the second powder chamber 260B of the second vial 238B to reconstitute the second powder into a second precursor solution. When the second plunger rod 214B is retracted from the distal end of the syringe assembly housing 220, the second precursor solution, including the second powder and the second liquid, is drawn back into the second fluid chamber 230B of the second syringe barrel cavity 224B. The second plunger rod 214B may be repeatedly reciprocated back and forth between the extended position and the retracted position to thoroughly mix the second liquid and the second powder to form the second precursor solution (e.g., a flowable liquid). In one embodiment, after the second precursor solution is formed, the second plunger rod 214B is preferably fully retracted to draw the entire volume of the second precursor solution back into the second fluid chamber 230B of the second syringe barrel cavity 224B.

[0180] In one embodiment, the first precursor solution and the second precursor solution may be mixed together to form a tissue sealant or hemostatic agent that is applied to tissue during a surgical procedure (e.g., a minimally invasive surgical procedure).

[0181] 22C, 23A-23B, and 24, in one embodiment, after the first and second precursor solutions are generated and pulled back into the first and second fluid chambers 230A and 230B of the first and second syringe barrel cavities 224A and 224B, respectively, the vial assembly 204 (FIG. 22C) may be separated from the distal end of the syringe assembly housing 220 to expose the first and second dispensing tips 226A and 226B (FIG. 22C). In one embodiment, a sealant delivery assembly housing 272 at a proximal end of the sealant delivery assembly 206 is preferably coupled with the distal end of the syringe assembly housing 220. The cannula 282 and the spray tip 288 preferably extend toward the distal end 270 of the sealant delivery assembly 206.

[0182] After the sealant delivery assembly 206 is secured to the distal end of the syringe assembly housing 220, the first fluid chamber 230A of the first syringe barrel cavity 224A containing the first precursor solution is preferably in fluid communication with the spray tip 288 via a first fluid pathway (e.g., the first flexible tube 184A shown in FIG. 11 ). The second fluid chamber 230B of the second syringe barrel cavity 224B containing the second precursor solution is preferably in fluid communication with the spray tip 288 via a second fluid pathway (e.g., the second flexible tube 184B shown in FIG. 11 ).

[0183] 23A and 23B, in one embodiment, a sealant delivery assembly 206 similar to that shown in FIGS. 9 and 10 above preferably includes an elongated cannula 282 having a proximal end and a distal end. A sealant delivery assembly housing 272 is secured to the proximal end of the cannula 282 and a spray tip 288 is secured to the distal end of the cannula 282 via a malleable connector 286. The malleable connector 286 desirably allows the spray tip 282 to be articulated at different angles relative to the longitudinal axis A1 of the elongated cannula 282. The malleable connector may include a malleable rod or pin that maintains its shape after being bent to a particular orientation, which in turn holds the spray tip 282 in a selected orientation relative to the elongated axis A1 of the cannula 282 (FIG. 24).

[0184] 23B and 24, in one embodiment, a proximal end of the sealant delivery assembly housing 272 of the sealant delivery assembly 206 is connected to a distal end of the syringe assembly housing 220 of the syringe assembly 202. In one embodiment, a first dispensing tip 226A (FIG. 22C) at the distal end of the syringe assembly housing 220 of the syringe assembly 202 is inserted into a first hub 276A at the proximal end of the sealant delivery assembly housing 272. A second dispensing tip 226B (FIG. 22C) at the distal end of the syringe assembly housing 220 is inserted into a second hub 276B at the proximal end of the sealant delivery assembly housing 272.

[0185] In one embodiment, the spray tip 288 is coupled to the distal end of the cannula 282 by a malleable connector 286. The malleable connector 286 allows the spray tip 288 to be positioned at different angles relative to the longitudinal axis A1 of the elongated cannula 282 of the sealant delivery assembly 206.

[0186] 24, in one embodiment, the distal end of the sealant delivery assembly 206 may have a structure similar to that shown and described above with respect to the embodiment shown in FIG. 12. A malleable connector 286 connects the spray tip 288 to the distal end of the cannula 282. The malleable connector 286 preferably includes an elongated malleable component (e.g., the malleable metal rod 190 shown in FIG. 12) extending along its length. The malleable component allows the spray tip 288 to be positioned at different angles relative to the longitudinal axis A1 of the cannula 282.

[0187] In one embodiment, the dual-barrel plunger 212 is depressed in a distal direction designated DIR1 to force the first and second precursor solutions out of the first and second fluid chambers 230A and 230B of the first and second syringe barrel cavities 224A and 224B, respectively ( FIG. 22C ), causing the first and second precursor solutions to flow toward the spray tip 288, mix together within the spray tip, and be forced out of the distal end 270 of the sealant delivery assembly 206.

[0188] In one embodiment, the sealant delivery system keeps the first and second precursor solutions separated from one another until they are mixed together in the spray tip 288. Once mixed together in the spray tip 288, the first and second precursor solutions preferably react with one another to form a sealant or hemostatic agent that controls bleeding. The sealant or hemostatic agent is preferably sprayed onto the tissue in fluid form such that the interacting first and second precursor solutions harden, coagulate, and / or gel to stop or control bleeding.

[0189] 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.

[0190] [Embodiment] (1) A sealant delivery system comprising: a syringe assembly including a first syringe and a second syringe arranged side by side, the first syringe having a first fluid chamber and the second syringe having a second fluid chamber; a vial assembly coupled to a distal end of the syringe assembly, the vial assembly including a first vial and a second vial in juxtaposition; the first vial has a proximal end aligned with a distal end of the first syringe, the first vial including a first vial opening at the proximal end closed by a first sealing membrane; the second vial has a proximal end aligned with the distal end of the second syringe, the second vial including a second vial opening at the proximal end closed by a second sealing membrane; the vial assembly includes a first piercing element disposed between the distal end of the first syringe and the proximal end of the first vial, the first piercing element having a first piercing spike protruding from its distal end, the first piercing element being movable between a retracted position in which the first piercing spike is disposed proximal to the first sealing membrane and an extended position in which the first piercing spike passes through the first sealing element to pierce the first sealing membrane to provide first fluid communication between the first fluid chamber of the first syringe and the first vial; 11. A sealant delivery system, wherein the vial assembly includes a second piercing element disposed between the distal end of the second syringe and the proximal end of the second vial, the second piercing element having a second piercing spike protruding from its distal end, the second piercing element being movable between a retracted position in which the second piercing spike is disposed proximal to the second sealing membrane and an extended position in which the second piercing spike passes through the second sealing element to pierce the second sealing membrane to provide second fluid communication between the second fluid chamber of the second syringe and the second vial. (2) the first piercing element defines a first fluid pathway extending along a length of the first piercing element to provide the first fluid communication between the first fluid chamber of the first syringe and the first vial; 2. The sealant delivery system of embodiment 1, further comprising: the second piercing element defining a second fluid path extending along a length of the second piercing element to provide the second fluid communication between the second fluid chamber of the second syringe and the second vial. (3) The sealant delivery system of embodiment 2, wherein the first fluid path and the second fluid path are isolated from one another, and the syringe assembly and the vial assembly can be connected to one another only in one configuration to ensure that the first syringe is always matched with the first vial and the second syringe is always matched with the second vial. (4) a first liquid disposed in the first fluid chamber of the first syringe; and a first powdered reaction component disposed in the first vial, wherein the first liquid and the first powdered reaction component are configured to be mixed together to reconstitute the first powdered reaction component to form a first therapeutic solution; a second liquid disposed in the second fluid chamber of the second syringe; and 2. The sealant delivery system of claim 1, further comprising: a second powdered reactive component disposed in the second vial, wherein the second liquid and the second powdered reactive component are configured to be mixed together to reconstitute the second powdered reactive component to form a second therapeutic solution. (5) The vial housing comprises: a first guide channel extending between a proximal end and a distal end of the vial housing, the first piercing element being disposed within the first guide channel and configured to move between the retracted position and the extended position; 2. The sealant delivery system of embodiment 1, further comprising: a second guide channel extending between the proximal end and the distal end of the vial housing, the second piercing element being disposed within the second guide channel and configured to move between the retracted position and the extended position.

[0191] (6) The vial housing comprises: a first proximal projection extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the retracted position; a first distal projection extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the extended position; a second proximal projection extending into the second guide channel adapted to contact the second piercing element to retain the second piercing element in the retracted position; 6. The sealant delivery system of claim 5, further comprising: a second distal protrusion extending into the first guide channel adapted to contact the first piercing element to hold the first piercing element in the extended position. (7) the first piercing element includes a first resilient flange adapted to sequentially engage the first proximal projection and the first distal projection of the vial housing when the first piercing element is moved from the retracted position to the extended position within the first guide channel; The sealant delivery system of embodiment 6, further comprising: a second piercing element including a second elastic flange adapted to sequentially engage with the second proximal projection and the second distal projection of the vial housing when the second piercing element is moved from the retracted position to the extended position within the second guide channel. (8) the first piercing element, the first piercing element having a central opening at a proximal end thereof; the first syringe having a first dispensing tip protruding from the distal end thereof, the first dispensing tip being inserted into the central opening of the proximal end of the first piercing element; the second piercing element having a central opening at a proximal end thereof; and 2. The sealant delivery system of claim 1, further comprising: a second syringe having a second dispensing tip protruding from the distal end thereof, the second dispensing tip being inserted into the central opening of the proximal end of the second piercing element. (9) The syringe assembly, a dual-barrel plunger including a first plunger rod inserted into a proximal end of the first syringe and a second plunger rod inserted into a proximal end of the second syringe; a thumb tab interconnecting a proximal end of the first plunger rod and a proximal end of the second plunger rod, 5. The sealant delivery system of embodiment 4, wherein the dual-barrel plunger is movable toward a distal end of the syringe assembly to push the first liquid into the first vial and the second liquid into the second vial. (10) A vial assembly comprising: a vial assembly housing having a proximal end and a distal end, the vial assembly housing having juxtaposed first and second guide channels extending between the proximal and distal ends of the vial assembly housing; a first vial secured to the vial assembly housing, the first vial having a proximal end aligned with the first guide channel and a first vial opening at the proximal end of the first vial closed by a first sealing membrane; a first piercing element disposed within the first guide channel, the first piercing element being movable between a retracted position in which the first piercing element is proximal to the first sealing membrane and an extended position in which the first piercing element passes through the first sealing element to pierce the first sealing membrane; a second vial secured to the vial assembly housing, the second vial having a proximal end aligned with the second guide channel and a second vial opening at the proximal end of the second vial closed by a second sealing membrane; a second piercing element disposed within the second guide channel, the second piercing element being movable between a retracted position in which the second piercing element is located proximal to the second sealing membrane and an extended position in which the second piercing element passes through the second sealing element to pierce the second sealing membrane.

[0192] (11) A first piercing element having a proximal end and a distal end, a central opening located at the proximal end of the first piercing element defining a first fluid pathway extending along a length of the first piercing element, and a first piercing spike protruding from the distal end of the first piercing element; 11. The vial assembly of embodiment 10, further comprising a second piercing element having a proximal end and a distal end, a central opening located at the proximal end of the second piercing element defining a second fluid pathway extending along the length of the second piercing element, and a second piercing spike protruding from the distal end of the second piercing element. (12) The vial assembly of embodiment 11, wherein the first fluid path and the second fluid path are separated from each other. (13) The vial housing, a first proximal projection extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the retracted position; a first distal projection extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the extended position; a second proximal projection extending into the second guide channel adapted to contact the second piercing element to retain the second piercing element in the retracted position; 11. The vial assembly of embodiment 10, further comprising a second distal protrusion extending into the second guide channel adapted to contact the second piercing element to hold the second piercing element in the extended position. (14) the first piercing element includes a first resilient flange adapted to sequentially engage the first proximal projection and the first distal projection of the vial assembly housing when the first piercing element is moved from the retracted position to the extended position within the first guide channel; The sealant delivery system of embodiment 13, further comprising: a second piercing element including a second elastic flange adapted to sequentially engage with the second proximal projection and the second distal projection of the vial assembly housing when the second piercing element is moved from the retracted position to the extended position within the second guide channel. (15) A sealant delivery system comprising the vial assembly of claim 11, wherein the sealant delivery system comprises: a syringe assembly including a first syringe and a second syringe arranged side by side, the first syringe having a first fluid chamber and the second syringe having a second fluid chamber; a distal end of the syringe assembly coupled to the proximal end of the vial assembly housing such that the distal end of the first syringe is aligned with the central opening in the proximal end of the first piercing element and the distal end of the second syringe is aligned with the central opening in the proximal end of the second piercing element.

[0193] (16) A first syringe having a first dispensing tip protruding from a distal end of the first syringe and in fluid communication with the first fluid compartment of the first syringe, the first dispensing tip being inserted into the central opening at the proximal end of the first piercing element to provide fluid communication between the first fluid chamber and the first fluid pathway extending along the length of the first piercing element; 16. The sealant delivery system of embodiment 15, further comprising: a second syringe having a second dispensing tip protruding from a distal end of the second syringe and in fluid communication with the second fluid compartment of the second syringe, the second dispensing tip being inserted into the central opening at the proximal end of the second piercing element to provide fluid communication between the second fluid chamber and the second fluid path extending along the length of the second piercing element. (17) a first liquid disposed in the first fluid chamber of the first syringe and a first powdered reaction component disposed in the first vial of the vial assembly, wherein the first fluid pathway provides fluid communication between the first fluid chamber and the first vial when the first piercing element is moved to the extended position; 17. The sealant delivery system of embodiment 16, further comprising: a second liquid disposed in the second fluid chamber of the second syringe; and a second powdered reactive component disposed in the second vial of the vial assembly, wherein the second fluid path provides fluid communication between the second fluid chamber and the second vial when the second piercing element is moved to the extended position. (18) A sealant delivery system comprising: a syringe assembly including a first syringe and a second syringe arranged side by side, the first syringe having a first fluid chamber for containing a first liquid and the second syringe having a second fluid chamber for containing a second fluid; a vial assembly coupled to a distal end of the syringe assembly, the vial assembly including a first vial and a second vial in juxtaposition; the first vial contains a first powdered reaction component, the first vial having a proximal end aligned with the distal end of the first syringe and a first vial opening at the proximal end of the first vial closed by a first sealing membrane; the second vial contains a second powdered component, the second vial having a proximal end aligned with the distal end of the second syringe and a second vial opening at the proximal end of the second vial closed by a second sealing membrane; the vial assembly includes a first piercing element disposed between the distal end of the first syringe and the first sealing membrane, the first piercing element being movable between a retracted position in which the first piercing element is disposed proximal to the first sealing membrane and an extended position in which the first piercing element pierces the first sealing membrane to provide fluid communication between the first fluid chamber and the first vial; the vial assembly includes a second piercing element disposed between the distal end of the second syringe and the second sealing membrane, the second piercing element being movable between a retracted position in which the second piercing element is disposed proximal to the second sealing membrane and an extended position in which the second piercing element pierces the second sealing membrane to provide fluid communication between the second fluid chamber and the second vial. (19) The syringe assembly, a dual-barrel plunger including a first plunger rod inserted into a proximal end of the first syringe and a second plunger rod inserted into a proximal end of the second syringe; a tab interconnecting a proximal end of the first plunger rod and the second plunger rod, 19. The sealant delivery system of embodiment 18, wherein the dual-barrel plunger is movable toward a distal end of the syringe assembly to push the first liquid into the first vial to reconstitute the first powdered reaction component to produce a first therapeutic solution and to push the second liquid into the second vial to reconstitute the second powdered reaction component to produce a second therapeutic solution. (20) The vial housing, juxtaposed first and second guide channels extending between proximal and distal ends of the vial assembly housing; a first proximal projection extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the retracted position; a first distal projection extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the extended position; a second proximal projection extending into the second guide channel adapted to contact the second piercing element to retain the second piercing element in the retracted position; 19. The sealant delivery system of embodiment 18, further comprising a second distal protrusion extending into the second guide channel adapted to contact the second piercing element to hold the second piercing element in the extended position.

Claims

1. 1. A sealant delivery system comprising: a syringe assembly including a first syringe and a second syringe arranged side by side, the first syringe having a first fluid chamber and the second syringe having a second fluid chamber; a vial assembly coupled to a distal end of the syringe assembly, the vial assembly including a first vial and a second vial in juxtaposition; the first vial has a proximal end aligned with a distal end of the first syringe, the first vial including a first vial opening at the proximal end closed by a first sealing membrane; the second vial has a proximal end aligned with the distal end of the second syringe, the second vial including a second vial opening at the proximal end closed by a second sealing membrane; the vial assembly includes a first piercing element disposed between the distal end of the first syringe and the proximal end of the first vial, the first piercing element having a first piercing spike protruding from its distal end, the first piercing element being movable between a retracted position in which the first piercing spike is disposed proximal to the first sealing membrane and an extended position in which the first piercing spike passes through the first sealing element to pierce the first sealing membrane to provide first fluid communication between the first fluid chamber of the first syringe and the first vial; 11. A sealant delivery system, wherein the vial assembly includes a second piercing element disposed between the distal end of the second syringe and the proximal end of the second vial, the second piercing element having a second piercing spike protruding from its distal end, the second piercing element being movable between a retracted position in which the second piercing spike is disposed proximal to the second sealing membrane and an extended position in which the second piercing spike passes through the second sealing element to pierce the second sealing membrane to provide second fluid communication between the second fluid chamber of the second syringe and the second vial.

2. the first piercing element defines a first fluid pathway extending along a length of the first piercing element to provide the first fluid communication between the first fluid chamber of the first syringe and the first vial; 2. The sealant delivery system of claim 1, further comprising: the second piercing element defining a second fluid path extending along a length of the second piercing element to provide the second fluid communication between the second fluid chamber of the second syringe and the second vial.

3. 3. The sealant delivery system of claim 2, wherein the first fluid path and the second fluid path are isolated from one another and the syringe assembly and the vial assembly can only be connected to one another in one configuration to ensure that the first syringe is always matched with the first vial and the second syringe is always matched with the second vial.

4. a first liquid disposed in the first fluid chamber of the first syringe; a first powdered reaction component disposed in the first vial, wherein the first liquid and the first powdered reaction component are configured to be mixed together to reconstitute the first powdered reaction component to form a first therapeutic solution; a second liquid disposed in the second fluid chamber of the second syringe; and 10. The sealant delivery system of claim 1, further comprising: a second powdered reactive component disposed in the second vial, wherein the second liquid and the second powdered reactive component are configured to be mixed together to reconstitute the second powdered reactive component to form a second therapeutic solution.

5. The vial housing comprises: a first guide channel extending between a proximal end and a distal end of the vial housing, the first piercing element being disposed within the first guide channel and configured to move between the retracted position and the extended position; 2. The sealant delivery system of claim 1, further comprising: a second guide channel extending between the proximal and distal ends of the vial housing, the second piercing element being disposed within the second guide channel and configured to move between the retracted position and the extended position.

6. The vial housing comprises: a first proximal protrusion extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the retracted position; a first distal projection extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the extended position; a second proximal protrusion extending into the second guide channel adapted to contact the second piercing element to retain the second piercing element in the retracted position; 6. The sealant delivery system of claim 5, further comprising: a second distal protrusion extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the extended position.

7. a first piercing element including a first resilient flange adapted to sequentially engage the first proximal projection and the first distal projection of the vial housing when the first piercing element is moved from the retracted position to the extended position within the first guide channel; 7. The sealant delivery system of claim 6, further comprising: a second piercing element including a second resilient flange adapted to sequentially engage the second proximal projection and the second distal projection of the vial housing when the second piercing element is moved from the retracted position to the extended position within the second guide channel.

8. the first piercing element having a central opening at a proximal end thereof; and the first syringe having a first dispensing tip protruding from the distal end thereof, the first dispensing tip being inserted into the central opening of the proximal end of the first piercing element; the second piercing element having a central opening at a proximal end thereof; and 2. The sealant delivery system of claim 1, further comprising: a second syringe having a second dispensing tip protruding from the distal end thereof, the second dispensing tip being inserted into the central opening of the proximal end of the second piercing element.

9. The syringe assembly comprises: a dual-barrel plunger including a first plunger rod inserted into a proximal end of the first syringe and a second plunger rod inserted into a proximal end of the second syringe; a thumb tab interconnecting a proximal end of the first plunger rod and a proximal end of the second plunger rod; 5. The sealant delivery system of claim 4, wherein the dual-barrel plunger is movable toward a distal end of the syringe assembly to force the first liquid into the first vial and the second liquid into the second vial.

10. 1. A vial assembly comprising: a vial assembly housing having a proximal end and a distal end, the vial assembly housing having juxtaposed first and second guide channels extending between the proximal and distal ends of the vial assembly housing; a first vial secured to the vial assembly housing, the first vial having a proximal end aligned with the first guide channel and a first vial opening at the proximal end of the first vial closed by a first sealing membrane; a first piercing element disposed within the first guide channel, the first piercing element being movable between a retracted position in which the first piercing element is located proximal to the first sealing membrane and an extended position in which the first piercing element passes through the first sealing element to pierce the first sealing membrane; a second vial secured to the vial assembly housing, the second vial having a proximal end aligned with the second guide channel and a second vial opening at the proximal end of the second vial closed by a second sealing membrane; a second piercing element disposed within the second guide channel, the second piercing element being movable between a retracted position in which the second piercing element is located proximal to the second sealing membrane and an extended position in which the second piercing element passes through the second sealing element to pierce the second sealing membrane.

11. a first piercing element having a proximal end and a distal end, a central opening located at the proximal end of the first piercing element defining a first fluid pathway extending along a length of the first piercing element, and a first piercing spike protruding from the distal end of the first piercing element; 11. The vial assembly of claim 10, further comprising a second piercing element having a proximal end and a distal end, a central opening located at the proximal end of the second piercing element defining a second fluid pathway extending along a length of the second piercing element, and a second piercing spike protruding from the distal end of the second piercing element.

12. 12. The vial assembly of claim 11, wherein the first fluid path and the second fluid path are isolated from each other.

13. The vial housing comprises: a first proximal protrusion extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the retracted position; a first distal projection extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the extended position; a second proximal protrusion extending into the second guide channel adapted to contact the second piercing element to retain the second piercing element in the retracted position; 11. The vial assembly of claim 10, further comprising: a second distal protrusion extending into the second guide channel adapted to contact the second piercing element to retain the second piercing element in the extended position.

14. a first piercing element including a first resilient flange adapted to sequentially engage the first proximal projection and the first distal projection of the vial assembly housing when the first piercing element is moved from the retracted position to the extended position within the first guide channel; The sealant delivery system of claim 13, further comprising: a second piercing element including a second resilient flange adapted to sequentially engage with the second proximal projection and the second distal projection of the vial assembly housing when the second piercing element is moved from the retracted position to the extended position within the second guide channel.

15. 12. A sealant delivery system including the vial assembly of claim 11, wherein the sealant delivery system comprises: a syringe assembly including a first syringe and a second syringe arranged side by side, the first syringe having a first fluid chamber and the second syringe having a second fluid chamber; a distal end of the syringe assembly coupled to the proximal end of the vial assembly housing such that the distal end of the first syringe is aligned with the central opening at the proximal end of the first piercing element and the distal end of the second syringe is aligned with the central opening at the proximal end of the second piercing element.

16. a first syringe having a first dispensing tip protruding from a distal end of the first syringe and in fluid communication with the first fluid compartment of the first syringe, the first dispensing tip being inserted into the central opening at the proximal end of the first piercing element to provide fluid communication between the first fluid chamber and the first fluid pathway extending along the length of the first piercing element; 16. The sealant delivery system of claim 15, further comprising: a second syringe having a second dispensing tip protruding from a distal end of the second syringe and in fluid communication with the second fluid compartment of the second syringe, the second dispensing tip being inserted into the central opening at the proximal end of the second piercing element to provide fluid communication between the second fluid chamber and the second fluid pathway extending along the length of the second piercing element.

17. a first liquid disposed in the first fluid chamber of the first syringe and a first powdered reaction component disposed in the first vial of the vial assembly, wherein the first fluid pathway provides fluid communication between the first fluid chamber and the first vial when the first piercing element is moved to the extended position; 17. The sealant delivery system of claim 16, further comprising: a second liquid disposed in the second fluid chamber of the second syringe; and a second powdered reactive component disposed in the second vial of the vial assembly, wherein the second fluid path provides fluid communication between the second fluid chamber and the second vial when the second piercing element is moved to the extended position.

18. 1. A sealant delivery system comprising: a syringe assembly including a first syringe and a second syringe arranged side by side, the first syringe having a first fluid chamber containing a first liquid and the second syringe having a second fluid chamber containing a second fluid; a vial assembly coupled to a distal end of the syringe assembly, the vial assembly including a first vial and a second vial in juxtaposition; the first vial contains a first powdered reaction component, the first vial having a proximal end aligned with the distal end of the first syringe and a first vial opening at the proximal end of the first vial closed by a first sealing membrane; the second vial contains a second powdered component, the second vial having a proximal end aligned with the distal end of the second syringe and a second vial opening at the proximal end of the second vial closed by a second sealing membrane; the vial assembly includes a first piercing element disposed between the distal end of the first syringe and the first sealing membrane, the first piercing element being movable between a retracted position in which the first piercing element is disposed proximal to the first sealing membrane and an extended position in which the first piercing element pierces the first sealing membrane to provide fluid communication between the first fluid chamber and the first vial; the vial assembly includes a second piercing element disposed between the distal end of the second syringe and the second sealing membrane, the second piercing element being movable between a retracted position in which the second piercing element is disposed proximal to the second sealing membrane and an extended position in which the second piercing element pierces the second sealing membrane to provide fluid communication between the second fluid chamber and the second vial.

19. The syringe assembly comprises: a dual-barrel plunger including a first plunger rod inserted into a proximal end of the first syringe and a second plunger rod inserted into a proximal end of the second syringe; a tab interconnecting a proximal end of the first plunger rod and the second plunger rod, 20. The sealant delivery system of claim 18, wherein the dual-barrel plunger is movable toward a distal end of the syringe assembly to force the first liquid into the first vial to reconstitute the first powdered reaction component to produce a first therapeutic solution and to force the second liquid into the second vial to reconstitute the second powdered reaction component to produce a second therapeutic solution.

20. The vial housing comprises: juxtaposed first and second guide channels extending between proximal and distal ends of the vial assembly housing; a first proximal projection extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the retracted position; a first distal projection extending into the first guide channel adapted to contact the first piercing element to retain the first piercing element in the extended position; a second proximal protrusion extending into the second guide channel adapted to contact the second piercing element to retain the second piercing element in the retracted position; 20. The sealant delivery system of claim 18, further comprising: a second distal protrusion extending into the second guide channel adapted to contact the second piercing element to retain the second piercing element in the extended position.

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