Patent Description:
Alternate materials for preventing excessive bleeding may include non-solid anti-adhesive materials, such as hemostatic matrix materials. Use of these materials requires that they be sufficiently fluid to enter and conform to the regions being treated, while simultaneously being sufficiently viscous to remain on the bleeding site until the tissue is healed. Viscous materials often require higher pressure forces for delivery. For example, it is often difficult to manually extrude a viscous material through a syringe. Furthermore, delivery of non-solid anti-adhesive materials to the bleeding site, on or in the body, necessitates a high degree of user-control. Materials should be delivered in a controlled fashion, so as to target the site of therapeutic effect, such as the bleeding site. For at least these reasons, any purported delivery device must be easy to use and control.

Typical procedures for delivery of a hemostatic material may include loading a delivery tube with hemostatic material. Specifically, a surgeon may load the delivery tube by filling it up via a syringe. This can be a time intensive process. Typically, in such a process, the delivery tube is positioned, by the surgeon, at a location on the patient's body. The surgeon then inserts a stylet, which is concentric with the delivery tube, into the back-end of the delivery tube. By inserting the stylet into the back-end of the delivery tube, hemostatic material is expelled from the front-end of the delivery tube at the location on the patient's body. This procedure requires two-hand implementation: one hand for holding and positioning the delivery tube and one hand for pushing the stylet. It is preferable to implement one-handed procedures. Moreover, because the stylet may not translate all the way through the delivery tube, a portion of hemostatic material may remain in the delivery tube, thus wasting hemostatic material. It is preferable to avoid needless wasting of hemostatic material.

For the above reasons, it is desirable to provide improved delivery devices, delivery systems, and related methods, for precise administration of hemostatic compositions. <CIT> relates to mechanisms and methods for syringe loading and dispensing fluid with assistance. <CIT> discloses a syringe device for mixing and delivering liquid medications. In <CIT>, a method and apparatus for applying a sealant is referred to. <CIT> discloses a fibrin glue applicator system for dispensing a first and a second protein solution to be applied to tissues or organs to form a fibrin sealant for sealing wounds, stopping bleeding and the like. In <CIT>, devices for mixing and delivering curable materials to parts of the body, e.g. in the course of surgical or other techniques, are referred to.

To improve medical treatment, especially to prevent excessive bleeding, new delivery devices, delivery systems, and methods of delivery are described herein. The present disclosure seeks to implement new devices, systems, and methods for delivering compositions to the patient with a high degree of user control, regarding both the delivery location and the delivery rate, which may additionally reduce clogging of the delivery device, improve preparation time associated with readying the delivery device for use, and reduce wasted material associated with incomplete delivery.

The present invention relates to a delivery device comprising a trigger mechanism, a first syringe, a pusher, a valve, and a cannula. The pusher is configured to engage with the trigger mechanism and to retain the first syringe at least by coupling with a plunger of the first syringe. The valve is fluidly coupled to the first syringe. The cannula extends distally from and is fluidly coupled to the valve. Activation of the trigger mechanism causes the pusher and the plunger of the first syringe to translate in a distal direction, such that a composition in the first syringe is expelled out of the first syringe, through the valve, through the cannula, and out of a distal end of the cannula. The valve is further configured to engage with a second syringe, such that the second syringe is in fluid communication with both the valve and the first syringe. The cannula includes an inner cannula configured to deliver the composition and an outer cannula, the outer cannula disposed concentrically around the inner cannula.

In an aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, prior to activation of the trigger mechanism, the valve is configured such that the composition can only flow in a first direction, from the second syringe through the valve into the first syringe, such that the first syringe is filled with the composition via the second syringe; and in a second direction, from the first syringe through the valve into the cannula.

In another aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, engagement between the valve and the second syringe is a luer lock engagement.

In another aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the valve is a two-way check valve.

In another aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the valve is a user-selectable stopcock valve.

In another aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the pusher includes a plurality of teeth, and wherein the trigger mechanism includes a ratchet, the ratchet configured to engage with the plurality of teeth of the pusher.

In another aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the composition is a viscous hemostatic material.

In another aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the device further includes a window indicator that indicates an amount of the composition remaining in the first syringe.

According to the present invention, the cannula includes an inner cannula configured to deliver the composition and an outer cannula, the outer cannula disposed concentrically around the inner cannula.

In another aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the outer cannula is stainless steel.

The present invention further relates to a delivery system comprising the delivery device according to the present invention. The delivery device includes the trigger mechanism, the first syringe, the pusher, the valve, and the cannula. The pusher is configured to engage with the trigger mechanism and to retain the first syringe at least by coupling with a plunger of the first syringe. The valve is fluidly coupled to the first syringe. The cannula extends distally from and is fluidly coupled to the valve. The delivery system further includes a second syringe fluidly coupled to the valve, the second syringe further including a composition. Depressing a plunger of the second syringe causes the composition to be expelled out of the second syringe, through the valve, and into the first syringe. Activation of the trigger mechanism causes the pusher and the plunger of the first syringe to translate in a distal direction, such that the composition in the first syringe is expelled out of the first syringe, through the valve, through the cannula, and out of a distal end of the cannula. The cannula includes an inner cannula configured to deliver the composition and an outer cannula, the outer cannula disposed concentrically around the inner cannula.

In another aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the valve is a two-way check valve, such that the composition can only flow in a first direction, from the second syringe through the valve into the first syringe, and in a second direction, from the first syringe through the valve into the cannula.

In another aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, a method of delivering a composition includes attaching a supply syringe to a valve of a delivery device, the supply syringe including the composition. The method includes depressing a plunger of the supply syringe such that, responsive to depressing the plunger, the composition is expelled out of the supply syringe, through the valve, and into a first syringe. The method includes activating a trigger mechanism of the delivery device such that, responsive to activating the trigger mechanism, a plunger of the first syringe is depressed and the composition is expelled out of the first syringe, through the valve, and into a cannula. The method includes further depressing the plunger of the supply syringe such that, responsive to depressing the plunger, additional composition is expelled out of the supply syringe, through the valve, and into the first syringe. The method includes further activating the trigger mechanism of the delivery device such that, responsive to activating the trigger mechanism, the plunger of the first syringe is depressed and the additional composition is expelled out of the first syringe, through the valve, and into the cannula.

In another aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the method includes detaching the supply syringe from the valve of the delivery device. The method includes attaching a flush syringe to the valve of the delivery device, the flush syringe including a flushing fluid different from the composition. The method includes depressing a plunger of the flush syringe such that, responsive to depressing the plunger, the flushing fluid is expelled out of the flush syringe, through the valve, and into the first syringe. The method includes activating the trigger mechanism of the delivery device such that, responsive to activating the trigger mechanism, the plunger of the first syringe is depressed and the flushing fluid is expelled out of the first syringe, through the valve, and into the cannula, such that the flushing fluid pushes the composition out of the cannula.

In another aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the flushing fluid is saline, or other liquid medium, or gas.

In another aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, prior to initially attaching the supply syringe to the valve of the delivery device, the composition is prepared for administration in the supply syringe.

The present invention also relates to a kit including a pre-filled sodium chloride solution syringe, a thrombin vial, a pre-filled gelatin matrix syringe, and the delivery device according to the present invention. The delivery device includes the trigger mechanism, the first syringe, the pusher, the valve, and the cannula. The pusher is configured to engage with the trigger mechanism, the pusher further configured to retain the first syringe at least by coupling with a plunger of the first syringe. The valve is fluidly coupled to the first syringe. The cannula extends distally from and is fluidly coupled to the valve. The pre-filled gelatin matrix syringe fluidly couples to the valve. Depressing a plunger of the pre-filled gelatin matrix syringe causes a composition to be expelled out of the pre-filled gelatin matrix syringe, through the valve, and into the first syringe. Activation of the trigger mechanism causes the pusher and the plunger of the first syringe to translate in a distal direction, such that the composition in the first syringe is expelled out of the first syringe, through the valve, through the cannula, and out of a distal end of the cannula.

Additional features and advantages of the disclosed devices, systems, and methods are described in, and will be apparent from, the following Detailed Description and the Figures. Also, any particular embodiment does not have to have all of the advantages listed herein. Moreover, it should be noted that the language used in the specification has been principally selected for readability and instructional purposes, and not to limit the scope of the inventive subject matter.

Understanding that the figures depict only typical embodiments of the invention and are not to be considered to be limiting the scope of the present disclosure, the present disclosure is described and explained with additional specificity and detail through the use of the accompanying figures.

As discussed briefly above, this disclosure is, in various embodiments, directed to devices, systems, and methods for inhibiting bleeding by applying a material topically to a wound site. The material is typically a hemostatic matrix material, such as a flowable hemostatic material. In particular embodiments, the delivery devices, systems, and methods are configured to deliver a viscous hemostatic matrix, such as FLOSEAL® VH S/D (also known as FLOSEAL® HEMOSTATIC MATRIX VH S/D, FLOSEAL® HEMOSTATIC MATRIX, and FLOSEAL®) (Baxter Healthcare Corporation), a bovine-derived gelatin matrix combined with a human-derived thrombin solution. It should be appreciated, however, that the delivery devices, systems, and methods disclosed herein may deliver other materials, such as any viscous materials, liquid materials, solid materials, or gaseous materials.

Prior to applying a hemostatic material, the bleeding tissue is generally blotted or gently suctioned to remove excess blood so that the hemostatic material can be applied immediately and directly to the site of active bleeding. Minimizing contact of the syringe or applicator tip with wet surfaces may reduce clogging of the syringe and/or the applicator tip. Similarly, clogging can be prevented by particular configurations of the delivery device or delivery system as discussed herein. After the hemostatic material is applied, gentle approximation is typically applied over the treated site using a non-adhering substrate such as moistened gauze. After an initial application, a user may apply additional hemostatic material if bleeding persists. If the non-adhering substrate adheres to the wound site, gentle irrigation with non-heparinized saline may aid in removal of the substrate with minimal disruption to the clot. Once bleeding has ceased, hemostatic material not incorporated into the clot is carefully removed by gentle irrigation and suctioned away from the treatment site.

Delivery of the compositions of the present disclosure is particularly suitable to inhibit bleeding (causing hemostasis) on an abraded or damaged tissue surface, which could be any organ surface such as the liver, spleen, heart, kidney, intestine, blood vessels, other vascular organs, and the like. For example, a delivery device or delivery system described herein may be used to apply the hemostatic material to the active bleeding area. Exemplary methods for applying the material include dispensing the material directly from the delivery device or using an applicator tip. An endoscopic applicator may be used to deliver the hemostatic material to the site of bleeding, as it is often difficult to access the site within the patient's body cavity.

As previously noted, typical endoscopic applicators cannot be easily used with one hand. For example, a typical applicator implements a hollow tube loaded with hemostatic material and a stylet that is manually inserted into the hollow tube to dispense the hemostatic material. This arrangement leaves room for improvement for several reasons. First, loading the endoscopic applicator requires the user to manually load the hollow tube by filling it (via a source syringe), which is often a time intensive process. Second, the source syringe needs to be disconnected from the hollow tube, so that the stylet can be inserted into the hollow tube for delivery. Third, positioning the endoscopic applicator requires the user to awkwardly hold the hollow tube with one hand, positioning the distal end at the delivery site, while simultaneously holding the stylet with the other hand. Fourth, delivery of material via the endoscopic applicator requires the user to simultaneously push the stylet into the hollow tube with one hand, while keeping the other hand still to ensure precise delivery. This is all the more difficult with viscous materials that require higher pressure forces for extrusion. Fifth, it is difficult for the user to gauge the quantity of delivered hemostatic material or rate of delivery. Finally, though not exhaustively, even when expelled to the full capability of the device, a holdup volume of hemostatic material remains unused in the hollow tube and on the stylet surface, effectively becoming waste material.

In comparison to the typical applicator system described above, the delivery devices, delivery systems, and related methods disclosed herein advantageously provide for precise administration, a high degree of user control regarding delivery location and delivery rate, reduced clogging, improved preparation time, and reduced wasted material.

Referring now to <FIG>, an exploded perspective view of a delivery device <NUM> is illustrated. In an embodiment, delivery device <NUM> includes a two-piece molded housing, including a left housing <NUM> and a right housing <NUM>. Each of the left housing <NUM> and right housing <NUM> are configured to couple to one another. In various embodiments, coupling can be accomplished via frictional fitting, mechanical press-fit, ultrasonic welding, or any other mechanical engagement. In an embodiment, left housing <NUM> and right housing <NUM> are constructed of injection-molded polycarbonate, glass-filled polyamide polymer, or other related material. Alternatively, the assembly of the left housing <NUM> and right housing <NUM>, also referred to herein as the "entire housing," may be injection molded as one piece of material, such as polypropylene, PVC, non-DEHP PVC, polyethylene, polystyrene, polypropylene mixture, or other similar materials and/or formed via other means such as 3D printing or other similar plastics manufacturing methods. In an embodiment, the entire housing is configured to be handheld, such that a user can hold the delivery device <NUM> in one hand.

Delivery device <NUM> includes a pusher <NUM>, which may be constructed of injection-molded polycarbonate, glass-filled polyamide polymer, or other related material. Delivery device <NUM> further includes a reservoir syringe <NUM>, having a plunger, assembled and arranged to engage and seal with an inner cylindrical surface of a barrel of the reservoir syringe <NUM>. In this way, the plunger may translate along a length of the barrel of the reservoir syringe <NUM>. Each of the plunger and barrel of the reservoir syringe <NUM> may be constructed of any suitable plastic material, such as polypropylene, PVC, non-DEHP PVC, polyethylene, polystyrene, polypropylene mixture, or other similar materials. Preferably, each of the plunger and barrel of the reservoir syringe <NUM> are constructed of polypropylene, but it should be appreciated that any known material or combination of materials could be employed for this function. In an embodiment, the reservoir syringe <NUM> contains a composition, such as a viscous hemostatic material.

Pusher <NUM> is configured to actuate the barrel of the reservoir syringe <NUM>. Specifically, the pusher <NUM> is configured to retain the reservoir syringe <NUM>, at least by coupling with the plunger of the reservoir syringe <NUM>. In an embodiment, the pusher <NUM> includes a slot configured to receive a flanged end of the plunger of reservoir syringe <NUM>. When pusher <NUM> translates, the barrel of the reservoir syringe <NUM> likewise translates. Translation of pusher <NUM> thus actuates reservoir syringe <NUM>.

Delivery device <NUM> includes a trigger mechanism <NUM> that, when activated, causes pusher <NUM> to translate. In one embodiment, trigger mechanism <NUM> includes an engagement pawl <NUM>, an engagement rack <NUM>, an engagement spring <NUM>, an engagement pin <NUM>, a trigger <NUM>, a trigger spring <NUM>, and a trigger pin <NUM>. It should be appreciated that each of engagement pawl <NUM>, engagement rack <NUM>, and trigger <NUM> may be constructed of injection-molded polycarbonate, glass-filled polyamide polymer, or other related material. Likewise, it should be appreciated that each of the springs and pins may be constructed of metal, such as <NUM> stainless steel, or other related metals.

Referring now to <FIG>, an exploded side view of a delivery device <NUM> is illustrated in various trigger configurations. More particularly, <FIG> illustrate how pusher <NUM> engages with trigger mechanism <NUM>, and its subcomponents. In this way, rotational force, such as that imparted by the user onto trigger <NUM> of trigger mechanism <NUM>, is converted into linear force that translates pusher <NUM> for syringe actuation.

More specifically, the bottom of pusher <NUM> may include pusher teeth <NUM>, or some other type of ridges such as linear gear teeth, which interface with engagement pawl <NUM>. Engagement pawl <NUM> may be spring-loaded, with engagement spring <NUM> (not illustrated) and pivotable about engagement pin <NUM>, such that engagement pawl <NUM> is biased in a particular direction toward pusher <NUM> and pusher teeth <NUM>. Generally, engagement pawl <NUM>, engagement rack <NUM>, engagement spring <NUM>, and engagement pin <NUM> are coupled to one another and may commonly be referred to as a mechanical dog that engages with the pusher teeth <NUM> of pusher <NUM>. Because engagement pawl <NUM> is biased in a particular direction toward pusher <NUM>, such as an angled direction, pusher <NUM> translates with engagement rack <NUM> and engagement pawl <NUM> in a particular direction, such as a distal direction toward cannula <NUM>; pusher <NUM> does not translate with engagement rack <NUM> and engagement pawl <NUM>, when those components translate in an opposite direction. For example, when engagement rack <NUM> and engagement pawl <NUM> translate in a proximal direction away from cannula <NUM>, pusher <NUM> does not translate; rather, pusher <NUM> remains in its current position. In this way, delivery device <NUM> implements a ratchet effect, described in greater detail below.

Engagement rack <NUM> further engages with the top of trigger <NUM>. For example, each of engagement rack <NUM> and the top of trigger <NUM> may include teeth or ridges, such as linear or curved gear teeth, so that force can be translated from trigger <NUM> to engagement rack <NUM>. Trigger <NUM> is pivotable about trigger pin <NUM>, and biased in an open configuration by trigger spring <NUM> (not illustrated).

Further, delivery device <NUM> includes a slot <NUM> with a straight end <NUM> and a curved end <NUM>. In an embodiment, slot <NUM> is located on one of the left housing <NUM> or the right housing <NUM>. In a different embodiment, slot <NUM> is located on both of the left housing <NUM> and the right housing <NUM>. Engagement rack <NUM> and its related components interface with the slot <NUM>, such that the slot <NUM> restricts motion of the engagement rack <NUM> to directions defined by the slot <NUM>, including straight directions and curved directions. Because the slot <NUM> includes both a straight end <NUM> and a curved end <NUM>, the slot <NUM> provides engagement and disengagement of engagement pawl <NUM> from the pusher teeth <NUM>.

For example, <FIG> illustrates a first trigger configuration, where the trigger <NUM> extends approximately fifty degrees from a handle of delivery device <NUM>. Each of engagement rack <NUM> and the top of trigger <NUM> include teeth, which engage one another. Because trigger <NUM> is located in an open position, such as at fifty degrees from the handle, the teeth on the trigger <NUM> push the engagement rack <NUM> in a proximal direction along slot <NUM>. Specifically, engagement rack <NUM> is located at the curved end <NUM> of slot <NUM>. Because a portion of engagement rack <NUM> is at the curved end <NUM>, the engagement rack <NUM> pivots slightly from the direction defined by the straight end <NUM> of slot <NUM>. In this way, pivoting the engagement rack <NUM> disengages the engagement pawl <NUM> from the pusher teeth <NUM>. Disengagement is useful, for example, so that the user can manually translate pusher <NUM> in the proximal direction to load the reservoir syringe <NUM> into the delivery device <NUM>, or so that the user can fill or re-fill the reservoir syringe <NUM>, as described in greater detail below.

It should be appreciated that the engagement pawl <NUM> is disengaged when trigger <NUM> is fifty degrees from the handle of delivery device <NUM>; however, alternate disengagement configurations of trigger <NUM> are contemplated and the engagement pawl <NUM> may be disengaged at any other rotational orientation of trigger <NUM>. Furthermore, the specific configuration and geometry of engagement pawl <NUM>, engagement rack <NUM>, and the slot <NUM> including the straight end <NUM> and the curved end <NUM> may affect the extent of disengagement.

<FIG> illustrates a second configuration, where the trigger <NUM> extends approximately forty degrees from the handle of delivery device <NUM>. For example, in this second configuration the user has partially squeezed trigger <NUM>. As a reminder, each of engagement rack <NUM> and the top of trigger <NUM> include teeth, which engage one another. Because trigger <NUM> is partially squeezed, the teeth on the trigger <NUM> rotate and push the engagement rack <NUM> in a distal direction along slot <NUM>. Engagement rack <NUM> is no longer located at the curved end <NUM> of slot <NUM>, and it therefore does not pivot away from the direction defined by the straight end <NUM> of slot <NUM>. By not pivoting, engagement rack <NUM> directly engages the engagement pawl <NUM> with the pusher teeth <NUM>. Engagement is useful, for example, so that the user can deliver material from reservoir syringe <NUM> by squeezing trigger <NUM>.

More specifically, when the user squeezes trigger <NUM>, trigger <NUM> rotates about trigger pin <NUM> to a closed configuration. As trigger <NUM> is squeezed, the rotational motion of trigger <NUM> converts into a linear motion at engagement rack <NUM>, via engagement between the gear teeth of these components. Thus, engagement rack <NUM> and its related components translate in a linear direction. For example, these components translate along the slot <NUM> towards the straight end <NUM>.

The linear motion of engagement rack <NUM> and engagement pawl <NUM> is further converted to linear motion of pusher <NUM>, via engagement between the engagement pawl <NUM> and the pusher teeth <NUM> as discussed above. In other words, as engagement rack <NUM> and engagement pawl <NUM> translate towards the straight end <NUM> of slot <NUM>, pusher <NUM> translates toward the distal end of delivery device <NUM>. In this way, trigger mechanism <NUM> effectively converts rotational motion from trigger <NUM> into linear motion at pusher <NUM>. Also, as noted previously, because pusher <NUM> retains the reservoir syringe <NUM>, translation of pusher <NUM> actuates reservoir syringe <NUM>.

When the user releases trigger <NUM>, trigger spring <NUM> biases trigger <NUM> to rotate about trigger pin <NUM> toward the open position. As trigger <NUM> is released, the rotational motion of trigger <NUM> converts into a linear motion at engagement rack <NUM>, via engagement between the gear teeth of these components. Each of the engagement rack <NUM> and its related components translate linearly, along the slot <NUM> towards the curved end <NUM>.

However, as engagement rack <NUM> and engagement pawl <NUM> translate along the slot <NUM> towards the curved end <NUM>, pusher <NUM> does not translate. For example, as previously noted, the engagement between engagement pawl <NUM> and pusher teeth <NUM> may commonly be referred to as a mechanical dog. Engagement pawl <NUM> is biased in a particular angled direction toward pusher <NUM>, such that pusher <NUM> only translates with engagement rack <NUM> and engagement pawl <NUM> in a particular direction, such as the distal direction toward cannula <NUM>; pusher <NUM> does not translate with engagement rack <NUM> and engagement pawl <NUM> when those components translate in the opposite direction. Due to this configuration, the user may repeatedly squeeze and release trigger <NUM>. The entire trigger mechanism <NUM> has a ratchet effect for engaging pusher <NUM>, to repeatedly translate pusher <NUM> in the distal direction and repeatedly actuate reservoir syringe <NUM>.

Once delivery device <NUM> has completely delivered the material in reservoir syringe <NUM>, pusher <NUM> will have translated to its distal-most point. At this configuration, it is advantageous for the user to have the ability to disengage engagement rack <NUM> and engagement pawl <NUM>, such as to load a new reservoir syringe <NUM>.

<FIG> illustrates a third trigger configuration, where the trigger <NUM> extends approximately fifty degrees from the handle of delivery device <NUM>. Similar to <FIG>, because trigger <NUM> is located in the open position, such as at fifty degrees, engagement rack <NUM> is located at the curved end <NUM> of slot <NUM>, thus pivoting slightly from the direction defined by the straight end <NUM> of slot <NUM>. In this way, engagement rack <NUM> disengages the engagement pawl <NUM> from the pusher teeth <NUM>. Disengagement is useful, for example, so that the user can manually slide pusher <NUM> in the proximal direction to load a new reservoir syringe <NUM> into the delivery device <NUM>, or so that the user can fill or re-fill the reservoir syringe <NUM>, as described in greater detail below. It should be appreciated that trigger <NUM> may include alternate disengagement configurations.

Additionally, the disengagement of engagement rack <NUM> and engagement pawl <NUM> is beneficial for other reasons, beyond reservoir syringe <NUM> loading, replacement, and/or filling and refilling. Specifically, disengagement of engagement rack <NUM> and engagement pawl <NUM> advantageously creates a pressure-release between successive squeezes of trigger <NUM>. As the user is repeatedly squeezing trigger <NUM>, the pusher <NUM> translates in the distal direction and pressure within the reservoir syringe <NUM> is increasing. This pressure is largely relieved as material exits the delivery device <NUM> via cannula <NUM>. However, due to the viscosity of certain materials in reservoir syringe <NUM>, a pressure differential can remain within reservoir syringe <NUM>, causing undesirable leakage from reservoir syringe <NUM>. To alleviate this pressure differential, delivery device is configured for pressure release. For example, the user may squeeze trigger <NUM>, such as from fifty degrees to forty degrees, to expel material from the reservoir syringe <NUM>. When the user releases trigger <NUM>, trigger <NUM> is biased back to its open configuration of fifty degrees. In this open configuration, engagement rack <NUM> and engagement pawl <NUM> are disengaged from pusher teeth <NUM>. Thus, pusher <NUM> is free to translate slightly in a distal direction, to relieve any pressure differential remaining within reservoir syringe <NUM>.

Furthermore, it should be appreciated that pusher <NUM> may engage with trigger mechanism <NUM> by any other related mechanical means and components, such as additional gears, pawls, and springs; these other mechanical components may be used to translate motion from the trigger mechanism <NUM> to the pusher <NUM>. Thus, regardless of the particular configuration, as the trigger mechanism <NUM> is actuated, the trigger mechanism <NUM> will translate motion to the pusher <NUM>.

Referring again to <FIG>, the delivery device further includes a window housing <NUM> including clear window <NUM> so that the user can see the reservoir syringe <NUM>. The clear window <NUM> may further include gradients or physical markings that the user may associate with a volume of composition remaining in reservoir syringe <NUM> and/or a volume of composition expressed from reservoir syringe <NUM>.

Delivery device <NUM> further includes a valve <NUM> configured to fluidly couple to the reservoir syringe <NUM>. In an embodiment, valve <NUM> is further configured to fluidly couple to a second syringe, as described in greater detail herein.

Delivery device <NUM> includes a cannula <NUM>, configured to deliver the composition to the delivery site. Cannula <NUM> is configured to engage with the valve <NUM> at connection point <NUM>, so that cannula <NUM> is in fluid communication with valve <NUM>. In an embodiment, connection point <NUM> is a luer lock fitting. In alternate embodiments, engagement between valve <NUM> and connection point <NUM> of cannula <NUM> may be threaded engagement, interference-fit engagement, hook-and-loop engagement, snap engagement, magnetic engagement, or any other sort of mechanical engagement for affixing the cannula <NUM> to the valve <NUM>. In a preferred embodiment, cannula <NUM> is a single lumen cannula. Cannula <NUM> may be provided in any variety of lengths, such as between <NUM> and <NUM> to support a number of different surgical applications including pediatric surgery and spinal surgery. In an embodiment, cannula <NUM> is trimmable, such that the user can customize the length of cannula <NUM> to particular surgical applications. Cannula <NUM> extends in the distal direction and includes a tip <NUM> at its distal end. In various embodiments, the tip <NUM> may be a rigid extension tip, a trimmable extension tip, a flexible tip, or a malleable tip such as a polyurethane tip with a stainless steel wire for manipulation by the user.

In an alternate embodiment, cannula <NUM> may include multiple lumens, such as an inner cannula <NUM>, an outer cannula <NUM>, and the tip <NUM>. According to the invention the cannula includes an inner cannula and an outer cannula. The inner cannula <NUM> is configured to deliver the composition to the delivery site. Inner cannula <NUM> may preferably have an inner diameter of <NUM> to <NUM>, which may optimize residual volume of the composition that remains inside inner cannula <NUM> after delivery. The diameter of inner cannula <NUM> may also be optimized for the particular material delivered from reservoir syringe <NUM>; for example, the diameter of the inner cannula <NUM> may be determined with respect to the viscosity of the material, such as to avoid clogging of inner cannula <NUM>. The outer cannula <NUM> is configured to be disposed concentrically around the inner cannula <NUM>, to protect inner cannula <NUM>. In an example, outer cannula <NUM> is constructed of stainless steel. Outer cannula <NUM> may preferably have a <NUM> length to support all surgical specialties, including endoscopic applications. Outer cannula <NUM> additionally provides enhanced rigidity to the entire cannula <NUM>, which is beneficial during surgical maneuvering and manipulation.

As previously noted, reservoir syringe <NUM> may contain the composition. Responsive to engagement of the trigger mechanism <NUM>, the pusher <NUM> and the plunger of the reservoir syringe <NUM> translate in the distal direction, toward the tip <NUM> of cannula <NUM>. In this way, the composition in the reservoir syringe <NUM> is expelled out of the reservoir syringe <NUM>, through the valve <NUM>, through the cannula <NUM> (or alternatively through the inner cannula <NUM> of cannula <NUM>), and out of tip <NUM> at the distal end of the cannula <NUM>.

<FIG> illustrate perspective views of delivery device <NUM>. As illustrated, delivery device <NUM> includes valve <NUM>, trigger <NUM>, and cannula <NUM>. It should be appreciated that delivery device <NUM> is self-contained, and thus may include all other aspects as described in greater detail above, such as the remaining components of trigger mechanism <NUM> and reservoir syringe <NUM>. Preferably, delivery device <NUM> is dimensioned and ergonomically designed for one-handed use by the user.

Valve <NUM> is further configured to engage with a second syringe, such as a supply syringe. For example, <FIG> illustrates a side elevation view of a delivery system <NUM>, which includes a supply syringe <NUM>. Initially, it should be appreciated that portions of left housing <NUM> and right housing <NUM> are removed for illustrative purposes in order to view reservoir syringe <NUM> and pusher <NUM>.

As illustrated in <FIG>, the valve <NUM> engages with supply syringe <NUM>, such that supply syringe <NUM> is fluidly coupled with valve <NUM>. In an embodiment, engagement between supply syringe <NUM> and valve <NUM> is a luer lock engagement. Supply syringe <NUM> may initially fill reservoir syringe <NUM> with composition and/or re-fill reservoir syringe <NUM> with additional composition. For example, prior to engagement of trigger <NUM>, the user depresses a plunger of the supply syringe <NUM> to expel composition out of the supply syringe <NUM>. The composition travels through the valve <NUM> and into the reservoir syringe <NUM>. In this way, the reservoir syringe <NUM> is supplied with composition via the supply syringe <NUM>. Consequently, as described above, engagement of trigger <NUM> and the entire trigger mechanism <NUM> causes the composition in the reservoir syringe <NUM> to be expelled out of the reservoir syringe <NUM>, through the valve <NUM>, through the cannula <NUM>, and out of the distal end of the cannula <NUM>.

Valve <NUM> may be characterized as a two-way check valve. In other words, valve <NUM> permits two separate fluid flow paths: a first flow path and a second flow path. <FIG> illustrates the first flow path, which is defined from the supply syringe <NUM>, through the valve <NUM>, and into the reservoir syringe <NUM>. The composition may only flow between the supply syringe <NUM> and the reservoir syringe <NUM> in the direction defined by the first flow path. One-directional flow ensures that composition will not inadvertently flow from the reservoir syringe <NUM>, through the valve <NUM>, and into the supply syringe <NUM>. <FIG> illustrates the second flow path, which is defined from the reservoir syringe <NUM>, through the valve <NUM>, and into the cannula <NUM>. The two-way check valve may advantageously remove the need for the user to manually switch flow directions, such as via a switch valve. However, in an alternate embodiment, the valve <NUM> may be a user-selectable stopcock valve, whereby the user can manually select which direction the composition can flow and which direction the composition cannot flow. In an embodiment, the valve <NUM> is configured such that the reservoir syringe <NUM> and the supply syringe <NUM> are oriented perpendicular to one another. In other embodiments, valve <NUM> is configured such that the reservoir syringe <NUM> and the supply syringe <NUM> are oriented parallel to one another, or any other angular orientation to one another.

To summarize, valve <NUM> is configured to engage with the reservoir syringe <NUM>, such that the reservoir syringe <NUM> is in fluid communication with the valve <NUM>. Cannula <NUM> is configured to engage with the valve <NUM>, such that the cannula <NUM> is in fluid communication with the valve <NUM> and extends in a distal direction. Valve <NUM> is configured to engage with supply syringe <NUM>, such that supply syringe <NUM> is in fluid communication with the valve <NUM>. Supply syringe <NUM> initially includes the composition. Responsive to depressing the plunger of the supply syringe <NUM>, the composition is expelled out of the supply syringe <NUM>, through the valve <NUM>, and into the reservoir syringe <NUM>. Responsive to engagement of trigger <NUM>, the pusher <NUM> and the plunger of the reservoir syringe <NUM> translate in the distal direction, such that the composition in the reservoir syringe <NUM> is expelled out of the reservoir syringe <NUM>, through the valve <NUM>, through the cannula <NUM>, and out of the distal end of the cannula <NUM>.

In an embodiment, the trigger mechanism <NUM> of delivery system <NUM> may be configured to deliver a particular amount of composition with each pull of trigger <NUM>. For example, by knowing the distance traveled by the pusher <NUM> with each pull of trigger <NUM>, and the cross-sectional area of the reservoir syringe <NUM>, one can easily calculate the volume delivered by delivery system <NUM> with each pull of trigger <NUM>. In a specific example, a half-squeeze of the trigger <NUM> delivers <NUM> of composition, whereas a full-squeeze of the trigger <NUM> delivers <NUM> of composition.

As disclosed, delivery system <NUM> herein provides a high degree of user control, regarding both the delivery location and the delivery rate. Delivery system <NUM> provides for one-handed delivery of compositions, such as hemostatic material. More specifically, single-hand positioning of the delivery device <NUM>, and related actuation of delivery device <NUM> via trigger mechanism <NUM>, improves both precision and control of hemostatic material delivery. With delivery device <NUM>, the user can position both the delivery device <NUM> and the cannula <NUM> with a single hand, thus freeing the other hand for other purposes. The user has better control to ensure proper positioning while simultaneously delivering hemostatic material. Beyond positioning, delivery of hemostatic material is controlled from both a quantity and a rate perspective. Hemostatic material is only delivered when the trigger <NUM> is pulled; when the trigger <NUM> is pulled, only a particular amount of hemostatic material is delivered. Similarly, hemostatic material cannot be inadvertently delivered, such as by inadvertently bumping a stylet; rather, the trigger <NUM> must be pulled by the user to deliver hemostatic material out of cannula <NUM>. Consistent trigger actuation will result in a consistent delivery of hemostatic material, thus preventing situations of accidental delivery, loss of product, and over-delivery, such as blowout, which can be especially problematic to the patient by causing an embolic event, flushing away previously delivered hemostatic material, or creating other undesirable side effects. Likewise, by biasing the trigger <NUM> to the open configuration such that engagement rack <NUM> and engagement pawl <NUM> are disengaged from pusher teeth <NUM>, pusher <NUM> is free to translate backward to relieve any pressure differential remaining within reservoir syringe <NUM> and avoid undesirable leakage.

In an alternate embodiment, delivery system <NUM> and delivery device <NUM> may implement additional components to replace the manual and repeated trigger actuation disclosed above. For example, delivery device <NUM> may include electromechanical components, such as an electromechanical motor, related gearing, and a battery or external power source, such that the trigger mechanism <NUM> may be engaged to deliver material without requiring physical engagement of the trigger <NUM>.

Delivery of hemostatic material via delivery device <NUM> and delivery system <NUM> also provide for mechanical optimization of the device itself. For example, trigger <NUM> and trigger mechanism <NUM> can generate a greater force when compared to previous delivery techniques, such as manual delivery via pushing a stylet through a delivery tube. With a greater delivery force available, dimensions of delivery device <NUM>, such as the diameter of cannula <NUM> and size of reservoir syringe <NUM>, can be reduced. Specifically, for example, the cannula <NUM> may be longer and narrower. Reducing particular dimensions of the delivery device <NUM>, such as the diameter of the cannula <NUM>, is a desirable whenever the delivery device <NUM> is to be used in endoscopic settings. For example, portions of the delivery device <NUM>, like the cannula <NUM>, may pass through an endoscopic port on the patient.

Furthermore, delivery device <NUM> and delivery system <NUM> provide for mechanical optimization through a "stepping down" of syringe diameters. For example, in an embodiment, the supply syringe <NUM> may be a <NUM> syringe. As a reminder, the user may implement the supply syringe <NUM> to deliver composition through valve <NUM>, in order to supply composition to the reservoir syringe <NUM>. The reservoir syringe <NUM> may be a <NUM> syringe. Because the size of the reservoir syringe <NUM>, including the cross sectional area of the syringe, is smaller than that of the supply syringe <NUM>, less force is required to generate pressure sufficient to expel the composition from the reservoir syringe <NUM>. In the same vein, an equivalent force on the plunger of the supply syringe <NUM> will generate a higher pressure within the supply syringe <NUM>, due to the smaller cross sectional area of reservoir syringe <NUM>. The higher pressure is advantageous to dispense viscous compositions down a long and narrow cannula. Thus, stepping down of syringe diameters may provide for optimization of forces required to dispense viscous compositions, optimization of sizes by reducing the overall size of supply syringe <NUM> for a more compact delivery device <NUM>, and the like.

As previously mentioned, delivery device <NUM> and delivery system <NUM> may be implemented in administering or delivering a composition. Specifically, the user may attach supply syringe <NUM> to the valve <NUM> of delivery device <NUM>. The supply syringe <NUM> includes the composition to be administered, such as a viscous hemostatic matrix. Prior to attachment to the valve <NUM>, the user may prepare the composition for administration in the supply syringe <NUM>.

For example, when a hemostatic matrix, such as FLOSEAL®, is to be administered, the FLOSEAL® must first be prepared for administration. FLOSEAL® VH S/D may be prepared according to the manufacturer's Instructions for Use (Baxter Healthcare Corporation, <NUM>). Particularly, a thrombin solution may be prepared by attaching a prefilled sodium chloride solution syringe to a luer connector of a vial adapter containing the thrombin solution. The rubber stopper of the thrombin vial is pierced, and all contents of the sodium chloride syringe are transferred to the thrombin vial. The thrombin vial is then vented and swirled until the thrombin is completely dissolved. FLOSEAL® VH S/D is then prepared by filling an empty <NUM> supply syringe <NUM> with thrombin solution to an indicated mark, such as <NUM>, and then connecting a gelatin matrix syringe to the supply syringe <NUM> containing the thrombin solution. The thrombin solution is then passed into the gelatin matrix syringe, and the mixture transfers back and forth between the two syringes for at least twenty passes. The resulting hemostatic matrix in the supply syringe <NUM> is ready for administration, typically between thirty seconds and twenty minutes after preparation.

Once the hemostatic matrix is prepared, the user attaches supply syringe <NUM> containing the hemostatic matrix to the valve <NUM> of delivery device <NUM>. In a preferred embodiment, the reservoir syringe <NUM> is initially empty and the plunger of reservoir syringe <NUM> is initially compressed. The user then depresses a plunger of the supply syringe <NUM> such that, responsive to depressing the plunger, the hemostatic matrix is expelled out of the supply syringe <NUM>, through the valve <NUM>, and into the reservoir syringe <NUM>. In an embodiment, the user only expels a portion of the supply syringe <NUM> into the reservoir syringe <NUM>. For example, the supply syringe <NUM> may have a much larger volume capacity than the reservoir syringe <NUM>.

The user then repeatedly engages the trigger mechanism <NUM>, specifically the trigger <NUM>, of delivery device <NUM> such that, responsive to engaging the trigger mechanism <NUM>, a plunger of the reservoir syringe <NUM> is depressed. For example, the pusher <NUM> translates in a distal direction to depress the plunger of reservoir syringe <NUM>. The hemostatic matrix is expelled out of the reservoir syringe <NUM>, through the valve <NUM>, and into the cannula <NUM>.

The user then further depresses the plunger of supply syringe <NUM>, such that additional hemostatic matrix is expelled out of the supply syringe <NUM>, through the valve <NUM>, and into the reservoir syringe <NUM>. For example, the user has the capability to re-load reservoir syringe <NUM> with additional hemostatic matrix. During reloading, components of the trigger mechanism <NUM> may reset and other components, such as the pusher <NUM> and the plunger of reservoir syringe <NUM> may translate in the proximal direction as the reservoir syringe <NUM> is filled with additional hemostatic matrix.

The user then further repeatedly engages the trigger mechanism <NUM>, specifically the trigger <NUM>, of delivery device <NUM> such that, responsive to engaging the trigger mechanism <NUM>, the plunger of the reservoir syringe <NUM> is depressed and additional hemostatic matrix is expelled out of the reservoir syringe <NUM>, through the valve <NUM>, and into the cannula <NUM>. By repeating this process, hemostatic matrix is expelled out of the tip <NUM> of cannula <NUM>.

If the user runs out of hemostatic matrix in the supply syringe <NUM>, the user may detach the empty supply syringe <NUM> from the valve <NUM> and attach a new supply syringe <NUM> to the valve <NUM> to continue the process. This may advantageously improve both preparation time associated with readying the delivery device <NUM> and reload time associated with reloading the delivery device <NUM> with additional hemostatic matrix.

In a related embodiment, delivery device <NUM> may include a liquid propellant for expelling material out of the tip <NUM> of cannula <NUM>. For example, in this embodiment, the reservoir syringe <NUM> is initially empty and the plunger of reservoir syringe <NUM> is initially compressed. As previously described, the user depresses a plunger of the supply syringe <NUM> such that, responsive to depressing the plunger, the hemostatic matrix is expelled out of the supply syringe <NUM>, through the valve <NUM>, and into the reservoir syringe <NUM>. The user then repeatedly engages the trigger mechanism <NUM>, specifically the trigger <NUM>, of delivery device <NUM> such that, responsive to engaging the trigger mechanism <NUM>, a plunger of the reservoir syringe <NUM> is depressed. The hemostatic matrix is expelled out of the reservoir syringe <NUM>, through the valve <NUM>, and into the cannula <NUM>.

At this point, the user may attach a second supply syringe, such as a liquid filled syringe, to valve <NUM>. The user depresses a plunger of the second supply syringe such that, responsive to depressing the plunger, liquid is expelled out of the second supply syringe, through the valve <NUM>, and into the reservoir syringe <NUM>. For example, the user has the capability to load reservoir syringe <NUM> with liquid, after delivery of hemostatic material into cannula <NUM>. During loading with liquid, components of the trigger mechanism <NUM> may reset and other components, such as the pusher <NUM> and the plunger of reservoir syringe <NUM> may translate in the proximal direction as the reservoir syringe <NUM> is filled with liquid. The user further repeatedly engages the trigger mechanism <NUM>, specifically the trigger <NUM>, of delivery device <NUM> such that, responsive to engaging the trigger mechanism <NUM>, the plunger of the reservoir syringe <NUM> is depressed and the liquid is expelled out of the reservoir syringe <NUM>, through the valve <NUM>, and into the cannula <NUM>. In this way, the liquid acts as a pressurized propellant and expels the hemostatic material out of the tip <NUM> of cannula <NUM>.

In a different related embodiment, all components of the delivery device <NUM> are stainless steel and can be configured for repeated use. For example, delivery device <NUM> may be used as described above, and may subsequently be sterilized via an autoclave or other commercial sterilizer. Once sterilized, delivery device <NUM> could effectively be reused at a later date for delivering hemostatic matrix to a different patient.

The delivery device <NUM> and delivery system <NUM> may further advantageously reduce wasted material associated with incomplete delivery. For example, the method described above may further include a flushing operation. Specifically, once the user is finished with expelling hemostatic matrix out of the tip <NUM> of cannula <NUM>, a holdup volume of hemostatic matrix remains unused in the cannula <NUM>. In this situation, the user may detach the supply syringe <NUM> from the valve <NUM> of delivery device <NUM>. The user then attaches a flush syringe to the valve <NUM> of delivery device <NUM>.

The flush syringe includes a flushing fluid, which is different from the hemostatic matrix. For example, the flushing fluid may be liquid saline, or other liquid medium, or gas. Once the flush syringe is attached to valve <NUM>, the user depresses a plunger of the flush syringe, such that the flushing fluid is expelled out of the flush syringe, through the valve <NUM>, and into the reservoir syringe <NUM>. The user may then engage the trigger mechanism <NUM>, such that the plunger of the reservoir syringe <NUM> is depressed to expel the flushing fluid out of the reservoir syringe <NUM>, through the valve <NUM>, and into the cannula <NUM>. In this way, the flushing fluid, and the associated pressure generated by the flushing fluid, expels any remaining hemostatic matrix out of the cannula <NUM>.

The flushing operation provides for optimal delivery of the hemostatic matrix, minimizing the waste of hemostatic matrix remaining in the cannula <NUM>. The flushing operation further eliminates clogging, by minimizing the amount of hemostatic material that remains in the cannula <NUM>.

Kits according to the present disclosure may comprise the hemostatic material and a delivery device <NUM>. The hemostatic materials are formed sterilely, by aseptic processing, or will be sterilized, preferably by terminal sterilization using γ-irradiation, ethylene oxide, electronic beam irradiation, and the like. While still in a sterile form, the hemostatic materials will be packaged in a sterile package, such as a pouch, tube, tray, box, or the like. Instructions for use setting forth a method of placing the material over tissue in the presence of blood at a wound, or surgical site, may also be provided as part of the kit. An exemplary kit includes the hemostatic material, such as dry bovine-derived gelatin matrix (granules) and a human-derived thrombin solution in individual syringes, an applicator tip, a delivery device described herein configured to be used with the syringe, and instructions for use setting forth methods for inhibiting bleeding by placing the sterilized materials at a target site in tissue, which could be any wound or other site of bleeding tissue, with a delivery device or delivery system, such as those disclosed herein.

In an embodiment, a kit includes a pre-filled sodium chloride solution syringe, a thrombin vial, a pre-filled gelatin matrix syringe, and a delivery device. The pre-filled sodium chloride solution syringe, thrombin vial, and pre-filled gelatin matrix syringe may be used to prepare a hemostatic matrix as described above. The delivery device <NUM> may be configured to engage with the pre-filled gelatin matrix supply syringe <NUM> as described in greater detail above.

As used in this specification, including the claims, the term "and/or" is a conjunction that is either inclusive or exclusive. Accordingly, the term "and/or" either signifies the presence of two or more things in a group or signifies that one selection may be made from a group of alternatives.

Claim 1:
A delivery device (<NUM>) comprising:
a trigger mechanism (<NUM>);
a first syringe;
a pusher (<NUM>), configured to engage with the trigger mechanism (<NUM>), the pusher (<NUM>) further configured to retain the first syringe at least by coupling with a plunger of the first syringe;
a valve (<NUM>) fluidly coupled to the first syringe; and
a cannula (<NUM>) extending distally from and fluidly coupled to the valve (<NUM>),
wherein activation of the trigger mechanism (<NUM>) causes the pusher (<NUM>) and the plunger of the first syringe to translate in a distal direction, such that a composition in the first syringe is expelled out of the first syringe, through the valve (<NUM>), through the cannula (<NUM>), and out of a distal end of the cannula (<NUM>),
wherein the valve (<NUM>) is further configured to engage with a second syringe, such that the second syringe is in fluid communication with both the valve (<NUM>) and the first syringe, and
characterised in that
the cannula (<NUM>) includes an inner cannula (<NUM>) configured to deliver the composition and an outer cannula (<NUM>), the outer cannula (<NUM>) disposed concentrically around the inner cannula (<NUM>).