The disclosure relates generally to medical systems and devices for delivering pressurized fluids, and in examples, to methods and tools for controlling the release of a medical agent from a medical device using a pressurized fluid source.
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 materials or agents, e.g., hemostatic agents, optimally delivered to tissue at an appropriate pressure and/or flow rate, for the particular application.
Medical fluid delivery systems often require delivering a fluid from a high pressure storage tank, such as a cartridge or similar housing, to a target via a housing containing a medical agent. Controlling the delivery of the medical agent may require appropriate dosing or metering of the medical agent to provide accurate and safe doses of the medical agent to the target. This may require controlling the release of the pressurized fluid and/or the medical agent. 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 medical device configured to deliver a material using a pressurized fluid includes an enclosure having a first chamber and a second chamber separated by a membrane, and an outlet, and a pin configured to move within the enclosure between a first position and a second position, wherein a proximal end of the pin is configured to block the outlet when the pin is in the first position.
The membrane may include a plurality of apertures fluidly connecting the first chamber and the second chamber.
The second chamber may be configured to contain the material, and wherein the membrane may be configured to prevent the material from moving from the second chamber to the first chamber.
The first chamber may include an inlet, and wherein the pressurized fluid may be configured to flow into the first chamber via the inlet.
The pin may be configured to move from the first position when a pressure of the pressurized fluid exceeds a pressure threshold.
The device may further include a spring, wherein the spring may be configured to urge the pin in the first position.
The pin may be configured to move from the first position when a pressure of the pressurized fluid overcomes a spring force exerted by the spring on the pin.
The pin may be configured to move from the first position when a pressure of the pressurized fluid overcomes a spring force exerted by the spring on the pin and a pressure of an exterior atmosphere exerted on the pin.
A distance between the proximal end of the pin and the membrane when the pin is in the second position may be sufficient to allow at least a portion of the material to move into the outlet from the second chamber.
The pin may be configured to move from the second position to the first position when the pressure of the pressurized fluid is below the pressure threshold.
The pin may include a protrusion, wherein the protrusion may be configured to extend into an opening of the outlet in the first position, to be disposed entirely outside the opening of the outlet in the second position, and to be disposed at least partially within the opening of the outlet in a third position of the pin between the first and second positions, wherein the pressurized fluid is flowable from the second chamber through the opening and the material is not flowable from the second chamber through the opening, when the pin is in the third position.
The pin may be configured to be moved to a third position, between the first position and the second position, when a pressure of the pressurized fluid in the first chamber is greater than a first threshold and lower than a second threshold.
The pressurized fluid may be configured to pass from the first chamber into the second chamber when the pin is in the third position, but the material may be configured to remain within the second chamber when the pin is in the third position.
The device may further comprise an actuator configured to supply the pressurized fluid to the first chamber when the actuator is actuated.
The device may further include a body having an input opening for receiving the pressurized fluid and an output opening for delivering the pressurized fluid, the body defining a fluid path between the input opening and the output opening, and a handle configured to receive an enclosure containing the pressurized fluid, wherein the enclosure is configured to be attached to the body and form a portion of the fluid path between the input opening and the output opening.
According to another aspect, a medical device configured to deliver a material includes a body having an input opening for receiving a pressurized fluid and an output opening for delivering the material, an enclosure having a first chamber and a second chamber, a membrane including a plurality of apertures, wherein the membrane is disposed between the first chamber and the second chamber, and a pin configured to move within the enclosure between a first position and a second position, wherein the pin is configured to close the output opening in the first position.
The second chamber may be configured to contain a material, and wherein a diameter of each of the plurality of apertures may be configured to be less than a particle size of particles of the material.
The pin may include a protrusion extending from a proximalmost end of the pin, and wherein the protrusion may be configured to extend into the output opening in the first position.
A distance between the protrusion and the output opening in the second position may be sufficient to allow a material and the propellant fluid to pass from the second chamber into the output opening.
According to another aspect, a method for controlling a material delivery to a body of a patient includes actuating an actuator to cause an enclosure containing a pressurized fluid to release the pressurized fluid from the enclosure, supplying the material to a first chamber, causing a pin in a second chamber, adjacent the first chamber, to move from a closed position to an open position, wherein the open position is configured to allow mixture of a material in the second chamber and the propellant fluid to pass from the second chamber, and supplying the mixture of the material in the second chamber and the propellant fluid to a target site.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and together with the description, serve to explain the principles of the disclosed embodiments.
The disclosure is described with reference to exemplary medical systems for dispensing a material or an agent (such as a therapeutic or 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 supplying the material in a regulated amount to a target site. In examples, an enclosure containing a material or an agent may be supplied with a pressurized fluid to agitate the material and supply the material in a proper dosed amount.
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, and the term “distal” is used herein to refer to portions further away from the user or downstream in the propellant fluid path. 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 +/−10% of a stated or implied value. Additionally, terms that indicate the geometric shape of a component/surface refer only to approximate shapes.
Referring to
A containment device 50 (e.g., a cartridge or enclosure) may be contained within, or otherwise attached to, handle 30. Containment device 50 is configured to contain a propellant fluid, such as a gas, e.g., carbon dioxide or any other gas or fluid known in the art for dispensing material, such as a medical powder or reagent, into a patient at a target location. While shown as a torpedo-shape, containment device 50 may be any shape, such as a sphere, or any other shape known in the art for containing gas. For example, containment device 50 may be a carbon dioxide tank or cylinder typically found in medical settings, such as a hospital, and may be connected to application device 20 by a conduit (not shown). Containment device 50 includes one or more outer walls defining one or more inner chambers (not shown), the inner chamber(s) configured to contain the propellant fluid. The walls of containment device 50 may be formed of any material suitable for containing the propellant fluid, such as but not limited to a metal alloy, a ceramic, or other material known in the art. The propellant fluid contained in the inner chamber of containment device 50 may be under pressure. Accordingly, the walls are formed of a material and/or a thickness suitable to contain the propellant fluid at a pressure of, for example, approximately 1200 pounds per square inch (PSI), or approximately 850 PSI or less. For example, gases which may be contained in containment device 20 include carbon dioxide (CO2) having a vapor pressure of approximately 2,000-8,000 kPa at typical device temperatures, or nitrogen (N2) having a vapor pressure less than 40 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 50.
With continued reference to
In some cases, a cap 33 may be releasably attached to a proximalmost end of handle 30 and may control and/or assist in the attachment of containment device 50 to application device 20 within handle 30. In some instances, cap 33 may contact a proximalmost end of containment device 50 and may move or urge containment device 50 toward an inlet 32 of application device 20. Cap 33 may provide additional support to secure containment device 50 to application device 20. In some cases, cap 33 may be movably connected to handle 30 and may include a lever or similar handle (not shown) connected thereto. Movement of the lever may cause cap 33 to move in a proximal and a distal direction relative to handle 30. This movement may move containment device 50 toward and away from attachment device 38.
Once containment device 50 is attached to application device 20, actuation of one or more actuation devices 36 (only a single actuation device 36 is shown in
As discussed above, one or more regulators 40 may assist in regulating an amount of propellant fluid released from containment device 20 at a specific pressure. For example, regulator 40 may be a dual stage regulator, or regulator 40 may be two single stage regulators, such as two piston regulators, aligned in series. Attachment device 38 may include a pierce pin to pierce a seal of containment device 50 when containment device 50 is attached to application device 20. A propellant fluid pressure may further be adjusted by a membrane regulator 44 provided in series after regulator 40. The combination of regulator 40 and membrane regulator 44 may reduce the pressure of gas from containment device 20 to an acceptable outlet pressure, i.e., a pressure of the gas and any material at outlet 34. A pressure of a gas within delivery system 10, after regulators 40, 44 in tubes 48 of application device 20, and at a target area in a patient, may be predetermined, based on the tissue to which the gas and material is being dispensed. Alternatively, or additionally, the pressure of the gas after regulators 40, 44 may be determined, at least in part, on a pressure necessary to open a valve in an enclosure storing an agent, as will be described herein. An acceptable pressure at outlet 34 may be approximately plus or minus 40% deviation from the target pressure, or approximately plus or minus 25% deviation from the target pressure. For example, regulator 40 may reduce inlet pressure of the dispensing propellant fluid to approximately 50-150 PSI, and membrane regulator 44 may subsequently reduce the propellant fluid to approximately 30-40 PSI. According to an example, regulator 40 and membrane regulator 44 reduce the propellant fluid to the desired output pressure of the propellant fluid based on a predetermined setting during manufacturing. Alternatively, or additionally, one or both of regulator 40 and membrane regulator 44 may include a mechanism (not shown) for adjusting the pressure of the propellant fluid output from each regulator. Further, the pressure of the propellant fluid at an outlet of membrane regulator 44 may be approximately equal to the pressure of the propellant fluid at outlet 34. Alternatively, the pressure of the propellant fluid at outlet 34 may be different from the pressure of the propellant fluid at the outlet of membrane regulator 44. In some cases, a burst or safety valve 22 may be in the fluid path of tubes 48, which may burst or release if a pressure of the propellant fluid downstream of regulators 40, 44 is greater the threshold. An example of delivery system 10, including one or more features described above, is shown in U.S. application Ser. No. 16/589,633, filed Oct. 1, 2019, the entirety of which is incorporated herein by reference.
As shown in
With continued reference to
A pin 70 may extend into and may be movable relative to chamber 66. A lumen 72 is defined through a top wall of body 62 in
A cap 63 may cover a topmost portion of body 62, as shown in
With reference to
With reference to
With continued reference to
When the propellant fluid is not activated and is not flowing into chamber 68, or when the propellant fluid flowing into chamber 68 is below a threshold, such as a pressure sufficient to overcome the spring force of spring 74 and/or the pressure of the exterior atmosphere, pin 70 remains in the closed position (
A method of applying an agent (e.g., a medical agent or a hemostatic agent) to a target site using medical system 10 will be described with reference to
Once the propellant gas supply is fluidly connected to application device 20, a user may activate medical system 10 by actuating one or more actuation devices 36. Actuation of the one or more actuation devices 36 causes propellant fluid to flow from containment device 50, through regulators 40, 44 and along tube 48, and into chamber 68, as shown by arrow A in
In some cases, the proximalmost end of pin 70 covers every aperture 78. In other cases, some (or all) of apertures 78 are uncovered or only partially covered by pin 70. As the propellant gas passes into chamber 66 via apertures 78 (in the direction indicated by arrow B), the propellant fluid mixes with material P. In some cases, the propellant fluid may mix with material P before pin 70 is moved from the closed position to the open position. Once pin 70 is in the open position, as shown in
With reference to
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It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed device without departing from the scope of the disclosure. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
This application claims the benefit of priority of U.S. Provisional Patent Application No. 63/081,057, filed Sep. 21, 2020, the entirety of which is incorporated herein by reference.
Number | Date | Country | |
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63081057 | Sep 2020 | US |