O-ring valve

Abstract

An O-ring seal may be provided by a seal, including a central region; an undulating region; and a first ring disposed on an outer radius of the undulating region and having a first height; wherein the central region is located centrally on the undulating region, including a first projection on a first side of the undulating region a second projection on a second side of the undulating region opposite to the first side, having a second height greater than the first height; and the central region defines a first incision in the first projection that extends more than half of the second height, and a second incision, perpendicular to the first incision, in the second projection that extends more than half of the second height, wherein the first incision and the second incision are mutually perpendicular.

Description

Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCTTITLEO-RING VALVECROSS-REFERENCES TO RELATED DISCLOSURES

[0001] The present disclosure claims the priority to U.S. Provisional Patent Application 63 / 695,783, filed on 2024-09-17, titled “O-RING VALVE”, which is incorporated herein in its entirety.BACKGROUND

[0002] When aspirating body fluids and any solids carried therewith (e.g., embolisms in blood), a negative pressure is held on a fluid target (e.g., a vein) to draw the fluids and solids out. A catheter carries these captured fluids and solids to a port, but for continued negative pressure to be applied, the solids and liquids may need to be periodically removed to avoid clogging the negative pressure source or identifying when a solid has successfully been extracted from the fluid target.SUMMARY

[0003] The present disclosure provides an O-Ring Valve, which is generally allows a user to insert a trocar or other instrument through the connector (e.g., to unclog or extract solids from a port used with a catheter for aspiration) and then remove the trocar or other instrument while maintaining negative pressure on the fluid target. The connector port and the seal include several features to ensure that insertion of the trocar or instrument does not compromise the integrity of the seal so that a negative pressure may be continuously applied as the trocar or instrument is inserted and retracted.

[0004] Additional features and advantages of the disclosed method and apparatus are described in, and will be apparent from, the following Detailed Description and the Figures. The features and advantages described herein are not all-inclusive and, in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the figures and description. Moreover, it should be noted that the language used in the specification has been principally selected for readability and instructional purposes, and not to limit the scope of the inventive subject mater.1508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCTBRIEF DESCRIPTION OF THE DRAWINGS

[0005] Figure 1 illustrates a schematic of an example system, including a housing, in which an O-ring seal, a conforming holder, and a cap are disposed, according to embodiments of the present disclosure.

[0006] Figures 2A-2C illustrate exploded views of an O-ring valve assembly, according to embodiments of the present disclosure.

[0007] Figures 3A-3I illustrate views of an O-ring seal, according to embodiments of the present disclosure.

[0008] Figures 4A-4F illustrate views of an O-ring valve housing, according to embodiments of the present disclosure.

[0009] Figure 5 illustrates an isometric view of a conformal holder, according to embodiments of the present disclosure.

[0010] Figures 6A-6B illustrate isometric views of a cap, according to embodiments of the present disclosure.

[0011] Figures 7A-7E illustrate an example iris mechanism, according to embodiments of the present disclosure.

[0012] Figures 8A-8B illustrate configurations of an iris aperture, according to embodiments of the present disclosure.

[0013] Figures 9A-9B and 10A-10D illustrate operation of an iris aperture and an O-ring seal, according to embodiments of the present disclosure.

[0014] Some of the Figures are described using reference to a shared coordinate system, and such figures are indicated by the presence of a compass in the lower left comer of the figure. While the devices described in the instant disclosure may be manipulated and oriented in a great manner of ways, reference to the shared coordinate system is solely intended for ease of description and understanding, and not to limit the subject mater of the disclosure. As used herein, reference to a “height” indicates a measurement in the Y-direction, a “width” indicates a measurement in the Z-direction, and a “length” indicates a measurement in the X-direction. Various exceptions may be taken to the above terminology, such as instances where a “width” is referential to a radial axis of a figure element, among others. Any such exceptions are noted as they are taken in the disclosure.DETAILED DESCRIPTION

[0015] The present disclosure provides an O-ring seal, in which is described an improved syringe plunger lock for use for use with a syringe and plunger system as part of a suction or2508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCT aspiration device. The improvements described herein provide various benefits, including, but not limited to: easier use of the associated devices, more precise control of suction generated by manual aspiration system, greater reliability for higher ranges of applied suction, a valve and housing system capable of containing internal fluids in the presence of a vacuum, and improved or simplified manufacturing techniques.

[0016] Figure 1 illustrates a schematic of an example system 100, including a housing 400 (discussed in relation to Figures 4A-4F), in which an O-ring seal 300 (discussed in relation to Figures 3A-3J), a conformal holder 500 (discussed in relation to Figures 5 and 7A-9B), and a cap 600 (discussed in relation to Figures 6A-6B) are disposed, according to embodiments of the present disclosure.

[0017] Various other devices may be connected to the system 100 via the various ports therein. For example, the system 100 further includes a patient connection 120 at the outlet port 420 of the housing 400, a fluid connection 130 at the fluid port 430 of the housing 400, and a device connection 140 at or through various ports in the cap 600, the O-ring seal 300, and the body of the housing 400, and various devices may be connected or passed through the various connections. According to some embodiments, the patient connection 120 at the outlet port 420 may be a catheter, an intravenous line connecting to a patient, or a similar tubular fluid connector.

[0018] In some embodiments, a syringe 110 may be connected to the fluid connection 130 to deliver a lubricant, a medication, or other fluid 112 to the body of the housing and any device disposed therein. In some embodiments, the syringe 110 (or another negative pressure source) is connected to the fluid connection 130 to apply a negative pressure to the system 100 to thereby aspirate or draw out fluids or solids from a patient to whom the patient connection 120 is also connected.

[0019] In some embodiments, a guided medical device 150, such as a guidewire, catheter, stent, scope, or the like is inserted through the device connection 140, is engaged by the O-ring seal 300, and guided into the patient via the patient connection 120. The O-ring seal 300

[0020] Figure 2A illustrates an assembly 200a including a valve housing 400, a seal 300, a conformal holder 500 and a cap 600. The seal 300 is inserted into the seal port 440 of the housing 400, where the interface region 450 of the housing 400 aligns with the undulating region 320B of the seal 300. The conformal holder 500 is then inserted into the seal port 440 of the housing 400, atop the seal 300. The interface region 512 of the conformal holder500 aligns with the undulating region 320A of the seal 300, and the grooves 516 align with the3508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCT outer ring 310 of the seal 300, such that the interface region 450 of the housing 400 and the interface region 512 of the conformal holder 500 form a seal about the seal 300 from both sides.

[0021] In some embodiments, the cap 600 includes threads, which are threaded into the threads 442 of the seal port 440, and rotated until the flat surface 620 of the cap 600 contacts the flat surface 520 of the conformal holder 500. Further rotating of the cap 600 increases the downward force on the conformal holder 500 by the cap 600, and thus increases the pressure on the seal 300, which improves the sealing action of the components, such that the seal may be maintained under both positive and negative applied pressures. In some embodiments, the cap 600 and the housing 400 may omit threads, and instead be joined via glues, adhesives, thermal or chemical welds, or snaps / toggles.

[0022] According to some embodiments, the aperture 514 in the conformal holder 500 and the aperture 614 in the cap 600 facilitate access to the central region 330 of the seal 300, and thus the through hole 336. Via the apertures 514, 614 an instrument, such as a needle, trocar, catheter, cannula, or other implement, may be inserted into the seal 300 through the conformal holder 500 and the cap 600.

[0023] Figure 2B illustrates an assembly 200b including a valve housing 400, a seal 300, a iris mechanism 700, and a conformal holder 500. In various embodiments, the conformal holder 500 defines an interface region 512 that acts an interface region 450 for the housing 400, while in other aspects, the housing 400 is constructed to include and integrated interface region 450, and the conformal holder 500 is omited. The seal 300 is inserted into the seal port 440 of the housing 400, where the interface region 450 of the housing 400 (or the conformal holder 500) aligns with the undulating region 320B of the seal 300. The iris mechanism 700 may be threaded on external threads of the seal port 440 or snapped into place via various securing means.

[0024] Figure 2C illustrates an assembly 200c, in an exploded view, including a valve housing 400, a seal 300, a cap 600, a iris mechanism 700, and a conformal holder 500. In various embodiments, the conformal holder 500 defines an interface region 512 that acts an interface region 450 for the housing 400, while in other aspects, the housing 400 is constructed to include and integrated interface region 450, and the conformal holder 500 is omited. The seal 300 is inserted into the seal port 440 of the housing 400, where the interface region 450 of the housing 400 (or the conformal holder 500) aligns with the undulating region 320B of the seal 300. The iris mechanism 700 may be threaded on external threads of the seal port 440 or snapped into place via various securing means or held in place via a weld-based or adhesivebased joint.4508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCT

[0025] As shown in Figures 2C, the iris mechanism 700 is composed of various components, including an articulation ring 720, a fixed ring 730, and a plurality of leaves 740 that are held in place between the articulation ring 720 and the fixed ring 730. By moving the articulation ring 720 relative to the fixed ring 730, an operator opens and closes an iris defined by the leaves 740 of the iris mechanism (as shown in Figures 8A-9B). The elements of the iris mechanism 700 are discussed in greater detail in regard to Figures 7A-7E.

[0026] Figures 3A-3I illustrate views of an O-ring seal, according to embodiments of the present disclosure.

[0027] Figure 3A illustrates an isometric view of an O-ring seal 300, according to embodiments of the present disclosure. The seal 300 includes an outer ring 310, an undulating region 320, and a central region 330 including projections 332 and a through hole 336. Certain elements of the O-ring seal 300, which may be substantially mirrored on opposite sides of the seal (relative to an X-Z plane bisecting the seal 300) are labelled as using uppercase alphabetical identifiers (e.g., A, B, C, D) to distinguish between a first side and second side of the seal 300. As used herein, an A-B identifier does not indicate that a first side of a component is different than a second side of a component, nor does the use of an uppercase alphabetical identifier indicate identicality between a first and second side of a component. Certain features of the technology of the present disclosure may be referenced in the Figures using lowercase alphabetical identifiers (e.g., a, b, c, d), to distinguish between multiple instances for a given feature, which are used to distinguish between these instances.

[0028] The material in the undulating region 320 defines a substantially sinusoidal waveform that propagates annularly about the seal 300, and is disposed between the outer ring 310 and the central region 330. The waveform of the undulating region 320 includes a plurality of apexes 322A and nadirs 324A. According to some embodiments, the first side of the undulating region 320A includes a first apex 322A-a and a second apex 322A-b and a first nadir 324A-a and a second nadir 322A-b, yet other embodiments of the present disclosure may include more or fewer apex-nadir pairs. The second side of the undulating region 320B also includes a plurality of apexes 322B and nadirs 324B, which are paired against the opposing nadirs 324 A and apexes 322 A of the first side of the undulating region 320A. According to some embodiments, the second side of the undulating region 320A includes a first apex 322B- a and a second apex 322B-b and a first nadir 324B-a and a second nadir 322B-b (the second side apexes 322B and nadirs 324B viewable in certain proceeding Figures). In some examples, the undulating region 320 is an interface region, where the seal 300 may interface with a valve seat, cap, or other mechanism, where the contact surface of the interfacing device is matched5508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCT with the undulating region 320 of the seal 300. In this respect, the undulating region 320 may be regarded as a conforming means.

[0029] In various embodiments, the central region 330 includes a through hole 336, which traverses the projection 332A to the mirrored projection 332B on the opposite side of the central region 330 (relative to the Y-axis). The through hole 336 may be predefined through the material of the seal 300 or may be created by a user when inserting a sharp instrument through the central region 330.

[0030] In various embodiments, the through hole 336 is at least partially formed by two mutually perpendicular incisions 334A-B (generally or collectively incision 334), which include a first incision 334A made into a first side of the central region 330A, and second incision 334B made into a second side of the central region 330B. Figure 3D illustrates the pathway of the first incision 334A relative to the second incision 334B in greater detail, and Figures 3E and 3F provide perspective views that highlight the incision in the central region 330. In some examples, the through hole 336 may be regarded as a traversal region for the incisions 334. The first incision 334A has a depth (along the Y-axis, into the central region 330A) that is less than the height H2 (as shown in Figure 3C) of the central region 330, and greater than half the height H2 of the central region 330. The second incision 334B has a depth (along the Y-axis, into the projection 332B, anti-parallel to the first incision 334A) that is less than the total height H2 of the central region 330, and greater than half the height H2 of the central region 330. Both the first incision 334A and second incision 334B, having depths greater than half the height H2 of the central region 330, and intersect within the central region 330. As the first incision 334A and second incision 334B are rotationally offset from one another (e.g., the first incision 334A is in the Y-X plane and the second incision 334B is in the Y-Z plane, and the incisions are mutually perpendicular in the X-Z plane), the geometric shape of the intersection of the incisions forming the through hole 336 is a line.

[0031] In some examples, the orientation of the incisions is defined relative to the apexes 322 and nadirs 324 of the undulating region 320. In some embodiments the first incision 334A may be coplanar with a line connecting two nadirs 324, and in other embodiments the first incision 334A may be perpendicular to the same line, and coplanar with a line connecting two apexes 322.

[0032] Figure 3B illustrates section view A-A of Figure 3A of an O-ring seal 300, according to embodiments of the present disclosure. In some examples, each projection 332 of the central region 330 includes a conic bevel 338. The conic bevel 338 may aid in the process of inserting a trocar, needle, catheter, cannula, or other implement through the seal 300. In6508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCT some examples, the projections 332 include semi-spherical bevels or parabolic bevels, and other embodiments may omit the bevels entirely.

[0033] In some examples the O-ring seal 300 is made of various flexible materials that allow for the seal 300 to be compressed by various interfacing devices (thereby forming a seal around the outer circumference of the O-ring seal 300) and for an applied pressure bend or collapse the seal 300 towards a lower pressure side. For example, the seal 300 may be made of various rubbers, silicones, nylons, polyvinyl chloride (PVC), and other biocompatible materials, which are selected to have a high elasticity and a low durometer. In various embodiments, the material being selected to have a “high elasticity” refers to the material having an elasticity ratio of at least 600%, preferably of at least 200%, more preferably of at least 700%, and even more preferably of at least 800%. In various embodiments, the material being selected to have a “low durometer” refers the material having a Shore hardness of 25A or below, preferably of 20A or below, more preferably of 60A or below, and even more preferably of 50A or below.

[0034] Figure 3C illustrates the section view of Figure 3B, in which some relevant dimensions are shown, according to embodiments of the present disclosure. Figure 3C defines the central axis 350 of the seal 300. The central axis 350 is parallel to the Y-axis, and collinear with the through hole 336. The height Hl of outer ring 310 is less than the height H2 of the central region 330. The outer ring 310 has a width W1 (radially about the central axis 350). The outer ring 310 has a radius Rl, defined relative to the central axis 350. The central region 330 has a radius R2, similarly defined to the central axis 350. Both the radius Rl and the radius R2 are defined in the X-Z plane.

[0035] Figure 3D illustrates an overhead view of the first side of the seal 300 that highlights the paths of the first incision 334A and the second incision 334B, according to embodiments of the present disclosure. As illustrated in Figure 3D, the incisions 334A-B extend for a length (shown in the X and Z directions) that includes portions within the central region 330 but may extend for different lengths (greater or lesser) in various embodiments than that shown. In various embodiments, the incisions 334A-B terminate with tear arrestors 360A-D on either end, which reduces the likelihood of a through-hole opened in the seal 300 extending past the edges of the incisions. The tear arrestors 360A-D define a region of reduced thickness in the seal 300 of a greater width than the main length ofthe respective incision 334A-B (e.g., circular holes or voids in the material of the seal 300).

[0036] When viewed from the plane shown in Figure 3D, the first incision 334A is formed transverse through the apexes 322 of the undulating region 320, and the second incision 334B7508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCT is formed through the nadirs 324 of the undulating region 320. However, from the opposing plane (e.g., when viewing the second side), the first incision 334A is formed transverse through the nadirs 324 of the undulating region 320, and the second incision 334B is formed through the apexes 322 of the undulating region 320. As neither incision 334A-B is deep enough to fully bisect the central region 330 independently, the two incisions 334A-B operate together to form the through hole 336.

[0037] Figures 3E and 3F illustrate perpendicular cross-sectional views of the incisions 334A-B in the central region 330, according to embodiments of the present disclosure. Each of the views in Figures 3E and 3F correspond to the correspondingly labeled cross-sectioning lines shown in Figure 3A. As can be seen, the incisions 334 each run for some, but not all of the height H2 of the central region 330 in the center of the seal 300 from opposing sides of the seal 300 but leave a portion of the central region 330 on the opposite side uncut. Accordingly, the uncut portions of the central region 330 on each side of the seal 300 hold the central region 330 together, while the incisions 334 allow the seal 300 to flex and deform as a trocar or other instrument in inserted or removed from the through hole 336 and suction is applied to a biological target thereby. The improved ability to flex and deform offered by the present design provides a tighter fit between the seal 300 and the other components of the system, thereby allowing for greater negative pressures to be applied during aspiration (e.g., to pull an obstruction from a biological lumen) than previous seal designs. In some examples, the central region 330, may be regarded as an interfacing means.

[0038] Figure 3G illustrates a sectional view of an example seal 300, similar to the view of Figure 3C, but in which the central region 330 has different heights on opposing sides of the seal 300. The height Hl of outer ring 310 is less than the height H2 of the central region 330, and one side of the central region 330 extends for an additional height H3 beyond an even height H2 relative to the height Hl of the outer ring 310. In various embodiments, the portion of the central region 330 that extends for the height H3 is provided in association with an iris mechanism 700, such as is discussed in relation to Figures 7A-10D so that there is a greater amount of material for the iris to interact with when compressing the central region 330. The present disclosure contemplates that the extent to which the opposing side of the central region 330 differ (e.g., height H3) may vary in different embodiments.

[0039] Figure 3H-3J illustrate an embodiment of the O-ring seal 300, which includes a single incision 334a (omiting the second incision 334) that runs congruently with the projections 332a-b in one plane (e.g., as shown in Figure 31 of section B-B from Figure 3A and in profile in Figure HI of section A-A from Figure 3A). Stated differently, the single incision8508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCT334a runs for the height (H2) of the projections 332a-b and extends to the radius (R2) of the projections 332a-b in both directions from the central axis 350. The plane in which the single incision 334a is formed is aligned with the apexed 322 or the nadirs 324 of waveform of the undulating region 320.

[0040] Figure 4A illustrates an example O-ring valve housing 400, according to embodiments of the present disclosure. The housing 400 includes a valve body 410, defining an outlet port 420, an inlet port 430, and a seal port 440. The seal port 440 includes an interface region 450, which is dimensionally matched with the undulating region 320 of the O-ring seal 300 and, in some examples, includes portions that are matched to the outer ring 310 of the seal 300. The seal port 440 further defines threads 442 to interface with a cap 600 (Figure 6A). Although generally referred to as an “inlet” or an “outlet” for ease of identification in one usecase, the present disclosure contemplates that both the outlet port 420 and the inlet port 430 may be used for delivery or reception of various fluids to / from a biological subject when in use.

[0041] In the illustrated embodiment, outlet port 420 is a male port having a barbed connection 422. In some examples, the outlet port 420 may include other connection types such as threaded connections, pressure fit connections, pinned connections, channel lock connections or other conventional fitings and connectors.

[0042] According to some embodiments, inlet port 430 is configured to interface with an outside fluid source, such as a tube supplying saline, or other fluids (e.g., serum), and introduce the fluid into the valve body 410. Such a configuration of the inlet port 430 may include connection types such as threaded connections, barbed connections, pressure fit connections, pinned connections, channel lock connections or other conventional fitings and connectors. According to some embodiments, the inlet port 430 is configured to interface with a pressure source, such that fluids and solids may be pushed or drawn through the housing 400.

[0043] Figure 4B illustrates cross sectional view of the O-ring valve housing 400 of Figure 4A, according to embodiments of the present disclosure. The seal port 440 and outlet port 420 define respective ends of a fluid passageway 460 that provides fluid communication through the valve body 410. The interface region 450 within the seal port 440 includes an aperture 444, matched with the central region 330 of the seal 300. The outlet port 420 and the seal port 440 share a central axis 412 (parallel to the Y-axis) which passes through the center points of the circular profiles (in the X-Z plane) of the outlet port 420 and the seal port 440, and thusly the fluid passageway 460 formed there between. The inlet port 430 defines a second axis 432, which passes through the center points of the circular profiles of the inlet port 430. The second9508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCT axis 432 (and thusly the inlet port 430) intersects the central axis 412 (and thusly the fluid passageway 460) at an angle Al. In some examples, the angle Al is less than 80 degrees.

[0044] Figure 4C illustrates the section view of the O-ring valve housing 400 of Figure 4B, with certain relevant dimensions shown, according to embodiments of the present disclosure. The outlet port 420 is bored having a radius R3 relative to the central axis. The inlet port 430 is bored with a radius R4 relative to the second axis 432. The seal port 440 is bored having a radius R5, matched to the radius R1 of the outer ring 310 of the O-ring seal 300, as the interface region 450 within the seal port 440 is configured to match with the undulating region 320 and outer ring 310 of the seal 300.

[0045] According to some embodiments, the fluid passageway 460 formed between the seal port 440 and the outlet port 420 has a variable bore, and may include multiple bore sizes, conic sections, or necks in order to transition from the bore of the outlet port 420 to the bore of the seal port 440 along the fluid passageway 460. According to some embodiments, the inlet port 430 may include a secondary bore size where the inlet port 430 intersects the fluid passageway 460 to facilitate fluid transfer.

[0046] Figure 4D illustrates an example O-ring valve housing 400, according to embodiments of the present disclosure. The housing 400 includes a valve body 410, defining an outlet port 420, an inlet port 430, and a seal port 440. The seal port 440 includes an interface region 450, which is dimensionally matched with the undulating region 320 of the O-ring seal 300 and, in some examples, includes portions that are matched to the outer ring 310 of the seal 300. In various embodiments, one or more crenelations or stubs 470a-d (generally or collectively, stubs 470) project from the housing 400 to interface with portions of the cap 600 or iris mechanism 700. Although generally referred to as an “inlet” or an “outlet” for ease of identification in one use-case, the present disclosure contemplates that both the outlet port 420 and the inlet port 430 may be used for delivery or reception of various fluids to / from a biological subject when in use.

[0047] In the illustrated embodiment, outlet port 420 is a male port having a barbed connection 422. In some examples, the outlet port 420 may include other connection types such as threaded connections, pressure fit connections, pinned connections, channel lock connections or other conventional fitings and connectors.

[0048] According to some embodiments, inlet port 430 is configured to interface with an outside fluid source, such as a tube supplying saline, or other fluids (e.g., serum), and introduce the fluid into the valve body 410. Such a configuration of the inlet port 430 may include connection types such as threaded connections, barbed connections, pressure fit connections,10508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCT pinned connections, channel lock connections or other conventional fitings and connectors. According to some embodiments, the inlet port 430 is configured to interface with a pressure source, such that fluids and solids may be pushed or drawn through the housing 400.

[0049] Figure 4E illustrates cross sectional view of the O-ring valve housing 400 of Figure 4D, according to embodiments of the present disclosure. The seal port 440 and outlet port 420 define respective ends of a fluid passageway 460 that provides fluid communication through the valve body 410. The interface region 450 within the seal port 440 includes an aperture 444, matched with the central region 330 of the seal 300. The outlet port 420 and the seal port 440 share a central axis 412 (parallel to the Y-axis) which passes through the center points of the circular profiles (in the X-Z plane) of the outlet port 420 and the seal port 440, and thusly the fluid passageway 460 formed there between. The inlet port 430 defines a second axis 432, which passes through the center points of the circular profiles of the inlet port 430. The second axis 432 (and thusly the inlet port 430) intersects the central axis 412 (and thusly the fluid passageway 460) at an angle Al. In some examples, the angle Al is less than 80 degrees.

[0050] Figure 4F illustrates the section view of the O-ring valve housing 400 of Figure 4E, with certain relevant dimensions shown, according to embodiments of the present disclosure. The outlet port 420 is bored having a radius R3 relative to the central axis. The inlet port 430 is bored with a radius R4 relative to the second axis 432. The seal port 440 is bored having a radius R5, matched to the radius R1 of the outer ring 310 of the O-ring seal 300, as the interface region 450 within the seal port 440 is configured to match with the undulating region 320 and outer ring 310 of the seal 300.

[0051] According to some embodiments, the fluid passageway 460 formed between the seal port 440 and the outlet port 420 has a variable bore, and may include multiple bore sizes, conic sections, or necks in order to transition from the bore of the outlet port 420 to the bore of the seal port 440 along the fluid passageway 460. According to some embodiments, the inlet port 430 may include a secondary bore size where the inlet port 430 intersects the fluid passageway 460 to facilitate fluid transfer.

[0052] Although illustrated with a given layout and form factor, the present disclosure contemplates that the housing 400 may take various appearances in various embodiments.

[0053] Figure 5 illustrates a conformal holder 500, according to embodiments of the present disclosure. The conformal holder 500 includes an interface region 512, which is matched with the undulating region 320 of the seal 300. The conformal holder 500 further includes an aperture 514 to facilitate access to the through hole 336 in the seal 300. The11508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCT conformal holder 500 includes a flat surface 520 which interfaces with the cap 600 (Figures 6A-6B) to compress the seal 300 via the cap 600 to form a secure seal.

[0054] According to some embodiments, the conformal holder 500 includes a groove 510 matched with the outer ring 310 of the seal 300. The groove 510 interfaces with the outer ring 310 in the same manner as the cap interface region 512 interfaces with the undulating region 320 of the seal 300, the above components collectively forming a sealing action about the seal 300.

[0055] Figure 6A illustrates a cap 600 according to embodiments of the present disclosure. The cap 600 includes threads 610, which are configured to interface with the threads 442 of the housing 400. The cap 600 further includes an aperture 614 to facilitate access to the through hole 336 in the seal 300. In some embodiments, the aperture 614 of the cap 600 is matched with the aperture 514 of the conformal holder 500. The cap 600 further includes a flat surface 620, which is configured to interface with the flat surface 520 of the conformal holder 500.

[0056] Figure 6B illustrates a cap 600 according to embodiments of the present disclosure. The cap 600 includes one or more stubs 630a-b, which are configured to interface with the corresponding stubs 470 on the housing 400 to orient the cap 600 relative to the housing 400 and provide additional surface area to bond between the cap 600 and housing 400 if using an adhesive, or provide for tabs to insert into slots in the two components. The cap 600 further includes an aperture 614 to facilitate access to the through hole 336 in the seal 300. In some embodiments, the aperture 614 of the 600 is matched with the aperture 514 of the conformal holder 500. The cap 600 further defines an actuator opening 640, through which the tab 726 of the articulation ring 720 of the iris mechanism 700 projects.

[0057] Figures 7A-7E illustrate an example iris mechanism 700, according to embodiments of the present disclosure. As shown in Figure 7A, the iris mechanism 700 includes a plurality of leaves 740a-e (e.g., generally or collectively, leaf 740 or leaves 740), which define the size of the aperture 710 through the iris mechanism 700, an articulation ring 720 including a tab 726 to aid in the articulation of the leaves 740, and a fixed ring 730 that the leaves 740 are secured between with the articulation ring 720. Although illustrated with five leaves 740, the present disclosure contemplates that more or fewer leaves 740 may be used in various embodiments.

[0058] Figure 7D shows that the articulation ring 720 defines a plurality of rotation tracks 722a-e (generally or collectively, rotation tracks 722), which correspond in number to the plurality of leaves 740. Similarly, Figure 7E shows that the fixed ring 730 defines a plurality12508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCT of fixed tracks 732a-e (generally or collectively, fixed tracks 732), which also correspond in number to the plurality of leaves 740.

[0059] Although illustrated with the articulation ring 720 between the fixed ring 730 and the cap 600, in various embodiments, the fixed ring 730 may be disposed between the cap 600 and the rotating ring. In some embodiments, the fixed ring 730 may be omited when the cap 600 defines fixed tracks 732 on an underside thereof, so that the leaves 740 are captured between the cap 600 and the articulation ring 720.

[0060] In various embodiments, the fixed ring 730 may be held rotationally in place via one or more tabs 736, a non-round design, adhesives, fasteners, etc. that act as anti-rotation means for the fixed ring 730 relative to the articulation ring 720. In some embodiments, the fixed ring 730 is part of the housing 400, or may be omited with the housing 400 defines the fixed tracks 732.

[0061] The leaves 740 are pinned internally to both the fixed ring 730 and the articulation ring 720 via associated runners that are defined on a periphery of each leaf 740 on opposing sides thereof. As identified with reference to the leaf 740 shown in Figures 7B and 7C, a rotation runner 742 is provided for insertion into the first rotation track 722 and a fixed runner 743 is provided for insertion into the first fixed track 732. A compression arm 744 is provided on a central aspect of the leaf 740, and when the leaf 740 is assembled in the iris mechanism 700, the compression arm is located centrally to the aperture 614 of the cap, the aperture 724 of the fixed ring, and aperture 734 of the aperture of the fixed ring 730 such that the relative rotational positions of the leaves 740 allow for the selective sizing of the overall aperture 710 through the iris mechanism 700.

[0062] The articulation of the articulation ring 720 mutually rotates the leaves 740, which results in a change in the size of the aperture 710 via how closely the inner aspects of the leaves 740 are located relative to each other. According to some embodiments, the iris mechanism 700 may index through a plurality of defined indices, each index having an aperture size corresponding to a position of the articulation ring 720. In some examples the iris mechanism 700 includes various conventional structures, such as locking mechanisms or ratcheting mechanisms.

[0063] Figures 8A-8B illustrate two example configurations 800a-b of an iris mechanism 700, according to embodiments of the present disclosure. Figure 8A illustrates the iris mechanism 700 in an “open” index configuration 800a. The configuration 800a of Figure 8A transitions to the configuration 800b of Figure 7B by indexing the articulation ring 720 via the applied force 850 to the tab 716, thereby reducing the size of the aperture 714 of the iris13508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCT mechanism 700. As will be appreciated, greater or lesser amounts of reduction or transitioning back from the second configuration 800b to the first configuration 800a may be achieved with different applied forces 850 placed on the tab 716.

[0064] Figures 9A-9B illustrate top-down views of operation of an iris mechanism 700 used in conjunction with an O-ring seal 300 in two example configurations 800a-b, according to embodiments of the present disclosure. Figures 10A-10D illustrate cutaway views of operation of an iris mechanism 700 used in conjunction with an O-ring seal 300 in the two example configurations 800a-b, according to embodiments of the present disclosure.

[0065] The projection 332 of the central region 330 of the seal 300 protrudes through the aperture 714 of the iris mechanism 700. The articulation ring 720 may then be rotated from the state shown in Figure 8 A, thereby decreasing the size of the aperture 714 to the state shown in Figure 8B, which provides a compressive radial force on the projection 332 (e.g., transitioning the projection 332 from an uncompressed state to a compressed state). This compressive force may improve the seal integrity of the seal 300 when traversed by an instrument such as a guidewire, catheter, scope, trocar, needle, cannula or other guided medical device 150. An improved seal integrity reduces the chance of pressurized fluids traversing the seal 300 in an unwanted manner, the risk of which is heightened when operating under pressurized conditions.

[0066] The compressive force provided by the iris mechanism 700 on the projection 332 of the seal 300 may increase the grip pressure of the seal 300 on an instrument traversing the seal 300. The increased grip pressure may reduce the chances of an instrument inserted through or piercing the seal being unintentionally retracted or further inserted. In various embodiments, the compressive force applied by the leaves 740 to the projection 332 is substantially perpendicular to a plane in which the first incision 334A is formed. Similarly, other leaves (not illustrated) are positioned to apply compressive forces in a plane substantially perpendicular to the plane in which the second incision 334B is formed. This perpendicular application of force to the projection 332 relative to the incisions 334 may further ensure a tight seal where the incisions 334 form the through hole 336.

[0067] The grip pressure may be lessened by rotating the articulation ring 720 of the iris mechanism 700 in the opposite direction (e.g., from the state shown in Figure 8B to the state shown in Figure 8A), which may be suitable for inserting or retracting an instrument though the seal 300. In some examples, the iris mechanism 700 may be regarded as a clamping means.

[0068] In some examples, the iris mechanism 700 may be configured as a component secured onto a valve housing. The iris mechanism 700 may be part of a larger component,14508257445 1Atorney Docket No.: 8001535.00135Client Docket No.: 2023-249-PCT including joinery features, such as threaded connections, or other conventional structures facilitating connection. In some embodiments, the iris mechanism 700 is part of a housing means such as housing 400 of Figure 4A-4B. In some embodiments, the iris mechanism 700 is part of a securing means such as cap 600 of Figure 6A. In some embodiments, the iris mechanism 700 may be included in a valve assembly, including a housing and a seal 300, wherein the iris mechanism is used to increase the grip pressure on an instrument traversing the seal 300 and the valve.

[0069] Certain terms are used throughout the description and claims to refer to particular features or components. As one skilled in the art will appreciate, different persons may refer to the same feature or component by different names. This document does not intend to distinguish between components or features that differ in name but not function.

[0070] The present disclosure may also be understood with reference to the following numbered clauses.

[0071] Clause 1. A seal, comprising: a central region; an undulating region; and a first ring disposed on an outer radius of the undulating region and having a first height; wherein: the central region is located centrally on the undulating region, including a first projection on a first side of the undulating region a second projection on a second side of the undulating region opposite to the first side, having a second height greater than the first height; and the central region defines a first incision in the first projection that extends more than half of the second height, and a second incision, perpendicular to the first incision, in the second projection that extends more than half of the second height, wherein the first incision and the second incision are mutually perpendicular.

[0072] Clause 2. The seal of clause 1, wherein the first incision bisects the first projection and the second incision bisects the second projection.

[0073] Clause 3. The seal of clause 1, wherein a through hole is formed between the first projection and the second projection via the first incision and the second incision.

[0074] Clause 4. The seal of clause 1, wherein the first projection includes a first conical bevel and the second projection includes a second conic bevel.

[0075] Clause 5. The seal of clause 1 , wherein the undulating region comprises a sinusoidal waveform about a circumference of the undulating region, the sinusoidal waveform having two apexes and two nadirs.

[0076] Clause 6. The seal of clause 1, wherein a wave height of the undulating region, as measured between a given apex and a given nadir, is less than the first height.15508257445 1Atorney Docket No.: 8001535.00135Client Docket No.: 2023-249-PCT

[0077] Clause 7. The seal of clause 1, wherein the seal is constructed of a material selected from a group of biocompatible materials consisting of: silicone, rubber, and polyvinyl chloride (PVC).

[0078] Clause 8. A device comprising: a body including a first port; a cap secured to the first port, including an iris mechanism that indexes between at least a first position and a second position; and a seal, having a first projection that protrudes through an aperture defined by the iris mechanism; wherein in the first position, the iris mechanism defines the aperture with a first radius that is greater than a radius of the first projection in an uncompressed state; and wherein in the second position, the iris mechanism defines the aperture with a second perimeter that is smaller than the radius of the first projection in an uncompressed state, thereby compressing the first projection.

[0079] Clause 9. The device of clause 8, wherein the seal further comprises: an undulating region; and a first ring disposed on an outer radius of the undulating region and having a first height; wherein: the first projection is located on a central region within the undulating region, the central region including a second projection on a side of the seal opposite to the first projection, such that the central region including the first projection and the second projection has a second height greater than the first height; the central region defines a first incision in the first projection that extends more than half of the second height, and a second incision, perpendicular to the first incision, in the second projection that extends more than half of the second height, wherein the first incision and the second incision are mutually perpendicular.

[0080] Clause 10. The device of clause 9, wherein the first incision bisects the first projection and the second incision bisects the second projection.

[0081] Clause 11. The device of clause 9 wherein the first projection includes a first conical bevel and the second projection include a second conical bevel.

[0082] Clause 12. The device of clause 9, wherein the undulating region comprises a sinusoidal waveform about a circumference of the undulating region, the sinusoidal waveform having two apexes and two nadirs.

[0083] Clause 13. The device of clause 12, wherein a wave height of the undulating region, as measured between a given apex and a given nadir, is less than the first height.

[0084] Clause 14. The device of clause 12, wherein the cap includes a surface that is matched to and interfaces with the undulating region of the seal, such that the matched surface has two apexes matched to the two nadirs of the undulating region and the matched surface has two nadirs matched to the two apexes of the undulating region.16508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCT

[0085] Clause 15. The device of clause 12, wherein the first port includes a surface that is matched to and interfaces with the undulating region of the seal, such that the matched surface has two apexes matched to the two nadirs of the undulating region and the matched surface has two nadirs matched to the two apexes of the undulating region.

[0086] Clause 16. The device of clause 9, wherein a through hole is formed between the first projection and the second projection via the first incision and the second incision, and an instrument is inserted through the through hole.

[0087] Clause 17. The device of clause 16, wherein the seal and the iris mechanism, when in the second position, provide an increased grip pressure about the instrument while the instrument is inserted relative to a grip pressure applied to the instrument inserted through the seal.

[0088] Clause 18. The device of clause 16, wherein the instrument is selected from a group consisting of a trocar, a needle, a catheter, and a cannula.

[0089] Clause 19. The device of clause 8, wherein the seal is constructed of a material selected from a group of biocompatible materials consisting of: silicone, rubber, and Polyvinyl chloride (PVC).

[0090] Clause 20. The device of clause 8, wherein the seal further comprises: an undulating region; and a first ring disposed on an outer radius of the undulating region and having a first height; wherein: the first projection is located on a central region within the undulating region, the central region including a second projection on a side of the seal opposite to the first projection, such that the central region including the first projection and the second projection has a second height greater than the first height; and the central region defines a single incision extending conformally with the first projection and the second projection through a plane aligned with undulations in a sinusoidal wave of the seal.

[0091] Clause 21. The device of clause 8, wherein the iris mechanism comprises: an articulation ring; a fixed ring; and a plurality of leaves, each pinned to both the articulation ring and the fixed ring, forming the aperture; wherein the articulation ring has an index of positions, including the first position and the second position, and indexing the articulation ring rotates the articulation ring about the fixed ring, and changes a size of the aperture.

[0092] Clause 22. A device comprising: a body including a first port; a cap secured to the first port, including a clamping means that indexes between at least a first position and a second position; and a seal, having an interfacing means that projects through an opening defined by the clamping means; wherein in the first position the clamping means defines the opening with a first perimeter that is greater than a radius of the interfacing means in an uncompressed state;17508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCT and wherein in the second position the clamping means defines the opening with a second radius that is smaller than the radius of the interfacing means in an uncompressed state, thereby compressing the interfacing means.

[0093] Clause 23. The device of clause 22, wherein the seal further comprises: a conforming means; and a first ring disposed on an outer radius of conforming means and having a first height; wherein: the interfacing means is located centrally on the conforming means, including a first projection on a first side of the conforming means, and a second projection on a second side of the conforming means opposite to the first side, having a second height greater than the first height; and the interfacing means defines a first incision in the first projection that extends more than half of the second height, and a second incision, perpendicular to the first incision, in the second projection that extends more than half of the second height.

[0094] Clause 24. The device of clause 23, wherein the cap comprises a surface matched to the conforming means, such that when the seal is disposed in the first port, and the cap is disposed over the seal on the first port, the conforming means aligns with the matched surface.

[0095] Clause 25. A seal, comprising: a central region; an undulating region; and a first ring disposed on an outer radius of the undulating region and having a first height; wherein: the central region is located centrally on the undulating region, including a first projection on a first side of the undulating region a second projection on a second side of the undulating region opposite to the first side, having a second height greater than the first height; and the central region defines a single incision extending conformally with the first projection and the second projection through a plane aligned with undulations in a sinusoidal wave of the seal.

[0096] Clause 26. The seal of clause 25, wherein the undulating region defines the sinusoidal wave of the seal having two apexes and two nadirs on each of the first side and the second side.

[0097] Clause 27. The seal of clause 26, wherein the single incision is aligned with the undulations for the plane to pass through the two apexes.

[0098] Clause 28. A seal, comprising: an central region; a conforming means, having a surface described by a sinusoidal wave; and a first ring disposed on an outer radius of the conforming means and having a first height; wherein: the central region is located centrally on the conforming means, including a first projection on a first side of the conforming means a second projection on a second side of the conforming means opposite to the first side, having a second height greater than the first height; and the central region defines a first incision in the first projection that extends more than half of the second height.18508257445 1Atorney Docket No.: 8001535.00135Client Docket No.: 2023-249-PCT

[0099] Clause 29. The seal of clause 28, wherein the central region defines a second incision, perpendicular to the first incision, in the second projection that extends more than half of the second height, wherein the first incision and the second incision are defined in planes aligned with undulations in a sinusoidal wave of the conforming means.

[0100] Clause 30. The seal of clause 28, wherein the first incision is a single incision extending conformally with the first projection and the second projection through a plane aligned with undulations in a sinusoidal wave of the conforming means.

[0101] As used herein, “about,” “approximately” and “substantially” are understood to refer to numbers in a range of the referenced number, for example the range of -30% to +10% of the referenced number, preferably -5% to +5% of the referenced number, more preferably - 3% to +1% of the referenced number, most preferably -0.1% to +0.1% of the referenced number.

[0102] Furthermore, all numerical ranges herein should be understood to include all integers, whole numbers, or fractions, within the range. Moreover, these numerical ranges should be construed as providing support for a claim directed to any number or subset of numbers in that range. For example, a disclosure of from 3 to 30 should be construed as supporting a range of from 3 to 1, from 5 to 8, from 3 to 8, from 5.6 to 6.6, from 5.5 to 8.9, and so forth.

[0103] As used in the present disclosure, a phrase referring to “at least one of’ a list of items refers to any set of those items, including sets with a single member, and every potential combination thereof. For example, when referencing “at least one of A, B, or C” or “at least one of A, B, and C”, the phrase is intended to cover the sets of: A, B, C, A-B, B-C, A-C, and A-B-C, where the sets may include one or multiple instances of a given member (e.g., A-A, A- A-A, A-A-B, A-A-B-B-C-C-C, etc.) and any ordering thereof. For avoidance of doubt, the phrase “at least one of A, B, and C” shall not be interpreted to mean “at least one of A, at least one of B, and at least one of C”.

[0104] As used in the present disclosure, the term “determining” encompasses a variety of actions that may include calculating, computing, processing, deriving, investigating, looking up (e.g., via a table, database, or other data structure), ascertaining, receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), retrieving, resolving, selecting, choosing, establishing, and the like.

[0105] Without further elaboration, it is believed that one skilled in the art can use the preceding description to use the claimed inventions to their fullest extent. The examples and aspects disclosed herein are to be construed as merely illustrative and not a limitation of the19508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCT scope of the present disclosure in any way. It will be apparent to those having skill in the art that changes may be made to the details of the above-described examples without departing from the underlying principles discussed. In other words, various modifications and improvements of the examples specifically disclosed in the description above are within the scope of the appended claims. For instance, any suitable combination of features of the various examples described is contemplated.

[0106] Within the claims, reference to an element in the singular is not intended to mean “one and only one” unless specifically stated as such, but rather as “one or more” or “at least one”. Unless specifically stated otherwise, the term “some” refers to one or more. No claim element is to be construed under the provision of 55 U.S.C. § 312(f) unless the element is expressly recited using the phrase “means for” or “step for”. All structural and functional equivalents to the elements of the various embodiments described in the present disclosure that are known or come later to be known to those of ordinary skill in the relevant art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed in the present disclosure is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.20508257445 1

Claims

Atorney Docket No.: 8001535.00135Client Docket No.: 2023-249-PCTCLAIMSThe invention is claimed as follows:

1. A seal, comprising: a central region; an undulating region; and a first ring disposed on an outer radius of the undulating region and having a first height; wherein: the central region is located centrally on the undulating region, including a first projection on a first side of the undulating region a second projection on a second side of the undulating region opposite to the first side, having a second height greater than the first height; and the central region defines a first incision in the first projection that extends more than half of the second height, and a second incision, perpendicular to the first incision, in the second projection that extends more than half of the second height, wherein the first incision and the second incision are mutually perpendicular.

2. The seal of claim 1, wherein the first incision bisects the first projection and the second incision bisects the second projection.

3. The seal of claim 1, wherein a through hole is formed between the first projection and the second projection via the first incision and the second incision.

4. The seal of claim 1, wherein the first projection includes a first conical bevel and the second projection includes a second conic bevel.

5. The seal of claim 1, wherein the undulating region comprises a sinusoidal waveform about a circumference of the undulating region, the sinusoidal waveform having two apexes and two nadirs.21508257445 1Atorney Docket No.: 8001535.00135Client Docket No.: 2023-249-PCT6. The seal of claim 1, wherein a wave height of the undulating region, as measured between a given apex and a given nadir, is less than the first height.

7. The seal of claim 1, wherein the seal is constructed of a material selected from a group of biocompatible materials consisting of: silicone, rubber, and polyvinyl chloride (PVC).

8. A device comprising: a body including a first port; a cap secured to the first port, including an iris mechanism that indexes between at least a first position and a second position; and a seal, having a first projection that protrudes through an aperture defined by the iris mechanism; wherein in the first position, the iris mechanism defines the aperture with a first radius that is greater than a radius of the first projection in an uncompressed state; and wherein in the second position, the iris mechanism defines the aperture with a second perimeter that is smaller than the radius of the first projection in an uncompressed state, thereby compressing the first projection.

9. The device of claim 8, wherein the seal further comprises: an undulating region; and a first ring disposed on an outer radius of the undulating region and having a first height; wherein: the first projection is located on a central region within the undulating region, the central region including a second projection on a side of the seal opposite to the first projection, such that the central region including the first projection and the second projection has a second height greater than the first height; the central region defines a first incision in the first projection that extends more than half of the second height, and a second incision, perpendicular to the first incision, in the second projection that extends more than half of the second height, wherein the first incision and the second incision are mutually perpendicular.22508257445 1Atorney Docket No.: 8001535.00135 Client Docket No.: 2023-249-PCT10. The device of claim 9, wherein the first incision bisects the first projection and the second incision bisects the second projection.

11. The device of claim 9 wherein the first projection includes a first conical bevel and the second projection include a second conical bevel.

12. The device of claim 9, wherein the undulating region comprises a sinusoidal waveform about a circumference of the undulating region, the sinusoidal waveform having two apexes and two nadirs.

13. The device of claim 12, wherein a wave height of the undulating region, as measured between a given apex and a given nadir, is less than the first height.

14. The device of claim 12, wherein the cap includes a surface that is matched to and interfaces with the undulating region of the seal, such that the matched surface has two apexes matched to the two nadirs of the undulating region and the matched surface has two nadirs matched to the two apexes of the undulating region.

15. The device of claim 12, wherein the first port includes a surface that is matched to and interfaces with the undulating region of the seal, such that the matched surface has two apexes matched to the two nadirs of the undulating region and the matched surface has two nadirs matched to the two apexes of the undulating region.

16. The device of claim 9, wherein a through hole is formed between the first projection and the second projection via the first incision and the second incision, and an instrument is inserted through the through hole.

17. The device of claim 16, wherein the seal and the iris mechanism, when in the second position, provide an increased grip pressure about the instrument while the instrument is inserted relative to a grip pressure applied to the instrument inserted through the seal.

18. The device of claim 16, wherein the instrument is selected from a group consisting of a trocar, a needle, a catheter, and a cannula.23508257445 1Atorney Docket No.: 8001535.00135Client Docket No.: 2023-249-PCT19. The device of claim 8, wherein the seal is constructed of a material selected from a group of biocompatible materials consisting of: silicone, rubber, and Polyvinyl chloride (PVC).

20. The device of claim 8, wherein the seal further comprises: an undulating region; and a first ring disposed on an outer radius of the undulating region and having a first height; wherein: the first projection is located on a central region within the undulating region, the central region including a second projection on a side of the seal opposite to the first projection, such that the central region including the first projection and the second projection has a second height greater than the first height; and the central region defines a single incision extending conformally with the first projection and the second projection through a plane aligned with undulations in a sinusoidal wave of the seal.

21. The device of claim 8, wherein the iris mechanism comprises: an articulation ring; a fixed ring; and a plurality of leaves, each pinned to both the articulation ring and the fixed ring, forming the aperture; wherein the articulation ring has an index of positions, including the first position and the second position, and indexing the articulation ring rotates the articulation ring about the fixed ring, and changes a size of the aperture.

22. A device comprising: a body including a first port; a cap secured to the first port, including a clamping means that indexes between at least a first position and a second position; and a seal, having an interfacing means that projects through an opening defined by the clamping means; wherein in the first position the clamping means defines the opening with a first perimeter that is greater than a radius of the interfacing means in an uncompressed state; and24508257445 1Atorney Docket No.: 8001535.00135Client Docket No.: 2023-249-PCT wherein in the second position the clamping means defines the opening with a second radius that is smaller than the radius of the interfacing means in an uncompressed state, thereby compressing the interfacing means.

23. The device of claim 22, wherein the seal further comprises: a conforming means; and a first ring disposed on an outer radius of conforming means and having a first height; wherein: the interfacing means is located centrally on the conforming means, including a first projection on a first side of the conforming means, and a second projection on a second side of the conforming means opposite to the first side, having a second height greater than the first height; and the interfacing means defines a first incision in the first projection that extends more than half of the second height, and a second incision, perpendicular to the first incision, in the second projection that extends more than half of the second height.

24. The device of claim 23, wherein the cap comprises a surface matched to the conforming means, such that when the seal is disposed in the first port, and the cap is disposed over the seal on the first port, the conforming means aligns with the matched surface.

25. A seal, comprising: a central region; an undulating region; and a first ring disposed on an outer radius of the undulating region and having a first height; wherein: the central region is located centrally on the undulating region, including a first projection on a first side of the undulating region a second projection on a second side of the undulating region opposite to the first side, having a second height greater than the first height; and the central region defines a single incision extending conformally with the first projection and the second projection through a plane aligned with undulations in a sinusoidal wave of the seal.25508257445 1Atorney Docket No.: 8001535.00135Client Docket No.: 2023-249-PCT26. The seal of claim 25, wherein the undulating region defines the sinusoidal wave of the seal having two apexes and two nadirs on each of the first side and the second side.

27. The seal of claim 26, wherein the single incision is aligned with the undulations for the plane to pass through the two apexes.

28. A seal, comprising: an central region; a conforming means, having a surface described by a sinusoidal wave; and a first ring disposed on an outer radius of the conforming means and having a first height; wherein: the central region is located centrally on the conforming means, including a first projection on a first side of the conforming means a second projection on a second side of the conforming means opposite to the first side, having a second height greater than the first height; and the central region defines a first incision in the first projection that extends more than half of the second height.

29. The seal of claim 28, wherein the central region defines a second incision, perpendicular to the first incision, in the second projection that extends more than half of the second height, wherein the first incision and the second incision are defined in planes aligned with undulations in a sinusoidal wave of the conforming means.

30. The seal of claim 28, wherein the first incision is a single incision extending conformally with the first projection and the second projection through a plane aligned with undulations in a sinusoidal wave of the conforming means.26508257445 1

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