阅读说明：本技术 止血阀以及制造和使用止血阀的方法 (Hemostatic valve and methods of making and using same ) 是由 亨利·J·佩平 萨米特·阿格拉沃尔 于 2018-02-26 设计创作，主要内容包括：本发明公开了止血阀以及制造和使用止血阀的方法。一种示例止血阀可以包括主体,其具有近端区。芯筒可以至少部分地设置在所述近端区内。所述芯筒可以包括密封构件。所述密封构件可以设计成在打开形态和密封形态之间转换。具有内管状区域和远端的柱塞可以联接到所述主体的所述近端区。所述内管状区域的所述远端可以与所述密封构件的近端间隔间隙距离,使得当所述密封构件在所述密封形态中并且暴露于每平方英寸80-250磅的压力时,所述密封构件偏转成与所述内管状区域的所述远端接触并且保持在所述密封形态中。(Hemostatic valves and methods of making and using hemostatic valves are disclosed. An example hemostasis valve can include a body having a proximal end region. A cartridge may be at least partially disposed within the proximal region. The cartridge may include a sealing member. The sealing member may be designed to transition between an open configuration and a sealed configuration. A plunger having an inner tubular region and a distal end may be coupled to the proximal region of the body. The distal end of the inner tubular region may be spaced a gap distance from a proximal end of the sealing member such that when the sealing member is in the sealed configuration and exposed to a pressure of 80-250 pounds per square inch, the sealing member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.)

1. A hemostatic valve, comprising:

A body having a proximal end region;

A cartridge disposed at least partially within the proximal region, the cartridge including a sealing member;

Wherein the sealing member is designed to be converted between an open configuration and a sealed configuration;

a plunger coupled to the proximal end region of the body, the plunger having an inner tubular region with a distal end;

wherein the distal end of the inner tubular region is spaced a gap distance from a proximal end of the sealing member such that when the sealing member is in the sealed configuration and exposed to a pressure of about 80 to about 250 pounds per square inch, the sealing member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

2. The hemostasis valve of claim 1, wherein the gap distance has an axial dimension of about 0.1 to about 5 millimeters.

3. The hemostasis valve of claim 1, wherein the gap distance has an axial dimension of about 0.3 to about 2 millimeters.

4. The hemostasis valve of any one of claims 1-3, wherein the gap distance is designed such that when the sealing member is in the sealed configuration and exposed to a pressure of about 100 to about 250 pounds per square inch, the sealing member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

5. the hemostasis valve of any one of claims 1-4, wherein the gap distance is designed such that when the sealing member is in the sealed configuration and exposed to a pressure of about 80 to about 200 pounds per square inch, the sealing member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

6. The hemostasis valve of any one of claims 1-5, wherein the proximal end region of the body includes a retention tab.

7. The hemostasis valve of claim 6, wherein the plunger has a distal retention flange designed to engage the retention tab.

8. The hemostasis valve of any one of claims 1-7, wherein a spring member is disposed within the plunger and engages a proximal end of the plunger.

9. The hemostasis valve of any one of claims 1-8, further comprising a nut threadably engaged with one or more threads along the proximal region of the body.

10. The hemostasis valve of any one of claims 1-9, wherein the inner tubular region has a wall thickness that varies along its length.

11. The hemostasis valve of any one of claims 1-10, wherein the inner tubular region has an inner diameter that varies along its length.

12. A hemostatic valve, comprising:

A body having a proximal end region;

A cartridge disposed at least partially within the proximal region, the cartridge including a sealing member;

wherein the sealing member is designed to be converted between an open configuration and a sealed configuration;

A plunger coupled to the proximal end region of the body, the plunger having an inner tubular region with a distal end;

Wherein the sealing member and the plunger are arranged such that there is a gap distance between a proximal face of the sealing member and the distal end of the inner tubular region such that when the sealing member is in the sealed configuration and exposed to a pressure of about 80 to about 250 pounds per square inch, the proximal face of the sealing member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

13. The hemostasis valve of claim 12, wherein the gap distance has an axial dimension of about 0.3 to about 2 millimeters.

14. The hemostasis valve of any one of claims 12-13, wherein the gap distance is designed such that when the sealing member is in the sealed configuration and exposed to a pressure of about 100 to about 250 pounds per square inch, the sealing member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

15. The hemostasis valve of any one of claims 12-13, wherein the gap distance is designed such that when the sealing member is in the sealed configuration and exposed to a pressure of about 80 to about 200 pounds per square inch, the sealing member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

Technical Field

The present invention relates to medical devices and methods of manufacturing medical devices. More particularly, the present invention relates to hemostatic valves and methods of making and using hemostatic valves.

background

A wide variety of medical devices have been developed for medical use, such as intravascular use. Some of these devices include guidewires, catheters, and the like. These devices are manufactured by any of a variety of different manufacturing methods and may be used according to any of a variety of methods. Each of the known medical devices and methods has certain advantages and disadvantages. There is a need to provide alternative medical devices and alternative methods for making and using medical devices.

Disclosure of Invention

The present invention provides design, materials, manufacturing methods and use alternatives for medical devices. An example hemostasis valve is disclosed. The hemostatic valve includes: a body having a proximal end region; a cartridge disposed at least partially within the proximal region, the cartridge including a sealing member; wherein the sealing member is designed to be switched between an open configuration and a sealed configuration; a plunger coupled to the proximal end region of the body, the plunger having an inner tubular region with a distal end; wherein the distal end of the inner tubular region is spaced a clearance distance from the proximal end of the sealing member such that when the sealing member is in the sealed configuration and exposed to a pressure of 80 to 250 pounds per square inch, the sealing member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

Alternatively or additionally to any of the embodiments above, the gap distance has an axial dimension of 0.1 to 5 millimeters.

Alternatively or additionally to any of the embodiments above, the gap distance has an axial dimension of 0.3 to 2 millimeters.

Alternatively or additionally to any of the embodiments above, the gap distance is designed such that when the sealing member is in the sealed configuration and exposed to a pressure of 100 to 250 pounds per square inch, the sealing member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

Alternatively or additionally to any of the embodiments above, the gap distance is designed such that when the sealing member is in the sealed configuration and exposed to a pressure of 80 to 200 pounds per square inch, the sealing member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

Alternatively or additionally to any of the embodiments above, the proximal region of the body comprises a retention tab.

Alternatively or additionally to any of the embodiments above, the plunger has a distal retention flange designed to engage the retention tab.

Alternatively or additionally to any of the embodiments above, the spring member is disposed within the plunger and engages the proximal end of the plunger.

Alternatively or additionally to any of the embodiments above, further comprising a nut threadably engaged with the one or more threads along the proximal region of the body.

Alternatively or additionally to any of the embodiments above, the inner tubular region has a wall thickness that varies along its length.

Alternatively or additionally to any of the embodiments above, the inner tubular region has an inner diameter that varies along its length.

The invention discloses a hemostatic valve. The hemostatic valve includes: a body having a proximal end region; a cartridge disposed at least partially within the proximal region, the cartridge including a sealing member; wherein the sealing member is designed to be switched between an open configuration and a sealed configuration; a plunger coupled to the proximal end region of the body, the plunger having an inner tubular region with a distal end; wherein the sealing member and the plunger are arranged such that there is a clearance distance between a proximal face of the sealing member and a distal end of the inner tubular region such that when the sealing member is in the sealed configuration and exposed to a pressure of 80 to 250 pounds per square inch, the proximal face of the sealing member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

Alternatively or additionally to any of the embodiments above, the gap distance has an axial dimension of 0.1 to 5 millimeters.

Alternatively or additionally to any of the embodiments above, the gap distance has an axial dimension of 0.3 to 2 millimeters.

Alternatively or additionally to any of the embodiments above, the gap distance is designed such that when the sealing member is in the sealed configuration and exposed to a pressure of 100 to 250 pounds per square inch, the sealing member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

alternatively or additionally to any of the embodiments above, the gap distance is designed such that when the sealing member is in the sealed configuration and exposed to a pressure of 80 to 200 pounds per square inch, the sealing member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

Alternatively or additionally to any of the embodiments above, the proximal region of the body comprises a retaining tab, and wherein the plunger has a distal retaining flange designed to engage the retaining tab.

Alternatively or additionally to any of the embodiments above, further comprising a nut threadably engaged with the one or more threads along the proximal region of the body.

The invention discloses a hemostatic valve. The hemostatic valve includes: a body having a threaded proximal end region; a nut threadedly engaged with the threaded proximal region; a cartridge disposed at least partially within the threaded proximal region, the cartridge including a sealing member; wherein the sealing member is designed to be switched between an open configuration and a sealed configuration; a plunger coupled to the threaded proximal end region of the body, the plunger having an inner tubular region with a distal end; wherein the sealing member and the plunger are arranged such that there is a clearance distance between a proximal face of the sealing member and a distal end of the inner tubular region such that when the sealing member is in the sealed configuration and exposed to a pressure of 80 to 250 pounds per square inch, the proximal face of the sealing member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

alternatively or additionally to any of the embodiments above, the gap distance has an axial dimension of 0.3 to 2 millimeters, and wherein the gap distance is designed such that when the sealing member is in the sealed configuration and exposed to a pressure of 80 to 200 pounds per square inch, the sealing member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The figures and the detailed description that follow more particularly exemplify these embodiments.

Drawings

The invention may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:

FIG. 1 is a perspective view of an example hemostasis valve;

FIG. 2 is an exploded view of an example hemostasis valve;

FIG. 3 is a cross-sectional view taken through line 3-3 of FIG. 1;

FIG. 4 is a cross-sectional view of an example hemostasis valve;

FIGS. 5A-5B are cross-sectional views of an example hemostasis valve;

FIG. 6 is a cross-sectional view of a portion of an example hemostasis valve;

Fig. 7 is a cross-sectional view of a portion of an example hemostasis valve.

While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

Detailed Description

For the following defined terms, these definitions shall apply, unless a different definition is given in the claims or elsewhere in this specification.

All numerical values are herein assumed to be modified by the term "about", whether or not explicitly indicated. The term "about" generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

it should be noted that reference in the specification to "one embodiment," "some embodiments," "other embodiments," or the like means that the embodiment described may include one or more particular features, structures, or characteristics. However, such recitation does not necessarily imply that all embodiments include the particular features, structures, and/or characteristics. Further, when a particular feature, structure, and/or characteristic is described in connection with an embodiment, it is understood that such feature, structure, and/or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless explicitly stated to the contrary.

The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered identically. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

Many medical procedures, such as endovascular procedures, utilize medical devices within a body cavity. For example, some endovascular procedures involve placing a guidewire, a guide catheter, an interventional device, etc. in a blood vessel. Because fluid under pressure (e.g., blood) is present within the blood vessel, the fluid may travel along or through the medical device and escape or leak from the patient. In some instances, it may be desirable to provide a hemostasis valve or hemostasis valve assembly at the proximal end of the medical device to reduce or otherwise limit leakage of fluid/blood from the proximal end of the device.

An example hemostasis valve 10 is shown in fig. 1. The hemostatic valve 10 may include a body 12. The body 12 may include a side port 14. The side port 14 may be connected to another device, such as an infusion device, an inflation device, or the like. An adapter 16 may be coupled to the distal end of the body 12. The adapter 16 may be used to couple the hemostatic valve 10 to a device, such as a catheter. A plunger 18 may be coupled to the proximal end of the body 12. The plunger 18 may be used to activate or otherwise close a seal within the hemostatic valve 10 (e.g., as discussed herein). These and other features of the hemostatic valve 10 are discussed herein.

fig. 2 is an exploded view of the hemostatic valve 10. Here, the various components of the hemostatic valve 10 can be seen. For example, the hemostatic valve 10 may include a cartridge 20. The cartridge 20 may be arranged such that at least a portion thereof may be disposed within the proximal end region 22 of the body 12, the cartridge 20 may include two pieces 20a, 20b coupled (e.g., press fit, heat bonded, etc.) to one another. The first seal member 24 may be disposed within the cartridge 20. A second sealing member 26 may be disposed within the proximal region 22 of the body 12. In at least some examples, the second sealing member 26 may be disposed distal to the cartridge 20. The second sealing member 26 may include a textured distal surface, grooves or recesses formed therein, or the like. Additionally or alternatively, the second sealing member 26 may include a proximal region having a reduced diameter. Nut 28 may be coupled to proximal end region 22 of body 12, such as at one or more threads 30 formed along proximal end region 22.

Other features of the hemostatic valve 10 that may be seen in fig. 2 include a spring member 32 and an O-ring 34. The spring member 32 may be coupled to the plunger 18. In at least some examples, the spring member 32 can be designed to exert a proximally directed force on the plunger 18. An O-ring 34 may be positioned adjacent to the adapter 16. Additionally, a ring member or "snap ring" 36 may be disposed along the proximal region 22 of the body 12.

fig. 3 is a cross-sectional view of the hemostatic valve 10. Here, some structural features of the hemostatic valve 10 can be seen. For example, the hemostatic valve 10 may include a central lumen 38. Generally, the central cavity 38 is designed to be placed in fluid communication with more than one cavity of a device coupled to the adapter 16. A second or infusion lumen 40 may be defined adjacent side port 14. The second chamber 40 may be in fluid communication with the central chamber 38.

As mentioned above, the hemostatic valve 10 is designed such that it may be coupled to another device. For example, adapter 16 (which may take the form of a Tuohy-Borst or other type of connector) may engage the proximal end of another device. When connected (and the plunger 18 is in the configuration shown in fig. 3), the second sealing member 26 may be in an open state or configuration. Conversely, when the hemostatic valve 10 is connected to another device (and the plunger 18 is in the configuration shown in fig. 3), the first sealing member 24 may be in a closed or sealed configuration.

Collectively, when the hemostatic valve 10 is connected to another device and in the configuration shown in fig. 3, the hemostatic valve 10 is capable of substantially maintaining a fluid-tight seal, which substantially prevents backflow and/or leakage of bodily fluids (e.g., blood). At some point during the medical intervention, it may be desirable to infuse additional fluid, such as contrast media, through the hemostasis valve 10. This may include attaching the infusion device to side port 14. Because the first sealing member 24 may be designed to substantially prevent backflow and/or leakage of relatively low pressure fluid, infusion fluid may flow past the first sealing member 24 if the infusion device infuses fluid at a relatively high pressure.

To prevent backflow of relatively high pressure fluid, the hemostasis valve 10 can be actuated to close or "seal" the second sealing member 26. To do so, plunger 18 may first be pushed distally until a distally facing proximal surface or cap 42 of plunger 18 is disposed adjacent a proximal end region 44 of nut 28, as shown in fig. 4. When doing so, the tubular region 46 of the plunger 18 may extend through (and open) the first sealing member 24. Additionally, a portion of plunger 18 may be moved distally beyond ring member 36. With the cap 42 of the plunger 18 disposed adjacent the nut 28, the plunger 18 may be rotated (e.g., in a clockwise direction) to close the second sealing member 26, as shown in fig. 5A. This rotation may cause nut 28 to rotate and move distally. Because the distal end region of the nut 28 may engage the cartridge 20, distal movement of the nut 28 pushes the cartridge 20 distally within the proximal end region 22 of the body 12, causing the cartridge 20 to engage and deform the second sealing member 26, thereby transitioning the second sealing member 26 to the closed or sealed configuration. The plunger 18 may be released or otherwise allowed to move proximally, as shown in fig. 5B, which may reclose the first sealing member 24 (while the second sealing member 26 remains closed).

As noted above, the first seal member 24 may be described as a "low pressure" seal designed to prevent fluid flow at relatively low pressures. For example, the first seal member 24 may be designed to withstand pressures of about 75-85 pounds per square inch (psi). While this performance is considered acceptable, it may still be desirable to further enhance the performance of the first sealing member 24. A hemostasis valve is disclosed herein in which the performance of the first sealing member 24 is enhanced.

Fig. 6 illustrates a portion of another example hemostasis valve 110, which can be similar in form and function to other hemostasis valves disclosed herein. Although only a portion of the hemostatic valve 110 is shown, it is understood that the remainder of the hemostatic valve 110 may include structures similar or identical to those in the hemostatic valve 10 described above. The hemostasis valve 110 can include a body 112 having a proximal end region 122. The cartridge 120 may be at least partially disposed within the proximal end region 122. The cartridge 120 may include a first sealing member 124. The second sealing member 126 may also be at least partially disposed within the proximal region 122. Plunger 118 may be coupled to proximal region 122, and nut 128 may be threadably engaged with proximal region 122.

plunger 118 may include an inner tubular region 148. The inner tubular member 148 can have a distal end 150. When plunger 118 is positioned in the manner shown in fig. 6, distal end 150 of inner tubular region 148 is designed to be arranged such that a clearance distance 152 is defined between distal end 150 of inner tubular region 148 and a proximal end or proximal surface 154 of first seal member 124. In at least some examples, the gap distance 152 is sufficiently small (e.g., at about 0.1 to 5mm or about 0.3 to 2mm) such that when the first sealing member 124 is exposed to elevated pressure, the proximal surface 154 of the first sealing member 124 may be slightly deformed or displaced into engagement with the distal end 150 of the inner tubular region 148, as shown in fig. 7. When doing so, the distal end 150 of the inner tubular region 148 may provide additional structural support such that the first seal member 124 can substantially maintain a seal under higher pressures. For example, the first seal member 124 may begin to deflect into engagement with the distal end 150 of the inner tubular region 14 when exposed to about 80-250 pounds per square inch (psi), or about 80-200psi, or about 100-250 psi. Such deflection may be understood as a localized deflection or deformation that is different from the deformation by which the first sealing member 124 is opened or otherwise allowed to flow therethrough. Because the first seal member 124 can partially deflect into contact with the inner tubular region 148, the inner tubular region 148 may provide additional structural support to the first seal member 124 such that the first seal member 124 may be able to withstand pressures of about 100-.

It will be appreciated that the hemostatic valve 110 may take on a variety of different designs to create the desired gap distance 152. For example, in some instances, the inner tubular region 148 of the plunger 118 may be sized such that the inner tubular region 148 is brought into a desired vicinity of the first seal member 124. This may include an inner tubular region 148 extending distally beyond the distal end of plunger 118, an inner tubular region 148 extending to the distal end of the plunger, an inner tubular region 148 extending to a location proximal to the distal end of plunger 118. Likewise, the first seal member 124 may also be designed with structural features that provide the desired gap distance 152. This may include the first sealing member 124 having an increased thickness, a decreased thickness, or the like. In addition, the cartridge 120 may also be designed with structural features that provide the desired gap distance 152. For example, the cartridge 120 may be designed such that the position of the first sealing member 124 therein may be moved proximally or distally. Many other variations are also contemplated.

examples of the invention

The invention will be further elucidated by reference to the following example, which is intended to illustrate some embodiments, but not to limit the invention.

Example 1

A number of hemostatic valves similar to the hemostatic valve 10 were manufactured without attaching a plunger assembly. A test is conducted to determine the amount of fluid pressure that can be applied until the first sealing member begins to leak fluid. It was determined that the average fluid pressure at the leak was 81.62psi observed on the sample sterilization hemostasis valve immediately after sterilization. It was determined that the average fluid pressure at the leak was 79.98psi observed on the sample sterilized hemostasis valve six months after sterilization.

Example 2

A plurality of hemostatic valves similar to hemostatic valve 110 are manufactured. A test is conducted to determine the amount of fluid pressure that can be applied until the first sealing member begins to leak fluid. No leakage was observed at 300psi and no leakage was observed until 400psi was applied.

example 3

A plurality of hemostatic valves similar to hemostatic valve 110 are manufactured. Tests were conducted to determine the amount of fluid pressure that can be applied under different conditions until the first sealing member begins to leak fluid. It was determined that the average fluid pressure where a leak was observed on the sample sterilizing hemostasis valve after a single "insertion" (e.g., which may be understood as a single actuation of the plunger, wherein the plunger was moved distally, rotated clockwise to close the second sealing member, rotated counterclockwise to open the second sealing member, and moved proximally) was 265.643 psi. It was also determined that after 50 "insertions", an average fluid pressure at the leak was observed of 257.467 psi.

Materials that can be used for the various components of the hemostatic valve 10 disclosed herein (and/or other hemostatic valves disclosed herein) and its various components can include those typically associated with medical devices. For simplicity, the following discussion makes reference to the body 12 and other components of the hemostatic valve 10. However, this is not intended to limit the devices and methods described herein, as the discussion may apply to the other hemostatic valves and/or components thereof disclosed herein.

The body 12 and/or other components of the hemostatic valve 10 may be made of metal, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, and the like, or other suitable materials. Some examples of suitable polymers may include Polytetrafluoroethylene (PTFE), Ethylene Tetrafluoroethylene (ETFE), Fluorinated Ethylene Propylene (FEP), polyoxymethylene (POM, e.g., available from DuPont) Polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM Engineering Plastics)) Ether or ester based copolymers (e.g., butylene/poly (alkylene ether) phthalate and/or other polyester elastomers such as those available from DuPont) Polyamides (e.g. available from Bayer)Or available from Elf Atochem) Elastomeric polyamides, polyamide/ether blocks, polyether block amides (PEBA, for example, available under the trade name PEBA)commercially available), ethylene vinyl acetate copolymer (EVA), silicone, Polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (e.g.,) Polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), Polyetheretherketone (PEEK), Polyimide (PI), Polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly (paraphenylene terephthalamide) (e.g.,) Polysulfone, nylon-12 (such as those available from EMS American Grilon)) Perfluoro (propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly (styrene-b-isobutylene-b-styrene) (e.g., SIBS and/or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer/metal composites thereof, and the like. In some embodiments, the jacket may be mixed with a Liquid Crystal Polymer (LCP). For example, the mixture can contain up to about 6% LCP.

Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steels; mild steel; nickel-titanium alloys, such as linear elastic and/or superelastic nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as625 UNS: N06022, such asUNS N10276, such as OthersAlloys, etc.), nickel-copper alloys (e.g., UNS: n04400, such as400、400、400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such asEtc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as) Other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; a cobalt-chromium alloy; cobalt-chromium-molybdenum alloys (e.g. UNS: R30003, such asetc.); platinum-rich stainless steel; titanium; combinations thereof; and the like; or any other suitable material.

The first sealing member 124 (and/or other sealing members disclosed herein) may be formed from a suitable material. For example, the sealing member 124 may be formed of a silicone and/or silicone rubber material, such as LSR6030 commercially available from Shenzhen SQUARE silicone co. In some examples, the sealing member 124 may be formed from an elastomeric material, such as Q7-4720, Q7-4735, GUMSTOCK, and the like, commercially available from DOW CORNING.

it should be understood that this invention is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the invention. To the extent appropriate, this may include using any of the features of one example embodiment used in other embodiments. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.