Device, assembly and method for delivering a powder

Abstract

A pressure relief mechanism includes a first housing including a first body defined between a first wall and a second wall, a cavity disposed within the first body and configured to receive a pressure relief device, a first lip extending from the first wall, and a second lip extending from the second wall. The pressure relief mechanism includes a second housing including a second body between a third wall and a fourth wall, a first protrusion extending from the third wall, and a second protrusion extending from the fourth wall. The first protrusion engages the first lip and the second protrusion engages the second lip to couple the first housing to the second housing with the pressure relief device enclosed within the cavity. The first housing and the second housing are configured to apply a clamping force along a perimeter of the pressure release device to seal the pressure release device between the first housing and the second housing.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 371,437, filed on August 15, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] Various aspects of the present disclosure are generally directed to devices for delivering agents. More specifically, in embodiments, the present disclosure is directed to a pressure release mechanism incorporated into a device for delivering a powdered agent, such as a hemostatic agent. Background Art

[0003] In certain medical procedures, it may be necessary to minimize or stop bleeding in the body. For example, endoscopic medical procedures may require hemostasis of bleeding tissue within the gastrointestinal tract, such as the esophagus, stomach, or intestines. During endoscopic surgery, a user inserts a sheath of an endoscope into a patient's body cavity. The user controls the endoscope during surgery using the handle of the endoscope. Tools can be passed through a working channel of the endoscope (e.g., a port in the handle) to perform treatment at a surgical site near the distal end of the endoscope. The surgical site is distal to the user.

[0004] In order to achieve hemostasis at the distal site, a hemostatic agent can be delivered by a device inserted into the working channel of the endoscope. For example, the delivery of the preparation can be achieved by using a pressurized fluid, which passes the preparation through the device and moves it to the distal site. However, such a system may not be able to achieve the desired preparation delivery rate or the desired preparation dosage, may cause the preparation to block some parts of the delivery device, may cause inconsistent preparation dosages, and / or when the pressurized fluid exceeds the required pressurization level, may cause the preparation to be unable to reach the treatment site deep in the gastrointestinal tract. A pressure release mechanism can ensure that the pressurized fluid is delivered at the required pressurization level, but the box body of the mechanism may be complex, large, or require many tools or steps to assemble. The current disclosure can solve one or more of these problems or other problems in the art. Summary of the invention

[0005] Each aspect disclosed herein may include one or more features described in relation to any other disclosed aspect.

[0006] Aspects of the present disclosure relate to systems, devices, and methods related to a pressure release mechanism that is incorporated into a dispensing device used to deliver various formulations (eg, powdered formulations) to a treatment site within a patient during certain medical procedures. According to an example, a pressure release mechanism may include: a first shell, the first shell including a first body defined between a first wall and a second wall opposite to the first wall, a cavity arranged in the first body between the first wall and the second wall (wherein the first body is configured to receive a pressure release device in the cavity), a first lip extending outward from the first wall, and a second lip extending outward from the second wall; and a second shell, the second shell including a second body defined between a third wall and a fourth wall opposite to the third wall, a first protrusion extending outward from the third wall, and a second protrusion extending outward from the fourth wall, wherein the first protrusion is configured to engage the first lip and the second protrusion is configured to engage the second lip to connect the first shell to the second shell while enclosing the pressure release device in the cavity, wherein the first shell and the second shell are configured to apply a clamping force along the periphery of the pressure release device to fluid-seal the pressure release device between the first shell and the second shell.

[0007] Any of the pressure release mechanisms described herein may include any of the following features. The first housing includes an input port disposed through a front wall of the first body, and an output port disposed through a rear wall of the first body, wherein each of the input port and the output port is in fluid communication with the cavity. The first housing is configured to receive a pressurized fluid in the cavity through the input port, and to release the pressurized fluid from the cavity through the output port. The first protrusion includes a tapered clip configured to form a snap-fit ​​connection with the first lip, such that when the tapered clip is coupled to the first lip, the second housing is immovable relative to the first housing. The tapered clip is elastically deformable and is configured to bend laterally outward relative to the third wall when the second housing is coupled to the first housing to form a snap-fit ​​connection. The tapered clip of the first protrusion includes a hook extending from the third wall to the fourth wall, and wherein the hook is configured to engage a lower interface of the first lip. The second protrusion includes a circular clip configured to form an articulated connection with the second lip, such that when the circular clip is coupled to the second lip, the second housing can move relative to the first housing about the articulated connection. The circular clip of the second protrusion includes a ball joint extending from the fourth wall to the third wall, wherein the ball joint is configured to pivot about an axis when received along the lower interface of the second lip. The second housing is configured to move about an axis between a first position and a second position relative to the first housing. In the first position, the first protrusion is disengaged from the lower interface of the first lip, and in the second position, the first protrusion is engaged with the lower interface of the first lip. The first housing includes at least one recessed surface along the second wall, the at least one recessed surface forming a first inner wall and a second inner wall positioned opposite to the first inner wall. The second protrusion of the second housing has a width corresponding to the distance between the first inner wall and the second inner wall, so that the second protrusion is configured to fit between the first inner wall and the second inner wall when the second protrusion is engaged with the second lip. The first inner wall and the second inner wall are configured to inhibit lateral movement of the second protrusion relative to the second lip when the first housing is coupled to the second housing. The second housing includes an opening extending through the second body, and when the first housing is coupled to the second housing, the opening is aligned with the cavity. The opening is configured to release pressurized fluid received in the cavity of the first housing when the pressure relief device is ruptured.

[0008] According to another example, the pressure release mechanism may include: a first shell, which includes a first body, a cavity arranged in the first body and configured to receive a pressure release device, a first lip extending outward from the first wall of the first body, and a second lip extending outward from the second wall of the first body; and a second shell, which includes a second body, a first protrusion extending outward from the first wall of the second body, and a second protrusion extending outward from the second wall of the second body, wherein the first protrusion is configured to form a hinged connection with the first lip so that the second shell can move around the hinged connection relative to the first shell, and the second protrusion is configured to form a snap-fit ​​connection with the second lip so that when the second protrusion and the second lip form a snap-fit ​​connection, the second shell is immovable relative to the first shell, wherein the first shell and the second shell are configured to apply a clamping force along the periphery of the pressure release device when the second protrusion and the second lip form a snap-fit ​​connection to fluidly seal the pressure release device between the first shell and the second shell.

[0009] Any of the pressure release mechanisms disclosed herein may include any of the following features. The pressure release mechanism is disposed within the medical device and is in fluid communication with a source of pressurized fluid of the medical device and an outlet of the medical device. The pressure release mechanism is configured to receive pressurized fluid from the source of pressurized fluid and move the pressurized fluid to the outlet when the pressurized fluid is below a pressure threshold. The pressure release device is configured to rupture, and the pressure release mechanism is configured to divert pressurized fluid received from the source of pressurized fluid away from the outlet and through the pressure release device when the pressurized fluid exceeds the pressure threshold.

[0010] According to another example, a method for fluidly sealing a pressure release device within a pressure release mechanism comprising a first shell and a second shell may include: connecting a first lip of the first shell to a first protrusion of the second shell to form a hinged connection so that the second shell can move relative to the first shell; moving the second shell relative to the first shell around the hinged connection; connecting the second lip of the first shell to the second protrusion of the second shell to form a snap-fit ​​connection so that the second shell is immovable relative to the first shell; and when forming the snap-fit ​​connection, fluidly sealing the pressure release device between the first shell and the second shell by applying a clamping force to the pressure release device from the first shell and the second shell.

[0011] It is understood that the foregoing general description and the following detailed description are exemplary and explanatory only and do not limit the claimed invention. As used herein, the terms "include", "comprising" or any other variant thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device containing a list of elements includes not only these elements, but also other elements that are not explicitly listed or inherent in such process, method, article or device. The term "diameter" may refer to the width of an element when it is not circular. The terms "top", "up" or "above" refer to the direction or side of the device relative to its direction during use, and the terms "bottom", "bottom" or "below" refer to the direction or side opposite to the "top", "up" or "above" of the device relative to its direction during use. The term "exemplary" is used as an "example" rather than an "ideal" meaning. The term "approximately" or similar terms (such as "substantially") include values ​​of + / -10% of the specified value. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate aspects of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0013] Figure 1 An exemplary delivery device according to some embodiments is shown.

[0014] Figure 2 A perspective view of an exemplary pressure release mechanism is shown in accordance with some embodiments.

[0015] Figure 3 According to some embodiments Figure 2 A perspective view of a first housing of a pressure release mechanism.

[0016] Figure 4 According to some embodiments Figure 2 Top view of the pressure release mechanism.

[0017] Figure 5 According to some embodiments Figure 2 Exploded perspective view of the pressure release mechanism.

[0018] Figure 6 According to some embodiments Figure 2 Exploded perspective view of the pressure release mechanism.

[0019] Figure 7 According to some embodiments Figure 2 Exploded perspective view of the pressure release mechanism.

[0020] Fig. 8A Shows Figure 2 A perspective view of a pressure release mechanism including first and second housings in a first position.

[0021] Figure 8B Shows Figure 2 A perspective view of a pressure release mechanism of claim 1, wherein the first housing and the second housing are in a second position.

[0022] Figure 8C Shows Figure 2 A perspective view of a pressure release mechanism of claim 1, wherein the first shell and the second shell are in a third position.

[0023] Fig. 9A Shows Figure 2 A cross-sectional side view of a pressure release mechanism with the first shell and the second shell in a second position.

[0024] Fig. 9B Shows Figure 2 A cross-sectional side view of a pressure release mechanism of claim 1, wherein the first shell and the second shell are in a third position. DETAILED DESCRIPTION

[0025] Embodiments of the present disclosure relate to pressure release mechanisms incorporated into dispensing devices that are used to deliver various formulations (e.g., powdered formulations) to treatment sites within a patient during certain medical procedures. For example, the dispensing device can be coupled to a source of pressurized media (e.g., a gas tank) from which a pressurized fluid (e.g., a gas) can be released into the dispensing device to interact with the formulation contained within the dispensing device. The pressurized fluid can mix with the formulation to facilitate movement of the formulation through the dispensing device and toward an outlet of the device located near a target treatment site within a subject (e.g., a patient).

[0026] The pressurized fluid can be released into the dispensing device at an initial (high) pressure (e.g., approximately 850 psi). In some embodiments, a device (e.g., a pressure regulator) incorporated into the dispensing device can be configured to reduce the initial (high) pressure of the fluid to a second (low) pressure, e.g., approximately 35 psi. Reducing the initial (high) pressure received from the medium source can help ensure that the preparation is delivered to the target treatment site at a desired flow rate suitable for the intended treatment. However, if the pressure regulator fails, the dispensing device may be damaged and / or unable to deliver the preparation to the target treatment site. Therefore, the dispensing device of the present disclosure may include a pressure release mechanism for accommodating a pressure release device, such as a valve or a bursting disc, which can be activated when exposed to a threshold pressure. Once activated, the pressure release device can expose the pressurized fluid to atmospheric pressure, thereby allowing the pressurized fluid to escape into the atmosphere and reduce the pressure of the dispensing device.

[0027] Figure 1A delivery system 10 is shown, which can be a formulation (e.g., powder) delivery system. The delivery system 10 can include a handle body 12. The handle body 12 can include or can be configured to receive a box body 14 (or other source or container) for storing a material (e.g., a powdered formulation). The box body 14 can be connected to the handle body 12 to provide the formulation to the handle body 12, or the cover / box body of the formulation can be screwed onto the box body 14 or otherwise connected to the box body 14 to supply the formulation to the box body 14. The formulation can be, for example, a powdered formulation, such as a hemostatic agent. The formulation can also be another type of formulation or material, or a formulation form (e.g., a liquid or gel formulation), and can have any desired function. The box body 14 can be removably connected to other components of the delivery system 10, including components of the handle body 12.

[0028] The handle body 12 can have a variety of features, which will be discussed in further detail herein. U.S. Patent Application No. 16 / 589,633, filed on October 1, 2019, published as U.S. Patent Application Publication No. 2020 / 0100986A1 on April 2, 2022, the disclosure of which is hereby incorporated by reference in its entirety, discloses features of exemplary delivery devices and systems. Features of the present disclosure may be combined with any features described in the above applications. The features described herein may be used alone or in combination and are not mutually exclusive. Where possible, the same reference numbers and / or terms are used to represent similar structures.

[0029] Still refer to Figure 1 , the delivery system 10 may include an actuation mechanism 30 for activating the flow of a pressurized fluid (e.g., gas) in a pressurized medium source that is fluidly connected to the delivery system 10. As described in detail herein, the pressurized fluid released from the pressurized medium source may be received by the delivery system 10 at an initial (high) pressure. The actuation mechanism 30 may be selectively actuated (e.g., manually pressed) or otherwise moved or actuated to control the delivery of a material (e.g., a powder formulation) and a pressurized fluid. A single pressurized fluid or a combination of a powder formulation and a fluid may be delivered from an outlet 34 of the handle body 12 at a second (low) pressure. The outlet 34 may be fluidly connected to a delivery conduit (e.g., a catheter 36 or another component for delivering a combination of a formulation and a fluid to a desired location in a patient's body cavity).

[0030] Figure 2 Aspects of an exemplary pressure release mechanism 200 according to some embodiments are shown. The pressure release mechanism 200 can be housed within the handle body 12 of the delivery system 10 and in fluid communication with a source of pressurized medium. As described herein, the pressure release mechanism 200 can be configured to provide an outlet for pressurized fluid received from the source of pressurized medium through the delivery system 10 if the pressure level of the fluid when passing through the pressure release mechanism 200 exceeds a threshold.

[0031] In some embodiments, the pressure release mechanism 200 may include a first housing 300, a second housing 400, and a pressure release device 500. The first housing 300 may be configured to engage with the second housing 400, wherein the pressure release device 500 is disposed therebetween. In some embodiments, the first housing 300 may include a base portion of the pressure release mechanism 200, and the second housing 400 may include a cover portion of the pressure release mechanism 200. The pressure release device 500 may include a bursting disc or rupture disc configured to elastically deform when exposed to a pressure exceeding a predetermined threshold, as described in further detail herein. When the pressure release mechanism 200 is in a fully assembled state, each of the first housing 300 and the second housing 400 may include one or more features or components for securing the pressure release device 500 therebetween.

[0032] like Figure 3 As shown, for example, the first housing 300 may include a body 301 defined by a plurality of walls, such as a first (front) wall 304, a second (rear) wall 308 opposite the first (front) wall 304, a first side wall 328, and a second side wall 338 opposite the first side wall 328. The first housing 300 may include a top (outermost) surface 303, a bottom (outermost) surface 309 opposite the top surface 303, a cavity 310 formed along the top surface 303, and a shoulder 312 disposed within the cavity 310. The cavity 310 may be accessible from the top surface 303 of the body 301 (e.g., defining an opening or recess therein). The top surface 303 may be approximately perpendicular to the first wall 304, the second wall 308, the first side wall 328, and the second side wall 338. As described herein, the cavity 310 may be configured to receive a pressurized fluid from a pressurized medium source, as well as one or more devices, such as along the shoulder 312.

[0033] For example, the first housing 300 can be configured to receive the gasket 502 and the pressure relief device 500 within the cavity 310 and along the shoulder 312 (see Figure 5-7 ). In some embodiments, the shim 502 can be positioned on the top surface of the shoulder seat 312 (in the orientation shown in the figure), and the pressure relief device 500 can be positioned on the top surface of the shim 502 (in the orientation shown in the figure). In some embodiments, the top surface of the shim 502 can be an outer surface of the shim 502, which is opposite to the opposite outer (bottom) surface of the shim 502, which can be configured to contact the shoulder seat 312.

[0034] In this case, when the second housing 400 is coupled to the first housing 300, the second housing 400 may be pressed against the top surface of the pressure release device 500, and the gasket 502 may be compressed between the pressure release device 500 and the shoulder 312, thereby generating a biasing force between the gasket 502 and the pressure release device 500. The biasing force applied by the gasket 502 to the pressure release device 500 may cause the pressure release device 500 to be pressed into the second housing 400, thereby generating a clamping force around the periphery of the pressure release device 500 for fluid-sealing the pressure release device 500 between the first housing 300 and the second housing 400.

[0035] refer to Figure 2 and Figure 3 , the first housing 300 may include at least one input port 302 disposed through the first (front) wall 304 and in fluid communication with the cavity 310. Figure 3 In the exemplary embodiment shown, the first housing 300 includes a pair of input ports 302. The first housing 300 may also include at least one output port 306 disposed through the second (rear) wall 308 and in fluid communication with the cavity 310. The input port 302 may be configured to connect to a source of pressurized fluid (e.g., a source of pressurized medium of the delivery system 10), and the output port 306 may be configured to connect to another component of the delivery device 10 (e.g., the cassette 14) to release the pressurized fluid received in the cavity 310 through the input port 302. As described herein, the pressure release mechanism 200 may fluidly couple the source of pressurized fluid to the cassette 14, and the input port 302 and the output port 306 may collectively allow the pressurized fluid to flow through the pressure release mechanism 200.

[0036] Although a pair of input ports 302 and a single output port 306 are shown and described herein as being positioned along a particular wall of the first housing 300, it should be understood that the first housing 300 may include additional input ports 302 and / or output ports 306 along various other walls without departing from the scope of the present disclosure. Alternatively, the first housing 300 may include fewer input ports 302 than shown in the figures without departing from the scope of the present disclosure, such as a single input port 302. In some embodiments, each of the pair of input ports 302 and output ports 306 may be configured to be connected to a corresponding connector (e.g., a pipe) for receiving and releasing a pressurized fluid, respectively. In some embodiments, the size, shape, and / or configuration of the input ports 302 and output ports 306 may allow them to be coupled to connectors having various suitable sizes, such as approximately 5 / 32 inches in diameter.

[0037] Reference now Figure 4, the second housing 400 may include a body 401 defined by a plurality of walls, such as a first (front) wall 404 and a second (rear) wall 408 that may be positioned opposite the first (front) wall 404. The body 401 may also include a pair of side walls, such as a first side wall 428 and a second side wall 438 that may be positioned opposite the first side wall 428. The body 401 may include a top surface 402 extending in the same direction as the top surface 303 (e.g., substantially parallel), and the top surface 402 may be substantially laterally (e.g., vertically) aligned with one or more of the first wall 404, the second wall 408, the first side wall 428, and the second side wall 438.

[0038] The second housing 400 may include an opening 410 extending through the body 401 and specifically extending between a top surface 402 of the second housing 400 and an opposing bottom surface 403 of the second housing 400, such as Figure 5 As shown. Bottom surface 403 may extend in the same direction as top surface 402 (e.g., substantially parallel to top surface 402), and may be generally laterally aligned with (e.g., perpendicular to) one or more of first wall 404, second wall 408, first side wall 428, and second side wall 438. As described in detail herein, when first shell 300 and second shell 400 are coupled to each other, opening 410 may be sized, shaped, and / or configured to align with cavity 310. In this case, pressure relief device 500 may be disposed between first shell 300 and second shell 400, and specifically between cavity 310 and opening 410.

[0039] like Figure 5 As shown, the body 301 may include a concave surface 340 extending along the second side wall 338. The concave surface 340 may be defined by a first inner wall 342 and a second inner wall 344, which are vertically positioned (e.g., extend in parallel) along the second side wall 338, and the second side wall 338 is located between the top surface 303 and the bottom surface 309. The first shell 300 may include a first lip 314 extending laterally outward from the concave surface 340 of the second side wall 338. In some embodiments, the first lip 314 may extend laterally outward from the concave surface 340 at a certain angle toward the bottom surface 309 of the first shell 300.

[0040] The second housing 400 may include a first protrusion 414 and a second protrusion 420 extending outward from the body 401, specifically extending downward from the bottom surface 403 of the body 401 (toward the first housing 300), for coupling the second housing 400 to the first housing 300. The first protrusion 414 may be a tapered clip extending outward from the first side wall 428 (e.g., downward from the bottom surface 403 and radially inward toward the second side wall 438), and the second protrusion 420 may be a circular clip extending outward from the second side wall 438 (e.g., downward from the bottom surface 403 and radially inward toward the first side wall 428). In this embodiment, the first protrusion 414 and the second protrusion 420 may be oriented such that the innermost portion (e.g., the tip 413) of the first protrusion 414 and the innermost portion (e.g., the second portion 423) of the second protrusion 420 are opposite to each other. The first and second protrusions 414, 420 may be sized, shaped, and / or otherwise configured to interface with corresponding features (eg, lips) of the first housing 300 to couple the second housing 400 thereto.

[0041] In some embodiments, the first protrusion 414 may include a first (vertical) portion 415 and a second (transverse) portion 417. The first (vertical) portion 415 may extend vertically downward from the first sidewall 428 (e.g., such that the first portion 415 and the first sidewall 428 are generally coplanar or generally parallel to each other) and include a distal end 416. The second (transverse) portion 417 may extend laterally inward from the distal end 416 toward the second protrusion 420 and may include an upper surface 419 and a tip 413. The second (transverse) portion 417 may define a hook or protrusion that may include an angled and / or tapered edge 418 for interfacing with a corresponding angled feature (e.g., the first lip 314) of the first housing 300. In some embodiments, the tapered edge 418 may form an angle of approximately 45 degrees relative to the longitudinal length of the first (vertical) portion 415.

[0042] The first protrusion 414 can be sized, shaped, and / or configured to interface with the first lip 314 when the second housing 400 is coupled to the first housing 300. For example, the angle of the first lip 314 can correspond to the angle of the tapered edge 418 to facilitate engagement between the first lip 314 and the first protrusion 414. As described herein, the first protrusion 414 can be configured to form a snap-fit ​​connection with the first lip 314 when the upper surface 419 of the second (lateral) portion 417 engages the lower interface 315 of the first lip 314. The lower interface 315 can be arranged along the recessed surface 340 and located between the top surface 303 and the bottom surface 309 of the body 301.

[0043] Still refer to Figure 5, the second protrusion 420 may include a first (vertical) portion 421 and a second (lateral) portion 423. The first (vertical) portion 421 may extend vertically downward from the second sidewall 438 (e.g., such that the first portion 421 and the second sidewall 438 are generally coplanar or generally parallel to each other) and include a distal end 422. The second (lateral) portion 423 may extend laterally inward from the distal end 422 and toward the first protrusion 414. In some embodiments, the second (lateral) portion 423 may include a spherical tip, a circular hook, or a ball joint for interfacing with a corresponding circular feature (e.g., the second lip 320) of the first housing 300. As described herein, when the second housing 400 is coupled to the first housing 300, the size, shape, and / or configuration of the second protrusion 420 may allow it to interface with the second lip 320. In addition, the second protrusion 420 may be configured to allow the second housing 400 to rotate relative to the first housing 300 when the second (lateral) portion 423 engages with the second lip 320.

[0044] like Figure 6 and 7 As shown, the body 301 may include a concave surface 330 extending along the first side wall 328, which may be defined between the first inner wall 332 and the second inner wall 334. In some embodiments, the second lip 320 may extend laterally outward from the first side wall 328 at a certain angle to the bottom surface 309 of the first housing 300. The second lip 320 may include a lower interface 324, which may be arranged along the concave surface 330 and located between the top surface 303 and the bottom surface 309 of the body 301. The width of the second lip 320 may correspond to the lateral distance between the first inner wall 332 and the second inner wall 334. The size, shape and / or configuration of the lower interface 324 can receive the second (lateral) portion 423 when the second protrusion 420 is engaged with the second lip 320.

[0045] When the pressure release mechanism 200 is fully assembled, the pressure release device 500 and the gasket 502 can be received between the first housing 300 and the second housing 400. The pressure release device 500 can be configured to form a fluid seal between the cavity 310 and the opening 410, so that the pressurized fluid received in the cavity 310 (e.g., through the input port 302) cannot exit the pressure release mechanism 200 through the opening 410, but is directed to the output port 306. The pressure release device 500 can be further configured to rupture, break, and / or deform when the cavity 310 receives the pressurized fluid at a pressure level exceeding a threshold. In this case, the pressure release device 500 can rupture to divert the pressurized fluid out of the pressure release mechanism 200 through the opening 410.

[0046] In some embodiments, the pressure release device 500 can be a rupture disk formed by a metal film. The pressure release device 500 can be configured to rupture when exposed to a fluid at a predetermined pressure level exceeding a threshold pressure value. Once ruptured, the pressurized fluid received in the pressure release mechanism 200 can leave the cavity 310 through the ruptured pressure release device 500 to release the high pressure received in the cavity 310. In other words, in order to prevent the pressurized fluid from flowing through the pressure release mechanism 200 and flowing to other components of the delivery system 10 (e.g., the box body 14, the catheter 36, etc.) at a pressure level exceeding the threshold pressure value, the pressure release device 500 can be configured to rupture and divert the pressurized fluid away from the aforementioned components. Therefore, the pressure release mechanism 200 can discharge the pressurized fluid to the interior of the handle body 12 through the opening 410.

[0047] As described herein, the pressure release mechanism 200 may be configured to generate a clamping force around the periphery of the pressure release device 500 when the first housing 300 is coupled to the second housing 400. In this case, the pressure release mechanism 200 may be configured to form an airtight seal between the first housing 300 and the second housing 400, with the pressure release device 500 disposed therebetween.

[0048] Figures 8A-8C An exemplary assembly of a pressure release mechanism 200 according to some embodiments is shown. As shown in the figure. For example, Fig. 8A As shown, the gasket 502 and the pressure relief device 500 can be positioned within the cavity 310, and in particular along the shoulder 312. The second lip 320 can be configured to engage the second protrusion 420 to movably couple the first housing 300 to the second housing 400. In some embodiments, the lower interface 324 can form a pocket below the second lip 320 for receiving at least a portion of the second protrusion 420 to form a hinged connection between the first housing 300 and the second housing 400. For example, the second (lateral) portion 423 defines a hook portion of the second protrusion 420, which can be sized and shaped to fit within the pocket formed by the lower interface 324. In this case, the second protrusion 420 can be configured to move (e.g., pivot, rotate, etc.) within the pocket and move about an axis 326 extending through the lower interface 324. In some embodiments, the width of the second protrusion 420 may correspond to the lateral distance between the first inner wall 332 and the second inner wall 334, so that the second protrusion 420 may fit between and contact the first inner wall 332 and the second inner wall 334. Therefore, during assembly and use of the pressure release mechanism 200, the first inner wall 332 and the second inner wall 334 may inhibit lateral movement of the second protrusion 420 relative to the second lip 320.

[0049] like Figure 8B and 8CAs shown, the second protrusion 420 can be configured to move (eg, pivot, rotate, etc.) about the axis 326 to move the second housing 400 relative to the first housing 300, for example, in the first position ( Fig. 8A ), second position ( Figure 8B ) and the third position ( Figure 8C ). In some embodiments, the second housing 400 and the first housing 300 may be arranged in a flip configuration, such that the second housing 400 is in an open configuration when in the first and second positions, and in a closed configuration when in the third position.

[0050] See also Figure 8B , when the second protrusion 420 is coupled and movable relative to the second lip 320, the first protrusion 414 can be configured to move toward the first lip 314. In some embodiments, as Figure 8C As shown, the pressure release mechanism 200 can be configured to form a snap-fit ​​connection when the second housing 400 is coupled to the first housing 300, specifically, by moving the second side wall 438 of the second housing 400 downward toward the first side wall 328 of the first housing 300 to form a snap-fit ​​connection between the first lip 314 and the first protrusion 414. It should be understood that the first protrusion 414 can contact the first lip 314, specifically, the tapered edge 418 can interface with the outer surface 316, as shown. Fig. 9A In this case, the tapered edge 418 can abut against the outer surface 316, and the first protrusion 414 can bend and / or flex laterally outward relative to the first sidewall 428 (e.g., away from the recessed surface 330) when contacting the first lip 314. The first protrusion 414 can flex laterally outward until the upper surface 419 is received within the lower interface 315, thereby moving the first protrusion 414 laterally inward relative to the first sidewall 428 (e.g., toward the recessed surface 330) and firmly coupling the first protrusion 414 to the first lip 314.

[0051] Still refer to Fig. 9A, it will be appreciated that when the second housing 400 moves toward the third position, the tapered edge 418 of the second (lateral) portion 417 can slide downwardly along the outer surface 316 of the first lip 314. The first protrusion 414 can be configured to flexibly deform, for example, laterally outwardly relative to the first side wall 428 while abutting against the outer surface 316. In other words, when the first housing 300 and the second housing 400 are coupled to each other, the first protrusion 414 can be configured to bend laterally outwardly relative to the first side wall 428. Once the tip 413 of the second (lateral) portion 417 is located near the lower interface 315 of the first lip 314, the second (lateral) portion 417 can return to its original unbent position, wherein the upper surface 419 of the second (lateral) portion 417 engages on the lower interface 315 to form a snap-fit ​​connection. The snap-fit ​​connection between the first protrusion 414 and the first lip 314 may fixedly couple the second housing 400 to the first housing 300 such that the second housing 400 is immovable relative to the first housing 300 .

[0052] The snap-fit ​​connection formed between the first protrusion 414 and the first lip 314 can generate feedback (e.g., tactile, auditory, visual, etc.). For example, when the snap-fit ​​connection is formed, an audible sound (e.g., a click) can be generated to alert the user of the connection between the first shell 300 and the second shell 400. Alternatively and / or in addition, the snap-fit ​​connection can generate tactile or visual feedback so that the user can feel or see when the pressure release mechanism 200 is fully assembled.

[0053] Reference now Fig. 9B , with the second housing 400 coupled to the first housing 300, the bottom surface 403 of the second housing 400 may be pressed against the surface of the pressure relief device 500, which may be located on top of the gasket 502. The downward force applied by the second housing 400 to the pressure relief device 500 may press the gasket 502 against the shoulder 312, thereby generating a biasing force between the gasket 502 and the pressure relief device 500. The upward force applied by the gasket 502 to the pressure relief device 500 may cause the pressure relief device 500 to be pressed upward against the second housing 400, which may provide a clamping force around the periphery of the pressure relief device 500, for example, when the pressure relief device 500 has a generally circular shape, a clamping force is provided around the periphery of the pressure relief device 500.

[0054] In this case, the pressure release mechanism 200 can be configured to fluidly seal the pressure release device 500 between the second housing 400 and the first housing 300 by providing a clamping force around the periphery of the pressure release device 500. The snap-fit ​​connection between the first protrusion 414 and the first lip 314 can ensure that the clamping force around the periphery of the pressure release device 500 is maintained throughout the use of the pressure release mechanism 200. Although the pressure release device 500 is shown as having a generally circular shape or geometry, it should be understood that the pressure release device 500 can have various other suitable shapes and / or configurations without departing from the scope of the present disclosure.

[0055] Since the snap-fit ​​connection formed by the pressure release mechanism 200 can generate a clamping force around the pressure release device 500 by squeezing the second housing 400 and the first housing 300, no tools or fasteners are required to assemble the pressure release mechanism 200. Instead, the user can use their hands to assemble the pressure release mechanism 200. In addition, the first housing 300 and the second housing 400 can be made entirely of a moldable polymer material (e.g., plastic), such as polycarbonate.

[0056] When the pressure relief device 500 is fixed between the first housing 300 and the second housing 400, one or more connectors (e.g., tubing) can be coupled to the pressure relief mechanism 200 through the input port 302 and the output port 306 to fluidly couple the pressure relief mechanism 200 to the pressurized fluid source and the cassette 14. In this case, the pressure relief mechanism 200 can be configured to control the delivery of the pressurized fluid from the pressurized fluid source to the cassette 14 and / or the conduit 36 ​​based on the pressurization level of the pressurized fluid received in the cavity 310.

[0057] As described in detail above, the pressure release mechanism 200 may be configured to direct the pressurized fluid received through the input port 302 through the cavity 310 and toward the cassette body 14 and / or the conduit 36 ​​through the output port 306 when the pressurization level of the fluid received therein is equal to or lower than a threshold pressure value (e.g., a first (low) pressure). The pressure release mechanism 200 may be further configured to divert the pressurized fluid received in the cavity 310 away from the output port 306 in response to the rupture of the pressure release device 500 when the pressurization level of the fluid exceeds a threshold pressure value (e.g., a second (high) pressure). In this case, the pressure release mechanism 200 may form a vent through the pressure release device 500 and fluidly couple the cavity 310 to the atmospheric pressure within the handle body 12 through the opening 410. In this case, the pressure release mechanism 200 may be configured to inhibit the pressurized fluid from moving toward the cassette body 14 and / or the conduit 36 ​​and divert the pressurized fluid into the handle body 12. In other embodiments, the pressure release mechanism 200 may be configured to transfer the pressurized fluid to various other suitable locations on the delivery device 10 and / or external to the delivery device 10 .

[0058] Although the principles of the present disclosure are described herein with reference to illustrative examples of specific applications, it should be understood that the present disclosure is not limited thereto. Those of ordinary skill in the art and the teachings provided herein will recognize that additional modifications, applications, and equivalent replacements are within the scope of the examples described herein. Therefore, the present invention should not be considered to be limited by the foregoing description.

Claims

1. A pressure release mechanism, comprising: The first housing comprises: a first body defined between a first wall and a second wall opposite the first wall; a cavity disposed within the first body between the first wall and the second wall, the first body being configured to receive a pressure relief device within the cavity; a first lip extending outwardly from the first wall; and a second lip extending outwardly from the second wall; and The second housing comprises: a second body defined between a third wall and a fourth wall opposite to the third wall; a first protrusion extending outwardly from the third wall; and a second protrusion extending outwardly from the fourth wall; wherein the first protrusion is configured to engage the first lip and the second protrusion is configured to engage the second lip to couple the first shell to the second shell with the pressure release device enclosed in the cavity, wherein the first shell and the second shell are configured to apply a clamping force along the periphery of the pressure release device to fluidly seal the pressure release device between the first shell and the second shell.

2. The pressure release mechanism of claim 1, wherein the first housing includes an input port disposed through a front wall of the first body, and an output port disposed through a rear wall of the first body; Wherein each of the input port and the output port is in fluid communication with the cavity.

3. The pressure release mechanism of claim 2, wherein the first housing is configured to receive pressurized fluid in the cavity through the input port and release the pressurized fluid from the cavity through the output port.

4. A pressure release mechanism according to any one of the preceding claims, wherein the first protrusion includes a tapered clip, which is configured to form a snap-fit ​​connection with the first lip, so that when the tapered clip is connected to the first lip, the second shell is immovable relative to the first shell.

5. The pressure release mechanism of claim 4, wherein the tapered clip is elastically deformable and configured to flex laterally outward relative to the third wall when the second housing is coupled to the first housing to form the snap-fit ​​connection.

6. The pressure release mechanism of any one of claims 4 to 5, wherein the tapered clip of the first protrusion includes a hook portion extending from the third wall toward the fourth wall, and wherein the hook portion is configured to engage a lower interface of the first lip.

7. A pressure release mechanism according to any one of claims 4 to 6, wherein the second protrusion includes a circular clip, which is configured to form a hinged connection with the second lip, so that when the circular clip is connected to the second lip, the second shell can move around the hinged connection relative to the first shell.

8. The pressure release mechanism of claim 7, wherein the circular clip of the second protrusion includes a ball joint extending inwardly from the second wall, and wherein the ball joint is configured to pivot about an axis when received along a lower interface of the second lip.

9. The pressure release mechanism of claim 8, wherein the second housing is configured to move about the axis relative to the first housing between a first position and a second position.

10. The pressure release mechanism of claim 9, wherein in the first position, the first protrusion is disengaged from the lower interface of the first lip, and in the second position, the first protrusion is engaged with the lower interface of the first lip.

11. A pressure release mechanism according to any of the preceding claims, wherein the first housing includes at least one recessed surface along the second wall, the at least one recessed surface forming a first inner wall and a second inner wall positioned opposite the first inner wall.

12. A pressure release mechanism according to claim 11, wherein the second protrusion of the second shell has a width corresponding to the distance between the first inner wall and the second inner wall, so that the second protrusion is configured to fit between the first inner wall and the second inner wall when the second protrusion engages with the second lip.

13. The pressure release mechanism of claim 12, wherein the first inner wall and the second inner wall are configured to inhibit lateral movement of the second protrusion relative to the second lip when the first housing is coupled to the second housing.

14. The pressure release mechanism of any of the preceding claims, wherein the second housing includes an opening extending through the second body, and when the first housing is coupled to the second housing, the opening is aligned with the cavity.

15. The pressure release mechanism of claim 14, wherein the opening is configured to release pressurized fluid received in the cavity of the first housing when the pressure release device is ruptured.

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