Apparatus, assembly, and method for delivering powder formulations

Abstract

The pressure relief mechanism includes a first housing including a first body between a first wall and a second wall, a recess in the first body configured to accommodate 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 with the first lip, and the second protrusion engages with the second lip, joining the first and second housings together with the pressure relief device trapped within the recess. The first and second housings are configured to seal the pressure relief device between the first and second housings by applying a clamping force along the periphery of the pressure relief device.

Description

[Technical Field]

[0001] Various aspects of this disclosure relate generally to devices for delivering medicaments. More specifically, in embodiments, this disclosure relates to a pressure relief mechanism incorporated into a device for delivery of a powdered agent, such as a hemostatic agent. [Background technology]

[0002] Certain medical procedures may require minimizing or stopping bleeding inside the body. For example, an endoscopic medical procedure may require hemostasis of bleeding tissue within the digestive tract, such as in the esophagus, stomach, or small intestine. During an endoscopic procedure, a user inserts an endoscope sheath into a patient's body lumen. The user utilizes the endoscope's handle to control the endoscope during the procedure. A treatment tool may be passed through the endoscope's working channel, for example, via a port in the handle, to deliver treatment at a treatment site near the distal end of the endoscope, which is remote from the user.

[0003] To achieve hemostasis at the remote site, a hemostatic agent may be delivered by an instrument inserted into the working channel of the endoscope. Drug delivery may be achieved, for example, by using pressurized fluid to move the agent through the instrument toward the remote site. However, if the pressurized fluid exceeds a desired pressurization level, such systems may fail to achieve a desired drug delivery rate or desired drug dosage, may cause drug clogging of the delivery instrument, result in inconsistent drug administration, and / or may not reach the treatment site deep in the gastrointestinal tract. While pressure relief mechanisms can ensure that pressurized fluid is delivered at the desired pressurization level, the housing of the mechanism may be complex, large, or require numerous tools or procedures for assembly. The present disclosure may solve one or more of these or other problems in the art. Summary of the Invention

[0004] Each of the aspects disclosed herein may include one or more of the features described in connection with the other disclosed aspects.

[0005] Aspects of the present disclosure relate, inter alia, to articles, systems, devices, and methods related to pressure relief mechanisms incorporated into dispensing devices used to deliver various medicaments (e.g., powdered medicaments) to treatment sites within a patient during certain medical procedures. According to one example, the pressure relief mechanism includes a first housing and a second housing, wherein the first housing includes a first body defined between a first wall and a second wall opposite the first wall, a recess disposed within the first body between the first and second walls, the first body configured to accommodate a pressure reliever within the recess, a first lip extending outwardly from the first wall, and a second lip extending outwardly from the second wall; and the second housing includes a second body defined between a third wall and a fourth wall opposite the third wall, and a recess disposed within the first body configured to accommodate a pressure reliever within the recess, a first lip extending outwardly from the first wall, and a second lip extending outwardly from the second wall. The housing includes a first protrusion extending outward from a wall and a second protrusion extending outward from the fourth wall, the first protrusion configured to engage with the first lip and the second protrusion configured to engage with the second lip to couple the first housing to the second housing with the pressure reliever trapped within the recess, and the first housing and the second housing configured to apply a clamping force along the outer periphery of the pressure reliever to fluidly seal the pressure reliever between the first housing and the second housing.

[0006] Any of the pressure relief mechanisms described herein may include any of the following features: the first housing includes an inlet port disposed through a front wall of the first body and an outlet port disposed through a rear wall of the first body, each of the inlet port and the outlet port being in fluid communication with the recess; the first housing is configured to receive pressurized fluid into the recess via the inlet port and to release the pressurized fluid from the recess via the outlet port; the first protrusion includes a tapered clip configured to form a snap-fit connection with the first lip, such that the second housing is immovable relative to the first housing when the tapered clip is coupled to the first lip; the tapered clip is elastically deformable and configured to deflect laterally outward relative to the third wall when the second housing is coupled to the first housing to form the snap-fit connection; and the tapered clip of the first protrusion includes a hook extending from the third wall toward the fourth wall, the hook configured to engage a lower contact surface of the first lip. The second protrusion includes a rounded clip configured to form a hinged connection with the second lip, and when the rounded clip is coupled to the second lip, the second housing is movable relative to the first housing about the hinged connection. The rounded clip of the second protrusion includes a ball joint extending from the fourth wall toward the third wall, and is configured to pivot about an axis when the ball joint is received along a lower contact surface of the second lip. The second housing is configured to move relative to the first housing about the axis between a first position and a second position. In the first position, the first protrusion is disengaged from the lower contact surface of the first lip, and in the second position, the first protrusion is engaged with the lower contact surface of the first lip.The first housing has 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 disposed opposite 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 such that the second protrusion is configured to fit between the first inner wall and the second inner wall when the second protrusion engages 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 aligned with the recess when the first housing is coupled to the second housing. The opening is configured to release pressurized fluid received in the recess of the first housing when the pressure relief device ruptures.

[0007] According to another example, a pressure relief mechanism may include a first housing and a second housing, wherein the first housing includes a first body, a recess disposed within the first body and configured to accommodate a pressure relief device, a first lip extending outwardly from a first wall of the first body, and a second lip extending outwardly from a second wall of the first body; and the second housing may include a second body, a first protrusion extending outwardly from the first wall of the second body, and a second protrusion extending outwardly from the second wall of the second body, wherein the first protrusion and the second lip form the snap-fit connection when the first protrusion and the second lip form the snap-fit connection. forms a hinge connection with the first lip such that the second housing is movable relative to the first housing about the hinge connection, the second protrusion forms a snap-fit connection with the second lip such that the second housing is immovable relative to the first housing, and when the second protrusion and the second lip form the snap-fit connection, the first housing and the second housing are configured to apply a clamping force along the outer periphery of the pressure relief device, thereby fluid-sealing the pressure relief device between the first housing and the second housing.

[0008] Any of the pressure relief mechanisms disclosed herein may include any of the following features: the pressure relief mechanism is disposed within a medical device and is in fluid communication with a pressurized fluid supply of the medical device and an outlet of the medical device; the pressure relief mechanism is configured to receive pressurized fluid from the pressurized fluid supply and transfer the pressurized fluid to the outlet when the pressurized fluid is below a pressure threshold; the pressure relief mechanism is configured to rupture when the pressurized fluid exceeds a pressure threshold, and the pressure relief mechanism is configured to divert the pressurized fluid received from the pressurized fluid supply through the pressure relief mechanism and away from the outlet.

[0009] According to another example, a method for fluidly sealing a pressure relief device in a pressure relief mechanism comprising a first housing and a second housing includes coupling a first lip of the first housing to a first protrusion of the second housing, thereby forming a hinge connection such that the second housing is movable relative to the first housing, moving the second housing relative to the first housing about the hinge connection, coupling the second lip of the first housing to a second protrusion of the second housing, thereby forming a non-movable snap-fit connection such that the second housing is immovable relative to the first housing, and fluidly sealing the pressure relief device between the first and second housings by applying a clamping force around the pressure relief device from the first and second housings when forming the snap-fit connection.

[0010] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not limiting of the invention as claimed. As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or mechanism that includes the listed elements does not include only those elements, but may also include other elements not expressly listed or inherent in such process, method, article, or mechanism. The term "diameter" may also refer to the width of an element when it is not circular. The terms "top," "up," or "upper" refer to directions or orientations of the device relative to the device's orientation in use, and the terms "bottom," "down," or "lower" refer to directions or orientations of the device opposite the "top," "up," or "upper" relative to the device's orientation in use. The term "exemplary" is used to mean "example" rather than "ideal." The term "about" or terms like it (e.g., "substantially") include values of + / - 10% of the stated value. [Brief explanation of the drawings]

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate aspects of the present disclosure: Together with the description they serve to explain the principles of the present disclosure.

[0012] [Figure 1] FIG. 1 illustrates an exemplary delivery device according to some embodiments. [Figure 2] FIG. 2 illustrates a perspective view of an exemplary pressure relief mechanism according to some embodiments. [Figure 3] FIG. 3 illustrates a perspective view of the first housing of the pressure relief mechanism of FIG. 2 according to some embodiments. [Figure 4] FIG. 4 shows a top view of the pressure relief mechanism of FIG. 2 according to some embodiments. [Figure 5]FIG. 5 shows an exploded perspective view of the pressure relief mechanism of FIG. 2 according to some embodiments. [Figure 6] FIG. 6 shows an exploded perspective view of the pressure relief mechanism of FIG. 2 according to some embodiments. [Figure 7] FIG. 7 shows an exploded perspective view of the pressure relief mechanism of FIG. 2 according to some embodiments. [Figure 8A] FIG. 8A shows a perspective view of the pressure relief mechanism of FIG. 2 with the first housing and the second housing in a first position. [Figure 8B] FIG. 8B illustrates a perspective view of the pressure relief mechanism of FIG. 2 with the first housing and the second housing in a second position. [Figure 8C] FIG. 8C illustrates a perspective view of the pressure relief mechanism of FIG. 2 with the first housing and the second housing in a third position. [Figure 9A] FIG. 9A shows a cross-sectional view of the pressure relief mechanism of FIG. 2 with the first housing and the second housing in a second position. [Figure 9B] FIG. 9B illustrates a cross-sectional view of the pressure relief mechanism of FIG. 2 with the first housing and the second housing in a third position. DETAILED DESCRIPTION OF THE INVENTION

[0013]

[0003] Embodiments of the present disclosure relate to pressure relief mechanisms incorporated into dispensing devices used to deliver various medicaments (e.g., powdered medicaments) to treatment sites within a patient during certain medical procedures. For example, the dispensing device may be coupled to a pressurized medium source (e.g., a gas canister) from which pressurized fluid (e.g., gas) may be released into the dispensing device to interact with the medicament contained therein. The pressurized fluid may mix with the medicament, thereby facilitating movement of the medicament through the dispensing device toward an outlet of the device positioned adjacent to a target treatment site within the subject's (e.g., patient's) body.

[0014] The pressurized fluid may be released into the dispensing device at an initial (high) pressure, such as about 850 psi (5861 kPa). In some embodiments, a device (e.g., a pressure regulator) incorporated into the dispensing device may be configured to reduce the initial (high) fluid pressure to a second (lower) pressure, such as about 35 psi (241 kPa). Reducing the initial (high) pressure received from the media source may help ensure that the agent is delivered to the target treatment site at a desired fluid rate commensurate with the intended treatment. However, if the pressure regulator were to fail, the dispensing device would be damaged and / or inoperable to deliver the agent to the target treatment site. Accordingly, dispensing devices of the present disclosure may include a pressure relief mechanism to accommodate a pressure reliever, such as a valve or burst disk, that can be activated when exposed to a threshold pressure. Upon activation, the pressure relief device may expose the pressurized fluid to atmospheric pressure, thereby allowing the pressurized fluid to escape to the atmosphere and depressurize the dispensing device.

[0015] FIG. 1 illustrates a delivery system 10, which may be a drug (e.g., powder) delivery system. The delivery system 10 may include a handle body 12. The handle body 12 may include or be configured to house an enclosure 14 (or other source or container) that stores a substance (e.g., a powder drug). The enclosure 14 may be coupled to the handle body 12 to provide the drug to the handle body 12, or a drug cap / enclosure may be threaded onto or coupled to the enclosure 14 to provide the drug to the enclosure 14. The drug may be, for example, a powder drug, such as a hemostatic agent. Alternatively, the drug may be another type of drug or substance, or another form of drug (e.g., a liquid or gel), and may have any desired functionality. The enclosure 14 may be removably attached to other components of the delivery system 10, including components of the handle body 12.

[0016] The handle body 12 may have various features, as described in more detail herein. U.S. Patent Application No. 16 / 589,633, filed October 1, 2019, and published April 2, 2022, as U.S. Patent Application Publication No. 2020 / 0100986A1, the disclosure of which is incorporated herein by reference in its entirety, discloses exemplary features of delivery devices and systems. Features disclosed herein may be combined with features described in the above-referenced applications. Features described herein may be used alone or in combination and are not mutually exclusive. Like reference numbers and / or terminology are used wherever possible to refer to similar structures.

[0017] 1 , the delivery system 10 may include an actuation mechanism 30 used to actuate the flow of pressurized fluid (e.g., gas) from a pressurized medium source in fluid communication with the delivery system 10. As described in detail herein, the pressurized fluid released from the pressurized medium source may be received through the delivery system 10 at an initial (high) pressure. The actuation mechanism 30 may be selectively actuated (e.g., manually depressible) or moved or driven to control the delivery of the substance (e.g., powdered agent) and pressurized fluid. The pressurized fluid, alone or in combination with the powdered agent, may be delivered from an outlet 34 in the handle body 12 at a second (lower) pressure. The outlet 34 may be in fluid communication with a delivery conduit (e.g., a catheter 36 or another component for delivering the agent and fluid combination to a desired location within a patient's body lumen).

[0018] 2 shows aspects of an exemplary pressure relief mechanism 200, according to some embodiments. The pressure relief mechanism 200 may be housed within the handle body 12 of the delivery system 10 and be in fluid communication with a pressurized media source. As described herein, the pressure relief mechanism 200 may be configured to provide an outlet for pressurized fluid received through the delivery system 10 from the pressurized media source if the pressure level of the fluid exceeds a threshold when passing through the pressure relief mechanism 200.

[0019] In some embodiments, the pressure relief mechanism 200 may comprise a first housing 300, a second housing 400, and a pressure relief device 500. The first housing 300 may be configured to engage the second housing 400 with the pressure relief device 500 disposed between the first and second housings. In some embodiments, the first housing 300 may include a base portion of the pressure relief mechanism 200, and the second housing 400 may include a lid portion of the pressure relief mechanism 200. As described further herein, the pressure relief device 500 may comprise a burst or rupture disk configured to resiliently deform in response to exposure to a pressure above a predetermined threshold. Each of the first housing 300 and the second housing 400 may comprise one or more features or components for securing the pressure relief device 500 between the first housing 300 and the second housing 400 when the pressure relief mechanism 200 is fully assembled.

[0020] 3 , for example, 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 disposed opposite first (front) wall 304, a first sidewall 328, and a second sidewall 338 disposed opposite first sidewall 328. First housing 300 may include a top surface (outermost surface) 303, a bottom surface (outermost surface) 309 disposed opposite top surface 303, a cavity 310 formed along top surface 303, and a shoulder seat 312 disposed within cavity 310. Cavity 310 may be accessible from top surface 303 of body 301 (e.g., define an opening or recess in top surface 303 of body 301). Top surface 303 may be substantially perpendicular to first wall 304, second wall 308, first sidewall 328, and second sidewall 338. As described herein, recess 310 may be configured to receive pressurized fluid from the pressurized media source and one or more instruments along shoulder seat 312, for example.

[0021] For example, first housing 300 may be configured to accommodate gasket 502 and pressure reliever 500 within recess 310 along shoulder seat 312 (see FIGS. 5-7). In some embodiments, gasket 502 may be disposed on the top surface of shoulder seat 312 (in the orientation shown in the drawings), and pressure reliever 500 may be disposed on the top surface of gasket 502 (in the orientation shown in the drawings). In some embodiments, the top surface of gasket 502 may be an outer surface of gasket 502, which may be disposed opposite an opposite outer (bottom) surface of gasket 502, which may be configured to contact shoulder seat 312.

[0022] In this example, when the second housing 400 is coupled to the first housing 300, the second housing 400 applies pressure against the top surface of the pressure relief device 500, and the gasket 502 is compressed between the pressure relief device 500 and the shoulder seat 312, thereby creating a biasing force between the gasket 502 and the pressure relief device 500. This biasing force applied to the pressure relief device 500 by the gasket 502 causes the pressure relief device 500 to be pressed against the second housing 400, creating a clamping force around the periphery of the pressure relief device 500 to fluidly seal the pressure relief device 500 between the first housing 300 and the second housing 400.

[0023] 2 and 3, the first housing 300 includes at least one inlet port 302 disposed through a first (front) wall 304, which is in fluid communication with a recess 310. In the exemplary embodiment illustrated in FIG. 3, the first housing 300 includes a pair of inlet ports 302. The first housing 300 may further include at least one outlet port 306 disposed through a second (rear) wall 308, which is in fluid communication with the recess 310. The inlet port 302 may be configured to connect to a source of pressurized fluid (e.g., a pressurized medium source of the delivery system 10), and the outlet port 306 may be configured to connect to another component of the delivery device 10 (e.g., the case 14) to release the pressurized fluid received into the recess 310 via the inlet port 302. As described herein, pressure relief mechanism 200 may fluidly couple the pressurized fluid source to case 14, and inlet port 302 and outlet port 306 may collectively allow the pressurized fluid to flow through pressure relief mechanism 200.

[0024] Although the pair of inlet ports 302 and the single outlet port 306 are shown and described herein as being located along a particular wall of the first housing 300, it should be understood that the first housing 300 may include additional inlet ports 302 and / or additional outlet ports 306 along various other walls without departing from the scope of the present disclosure. Alternatively, the first housing 300 may include fewer inlet ports 302 than shown in the drawings, such as a single inlet port 302, without departing from the scope of the present disclosure. In some embodiments, each of the pair of inlet ports 302 and the outlet port 306 may be configured to connect to connectors (e.g., tubing) for receiving and discharging the pressurized fluid, respectively. In some embodiments, the inlet ports 302 and the outlet ports 306 may be sized, shaped, and / or configured to mate with connectors having various suitable diameters, for example, a diameter of about 5 / 32 inches (about 3.97 mm).

[0025] 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 disposed opposite the first (front) wall 404. The body 401 may further include a pair of side walls, such as a first side wall 428 and a second side wall 438 that may be disposed opposite the first side wall 428. The body 401 may include a top surface 402 that extends in the same direction as the top surface 303 (e.g., substantially parallel to the top surface 303), and the top surface 402 may be aligned substantially transversely to (e.g., perpendicular to) one or more of the first wall 404, the second wall 408, the first side wall 428, and the second side wall 438.

[0026] The second housing 400 may include an opening 410 extending through the body 401, particularly between a top surface 402 of the second housing 400 and an opposing bottom surface 403 of the second housing 400, as shown in FIG. 5 . The bottom surface 403 may extend in the same direction as the top surface 402 (e.g., substantially parallel to the top surface 402) and may be aligned generally transversely to (e.g., perpendicular to) one or more of the first wall 404, the second wall 408, the first side wall 428, and the second side wall 438. As described in detail herein, the opening 410 may be sized, shaped, and / or configured to align with the recess 310 when the first housing 300 and the second housing 400 are coupled to one another. In this example, the pressure relief device 500 may be disposed between the first housing 300 and the second housing 400, particularly between the recess 310 and the opening 410.

[0027] As best shown in FIG. 5 , the body 301 may include a recessed surface 340 extending along the second sidewall 338. The recessed surface 340 may be defined by a first inner wall 342 and a second inner wall 344 disposed perpendicularly along the second sidewall 338 between the top surface 303 and the bottom surface 309. The first housing 300 may include a first lip 314 extending laterally outward from the recessed surface 340 of the second sidewall 338. In some embodiments, the first lip 314 may extend laterally outward from the recessed surface 340 at an angle toward the bottom surface 309 of the first housing 300.

[0028] The second housing 400 may include a first protrusion 414 and a second protrusion 420 extending outward from the main body 401, and particularly downward (toward the first housing 300) from the bottom surface 403 of the main body 401, 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 rounded 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 embodiments, the first protrusion 414 and the second protrusion 420 may be oriented such that an innermost portion of the first protrusion 414, e.g., tip 413, and an innermost portion of the second protrusion 420, e.g., second portion 423, face each other. The first protrusion 414 and the second protrusion 420 may be sized, shaped, and / or configured to connect with a corresponding portion (e.g., a lip) of the first housing 300 to couple the second housing 400 thereto.

[0029] In some embodiments, the first protrusion 414 may include a first (vertical) portion 415 and a second (lateral) 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 one another) and may include a distal end 416. The second (lateral) 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 (lateral) portion 417 may define a hook or ledge, which may include an angled and / or tapered end 418 for contacting a corresponding angled portion of the first housing 300 (e.g., the first lip 314). In some embodiments, the tapered end 418 may be at an angle of approximately 45 degrees relative to the longitudinal length of the first (vertical) portion 415 .

[0030] The first protrusion 414 may be sized, shaped, and / or configured to contact 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 may correspond to the angle of the tapered end 418 to facilitate engagement between the first lip 314 and the first protrusion 414. As described herein, the first protrusion 414 may 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 contact surface 315 of the first lip 314. The lower contact surface 315 may be disposed along the recess surface 340 and between the top surface 303 and the bottom surface 309 of the body 301.

[0031] 5 , second protrusion 420 may include a first (vertical) portion 421 and a second (lateral) portion 423. First (vertical) portion 421 may extend vertically downward from second sidewall 438 (e.g., such that first portion 421 and second sidewall 438 are generally coplanar or generally parallel to one another) and may include a distal end 422. Second (lateral) portion 423 may extend laterally inward from distal end 422 toward first protrusion 414. In some embodiments, second (lateral) portion 423 may include a bulbous tip, a rounded hook, or a ball joint for contacting a corresponding rounded feature (e.g., second lip 320) on first housing 300. As described herein, the second protrusion 420 may be sized, shaped, and / or configured to contact the second lip 320 when the second housing 400 is coupled to the first housing 300. Additionally, the second protrusion 420 may be configured to allow rotation of the second housing 400 relative to the first housing 300 upon engagement of the second (lateral) portion 423 with the second lip 320.

[0032] As best shown in FIGS. 6 and 7 , the body 301 may include a recessed surface 330 extending along the first sidewall 328, which may be defined between a first inner wall 332 and a second inner wall 334. In some embodiments, the second lip 320 may extend laterally outward from the first sidewall 328 at an angle toward the bottom surface of the first housing 300. The second lip 320 includes a lower contact surface 324, which may be disposed between the top surface 303 and the bottom surface 309 of the body 301 along the recessed surface 330. 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 lower contact surface 324 may be sized, shaped, and / or configured to receive the second (lateral) portion 423 when the second protrusion 420 engages the second lip 320.

[0033] The pressure relief device 500 and gasket 502 may be received between the first housing 300 and the second housing 400 when the pressure relief mechanism 200 is fully assembled. The pressure relief device 500 may be configured to form a fluid seal between the recess 310 and the opening 410, such that the fluid seal prevents pressurized fluid received into the recess 310 (e.g., via the inlet port 302) from escaping the pressure relief mechanism 200 through the opening 410 and directs the fluid toward the outlet port 306. The pressure relief device 500 may further be configured to break, rupture, and / or deform when the recess 310 receives the pressurized fluid at a pressure level that exceeds a threshold pressure value. In this example, the pressure relief device 500 may rupture and divert the pressurized fluid out of the pressure relief mechanism 200 through the opening 410.

[0034] In some embodiments, the pressure relief device 500 may be a rupture disk formed of a metal film. The pressure relief device 500 may be designed to rupture when exposed to fluid at a predetermined pressure level above a threshold pressure value. Once ruptured, pressurized fluid received within the pressure relief mechanism 200 escapes from the recess 310 through the ruptured pressure relief device 500, releasing the high pressure received within the recess 310. In other words, to prevent the pressurized fluid from flowing through the pressure relief mechanism 200 toward other components of the delivery system 10 (e.g., the casing 14, the catheter 36, etc.) at pressure levels above the threshold pressure value, the pressure relief device 500 may be configured to rupture and redirect the pressurized fluid away from the components. Thus, the pressure relief mechanism 200 may vent the pressurized fluid through the opening 410 to an interior portion of the handle body 12.

[0035] As described herein, the pressure relief mechanism 200 may be configured to create a clamping force about the periphery of the pressure relief device 500 when the first housing 300 is coupled to the second housing 400. In this example, the pressure relief mechanism 200 is configured to create an airtight seal between the first housing 300 and the second housing 400, and the pressure relief device 500 is disposed between the first housing 300 and the second housing 400.

[0036] 8A-8C illustrate an exemplary assembly of the pressure relief mechanism 200, according to some embodiments. As shown in FIG. 8A , for example, the gasket 502 and the pressure relief device 500 may be disposed within the recess 310, particularly along the shoulder seat 312. The second lip 320 may 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 contact surface 324 may form a pocket beneath the second lip 320 to receive at least a portion of the second protrusion 420 to form a hinge connection between the first housing 300 and the second housing 400. For example, the second (lateral) portion 423 defines a hook of the second protrusion 420, which may be sized and shaped to fit into the pocket formed by the lower contact surface 324. In this example, second protrusion 420 may be configured to move (e.g., pivot, rotate, etc.) within the pocket and about axis 326 that passes through lower contact surface 324. In some embodiments, the width of second protrusion 420 may correspond to the lateral distance between first inner wall 332 and second inner wall 334 such that second protrusion 420 may fit between and contact first inner wall 332 and second inner wall 334. Accordingly, first inner wall 332 and second inner wall 334 may inhibit lateral movement of second protrusion 420 relative to second lip 320 during assembly and use of pressure relief mechanism 200.

[0037] 8B and 8C, the second protrusion 420 may be configured to move (e.g., pivot, rotate) about an axis 326 to move the second housing 400 relative to the first housing 300 between a first position ( FIG. 8A ), a second position ( FIG. 8B ), and a third position ( FIG. 8C ). In some embodiments, the second housing 400 and the first housing 300 may be arranged in a clamshell configuration such that the second housing 400 is in an open configuration when in the first and second configurations and the second housing 400 is in a closed configuration when in the third position.

[0038] 8B , the first protrusion 414 may be configured to move toward the first lip 314 while the second protrusion 420 is coupled to and movable relative to the second lip 320. In some embodiments, as shown in FIG. 8C , the pressure relief mechanism 200 may be configured to form a snap-fit connection when the second housing 400 is coupled to the first housing 300, and in particular may be configured to form a snap-fit connection between the first lip 314 and the first protrusion 414 by moving the second side wall 438 of the second housing 400 downwardly toward the first side wall 328 of the first housing 300. It should be understood that the first protrusion 414 mates with the first lip 314, particularly when the tapered end 418 contacts the outer surface 316, as best shown in FIG. 9A . In this example, tapered end 418 may abut against outer surface 316, and first protrusion 414 may expand and / or contract laterally outward relative to first sidewall 428 (e.g., away from recess surface 330) when contacting first lip 314. First protrusion 414 may contract laterally outward until upper surface 419 is received within lower contact surface 315, which may move first protrusion 414 laterally inward relative to first sidewall 428 and securely couple first protrusion 414 to first lip 314.

[0039] 9A , when the second housing 400 is moved toward the third position, the tapered end 418 of the second (lateral) portion 417 may slide down along the outer surface 316 of the first lip 314. The first protrusion 414 may be configured to flex laterally outward, for example, relative to the first sidewall 428, while abutting against the outer surface 316. In other words, the first protrusion 414 may be configured to deflect laterally outward relative to the first sidewall 428 when the first housing 300 and the second housing 400 are coupled together. Once the tip 413 of the second (lateral) portion 417 is positioned adjacent the lower contact surface 315 of the first lip 314, the second (lateral) portion 417 may return to its original, unbent position while the upper surface 419 of the second (lateral) portion 417 engages and forms a snap-fit connection against the lower contact surface 315. This 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.

[0040] The formation of the snap-fit connection between first protrusion 414 and first lip 314 may provide feedback (e.g., tactile, audible, visible, etc.). For example, when the snap-fit connection is formed, an audible sound, such as a click, may be produced to alert a user of the connection between first housing 300 and second housing 400. Alternatively and / or additionally, the snap-fit connection may provide tactile or visible feedback so that a user can feel or see when pressure relief mechanism 200 is fully assembled.

[0041] 9B , with the second housing 400 coupled to the first housing 300, the bottom surface 403 of the second housing 400 may apply pressure against a surface of the pressure relief device 500 (which may be disposed on top of the gasket 502). The downward force applied by the second housing 400 to the pressure relief device 500 may compress the gasket 502 against the shoulder seat 312, thereby creating 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 press the pressure relief device 500 upward against the second housing 400, creating a clamping force around the outer periphery of the pressure relief device 500, for example, around the circumference of the pressure relief device 500 if the pressure relief device 500 is generally circular in shape.

[0042] In this example, pressure relief mechanism 200 may be configured to fluidly seal pressure relief device 500 between second housing 400 and first housing 300 by applying a clamping force about the periphery of pressure relief device 500. The snap-fit connection between first protrusion 414 and first lip 314 may ensure that this clamping force about the periphery of pressure relief device 500 is maintained through use of pressure relief mechanism 200. While pressure relief device 500 is shown as having a generally circular or geometric shape, it should be understood that pressure relief device 500 may have a variety of other suitable shapes and / or configurations without departing from the scope of this disclosure.

[0043] Because the snap-fit connection formed by pressure relief mechanism 200 may be achieved by pressing second housing 400 and first housing 300 together to create a clamping force about pressure relief device 500, no tools or fasteners are required to assemble pressure relief mechanism 200. In fact, a user may use their own hands to assemble pressure relief mechanism 200. Furthermore, first housing 300 and second housing 400 may be integrally made from a moldable polymeric material (e.g., plastic), such as polycarbonate.

[0044] With pressure relief device 500 secured between first housing 300 and second housing 400, one or more connectors (e.g., tubing) may be coupled to pressure relief mechanism 200 via inlet port 302 and outlet port 306 to fluidly couple pressure relief mechanism 200 to a pressurized fluid source and case 14. In this example, pressure relief mechanism 200 may be configured to control delivery of pressurized fluid from the pressurized fluid source to case 14 and / or catheter 36 based on the pressurization level of the pressurized fluid received in recess 310.

[0045] As described in detail above, pressure relief mechanism 200 may be configured to direct pressurized fluid received therein via inlet port 302, through recess 310, and toward case 14 and / or catheter 36 via outlet port 306 when the pressurized level of the fluid received therein is below a threshold pressure value (e.g., a first (low) pressure). Pressure relief mechanism 200 may be further configured to redirect the pressurized fluid received in recess 310 away from outlet port 306 in response to pressure relief device rupture when the pressurized level of the fluid exceeds the threshold pressure value (e.g., a second (high) pressure). In this example, pressure relief mechanism 200 may form a vent through pressure relief device 500 and fluidly couple recess 310 to atmospheric pressure within handle body 12 via opening 410. In this example, pressure relief mechanism 200 may be configured to inhibit the pressurized fluid from traveling toward case 14 and / or catheter 36 and redirect the pressurized fluid toward handle body 12. In other embodiments, pressure relief mechanism 200 may be configured to redirect the pressurized fluid to various other suitable locations on delivery device 10 and / or outside of delivery device 10.

[0046] While the principles of the present disclosure have been described herein with reference to illustrative examples for specific applications, it should be understood that the disclosure is not limited thereto. Those skilled in the art and with access to the teachings provided herein will recognize additional modifications, applications, and substitutions of equivalents, all within the scope of the examples described herein. Accordingly, the present invention is not intended to be limited by the foregoing description.

Claims

1. A pressure relief mechanism, this mechanism is: It comprises a first housing and a second housing, The first housing described above is: The first main body is defined between the first wall and the second wall facing this first wall, A recess located within the first body between the first wall and the second wall, wherein the first body is configured to house a pressure relief device within the recess, A first lip extending outward from the first wall; A second lip extending outward from the second wall; Includes, The aforementioned second housing is: The second body is defined between the third wall and the fourth wall facing this third wall, A first projection extending outward from the third wall; A second projection extending outward from the fourth wall; It includes, A mechanism comprising: a first projection configured to engage with the first lip and a second projection configured to engage with the second lip in order to connect the first housing to the second housing while the pressure relief device is confined within the recess; and the first housing and the second housing configured to apply a clamping force along the outer circumference of the pressure relief device in order to fluidly seal the pressure relief device between the first housing and the second housing.

2. The pressure relief mechanism according to claim 1, wherein the first housing comprises an inlet port disposed through the front wall of the first body and an outlet port disposed through the rear wall of the first body, and each of the inlet port and the outlet port is in fluid communication with the recess.

3. The pressure relief mechanism according to claim 2, wherein the first housing is configured to receive pressurized fluid into the recess via the inlet port and to release the pressurized fluid from the recess via the outlet port.

4. The pressure relief mechanism according to any one of claims 1 to 3, wherein the first projection is provided with a tapered clip configured to form a snap-fit ​​connection with the first lip, and the second housing is immovable relative to the first housing when the tapered clip is coupled to the first lip.

5. The pressure relief mechanism according to claim 4, wherein the tapered clip is elastically deformable and configured to bend 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 relief mechanism according to claim 4, wherein the tapered clip of the first projection is provided with a hook extending from the third wall toward the fourth wall, and the hook is configured to engage with the lower contact surface of the first lip.

7. The pressure relief mechanism according to claim 4, wherein the second projection is provided with a rounded clip configured to form a hinge connection with the second lip, and when the rounded clip is coupled with the second lip, the second housing is movable relative to the first housing around the hinge connection.

8. The pressure relief mechanism according to claim 7, wherein the round-shaped clip of the second projection comprises a ball joint extending inward from the second wall, the ball joint being configured to pivot about an axis when received along the lower contact surface of the second lip.

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

10. The pressure relief mechanism according to claim 9, wherein in the first position, the first projection is disengaged from the lower contact surface of the first lip, and in the second position, the first projection is engaged with the lower contact surface of the first lip.

11. The pressure relief mechanism according to any one of claims 1 to 3, wherein the first housing comprises at least one recessed surface along the second wall, and the at least one recessed surface forms a first inner wall and a second inner wall positioned opposite the first inner wall.

12. The pressure relief mechanism according to claim 11, wherein the second projection of the second housing has a width corresponding to the distance between the first inner wall and the second inner wall, such that the second projection fits between the first inner wall and the second inner wall when the second projection engages with the second lip.

13. The pressure relief mechanism according to claim 12, wherein when the first housing is coupled to the second housing, the first inner wall and the second inner wall are configured to obstruct the lateral movement of the second projection relative to the second lip.

14. The pressure relief mechanism according to any one of claims 1 to 3, wherein the second housing includes an opening that penetrates the second body and is aligned with the recess when the first housing is coupled to the second housing.

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

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