Patent ID: 12220118

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring toFIG.1, in one embodiment, a sealant delivery system100for dispensing a tissue sealant (e.g., a hemostat; a sealant for sealing air leaks during lung surgery) preferably includes a syringe assembly102, a vial assembly104, and a sealant delivery assembly106. In one embodiment, the syringe assembly102may include first and second syringes, whereby each syringe contains a liquid (e.g., a diluent; a buffer solution; a catalyst; an initiator; an activation fluid, etc.). In one embodiment, the vial assembly104may include first and second vials, whereby each vial contains a reactive powder component (e.g.; a fibrinogen powder; a thrombin powder; a reactive synthetic powder; a crosslinker, etc.), as will be described in more detail herein.

Referring toFIGS.2and3, in one embodiment, the syringe assembly102preferably has a proximal end108and a distal end110. In one embodiment, the syringe assembly102includes a dual barrel plunger112having a first plunger rod114A and a second plunger rod114B. In one embodiment, the proximal ends of the first and second plunger rods114A,114B are connected to a depressible thumb tab116, which may be utilized by surgical personnel (e.g., a surgeon) for depressing the plunger rods114A,114B in the direction DIR1toward the distal end110of the syringe assembly102(e.g., to express one or more sealant precursors from the distal of the syringe assembly).

In one embodiment, the syringe assembly102preferably includes a first plunger118A secured to a distal end of the first plunger rod114A, and a second plunger1188secured to a distal end of the second plunger rod114B, The first and second plungers118A,118B preferably have outer perimeters that form fluid-tight seals with inner surfaces of first and second syringe barrels, as will be described in more detail herein.

In one embodiment; the syringe assembly102preferably includes a syringe assembly housing120including a first housing part122A and a second housing part122B that are configured for being connected together. In one embodiment, the first and second housing parts122A,122B may be snap-fit together.

In one embodiment, the syringe assembly housing120is preferably adapted to hold a first syringe124A and a second syringe124B. The first and second syringes124A,124B are preferably configured for containing fluids (e.g., a diluent; a buffer solution; a catalyst; an initiator; an activation fluid, etc.) that are mixed with the reactive powder components disposed within the respective first and second vials of the vial assembly104(FIG.1).

In one embodiment, the first syringe124A is configured to receive a distal end of the first plunger rod114A and the first plunger118A that is secured to the distal end of the first plunger rod. In one embodiment, the second syringe124B is configured to receive a distal end of the second plunger rod114B and the second plunger118B that is secured to the distal end of the second plunger rod.

Referring toFIG.3, in one embodiment, the distal end of the first syringe124A has a first dispensing tip126A with an opening for dispensing a first fluid contained within a first fluid chamber (not shown) of the first syringe, and the distal end of the second syringe124B has a second dispensing tip126B with an opening for dispensing a second fluid contained within a second fluid chamber (not shown) of the second syringe.

In one embodiment, the syringe assembly102preferably includes first and second end caps128A,128B that are adapted to be releasably secured over the first and second dispensing tips126A,126B located at distal ends of the respective first and second syringes124A,124B.

In one embodiment, after the first and second end caps128A,128B are removed from the respective first and second dispensing tips126A,128B of the first and second syringes124A,124B, the thumb tab116may be depressed in the direction DIR1(FIG.2) toward the distal end of the syringe assembly, whereupon the first and second fluids (e.g., a diluent; a buffer solution; a catalyst; an initiator; an activation fluid, etc.) contained within the fluid chambers of the respective first and second syringes124A,124B are dispensed from the first and second dispensing tips126A,126B.

Referring toFIGS.4A and4B, in one embodiment, the syringe assembly102preferably includes the first syringe124A and the second syringe124B that are positioned side-by-side between the first housing part122A and the second housing part122B of the syringe assembly housing120. The first syringe124A preferably has a first fluid chamber130A that is configured to receive a first liquid (e.g., a diluent; a buffer solution; a catalyst; an initiator; an activation fluid, etc.). The second syringe124B preferably includes a second fluid chamber130B that is configured to receive a second liquid (e.g., a diluent; a buffer solution; a catalyst; an initiator; an activation fluid, etc.). In one embodiment, the first and second fluids contained within the respective first and second fluid chambers130A,130B may have the same properties or different properties.

In one embodiment, the distal end of the dual barrel plunger112is preferably assembled with the proximal ends of the respective first and second syringes124A,124B so that the first plunger118A and the distal end of the first plunger rod114A are inserted into the proximal end of the first syringe124A and the second plunger118B and the distal end of the second plunger rod114B are inserted into the proximal end of the second syringe124B.

In one embodiment, the first end cap128A is preferably secured over the first dispensing tip126A of the first syringe124A, and the second end cap128B is preferably secured over the second dispensing tip126B of the second syringe124B. The end caps may remain over the dispensing tips during storage and prior to use, and may be removed from covering the end caps immediately prior to use during a surgical procedure.

In one embodiment, the first and second end caps128A,128B may be removed from the distal end110of the syringe assembly102for exposing the dispensing tips126A,126B located at the distal ends of the respective first and second syringes124A,124B. In one embodiment, the thumb tab116of the dual barrel plunger112may be depressed in the distal direction DIR1toward the distal end110of the syringe assembly102for dispensing and/or expressing the first and second liquids (e.g., a diluent; a buffer solution; a catalyst; an initiator; an activation fluid, etc.) contained within the first and second fluid chambers130A,130B of the respective first and second syringes124A,124B. In one embodiment, the first and second liquids are utilized for reconstituting and mixing the powder components that are contained within the first and second vials of the vial assembly104(FIG.1).

As will be described in more detail herein, in one embodiment, after the activation fluids have been initially forced into the vials of the vial assembly, the thumb tab116and the dual barrel plunger112may be retracted in the proximal direction designated DIR2for drawing solutions and/or mixtures of the activation fluids and the powdered reactive components back into the fluid chambers130A,130B of the respective first and second syringes124A,124B for further mixing together of the activation fluids and the powdered reactive components.

Certain types of therapeutic components must be stored in a powdered form because they will rapidly react and/or lose their effectiveness once they are mixed into a liquid or a solution. These therapeutic components are required to be reconstituted with a liquid (e.g., a diluent; a buffer solution; a catalyst; an initiator; an activation fluid, etc.) before they may be used on a patient. The first and second liquids in the syringes may be used to activate the reactive powdered components contained within the vial assembly to form a tissue sealant or a hemostat that may be sprayed and/or expressed onto tissue. In one embodiment, the first liquid is used to reconstitute a first reactive powder component (e.g., fibrinogen in powder form; a reactive synthetic powder; a crosslinker, etc.), and the second liquid is used to reconstitute a second reactive powder component (e.g., thrombin in powder form; a reactive synthetic powder; a crosslinker, etc.).

Referring toFIGS.5A and5B, in one embodiment, a vial assembly104(FIG.1) of a sealant delivery system preferably includes a vial assembly housing132having a proximal end134and a distal end136. In one embodiment, the vial assembly104desirably includes first and second vials138A,138B that are configured to contain powdered reactive components that are mixed together using liquids (e.g., a diluent; a buffer solution; a catalyst; an initiator; an activation fluid, etc.) contained within the first and second syringes of the syringe assembly. In one embodiment, the first and second vials138A,138B are preferably secured to the distal end136of the vial assembly housing132. In one embodiment, the first vial138A may contain a first reactive powder component (e.g., fibrinogen powder; a reactive synthetic powder; a crosslinker, etc.), and the second vial138B may contain a second reactive powder component (e.g., thrombin powder; a reactive synthetic powder; a crosslinker, etc.). In one embodiment, the vial assembly104preferably includes a first piercing element140A having a first piercing spike (not shown) that is aligned with a first vial opening at a proximal end of the first vial138A, and a second piercing element140B having a second piercing spike (not shown) that is aligned with a second vial opening at a proximal end of the second vial138B.

In one embodiment, the first and second piercing elements140A,140B are moveable between retracted and extended positions. In one embodiment, the first and second piercing elements move independently of one another. In one embodiment, the first and second piercing elements move simultaneously with one another.

The vial assembly104is designed to maintain the first and second reactive powdered components isolated from one another during storage of the vial assembly and prior to use of the powdered components for forming a therapeutic solution (e.g., a tissue sealant; a hemostat; a sealant for sealing air leaks during lung surgery).

Referring toFIG.6, in one embodiment, the vial assembly104desirably includes the vial assembly housing132having a first housing part142A, and a second housing part142B. In one embodiment, the first and second housing parts142A,142B are adapted for being snap-fit together to form the vial assembly housing. In one embodiment, when the first and second housing parts142A,142B are assembled together, the vial assembly housing132is adapted to contain the first and second piercing elements140A,140B, whereby the first and second piercing elements may slide relative to the vial assembly housing between retracted and extended positions, as will be described in more detail herein.

In one embodiment, the vial assembly104preferably includes a first powder vial138A having a proximal end144A with a first vial opening146A, and a first sealing membrane148A that covers and/or seals the first vial opening146A. During storage and prior to use, the first sealing membrane148A preferably maintains a first powder (e.g., a first powdered reactive component) that is disposed within the first powder vial138A in a dry state. The vial assembly104preferably includes a first sealing ring150A having a central opening152A that is configured to receive a first piercing spike154A that projects from a distal end of the first piercing element140A. In one embodiment, the vial assembly104includes a first O-ring156A that is inserted into an opening at a proximal end of the first piercing element140A, and a first O-ring retainer158A that preferably retains the first O-ring156A within the openings at the proximal end of the first piercing element140A.

In one embodiment, the vial assembly104preferably includes a second powder vial188B having a proximal end144B with a second vial opening146B, and a second sealing membrane148B that covers and/or seals the second vial opening146B. During storage and prior to use, the second sealing membrane148B preferably maintains a second powder (e.g., a second powdered reactive component) that is disposed within the second powder vial138B in a dry state. The vial assembly104preferably includes a second sealing ring150B having a central opening152B that is configured to receive a second septum piercing spike154B that projects from a distal end of the second piercing element140B. In one embodiment, the vial assembly104includes a second O-ring156B that is inserted into an opening at a proximal end of the second piercing element140B, and a second O-ring retainer158B that preferably retains the second O-ring156B within the opening at the proximal end of the second piercing element140B.

In one embodiment, the first and second housing parts142A,142B of the vial housing132are molded components that have guide channels145A,145B that extend side-by-side between the proximal and distal ends of the vial housing132. The guide channels145A,145B are preferably configured to receive the respective first and second piercing elements140A,140B for guiding the sliding movement of the first and second piercing elements between the retracted and extended positions. When the first and second piercing elements140A,140B are disposed within the vial housing132, the first and second piercing elements140A,140B may slide and/or move between a retracted position and an extended position. In one embodiment, when the first and second piercing elements are in the extended position, the first and second piercing spikes154A,154B pierce the respective first and second sealing membranes140A,140B that seal the first and second vial openings146A,146B of the respective first and second vials138A,138B.

Referring toFIG.7, in one embodiment, the vial assembly104preferably includes the first vial138A secured to the distal end136of the vial assembly housing132. The first sealing membrane148A covers and/or seals the first vial opening146A located at the proximal end144A of the first vial138A. The first piercing element140A is assembled with the vial assembly housing132so that the first piercing spike154A of the first piercing element140A is aligned with the first sealing membrane148A that covers and/or seals the first vial opening146A of the first vial138A.

In one embodiment, the vial assembly104preferably includes the second vial138B secured to the distal end136of the vial assembly housing132. The second sealing membrane148B covers and/or seals the second vial opening140B located at the proximal end144B of the second vial138B. The second piercing element140B is assembled with the vial assembly housing132so that the second piercing spike154B of the second piercing element140B is aligned with the second sealing membrane148B that covers and/or seals the second vial opening146B of the second vial138B.

In one embodiment, the vial assembly housing132preferably includes first proximal projections162A for locking and/or holding the first piercing element140A is the retracted position and first distal projections163A for locking and/or holding the first piercing element in the extended position. In one embodiment, the first piercing element140A preferably includes first resilient flanges164A that are adapted to selectively engage the first proximal projections162A and the first distal projections163A. In one embodiment, when the first piercing element140A is in the retracted position shown inFIG.7, the first resilient flanges164A desirably engage the first proximal projections162A for holding the first piercing element140A in the retracted position. In one embodiment, the first piercing element140A may be slid and/or pressed in the distal direction DIR1, whereupon the first resilient flanges164A release from the first proximal projections162A and slide into engagement with the first distal projections163A for locking and/or holding the first piercing element140A in the extended position (FIG.8B).

In one embodiment, the vial assembly housing132preferably includes second proximal projections162B for locking and/or holding the second piercing element140B in the retracted position and second distal projections163B for locking and/or holding the second piercing element140B in the extended position. In one embodiment, the second piercing element140B preferably includes second resilient flanges164B that are adapted to selectively engage the second proximal projections162B and the second distal projections163B. In one embodiment, when the second piercing element140B is in the retracted position shown inFIG.7, the second resilient flanges164B engage the second proximal projections162B for holding the second piercing element140B in the retracted position. In one embodiment, the second piercing element140B may be slid and/or pressed in the distal direction DIR1, whereupon the second resilient flanges164B release from the second proximal projections162B and slide into engagement with the second distal projections163B for locking and/or holding the second piercing element146B in the extended position (FIG.8B).

In one embodiment, when the first piercing element140A is assembled with the vial assembly housing132, the first piercing spike154A is in alignment with the first sealing membrane148A that seals the first vial opening146A of the first vial138A. When the first piercing element140A is advanced into the extended position (FIG.8B), the first piercing spike154A pierces the first sealing membrane148A for providing fluid communication between the first liquid contained within the first fluid chamber of the first syringe124A (FIG.4A) and the first powder (e.g., a first powdered reactive component) contained within the first powder chamber160A of the first vial138A.

In one embodiment, when the second piercing element140B is assembled with the vial assembly housing132, the second piercing spike154E is in alignment with the second sealing membrane148B that seals the second vial opening146B of the second vial138B. When the second piercing element140B is advanced into the extended position (FIG.8B), the second piercing spike154B pierces the second sealing membrane148B for providing fluid communication between the second liquid contained within the second fluid chamber of the second syringe124B (FIG.4A) and the second powder (e.g., a second powdered reactive component) contained within the second powder chamber160B of the second vial138B.

In one embodiment, the first piercing element140A has an elongated conduit that defines a first fluid pathway that extends through both the first piercing element and the first piercing spike154A for providing fluid communication between the first fluid chamber of the first syringe and the powder chamber160A of the first vial138A, which enables the first liquid to be used for reconstituting the first powder disposed within the first vial. In one embodiment, a first O-ring156A is inserted into an opening at a proximal end of the first piercing element140A and a first O-ring retainer158A holds the first O-ring156A within the proximal opening of the first piercing element140A.

In one embodiment, the second piercing element140B has an elongated conduit that defines a second fluid pathway that extends through both the second piercing element and the second piercing spike154B for providing fluid communication between the second fluid chamber of the second syringe and the second powder chamber160B of the second vial138B, which enables the second liquid to be used for reconstituting the second powder (e.g., a second powdered reactive component) disposed within the second vial. In one embodiment, a second O-ring156B is inserted into an opening at a proximal end of the second piercing element140B and a second O-ring retainer158B holds the second O-ring156B within the proximal opening of the second piercing element140B.

Referring toFIG.8A, in one embodiment, the vial assembly104preferably includes the first and second vials138A,138B secured to the distal end136of the vial assembly housing132. In one embodiment, the first vial138A includes a first powder chamber160A that is configured to contain a first powder (e.g., a first powdered reactive component; a fibrinogen powder; a thrombin powder; a crosslinker, etc.), and the second vial138B includes a second powder chamber160B that is configured to contain a second powder (e.g., a second reactive powder; a fibrinogen powder; a thrombin powder; a crosslinker, etc.). InFIG.8A, the first piercing element140A is in the retracted position with the first piercing spike154A located proximal to the first sealing membrane148A. The first piercing element140A includes the first resilient flanges164A engaging the first proximal projections162A of the vial housing132for holding the first piercing element140A in the retracted position. The vial assembly104includes the first distal projections163A that are adapted to engage the distal ends of the first resilient flanges164A for holding the first piercing element140A in the extended configuration, as will be described in more detail herein.

In one embodiment, the second piercing element140B is in the retracted position with the second piercing spike154B located proximal to the second sealing membrane148B. The second piercing element140B includes the second resilient flanges184B engaging the second proximal projections162B of the vial housing132for holding the second piercing element140B in the retracted position. The vial assembly104includes the second distal projections163B that are adapted to engage the distal ends of the second resilient flanges164B for holding the second piercing element140B in the extended configuration, as will be described in more detail herein.

Referring toFIG.8B, in one embodiment, the first and second piercing elements140A,140B may be advanced in the distal direction DIR1toward the distal end136of the vial assembly housing132for moving the first and second piercing elements into the extended position. In the extended position shown inFIG.8B, the first piercing spike154A pierces the first sealing membrane148A, and the second piercing spike154B pierces the second sealing membrane148B. The first resilient flanges162A of the first piercing element140A engage the first distal projections163A of the vial assembly housing132for holding and/or locking the first piercing element140A in the extended position, and the second resilient flanges162B of the second piercing element140B engage the second distal projections163B of the vial assembly housing132for holding and/or locking the second piercing element140B in the extended position.

Referring toFIGS.9and10, in one embodiment, the sealant delivery assembly106of the sealant delivery system100(FIG.1) preferably includes a proximal end168that is configured for being connected with a distal end of the syringe assembly102(FIG.1) and a distal end170that is adapted to express and/or spray a tissue sealant (e.g., a hemostat; a sealant for sealing air leaks during lung surgery). In one embodiment, the proximal end168of the sealant delivery assembly106desirably includes a sealant delivery assembly housing172having a first housing part172A and a second housing part172B, which may be snap-fit together.

In one embodiment, the housing172preferably includes an H-connector174having a first hub176A adapted to receive a first O-ring178A and a first O-ring retainer180A. In one embodiment, the first hub176A, the first O-ring178A, and the first O-ring retainer180A are preferably in alignment with the first fluid pathway that provides fluid communication between the first fluid compartment130A of the first syringe124A (FIG.4A) and the distal end of the sealant delivery assembly106.

In one embodiment, the H-connector174preferably includes a second hub176B adapted to receive a second O-ring178B and a second O-ring retainer180B. In one embodiment, the second hub176B, the second O-ring178B, and the second O-ring retainer180B are preferably in alignment with the second fluid pathway that provides fluid communication between the second fluid compartment130B of the second syringe124B (FIG.4A) and the distal end of the sealant delivery assembly106.

In one embodiment, the sealant delivery assembly106preferably includes a cannula182(e.g., a rigid tube) that is adapted to receive first and second flexible tubes184A,184B. The cannula may be rigid and may be made of biocompatible materials such as metals and polymers. The first flexible tube184A preferably has a proximal end that is in fluid communication with the first hub176A of the H-connector174. The second flexible tube184B preferably has a proximal end that is in fluid communication with the second hub176B of the H-connector174.

In one embodiment, the sealant delivery assembly106desirably includes a malleable connector186that is secured to a distal end of the cannula182. The sealant delivery assembly106preferably includes a spray tip188that is secured to a distal end of the malleable connector186. The spray tip188may contain a static mixer for mixing together first and second precursor solutions that are directed into the spray tip188.

Referring toFIG.11, in one embodiment, the proximal end of the elongated cannula182is assembled with a distal end of the sealant delivery assembly housing172. The first and second flexible tubes184A,184B extend through an elongated conduit of the cannula182. A proximal end of the first flexible tube184A is in fluid communication with the first hub176A. A proximal end of the second flexible tube184B is in fluid communication with the second hub176B. The first O-ring178A is inserted into the first hub176A and is held in place by the first O-ring retainer180A. The second O-ring178B is inserted into the second hub176B and is held in place by the second O-ring retainer180B.

Referring toFIG.12, in one embodiment, the malleable connector186at the distal end of the sealant delivery assembly106preferably couples the spray tip188with the distal end of the cannula182. The malleable connector186desirably includes a malleable component190(e.g., a malleable metal rod; a malleable pin) disposed therein that enables the spray tip188to be positioned and held at different angles relative to the longitudinal axis A1of the cannula182.

In one embodiment, the spray tip188preferably includes a spray tip housing192that contains a static mixer194having mixing fins195. The first and second precursor solutions that are delivered to the spray tip188via the first and second flexible tubes184A,184B are preferably mixed together within the spray tip housing194by the mixing fins195of the static mixer192. The mixed precursor solutions may be expressed and/or sprayed from the distal end of the sealant applicator via an expression opening196of a spray cap197, which is located at the distal end170of the sealant delivery assembly106. In one embodiment, the sealant delivery assembly106and the spray cap may include one or more structural features (e.g., swirl chambers) that are disclosed in commonly assigned U.S. Patent Application Publication No. 2021/0101162 to Trezza I I et al., the disclosure of which is hereby incorporated by reference herein.

Referring toFIG.13A, in one embodiment, the vial assembly104includes the vial assembly housing132with the first and second vials138A,138B secured to the distal end136of the vial assembly housing132. The first vial138A contains a first reactive powder component (e.g., fibrinogen powder; a reactive synthetic powder; a crosslinker, etc.), and the second vial138B contains a second reactive powder component (e.g., thrombin powder; a reactive synthetic powder; a crosslinker, etc.).

Referring toFIG.13B, in one embodiment, the first and second piercing elements140A,140B may be advanced in the distal direction DIR1toward the distal end136of the vial assembly housing132for moving the first and second piercing elements into the extended position shown inFIG.8B, In the extended position, the first and second piercing spikes154A,154B of the respective first and second piercing elements pierce the respective first and second sealing membranes148A,148B (FIG.8B) that seal the vial openings at the proximal ends of the respective first and second vials138A,138B.

Referring toFIG.14, in one embodiment, the syringe assembly102that contains the first and second liquids that are used to reconstitute the reactive powder components may be prepared for being connected to a proximal end of the vial assembly housing132(FIG.13B) by removing the first and second end caps128A,128B. Removing the first and second end caps128A,128B exposes the respective first and second dispensing tips126A,126B that are accessible at the distal end of the syringe assembly housing120.

Referring toFIG.15A, in one embodiment, after the first and second end caps128A,128B (FIG.14) have been removed from the distal end of the syringe assembly housing120of the syringe assembly102; the distal end of the syringe assembly housing120is preferably coupled with the proximal end134of the vial assembly housing132. The first dispensing tip126A is preferably inserted into an opening at the proximal end of the first piercing element140A and the second dispensing tip126B is preferably inserted into an opening at the proximal end of the second piercing element140B.

Referring toFIG.15B, after the vial assembly104has been assembled with the distal end of the syringe assembly102, the first liquid disposed within the first syringe124A (FIG.4A) of the syringe assembly is preferably in fluid communication with the first powder (e.g.; a powdered reactive component) disposed within the first powder chamber160A of the first vial138A. Similarly, the second liquid disposed within the second syringe124B (FIG.4A) of the syringe assembly is preferably in fluid communication with the second powder (e.g., powdered reactive component) disposed within the second powder chamber160B of the second vial138B.

FIG.15Cshows the distal end of the syringe assembly102connected with the proximal end of the vial assembly104. The syringe assembly includes the first syringe124A having a first fluid chamber130A that contains a first activation fluid (e.g., a diluent; a buffer solution; a catalyst; an initiator; an activation fluid, etc. that activates the first powder). The syringe assembly102also desirably includes a second syringe barrel124B having a second fluid chamber130B that contains a second activation fluid (e.g.; a diluent; a buffer solution; a catalyst; an initiator; an activation fluid, etc. that activates the second powder). The first syringe barrel124A is connected with the proximal end of the vial assembly104so that the first dispensing tip128A of the first syringe barrel124A is aligned with and in fluid communication with the first vial opening146A of the first vial138A. The first vial138A has a first powder chamber160A that contains a first powder, which will be reconstituted using the first activation fluid disposed within the first fluid chamber130A of the first syringe barrel124A. The second dispensing tip128B at the distal end of the second syringe124B is preferably in alignment with the second vial opening146B of the second vial138B. The second vial138B preferably includes a second powder chamber160B that contains a second powder, which will be reconstituted using the second activation fluid disposed within the second fluid chamber130B of the second syringe124B.

During the stage shown inFIG.15C, the first liquid and the first powder remain isolated from the second liquid and the second powder.

In one embodiment, the first activation fluid within the first syringe124A is mixed with the first powder in the first vial138A by advancing and retracting the dual barrel plunger112in distal and proximal directions. As the first plunger rod114A is advanced toward the distal end of the syringe housing120, the first activation fluid within the first fluid chamber130A of the first syringe124A is forced into the first powder chamber160A of the first vial138A for reconstituting the first powder into a first therapeutic solution. Mien the first plunger rod114A is retracted away from the distal end of the syringe housing120, the first therapeutic solution of the first powder and the first activation fluid is drawn back into the first fluid chamber130A of the first syringe124A. The first plunger rod114A may be repeatedly reciprocated back and forth between an extended position and a retracted position for thoroughly mixing the first activation fluid and the first powder to form the first precursor solution (e.g., a flowable liquid). In one embodiment, after the first precursor solution has been formed, the first plunger rod114A is preferably fully retracted for drawing the entire volume of the first precursor solution into the first fluid chamber130A of the first syringe124A.

In one embodiment, the second activation fluid within the second syringe124B is mixed with the second powder within the second vial138B by advancing and retracting the dual barrel plunger112in distal and proximal directions. As the second plunger rod114B is advanced toward the distal end of the syringe assembly housing120, the second activation fluid within the second fluid chamber130B of the second syringe124B is forced into the second powder chamber160B of the second vial138B for reconstituting the second powder into a second therapeutic solution. When the second plunger rod114B is retracted away from the distal end of the syringe assembly housing120, the second therapeutic solution of the second powder and the second activation fluid is drawn back into the second fluid chamber130B of the second syringe124B. The second plunger rod114B may be repeatedly reciprocated back and forth between an extended position and a retracted position for thoroughly mixing the second activation and the second powder to form the second precursor solution (e.g., a flowable liquid). In one embodiment, after the second precursor solution has been formed, the second plunger rod114B is preferably fully retracted for drawing the entire volume of the second precursor solution into the second fluid chamber130B of the second syringe124B.

Referring toFIGS.15C and16, in one embodiment, after the first and second precursor solutions have been generated and drawn back into the first and second fluid chambers130A,180B of the respective first and second syringes124A,124B of the syringe assembly102, the vial assembly104may be uncoupled from the distal end of the syringe assembly housing120and the sealant delivery assembly106may be secured to the distal end of the syringe assembly housing120for expressing the first and second precursor solutions from the distal end of the sealant applicator. In one embodiment, the sealant delivery assembly housing172at the proximal end of the sealant delivery assembly106is preferably connected with the distal end of the syringe assembly housing120. The cannula182and the spray tip188preferably extend toward the distal end170of the sealant delivery assembly106.

After the sealant delivery assembly has been secured to the distal end of the syringe assembly housing, the first fluid chamber130A of the first syringe124A that contains the first precursor is preferably in fluid communication with the spray tip188via the first flexible tube184A. The second fluid chamber130B of the second syringe124B that contains the second precursor is preferably in fluid communication with the spray tip188via the second flexible tube184B.

In one embodiment, the dual barrel plunger112is depressed in the distal direction designated DIR1to force the first and second precursor solutions from the first and second fluid chambers130A,130B of the respective first and second syringes124A,124B, whereupon the first and second precursor solutions flow through the respective first and second flexible tubes184A,184B until they reach the spray tip188. Upon reaching the spray tip, the first and second precursor solutions are mixed together by the static mixer194(FIG.12), whereupon the first and second precursor solutions react with one another to form a tissue sealant or hemostat, which is expressed from the dispensing opening196of the spray cup197(FIG.12) located at the distal end170of the sealant delivery assembly106.

Referring toFIG.17, in one embodiment, a sealant delivery system200preferably includes a syringe assembly202that contains one or more liquids or fluids for reconstituting therapeutic powders, a vial assembly204having first and second vials238A,238B containing powdered reactive components, and a sealant delivery assembly206for expressing a sealant or hemostat. In one embodiment, the syringe assembly202may be a molded component having side-by-side double barrel cavities that are configured for holding the liquids that are used for reconstituting the reactive powdered components. In one embodiment, the vial assembly204may be similar to the vial assembly104disclosed above in the embodiments shown inFIGS.5A-58,6,7, and8A-88. In one embodiment, the sealant delivery assembly206may be similar to the sealant delivery assembly106shown and described above inFIGS.9-12.

Referring toFIG.18, in one embodiment, the syringe assembly202preferably includes a syringe assembly housing220that is adapted to receive the distal end of a dual barrel plunger212. The dual barrel plunger212preferably includes a first plunger rod214A that is insertable into a first syringe barrel cavity formed in the syringe assembly housing220of the syringe assembly202and a second plunger rod214B that is insertable into a second syringe barrel cavity of the syringe assembly housing220of the syringe assembly202. In one embodiment, the proximal ends of the first and second syringe plunger rods214A,214B are interconnected by a thumb tab216that defines a proximal end of the dual barrel plunger212.

In one embodiment, the syringe assembly202preferably includes a syringe end cap228that is releasably secured to the distal end of the syringe assembly housing220of the syringe assembly202for covering syringe dispensing tips that are in fluid communication with the respective syringe barrel cavities formed in the syringe assembly housing220, as will be described in more detail herein.

Referring toFIG.19, the syringe assembly202preferably includes the syringe assembly housing220having a proximal end that is adapted to receive the dual barrel plunger212and a distal end that is adapted to be connected with the syringe end cap228. The syringe assembly housing220preferably includes a first dispensing tip226A that projects from a distal end of the syringe housing220and that is in fluid communication with a first fluid chamber of a first syringe barrel cavity that is integrally formed within the syringe assembly housing220. The syringe assembly housing220preferably includes a second dispensing tip226B that projects from a distal end of the syringe housing220and that is in fluid communication with a second fluid chamber of a second syringe barrel cavity that is integrally formed within the syringe assembly housing220.

In one embodiment, the syringe end cap228may be disconnected from the distal end of the syringe assembly housing220for exposing the first and second dispensing tips226A,226B. After the syringe end cap228has been removed for exposing the dispensing tips226A,226B, the distal end of the syringe assembly housing may be assembled with a vial assembly or a sealant delivery assembly.

In one embodiment, the double barrel plunger212preferably includes a first plunger rod214A having a distal end that is adapted to be connected with a first plunger218A. The double barrel plunger212also includes a second plunger rod214B having a distal end that is adapted to be connected with a second plunger218B. In one embodiment, the distal end of the first plunger rod214A with the first plunger218A secured thereto is insertable into the first fluid chamber defined by the first syringe barrel cavity of the syringe assembly housing and the distal end of the second plunger rod214B with the second plunger218B secured thereto is inserted into the second fluid chamber defined by the second syringe barrel cavity of the syringe assembly housing.

Referring toFIG.20, in one embodiment, the first plunger218A and distal end of the first plunger rod214A are inserted into the first fluid chamber230A of the first syringe barrel cavity224A that is integrally formed in the syringe assembly housing220of the syringe assembly202. In a similar manner, the second plunger218B and the distal end of the second plunger rod214B are inserted into the second fluid chamber230B of the second syringe barrel cavity that is integrally formed in the syringe assembly housing220of the syringe assembly202. In one embodiment, a first liquid (e.g., a diluent; a buffer solution; a catalyst; an initiator; an activation fluid; etc.) is disposed within the first fluid chamber230A of the first syringe barrel cavity224B. In one embodiment, a second liquid (e.g., a diluent; a buffer solution; a catalyst; an initiator; an activation fluid, etc.) is disposed within the second fluid chamber230B of the second syringe barrel cavity224B, The first and second activation fluids may have the same or different properties.

In one embodiment, during storage, the syringe assembly end cap228is preferably connected with the distal end of the syringe assembly housing220of the syringe assembly202for covering the first and second dispensing tips226A,228B that are in fluid communication with the respective first and second fluid chambers230A,230B.

Referring toFIG.21, in one embodiment, the syringe assembly end cap228(FIG.20) may be removed from the distal end of the syringe assembly housing220for uncovering the syringe dispensing tips226A,226B that are in fluid communication with the first and second fluid chambers230A,236B of the respective first and second syringe barrels cavities224A,224B.

Referring toFIG.22A, in one embodiment, after the syringe end cap228(FIG.20) has been removed from the distal end of the syringe assembly housing220of the syringe assembly202, the distal end of the syringe assembly housing220may be coupled with a proximal end234of a vial assembly housing232of the vial assembly204. The first syringe dispensing tip226A is preferably inserted into an opening at the proximal end of a first piercing element240A for providing fluid communication between the first fluid chamber230A (FIG.21) and the first vial238A. The second syringe dispensing tip226B is preferably inserted into an opening at the proximal end of a second piercing element240B for providing fluid communication between the second fluid chamber230B (FIG.21) and the second vial238B.

Referring toFIG.22B, after the vial assembly204has been assembled with the distal end of the syringe assembly housing220of the syringe assembly202, the first liquid (e.g., a diluent; a buffer solution; a catalyst; an initiator; an activation fluid; a reconstitution fluid, etc.) disposed within the first fluid chamber230A of the first syringe barrel cavity224A (FIG.21) of the syringe assembly housing220of the syringe assembly202is preferably in fluid communication with the first powder disposed within a first powder chamber260A of a first vial238A of the vial assembly204. Similarly, the second liquid (e.g., a diluent; a buffer solution; a catalyst; an initiator; an activation fluid; a reconstitution fluid, etc.) disposed within the second fluid chamber230B of the second syringe barrel cavity224B (FIG.21) of the syringe assembly housing220of the syringe assembly202is preferably in fluid communication with the second powder disposed within a second powder chamber268B of a second vial238B of the vial assembly204.

Referring toFIG.22C, in one embodiment, the distal end of the syringe assembly202is connected with the proximal end of the vial assembly204. The syringe assembly includes the first syringe barrel cavity224A having a first fluid chamber230A that contains the first liquid for reconstitution the first powder. The first syringe barrel cavity224A is connected with the proximal end of the vial assembly204so that the first dispensing tip226A of the first syringe barrel cavity224A is aligned with and in fluid communication with the first vial opening246A of the first vial238A. The first vial238A has a first powder chamber260A that contains a first powder, which will be reconstituted using the first liquid that is disposed within the first fluid chamber230A of the first syringe barrel cavity224A.

In one embodiment, the syringe assembly202desirably includes the second syringe barrel cavity224B having a second fluid chamber230B that contains a second liquid that is used for reconstituting the second powder. The second dispensing tip2268at the distal end of the second syringe barrel cavity224B is preferably in alignment with the second vial opening246B of the second vial238B. The second vial238B preferably includes a second powder chamber260B that contains a second powder, which will be reconstituted using the second liquid disposed within the second fluid chamber230B of the second syringe barrel cavity224B.

In one embodiment, by advancing and retracting the dual barrel plunger112in distal direction DIR1and the proximal direction DIR2, the first liquid within the first fluid chamber230A of the first syringe barrel cavity224A is mixed with the first powder disposed within the first powder compartment260A of the first vial138A. As the first plunger rod114A is advanced distally in the direction DIR1toward the distal end of the syringe assembly housing220, the first liquid within the first fluid chamber230A of the first syringe barrel cavity224A is forced into the first powder chamber260A of the first vial238A. When the first plunger rod214A is retracted away from the distal end of the syringe assembly housing220, a first precursor solution including the first powder and first liquid is drawn back into the first fluid chamber230A of the first syringe barrel cavity224A. The first plunger rod214A may be repeatedly reciprocated back and forth between an extended position and a retracted position for thoroughly mixing the first liquid and the first powder component to form the first precursor solution (e.g., a flowable liquid). In one embodiment, after the first precursor solution has been generated, the first plunger rod214A is preferably fully retracted for drawing the entire volume of the first precursor solution back into the first fluid chamber230A of the first syringe barrel cavity224A.

In one embodiment, the second liquid contained within the second syringe barrel cavity224B may be mixed with the second powder disposed within the second powder component260B of the second vial138B by advancing and retracting the dual barrel plunger112in distal (DIR1) and proximal (DIR2) directions. As the second plunger rod114B is advanced toward the distal end of the syringe assembly housing220, the second liquid within the second fluid chamber230B of the second syringe barrel cavity224B is forced into the second powder chamber260B of the second vial2388for reconstituting the second powder into a second precursor solution. When the second plunger rod214B is retracted away from the distal end of the syringe assembly housing220, the second precursor solution including the second powder and the second liquid is drawn back into the second fluid chamber230B of the second syringe barrel cavity224B. The second plunger rod214B may be repeatedly reciprocated back and forth between an extended position and a retracted position for thoroughly mixing 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 has been formed, the second plunger rod214B is preferably fully retracted for drawing the entire volume of the second precursor solution back into the second fluid chamber230B of the second syringe barrel cavity224B.

In one embodiment, the first and second precursor solutions may be mixed together to form a tissue sealant or hemostat that is applied on tissue during a surgical procedure, such as a minimally invasive surgical procedure.

Referring toFIGS.22C,23A-238, and24, in one embodiment, after the first and second precursor solutions have been generated and drawn back into the first and second fluid chambers230A,230B of the respective first and second syringe barrel cavities224A,224B, the vial assembly204(FIG.22C) may be uncoupled from the distal end of the syringe assembly housing220for exposing the first and second dispensing tips226A,226B (FIG.22C). In one embodiment, the sealant delivery assembly housing272at the proximal end of the sealant delivery assembly206is preferably coupled with the distal end of the syringe assembly housing220. The cannula282and the spray tip288preferably extend toward the distal end270of the sealant delivery assembly206.

After the sealant delivery assembly206has been secured to the distal end of the syringe assembly housing220, the first fluid chamber230A of the first syringe barrel cavity224A that contains the first precursor solution is preferably in fluid communication with the spray tip288via a first fluid pathway (e.g., the first flexible tube184A shown inFIG.11). The second fluid chamber200B of the second syringe barrel cavity224B that contains the second precursor solution is preferably in fluid communication with the spray tip288via a second fluid pathway (e.g., the second flexible tube1848shown inFIG.11).

Referring toFIGS.23A and23B, in one embodiment, the sealant delivery assembly206, similar to that shown and described above inFIGS.9and10, preferably includes an elongated cannula282having a proximal end and a distal end. A sealant delivery assembly housing272is secured to the proximal end of the cannula282, and spray tip288is secured to a distal end of the cannula282via a malleable connector286. The malleable connector286desirably enables the spray tip282to be articulated to different angles relative to the longitudinal axis A1of the elongated cannula282. The malleable connector may include a malleable rod or pin that maintains its shape after being bent into a particular orientation, which, in turn, holds the spray tip282in a selected orientation relative to the elongated axis A1of the cannula282(FIG.24)

Referring toFIGS.23B and24, in one embodiment, the proximal end of the sealant delivery assembly housing272of the sealant delivery assembly206is connected with the distal end of the syringe assembly housing220of the syringe assembly202. In one embodiment, the first dispensing tip226A (FIG.220) at the distal end of the syringe assembly housing220of the syringe assembly202is inserted into the first hub276A at the proximal end of the sealant delivery assembly housing272. The second dispensing tip2268(FIG.22C) at the distal end of the syringe assembly housing220is inserted into the second hub276B at the proximal end of the sealant delivery assembly housing272.

In one embodiment, the spray tip288is coupled with the distal end of the cannula282by the malleable connector286. The malleable connector286enables the spray tip288to be positioned at different angles relative to the longitudinal axis A1of the elongated cannula282of the sealant delivery assembly206.

Referring toFIG.24, in one embodiment, the distal end of the sealant delivery assembly206may have a similar construction as that shown and described above for the embodiment shown inFIG.12. The malleable connector286couples the spray tip288to the distal end of the cannula282. The malleable connector286preferably includes an elongated malleable component (e.g., the malleable metal rod190shown inFIG.12) that extends along the length thereof. The malleable component enables the spray tip288to be positioned at different angles relative to the longitudinal axis A1of the cannula282.

In one embodiment, the dual barrel plunger212is depressed in the distal direction designated DIR1to force the first and second precursor solutions from the first and second fluid chambers230A,230B of the respective first and second syringe barrel cavities224A,224B (FIG.22C), whereupon the first and second precursor solutions flow toward the spray tip288for being mixed together within the spray tip and expressed from the distal end270of the sealant delivery assembly206.

In one embodiment, the sealant delivery system maintains the first and second precursor solutions isolated from one another until they are mixed together within the spray tip288. Upon being mixed together within the spray tip288, the first and second precursor solutions preferably react with one another to form a sealant or hemostat that controls bleeding. The sealant or hemostat is preferably sprayed onto tissue in fluid form, whereupon the interacting first and second precursor solutions cure, coagulate and/or gel to stop or control bleeding.

While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, which is only limited by the scope of the claims that follow. For example, the present invention contemplates 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 fail within the scope of the present invention.