Hemostatic powder delivery and liquid delivery composite device for controlling bleeding at the surgical site and sealing tissue

Abstract

The combined powder and liquid delivery device includes a housing having a powder chamber and a liquid chamber. The device includes an applicator tip having a powder delivery channel extending between a proximal end and a distal end of the applicator tip in fluid communication with the powder chamber and a liquid delivery channel extending from the proximal end to the distal end of the applicator tip in fluid communication with the liquid chamber. The delivery device includes a powder inlet port in fluid communication with the powder chamber and a liquid inlet port in fluid communication with the liquid chamber. A powder delivery system is in fluid communication with the powder inlet port, the powder chamber, and the powder delivery channel. The liquid delivery system is in fluid communication with the liquid inlet port, the liquid chamber, and the liquid delivery channel.

Description

Technical Field

[0001] This patent application generally relates to methods and devices for sealing and / or controlling bleeding, and more specifically, to methods and devices capable of dispensing a therapeutic powder and an activating fluid that interact to control bleeding and seal a wound.

Background Art

[0002] In a variety of situations, animals, including humans, may be affected by bleeding due to a wound or during a surgical procedure. Depending on the situation, the bleeding may be relatively minor and normal blood clotting, combined with the implementation of simple first aid measures, may be sufficient. In other situations, significant bleeding can occur. In these situations, specialized equipment and supplies, as well as personnel trained to provide appropriate assistance, are usually required.

[0003] To address the above problems, substances for controlling excessive bleeding have been developed. 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, and the like. To improve the hemostatic performance, scaffolds based on the above substances can be combined with biologically induced clotting factors such as thrombin and fibrinogen.

[0004] Control of bleeding is essential and important in surgical procedures to minimize blood loss, reduce postoperative complications, and shorten the time of surgery in the operating room. Due to their biodegradability, bactericidal properties, and hemostatic characteristics, oxidized cellulose and oxidized regenerated cellulose have long been used as topical hemostatic wound dressings in a variety of surgical procedures, including neurosurgery, abdominal surgery, cardiovascular surgery, thoracic surgery, head and neck surgery, pelvic surgery, and skin and subcutaneous tissue procedures. Several methods for forming various types of hemostatic materials based on oxidized cellulose materials are well known, regardless of whether they are made in powder, woven, non-woven, knitted, or other forms. Currently available hemostatic wound dressings include knitted or non-woven fabrics containing oxidized regenerated cellulose (ORC), an oxidized cellulose that increases the homogeneity of cellulose fibers.

[0005] U.S. Patent No. 7,923,031, "Haemostatic sprays and compositions", discloses a powder delivery system comprising a chamber for storing a hemostatic composition containing dry gelatin powder and hyaluronic acid having an average particle size in the range of 30 to 250 micrometers, the chamber having at least one discharge opening sized to dispense the composition.

[0006] U.S. Patent No. 8,056,762 discloses a handheld dispenser for dispensing pharmaceuticals, the dispenser comprising a housing providing a duct, a frangible membrane provided within the duct, a probe having a perforated tip mounted within the duct, the probe being arranged such that the perforated tip pierces the frangible membrane in use, a pneumatic compression device for compressing air to dispense the pharmaceuticals through the probe, and a channel for substantially equalizing the pressure within the pneumatic compression device and the pressure above the frangible membrane. The frangible membrane is provided on a sheath and includes a first large-diameter portion and a second axially spaced small-diameter portion, defining an outer shoulder therebetween. The inner surface of the duct has a corresponding inner shoulder engaged by the outer shoulder of the sheath, and an axial spacer is provided on one or both of the outer and inner shoulders to maintain the channel past the engaged shoulders.

[0007] U.S. Patent Publication No. 2012 / 108509, entitled "Artificial Scab For Use In An Airway", discloses a bellows-shaped dispenser.

[0008] U.S. Patent Publication No. 2011 / 0178495, "Internal dry powder delivery system and method thereof", discloses a powder delivery device comprising a gas-powder mixer providing a gas-powder mixing chamber, and a powder dispenser (bellows) screwed into the gas-powder mixer and communicating with the gas-powder mixing chamber therein. Hemostatic powder is filled within the powder dispenser (bellows) and adapted to be delivered to a bleeding site via a powder delivery catheter.

[0009] U.S. Patent No. 4,411,656, "Compressible syringe", discloses a compressible syringe comprising a hollow body made compressible by a bellows structure extending along the entire length of the body.

[0010] U.S. Patent No. 4,723,691, "Powder dispenser", discloses a handheld manually-operated powder dispenser having a container that includes a handle / nozzle portion terminating at its discharge end at an unobstructed powder dispensing opening, a hand gripping portion, and a central, flexible bellows portion connected between the handle / nozzle portion and the hand gripping portion. The bellows portion is adapted to be axially contracted and extended so as to act 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 the direction toward the powder dispensing opening. The ratio of the length of the handle / nozzle portion to the maximum value of its inner diameter is substantially greater than 1.4.

[0011] U.S. Patent No. 3,844,284 discloses a disposable irrigator comprising a collapsible bellows forming a syringe and containing a pre-measured amount of cleansing powder, and an elongated dispensing nozzle adapted to be fixed to the open end of the bellows.

[0012] U.S. Patent No. 5,957,340, "Container with surmounting bellows pump", discloses a container for storing, dispensing, and delivering a fluid composition contained therein. The container includes a body defining a fluid reservoir, the body including a floor-like base and a wall extending upward therefrom. The wall is integrally formed with the wall of the container as a coaxial extension thereof and is a vertically compressible bellows that surmounts the wall. The bellows defines a fluid reservoir of the container, an integrally formed neck-like connection pipe, and an inner region in coaxial fluid flow communication. At its upper limit, it is mounted on the bellows. The connection pipe has an upwardly open port through which the container is filled and includes a vertically compressible bellows. It includes cap-like closing means for sealing the port after introduction of the fluid composition into the reservoir. At a location adjacent to the bottom of the container, it includes tubular conduit means including dispenser pipe means integrally formed and supported outside and radially outward of the diameter boundary of the container to establish fluid flow communication with the reservoir. The conduit means projects upward from the base and extends within vertical limits that coincide with the upper and lower limits of the body of the container. The conduit means has a terminal discharge end, and a nozzle is integrally formed with the dispenser pipe means at the terminal discharge end. It includes orifice means at the terminal discharge end of the conduit and means for delivering a fluid composition that is clearly dispensed from the reservoir when a compressive force is directly manually applied downward to the bellows of the container. It includes web means that projects outward from the wall means and extends along the wall means for connecting the wall means to the tubular conduit means to support and stabilize the conduit means, and web means that is integrally formed with the wall means and the conduit means and extends along the upper range of the conduit means.

[0013] Chinese Patent Application Publication No. 201346338, "Surgery styptic powder unidirectional propeller", belongs to the propeller structure attached to the endoscope and is used to deliver the hemostatic powder forward. It comprises an insertion tube and a flexible drug delivery bottle. The insertion tube abuts and communicates with the flexible drug supply bottle, and the hemostatic powder is arranged in the flexible drug supply bottle, and discloses a surgical hemostatic powder unidirectional propeller. The unidirectional propeller also comprises a unidirectional intake valve that is opened in the forward intake direction and closed in the backward intake direction. The unidirectional propeller has the advantages that the unidirectional intake valve is combined with the insertion tube of the drug supply device for powder administration under the endoscope, and thus can effectively and quickly deliver the hemostatic powder to the required site, reduce the reciprocating movement of the hemostatic powder in the insertion tube, prevent blood backflow and blockage, and improve the hemostatic effect in the process of clinical endoscopic surgery and minimally invasive surgery. Biocompatible medical materials such as high-density polyethylene, low-density polyethylene, polypropylene, and medical silicone rubber are adopted to manufacture the propeller.

[0014] U.S. Patent Publication No. 2014 / 0005636, "Multi-Compartment Pre-filled Mixing Syringes with Bypass" and the references cited therein are referred to, and commercially available Dermabond (trademark) products and Evicel (trademark) products are also referred to.

[0015] U.S. Patent No. 8,376,989, "Compartmented syringe" includes at least two chambers for containing at least two of a plurality of substances, and at least two bypass portions operably connected to at least two of the chambers of a first fluid conduit to enable mixing of at least two substances, a first fluid conduit, a second fluid conduit disposed adjacent to the first fluid conduit and having at least one chamber for containing at least one of a plurality of substances, each substance being mixable, and when a plunger operably associated with each fluid conduit advances, forming a release material for external application, the release material being defined by a predetermined mixture composition of at least two substances of the fluid conduit, and an end cap disposed at at least one distal end of the fluid conduit, the end cap including at least one vent hole and a filter, the filter being in fluid communication with at least one vent hole to facilitate passage of gas from the end cap, at least one vent hole being defined through the wall of the end cap, the filter being disposed within the end cap and spaced apart from at least one vent hole, and an end cap.

[0016] U.S. Patent No. 7,946,417, "Curable material mixing and delivery device" discloses an apparatus and method for mixing two components and delivering the mixture to a patient. The apparatus includes a mixing chamber for mixing a liquid component and a powder component. The liquid component and the powder component are mixed within the mixing chamber by rotation of a foldable mixing element. Next, a plunger is advanced through the mixing chamber to extrude the mixture from the mixing chamber and deliver the mixture to the patient.

[0017] U.S. Patent No. 7,951,108, "Dual chamber mixing syringe and method for use", discloses a mixing syringe and provides a method for using the mixing syringe. The mixing syringe includes a housing having a first compartment for containing a first component, an outer plunger having a second compartment for containing a second component, and an inner plunger. Prior to use, a seal separates the first component and the second component. To prepare the mixture, a hole is made in the seal to mix the two components. The mixing syringe and method of using it are particularly suitable for applications where at least one of the mixture components is a relatively highly viscous material.

[0018] U.S. Patent No. 7,967,779, "Powder and liquid mixing syringe", discloses a mixing syringe having a first sealed chamber (powder housing) for containing powder and a second sealed chamber (liquid housing) for containing liquid. When the user needs to inject a patient, the device is held substantially upright while the plunger is being pushed. This movement causes a piercing element to pierce a foil seal that separates the two chambers. Next, the liquid drips into the powder housing. The liquid flows through a passage in a piston disposed within the powder housing where it contacts the powder itself. As the user continues to push the plunger downward, the piercer remains stationary within the piston and seals the passage through the piston, thereby locking the piercer and the piston together. Next, the device is ready for injection. As the plunger is further depressed, the piston discharges the mixture of powder and liquid through the needle.

[0019] U.S. Patent No. 6,458,095, "Dispenser for an adhesive tissue sealant having a housing with multiple cavities", discloses a dispenser for simultaneously dispensing a first component and a second component of an adhesive tissue sealant, wherein 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) 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 containing an amount of the first component in the form of a dry powder stored between the first partition and the first movable plug; (b) a second container having a second partition at one end, an open end opposite the second partition, and a second movable plug disposed therein, the second container containing an amount of the second component; (c) a housing sized and configured to receive and support the first container and the second container, the housing having a pair of cavities, each cavity having a base; (d) a piston sized and configured to be received at the open ends of the first container and the second container to advance the first movable plug and the second movable plug. The housing includes a manifold sized and configured such that the first component and the second component can pass therethrough via a first flow path and a second flow path to a nozzle from which the first component and the second component are dispensed and combined to form an adhesive tissue sealant. The first piercer and the second piercer are attached to the manifold to penetrate the first partition and the second partition, each piercer extending through and being supported by a disk adjacent to the base of each cavity, each disk being supported at a distance from the base of the first cavity and the second cavity to form a first plenum and a second plenum, each plenum being defined by the respective disk and the adjacent wall of each cavity, and the first piercer and the second piercer passing the first component and the second component into the first plenum and the second plenum.

[0020] U.S. Patent No. 6,699,229, "Fluid transfer device", discloses a fluid transfer and mixing device for use in the aseptic mixing of powder and fluid components. The device has a simple and compact structure including a first adapter that can be easily connected to a container containing the powder component, and a second adapter that can be removably interconnected to the first adapter and can be easily connected to a container containing a fluid such as a diluent, enabling the aseptic mixing of the diluent and the powder. In use, a conventional needleless syringe can be easily connected to the first adapter, whereby a mixture of the powder and the diluent can be aseptically aspirated from the first container and then delivered to a patient.

[0021] Japanese Patent Publication No. 9182786A discloses an enema that enables the injection of both liquid and powder enemas. This enema consists of an injection cylinder protruding from one end of a bellows-shaped cylinder, puncturing means provided on the injection cylinder at the inner base end of the bellows-shaped cylinder, and a powder storage bag and a liquid storage bag made of flexible materials arranged in order from the base end side of the injection cylinder within the bellows-shaped cylinder.

[0022] U.S. Patent No. 369,767 discloses a combined nebulizer and syringe.

[0023] U.S. Patent Publication No. 2011 / 0021982, "DISPENSING DEVICE WITH BYPASS", discloses a device for dispensing a plurality of components having a syringe housing that is divided into at least two chambers and includes at least one storage container having a bypass configuration and a second storage container having or not having a bypass configuration, with the syringe housing being realized as part of a double syringe or double cartridge having a double plunger and a common outlet. The bypass arrangement has at least two recesses.

[0024] U.S. Patent Publication No. 2010 / 0219200 discloses an apparatus and method for mixing two components and delivering the mixture to a patient. The apparatus includes a mixing chamber for mixing a liquid component and a powder component. The liquid component and the powder component are mixed within the mixing chamber by rotation of a collapsible mixing element. Next, a plunger is advanced through the mixing chamber to extrude the mixture from the mixing chamber and deliver the mixture to the patient.

[0025] U.S. Patent Publication No. 2003 / 0040701, "Dual chamber syringe with a dual function piston", 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 to force the substances to mix within the forward compartment. During advancement of the piston, the passage between the two compartments is closed to extrude the mixture of substances from the discharge opening of the syringe.

[0026] U.S. Patent No. 10,183,132, assigned to Ethicon LLC and incorporated herein by reference, teaches an integrated delivery device that is operable with one hand and provides simultaneous delivery of a liquid drug and a powder drug from a liquid drug extrusion sub-unit and a powder drug extrusion sub-unit onto tissue or a wound. Each extrusion sub-unit has an actuator for the liquid drug and the powder drug contained therein, disposed adjacent to each other at the proximal end of the extrusion sub-unit, and a delivery cannula for each of the extrusion sub-units, disposed adjacent to each other at the distal end of the extrusion sub-unit.

[0027] 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 extruding a hemostatic powder. The device has an elongate reservoir with a manual air pump, such as a bellows, at a proximal end and an extrusion port at a distal end. A porous filter is slidably disposed within the reservoir between the bellows, a plunger, and the extrusion port, and a spring is disposed within the reservoir between the air pump and the plunger. A powder is disposed within the reservoir between the porous filter and the extrusion port, and the pump is in fluid communication with the extrusion port through the porous filter and the powder. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0028] Notwithstanding the above progress, there remains a need for an improved device for delivering powders and liquids for sealing tissue and / or controlling bleeding. MEANS FOR SOLVING THE PROBLEM

[0029] In one embodiment, a powder delivery and liquid delivery composite device is configured to dispense a powder (e.g., a therapeutic powder, a hemostatic powder) and a liquid that activates the powder to form a sealing gel.

[0030] In one embodiment, the powder delivery and liquid delivery composite device preferably includes a delivery device housing having a first chamber configured to hold the powder and a second chamber configured to hold the liquid.

[0031] In one embodiment, each chamber may have a separate port for conveniently loading the powder and the liquid into their respective chambers.

[0032] In one embodiment, the chamber may be pre-filled with powder and liquid.

[0033] In one embodiment, the powder delivery and liquid delivery composite device preferably includes a powder delivery system that delivers powder to the surgical site through a delivery channel or lumen. In one embodiment, the powder delivery system preferably includes a manual actuator (e.g., bellows) for dispensing the powder.

[0034] In one embodiment, when the manual actuator is activated (e.g., the bellows is pushed), the air flow generated by the manual actuator transports and delivers the powder through the powder delivery channel to the surgical site.

[0035] In one embodiment, the liquid delivery system may be used to deliver a liquid (e.g., activation fluid, saline) to activate the powder for forming a tissue sealing gel. In one embodiment, the liquid delivery system may include one or more components of a syringe, such as a syringe barrel for holding the liquid and a syringe plunger that can be depressed to dispense the liquid from the syringe barrel. In one embodiment, the liquid may be sprayed as a fine mist onto the powder layer dispensed onto the tissue or wound at the surgical site.

[0036] In one embodiment, the powder delivery and liquid delivery composite device may include an applicator tip having a double-lumen cannula with separate delivery channels for the powder and the liquid.

[0037] In one embodiment, the applicator tip has a triple-lumen cannula structure that includes a first lumen for delivering the powder, a second lumen for delivering the liquid, and a third lumen that includes a malleable wire that allows the user to change the angle of the distal end of the applicator tip to access various surgical sites. In one embodiment, the malleable wire allows the surgeon to selectively angle the dispensing tip at various angles relative to the elongate shaft of the applicator tip.

[0038] In one embodiment, the powder delivery and liquid delivery composite device may have a dual-lumen dispensing tip that enables both powder dispensing and liquid spraying from the same dual-lumen dispensing tip. In one embodiment, the liquid outlet (e.g., liquid spray outlet) and the powder dispensing outlet may be offset relative to each other to prevent liquid from entering the powder dispensing channel. In one embodiment, the liquid outlet is preferably disposed downstream of the powder outlet to prevent liquid from entering the powder dispensing channel.

[0039] In one embodiment, the powder delivery and liquid delivery composite device is configured such that the powder and liquid can be applied sequentially (e.g., power is delivered first and then the liquid is sprayed onto the powder layer) or simultaneously (e.g., the powder and liquid are delivered simultaneously to the surgical site). In one embodiment, the combined powder and activated liquid applicator may apply the powder and liquid to the surgical site continuously or simultaneously with one hand.

[0040] In one embodiment, for sequential application, a powder layer may be applied onto the surgical site and then a liquid (e.g., activated fluid, saline) is sprayed onto the powder layer to form a tissue sealing gel layer.

[0041] In one embodiment, for simultaneous application, the powder and liquid may be applied by simultaneously pushing the bellows and the syringe plunger.

[0042] In one embodiment, a one-way valve may be present in the powder delivery channel, such as between the powder reservoir and the applicator tip, to prevent moist air within the surgical site from being drawn back into the powder reservoir. The presence of the one-way valve eliminates the possibility of moist air entering the powder reservoir and activating the powder while the powder is disposed within the powder reservoir. The presence of the one-way valve also preferably eliminates the possibility of fine liquid / water droplets being drawn into the powder delivery channel and causing clogging of the powder delivery channel due to premature powder / liquid reaction.

[0043] In one embodiment, the powder delivery and liquid delivery composite device preferably provides powder dosage control. In one embodiment, the dosage control may be achieved by storing a fixed amount of powder (i.e., dosage) in the powder delivery channel by the suction action of the bellows when the bellows returns to the extended position.

[0044] In one embodiment, the powder is a therapeutic powder that can be used to control bleeding at the surgical site and seal the wound.

[0045] In one embodiment, the powder may be a composite of fibrinogen and thrombin powder aggregated with ORC fibers to enable rapid dissolution and gel formation to stop bleeding and seal the tissue surface.

[0046] In one embodiment, a ready-to-use powder (e.g., hemostatic powder) may be dispensed onto the sealing surface of the lung to form a highly adhesive gel sealing layer. The powder may be sprayed with an activating fluid (e.g., saline) to promote gel formation.

[0047] In one embodiment, multiple layers of powder may be applied to improve effectiveness.

[0048] In one embodiment, the powder may have a density of about 0.20 - 0.25 g / cm 3 of.

[0049] In one embodiment, the powder may have a particle size of < 355 μm.

[0050] In one embodiment, the powder may be supplied in a reservoir (e.g., a vial).

[0051] In one embodiment, the powder vial may contain about 1 - 2 grams of powder, more specifically, about 1.2 grams of powder.

[0052] In one embodiment, the vial may have a size of about 10 ml.

[0053] In one embodiment, the vial may have a seal that can be removed and / or perforated for dispensing the powder. In one embodiment, the seal may include a removable foil tip or septum top.

[0054] In one embodiment, the vial may be made of glass or a polymeric material (e.g., plastic).

[0055] In one embodiment, the ratio of powder to liquid delivered from the applicator tip is preferably about 1 g of powder: 2.5 ml of liquid.

[0056] In one embodiment, the powder delivery and liquid delivery composite device preferably includes a delivery device housing having a powder chamber and a liquid chamber. The powder chamber and the liquid chamber are preferably separated from each other.

[0057] In one embodiment, the powder delivery and liquid delivery composite device includes an applicator tip having a powder delivery channel extending between a proximal end and a distal end of the applicator tip in fluid communication with the powder chamber.

[0058] In one embodiment, the applicator tip preferably has a liquid delivery channel extending from the proximal end to the distal end of the applicator tip in fluid communication with the liquid chamber.

[0059] In one embodiment, the powder delivery and liquid delivery composite device preferably includes a powder inlet port in fluid communication with the powder chamber and a liquid inlet port in fluid communication with the liquid chamber.

[0060] In one embodiment, the powder delivery and liquid delivery composite device preferably includes a powder inlet port, a powder chamber, and a powder delivery system in fluid communication with the powder delivery channel.

[0061] In one embodiment, the powder delivery and liquid delivery composite device preferably includes a liquid inlet port, a liquid chamber, and a liquid delivery system in fluid communication with a liquid delivery channel.

[0062] In one embodiment, the powder delivery and liquid delivery composite device preferably includes a powder vial connector fixed to the delivery device housing, and the powder vial includes a powder inlet port.

[0063] In one embodiment, the powder delivery and liquid delivery composite device preferably includes a liquid vial connector fixed to the delivery device housing, and the liquid vial includes a liquid inlet port.

[0064] In one embodiment, the powder delivery and liquid delivery composite device preferably includes a powder vial connected to the powder vial connector. The powder vial preferably has an opening in fluid communication with the powder inlet port.

[0065] In one embodiment, the powder delivery and liquid delivery composite device preferably includes a liquid vial connected to the liquid vial connector. The liquid vial preferably has an opening in fluid communication with the liquid inlet port.

[0066] In one embodiment, the powder is disposed within the powder vial and the liquid is disposed within the liquid vial.

[0067] In one embodiment, the powder may include a hemostatic powder, and the liquid may include an activating fluid (e.g., saline) for activating the hemostatic powder to form a sealing gel for sealing tissue or controlling bleeding.

[0068] In one embodiment, the powder delivery system is movable between a depressed configuration and an extended configuration. In one embodiment, when the powder delivery system moves from the depressed configuration to the extended configuration, a vacuum is generated in the powder chamber to draw a dose of powder from the powder vial into the powder chamber. In one embodiment, when the powder delivery system moves from the extended configuration to the depressed configuration, a positive pressure is generated in the powder chamber to push a dose of powder out of the powder chamber and cause the powder to flow into the powder delivery channel.

[0069] In one embodiment, the liquid delivery system is movable between a depressed configuration and an extended configuration. In one embodiment, when moving from the depressed configuration to the extended configuration, the liquid delivery system generates a vacuum in the liquid chamber to draw a dose of liquid from the liquid vial into the liquid chamber. In one embodiment, when moving from the extended configuration to the depressed configuration, the liquid delivery system generates a positive pressure in the liquid chamber to push a dose of liquid out of the liquid chamber and cause the liquid to flow into the liquid delivery channel.

[0070] In one embodiment, the powder delivery and liquid delivery composite device preferably includes a dual-lumen powder and liquid connector that can be fixed to the distal end of the applicator tip. In one embodiment, the dual-lumen powder and liquid connector preferably has a powder outlet opening in fluid communication with the powder delivery channel and a liquid spray opening in fluid communication with the liquid delivery channel.

[0071] In one embodiment, the powder outlet opening and the liquid spray opening are offset from each other. In one embodiment, the liquid spray opening is disposed downstream of the powder outlet opening to prevent moisture in the liquid delivery channel from entering the powder delivery channel.

[0072] In one embodiment, the powder delivery and liquid delivery composite device preferably includes a one-way valve located downstream of the powder chamber and in fluid communication with the powder delivery system.

[0073] In one embodiment, the one-way valve is disposed within the powder delivery channel and is positioned between the powder chamber and the proximal end of the applicator tip. In one embodiment, when there is a negative pressure within the powder chamber to draw powder into the powder chamber, the one-way valve prevents moisture or liquid from being drawn into the powder chamber. In one embodiment, the one-way valve may include a ball that freely moves toward the proximal end of the delivery device under negative pressure and freely moves toward the distal end of the delivery device under positive pressure.

[0074] In one embodiment, the powder delivery system may include a first air inlet in fluid communication with the powder chamber and a one-way valve disposed at the first air inlet that allows ambient air to be drawn into the powder chamber when the powder delivery system moves from a depressed configuration to an extended configuration.

[0075] In one embodiment, the liquid delivery system may include a second air inlet in fluid communication with the liquid chamber and a one-way valve disposed within the second air inlet that allows ambient air to be drawn into the liquid chamber when the liquid delivery system moves from a depressed configuration to an extended configuration.

[0076] In one embodiment, the liquid delivery system may include a first one-way valve disposed within the liquid inlet port that allows liquid to be drawn from the liquid vial into the liquid chamber of the delivery device housing.

[0077] In one embodiment, the liquid delivery system may include a second one-way valve disposed within the liquid delivery channel and downstream of the first one-way valve disposed within the liquid inlet port, and the second one-way valve allows the liquid within the liquid chamber to flow downstream and enter the liquid delivery channel.

[0078] In one embodiment, the powder delivery system preferably includes a bellows assembly having threads for releasably securing the bellows assembly to the proximal end of the delivery device housing. In one embodiment, the bellows assembly is configured to be unscrewed and released from the delivery device housing to allow powder to be loaded into the powder chamber.

[0079] In one embodiment, the proximal end of the delivery device housing preferably has an access opening for providing access to the powder chamber. In one embodiment, the access opening has internal threads configured to engage the threads of the bellows assembly for securing the bellows assembly to the proximal end of the delivery device housing.

[0080] In one embodiment, the powder chamber may be surrounded by a tubular wall having a closed distal end. In one embodiment, the closed distal end has a distal outlet opening formed therein that provides fluid communication between the powder chamber and the powder delivery channel.

[0081] In one embodiment, the powder and liquid delivery composite device preferably includes an anti-consolidation wall disposed within the powder chamber and spaced from the closed distal end of the tubular wall. In one embodiment, the anti-consolidation wall is disposed between the closed distal end of the tubular wall and the proximal end of the powder chamber. In one embodiment, the anti-consolidation wall has an outer perimeter spaced from the inner surface of the tubular wall surrounding the powder chamber.

[0082] In one embodiment, the bellows assembly includes an end cap disposed at an access opening of the delivery device housing, a bellows protruding from a proximal surface of the end cap, an elongated shaft protruding from a distal surface of the end cap such that a distal end portion of the elongated shaft is disposed within the powder chamber and faces a proximal surface of the anti-consolidation wall, a filter holder attached to the elongated shaft between the end cap and the distal end portion of the elongated shaft, a filter attached to the filter holder between the filter holder and the distal end portion of the elongated shaft, and a compression spring extending between the bellows and the filter holder and having a proximal end portion disposed inside the bellows and a distal end portion disposed adjacent to a proximal surface of the filter holder.

[0083] In one embodiment, when the bellows is pushed downward toward the distal end of the powder chamber, the compression spring is compressed, whereby the distal end portion of the compression spring biases the filter holder and the filter toward the anti-consolidation wall.

[0084] In one embodiment, the filter holder and the filter are configured to move simultaneously with each other within the powder chamber. In one embodiment, the filter holder and the filter each have an outer diameter, and the outer diameters are configured to form an airtight seal between the respective outer diameters of the filter holder and the filter and an inner surface of a tubular wall surrounding the powder chamber, and are equal to the inner diameter of the tubular wall surrounding the powder chamber.

[0085] In one embodiment, the powder delivery and liquid delivery composite device preferably includes a delivery device housing having a powder chamber and a liquid chamber separated from the powder chamber.

[0086] In one embodiment, the delivery device preferably includes an applicator tip having a powder delivery channel extending between a proximal end portion and a distal end portion of the proximal end of the applicator tip in fluid communication with the powder chamber.

[0087] In one embodiment, the applicator tip has a liquid delivery channel that extends from the proximal end to the distal end of the applicator tip and is preferably in fluid communication with the liquid chamber.

[0088] In one embodiment, the delivery device preferably includes a powder inlet port in fluid communication with a powder chamber and a liquid inlet port in fluid communication with a liquid chamber.

[0089] In one embodiment, the delivery device preferably includes a powder delivery system that is in fluid communication with the powder inlet port, the powder chamber, and the powder delivery channel.

[0090] In one embodiment, the delivery device preferably includes a liquid delivery system that is in fluid communication with the liquid inlet port, the liquid chamber, and the liquid delivery channel.

[0091] In one embodiment, the liquid delivery system is movable between a depressed configuration and an extended configuration.

[0092] In one embodiment, when moving from the depressed configuration to the extended configuration, the liquid delivery system creates a vacuum in the liquid chamber to draw a dose of liquid into the liquid chamber.

[0093] In one embodiment, when moving from the extended configuration to the depressed configuration, the liquid delivery system creates a positive pressure in the liquid chamber to push a dose of liquid out of the liquid chamber and into the liquid delivery channel.

[0094] In one embodiment, the powder vial assembly for delivering powder to a powder delivery and liquid delivery composite device preferably includes a powder housing having a proximal end, a distal end, an outer wall extending between the proximal end and the distal end, a proximal opening disposed at the proximal end of the powder housing, and a powder dispensing opening disposed at the distal end of the powder housing.

[0095] In one embodiment, the powder vial assembly preferably includes a fixed guide portion disposed within the powder housing and fixed to the inner surface of the outer wall adjacent to the proximal end of the powder housing.

[0096] In one embodiment, the powder vial assembly preferably includes an actuator assembly disposed within the fixed guide portion, the actuator assembly including a knob accessible at the proximal end of the powder housing and a guide shaft extending distally between the knob and the distal end of the powder housing.

[0097] In one embodiment, the powder vial assembly desirably includes an air inlet extending through the actuator assembly in fluid communication with the powder dispensing opening and a one-way valve (e.g., a one-way duckbill valve) disposed within the air inlet.

[0098] In one embodiment, the powder vial assembly desirably includes a filter cartridge mounted on the guide shaft of the actuator assembly and configured to slide along the guide shaft toward the distal end of the powder housing.

[0099] In one embodiment, a filter is mounted on the filter cartridge between the filter cartridge and the distal end of the powder housing. Desirably, the filter is configured to slide toward the distal end of the powder housing simultaneously with the filter cartridge.

[0100] In one embodiment, a compression spring is mounted on the guide shaft of the actuator assembly. In one embodiment, the compression spring preferably has a proximal end in contact with the actuator assembly and a distal end in contact with the filter cartridge to bias the filter cartridge and the filter toward the distal end of the powder housing.

[0101] In one embodiment, the actuator assembly is movable between a locked position where the filter carriage is coupled to the fixed guide to prevent the filter carriage from moving toward the distal end of the powder housing, and an unlocked position where the filter carriage is decoupled from the fixed guide to allow the compression spring to slide the filter carriage and filter distally on the guide shaft toward the distal end of the powder housing.

[0102] In one embodiment, the fixed guide may include a stop, and the filter carriage may include one or more hooks that contact the stop of the fixed guide when the actuator assembly is in the locked position. In one embodiment, the one or more hooks of the filter carriage are decoupled from the stop of the fixed guide when the actuator assembly is in the unlocked position.

[0103] In one embodiment, the powder vial assembly may include a powder chamber disposed within the powder housing between the filter and the powder dispensing opening. The powder may be filled into the powder chamber.

[0104] In one embodiment, the filter carriage guide shaft support may be disposed within the powder housing adjacent to the powder dispensing opening to support the distal end of the guide shaft.

[0105] In one embodiment, the actuator assembly preferably includes a pair of actuating legs for engaging and rotating the filter carriage to decouple the filter carriage from the fixed guide. In one embodiment, the actuator assembly preferably includes a rotatable knob that can be rotated about the longitudinal axis of the guide shaft. The actuating legs are preferably coupled to the rotatable knob and rotate simultaneously with the rotatable knob.

[0106] In one embodiment, the distal end of the actuating leg may include a hook for axially locking the actuator assembly to the fixed guide.

[0107] In one embodiment, the actuator assembly preferably includes an intake opening extending therethrough and an air channel in communication with the intake opening. The air channel may be disposed adjacent to the proximal end of the guide shaft for the filter cartridge.

[0108] The intake port enables air to be drawn into the proximal end of the powder vial housing for dispensing powder through the powder dispensing opening.

[0109] In one embodiment, the distal end of the guide shaft preferably includes a compressible structure that can be compressed to install (e.g., attach) the filter cartridge onto the guide shaft. In one embodiment, the distal end of the guide shaft preferably includes a step (e.g., an annular step) that functions as a stop to prevent the filter cartridge from slipping off the distal end of the guide shaft after the filter cartridge is attached onto the guide shaft.

[0110] In one embodiment, it may be beneficial to use the powder vial assembly disclosed herein when the powder disposed within the powder vial housing is not very fluid.

[0111] In one embodiment, the powder vial assembly may be effectively operated in any orientation such that powder can be dispensed through the powder dispensing opening when the powder delivery and liquid delivery devices are held in any orientation (e.g., upright, inverted, vertical, horizontal, sideways, angled, etc.).

[0112] In one embodiment, the filter cartridge is first locked onto the fixed guide portion, and the compression spring is in a compressed state with energy stored therein.

[0113] In one embodiment, the user may fill the powder chamber with powder through a proximal opening located at the proximal end of the powder vial housing. In one embodiment, the powder vial assembly may be pre-filled with powder (e.g., at the factory) before being shipped to the end user.

[0114] In one embodiment, the knob of the actuator assembly may be rotated to rotate the actuator leg, which rotates the filter cartridge to disengage the hook of the filter cartridge from the stop of the fixed guide, and the compression spring biases the filter cartridge to slide towards the distal end of the filter cartridge guide shaft.

[0115] In one embodiment, the stop of the fixed guide has an axially extending slot that is used to disconnect the filter cartridge from the fixed guide. In one embodiment, when the rotatable knob of the actuator assembly is rotated, the actuating leg of the actuator assembly engages the hook of the filter cartridge, rotates the hook, and aligns it with the axially extending slot of the stop, so that the compressed spring slides the filter cartridge distally on the guide shaft, whereby the powder in the powder chamber is then pushed towards the dispensing opening of the powder vial housing.

[0116] In one embodiment, the inner surface of the outer wall of the powder vial housing preferably includes one or more surfaces (e.g., slots or pads) that engage corresponding structures (e.g., reverse structures) on the outer surface of the fixed guide to prevent rotation of the fixed guide relative to the powder vial housing.

[0117] In one embodiment, the inner surface of the powder vial housing has an internal locking mechanism that engages the outer surface of the fixed guide to axially lock the position of the fixed guide relative to the powder vial housing so that the fixed guide does not move axially relative to the powder vial housing.

[0118] In one embodiment, the distal end of the powder vial housing preferably includes an internal support (e.g., a support ring) configured to engage the distal end of the filter cartridge guide shaft to support and stabilize the guide shaft within the powder vial housing.

[0119] In one embodiment, the filter cartridge has a proximally extending hub adapted to engage the distal end of a compression spring.

[0120] In one embodiment, the filter cartridge has a distally extending hub adapted to seat the filter. The filter cartridge may include a stop ring located at a distal end that extends distally to hold the filter on the distally extending hub after the filter is attached onto the filter cartridge.

[0121] In one embodiment, preferably, the filter cartridge includes one or more hooks that project toward the proximal end of the powder vial housing to connect the filter cartridge to the fixed guide.

[0122] In one embodiment, the proximal end of the fixed guide preferably includes one or more anti-rotation components (e.g., slots, pads) that engage corresponding structures at the proximal end of the powder vial housing to prevent the fixed guide from rotating relative to the powder vial housing.

[0123] In one embodiment, the proximal end of the fixed guide may include a structure (e.g., an annular protrusion) that engages the inner surface of the powder housing at the proximal end of the powder housing to prevent axial movement of the fixed guide relative to the powder vial housing.

[0124] In one embodiment, the distal end of the fixed guide may include a stop that engages the hook of the filter cartridge to lock the filter cartridge to the fixed guide.

[0125] In one embodiment, the stop on the fixed guide preferably includes one or more axially extending slots that can be used to disconnect the hook of the filter carriage from the stop of the fixed guide. In one embodiment, the hook of the filter carriage is rotated to align with the slot of the stop to disconnect the filter carriage from the fixed guide, such that the potential energy stored in the compression spring biases the filter carriage (and filter) to slide toward the distal end of the guide shaft.

[0126] These and other preferred embodiments of the present invention are described in more detail herein.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0128] Referring to FIGS. 1A - 1D, in one embodiment, the powder delivery and liquid delivery composite device 100 is configured to deliver powder (e.g., hemostatic powder) and liquid (e.g., activation fluid, saline) to a surgical site. In one embodiment, the powder delivery and liquid delivery composite device generally has a proximal end 102 positioned closer to the surgeon and a distal end 104 positioned farther from the surgeon. The powder and liquid are preferably dispensed from the distal end 104 of the powder delivery and liquid delivery composite device 100.

[0129] In one embodiment, the powder delivery and liquid delivery composite device 100 preferably includes a delivery device housing 106 having a proximal end 108 and a distal end 110. In one embodiment, the delivery device housing 106 preferably includes a first vial connector 112 adapted to connect a first vial 114 (e.g., a vial containing hemostatic powder) to the delivery device housing 106.

[0130] In one embodiment, the delivery device housing 106 preferably includes a second vial connector 116 adapted to connect a second vial 118 (e.g., a vial containing a liquid such as saline) to the device housing 106. In one embodiment, the powder is dispensed onto the tissue and the liquid is sprayed onto the powder to activate the powder and form a sealing layer of the hemostatic material.

[0131] In one embodiment, the powder delivery and liquid delivery composite device 100 preferably includes a powder delivery system 120 connected to the proximal end 108 of the delivery device housing 106. In one embodiment, the powder delivery system 120 is preferably configured to draw a dose of powder from the first vial 114, such that a dose of powder is directed into the powder chamber of the delivery device housing 106. The powder delivery system 120 may be activated to deliver a dose of powder from the powder chamber to the distal end 104 of the powder delivery and liquid delivery composite device 100.

[0132] In one embodiment, the powder delivery and liquid delivery composite device 100 preferably includes a liquid delivery system 122 connected to the proximal end 108 of the delivery device housing 106. In one embodiment, the liquid delivery system 122 is preferably configured to draw a dose of liquid from the second first vial 118 into the liquid chamber of the delivery device housing 106 and to deliver a dose of liquid from the distal end 104 of the powder delivery and liquid delivery composite device 100.

[0133] In one embodiment, the powder delivered from the distal end 104 of the powder delivery and liquid delivery composite device 100 is preferably dispensed onto tissue or a wound to form a powder layer, and the liquid is sprayed onto the dispensed powder layer to transform the powder into a hemostatic layer (e.g., a sealing gel) that seals the tissue or wound.

[0134] In one embodiment, the powder delivery and liquid delivery composite device 100 preferably includes an applicator tip 124 configured to deliver powder and liquid from the distal end 104 of the powder delivery and liquid delivery composite device 100. In one embodiment, the applicator tip 124 preferably includes an applicator tip base 126 utilized to connect the proximal end of the applicator tip 124 to an applicator tip connector 128, and the applicator tip connector is then fixed to the distal end 110 of the delivery device housing 106. In one embodiment, the applicator tip base 126 preferably includes a powder connector 130 for connecting the applicator tip base 126 to the applicator tip connector 128 and a liquid connector 132 for connecting the applicator tip base 126 to the applicator tip connector 128. In one embodiment, the applicator tip 124, the applicator tip base 126, the powder connector 130, and the applicator tip connector 128 preferably have a powder channel (not shown) extending therethrough that is configured to deliver powder to the distal end 104 of the applicator tip 124. In one embodiment, the applicator tip 124, the applicator tip base 126, the liquid connector 132, and the applicator tip connector 128 preferably define a liquid channel (not shown) for delivering liquid to the distal end 104 of the applicator tip 124.

[0135] In one embodiment, the powder delivery and liquid delivery composite device 100 preferably includes a first connecting pipe 134 adapted to connect a powder connector 130 to an applicator tip connector 128. In one embodiment, the powder delivery and liquid delivery composite device 100 preferably includes a second connecting pipe 136 adapted to connect a liquid connector 132 to an applicator tip connector 128.

[0136] In one embodiment, the distal end 104 of the applicator tip 124 preferably includes a powder delivery opening 138 (FIGS. 1A and 1D), which is adapted to deliver powder (e.g., hemostatic powder) from the distal end 104 of the powder delivery and liquid delivery composite device 100. In one embodiment, the powder delivery and liquid delivery composite device 100 preferably includes a liquid spray cap 140 connected to the distal end of the applicator tip 124 for spraying liquid from the distal end 104 of the delivery device 100. In one embodiment, the liquid spray cap 140 is preferably disposed downstream from the powder delivery opening 138 so that moisture present in the liquid is not drawn into the powder delivery opening 138, which can clog the powder channel when the powder moves distally through the applicator tip 124.

[0137] In one embodiment, the powder delivery and liquid delivery composite device 100 preferably includes a one-way valve 142 in communication with a first vial connector 112 and a powder delivery system 120 to allow ambient air to be drawn into the delivery device housing 106 and the powder delivery system 120. As described in more detail herein, the ambient air drawn into the powder delivery system draws a dose of powder from the first vial 114 and is used to deliver a dose of powder from the distal end 104 of the powder delivery and liquid delivery composite device 100.

[0138] Referring to FIG. 2, in one embodiment, the powder delivery and liquid delivery composite device 100 preferably includes a delivery device housing 106 having a first vial connector 112 adapted to connect a first vial 114 to the delivery device housing 106, such that the first vial 114 is in fluid communication with the powder delivery system 120 and the powder chamber 145 of the powder delivery and liquid delivery composite device 100.

[0139] In one embodiment, the powder delivery system 120 may be operated to generate a vacuum to draw a dose of powder from the first vial 114 into the powder chamber 145 of the delivery device housing 106 and then to generate high-pressure air to dispense a dose of powder from the distal end of the powder delivery and liquid delivery composite device 100. In one embodiment, the powder delivery system 120 preferably includes a powder chamber 145 that communicates with the powder supply channel 144 of the first vial connector 112.

[0140] In one embodiment, the scale of the dose of powder that can be drawn into the powder chamber 145 may be controlled by adjusting and / or modifying the diameter and / or length of the powder chamber. For example, a larger diameter results in a larger dose, and a smaller diameter results in a smaller dose.

[0141] In one embodiment, the powder delivery system 120 includes a filter 146 that allows air to pass in the proximal and distal directions but preferably prevents powder from passing through the filter.

[0142] In one embodiment, the powder delivery system 120 preferably includes a one-way valve 148 that includes a ball 150 that moves freely in the proximal and distal directions within the central chamber 154 of the one-way valve 148.

[0143] In one embodiment, the powder delivery system 120 preferably includes a bellows 152 that can be compressed in the distal direction DIR1 to force air to flow distally through the powder chamber 145. In one embodiment, the powder delivery system 120 preferably includes an internal spring 180 (FIG. 7) disposed inside the bellows 152, which normally biases the bellows to the extended position shown in FIG. 2. Thus, the bellows 152 is compressed in the distal direction DIR1, and after the compressive force is removed, the internal spring 180 disposed inside the bellows biases the bellows to move in the proximal direction DIR2 and returns the bellows to the extended position shown in FIG. 2.

[0144] In one embodiment, when the internal spring extends the bellows 152 in the proximal direction DIR2, ambient air is drawn in through a one-way valve 142 (FIGS. 1A-1D) that communicates with the first vial connector 112. The expanding bellows 152 generates a vacuum that draws ambient air into the powder chamber 145. The ambient air flows through the filter 146 and fills the internal volume of the bellows 152. The vacuum generated by the bellows 152 draws a dose of powder from the first vial 114. Under vacuum, a dose of powder preferably flows from the first vial 114 through the powder supply channel 144 into the powder chamber 145. The filter 146 preferably prevents a dose of powder from being drawn into the bellows 152. After a dose of powder is loaded into the powder chamber 145, the bellows 152 may be compressed in the distal direction DIR1 to force the powder distally through the one-way valve 148 and toward the distal end of the powder delivery and liquid delivery composite device 100.

[0145] In one embodiment, the one-way valve 148 preferably includes a ball 150 configured to move in the proximal direction DIR2 in response to the vacuum generated by the bellows 152 of the powder delivery system 120 and to move in the distal direction DIR1 in response to the higher pressure air generated by compressing the bellows 152 of the powder delivery system 120.

[0146] Referring to FIG. 3, in one embodiment, preferably, the one-way valve 148 is disposed downstream of the filter 146 and the powder chamber 145. In one embodiment, the one-way valve 148 preferably includes a central chamber 154 that is adapted to receive a ball 150 (FIG. 2). The ball is free to move in the proximal and distal directions along the length of the central chamber 154 of the one-way valve 148.

[0147] In one embodiment, the central chamber 154 of the one-way valve 148 preferably has a length L1 that is greater than the outer diameter of the ball 150 (FIG. 2) such that the ball can move in the proximal and distal directions along the length of the central chamber 154.

[0148] In one embodiment, the central chamber 154 has a proximal end 156 having a proximal sealing surface 162 that is adapted to engage the outer surface of the ball to form a seal.

[0149] In one embodiment, when the bellows 152 (FIG. 2) moves from the compressed configuration to the extended configuration, a vacuum is generated in the powder chamber 145. The vacuum draws the ball 150 (FIG. 2) disposed in the central chamber 154 in the proximal direction DIR2 such that the ball seals against the proximal sealing surface 162 of the one-way valve 148. By sealing the proximal sealing surface 162, the ball 150 prevents moisture from being drawn into the powder chamber 145, which prevents premature activation of the powder.

[0150] Referring to FIG. 4, the one-way valve 148 preferably includes a ball stop 165 adjacent to the distal end 158 of the central chamber 154 of the one-way valve 148. The ball stop 165 preferably has a proximal surface disposed proximally to the distal end 158 of the central chamber 154. When the ball 150 (FIG. 2) is moved by positive air pressure to the distal end 158 of the central chamber 154, the ball stop 165 holds the ball away from the distal end 158, preventing a sealing portion from being formed between the outer surface of the ball and the distal end of the central chamber of the one-way valve. Thus, when the ball engages the ball stop 165, the high-pressure air and powder flowing in the distal direction DIR1 freely flow through the gaps 166A, 166B disposed on both side surfaces of the ball stop 165. As a result, the powder can flow downstream and reach the powder delivery channel 160.

[0151] Referring to FIG. 5, in one embodiment, when the bellows expands to generate a vacuum in the powder chamber 145, a dose of powder in the first vial 114 (FIG. 2) is drawn through the powder supply channel 144 of the first vial connector 112 to fill the powder chamber 145. The vacuum preferably draws the ball 150 in the proximal direction DIR2 until the outer surface of the ball seats against the proximal sealing surface 162 disposed at the proximal end of the central chamber 154 of the one-way valve 148. The sealing portion formed between the outer surface of the ball 150 and the proximal sealing surface 162 preferably prevents any moisture that may be present in the powder dispensing channel 160 from moving upstream beyond the proximal end 156 of the one-way valve 148, which prevents any clogging and / or agglomeration of any powder in the powder chamber 145 or the powder supply channel 144. Thus, the one-way valve 148 preferably prevents clogging of the powder delivery and liquid delivery system 100 that may occur due to activation of the powder (e.g., by liquid) before the powder is dispensed from the distal end of the device.

[0152] Referring to FIG. 6, in one embodiment, when the bellow 152 (FIG. 2) is compressed in the distal direction DIR1, positive air pressure flows in the distal direction DIR1 through the filter 146 and the powder chamber 145, and a certain dosage of powder in the powder chamber flows distally until it reaches the one-way valve 148. The air flowing distally moves the ball 150 in the distal direction DIR1 until the outer surface of the ball abuts against the proximal surface of the ball stop 165. The proximal surface of the ball stop located proximal to the distal end 158 of the central chamber 154 of the one-way valve 148 spaces the outer surface of the ball 150 from the distal end 158 of the central chamber 154, allowing the powder and air flowing distally to pass through the gaps 166A and 166B present on both side surfaces of the ball stop 165. Thus, the outer surface of the ball 150 does not seal the powder delivery channel 160, and as a result, the powder freely flows distally over the ball 150 and the ball stop 165 until it reaches the powder delivery channel 160. The high-pressure air generated by the powder delivery system preferably flows the powder distally through the powder delivery channel 160 until the powder is delivered from the powder delivery opening 138 disposed at the distal end 104 of the applicator tip 124 of the powder and liquid delivery composite device 100 (FIG. 1D).

[0153] Referring to FIG. 7, in one embodiment, the powder and liquid delivery composite device 100 preferably includes a liquid delivery system 122 for drawing a liquid (e.g., an activating fluid, physiological saline) into a liquid chamber or liquid reservoir of the delivery device housing 106 and dispensing the liquid at the distal end of the applicator tip of the delivery device. In one embodiment, the powder and liquid delivery composite device 100 preferably includes a second vial connector 116 (FIG. 1A) adapted to connect a second vial 118 to the delivery device housing 106. In one embodiment, the powder and liquid delivery composite device 100 preferably includes a liquid reservoir connector 170 having a liquid supply channel 172 adapted to direct the liquid from the second vial 118 into the liquid chamber of the delivery device housing 106.

[0154] In one embodiment, the liquid delivery system 122 preferably includes a syringe barrel 174 disposed inside the delivery device housing 106, a syringe plunger 176 disposed inside the syringe barrel, and a syringe piston 178 fixed to the distal end of the syringe plunger 176. In one embodiment, the syringe plunger 176 preferably engages the inner surface of the syringe barrel 174 to push the liquid out of the opening at the distal end of the syringe barrel 174. In one embodiment, the liquid delivery system 122 preferably includes a syringe plunger spring 180 that biases the syringe plunger 176 back to the extended position shown in FIG. 7. In one embodiment, the volume of liquid drawn into the syringe barrel 174 (i.e., dose control) is determined by how far the syringe plunger 176 is extended by the syringe plunger spring 180. Specifically, the less the syringe plunger is extended by the syringe plunger spring, the relatively smaller the volume of liquid drawn into the syringe barrel, and the more the syringe plunger is extended by the syringe plunger spring, the relatively larger the volume of liquid drawn into the syringe barrel.

[0155] In one embodiment, the liquid delivery system 122 preferably includes a first one-way valve 182 that allows the liquid stored in the second vial 118 to be drawn into the syringe barrel 174 when the syringe plunger 176 is retracted in the proximal direction DIR2. The liquid delivery system 122 preferably includes a second one-way valve 184 that is located downstream of the first one-way valve 182. The second one-way valve 184 preferably allows the liquid from the syringe barrel 174 to flow in the distal direction DIR1, but the second one-way valve 184 prevents the liquid from reversing direction and flowing in the proximal direction DIR2. In one embodiment, when the syringe plunger 176 is retracted, the liquid in the second vial 118 passes through the liquid supply channel 172 and the first one-way valve 182 to fill the syringe barrel 174. When the syringe plunger 176 is pushed down in the distal direction DIR1, the liquid in the syringe barrel 174 is forced to flow through the opening at the distal end of the syringe barrel 174 and through the second one-way valve 184, such that the liquid flows distally into the liquid delivery channel 168 and can thus be delivered to the distal end of the powder delivery and liquid delivery composite device 100.

[0156] Referring to FIG. 8, in one embodiment, the powder delivery and liquid delivery composite device 100 preferably includes an applicator tip 124 (FIG. 1A) that is configured to deliver powder and liquid to the distal end 104 of the delivery device 100. In one embodiment, the powder delivery and liquid delivery composite device 100 preferably includes an applicator tip base 126 (FIG. 1A) that is designed to interconnect the proximal end of the applicator tip 124 with the distal end 110 of the delivery device housing 106. The applicator tip base 126 preferably includes a stabilizing bar 186 that is configured to engage the distal end of the applicator tip connector 128, stabilizing the applicator tip 124 and preventing the applicator tip from twisting and / or rotating about its longitudinal axis (FIG. 1C).

[0157] In one embodiment, the stabilization bar 186 is positioned off-center with respect to the center of the elongate tube 125 of the applicator tip 124, ensuring that the applicator tip can be attached in only one orientation with respect to the distal end of the delivery device housing. In one embodiment, the stabilization bar 186 preferably has a first side surface 188 that defines a first distance D1 between the first side surface 188 and the inner surface of the powder connector 130. The stabilization bar 186 preferably includes a second side surface 190 that defines a second distance D2 between the second side surface 190 and the inner surface of the liquid connector 132. In one embodiment, the second distance D2 is longer than the first distance D1, and thus the spacing between the stabilization bar 186 and the powder connector 130 is shorter than the spacing between the stabilization bar 186 and the liquid connector 132. By offsetting the stabilization bar 186 from the center, the applicator tip 124 can be assembled in only one orientation as a powder delivery and liquid delivery composite device such that the powder delivery channel 160 of the applicator tip 124 is in fluid communication with the powder delivery system and the liquid delivery channel 168 of the applicator tip 124 is in fluid communication with the liquid delivery system. Thus, the configuration of the stabilization bar 186 provides a fail-safe method of making connections that prevent incorrect connection of the applicator tip 124 to the respective powder delivery system and liquid delivery system. As a result, the user is assured that the powder delivery channel within the applicator tip is in fluid communication with the powder delivery system and the liquid delivery channel within the applicator tip is in fluid communication with the liquid delivery system.

[0158] In one embodiment, the distal end of the applicator tip 124 preferably includes a powder delivery opening 138 that communicates with the powder delivery channel 160 (FIG. 5) of the powder delivery system. The distal end of the applicator tip 124 also preferably includes a liquid spray cup 140 that is adapted to spray liquid from the distal end 104 of the liquid delivery channel 168 of the powder and liquid delivery composite device 100. In one embodiment, the spray cup 140 preferably has a liquid spray opening 149 disposed distally of the powder delivery opening 138 to prevent any moisture present in the liquid from entering into the powder delivery opening 138 or the powder delivery channel 160 and clogging the powder delivery channel and / or the powder delivery system of the powder and liquid delivery composite device 100.

[0159] Referring to FIGS. 8 and 9, in one embodiment, the applicator tip 124 preferably includes an elongate tube 125 that houses the powder delivery channel 160 and the liquid delivery channel 168. The applicator tip 124 preferably includes a powder connector 130 that is adapted to be coupled to the powder delivery channel and a liquid connector 132 that is adapted to be coupled to the liquid delivery channel 168, and includes an applicator tip base 126. The applicator tip base 126 preferably projects in the proximal direction and includes a stabilizing bar 186 that is adapted to engage the distal end of the applicator tip connector 128 to stabilize the applicator tip 124 when fixed to the distal end of the delivery device housing 106 (FIG. 1A) (FIG. 1C).

[0160] In one embodiment, the applicator tip 124 preferably includes a malleable wire 192 disposed between the powder delivery channel 160 and the liquid delivery channel 168. The malleable wire 192 preferably enables the distal end of the applicator tip 124 to be moved at an angle to facilitate delivery of the hemostatic powder and liquid to tissue or a wound. A surgeon may bend the malleable wire to select an angle for delivering the powder and liquid.

[0161] In one embodiment, the applicator tip 124 preferably includes a dual lumen powder and liquid connector 194 fixed on the distal end of an elongated tube 125. The dual lumen powder and liquid connector 194 preferably includes a powder delivery opening 138 for delivering the powder within the powder delivery channel / lumen 160. The dual lumen powder and liquid connector 194 also communicates with the distal end of the liquid delivery channel 168 and has an opening adapted to seat a liquid spray cup 140 for spraying liquid from the distal end of the applicator tip 124. In one embodiment, the dual lumen powder connector and liquid connector 194 preferably positions the spray cup 140 at a position distal to the powder delivery opening 138 so that the liquid dispensed from the spray cup does not move into and / or does not move within the powder delivery opening 138, which may clog the powder delivery channel 160.

[0162] Referring to FIGS. 10A-10D, in one embodiment, the liquid cup 140 preferably has a proximal end 196, a distal end 198, and a cylindrical outer wall 200 extending from the proximal end 196 to the distal end 198. In one embodiment, the proximal end of the cylindrical outer wall 200 is open, and the distal end of the cylindrical outer wall 200 is closed by an end wall 202 in which a liquid spray opening 149 is formed. Referring to FIGS. 10B-10D, in one embodiment, the end wall 202 has a proximal surface 204 in which a swirling chamber 206 is formed, which is adapted to rotate the liquid, for example, in a clockwise direction R1 (FIG. 10C) when the liquid is dispensed from the liquid spray opening 149 of the liquid spray cup 140, preferably generating a fine mist of the liquid that is sprayed from the distal end of the powder delivery and liquid delivery composite device.

[0163] In one embodiment, the opening at the proximal end 196 of the liquid spray cup 140 is preferably in fluid communication with a liquid delivery lumen 168 that passes through the elongated tube 125 of the applicator tip 124 (FIG. 8).

[0164] In one embodiment, the liquid spray cup 140 shown and described in FIGS. 10A-10D preferably incorporates one or more of the structural features disclosed in U.S. Patent Application Publication No. 2021 / 0101162 (Trezza, II et al., assigned to Ethicon, Inc., Somerville, New Jersey), the disclosure of which is incorporated herein by reference.

[0165] The powder delivery and liquid delivery composite devices disclosed herein have a wide range of functionality and can provide a number of advantages.

[0166] In one embodiment, the powder delivery and liquid delivery composite applicator device can apply powder and liquid to a surgical site continuously or simultaneously with one hand. In one embodiment, the powder may be dispensed onto the surgical site and then the liquid may be dispensed over the powder. In one embodiment, the powder and liquid may be dispensed simultaneously at the surgical site.

[0167] In one embodiment, the powder delivery and liquid delivery composite device may provide a system in which powder dispensing is dosage controlled so that the powder can be uniformly dispensed and applied in a controlled manner.

[0168] In one embodiment, the powder delivery and liquid delivery composite device may provide a system in which liquid dispensing is dosage controlled so that the liquid can be uniformly dispensed and applied in a controlled manner. In one embodiment, an activation liquid may be sprayed onto the powder (e.g., a previously applied powder layer) using a spray tip.

[0169] In one embodiment, the spray tip used to dispense the liquid and the powder delivery opening used to deliver the powder are offset from each other to prevent the liquid from moving into and / or contacting the powder delivery opening.

[0170] In one embodiment, a one-way valve is disposed within the powder delivery channel to prevent moist air and / or liquid from being drawn into the powder chamber, thereby preventing clogging and / or premature powder activation.

[0171] In one embodiment, the powder delivery and liquid delivery composite device may include and / or utilize a vial pre-filled with powder and activation liquid. For example, the first vial may be pre-filled with powder, and the second vial may be pre-filled with activation liquid.

[0172] In one embodiment, the powder delivery and liquid delivery composite device preferably includes one or more powder vials designed to assist in the supply of powder into the powder chamber or powder delivery channel. In one embodiment, the powder vial may include a spring / filter assembly configured to push the powder onto the powder dispensing opening and / or the powder delivery channel.

[0173] In one embodiment, the powder vial may include an air valve (e.g., located at the proximal end of the powder vial) to allow air to flow into the powder vial when a dose of powder is being dispensed and / or aspirated into the powder delivery channel.

[0174] Referring to FIG. 11, in one embodiment, a powder vial 114' for use in a powder delivery system of a powder and liquid delivery composite device is preferably designed to ensure that the powder stored within the powder vial can be reliably and efficiently withdrawn from the open end of the vial. In prior art vials, the opening of the powder vial may be surrounded by a shelf or ledge portion that extends orthogonally or perpendicular to the longitudinal axis of the powder vial. The orthogonally extending shelf or ledge portion may present an obstacle that blocks the flow of powder exiting the open end of the prior art powder vial. To avoid the above-described clogging problems observed in prior art vials, in one embodiment, the powder vial 114' preferably functions as a funnel and has an outer wall 115' that defines a conical inner surface 117' (FIG. 12) that eliminates the presence of any ledge or shelf portions within the powder vial 114' that might prevent powder from exiting the open end of the powder vial.

[0175] Referring to FIG. 12, in one embodiment, the powder vial 114' may be coupled to a powder vial connector 112' on a delivery device housing 106' of the powder and liquid delivery composite device 100'. The conical inner surface 117' of the powder vial 114' preferably ensures that the powder within the powder chamber 119' of the powder vial 114' can flow into the delivery device housing 106' through the powder vial connector 112' and be dispensed using the powder delivery system 120' of the powder and liquid delivery composite device 100'.

[0176] Referring to FIG. 13, in one embodiment, preferably, from the distal end of the device, a powder delivery and liquid delivery composite device 200 for delivering powder and liquid includes a delivery device housing 206 having a powder connector / liquid connector 212 adapted to connect both a powder vial 214 and a liquid vial 218 to the delivery device housing 206. In one embodiment, the upper end of the powder connector / liquid connector 212 preferably includes a first opening adapted to receive a powder vial 214 containing powder (e.g., hemostatic powder) and a second opening adapted to receive a liquid vial 218 containing liquid (e.g., physiological saline).

[0177] Referring to FIG. 14, in one embodiment, preferably, the powder vial 214 includes a powder reservoir 219 adapted to receive powder. The powder vial 214 preferably has a conical inner surface 217 that eliminates vertical ledges or shelves that could prevent and / or impede the movement of the powder into the powder chamber 245 of the powder delivery and liquid delivery composite device 200.

[0178] In one embodiment, the powder vial 214 preferably includes a filter 246 held by a filter holder 247 adapted to support the filter 246 when the filter moves along axis A1 towards the lower ends of the powder vial 214 and the powder chamber 245.

[0179] In one embodiment, the powder vial 214 preferably includes a spring 249 that biases the filter holder 247 and the filter 246 towards the lower open end of the powder vial 214 to push the powder from the powder reservoir 219 into the powder chamber 245.

[0180] In one embodiment, the powder reservoir 219 is maintained such that the volume of the powder chamber 245 is substantially filled with powder and has no or minimal free air space. The inventors of U.S. Patent No. 10,507,293, the disclosure of which is incorporated herein by reference, have found that such a configuration provides better uniformity of powder extrusion throughout the extrusion cycle, i.e., from the time when the powder delivery and liquid delivery composite device 200 is completely filled with powder until the powder reservoir 219 has emptied all of the remaining powder substantially completely, and also provides better directional extrusion uniformity, i.e., minimal difference between the extrusion of powder having an applicator tip oriented vertically versus horizontally.

[0181] In one embodiment, the spring 249 functions as a compressible pusher for the filter holder 247 and the filter 246. In one embodiment, when the powder delivery system is activated, an air flow pushes the powder out from the distal end of the powder delivery and liquid delivery composite device 200. At the same time, the filter holder 247 and the filter 246 are compressed by the spring 249, which then applies pressure to the filter holder 247 and the filter 246, thereby moving the filter holder 247 and the filter 246 along the axis A1 towards the lower end of the powder vial 214 and reducing the volume of the powder reservoir 219 as the powder is squeezed out of the powder delivery and liquid delivery composite device 200.

[0182] Thus, upon each extrusion of powder from the powder delivery and liquid delivery composite device 200, the filter holder 247 and the filter 246 advance towards the lower end of the powder vial 214 and occupy the space within the powder reservoir 219 that is freed up by the extruded powder. As a result of this operation, the volume of the powder reservoir 219 is always adjusted to correspond to the volume of powder remaining within the powder reservoir 219 of the powder vial 214.

[0183] In one embodiment, the powder vial 214 preferably includes an end cap 255 incorporating a one-way valve 257 that allows ambient air to be drawn into the delivery device housing 206 through the length of the powder vial. In one embodiment, when a vacuum is generated within the powder delivery system, a dose of powder within the powder vial 214 is drawn into the powder chamber 245.

[0184] In one embodiment, when a vacuum is generated by the powder delivery system, ambient air is drawn into the powder vial 214 through the one-way valve 257. The ambient air passes through one or more openings within the filter holder 247 and through the filter 246. The air preferably fills the bellows of the powder delivery system. When powder is supplied from the lower end of the powder vial 214, the spring 249 pushes the filter holder 247 and the filter 246 downward (i.e., toward the lower opening end of the powder vial) to push the powder remaining within the powder reservoir 219 of the powder vial 214 toward the lower end of the powder reservoir 219.

[0185] Referring to FIGS. 15A and 15B, in one embodiment, the applicator tip 324 of the powder and liquid delivery composite device 300 preferably includes an elongated tube 325 having a rigid sheath portion 325A and a flexible sheath portion 325B that allows the distal end 304 of the applicator tip to be angled at a selected angle with respect to the longitudinal axis A2 of the rigid sheath portion 325A for delivering powder and liquid.

[0186] Referring to FIG. 15B, in one embodiment, the powder delivery channel 360 passes through both the rigid sheath portion 325A and the flexible sheath portion 325B to deliver powder to the distal end 304 of the powder and liquid delivery composite device 300. As a result, the powder may be delivered through the powder delivery opening 338 located at the distal end of the applicator tip 324. The liquid delivery channel 368 also preferably passes through the rigid sheath portion 325A and the flexible sheath portion 325B of the applicator tip to deliver liquid to the distal end 304 of the powder and liquid delivery composite device 300. In one embodiment, the liquid may be sprayed as a fine mist through the liquid spray opening 349 formed in the liquid spray cup 340. In one embodiment, the liquid is dispensed at a position distal to the powder delivery opening 338.

[0187] Referring to FIG. 16, in one embodiment, the proximal end of the applicator tip 424 of the powder and liquid delivery composite device 400 preferably includes a powder connector 430 having an outer surface defining a first outer diameter OD1, and a liquid connector 432 having an outer surface defining a second outer diameter OD2 that is smaller than the first outer diameter OD1. The different outer diameters of the respective powder connector 430 and liquid connector 432 ensure that the powder delivery channel 460 within the applicator tip 424 is properly aligned with the powder delivery system of the powder and liquid delivery composite device 400, and the liquid delivery channel 468 within the applicator tip 424 is properly aligned with the liquid delivery system of the powder and liquid delivery composite device 400, so that the applicator tip 424 can be connected to the delivery device in only a single orientation. Provide fail-safe means. In one embodiment, a connecting pipe 434 may be used to fix the powder connector 430 and the liquid connector 432 to the applicator tip connector 428. The connecting pipe 434 may have a thread for making a secure connection.

[0188] In one embodiment, the outer diameter of the powder connector may be smaller than the outer diameter of the liquid connector in order to provide a fail-safe means to ensure that the applicator tip can only be connected in a single orientation such that the powder delivery channel within the applicator tip is properly aligned with the powder delivery system of the powder and liquid delivery composite device and the liquid delivery channel is properly aligned with the liquid delivery system of the powder and liquid delivery composite device.

[0189] Referring to FIG. 17, in one embodiment, the applicator tip 524 of the powder and liquid delivery composite device 500 preferably includes a flexible connector 525 that preferably enables the liquid spray cup 540 and the powder delivery opening 538 to be angled with respect to the longitudinal axis A3 of the proximal portion of the applicator tip 524. In one embodiment, the powder delivery channel 560 preferably passes through the length of the applicator tip 524 to deliver powder through the powder delivery opening 538 at the distal end 504 of the powder and liquid delivery composite device 500. In one embodiment, the liquid delivery channel 568 preferably extends through the length of the applicator tip 524 to deliver liquid to the liquid spray cup 540 disposed at the distal end 504 of the powder and liquid delivery composite device 500.

[0190] Referring to FIGS. 18A - 18C, in one embodiment, a powder delivery and liquid delivery composite device 600 for delivering powder and liquid to a surgical site preferably has a proximal end 602 and a distal end 604. In one embodiment, the powder delivery and liquid delivery composite device 600 preferably includes a powder housing 606A adapted to receive powder and a liquid housing 606B adapted to receive liquid. In one embodiment, the powder delivery and liquid delivery composite device 600 preferably includes a powder delivery system 620 adapted to deliver powder (e.g., a dose of hemostatic powder) from the distal end 604 of the powder delivery and liquid delivery composite device 600, and a liquid delivery system 622 adapted to deliver liquid (e.g., a saline spray) from the distal end 604 of the powder delivery and liquid delivery composite device 600.

[0191] In one embodiment, the powder delivery and liquid delivery composite device 600 preferably includes an applicator tip 624 that includes a powder delivery channel (e.g., a powder lumen) in fluid communication with the powder housing 606A and the powder delivery system 622, and a liquid delivery channel (e.g., a liquid lumen) in fluid communication with the liquid housing 606B and the liquid delivery system 620. In one embodiment, the powder delivery and liquid delivery composite device 600 preferably includes an applicator tip base 626 that has a powder connector 630 and a liquid connector 632 that include portions of the respective powder and liquid delivery channels.

[0192] In one embodiment, the powder delivery and liquid delivery composite device 600 preferably includes a delivery device frame 615 that interconnects and supports the powder housing 606A and the liquid housing 606B. In one embodiment, the applicator tip base 626 preferably includes a stabilizing bar 686 connected to the distal end of the delivery device frame 615 to stabilize the applicator tip 624 and prevent the applicator tip 624 from twisting and / or rotating about its longitudinal axis.

[0193] In one embodiment, the first connection pipe 634 fixes the powder connector 630 of the applicator tip 624 to the distal end of the powder housing 606A, and the second connection pipe 636 fixes the liquid connector 632 of the applicator tip 624 to the distal end of the liquid housing 606B.

[0194] In one embodiment, the powder delivery and liquid delivery composite device 600 preferably includes a first one-way valve 642 in communication with the powder housing 606A to allow ambient air to be drawn into the powder housing 606A when the powder delivery system 620 is operated to generate a vacuum within the powder housing 606A.

[0195] In one embodiment, the powder delivery and liquid delivery composite device 600 preferably includes a second one-way valve 659 that allows ambient air to be drawn into the liquid housing 606B when the syringe plunger 676 of the liquid delivery system 622 is retracted in the distal direction DIR2.

[0196] Referring to FIG. 19, in one embodiment, the powder housing 606A is adapted to receive the powder delivery system 620. The powder delivery system 620 preferably includes a bellows 652, an internal spring 655 that normally biases the bellows 652 to the extended position shown in FIG. 19, a filter holder 647, and a filter 646 fixed to the filter holder. The powder housing 606A preferably includes a powder chamber 645 for containing powder. In one embodiment, the bellows may be removed (e.g., unscrewed) from the powder housing 606A so that the powder can be disposed within the powder chamber 645.

[0197] In one embodiment, the powder delivery and liquid delivery composite device 600 preferably includes a device frame 615 that supports a powder housing 606A and a liquid housing 606B. In one embodiment, a powder delivery system 620 is assembled with the powder housing 606A, and a liquid delivery system 622 is assembled with the liquid housing 606B. In one embodiment, the powder delivery system 620 is activated to dispense powder from the distal end of the powder delivery and liquid delivery composite device 600, and the liquid delivery system 622 is activated to dispense liquid from the distal end of the powder delivery and liquid delivery composite device 600.

[0198] In one embodiment, the powder housing 606A preferably includes a powder chamber 645 that is adapted to receive powder that can be delivered from the distal end of the powder delivery and liquid delivery composite device 600 using the powder delivery system 620. In one embodiment, the powder chamber 645 is in fluid communication with a powder delivery channel 660 of the powder delivery and liquid delivery composite device 600. The powder delivery channel 660 preferably extends to the distal end 604 of the applicator tip 624 (FIG. 18A).

[0199] In one embodiment, the powder delivery system 620 that includes a bellows 652 may be removed from the proximal end of the powder housing 606A such that powder can be inserted and / or filled into the powder chamber 645. When the powder chamber 645 is filled with powder, the powder delivery system 620 may be reattached to the proximal end of the powder housing 606A. In one embodiment, the powder delivery system 620 preferably includes an end cap 685 that can be releasably fixed to the proximal end of the powder housing 606A. In one embodiment, the powder delivery system 620 preferably includes a filter 646 and a filter holder 647 that supports the filter 646 when the filter moves distally (DIR1) within the powder housing 606A.

[0200] In one embodiment, the powder delivery system 620 preferably includes a bellows 652 and an internal bellows spring 655 that biases the bellows 652 to return to the extended position shown in FIGS. 19 and 20.

[0201] Referring to FIGS. 19, 21, and 22, in one embodiment, the powder housing 606A preferably includes a consolidation prevention wall 601 disposed adjacent to a distal opening at the distal end of the powder housing 606A. The consolidation prevention wall 601 preferably defines gaps 649A, 649B (FIG. 24) disposed on both sides of the wall 601, thereby allowing the powder in the powder chamber 645 to pass around the consolidation prevention wall 601 and into the powder delivery channel 660 disposed downstream of the one-way valve 648. The consolidation prevention wall 601 preferably prevents the powder in the powder chamber 645 from being filled into the opening at the distal end of the powder housing 606A, closing the opening, and preventing further delivery of powder from the distal end of the applicator tip 624.

[0202] In one embodiment, the powder and liquid delivery composite device 600 preferably includes a one-way valve 648 disposed between the distal opening of the powder housing 606A and a section of the powder delivery channel 660 that extends into the powder connector 630 of the applicator tip base 626. In one embodiment, the one-way valve 648 preferably includes a ball 650 that moves freely in the proximal and distal directions within the central chamber of the one-way valve 648. In one embodiment, the one-way valve may operate in a manner similar to the one-way valve shown and described above in FIGS. 2 - 6.

[0203] Referring to FIG. 19, in one embodiment, the powder delivery and liquid delivery composite device 600 preferably includes a liquid delivery system 622 that can be utilized to deliver liquid from the distal end of the applicator tip 624. In one embodiment, the liquid delivery system 622 preferably includes a syringe barrel 674 that is disposed inside the liquid housing 606B. The liquid delivery system 622 preferably includes a syringe plunger 676 disposed within the syringe barrel 674 and a piston 678 fixed to the distal end of the syringe plunger 676.

[0204] In one embodiment, the syringe barrel 674 preferably surrounds a liquid chamber 675 that is adapted to receive a liquid (e.g., a powder activating fluid).

[0205] In one embodiment, the liquid delivery system 622 preferably includes a syringe plunger spring 680 that is configured to bias the syringe plunger to return to the extended position shown in FIGS. 19 and 20.

[0206] In one embodiment, the liquid delivery system 622 is preferably adapted to draw liquid into the liquid chamber 675 of the syringe barrel 674 and then to extrude the liquid through an opening at the distal end of the syringe barrel, such that the liquid flows downstream through the liquid delivery channel 668 and is delivered from the distal end of the applicator tip 624. The powder delivery and liquid delivery composite device 600 preferably includes a first one-way valve 682 that allows liquid to be drawn into the liquid chamber 675 of the syringe barrel 674 when the syringe plunger 676 is retracted in the proximal direction DIR2. When the syringe plunger 676 and the piston 678 are retracted in the proximal direction DIR2, a vacuum is created within the liquid chamber 675 of the syringe barrel 674, and liquid is drawn into the liquid chamber 675 through the first one-way valve 682.

[0207] In one embodiment, when the syringe plunger 676 is pushed downward in the distal direction DIR1, the liquid in the liquid chamber 675 of the syringe barrel 674 is forced to flow in the distal direction DIR1, pass through the second one-way valve 684, and enter the liquid delivery channel 668 of the powder delivery and liquid delivery composite device 600. The liquid preferably moves through the liquid connector 632 at the base 626 of the applicator tip 624 of the applicator tip 624.

[0208] Referring to FIG. 20, in one embodiment, the powder delivery system 620 can be removed from and removed through an opening at the proximal end of the powder housing 606A of the powder delivery and liquid delivery composite device 600. The powder delivery system 620 preferably includes an end cap 685 that can be used to secure the powder delivery system 620 to the proximal end of the powder housing 606A. In one embodiment, the powder delivery system 620 preferably includes a bellows 652, a filter 646, a filter holder 647, and a male thread 651 that is adapted to engage a female thread within the powder housing 606A to secure the powder delivery system 620 within the powder housing 606A.

[0209] In one embodiment, the powder delivery system 620 may be removed from the powder housing 606A so that powder can be disposed (e.g., filled) within the powder chamber 645 (FIG. 19) of the powder housing 606A. In one embodiment, after the powder is disposed within the powder chamber of the powder housing 606A, the powder delivery system 620 may be reinserted into the powder housing 606A and secured to the powder housing, such as by using the thread 651.

[0210] Referring to FIG. 21, in one embodiment, when the bellows spring 655 extends the bellows 652 to the extended position, air is drawn in through the first intake port 642 and the one-way valve 643 to fill the interior of the bellows 652. The air flowing through the one-way valve 643 preferably passes through the twisted path 651 (FIG. 22) and generally moves distally through the filter 646 around the gaps 649A, 649B (FIG. 19) between the outer periphery of the powder consolidation prevention wall 601 (FIG. 24) and the inner surface of the powder housing 606A to fill the interior of the bellows 652.

[0211] In one embodiment, when air is drawn into the bellows 652, a vacuum is generated in the powder chamber 645 of the powder housing 606A. The vacuum draws the ball 650 of the one-way valve 648, and the ball seats on the proximal sealing surface 662 of the one-way valve 648 to prevent moisture in the powder delivery channel 660 from reaching the powder chamber 645. The one-way valve 648 also preferably prevents moisture from entering the twisted path 651 or the powder chamber 645, which can clog the powder delivery and liquid delivery composite device 600.

[0212] In one embodiment, when the bellows 652 is compressed in the distal direction DIR1, the filter holder 647 and the filter 646 move distally to push the powder in the powder chamber 645 toward the distal end of the powder housing 606A. The high-pressure air generated by the compressed bellows 652 preferably flows distally through the filter 646 and forces the powder to flow around the gaps 649A, 649B (FIG. 19) surrounding the powder consolidation prevention wall 601. The air and powder flowing distally pass through the twisted path 651, flow around the ball 650 of the one-way valve 648, and flow into the powder delivery channel 660 for delivery from the distal end of the applicator tip 624 of the powder delivery and liquid delivery composite device 600 (FIG. 19).

[0213] When high-pressure air flows in the distal direction (DIR1) through the one-way valve 648, the high-pressure air presses the ball 650 against the ball stop 665 (FIG. 22), thereby enabling air and powder to flow around the ball 650 and enabling the powder to flow into the powder delivery channel 660.

[0214] Referring to FIGS. 21, 22, 23A, and 23B, in one embodiment, the powder delivery system 620 of the powder and liquid delivery composite device 600 preferably includes a powder housing 606A (FIG. 21) having a proximal end and a distal end. The powder delivery system 620 preferably includes a manual air pump, such as a compressible bellows 652, attached to the proximal end of the powder housing 606A. The powder housing preferably has a hand grip portion 605 (FIG. 21) at its proximal end. The powder delivery system 620 preferably includes a filter holder 647 (FIG. 21) positioned within the powder housing 606A and a filter 646 attached to the filter holder 647. The filter holder 647 and the filter 646 are slidably attached within the powder housing 606A and are configured to move together toward the distal end of the powder housing 606A. The distal end of the powder housing 606A preferably has a powder outlet opening 691 (FIGS. 25A-25C). Proximal to the powder outlet opening 691 (FIGS. 21 and 22), a powder consolidation prevention wall 601 (FIGS. 21 and 22) is attached. The twisted path 651 (FIGS. 21 and 22) preferably extends between the distal side of the powder consolidation prevention wall 601 and the powder outlet opening 691.

[0215] In one embodiment, the filter holder 647 preferably has a plunger stem 653 that extends proximally from the filter holder 647 toward the proximal end of the powder housing 606A. The bellows spring 655 is positioned on the plunger stem 653. The bellows spring 655 is preferably disposed between the bellows 652 and the filter holder 647, is partially inside the bellows 652, and more specifically, is between the upper free end of the bellows 652 and the filter holder 647.

[0216] In one embodiment, the filter holder 647 and the filter 646 are movable coaxially and slidably within the powder housing 606A. In one embodiment, the filter holder 647 preferably has one or more apertures 657 (FIGS. 23A and 23B) that extend therethrough and provide a path for air or gas to flow through the filter holder 647.

[0217] In one embodiment, the filter 646 (e.g., a microporous filter) fits snugly and slidably within the powder housing 606A and moves with the filter holder 647. The portion of the powder housing 606A disposed between the filter 646 and the powder outlet opening 691 of the powder housing defines a powder chamber 645, which may be filled with powder (not shown). In one embodiment, the volume of the powder chamber 645 preferably decreases as the filter holder 647 and the filter 646 advance toward the distal end of the powder housing 606A.

[0218] In one embodiment, the powder housing 606 preferably includes a twisted path 651 (FIGS. 21 and 22) for powder and air exiting the powder chamber 645. In one embodiment, the twisted path 651 is a channel that has several bends and starts from an orifice located within the powder chamber 645. The twisted path 651 causes a change in the direction in which air and powder travel within the powder delivery and liquid delivery composite device 600, and in particular, generally, a change from movement in the proximal direction to the distal direction, i.e., from movement from the powder chamber 645 to the powder outlet opening 691 (FIGS. 25A-25C), to a short distance movement in another direction, such as a lateral direction (i.e., perpendicular to the longitudinal axis of the powder housing) or the opposite direction (i.e., rearward from the distal end of the powder housing towards the proximal end). The change in the direction in which air and powder travel through the powder housing 606A, the powder chamber 645, and the twisted path 651 is schematically indicated by arrows (FIG. 22), which shows that air and powder travel from the proximal end to the distal end of the powder housing 606A, with short intermittent changes in direction when traveling through the twisted path 651.

[0219] In one embodiment, the twisted path 651 preferably prevents powder (not shown) within the powder chamber 645 from exiting the powder delivery and liquid delivery composite device 600 via the powder delivery channel 660 in the absence of an air flow (e.g., when the powder delivery and liquid delivery composite device 600 is oriented downward, and in particular, when the powder delivery and liquid delivery composite device is subject to rocking or vibration or any variable acceleration motion, preventing powder loss). The twisted path 651 prevents unintentional extrusion of a small amount of powder from the powder chamber 645 while enabling extrusion of the powder when driven by an air flow.

[0220] Referring to FIGS. 21 and 22, in one embodiment, the flow of air with entrained powder from the powder chamber 645 is schematically shown by the arrows. The bellows 652 is in fluid communication with the outlet opening 691 through one or more openings 657 (FIGS. 23A and 23B) in the filter holder 647, the filter 646, and the twisted path 651. In one embodiment, when the bellows 652 is compressed, air moves from the bellows 652, through one or more openings 657 (FIGS. 23A and 23B) of the filter holder 647, through the filter 646, and into the powder chamber 645. From the powder chamber 645, as schematically shown by the arrows (FIG. 22), the powder and air flow enter the twisted path 651 and then move from the twisted path 651 into the powder outlet opening 691 of the powder housing 606A.

[0221] In one embodiment, when pressure is applied to the free end of the bellows 652, the bellows 652 compresses, thereby creating a positive air pressure within the bellows. Air flows distally through one or more openings 657 (FIGS. 23A and 23B) of the filter holder 647 and through the filter 646 into the powder chamber 645. From the powder chamber 645, the powder and air flow are extruded from the device via the one-way valve 648 and the powder delivery channel 660 (FIG. 22).

[0222] In one embodiment, when the pressure on the bellows 652 is released, the bellows spring 655 returns the bellows to its uncompressed state, creating a vacuum inside the bellows 652. Air or gas is drawn into the bellows 652, and air enters the powder housing 606A via the one-way valve 643 (FIG. 22). Under vacuum, air flows proximally through the twisted path 651, around the powder consolidation prevention wall 601, through the powder chamber 645, through the filter 646, and through one or more openings 657 (FIG. 23A) of the filter holder 657 to fill the interior of the bellows 652. The filter 646 prevents powder from reaching the bellows, such that the bellows 652 remains substantially powder-free throughout the extrusion.

[0223] In one embodiment, the powder chamber 645 is maintained such that the volume of the powder chamber 645 is substantially filled with powder and has no or minimal free air space. The inventors of U.S. Patent No. 10,507,293, the disclosure of which is incorporated herein by reference, have found that such a configuration provides better uniformity of powder extrusion throughout the extrusion cycle, i.e., from when the powder delivery and liquid delivery composite device 600 is completely filled with powder until the powder chamber 645 is completely emptied of all remaining powder, and also provides better directional extrusion uniformity, i.e., minimal difference between the extrusion of powder having an applicator tip directed vertically versus horizontally.

[0224] In one embodiment, the bellows spring 655 functions as a compressible pusher for the filter holder 647 (FIG. 21) and the filter 646. When the bellows 652 is pushed down, the bellows generates a positive air pressure flow for extruding powder from the distal end of the powder delivery and liquid delivery composite device 600. At the same time, the upper or free end of the bellows 652 compresses the bellows spring 655, which in turn applies pressure to the filter holder 647 and the filter 646, thereby moving the filter holder 647 and the filter 646 in the distal direction DIR1 to reduce the volume of the powder chamber 645 as the powder is extruded from the powder delivery and liquid delivery composite device 600.

[0225] In one embodiment, during each depression or compression of the bellows 652 that generates an air flow and powder extrusion from the powder chamber 645, the filter holder 647 and the filter 646 are simultaneously driven towards the distal end of the powder housing 606A by the bellows spring 655 that is depressed when the bellows 652 is compressed.

[0226] Accordingly, upon each extrusion of powder from the powder and liquid delivery composite device 600, the filter holder 647 and the filter 646 advance distally so as to occupy the space within the powder chamber 645 that is released by the extruded powder. As a result of this operation, the volume of the powder chamber 645 is always adjusted to correspond to the volume of the powder remaining within the powder chamber 645.

[0227] In one embodiment, when the bellows 652 is released so that it is no longer compressed, the compression on the spring 655 is released so that the spring freely extends in the proximal direction DIR2 (FIG. 21) without pulling in the filter holder 647 and the attached filter 646. In one embodiment, the spring 655 is not attached to the bellows 652, and as a result, the spring 655 is not pulled proximally when the pressure on the bellows 652 is released and the bellows extends to its uncompressed state of extension.

[0228] In one embodiment, the filter holder 647 and the filter 646 are configured to fit snugly and slidably inside the powder housing 606A. After each cycle, the plunger 653 and the filter 646 remain in the most advanced position during the last cycle of powder extrusion. When the pressure on the bellows 652 is removed and the bellows extends to draw air into the bellows, the filter holder 647 and the filter 646 do not move in the proximal direction DIR2. Instead, they maintain the position closest to the distal end of the powder housing 606A achieved during the previous powder extrusion cycle. The frictional engagement of the filter holder 647 and the filter 646 with the inner surface of the powder housing 606A preferably prevents easy movement of the filter holder 647 and the filter 646 in the rearward direction, i.e., the proximal direction DIR2.

[0229] The depression of bellows 652 results in the simultaneous occurrence of gas pressure within powder delivery and liquid delivery composite device 600 and the pressure on spring 655, which in turn advances filter holder 647 with filter 646 in the distal direction (DIR1) within powder chamber 645 and occupies any space liberated by the powder extruded from powder chamber 645.

[0230] In one embodiment, prior to any extrusion of the powder, spring 655 generates no or very little pressure on the powder within powder chamber 645. Since there is no or very little constant pressure from spring 655 on the powder within powder chamber 645, potential agglomeration and solidification of the powder are prevented.

[0231] In one embodiment, spring 655 is positioned on plunger stem 653. Spring 655 is preferably disposed between the upper or free end of bellows 652 and the proximal side of filter holder 647. In one embodiment, the proximal end of spring 655 contacts the upper or free end of bellows 652. In one embodiment, the proximal end of the spring may be positioned at a distance (e.g., about 0 - 20 mm) from the upper part of bellows 652.

[0232] Figures 21 and 22 show the positions of spring 655, filter holder 647, filter 646, and powder chamber 645 after one or more powder extrusions. When powder is extruded from powder chamber 645, the volume of powder chamber 645 decreases, and filter holder 647 and filter 646 advance distally within powder housing 606A, occupying the free space within powder chamber 645. In one embodiment, the proximal end of spring 655 may be positioned at a distance from the upper or free end of bellows 652, and the distance increases after each powder extrusion.

[0233] Referring to FIG. 26, in one embodiment, when the syringe plunger 676 and the piston 678 of the liquid delivery device are retracted in the proximal direction DIR2, a vacuum is generated in the liquid chamber 675 of the syringe barrel 674. The vacuum in the liquid chamber 675 draws in liquid through the first one-way valve 682. After passing through the first one-way valve 682, the liquid fills the liquid chamber 675 of the syringe barrel 674. In one embodiment, when the syringe plunger 676 is pushed downward in the distal direction DIR1, the piston 678 (FIG. 19) of the liquid delivery system 622 pushes the liquid out from the opening at the distal end of the syringe barrel 674. The liquid flowing in the distal direction DIR1 preferably passes through the second one-way valve 684 to enter the liquid delivery channel 668. The liquid flowing in the distal direction preferably passes through the liquid connector 632 at the applicator tip base 626 (FIG. 19) of the applicator tip 624 and is delivered to the distal end of the powder delivery and liquid delivery composite device 600.

[0234] Referring to FIGS. 27A and 27B, in one embodiment, a powder delivery and liquid delivery composite device 700 for delivering powder and liquid from its distal end preferably has a proximal end 702 and a distal end 704. In one embodiment, the powder delivery and liquid delivery composite device 700 preferably includes a delivery device housing 706 having a handle 725, and a trigger 723 pivotally connected to the housing 706 for operating the liquid delivery system 722.

[0235] In one embodiment, the powder delivery and liquid delivery composite device 700 preferably includes a first vial 714 (e.g., a powder vial, a hemostatic powder vial) configured to be connected to the delivery device housing 706 to supply powder, and a liquid tank 718 configured to be connected to the lower end of the handle 725 to supply liquid.

[0236] In one embodiment, the powder delivery and liquid delivery composite device 700 preferably includes an applicator tip 724 that is coupled to the distal end of the device housing 706 via a connecting tube 734. The applicator tip 724 is preferably adapted to deliver powder and liquid from the distal end 704 of the powder delivery and liquid delivery composite device 700. In one embodiment, the applicator tip 724 preferably includes a dual lumen powder and liquid connector 794 that joins together the powder delivery channel 760 and the liquid delivery channel 768 of the powder delivery and liquid delivery composite device 700. In one embodiment, the applicator tip 724 includes a powder delivery opening 738 for delivering powder from the distal end of the powder delivery and liquid delivery composite device. The applicator tip 724 also preferably includes a liquid spray cup 740 for delivering liquid from the distal end of the powder delivery and liquid delivery composite device.

[0237] In one embodiment, the applicator tip 724 preferably includes a flexible portion 725 that allows the dual lumen powder and liquid connector 794 and / or the distal end of the applicator tip 724 to be angled relative to the proximal portion of the applicator tip that extends along axis A4 (FIG. 27A). In one embodiment, preferably, the powder delivery and liquid delivery composite device 700 includes a powder delivery system 720 configured to draw powder into the device housing 706 and dispense the powder from the distal end 704 of the powder delivery and liquid delivery composite device. In one embodiment, the powder delivery and liquid delivery composite device 700 preferably includes a liquid delivery system 722 adapted to draw liquid from a liquid tank 718 and dispense the liquid from the distal end 704 of the powder delivery and liquid delivery composite device.

[0238] Referring to FIG. 27B, in one embodiment, when the bellows 752 extends in the distal direction designated as DIR1, a dose of powder is drawn from the powder vial 714 into the powder chamber 745 of the powder delivery channel 760. When the bellows 752 is compressed in the proximal direction DIR2, the dose of powder in the powder chamber 745 of the powder delivery channel 760 is moved distally through the powder delivery channel 760 so as to be delivered from the powder delivery opening 738 at the distal end 704 of the applicator tip 724.

[0239] In one embodiment, when the lower end of the trigger 723 of the liquid delivery system 722 moves in the distal direction DIR1, the liquid stored in the liquid tank 718 is drawn into the liquid delivery channel 768 of the device housing 706. When the trigger 723 is compressed in the proximal direction DIR2 toward the handle 725, the liquid in the liquid delivery channel 768 is moved downstream through the applicator tip 724 so as to be sprayed from the liquid spray cup 740 disposed at the distal end 704 of the applicator tip 724.

[0240] Referring to FIG. 28, in one embodiment, the powder delivery and liquid delivery composite device 700 preferably includes a powder delivery system 720 for first drawing powder from the powder compartment 742 of the powder vial 714 into the powder chamber 745 and then dispensing the powder from the distal end of the applicator tip 724 via the powder delivery channel 760. In one embodiment, the device housing 706 includes a powder vial connector 712 adapted to mate with the open end of the powder vial 714 that houses the powder in the powder chamber 742 of the powder vial 714. The powder connector 712 preferably includes a powder inlet port 715 that provides a path between the powder compartment 742 of the powder vial 714 and the powder chamber 745.

[0241] In one embodiment, the powder delivery system 720 of the powder and liquid delivery composite device 700 preferably includes a filter 746 located between the bellows 752 and the powder chamber 745. The filter 746 preferably allows air to pass through, but the filter 746 prevents powder from passing through it and entering the bellows 752 when air enters and exits the bellows 752.

[0242] In one embodiment, the powder vial 714 containing powder in the powder compartment 742 is connected to the powder connector 712 of the delivery device housing 706 such that the powder can be drawn into the powder chamber 745 of the delivery channel 760 through the powder inlet port 715. In one embodiment, when the bellows 752 is extended in the distal direction DIR1, a vacuum is generated by the extending bellows 752 that draws air through the filter 746 to fill the bellows 752. The operation of the powder delivery system 720 preferably creates a vacuum in the powder chamber 745, which draws powder from the powder compartment 742 of the powder vial 714 through the powder inlet port 715 into the powder chamber 745 of the powder delivery channel 760.

[0243] In one embodiment, when the bellows 752 creates a vacuum in the powder delivery channel 760, the ball 750 of the check valve 748 prevents any moist air in the powder delivery channel 760 from being drawn into the portion of the powder delivery channel 760 disposed within the device housing 706, thereby minimizing the possibility that moisture can react with the powder in the powder chamber 745 and the proximal end of the powder delivery channel 760 and clog the device.

[0244] In one embodiment, after the expanding bellows 752 generates a vacuum for drawing powder into the powder chamber 745, the bellows 752 causes the powder in the powder chamber 745 to flow downstream through the powder delivery channel 760, flow around the ball 750 of the one-way valve 748, and flow into the distal portion of the powder delivery channel 760 disposed within the applicator tip 724 of the powder delivery and liquid delivery composite device 700. To generate high-pressure air, it may be compressed in the proximal direction designated as DIR2.

[0245] In one embodiment, the applicator tip 724 preferably includes both a powder delivery channel 760 and a liquid delivery channel 768 (FIG. 28). The liquid delivery channel 768 is preferably maintained spaced apart (e.g., separated) from the powder delivery channel 760 along the length of the applicator tip 724.

[0246] Referring to FIG. 29, in one embodiment, the liquid delivery system 722 draws liquid from the liquid tank 718 into the liquid delivery channel 768 of the powder delivery and liquid delivery composite device and flows the liquid distally through the liquid delivery channel 768 for dispensing from the distal end of the applicator tip of the powder delivery and liquid delivery composite device 700. In one embodiment, the powder delivery and liquid delivery composite device 700 preferably includes a device housing 706 having a handle 725 protruding from its lower end. The powder delivery and liquid delivery composite device 700 preferably includes a liquid tank 718 having a liquid reservoir 773 adapted to store liquid therein. In one embodiment, the liquid tank 718 preferably includes a valve 755 that can be used to fill the liquid chamber 775 with liquid. In one embodiment, the valve 755 may also be used to draw air into the liquid reservoir 773, such as when a vacuum is generated by the trigger 723 of the liquid delivery system 722.

[0247] In one embodiment, the liquid delivery system 722 may include a drain tube 765 that is utilized to draw liquid and / or air into the liquid delivery channel 768 of the powder delivery and liquid delivery composite device 700.

[0248] In one embodiment, the powder delivery and liquid delivery composite device 700 preferably includes a storage device 774 (e.g., a barrel) that defines a liquid chamber 775. The powder delivery and liquid delivery composite device 700 preferably includes a plunger 776 having a proximal end coupled to a trigger 723 and a distal end coupled to a piston 778. The distal end of the plunger 776 and the piston 778 are disposed within the liquid chamber 775 of the barrel 774.

[0249] In one embodiment, the powder delivery and liquid delivery composite device 700 preferably includes a first one-way valve 782 disposed downstream of the distal end of the drain tube 765 and a second one-way valve 784 disposed downstream of the liquid chamber 775 of the barrel 774.

[0250] In one embodiment, the trigger 723 may extend in the distal direction DIR1 to create a vacuum within the liquid chamber 775 to draw liquid from the liquid tank 718 into the liquid chamber 775. A spring 727 (Figs. 27A and 27B) may extend between the trigger 723 and the handle 725 to return the trigger to the extended position shown in Fig. 29. In one embodiment, when the lower end of the trigger 723 is moving in the distal direction designated as DIR1, the syringe plunger 776 and the piston 778 move away from the liquid delivery channel 768 to create a vacuum within the liquid chamber 775. The vacuum draws liquid from the liquid tank 718 into the liquid chamber 775. The liquid drawn from the liquid tank 718 preferably flows through the drain tube 765 and through the first one-way valve 782, such that the liquid flows into and fills the liquid chamber 775 of the barrel 774.

[0251] In one embodiment, after the liquid chamber 775 is at least partially filled with liquid, the trigger 723 may be pulled proximally (DIR2), which moves the liquid from the liquid chamber 775 into the liquid delivery channel 768 of the powder delivery and liquid delivery composite device. When the trigger 723 is squeezed, the spring 727 (Figs. 27A and 27B) is preferably compressed between the trigger 723 and the handle 725. When the trigger 723 is squeezed, the liquid is forced to flow downstream through the second one-way valve 784 and into the downstream portion of the liquid delivery channel 768 for dispensing from the distal end of the applicator tip.

[0252] Referring to Fig. 30, in one embodiment, a composite powder and liquid delivery device 800, which may have a structure similar to and operate in a manner similar to the powder delivery and liquid delivery composite device shown in Figs. 27A - 29 and described above, preferably includes a powder vial assembly 802 that may be connected to the powder delivery and liquid delivery composite device to supply powder to the powder delivery and liquid delivery composite device.

[0253] Referring to Figs. 31A and 31B, in one embodiment, the powder vial assembly 802 preferably includes a powder housing 804, a filter 806, a filter cartridge 808, a fixed guide 810, an actuator assembly 812 having a filter cartridge guide shaft 878, a spring 814 extending between the proximal side of the filter cartridge 808 and the distal side of the actuator 812, and a one-way valve 816.

[0254] In one embodiment, the filter 806 is mounted on the filter cartridge 808, and the sub-assembly of the filter and the filter cartridge is mounted on the filter cartridge guide shaft 878 of the actuator assembly.

[0255] Referring to FIGS. 32A - 32D, in one embodiment, the powder housing 804 preferably has a proximal end 818 surrounding a proximal opening 820 (FIG. 32C) and a distal end 822 having an attachment flange 824 surrounding a powder dispensing opening 826.

[0256] Referring to FIG. 32B, in one embodiment, the connection flange 824 is preferably adapted to be inserted into an opening of a powder delivery and liquid delivery composite device 800 (FIG. 30) to fix the distal end 822 of the powder housing 804 to the powder delivery and liquid delivery composite device. The connection flange 824 surrounds the powder dispensing opening 826 to enable the powder stored in the powder chamber 824 of the powder housing 804 to be directed into the powder delivery and liquid delivery composite device 800 (FIG. 30).

[0257] Referring to FIGS. 32B - 32D, in one embodiment, the powder housing 804 preferably includes a support 828 disposed adjacent to the powder dispensing opening 826 at the distal end 822 of the powder housing 804. The support 828 has a central opening 830 adapted to receive a filter cartridge guide shaft 878 of an actuator assembly 812 (FIG. 31A) as described in more detail herein.

[0258] Referring to FIGS. 32C and 32D, in one embodiment, the powder housing 804 surrounds a powder chamber 832 adapted to be filled with powder that can be dispensed from the powder dispensing opening 826 of the powder vial assembly.

[0259] In one embodiment, the proximal end 818 of the powder housing 804 preferably includes a proximal opening 834 providing access to the powder chamber 832. In one embodiment, the proximal end 818 of the powder housing 804 includes a pair of alignment tabs 836A, 836B adapted to engage corresponding pairs of alignment notches formed on the outer surface of the fixed guide 810 (FIG. 31A) as described in more detail herein.

[0260] Referring to FIGS. 33A and 33B, in one embodiment, the filter carriage 808 is adapted to support the filter 806 (FIG. 31A). The filter carriage 808 preferably includes a filter support base 838 that engages the main surface of the filter, and a central hub 840 that preferably passes through a central opening of the filter to secure the filter on the filter carriage 808. The central hub 840 preferably surrounds a central opening 842 that extends through the center of the filter carriage 808 to enable the filter carriage to be mounted on the filter carriage guide shaft 878 of the actuator assembly 812 (FIG. 31A).

[0261] In one embodiment, the filter carriage 808 preferably includes a spring hub 844 that projects proximally from the filter support base 838 and is adapted to engage the distal end of the compression spring 814 (FIG. 31A). The central opening 842 that extends through the filter carriage 808 also passes through the filter support base 838 and the spring hub 844 to enable the filter carriage 808 to be mounted on the filter carriage guide shaft 878 (FIG. 31A) of the actuator assembly 812.

[0262] In one embodiment, the filter carriage 808 preferably includes a pair of hooks 846A, 846B that are used to lock and unlock the filter carriage 808 to the fixed guide 810 (FIG. 31A) as described in more detail herein.

[0263] Referring to FIGS. 34A and 34B, in one embodiment, the fixed guide 810 preferably has a proximal end 848, a distal end 850, and a central opening 852 that extends from the proximal end 848 to the distal end 850.

[0264] In one embodiment, the proximal end portion 848 of the fixed induction portion 810 preferably includes an annular flange 854 adapted to abut against the proximal end portion 818 of the powder housing 804 (FIG. 32D) in order to fix the fixed induction portion 810 to the proximal end of the powder housing. In one embodiment, the fixed induction portion 810 preferably includes an annular band 854 adapted to engage the inner surface of the proximal end portion of the powder housing in order to form an airtight fit between the fixed induction portion 810 and the proximal opening at the proximal end of the powder housing 804 (FIG. 32D). The annular band 854 preferably forms an airtight fit with the proximal end portion of the powder housing and prevents the fixed induction portion 810 from moving axially relative to the longitudinal axis of the powder housing.

[0265] In one embodiment, the fixed induction portion 810 preferably includes a pair of alignment notches 856A, 856B that extend through the band 854. The pair of alignment notches 856A, 856B preferably engage respective alignment tabs 836A, 836B at the proximal end portion 818 (FIGS. 32C and 32D) of the powder housing 804 to prevent the fixed induction portion 810 from rotating relative to the powder housing.

[0266] Thus, in one embodiment, when the fixed induction portion 810 is assembled with the proximal end portion of the powder housing, the fixed induction portion remains stationary relative to the powder housing and does not rotate axially any further relative to the powder housing.

[0267] In one embodiment, the distal end portion 850 of the fixed guide portion 810 preferably includes a stepped portion 858, also referred to as a stop portion, which is used to initially lock the filter carriage 808 (Figs. 33A and 33B) to the fixed guide portion 810. In one embodiment, the fixed guide portion 810 preferably includes a pair of release slots 860A, 860B formed in the stepped portion 858 to allow the hooks 846A, 846B of the filter carriage 808 to be released from the fixed guide portion 810. In one embodiment, the hooks 846A, 846B (Fig. 33B) of the filter carriage first engage the stepped portion 858 of the fixed guide portion 810 to prevent the filter carriage and the filter from moving axially towards the distal end of the powder housing. In one embodiment, the hooks may be rotated relative to the fixed guide portion 810 such that the hooks are aligned with the release slots 860A, 860B of the fixed guide portion, and as a result, the filter carriage and the filter are free to move axially relative to the fixed guide portion 810.

[0268] In one embodiment, when the hooks of the filter carriage are aligned with the release slots 860A, 860B of the fixed guide portion 810, the compression spring 814 (Fig. 31A) will bias the filter / filter carriage subassembly and slide it distally along the filter carriage guide shaft 878 (Fig. 31A).

[0269] Referring to FIGS. 35A and 35B, in one embodiment, the actuator assembly 812 of the powder vial assembly 802 (FIG. 30) preferably includes a rotatable operating knob 862 having a proximal surface 864 and a distal surface 886 adapted to abut the proximal end 848 of the fixed guide portion 810. The actuator assembly 812 preferably includes an intake opening 868 that passes through the rotatable operating knob 862. The intake opening 868 is adapted to receive a one-way valve 816 (FIG. 31A) to allow air to be drawn into the powder vial assembly. The intake opening 868 preferably communicates with air channels 870A, 870B located downstream from the distal surface 866 of the rotatable operating knob 862. The air channels 870A, 870B preferably direct air passing through the intake opening 868 into the interior region of the powder vial assembly.

[0270] In one embodiment, the actuator assembly 812 preferably includes a sealing band 872 adapted to engage the inner surface of the fixed guide portion 810 at the proximal end 848 of the fixed guide portion to form an airtight fit between the actuator assembly 812 and the proximal end of the fixed guide portion 810. The actuator assembly 812 may be rotated relative to the fixed guide portion while maintaining an airtight seal between the actuator assembly and the fixed guide portion.

[0271] In one embodiment, the actuator assembly 812 preferably includes a pair of actuating legs 874A, 874B that project distally beyond the distal surface 866 of the rotatable operating knob 862. In one embodiment, the distal ends of the actuating legs 874A, 874B each have actuating leg hooks 876A, 876B adapted to engage the distal end 850 (FIG. 34B) of the fixed guide portion 810 to fix the actuator assembly 812 to the fixed guide portion 810.

[0272] In one embodiment, when the rotatable operation knob 862 is rotated, the operation legs 874A, 874B rotate simultaneously with the rotatable operation knob.

[0273] In one embodiment, the actuator assembly 812 preferably includes a filter cartridge guide shaft 878 that projects distally beyond the distal ends of the operation legs 874A, 874B. In one embodiment, the subassembly of the filter 806 and the filter cartridge 808 (FIG. 31B) may be mounted on the filter cartridge guide shaft 878 of the actuator assembly 812. The filter / filter cartridge subassembly is adapted to slide along the length of the filter cartridge guide shaft 878.

[0274] In one embodiment, the distal end 880 of the filter cartridge guide shaft 878 preferably includes a compressible structure 882 that can be compressed to install the filter / filter cartridge subassembly on the filter cartridge guide shaft 878. In one embodiment, the filter cartridge guide shaft 878 preferably includes an annular stop 884 disposed adjacent to the distal end of the guide shaft to hold the filter / filter cartridge subassembly on the guide shaft and prevent the filter / filter cartridge subassembly from slipping off the distal end 880 of the filter cartridge guide shaft 878.

[0275] In one embodiment, a pair of intake channels 870A, 870B are disposed adjacent to the proximal end 886 of the filter cartridge guide shaft 878. In one embodiment, the pair of intake channels 870A, 870B direct the air entering the powder housing 804 (FIG. 31A) to flow around the outer surface of the filter cartridge guide shaft 878 of the actuator assembly.

[0276] Referring to FIGS. 31A - 35B, in one embodiment, when the rotatable actuation knob 862 of the actuator assembly 812 is rotated, the actuating legs 874A, 874B rotate simultaneously with the rotatable actuation knob 862. In one embodiment, when the actuating legs 874A, 874B rotate about the longitudinal axis of the filter carriage guide shaft 878, the actuating legs engage the hooks 846A, 846B (FIGS. 33A and 33B) of the filter carriage 808 to rotate the filter carriage about the longitudinal axis of the filter carriage guide shaft 878. In one embodiment, when the hooks 846A, 846B of the filter carriage rotate about the longitudinal axis of the filter carriage guide shaft 878, the hooks 846A, 846B rotate to align with release notches 860A, 860B disposed at the distal end 850 of the fixed guide 810 to release the filter carriage 808 from engagement with the fixed guide 810 (FIGS. 34A and 34B). Upon release of the filter carriage 808, the spring 814 (FIG. 31B) under compression pushes the filter carriage 808 and the filter 806 and moves them towards the distal end 880 of the filter carriage guide shaft 878.

[0277] Referring to FIG. 36A, in one embodiment, the powder vial assembly 802 preferably includes a powder housing 804 that houses a powder chamber 832. The powder housing 804 preferably has a proximal end 818, a distal end 822, and a connection flange 824 utilized to secure the distal end 822 of the powder housing 804 to the powder delivery and liquid delivery composite device 800 (FIG. 30). The powder vial assembly 802 preferably includes a powder dispensing opening 826 disposed at the distal end 822 of the powder housing 804.

[0278] The powder vial assembly 802 preferably includes an actuator assembly 812 fixed to a fixed guide portion 810 adjacent to the proximal end 818 of the powder housing 804. The actuator assembly 812 preferably includes a filter cartridge guide shaft 878 that supports a sub-assembly of the filter 806 and the filter cartridge 808 and is adapted to slide on the filter cartridge guide shaft 878.

[0279] In one embodiment, the one-way valve 816 is disposed within an intake opening 868 (FIG. 35B) that extends through the rotatable operating knob 862 of the actuator assembly 812. In one embodiment, the hook 846 of the filter cartridge 808 engages a stepped portion 858 (FIG. 34B) of the fixed guide portion 810 to prevent the filter cartridge 808 and the filter 806 from sliding distally in the distal direction DIR1 toward the distal end 822 of the powder housing 804.

[0280] Referring to FIG. 36B, in one embodiment, the hook 876 of the actuator assembly 812 couples the actuator assembly 812 to the fixed guide portion 810. The first O-ring seal 885 preferably forms an airtight seal between the actuator assembly 812 and the fixed guide portion 810. The second O-ring seal 887 preferably forms an airtight seal between the outer surface of the fixed guide portion 810 and the inner surface of the powder housing 804 of the powder vial assembly 802.

[0281] In one embodiment, the rotatable actuation knob 862 of the actuator assembly 812 may be rotated to rotate the actuation legs 874A, 874B (FIG. 35A), which then aligns the hooks 846A, 846B of the filter cartridge 808 with the release slots 860A, 860B (FIGS. 34A and 34B) of the stepped portion 858 of the fixed guide 810 and engages the hooks 846A, 846B to release the filter cartridge 808 from the fixed guide 810. At this stage, the sub-assembly of the filter 806 and the filter cartridge 808 is free to slide distally in the distal direction DIR1 on the filter cartridge guide shaft 878.

[0282] Referring to FIGS. 36B and 36C, in one embodiment, when the hooks 846A, 846B of the filter cartridge 808 are released from the stepped portion 858 of the fixed guide 810, the compression spring 814 releases energy and pushes the filter cartridge 808 and the filter 806 in the distal direction DIR1. At this stage, the filter / filter cartridge sub-assembly slides distally on the filter cartridge guide shaft 878 to push a dose of powder out of the powder chamber 832. A dose of powder preferably passes through the powder dispensing opening 826 located at the distal end 822 of the powder housing 804 of the powder vial assembly.

[0283] In one embodiment, ambient air may be drawn through the one-way valve 816 so as to be directed through the pair of air channels 870A, 870B. In one embodiment, the incoming air preferably flows distally around the outer surface of the filter cartridge guide shaft 878. The air provides a positive pressure for flowing the powder in the powder chamber 832 towards the powder dispensing opening 826 disposed at the distal end 822 of the powder housing 804.

[0284] Spring 814 applies a continuous force to the filter support plate 838 of the filter cartridge 808. When the filter cartridge 808 guiding portion is released from the fixed guiding portion 810, as each dose of powder is dispensed from the powder chamber 832, voids are formed in the powder chamber, and as a result, the compression spring 814 moves the filter cartridge 808 distally (e.g., slides distally in the direction DIR1 on the filter cartridge guiding shaft) to close any excess space created by removing a dose of powder from the powder chamber 832, applying a force to the filter cartridge.

[0285] In one embodiment, when a dose of powder is withdrawn from the powder dispensing opening 826 disposed at the distal end 822 of the powder housing 804, the spring 814 pushes the filter cartridge 808 and the filter 806 toward the distal end 822 of the powder housing 804 to fill the extra space created when pushing out a dose of powder. The action of the compression spring 814 continues when each dose of powder is dispensed from the powder housing 804.

[0286] The powder vial assembly 802 disclosed herein provides a number of advantages over the prior art, including, but not limited to, the ability to store powder separately from a powder delivery and liquid delivery composite device to maintain the powder in an optimal state and / or condition.

[0287] In one embodiment, the powder vial assembly is specially designed to assist in the supply of powder into the powder delivery channel. In one embodiment, the powder vial assembly may comprise a spring / filter assembly configured to push the powder into the powder dispensing opening of the powder housing. In one embodiment, the powder vial assembly may comprise an air valve at the proximal end of the powder vial assembly that allows air to enter the powder vial assembly when a dose of powder is aspirated into the powder delivery channel.

[0288] The foregoing description relates to embodiments of the present invention, but other embodiments and further embodiments of the present invention may be devised without departing from the basic scope of the present invention, and the scope of the present invention is limited only by the appended claims. For example, in the present invention, 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 may still be included within the scope of the present invention.

[0289] 〔Embodiment〕 (1) A powder delivery and liquid delivery composite device, comprising: A delivery device housing having a powder chamber and a liquid chamber, wherein the powder chamber and the liquid chamber are separated from each other; An applicator tip having a powder delivery channel extending between a proximal end and a distal end of the applicator tip, the powder delivery channel being in fluid communication with the powder chamber; An applicator tip having a liquid delivery channel extending from the proximal end to the distal end of the applicator tip, the liquid delivery channel being in fluid communication with the liquid chamber; A powder inlet port in fluid communication with the powder chamber; A liquid inlet port in fluid communication with the liquid chamber; A powder delivery system in fluid communication with the powder inlet port, the powder chamber, and the powder delivery channel; A liquid delivery system in fluid communication with the liquid inlet port, the liquid chamber, and the liquid delivery channel. (2) A powder vial connector fixed to the delivery device housing, wherein the powder vial includes the powder inlet port; A liquid vial connector fixed to the delivery device housing, the liquid vial further comprising a liquid vial connector including the liquid inlet port, the powder delivery and liquid delivery composite device according to Embodiment 1. (3) A powder vial connected to the powder vial connector, the powder vial having an opening in fluid communication with the powder inlet port. A liquid vial connected to the liquid vial connector, the liquid vial having an opening in fluid communication with the liquid inlet port, the powder delivery and liquid delivery composite device according to Embodiment 2. (4) Powder disposed within the powder vial. A liquid disposed within the liquid vial, the powder delivery and liquid delivery composite device according to Embodiment 3. (5) The powder includes a hemostatic powder, and the liquid includes an activating liquid that activates the hemostatic powder to form a sealing gel, the powder delivery and liquid delivery composite device according to Embodiment 4.

[0290] (6) The powder delivery system is movable between a depressed configuration and an extended configuration, and when moving from the depressed configuration to the extended configuration, the powder delivery system generates a vacuum in the powder chamber to draw a dose of powder from the powder vial into the powder chamber, and when moving from the extended configuration to the depressed configuration, the powder delivery system generates a positive pressure in the powder chamber to extrude the dose of powder from the powder chamber and cause the powder to flow into the powder delivery channel, the powder delivery and liquid delivery composite system according to Embodiment 4. (7) The liquid delivery system is movable between a depressed configuration and an extended configuration, and when moving from the depressed configuration to the extended configuration, the liquid delivery system generates a vacuum in the liquid chamber to draw a dose of liquid from the liquid vial into the liquid chamber, and when moving from the extended configuration to the depressed configuration, the liquid delivery system generates a positive pressure in the liquid chamber to extrude the dose of liquid from the liquid chamber and cause the liquid to flow into the liquid delivery channel. The powder delivery and liquid delivery composite system according to embodiment 4. (8) Further comprising a double-lumen powder and liquid connector fixed to the distal end of the applicator tip, the double-lumen powder and liquid connector having a powder outlet opening in fluid communication with the powder delivery channel and a liquid spray opening in fluid communication with the liquid delivery channel. The powder delivery and liquid delivery composite system according to embodiment 1. (9) The powder outlet opening and the liquid spray opening are arranged offset from each other, and the liquid spray opening is arranged downstream of the powder outlet opening to prevent moisture in the liquid delivery channel from entering the powder delivery channel. The powder delivery and liquid delivery composite system according to embodiment 8. (10) Further comprising a one-way valve arranged downstream of the powder chamber and in fluid communication with the powder delivery system. The powder delivery and liquid delivery composite system according to embodiment 1.

[0291] (11) The one-way valve is arranged in the powder delivery channel and between the powder chamber and the proximal end of the applicator tip. The powder delivery and liquid delivery composite system according to embodiment 10. (12) The powder delivery system of embodiment 6 further comprises a first air inlet in fluid communication with the powder chamber, and a one-way valve disposed at the first air inlet that allows ambient air to be drawn into the powder chamber when the powder delivery system moves from the depressed configuration to the extended configuration. (13) The liquid delivery system of embodiment 7 further comprises a second air inlet in fluid communication with the liquid chamber, and a one-way valve disposed at the second air inlet that allows ambient air to be drawn into the liquid chamber when the liquid delivery system moves from the depressed configuration to the extended configuration. (14) The liquid delivery system of embodiment 13 further comprises a first one-way valve disposed within the liquid inlet port that allows the liquid to be drawn from the liquid vial into the liquid chamber of the delivery device housing, and a second one-way valve disposed within the liquid delivery channel and downstream of the first one-way valve disposed within the liquid inlet port that allows the liquid within the liquid chamber to flow downstream into the liquid delivery channel. (15) The powder delivery system of embodiment 6 comprises a bellows assembly having threads for releasably securing the bellows assembly to the proximal end of the delivery device housing, and the bellows assembly is configured to be unscrewed from the delivery device housing to allow powder to be loaded into the powder chamber.

[0292] (16) The proximal end of the delivery device housing has an access opening for providing access to the powder chamber, and the access opening has a female thread configured to engage with the thread of the bellows assembly to fix the bellows assembly to the proximal end of the delivery device housing. The powder delivery and liquid delivery composite device according to embodiment 15. (17) The powder chamber surrounded by a tubular wall having a closed distal end, the closed distal end having a distal outlet opening formed therein for providing fluid communication between the powder chamber and the powder delivery channel. The powder chamber, A consolidation prevention wall disposed within the powder chamber and spaced from the closed distal end of the tubular wall, the consolidation prevention wall being disposed between the closed distal end of the tubular wall and the proximal end of the powder chamber, and the consolidation prevention wall having an outer periphery spaced from the inner surface of the tubular wall surrounding the powder chamber. The powder delivery and liquid delivery composite device according to embodiment 16, further comprising a consolidation prevention wall. (18) The bellows assembly is An end cap disposed within the access opening of the delivery device housing, A bellows protruding from the proximal surface of the end cap, An elongated shaft protruding from the distal surface of the end cap, the distal end of the elongated shaft being disposed within the powder chamber and facing the proximal surface of the consolidation prevention wall. The elongated shaft, A filter holder attached to the elongated shaft between the end cap and the distal end of the elongated shaft, A filter attached to the filter holder between the filter holder and the distal end of the elongated shaft, A compression spring extending between the bellows and the filter holder, the compression spring having a proximal end disposed within the bellows and a distal end disposed adjacent to a proximal surface of the filter holder, the powder delivery and liquid delivery composite system according to embodiment 17. (19) When the bellows is pushed downward toward the distal end of the powder chamber, the compression spring is compressed, whereby the distal end of the compression spring biases the filter holder and the filter toward the anti-consolidation wall. The powder delivery and liquid delivery composite system according to embodiment 18. (20) The filter holder and the filter are configured to move simultaneously within the powder chamber. The filter holder and the filter each have an outer diameter, and the respective outer diameters are configured to form an airtight seal between the respective outer diameters of the filter holder and the filter and the inner surface of the tubular wall surrounding the powder chamber. The powder delivery and liquid delivery composite device according to embodiment 19.

[0293] (21) A powder delivery and liquid delivery composite device, A delivery device housing having a powder chamber and a liquid chamber, the powder chamber and the liquid chamber being separated from each other, the delivery device housing, An applicator tip having a powder delivery channel extending between a proximal end and a distal end of the applicator tip, the powder delivery channel being in fluid communication with the powder chamber, An applicator tip having a liquid delivery channel extending from the proximal end to the distal end of the applicator tip, the liquid delivery channel being in fluid communication with the liquid chamber, A powder inlet port in fluid communication with the powder chamber, A liquid inlet port in fluid communication with the liquid chamber, A powder delivery system in fluid communication with the powder inlet port, the powder chamber, and the powder delivery channel, A liquid delivery system in fluid communication with the liquid inlet port, the liquid chamber, and the liquid delivery channel, the liquid delivery system being movable between a depressed configuration and an extended configuration, and when moving from the depressed configuration to the extended configuration, the liquid delivery system generating a vacuum in the liquid chamber to draw a dose of liquid into the liquid chamber, and when moving from the extended configuration to the depressed configuration, the liquid delivery system generating a positive pressure in the liquid chamber to extrude the dose of liquid from the liquid chamber and flow the liquid into the liquid delivery channel, a liquid delivery system, a powder delivery and liquid delivery composite device comprising. (22) A powder vial assembly, A powder housing, including a proximal end, a distal end, an outer wall extending between the proximal end and the distal end, a proximal opening disposed at the proximal end of the powder housing, and a powder dispensing opening disposed at the distal end of the powder housing, a powder housing, A fixed guide disposed within the powder housing and fixed to the inner surface of the outer wall adjacent to the proximal end of the powder housing, An actuator assembly disposed within the fixed guide, the actuator assembly including a knob accessible at the proximal end of the powder housing and a guide shaft extending distally between the knob and the distal end of the powder housing, an actuator assembly, An air inlet extending through the actuator assembly and in fluid communication with the powder dispensing opening, A one-way valve disposed within the air inlet, A filter cartridge mounted on the guide shaft of the actuator assembly and configured to slide on the guide shaft toward the distal end of the powder housing, A filter mounted on the filter carriage between the filter carriage and the distal end of the powder housing, configured to slide simultaneously with the filter carriage toward the distal end of the powder housing; A compression spring mounted on the guide shaft of the actuator assembly, the compression spring having a proximal end in contact with the actuator assembly and a distal end in contact with the filter carriage and biasing the filter carriage and the filter toward the distal end of the powder housing; a powder vial assembly comprising the compression spring. (23) The actuator assembly is movable between a locked position in which the filter carriage is connected to the fixed guide portion to prevent the filter carriage from moving toward the distal end of the powder housing, and an unlocked position in which the filter carriage is disconnected from the fixed guide portion to allow the compression spring to slide the filter carriage and the filter on the guide shaft toward the distal end of the powder housing. The powder vial assembly according to embodiment 22. (24) The fixed guide portion including a stop portion; The filter carriage including one or more hooks that contact the stop portion of the fixed guide portion when the actuator assembly is in the locked position, the one or more hooks of the filter carriage being disconnected from the stop portion of the fixed guide portion when the actuator assembly is in the unlocked position. The powder vial assembly according to embodiment 23, further comprising the filter carriage. (25) A powder chamber disposed within the powder housing between the filter and the powder dispensing opening; A guide shaft support disposed within the powder housing adjacent to the powder dispensing opening to support the distal end of the guide shaft. The powder vial assembly according to embodiment 23, further comprising the guide shaft support.

[0294] (26) A powder delivery and liquid delivery composite device, a delivery device housing having a powder chamber and a liquid chamber, wherein the powder chamber and the liquid chamber are separated from each other, the delivery device housing, an applicator tip having a powder delivery channel extending between a proximal end and a distal end of the applicator tip, which is in fluid communication with the powder chamber, the applicator tip having a liquid delivery channel extending from the proximal end to the distal end of the applicator tip, which is in fluid communication with the liquid chamber, a powder inlet port in fluid communication with the powder chamber, a powder vial assembly connected to the powder inlet port and in fluid communication with the powder chamber and the powder delivery channel, a liquid inlet port in fluid communication with the liquid chamber, a liquid delivery system in fluid communication with the liquid inlet port, the liquid chamber, and the liquid delivery channel, a powder delivery and liquid delivery composite device comprising. (27) The powder vial assembly, a powder housing including a proximal end, a distal end, an outer wall extending between the proximal end and the distal end, a proximal opening disposed at the proximal end of the powder housing, and a powder dispensing opening disposed at the distal end of the powder housing, the powder housing, a fixed guide portion disposed within the powder housing and fixed to an inner surface of the outer wall adjacent to the proximal end of the powder housing, an actuator assembly disposed within the fixed guide portion, the actuator assembly including a knob accessible at the proximal end of the powder housing and a guide shaft extending distally between the knob and the distal end of the powder housing, the actuator assembly, an air inlet extending through the actuator assembly and in fluid communication with the powder dispensing opening, A one-way valve disposed within the intake port, and A filter cartridge mounted on the guide shaft of the actuator assembly and configured to slide on the guide shaft toward the distal end of the powder housing; A filter mounted on the filter cartridge between the filter cartridge and the distal end of the powder housing and configured to slide simultaneously with the filter cartridge toward the distal end of the powder housing; A compression spring mounted on the guide shaft of the actuator assembly, the compression spring having a proximal end in contact with the actuator assembly and a distal end in contact with the filter cartridge and biasing the filter cartridge and the filter toward the distal end of the powder housing. The powder delivery and liquid delivery composite device according to Embodiment 26, comprising a compression spring. (28) The powder vial assembly, A powder chamber disposed within the powder housing between the filter and the powder dispensing opening; The powder delivery and liquid delivery composite device according to Embodiment 27, further comprising powder disposed within the powder chamber.

Claims

1. A powder delivery and liquid delivery composite device, A delivery device housing having a powder chamber and a liquid chamber, wherein the powder chamber and the liquid chamber are separated from each other, and the delivery device housing, An applicator tip having a powder delivery channel extending between a proximal end and a distal end of the applicator tip, which is in fluid communication with the powder chamber, An applicator tip having a liquid delivery channel extending from the proximal end to the distal end of the applicator tip, which is in fluid communication with the liquid chamber, A powder inlet port, which is in fluid communication with the powder chamber, A liquid inlet port, which is in fluid communication with the liquid chamber, A powder delivery system, which is in fluid communication with the powder inlet port, the powder chamber, and the powder delivery channel, A liquid delivery system, which is in fluid communication with the liquid inlet port, the liquid chamber, and the liquid delivery channel, A one-way valve disposed downstream of the powder chamber and in fluid communication with the powder delivery system. A powder delivery and liquid delivery composite device comprising.

2. A powder vial connector fixed to the delivery device housing, wherein the powder vial connector includes the powder inlet port, and the powder vial connector, A liquid vial connector fixed to the delivery device housing, wherein the liquid vial connector includes the liquid inlet port, and the liquid vial connector. The powder delivery and liquid delivery composite device according to claim 1, further comprising.

3. A powder vial connected to the powder vial connector, the powder vial having an opening in fluid communication with the powder inlet port, A liquid vial connected to the liquid vial connector, the liquid vial having an opening in fluid communication with the liquid inlet port, and further comprising: the powder delivery and liquid delivery composite device according to claim 2.

4. The powder disposed in the powder vial, The liquid disposed in the liquid vial, and further comprising: the powder delivery and liquid delivery composite device according to claim 3.

5. The powder contains a hemostatic powder, and the liquid contains an activating liquid that activates the hemostatic powder to form a sealing gel. The powder delivery and liquid delivery composite device according to claim 4.

6. The powder delivery system is movable between a depressed configuration and an extended configuration, and when moving from the depressed configuration to the extended configuration, the powder delivery system generates a vacuum in the powder chamber to draw a dose of powder from the powder vial into the powder chamber, and when moving from the extended configuration to the depressed configuration, the powder delivery system generates a positive pressure in the powder chamber to extrude the dose of powder from the powder chamber and cause the powder to flow into the powder delivery channel. The powder delivery and liquid delivery composite system according to claim 4.

7. The liquid delivery system is movable between a depressed configuration and an extended configuration, and when moving from the depressed configuration to the extended configuration, the liquid delivery system generates a vacuum in the liquid chamber to draw a dose of liquid from the liquid vial into the liquid chamber, and when moving from the extended configuration to the depressed configuration, the liquid delivery system generates a positive pressure in the liquid chamber to extrude the dose of liquid from the liquid chamber and cause the liquid to flow into the liquid delivery channel. The powder delivery and liquid delivery composite system according to claim 4.

8. Further comprising a double lumen powder and liquid connector fixed to the distal end of the applicator tip, the double lumen powder and liquid connector having a powder outlet opening in fluid communication with the powder delivery channel and a liquid spray opening in fluid communication with the liquid delivery channel. The powder delivery and liquid delivery composite system according to claim 1.

9. The powder outlet opening and the liquid spray opening are arranged offset from each other, and the liquid spray opening is arranged downstream of the powder outlet opening to prevent moisture in the liquid delivery channel from entering the powder delivery channel. The powder delivery and liquid delivery composite system according to claim 8.

10. The one-way valve is arranged in the powder delivery channel and is arranged between the powder chamber and the proximal end of the applicator tip. The powder delivery and liquid delivery composite system according to claim 1.

11. A powder delivery and liquid delivery composite device, A delivery device housing having a powder chamber and a liquid chamber, the powder chamber and the liquid chamber being separated from each other, and the delivery device housing, An applicator tip having a powder delivery channel extending between the proximal end and the distal end of the applicator tip in fluid communication with the powder chamber, An applicator tip having a liquid delivery channel extending from the proximal end to the distal end of the applicator tip in fluid communication with the liquid chamber, A powder inlet port in fluid communication with the powder chamber, A liquid inlet port in fluid communication with the liquid chamber, A powder delivery system in fluid communication with the powder inlet port, the powder chamber, and the powder delivery channel, A liquid delivery system in fluid communication with the liquid inlet port, the liquid chamber, and the liquid delivery channel, A powder vial connector fixed to the delivery device housing, the powder vial connector including a powder vial connector including the powder inlet port, and A liquid vial connector fixed to the delivery device housing, the liquid vial connector including a liquid vial connector including the liquid inlet port, and A powder vial connected to the powder vial connector, the powder vial having an opening in fluid communication with the powder inlet port, and A liquid vial connected to the liquid vial connector, the liquid vial having an opening in fluid communication with the liquid inlet port, and Powder disposed within the powder vial, and Liquid disposed within the liquid vial, comprising, The powder delivery system is movable between a depressed configuration and an extended configuration, and when moving from the depressed configuration to the extended configuration, the powder delivery system generates a vacuum in the powder chamber to draw a dose of powder from the powder vial into the powder chamber, and when moving from the extended configuration to the depressed configuration, the powder delivery system generates a positive pressure in the powder chamber to extrude the dose of powder from the powder chamber and cause the powder to flow into the powder delivery channel, The powder delivery system is A first air inlet in fluid communication with the powder chamber, and A one-way valve disposed at the first air inlet that allows ambient air to be drawn into the powder chamber when the powder delivery system moves from the depressed configuration to the extended configuration, A powder delivery and liquid delivery composite system further comprising. A powder delivery and liquid delivery composite device according to claim 12, A delivery device housing having a powder chamber and a liquid chamber, wherein the powder chamber and the liquid chamber are separated from each other, and the delivery device housing, An applicator tip having a powder delivery channel extending between a proximal end and a distal end of the applicator tip, the powder delivery channel being in fluid communication with the powder chamber, An applicator tip having a liquid delivery channel extending from the proximal end to the distal end of the applicator tip, the liquid delivery channel being in fluid communication with the liquid chamber, A powder inlet port in fluid communication with the powder chamber, A liquid inlet port in fluid communication with the liquid chamber, A powder delivery system in fluid communication with the powder inlet port, the powder chamber, and the powder delivery channel, A liquid delivery system in fluid communication with the liquid inlet port, the liquid chamber, and the liquid delivery channel, A powder vial connector fixed to the delivery device housing, the powder vial connector including the powder inlet port, A liquid vial connector fixed to the delivery device housing, the liquid vial connector including the liquid inlet port, A powder vial connected to the powder vial connector, the powder vial having an opening in fluid communication with the powder inlet port, A liquid vial connected to the liquid vial connector, the liquid vial having an opening in fluid communication with the liquid inlet port, Powder disposed within the powder vial, Liquid disposed within the liquid vial, and comprising, The liquid delivery system is movable between a depressed configuration and an extended configuration, and when moving from the depressed configuration to the extended configuration, the liquid delivery system generates a vacuum in the liquid chamber to draw a dose of liquid from the liquid vial into the liquid chamber, and when moving from the extended configuration to the depressed configuration, the liquid delivery system generates a positive pressure in the liquid chamber to push the dose of liquid out of the liquid chamber and into the liquid delivery channel. The liquid delivery system is a second air inlet in fluid communication with the liquid chamber, a one-way valve disposed at the second air inlet that allows ambient air to be drawn into the liquid chamber when the liquid delivery system moves from the depressed configuration to the extended configuration, A powder delivery and liquid delivery composite system further comprising.

13. The liquid delivery system is a first one-way valve disposed within the liquid inlet port that allows the liquid to be drawn from the liquid vial into the liquid chamber of the delivery device housing, a second one-way valve disposed within the liquid delivery channel and downstream of the first one-way valve disposed within the liquid inlet port that allows the liquid within the liquid chamber to flow downstream into the liquid delivery channel, The powder delivery and liquid delivery composite system according to claim 12, further comprising.

14. A powder delivery and liquid delivery composite device, a delivery device housing having a powder chamber and a liquid chamber, the powder chamber and the liquid chamber being separated from each other, an applicator tip having a powder delivery channel extending between a proximal end and a distal end of the applicator tip in fluid communication with the powder chamber. An applicator tip having a liquid delivery channel extending from the proximal end to the distal end of the applicator tip and in fluid communication with the liquid chamber, A powder inlet port in fluid communication with the powder chamber, A liquid inlet port in fluid communication with the liquid chamber, A powder delivery system in fluid communication with the powder inlet port, the powder chamber, and the powder delivery channel, A liquid delivery system in fluid communication with the liquid inlet port, the liquid chamber, and the liquid delivery channel, A powder vial connector fixed to the delivery device housing, the powder vial connector including the powder inlet port, A liquid vial connector fixed to the delivery device housing, the liquid vial connector including the liquid inlet port, A powder vial connected to the powder vial connector and having an opening in fluid communication with the powder inlet port, A liquid vial connected to the liquid vial connector and having an opening in fluid communication with the liquid inlet port, Powder disposed within the powder vial, Liquid disposed within the liquid vial, and The powder delivery system is movable between a depressed configuration and an extended configuration, and when moving from the depressed configuration to the extended configuration, the powder delivery system creates a vacuum in the powder chamber to draw a dose of powder from the powder vial into the powder chamber, and when moving from the extended configuration to the depressed configuration, the powder delivery system creates a positive pressure in the powder chamber to extrude the dose of powder from the powder chamber and allow the powder to flow into the powder delivery channel. The powder delivery system includes a bellows assembly having threads for releasably securing the bellows assembly to the proximal end of the delivery device housing, and the bellows assembly is configured to be unscrewed from the delivery device housing to allow powder to be loaded into the powder chamber. A powder delivery and liquid delivery composite device.

15. The proximal end of the delivery device housing has an access opening for providing access to the powder chamber, and the access opening is configured to engage the threads of the bellows assembly to secure the bellows assembly to the proximal end of the delivery device housing. The powder delivery and liquid delivery composite device according to claim 14, having female threads.

16. The powder chamber surrounded by a tubular wall having a closed distal end, the closed distal end having a distal outlet opening formed therein for providing fluid communication between the powder chamber and the powder delivery channel. The powder chamber, and A consolidation prevention wall disposed within the powder chamber and spaced from the closed distal end of the tubular wall, the consolidation prevention wall being disposed between the closed distal end of the tubular wall and the proximal end of the powder chamber, and the consolidation prevention wall having an outer periphery spaced from the inner surface of the tubular wall surrounding the powder chamber. The powder delivery and liquid delivery composite device according to claim 15, further comprising a consolidation prevention wall.

17. The bellows assembly includes An end cap disposed within the access opening of the delivery device housing, and A bellows protruding from the proximal surface of the end cap, and An elongated shaft protruding from the distal surface of the end cap, wherein the distal end of the elongated shaft is disposed within the powder chamber and faces the proximal surface of the anti-consolidation wall, and the elongated shaft. A filter holder attached to the elongated shaft between the end cap and the distal end of the elongated shaft. A filter attached to the filter holder between the filter holder and the distal end of the elongated shaft. A compression spring extending between the bellows and the filter holder, the compression spring having a proximal end disposed within the bellows and a distal end disposed adjacent to the proximal surface of the filter holder. The powder delivery and liquid delivery composite system according to claim 16.

18. When the bellows is pushed down toward the distal end of the powder chamber, the compression spring is compressed, whereby the distal end of the compression spring biases the filter holder and the filter toward the anti-consolidation wall. The powder delivery and liquid delivery composite system according to claim 17.

19. The filter holder and the filter are configured to move simultaneously within the powder chamber, the filter holder and the filter each having an outer diameter, and the outer diameters are such that the powder chamber is surrounded by the filter holder and the filter. The powder delivery and liquid delivery composite device according to claim 18, which forms an airtight seal between the respective outer diameters and the inner surface of the tubular wall surrounding the powder chamber and is equal to the inner diameter of the tubular wall surrounding the powder chamber.

20. A powder delivery and liquid delivery composite device, A delivery device housing having a powder chamber and a liquid chamber, the powder chamber and the liquid chamber being separated from each other, and the delivery device housing. An applicator tip having a powder delivery channel extending between a proximal end and a distal end of the applicator tip, the powder delivery channel being in fluid communication with the powder chamber, An applicator tip having a liquid delivery channel extending from the proximal end to the distal end of the applicator tip, the liquid delivery channel being in fluid communication with the liquid chamber, and A powder inlet port in fluid communication with the powder chamber, A liquid inlet port in fluid communication with the liquid chamber, A powder delivery system in fluid communication with the powder inlet port, the powder chamber, and the powder delivery channel, A liquid delivery system in fluid communication with the liquid inlet port, the liquid chamber, and the liquid delivery channel, the liquid delivery system being movable between a depressed configuration and an extended configuration, and when moving from the depressed configuration to the extended configuration, the liquid delivery system generating a vacuum in the liquid chamber to draw a certain dose of liquid into the liquid chamber, and when moving from the extended configuration to the depressed configuration, the liquid delivery system generating a positive pressure in the liquid chamber to push the certain dose of liquid out of the liquid chamber and into the liquid delivery channel, and The liquid delivery system further includes A second air inlet in fluid communication with the liquid chamber, and A one-way valve disposed at the second air inlet that allows ambient air to be drawn into the liquid chamber when the liquid delivery system moves from the depressed configuration to the extended configuration, A powder delivery and liquid delivery composite system.

21. A powder delivery and liquid delivery composite device, A delivery device housing having a powder chamber and a liquid chamber, the powder chamber and the liquid chamber being separated from each other, An applicator tip having a powder delivery channel extending between a proximal end and a distal end of the applicator tip, the powder delivery channel being in fluid communication with the powder chamber, An applicator tip having a liquid delivery channel extending from the proximal end to the distal end of the applicator tip, the liquid delivery channel being in fluid communication with the liquid chamber, and A powder inlet port in fluid communication with the powder chamber, A powder vial assembly connected to the powder inlet port and in fluid communication with the powder chamber and the powder delivery channel, A liquid inlet port in fluid communication with the liquid chamber, A liquid delivery system in fluid communication with the liquid inlet port, the liquid chamber, and the liquid delivery channel, comprising: The powder vial assembly comprising: A powder housing including a proximal end, a distal end, an outer wall extending between the proximal end and the distal end, a proximal opening disposed at the proximal end of the powder housing, and a powder dispensing opening disposed at the distal end of the powder housing, A fixed guide disposed within the powder housing and fixed to an inner surface of the outer wall adjacent to the proximal end of the powder housing, An actuator assembly disposed within the fixed guide, the actuator assembly including a knob accessible at the proximal end of the powder housing and a guide shaft extending distally between the knob and the distal end of the powder housing, An air inlet extending through the actuator assembly and in fluid communication with the powder dispensing opening, A one-way valve disposed within the air inlet, A filter cartridge mounted on the guide shaft of the actuator assembly and configured to slide on the guide shaft toward the distal end of the powder housing, A filter mounted on the filter carriage between the filter carriage and the distal end of the powder housing and configured to slide simultaneously with the filter carriage toward the distal end of the powder housing. A compression spring mounted on the guide shaft of the actuator assembly, the compression spring having a proximal end in contact with the actuator assembly and a distal end in contact with the filter carriage and biasing the filter carriage and the filter toward the distal end of the powder housing. A powder delivery and liquid delivery composite device comprising a compression spring.

22. The powder vial assembly is A powder chamber disposed within the powder housing between the filter and the powder dispensing opening. The powder delivery and liquid delivery composite device according to claim 21, further comprising powder disposed within the powder chamber.

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