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

<CIT> discloses an apparatus for delivering a powdered agent into a subject's body. The apparatus includes a first passage for receiving a pressurized gas and a container housing a powdered agent.

Conventional endoscopic devices and methods for dispensing fluids, powders, and/or reagents in a patient include advancing a catheter to a target site within the patient and subsequently dispensing the fluid. Drawbacks of conventional devices include, for example, clogging of the catheter with the fluid or powder, large variations in the flow rate and pressures of fluids during dispensing, and inconsistency in the material dispensed at the target site. These drawbacks may prevent a proper amount of fluid and/or material from being expelled at a target location and/or may prevent dosing of material, thereby decreasing the accuracy and increasing the time and cost of procedures using these conventional devices. The scope of the disclosure, however, is defined by the attached claims and not the ability to solve a specific problem.

The present invention is defined by independent claim <NUM>. Optional embodiments are disclosed in the dependent claims. According to an aspect, a medical system includes a handle having (<NUM>) a handle chamber including an outlet and (<NUM>) a barrel extending into the handle chamber and defining a lumen having a longitudinal axis, and a spindle movably disposed within the lumen of the barrel, wherein the spindle includes a plurality of spindle enclosures, and wherein the spindle is configured to move between a first configuration, in which at least a portion of each of the plurality of spindle enclosures is positioned within a first portion of the lumen within the handle chamber, and a second configuration, in which at least the portion of each of the plurality of spindle enclosures is positioned in a second portion of the lumen outside the handle chamber.

The medical system may further include an inlet proximal the distal end of the handle chamber, wherein the inlet may be configured to receive a propellant fluid.

The medical system may further include a containment device configured to contain the propellant fluid, and an actuator configured to be actuated between a first state, wherein the propellant fluid may be supplied from the containment device to the handle chamber, and a second state, wherein the propellant fluid may not be supplied to the handle chamber.

The plurality of spindle enclosures may be radially disposed around a central axis of the spindle.

The medical system may further include a locking mechanism configured to allow the spindle to rotate about the longitudinal axis of the lumen of the barrel when the spindle is in the first configuration or in the second configuration, and to prevent the spindle from rotating about the longitudinal axis of the lumen of the barrel when the spindle translates between the first and the second configurations.

The handle chamber may be tapered toward a distal end of the handle chamber.

The barrel may include an opening fluidly connecting the lumen to the handle chamber.

The opening of the barrel may be disposed within the handle chamber.

The distal opening may have a same size as an opening of each of the plurality of spindle enclosures.

The barrel may include an opening on an exterior of the handle and configured to be in fluid communication with one of the plurality of spindle enclosures when the spindle is in the second configuration.

The spindle may be configured to slide along the barrel parallel to the longitudinal axis, and wherein the spindle may be configured to rotate within the barrel about the longitudinal axis.

The spindle may include a first seal disposed on a first side of the plurality of spindle enclosures along a longitudinal axis of the spindle, and a second seal disposed on a second side of the plurality of spindle enclosures along the longitudinal axis of the spindle, wherein the second side is opposite the first side.

The medical system may further include a catheter extending from the outlet.

A propellant fluid may be configured to mix with a medical agent in the handle chamber dispensed by one or more of the plurality of spindle enclosures, and wherein the mixture may be configured to be supplied to a target site via the catheter.

The handle chamber may include a proximal opening at a proximal end of the handle, and wherein the medical system may further include a cover configured to seal the proximal opening.

According to another aspect, a medical device may include a handle having (<NUM>) a handle chamber including an outlet and a propellant fluid inlet proximate a distal end of the handle chamber and (<NUM>) a barrel extending into the handle chamber and defining a lumen having a longitudinal axis and a distal opening fluidly connecting the lumen with the handle chamber, and a spindle rotatable and longitudinally movable within the lumen of the barrel, wherein the spindle includes a plurality of enclosures, wherein one or more of the plurality of enclosures are configured to contain a medical agent, wherein the medical agent is configured to be dispensed from the one or more of the plurality of enclosures to the handle chamber when the one or more of the plurality of enclosures are aligned with the distal opening.

The barrel may further comprise a fill opening disposed outside the handle chamber, wherein the spindle may be configured to move within the lumen between a first state, in which one of the plurality of enclosures is aligned with the fill opening, and a second state, in which one of the plurality enclosures is aligned with the distal opening, and wherein the spindle further includes a locking mechanism configured to allow the spindle to rotate within the lumen of the barrel when the spindle is in the first configuration or in the second configuration, and may prevent the spindle from rotating within the lumen of the barrel when the spindle translates between the first and the second configurations.

According to another aspect, a method for performing a medical treatment in a body may include inserting a catheter, connected at a proximal end to a handle, through an opening in the body, and advancing the catheter to a target site, rotating a spindle within a lumen of a barrel about a longitudinal axis of the lumen, wherein the spindle includes a plurality of enclosures arranged radially about the spindle, supplying a medical agent from one or more of the plurality of enclosures to the handle chamber, wherein the medical agent is configured to mix with the propellant fluid, supplying a propellant fluid to a handle chamber of the handle, and supplying the mixture of the medical agent and the propellant gas to the target site via the catheter.

The method may further include dispensing the medical agent into one or more of the plurality of enclosures via a fill opening in the barrel prior to supplying the medical agent to the handle chamber.

The method may further include sliding the spindle along a longitudinal axis of the barrel between a first state, in which the medical agent is dispensed into the one or more of the plurality of enclosures via the fill opening, and a second state, in which the medical agent is dispensed from one or more of the plurality of enclosures via the distal opening.

This disclosure is now described with reference to exemplary medical devices that may be used in dispensing materials. However, it should be noted that reference to any particular procedure is provided 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 devices and application methods may be utilized in any suitable procedure, medical or otherwise. This 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.

For ease of description, portions/regions/ends of a device and/or its components are referred to as proximal and distal ends/regions. It should be noted that the term "proximal," as it relates to an application device, is intended to refer to ends/regions closer to an inlet of a propellant gas to the application device (e.g., at a location of the application device where the propellant gas is released from a containment device into the application device), and the term "distal," as it relates to an application device, is used herein to refer to ends/regions where the propellant gas and/or any material is released from the application device to a target area or, if a catheter is attached to the application device, from the catheter to the target area. "Proximal" therefore refers to areas closer to a user of the device, and "distal" refers to areas further from a user of the device. Similarly, extends "distally" indicates that a component extends in a distal direction, and extends "proximally" indicates that a component extends in a proximal direction. 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. In this disclosure, relative terms, such as, for example, "about," "substantially," "generally," and "approximately" are used to indicate a possible variation of ±<NUM>% in a stated value or characteristic.

Referring to <FIG>, a medical system <NUM> (e.g., a delivery system) according to an embodiment is shown. Medical system <NUM> includes a handle having a body <NUM>, a catheter <NUM> connected to a distal end of body <NUM>, and a containment device <NUM> connected to body <NUM> via a tube <NUM>. It is desirable for material to be properly and consistently dispensed to the target location, and medical system <NUM> may solve one or more of these problems or other problems in the art.

Containment device <NUM> may include any fluid for delivering powder, fluid, or other particles contained within body <NUM> to a target site. For example, the fluid contained in containment device <NUM> may include carbon dioxide (CO<NUM>) or any other known delivery fluid, such as oxygen or nitrogen. The fluid may be pressurized, for example, to a pressure of approximately <NUM> bar (approximately <NUM> pounds per square inch (PSI)) to a pressure of approximately <NUM>,<NUM> bar (approximately <NUM> PSI). Containment device <NUM> may include an actuator (e.g., a trigger device) (not shown) for actuating the release of the fluid from containment device <NUM>. Alternatively, or additionally, an actuator (not shown) may be provided along tube <NUM> and/or on body <NUM> to actuate the release of fluid from containment device <NUM> during use. Containment device <NUM> may include any structure and material suitable for containing pressurized propellant fluids. Containment device <NUM> may also be a propellant fluid line connected to a centralized propellant fluid source, e.g., a propellant fluid line in a hospital or other medical center.

Containment device <NUM> may be connected to body <NUM> via tube <NUM>. Tube <NUM> may be flexible or inflexible, and may be any shape and size. Tube <NUM> may include a medical-grade resin, a medical-grade metal, or any other material suitable for dispersing propellant fluid from containment device <NUM> to body <NUM>. An actuator device (not shown) may be attached to tube <NUM>, which may be actuated to release fluid from containment device <NUM> to body <NUM>.

Catheter <NUM> may extend from the distal end of body <NUM>. Catheter <NUM> may transport a mixture of propellant fluid and medicament, particles, and/or other fluid from body <NUM> to a target site via a lumen <NUM> (<FIG>). As discussed herein, a distal tip <NUM> may be advanced to a target site, e.g., a target site within a patient, and the mixture of propellant fluid and other fluid or solid (e.g., in the form of particles) from body <NUM> may be applied to the target site. Catheter <NUM> may comprise any medical-grade material suitable for insertion into a human body. Catheter <NUM> may be flexible to access tortuous paths within the body, and/or may have sufficient rigidity to be pushed distally into a patient. In some embodiments, distal tip <NUM> may be an articulation tip and may be articulated in one or more directions around a longitudinal axis of catheter <NUM>. Alternatively, or additionally, catheter <NUM> may be introduced to a patient via an endoscope device. For example, a sheath of an endoscope device
may be positioned within the patient, and catheter <NUM> may be advanced along a lumen of the sheath and out a distal opening of the lumen. In this manner, the fluid mixture from body <NUM> may be supplied to the target site. The mixture may be supplied to the target site at a rate of approximately <NUM>-<NUM> liters/minute, although other application rates may be used.

With reference to <FIG>, body <NUM> of handle <NUM> includes a chamber <NUM> and a barrel (e.g., a shaft having a central lumen) <NUM>, and a spindle <NUM> extending through the central lumen of barrel <NUM> into chamber <NUM>. A cap <NUM> is provided at a proximal end of body <NUM> and seals chamber <NUM> from an outer atmosphere. Cap <NUM> may be any shape and may conform to a shape of body <NUM>. For example, body <NUM> may be cylindrically shaped, and cap <NUM> may have a similar cylindrical shape. According to examples, cap <NUM> may be flush with a radially outer surface of body <NUM>, or cap <NUM> may extend past the radially outer surface of body <NUM> to allow a user to grasp cap <NUM> and remove cap <NUM>. Cap <NUM> may include a protrusion 24a which may conform to a shape of an outer wall of chamber <NUM>. For example, protrusion 24a may extend at least partially into chamber <NUM> to affix cap <NUM> to body <NUM>. Cap <NUM> may be attached in any manner, e.g., via a friction fit between protrusion 24a and the outer wall of chamber <NUM>, via an adhesive, or via other attachment means. Further, cap <NUM> may be removably affixed to body <NUM>, or may be welded or otherwise permanently affixed to body <NUM>. Cap <NUM> may be attached in a manner that sustains sufficient pressures within chamber <NUM> such that cap <NUM> maintains a proper seal when the propellant fluid is introduced into chamber <NUM>. For example, a pressure within chamber <NUM> may be approximately <NUM> bar (approximately <NUM> PSI) to approximately <NUM>,<NUM> bar (approximately <NUM> PSI) when the propellant fluid is supplied to chamber <NUM>. In one example, chamber <NUM> may have
volume approximately equal to the volume equivalent of one gram of the medical agent.

Spindle <NUM> is described with reference to <FIG>, <FIG>, and <FIG>. Spindle <NUM> is generally cylindrical and is configured to rotate within barrel <NUM>, about a longitudinal axis A and to move longitudinally along longitudinal axis A of barrel <NUM>, as will be described herein. At a first end, spindle <NUM> includes a handle <NUM> and a body <NUM> extending from handle <NUM>. Handle <NUM> may be any shape, and is configured to be grasped by a user to move spindle <NUM> relative to barrel <NUM>. Handle <NUM> may have a diameter greater than an outer diameter of the lumen of barrel <NUM>. For example, handle <NUM> may contact an outer surface of barrel <NUM> to prevent movement of spindle <NUM> into barrel <NUM> along longitudinal axis A. In another example, body <NUM> of spindle <NUM> may have a length greater than a length of the lumen of barrel <NUM> such that handle <NUM> does not contact barrel <NUM>.

Body <NUM> of spindle <NUM> includes a plurality of enclosures (e.g., spindle enclosures) <NUM> at an end of spindle <NUM> opposite handle <NUM>. Enclosures <NUM> are arranged radially about spindle <NUM> and are configured to receive and dispense a medical agent, e.g., a powder, a fluid, or the like. Enclosures <NUM> may be sized to receive a specific amount of the medical agent. For example, each enclosure <NUM> may have a size equal to a predetermined dose, such that a user filling each enclosure <NUM> will understand the amount of medical agent that will be dispensed to the patient using each enclosure <NUM>. In some cases, each enclosure <NUM> may contain a portion of the total dose of the medical agent. For example, if there are ten enclosures, each enclosure <NUM> may contain <NUM>% of the total dosage. In this manner, the user may administer the medical agent at a known rate, e.g., <NUM>% of the total dosage at a time. Alternatively, or additionally, the user may determine that only a portion of the total dosage is necessary. Thus, a user may empty only some of enclosure <NUM> into chamber <NUM>, such that the patient is administered only a portion of the dose. The number of enclosures <NUM> used for delivery may be determined based on a medical procedure or the like to allow the user to select different doses of the medical agent for delivery to the patient, based on patient feedback or other feedback (e.g., via sensor, tests, or the like). Additionally, or alternatively, enclosures <NUM> may have difference sizes or volumes to provide different dosages. Additionally, handle <NUM> may include a label or other indication indicating the dosage and/or the chamber being used. In this manner, a user may better understand how much medical agent is administered during a procedure.

Body <NUM> may also include one or more seals 32a. Seals 32a may include a rubber gasket, an O-ring, or any like sealing device. Seals 32a may be disposed on either side of enclosures <NUM> along longitudinal axis A and may prevent the medical agent contained within enclosures <NUM> from being released as spindle <NUM> is moved along longitudinal axis A, as will be described herein. Seals 32a may include a square cross-sectional shape for sealing contact with inner surface of barrel <NUM>.

Spindle <NUM> may further include a locking mechanism <NUM>, which may prevent spindle <NUM> from rotating about longitudinal axis A when the end of spindle <NUM> opposite handle <NUM> is not flush against a sidewall of barrel <NUM> opposite the opening of the lumen in barrel <NUM> (e.g., the closed position). Locking mechanism <NUM> may prevent spindle <NUM> from dispensing the medical agent until enclosures <NUM> are disposed entirely within chamber <NUM>. In this manner, it may be possible to ensure that all of the medical agent is dispensed into chamber <NUM>, such that the medical agent may be properly administered to the patient. Locking mechanism <NUM> may also allow spindle <NUM> to rotate about longitudinal axis A when enclosures <NUM> are aligned with a proximally facing opening <NUM> in barrel <NUM> (e.g., an open configuration or a second configuration), as will be described herein. In this manner, enclosures <NUM> may be filled with the medical agent. Alternatively, or additionally, markers may be arranged on spindle <NUM> and barrel <NUM>. The markers may, for example, indicate which number enclosure <NUM> is aligned with distally facing opening <NUM> (see <FIG>, <FIG>, and <FIG>). To deliver the medical agent stored from the number two enclosure <NUM> to chamber <NUM>, for example, a user may rotate spindle <NUM> to align marker "<NUM>" with the marker on barrel <NUM>. Subsequently, the user may rotate spindle <NUM> to align marker "<NUM>" with the marker on barrel <NUM>, and may continue this process until the desired amount of the medical agent is supplied to the target site.

With continued reference to <FIG>, <FIG>, and <FIG>, barrel <NUM> includes proximally facing opening <NUM> (e.g., a first opening or a fill inlet) and distally facing opening <NUM> (e.g., a second opening or an outlet). Opening <NUM> is configured to receive the medical agent and deliver the medical agent to enclosures <NUM> when enclosures <NUM> are aligned with opening <NUM> in the open configuration. Openings <NUM> and <NUM> are on opposite sides of barrel <NUM>. Opening <NUM> may be any size or shape suitable for filling enclosures <NUM>. After an enclosure <NUM> is filled via opening <NUM>, the user may rotate spindle <NUM> via handle <NUM> until each enclosure <NUM> is filled. In some instances, it may be desired that only some of enclosures <NUM> are filled with the medical agent.

Opening <NUM> is configured to allow the medical agent in enclosures <NUM> to be emptied into chamber <NUM>. As will be described herein, spindle <NUM> may be rotated about longitudinal axis A when in a closed configuration (e.g., a first configuration). As spindle <NUM> is rotated and an enclosure <NUM> is aligned with opening <NUM>, the medical agent contained within that enclosure <NUM> may be emptied into chamber <NUM> via, e.g., gravity. Opening <NUM> may be any size and shape suitable for emptying the medical agent from enclosures <NUM>. In one example, opening <NUM> may be equal to or greater than a size and an area of enclosures <NUM>. In another instance, the size and the area of opening <NUM> may be less than the size and the area of enclosures <NUM>. The side walls of opening <NUM> may be tapered outwardly to allow the medical agent to pass from the enclosures <NUM> into chamber <NUM>. It will be understood that enclosures <NUM> not aligned with opening <NUM> are fluidly sealed from chamber <NUM>. As spindle <NUM> is rotated, each enclosure <NUM> is aligned with opening <NUM>. Each enclosure <NUM> aligned with opening <NUM> is fluidly coupled to chamber <NUM> only while enclosure <NUM> is aligned with opening <NUM>.

With continued reference to <FIG>, <FIG>, and <FIG>, chamber <NUM> is generally cylindrical in shape with a distal portion <NUM> having a cone or funnel shape. Chamber <NUM> is bisected by barrel <NUM>, which passes into chamber <NUM> via an opening (not shown). In this manner, opening <NUM> is positioned in chamber <NUM> to allow the medical agent to be dispensed into chamber <NUM>.

Distal portion <NUM> tapers in a distal direction away from chamber <NUM>. A distal opening 72a (<FIG>) connects distal portion <NUM> to catheter <NUM>. An opening 54a in a sidewall of distal portion <NUM> allows tube <NUM> to be connected to chamber <NUM> and to form a fluid path from containment device <NUM> to chamber <NUM>. In this manner, propellant fluid may travel from containment device <NUM> to chamber <NUM>, mix with the medical agent released from enclosures <NUM>, and the mixture may travel along catheter <NUM> to the target site.

An example of filling enclosures <NUM> and dispensing the medical agent from enclosures <NUM> will be described with reference to <FIG>, <FIG>, and <FIG>. In some instances, medical system <NUM> is not preloaded with the medical agent. In this case, the user may fill one or more of enclosures <NUM>. As shown in <FIG>, spindle <NUM> is moved along longitudinal axis A to the open configuration, such that one of the plurality of enclosures <NUM> is aligned with opening <NUM>. The user may deposit the medical agent into enclosure <NUM> via opening <NUM>. Subsequently, the user may rotate spindle <NUM> via handle <NUM> in a clockwise direction such that an adjacent enclosure <NUM> is aligned with opening <NUM>. The user may deposit the medical agent in the adjacent enclosure. The user may continue to perform these steps until each of enclosures <NUM> are filled with the medical agent. Alternatively, the user may fill only some of enclosures <NUM>. It will be understood that different medical agents may be used in some of enclosures <NUM>, according to a desired medical treatment.

Once enclosures <NUM> are filled with the medical agent, the user may slide spindle <NUM> along longitudinal axis A to the closed position, as shown in <FIG> and <FIG>. In the event each enclosure <NUM> is filled with the medical agent, moving spindle <NUM> to the closed position will result in the medical agent in enclosure <NUM> aligned with opening <NUM> to be deposited into distal portion <NUM>. In some instances, spindle <NUM> is rotated to align one of the enclosures <NUM> without the medical agent to be pointed in the distal direction prior to moving spindle <NUM> to the closed position. In this manner, the medical agent may not be deposited into distal portion <NUM> until the propellant fluid is supplied from containment device <NUM>. Once spindle <NUM> is moved to the closed configuration, the medical agent may be supplied to the target tissue.

For example, a method of applying the medical agent to the target site will now be described with reference to <FIG> and <FIG>. Distal tip <NUM> of catheter <NUM> is inserted into a patient via an opening in the body, e.g., an incision or a natural orifice. Alternatively, catheter <NUM> may be inserted through a prepositioned scope, e.g., an endoscope, an ureteroscope, or the like. Distal tip <NUM> is advanced to the target site. Imaging devices associated with the scope and/or external devices may be used to assist in positioning distal tip <NUM> at the target site.

Once distal tip <NUM> is positioned at the target site and spindle <NUM> is in the closed configuration, the actuator is actuated to release propellant fluid from containment device <NUM> to chamber <NUM>, via tube <NUM>. At this time, spindle <NUM> is in the closed configuration and enclosure <NUM> aligned with opening <NUM> is empty. The user may subsequently rotate spindle <NUM> via handle <NUM> such that an adjacent enclosure <NUM> is aligned with opening <NUM> (e.g., spindle <NUM> may be rotated clockwise). As the adjacent enclosure <NUM> is aligned with opening <NUM>, the medical agent is dispensed from enclosure <NUM> through opening <NUM> and into distal portion <NUM> of chamber <NUM> via, e.g., gravity. As the medical agent is dispensed toward distal portion <NUM>, the propellant fluid entering distal portion <NUM> via tube <NUM> mixes with the medical agent. The medical agent and propellant fluid mixture is supplied from distal portion <NUM>, through catheter <NUM>, to the target site. Alternatively, the user may dispense the medical agent into distal portion <NUM> of chamber <NUM> before actuating the propellant gas. Once the medical agent is dispensed in chamber <NUM>, the user may then actuate the propellant gas as described herein.

In the event the user wishes to supply additional medical agent to the target site, the user may again rotate spindle <NUM> in the clockwise or counterclockwise direction to the next adjacent enclosure <NUM>. The medical agent from this enclosure <NUM> is dispensed into distal portion <NUM> and supplied to the target site, as described above. The user may continue to rotate spindle <NUM> until a desired amount of the medical agent is dispensed from enclosures <NUM> and supplied to the target site. Once the user determines that a sufficient amount of the medical agent has been supplied to the target site, the user may activate the actuator to turn of supply of the propellant gas to chamber <NUM>. In this manner, enclosures <NUM> may be prefilled with a medical agent and the user may dispense the medical agent from each of enclosures <NUM> and supply all of the medical agent from enclosures <NUM> to the target site, or may select to dispense the medical agent from less than all of enclosures <NUM> and supply only a portion of the total amount of medical agent stored in enclosures <NUM> to the target site.

It will be understood that, unless specifically set forth herein, any material known in the art may be used for the various elements. For example, features may include a medical grade plastic or rubber, a ceramic, a metal, or a combination thereof.

Claim 1:
A medical system (<NUM>), comprising:
a handle (<NUM>) having (a) a handle chamber (<NUM>) including an outlet and (b) a barrel (<NUM>) extending into the handle chamber and defining a lumen having a longitudinal axis; and
a spindle (<NUM>) movably disposed within the lumen of the barrel (<NUM>), wherein the spindle (<NUM>) includes a plurality of spindle enclosures (<NUM>), and wherein the spindle (<NUM>) is configured to move between a first configuration, in which at least a portion of each of the plurality of spindle enclosures is positioned within a first portion of the lumen within the handle chamber, and a second configuration, in which at least the portion of each of the plurality of spindle enclosures is positioned in a second portion of the lumen outside the handle chamber,
wherein the barrel (<NUM>) includes an opening (<NUM>) on an exterior of the handle (<NUM>) and configured to be in fluid communication with one of the plurality of spindle enclosures when the spindle (<NUM>) is in the second configuration.