Patent Description:
Fluid delivery systems and devices are used to supply various fluids, such as a gas, during medical procedures. These procedures may include supplying fluids within a range of appropriate pressures and/or flow rates. These fluids may include agents, e.g., hemostatic agents, optimally delivered to tissue at an appropriate pressure and/or flow rate, for the particular application.

Handheld medical fluid delivery systems often require delivering a fluid from a high pressure storage tank, such as a cartridge or similar housing. Such cartridges may be loaded into a handle of the delivery system and may energize or charge the delivery system when a seal on the cartridge is pierced by a pierce pin or similar device on the delivery system. These fluids may be under high pressures and may cause injury if the medical system is not used properly. The following medical systems for dispensing agents using pressurized fluids are known in the art, namely <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>. In some instances pressurized fluid may leak from the cartridges or containment devices into a sealed lumen of the handle of the medical fluid delivery systems. Over pressurization of the lumen and the handle may result in failure of the medical fluid delivery system and may result in injury to the user or the patient. The disclosure may solve one or more of these problems or other problems in the art. The scope of the disclosure, however, is defined by the attached claims and not the ability to solve a specific problem.

According to an aspect, a device configured to deliver a pressurized fluid includes a body having an input opening for receiving the pressurized fluid and an output opening for delivering the pressurized fluid, a handle defining a lumen, wherein the lumen is configured to receive a container containing the pressurized fluid, and at least one aperture fluidly connecting the lumen to an atmosphere external of the device.

The at least one aperture may be defined by a wall of the handle.

The at least one aperture may include a plurality of apertures, and wherein the plurality of apertures may be arranged in an asymmetrical pattern on the handle.

A distal end of the handle may be configured to be connected to the body via screw threads, and wherein the at least one aperture may extend through a portion of the screw threads.

The handle may include one or more screw threads, wherein the body may include one or more screw threads, wherein the one or more apertures may be configured to be formed through the one or more screw threads of each of the handle and the body, and wherein the one or more apertures on the handle and the one or more apertures on the body may be configured to align when the handle is attached to the body.

The one or more apertures may be a single aperture disposed at a proximalmost end of the handle, and wherein the single aperture may face a proximal direction.

The device may include a plurality of crenellations and a plurality of openings defined between adjacent crenellations, and wherein the openings may be fluidly connected to the single aperture.

The plurality of crenellations may be configured to contact a proximal most end of the container when the container is attached to the device.

A sum of a cross-sectional area of each of the plurality of openings may be equal to a cross-sectional area of the single aperture.

Only proximally facing surfaces of an outermost surface of the container may contact an innermost surface of the handle when the container is connected to the device.

The at least one aperture may be configured to release the pressurized gas in a time equal to or less than <NUM> seconds.

The body may be configured to form a hole in the container, wherein the pressurized fluid may be configured to pass from the container via the hole, and wherein a diameter of the hole may be less than or equal to <NUM> (<NUM> inches).

A cross-sectional area of a sum of each of the at least one aperture may be equal to or greater than approximately <NUM><NUM> (<NUM> square inches).

The device may further include the container, and, according to the invention, a membrane covering each aperture of the at least one aperture, wherein the membrane may be configured to rupture when a pressure of the pressurized fluid within the lumen exceeds a threshold.

The pressurized fluid may have a pressure of approximately <NUM> bar (<NUM> pounds per square inch).

According to another aspect, a device configured to deliver a pressurized fluid includes a body having an input opening for receiving the pressurized fluid and an output opening for delivering the pressurized fluid, a handle defining a lumen, wherein the lumen is configured to receive a container containing the pressurized fluid, and a plurality of apertures fluidly connecting the lumen and an outer surface of the device, wherein a cross-sectional area of a sum of each of the plurality of apertures is equal to or greater than approximately <NUM><NUM> (<NUM> square inch), and wherein the pressurized fluid is configured to be released from the lumen in approximately <NUM> seconds or less.

The plurality of apertures may be arranged in an asymmetrical shape on the handle.

The handle may be connected to the body via a threaded connection, and wherein the plurality of apertures may pass through the threaded connection.

The device may further include a membrane covering each aperture of the at least one aperture, wherein the membrane may be configured to rupture when a pressure of the pressurized fluid within the lumen is equal to or greater than a threshold.

According to another aspect, a method for controlling a fluid delivery to a body of a patient includes inserting a container containing a pressurized fluid into a lumen of a handle of a fluid delivery device, the fluid delivery device defining one or more apertures fluidly connecting the lumen to an atmosphere external the fluid delivery device, and causing an opening in the container.

The disclosure is described with reference to exemplary medical systems for dispensing an agent (such as a hemostatic agent) using a pressurized fluid. The devices associated with the medical systems may improve the functionality and/or the safety of the medical systems by venting pressurized fluids to atmosphere (e.g., air outside a handle and/or the medical system) if fluid from a pressurized fluid container leaks into an undesired location in the medical system. In examples, ventilation openings provided on or in the medical system may vent pressurized fluid from the lumen of the handle and may prevent over pressurization of the handle and/or the medical fluid delivery system.

Reference to any particular procedure is provided in this disclosure only for convenience and not intended to limit the disclosure. A person of ordinary skill in the art would recognize that the concepts underlying the disclosed device and application method may be utilized in any suitable procedure, medical or otherwise. The disclosure may be understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals.

Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms "comprises," "comprising," "having," "including," or other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus.

For ease of description, portions of the device and/or its components are referred to as proximal and distal portions. It should be noted that the term "proximal" is intended to refer to portions closer to a user of the device or upstream in a propellant fluid path (in the direction of arrow A in <FIG>), and the term "distal" is used herein to refer to portions further away from the user or downstream in the propellant fluid path (in the direction of arrow B in <FIG>). Similarly, extends "distally" indicates that a component extends in a distal direction, and extends "proximally" indicates that a component extends in a proximal direction. Further, as used herein, the terms "about," "approximately" and "substantially" indicate a range of values within +/- <NUM>% of a stated or implied value. Additionally, terms that indicate the geometric shape of a component/surface refer only to approximate shapes.

Referring to <FIG>, a delivery system <NUM> according to an embodiment is shown. Delivery system <NUM> includes an application device <NUM>, e.g., a hand-held device, having a handle <NUM> at a proximal end, and one or more triggers or actuators <NUM>, <NUM> configured to actuate delivery system <NUM> to release a propellant fluid. A tube <NUM> (e.g., a catheter), or an application tip, may be attached to a distal outlet of delivery system <NUM> to aid in supplying the propellant fluid and/or a mixture of the propellant fluid and a hemostatic agent (or other agent) to a desired location. As will be described herein, a containment device <NUM> (e.g., a cartridge or container) may be contained within handle <NUM> (<FIG>). A cap <NUM> may be releasably attached to handle <NUM> and may control and/or assist in the attachment of containment device <NUM> to application device <NUM> within handle <NUM>. Cap <NUM> may be a proximalmost end of handle <NUM> in the instance that handle <NUM> is twisted onto delivery system <NUM> via threads positioned at a distal end of handle <NUM> (e.g., threads 30b on handle <NUM> and threads 26b on application device <NUM> shown in <FIG>). An example of delivery system <NUM> is shown in<CIT>.

With reference to <FIG> and <FIG>, containment device <NUM> is configured to contain a propellant fluid, such as a gas, e.g., carbon dioxide or any other propellant gas or fluid known in the art. While shown as a cylinder, containment device <NUM> may be any shape, such as a torpedo-shape, a sphere, or any other shape known in the art for containing gas. For example, containment device <NUM> could be a carbon dioxide cylinder for insertion into a lumen <NUM> of handle <NUM> (<FIG>). Containment device <NUM> includes one or more outer walls 50a defining one or more inner chambers 50b, inner chamber(s) 50b configured to contain the propellant fluid. Walls 50a of containment device <NUM> may be formed of any material suitable for containing the fluid, such as but not limited to a metal alloy, a ceramic, or other material known in the art. The fluid contained in inner chamber 50b of containment device <NUM> may be under pressure. Accordingly, walls 50a are formed of a material and/or a thickness suitable to contain the fluid at a pressure of, for example, at least approximately <NUM> bar (<NUM> pounds per square inch (PSI)), or approximately <NUM> bar (<NUM> pounds per square inch (PSI)), For example, gases which may be contained in containment device <NUM> include carbon dioxide (CO2) having a vapor pressure of approximately <NUM>,<NUM>-<NUM>,<NUM> kPa at typical device temperatures, or nitrogen (N2) having a vapor pressure less than <NUM> MPa at typical device temperatures. It will be understood that these gases are examples and are not limiting to the types of gases contained in containment device <NUM>.

With continued reference to <FIG>, application device <NUM> is attached to containment device <NUM> by inserting containment device <NUM> into lumen <NUM> of handle <NUM>. For example, an inlet (e.g., inlet <NUM> in <FIG> and <FIG>) of application device <NUM> may be connected directly to an output, such as a protuberance 30c (<FIG>, <FIG>, and <FIG>) of containment device <NUM> using a threaded connection, pressure washer adapter, or the like. Protuberance 30c of containment device <NUM> may extend into inlet <NUM> of application device <NUM> and connect, directly or indirectly, to a regulator (not shown). Directly connecting application device <NUM> to containment device <NUM> may be suitable for, e.g., a small-volume containment device <NUM> containing approximately <NUM> to <NUM> of compressed gas, or preferably approximately <NUM> to <NUM> of compressed gas, to allow for greater portability of delivery system <NUM>.

Referring to <FIG>, actuation of one or both of actuating devices <NUM>, <NUM> of application device <NUM> causes the fluid to exit delivery system <NUM> to a target site via tube <NUM>. It will be understood that only one actuating device <NUM>, <NUM> may need to be actuated in some embodiments. Actuation of one or both actuating devices <NUM>, <NUM> releases a buildup of pressure within delivery system <NUM>, causing the regulator to release fluid from containment device <NUM> at a predetermined pressure to delivery system <NUM> downstream of the regulator. Application device <NUM> may be, e.g., a garden-hose handle or other pistol-like configuration. Actuating devices <NUM>, <NUM> may be any push button, trigger mechanism, or other device that, when actuated, opens a valve and releases fluid, as will be described in greater detail herein.

Cap <NUM> may be attached to a proximal end of handle <NUM>, or handle <NUM> may be attached to a proximal end of application device <NUM> (see <FIG>) such that lumen <NUM> of handle <NUM> is fluidly sealed (absent the apertures described herein). Handle <NUM> may be attached to the proximal end of application device <NUM> using a threaded connection (e.g., threads 30b and 26b in <FIG>). For example, after containment device <NUM> is inserted into lumen <NUM>, handle <NUM> may be placed at the proximal end of application device <NUM>. An inner surface of a wall 30a at a proximal end of handle <NUM> may contact containment device <NUM>. Handle <NUM> may be twisted onto application device <NUM> via the threaded connection, e.g., threads 30b of handle <NUM> and threads 26b of application device <NUM>. In some instances, as handle <NUM> is twisted onto application device <NUM>, the proximal end of wall 30a may urge containment device <NUM> toward a pierce pin located at inlet <NUM> of application device <NUM>, such that a distal end 30c of containment device <NUM> moves into fluid communication with a fluid path of application device <NUM>. Alternatively, containment device <NUM> may be urged toward the pierce pin by cap <NUM> when cap <NUM> is attached to the proximal end of handle <NUM>, as in<CIT>.

In this manner, containment device <NUM> may be in fluid connection with the fluid path of application device <NUM>, and the fluid propellant may be used to supply an agent from application device <NUM> to a target site via tube <NUM>. As yet another example, a lever (not shown) may be used to urge containment device <NUM> in the distal direction to bring containment device <NUM> into fluid communication with the fluid path of application device <NUM>.

However, sealing containment device <NUM> within lumen <NUM> of handle <NUM> may cause fluid pressure to increase if containment device <NUM> is not properly connected to application device <NUM> (e.g., a leak in a seal, eroded threads, etc.) and/or if containment device <NUM> is damaged and leaks pressurized fluid into lumen <NUM>. Thus, there may be a need to vent fluid from lumen <NUM> to atmosphere (e.g., outside handle <NUM>).

With reference to <FIG> and <FIG>, apertures <NUM> are formed in sidewall 30a of handle <NUM>. Apertures <NUM> fluidly connect an outer surface of handle <NUM>, e.g., an atmosphere or a neutral atmosphere, to lumen <NUM> of handle <NUM>. Apertures <NUM> are rectangular in <FIG>, but are not limited to this shape. For example, apertures <NUM> may be circular, oval, triangular, curved, spiral, sinusoidal, or irregular. Apertures <NUM> may extend along an entire length of handle <NUM> from the proximal end to the distal end, or apertures <NUM> may be disposed on only a portion of handle <NUM>. Alternatively, apertures <NUM> may be placed asymmetrically about handle <NUM> based on ergonomics. For example, apertures <NUM> may be placed in areas of handle <NUM> where a user is less likely to grasp handle <NUM> during use. In this manner, apertures <NUM> may not be covered by a user's hand during use.

Apertures <NUM> may have a cross-sectional area sufficient to allow a fluid to pass from lumen <NUM> to the neutral atmosphere in the event fluid leaks from containment device <NUM> and does not pass into the fluid pathway of delivery system <NUM>. According to an example, apertures <NUM> may have a cross-sectional area large enough to permit fluid to escape within approximately <NUM> seconds. For example, once fluid is released into lumen <NUM> from containment device <NUM>, the fluid may be dispersed from lumen <NUM> within <NUM> seconds. For example, in the event containment device <NUM> is not properly attached to the fluid pathway of delivery system <NUM>, or in the event wall 50a of containment device <NUM> fails and pressurized fluid is released into lumen <NUM> of handle <NUM>, the pressurized fluid may be vented to atmosphere to prevent pressure buildup in handle <NUM>. In the absence of apertures <NUM>, pressure buildup within lumen <NUM> of handle <NUM> may cause wall 30a of handle <NUM> to burst, which may cause injury to the user and/or the patient.

For example, if the pressure of the fluid in lumen <NUM> is at room temperature (<NUM> degrees C) at an average pressure of <NUM> bar (<NUM> pounds per square inch (PSI)), and an opening in containment device <NUM> is approximately <NUM> (<NUM> inches) in diameter, sidewall 30a of handle <NUM> may rupture if the fluid is not vented within approximately <NUM> seconds. According to an example, a total cross-sectional area of all ventilation openings may be greater than approximately <NUM><NUM> (<NUM> square inches). In other words, a sum of the cross-sectional areas of each aperture <NUM> in handle <NUM> may be greater than approximately <NUM> mm2 (<NUM> square inches). This cross-sectional area of apertures <NUM> may provide a release of pressurized fluid equal to or less than approximately <NUM> seconds.

As one example, in the event aperture <NUM> is a single cylinder (extending through sidewall 30a from lumen <NUM> to atmosphere) having a circular cross-section, a minimum radius of the circular cross-section of aperture <NUM> may be determined based on Formula <NUM>. In Formula <NUM>, R is the radius of the circular cross-section of aperture <NUM>, Q is the flow rate of the fluid through aperture <NUM> in standard liters per minute (Q is predetermined value based at least in part on the time in which lumen <NUM> is to be vented, e.g., <NUM> seconds), η is the viscosity of the fluid flowing through aperture <NUM>, L is a thickness of handle <NUM> (e.g., a length of aperture <NUM> from lumen <NUM> to the atmosphere), and ΔP is a pressure difference (in bar or PSI) between a pressure inside lumen <NUM> and atmospheric pressure.

In some examples, a membrane (not shown) may cover each aperture <NUM>, or a burst disc or pressure relief valve may be used in place of one or more apertures <NUM>. The membrane may be provided on an outer surface and/or an inner surface of handle <NUM>, may be any color, and may be translucent or transparent. A material of the membrane may include preformed separation zones and/or or perforations to assist in rupturing at a threshold. The membrane may be made of a flexible material and/or a material suitable to rupture when a pressure within lumen <NUM> exceeds a threshold, e.g., greater than or equal to approximately <NUM> bar (<NUM> pounds per square inch (PSI)). In some examples, the pressure may change based on atmospheric pressure outside handle <NUM> (e.g., atmospheric pressure may change based on a location of use of the device). Similarly, a burst disc or pressure relief valve may open once the pressure with lumen <NUM> exceeds a threshold.

Apertures <NUM>' according to another example are shown in <FIG>. As discussed herein, containment device <NUM> may be attached to application device <NUM> via threads 30b on handle <NUM> and threads 26b on application device <NUM>. One or more apertures <NUM>' may be formed through and 26b. For example, apertures <NUM>' may extend from an opening <NUM>' at a proximalmost end of threads 26b to an opening <NUM>' at a distalmost end of threads 26b. Opening <NUM>' is open to and/or in fluid communication with the external atmosphere. In some instances, apertures <NUM>' may be formed by removing a portion of threads 26b at locations around a circumference of the threaded portion of application device <NUM>. That portion may be part of a regulator or pierce system. For example, threads 26b may be disconnected at a same circumferential location along an entire length of threads 26b to form apertures <NUM>', as shown in <FIG>. Alternatively, or additionally, apertures <NUM>' may be formed in threads 30b of handle <NUM>. In some instances, apertures <NUM>' formed on handle <NUM> may match up with apertures <NUM>' on application device <NUM> when handle <NUM> is completely attached to application device <NUM>. This may increase the cross-sectional area of apertures <NUM>', which may increase the ventilation of pressurized fluid from lumen <NUM>. In some cases, a membrane may cover one or both of openings <NUM>', <NUM>' of apertures <NUM>'. The membrane may be made of a flexible material and/or a material suitable to rupture when a pressure within lumen <NUM> exceeds a threshold, such as the pressures mentioned above.

Another example of a fluid release mechanism is shown with reference to <FIG> and <FIG>. Handle <NUM> includes a member <NUM> at the proximal most end of handle <NUM>. Member <NUM> includes crenellations <NUM>" (supports), and a plurality of apertures <NUM>" defined between adjacent crenellations <NUM>". In some instances, a portion or entirety of member <NUM> may include a material that increases a friction coefficient between member <NUM> and containment device <NUM> to assist in urging containment device <NUM> in the distal direction. As discussed herein, containment device <NUM> may be urged toward the pierce pin by an inner surface of handle <NUM> (e.g., cap <NUM> or the proximal end of handle <NUM>) as handle <NUM> is twisted onto application device <NUM>, or as cap <NUM> is twisted onto application device <NUM>. In this situation, crenellations <NUM>" may contact a proximalmost outer surface of containment device <NUM> and support device <NUM> above apertures <NUM>". As handle <NUM> and/or cap <NUM> are moved toward application device <NUM> via a twisting motion, crenellations <NUM>" may contact the proximal most outer surface of containment device <NUM> to aid in the movement of containment device <NUM> in the distal direction (e.g., in the direction indicated by arrow B in <FIG>). Crenellations <NUM>" may assist in moving containment device in the distal direction, and/or may aid in creating a space between an outermost surface of containment device <NUM> and an innermost surface of sidewall 30a. This space (e.g., a portion of lumen <NUM>) may allow any fluid escaping from containment device <NUM> to pass unimpeded to apertures <NUM>" and to an outside atmosphere, as discussed herein. It will be understood that any number of crenellations <NUM>" may be formed, for example, two, three, or more crenellations <NUM>".

A proximal-facing opening <NUM>" may be formed in member <NUM>. Opening <NUM>" is fluidly connected to each of apertures <NUM>", which are in turn fluidly connected to lumen <NUM> of handle <NUM>. When handle <NUM> is connected to application device <NUM>, apertures <NUM>" and opening <NUM>" allow any pressurized fluid buildup within lumen <NUM> to be vented to an atmosphere. In an example, venting may occur in approximately <NUM> seconds. For example, as discussed herein, an opening or an aperture may have a size of approximately <NUM><NUM> (<NUM> square inches). or greater to allow any fluid buildup to pass to the outside atmosphere. In this case, the sum of the cross-sectional areas of all apertures <NUM>" may be greater than or equal to <NUM><NUM> (<NUM> square inches). and the cross-sectional area of opening <NUM>" may be greater than or equal to approximately <NUM><NUM> (<NUM> square inches).

It will also be understood that any pathway formed between apertures <NUM>" and opening <NUM>" (e.g., a sidewall of member <NUM>) may have a cross-sectional area of greater than or equal to approximately <NUM><NUM> (<NUM> square inches). It will be understood that member <NUM> may be integral with handle <NUM>, and not a separate part or component. For example, crenellations <NUM>" may be formed integrally with handle <NUM>, e.g., integrally molded, leaving apertures <NUM>" and opening <NUM>" in the molding process.

While the apertures described herein have been described as having a total cross-sectional area of greater than or equal to approximately <NUM><NUM> (<NUM> square inches), it will be understood that this is an example and may change based on design factors. For example, pressurized fluid may be dispersed from lumen <NUM> in less than or equal to approximately <NUM> seconds. If the fluid is not dispersed from lumen <NUM> in this timeframe or other suitable timeframe depending on design factors (including the strength of sidewall 30a), the structural integrity of sidewall 30a may fail, causing injury. In some instances, containment device <NUM> may include a pressurized fluid greater than <NUM> bar (<NUM> pounds per square inch (PSI)), and/or delivery system <NUM> may be designed for use at a temperature different from room temperature (e.g., approximately <NUM> degrees C). In these instances, the apertures and openings described herein may be designed to have a cross-sectional area large enough to disperse the pressurized fluid in less than or equal to approximately <NUM> seconds, or other suitable timeframe, based on Formula <NUM> and the corresponding discussion above. It will also be understood that one or more of apertures <NUM>, <NUM>', and/or <NUM>" may be combined in a same delivery system <NUM> to provide fluid dispersement.

Claim 1:
A medical device (<NUM>) configured to dispense a hemostatic agent using a pressurized fluid, the device comprising:
a body having an input opening for receiving the pressurized fluid and an output opening for delivering the pressurized fluid;
a handle (<NUM>) defining a lumen (<NUM>), wherein the lumen (<NUM>) is configured to receive a container containing the pressurized fluid; and
at least one aperture (<NUM>) fluidly connecting the lumen (<NUM>) to an atmosphere external of the device and configured to vent fluid from the lumen (<NUM>) to the atmosphere external of the device, and
wherein the at least one aperture (<NUM>) is formed in a sidewall (30a) of the handle (<NUM>),
characterized in that a membrane covering each aperture (<NUM>) of the at least one aperture (<NUM>), and wherein the membrane is configured to rupture when a pressure of the pressurized fluid within the lumen (<NUM>) exceeds a threshold.