阅读说明：本技术 止血阀和用于制造和使用止血阀的方法 (Hemostatic valve and methods for making and using a hemostatic valve ) 是由 亨利·J·佩平 萨米特·阿格拉沃尔 马扬克·巴特纳戈尔 艾伦·詹姆士·奥弗里恩 索马什卡尔· 于 2018-02-23 设计创作，主要内容包括：本发明公开了止血阀和用于制造和使用止血阀的方法。一种用于组装止血阀的示例方法可以包括沿主体的螺纹近端区定位柱塞。所述螺纹近端区可以包括一个或多个螺纹以及延伸通过所述一个或多个螺纹的轴向狭槽。所述方法还可以包括沿所述螺纹近端区将所述柱塞推进到所述柱塞的近端设置在所述一个或多个螺纹中的至少一部分的远侧的位置,以及将螺母设置在邻近所述螺纹近端区处。所述方法还可以包括对准所述螺母的对准凸耳与所述轴向狭槽,在所述对准凸耳与所述轴向狭槽对准的同时接合所述螺母与所述一个或多个螺纹,并且旋转所述螺母45至270°。(Hemostatic valves and methods for making and using hemostatic valves are disclosed. An example method for assembling a hemostatic valve may include positioning a plunger along a threaded proximal region of a body. The threaded proximal region may include one or more threads and an axial slot extending through the one or more threads. The method may further include advancing the plunger along the threaded proximal end region to a position where a proximal end of the plunger is disposed distal to at least a portion of the one or more threads, and disposing a nut adjacent the threaded proximal end region. The method may further include aligning an alignment lug of the nut with the axial slot, engaging the nut with the one or more threads while the alignment lug is aligned with the axial slot, and rotating the nut 45 to 270 °.)

1. A method for assembling a hemostatic valve, the method comprising:

positioning a plunger along a threaded proximal region of the body;

wherein the threaded proximal region of the body comprises one or more threads and an axial slot extending through the one or more threads;

advancing the plunger along the threaded proximal end region of the body to a location where a proximal end of the plunger is disposed distal to at least a portion of the one or more threads;

disposing a nut adjacent the threaded proximal end region of the body, the nut having an alignment lug formed thereon;

aligning the alignment lug with the axial slot;

engaging the nut with the one or more threads while the alignment lugs are aligned with the axial slots; and

rotating the nut 45 to 270 ° relative to the threaded proximal region of the body.

2. The method of claim 1, further comprising disposing a first sealing member within the threaded proximal region of the body.

3. The method of any of claims 1-2, further comprising disposing a cartridge at least partially within the threaded proximal region of the body, the cartridge comprising a second sealing member.

4. The method of claim 3, wherein rotating the nut 45 to 270 ° relative to the threaded proximal region of the body engages the nut with the cartridge.

5. The method of any one of claims 1-4, further comprising moving the plunger proximally relative to the threaded proximal end region of the body.

6. The method of claim 5, further comprising disposing a spring within the plunger.

7. The method of claim 6, further comprising securing a plunger cap to the plunger.

8. The method of any one of claims 1-7, wherein the threaded proximal region of the body has a first lock indicator.

9. The method of claim 8, wherein the plunger comprises a second locking indicator, and wherein positioning the plunger along the threaded proximal end region of the body comprises aligning the first locking indicator with the second locking indicator.

10. The method of any one of claims 1-9, wherein rotating the nut 45-270 ° relative to the threaded proximal region of the body comprises rotating the nut 90-180 ° relative to the threaded proximal region of the body.

11. The method of any one of claims 1-9, wherein rotating the nut 45-270 ° relative to the threaded proximal region of the body comprises rotating the nut 180 ° relative to the threaded proximal region of the body.

12. A method for assembling a hemostatic valve, the method comprising:

advancing the plunger along the threaded proximal region of the body;

wherein the threaded proximal region has one or more threads and an axial slot;

wherein advancing the plunger along the threaded proximal region of the body comprises advancing the plunger to a position where the proximal end of the plunger is disposed distal to at least a portion of the one or more threads;

engaging a nut with the threaded proximal end region of the body, the nut having an alignment lug formed thereon;

aligning the alignment lug with the axial slot; and

rotating the nut 90 to 180 ° relative to the threaded proximal region of the body.

13. The method of claim 12, further comprising disposing a first sealing member within the threaded proximal end region of the body, and further comprising disposing a cartridge at least partially within the threaded proximal end region of the body, the cartridge comprising a second sealing member.

14. The method of claim 13, wherein rotating the nut 45 to 270 ° relative to the threaded proximal region of the body engages the nut with the cartridge.

15. The method of any of claims 12-14, wherein the threaded proximal end region of the body has a first locking indicator, wherein the plunger comprises a second locking indicator, and wherein positioning the plunger along the threaded proximal end region of the body comprises aligning the first locking indicator with the second locking indicator.

Technical Field

The present invention relates to a medical device and a method for manufacturing a medical device. More particularly, the present invention relates to hemostatic valves and methods for 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. A method for assembling a hemostatic valve is disclosed. The method comprises the following steps: positioning a plunger along a threaded proximal region of the body; wherein the threaded proximal region of the body comprises one or more threads and an axial slot extending through the one or more threads; advancing the plunger along the threaded proximal end region of the body to a location where the proximal end of the plunger is disposed distal to at least a portion of the one or more threads; disposing a nut adjacent the threaded proximal end region of the body, the nut having an alignment lug formed thereon; aligning the alignment lug with the axial slot; engaging the nut with the one or more threads while the alignment lugs are aligned with the axial slots; and rotating the nut 45 to 270 ° relative to the threaded proximal region of the body.

Alternatively or additionally to any of the embodiments above, further comprising disposing a first sealing member within the threaded proximal region of the body.

Alternatively or additionally to any of the embodiments above, further comprising disposing a cartridge at least partially within the threaded proximal end region of the body, the cartridge comprising a second sealing member.

Alternatively or additionally to any of the embodiments above, rotating the nut 45 to 270 ° relative to the threaded proximal region of the body engages the nut with the cartridge.

Alternatively or additionally to any of the embodiments above, further comprising moving the plunger proximally relative to the threaded proximal end region of the body.

Alternatively or additionally to any of the embodiments above, further comprising disposing a spring within the plunger.

Alternatively or additionally to any of the embodiments above, further comprising securing a plunger cap to the plunger.

Alternatively or additionally to any of the embodiments above, the threaded proximal region of the body has a first lock indicator.

Alternatively or additionally to any of the embodiments above, the plunger comprises a second locking indicator, and wherein positioning the plunger along the threaded proximal end region of the body comprises aligning the first locking indicator with the second locking indicator.

Alternatively or additionally to any of the embodiments above, rotating the nut 45 to 270 ° relative to the threaded proximal region of the body comprises rotating the nut 90 to 180 ° relative to the threaded proximal region of the body.

Alternatively or additionally to any of the embodiments above, rotating the nut 45 to 270 ° relative to the threaded proximal region of the body comprises rotating the nut 180 ° relative to the threaded proximal region of the body.

A method for assembling a hemostatic valve is disclosed. The method comprises the following steps: advancing the plunger along the threaded proximal region of the body; wherein the threaded proximal region has one or more threads and an axial slot; wherein advancing the plunger along the threaded proximal end region of the body comprises advancing the plunger to a position where the proximal end of the plunger is disposed distal to at least a portion of the one or more threads; engaging a threaded proximal end region of a nut with the body, the nut having an alignment lug formed thereon; aligning the alignment lug with the axial slot; and rotating the nut 90 to 180 ° relative to the threaded proximal region of the body.

Alternatively or additionally to any of the embodiments above, further comprising disposing a first sealing member within the threaded proximal end region of the body, and further comprising disposing a cartridge at least partially within the threaded proximal end region of the body, the cartridge comprising a second sealing member.

Alternatively or additionally to any of the embodiments above, rotating the nut 45 to 270 ° relative to the threaded proximal region of the body engages the nut with the cartridge.

Alternatively or additionally to any of the embodiments above, further comprising moving the plunger proximally relative to the threaded proximal end region of the body.

Alternatively or additionally to any of the embodiments above, further comprising disposing a spring within the plunger and securing the plunger cap to the plunger.

Alternatively or additionally to any of the embodiments above, the threaded proximal end region of the body has a first locking indicator, wherein the plunger comprises a second locking indicator, and wherein positioning the plunger along the threaded proximal end region of the body comprises aligning the first locking indicator with the second locking indicator.

Alternatively or additionally to any of the embodiments above, rotating the nut 90 to 180 ° relative to the threaded proximal region of the body comprises rotating the nut 180 ° relative to the threaded proximal region of the body.

A method for assembling a hemostatic valve is disclosed. The method comprises the following steps: disposing a cartridge at least partially within the threaded proximal end region of the body; wherein the proximal end region of the body has an axial slot formed therein; engaging a threaded proximal end region of a nut with the body, the nut having an alignment slot formed thereon; aligning the alignment slot with the axial slot; rotating the nut 90 to 180 ° relative to the threaded proximal region of the body; and coupling the plunger to the body.

Alternatively or additionally to any of the embodiments above, rotating the nut 90 to 180 ° relative to the threaded proximal region of the body comprises rotating the nut 180 ° relative to the threaded proximal region of the body.

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 in fig. 1.

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

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

Fig. 6-10 illustrate example hemostatic valves and example methods for assembling hemostatic valves.

Fig. 11-12 illustrate example hemostatic valves and example methods for assembling hemostatic valves.

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.

Recitation of ranges of numbers 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. Such recitation, however, does not necessarily imply that all embodiments include the particular features, structures, and/or characteristics. Additionally, 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 intravascular 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 connect 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, which may include two pieces 20a, 20b coupled (e.g., press fit, heat bonded, etc.) to one another such that at least a portion thereof may be disposed within the proximal end region 22 of the body 12. 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, a groove or hole 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, for example 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, central lumen 38 is designed to be placed in fluid communication with one or more lumens of a device coupled to 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, an adapter 16, which may take the form of a Tuohy-Borst or other type of connector, may be engaged with 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 maintaining a substantially 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).

For purposes of this disclosure, "clockwise" rotation of plunger 18 and/or nut 28 may be understood as rotation of plunger 18 in a clockwise direction relative to body 12 when plunger 18 is viewed from the proximal end of plunger 18. Similarly, "counterclockwise" rotation of plunger 18 and/or nut 28 may be understood as rotation of plunger 18 in a counterclockwise direction relative to body 12 when plunger 18 is viewed from the proximal end of plunger 18. This clockwise/counterclockwise convention is used throughout this disclosure.

The process for assembling the hemostatic valve 10 (and/or other hemostatic valves disclosed herein) is generally designed such that the assembly can be performed using mechanical fittings (e.g., using only mechanical fittings such that gluing is not required). In addition, the process is designed such that the nut 28 can apply an appropriate amount of force to the cartridge 20 such that the cartridge 20 seats within the proximal region 22 of the body 12 in a desired manner and such that the second sealing member 26 remains open. Some additional details of the assembly process are described herein.

Fig. 6-10 illustrate a portion of an example hemostasis valve 110 (which can be similar to other hemostasis valves disclosed herein), and illustrate a process for assembling the hemostasis valve 110. In at least some examples, the proximal region 122 of the body 112 can include threads 130 and one or more axial slots 148. In this example, the proximal section 122 includes a pair of opposing axial slots 148. However, different numbers and/or arrangements of axial slots 148 are contemplated. The axial slot 148 may be designed to engage a protrusion 150 on the cartridge 120, as discussed herein, such that rotation of the cartridge 120 during actuation of the plunger 118 and/or the nut 128 may be reduced or eliminated. A ring member 136 may also be disposed adjacent the proximal end region 122. The ring member 136 may have an opening 137 formed therein. The locking rib 139 may be disposed adjacent to the ring member 136. The locking rib 139 may be designed to prevent the plunger 118 and/or the nut 128 from rotating counterclockwise in a manner that may cause the nut 128 to become unthreaded from the proximal end region 122.

The process for assembling the hemostasis valve 110 can include disposing a second sealing member (not shown, but can be similar to the second sealing member 26 disclosed herein) and the cartridge 120 within the proximal region 122 of the body 112. The cartridge 120 may be similar in form to other cartridges disclosed herein and may include a first sealing member (e.g., similar to the first sealing member 24). Additionally, plunger 118 may be advanced along proximal region 122 of body 112, as shown in FIG. 7. When doing so, plunger 118 may be advanced distally beyond at least a portion of threads 130 such that threads 130 are exposed proximally of plunger 118 (e.g., which may include advancing locking lugs 141 formed along plunger 118 through openings 137 of ring member 136). This allows the nut 128 to be placed in contact or otherwise engaged with the proximal end region 122 of the body 112 and/or the threads 130, as shown in fig. 8. It may be desirable to secure the nut 128 to the proximal end region 122 of the body 112 by, for example, threadably engaging the nut 128 with threads 130 along the proximal end region 122. Further, it may also be desirable to thread the nut 128 onto the threads 130 in such a manner that the nut 128 engages the cartridge 120 and applies an amount of force to the cartridge 120 such that the cartridge 120 remains in place within the proximal region 122. Further, the force applied to the cartridge 120 may also apply an appropriate amount of force to the second sealing member (not shown) such that the second sealing member is also properly held in place.

As shown in fig. 8, nut 128 may include one or more alignment lugs 152a/152 b. In this example, the nut 128 includes two alignment lugs 152a/152 b. However, other numbers are also contemplated, including one, three, four, five, six, or more alignment lugs. The alignment lugs 152a/152b may be aligned with the axial slots 148 formed in the proximal end region 122 of the body 112. In this example, the proximal region 122 of the body 112 includes two opposing axial slots 148, and each of the alignment lugs 152a/152b is aligned with one of the axial slots 148. The nut 128 may then be rotated in a clockwise direction to secure the nut 128 to the proximal region 122 of the body 112, as schematically illustrated in fig. 9. In this example, alignment lug 152a is rotated 180 degrees relative to proximal region 122 of body 112. This is indicated by alignment lug 152a being aligned with axial slot 148 along the left side of proximal region 122 of body 112 in fig. 8, and then, after rotation, alignment lug 152a is rotated 180 degrees to align with axial slot 148 (not shown in fig. 9) along the right side of proximal region 122 of body 112. The amount of rotation may be suitable to secure the nut 128 to the proximal end region 122 and provide a desired amount of force on the cartridge 120 and/or the second sealing member. However, other amounts of rotation are also contemplated. For example, the nut 128 may be rotated 45 to 315 degrees, or about 45 to 270 degrees, or about 90 to 180 degrees. In some examples, the nut 128 may be rotated about 45 degrees, about 90 degrees, about 135 degrees, about 180 degrees, about 215 degrees, about 270 degrees, or about 315 degrees.

Plunger 118 may be moved proximally as shown in fig. 9-10. When plunger 118 is moved proximally beyond nut 128, as shown in fig. 10, spring member 154 may be disposed within nut 128. The plunger cap 156 may then be coupled to the plunger 118. The plunger cap 156 may include an inner tubular region 158 and a proximal end region 160.

As also shown in fig. 10, the proximal region 122 of the body 112 may include a first locking indicator 161. The plunger 118 may include a second locking indicator 159. The locking indicator 161/159 may vary, but may generally include a visual indicator designed to communicate to a user in which direction (e.g., clockwise) the plunger 118 may be rotated to close the second sealing member. The locking indicator 161/159 may be different than shown. Proximally retracting plunger 118 may include aligning first lock indicator 161 with second lock indicator 159.

Other manufacturing methods are also contemplated. In at least some of these examples, the plunger 118 may be "pre-assembled". For example, the plunger cap 156 may be secured to the plunger 118. Spring member 154 may be loaded into plunger 118 (e.g., over inner tubular region 158), and nut 128 may be loaded into plunger 118. The subassembly may be engaged with the proximal region 122 of the body 112. This may include advancing the locking lug 141 through the opening 137 of the ring member 136 and engaging the nut 128 with the threads 130. Locking lugs 141 may be located along the distal end of plunger 118 and project radially inward. Plunger 118 may be rotated to engage nut 128 with threads 130. In doing so, locking indicator 139 may be used to track the amount of rotation of plunger 118 (e.g., and/or nut 128) such that nut 128 may be threaded onto threads 130 by a desired amount.

Fig. 11-12 illustrate a portion of an example hemostasis valve 210 (which can be similar to other hemostasis valves disclosed herein), and illustrate a process for assembling the hemostasis valve 210. Although only a portion of the hemostasis valve 210 is shown, it is understood that the hemostasis valve 210 may include structures similar or identical to those in the hemostasis valve 10/110 described above. The proximal region 222 of the body 212 includes threads 130 and one or more axial slots 248. In this example, the proximal region 222 includes a pair of opposing axial slots 248. A ring member 236 may also be disposed adjacent the proximal end region 222. The ring member 236 may have an opening 237 formed therein. Locking rib 239 may be disposed adjacent to ring member 236.

A method for assembling the hemostasis valve 210 can include disposing a second sealing member (not shown, but can be similar to the second sealing member 26) and a cartridge at least partially within the proximal region 222 of the body 212. Although the entire cartridge is not shown, a projection 250 of the cartridge similar to the projection 150 can be seen in FIG. 11. The nut 228 may be disposed adjacent to the proximal region 222 and/or otherwise engaged with the proximal region 222. When doing so, the slot 262 formed in the nut 228 may be aligned with the axial slot 248. The nut 228 can be rotated (e.g., in a clockwise direction) an appropriate amount to secure the nut 228 to the proximal end region 222. This is indicated by the slots 262 in the nut 228 aligning with the axial slots 248 along the left side of the proximal end region 222 of the body 212 in fig. 11, and then, after rotation, the slots 262 in the nut 228 are rotated 180 degrees to align with the axial slots 248 on the opposite side of the proximal end region 222 of the body 212, as shown in fig. 12. The amount of rotation may vary. For example, in some examples, the nut 228 may be rotated about 45-315 degrees, or about 45-270 degrees, or about 90-180 degrees, or about 45 degrees, or about 90 degrees, or about 135 degrees, or about 180 degrees, or about 215 degrees, or about 270 degrees, or about 315 degrees.

Once the nut 228 is secured to the proximal region 222 in the desired manner, the plunger 218 may be slid over the nut 228. When doing so, the locking lugs 264 may pass through the slots 262 in the nut 228. This may include passing at least a portion of the plunger 218 over or through an opening of a ring member 236 disposed along the proximal end region 222 of the body 212.

It will be appreciated that the assembly process of the hemostasis valve 210, for example, allows for the use of a one-piece plunger 218 (in contrast to the 2-piece plunger 118 shown in fig. 6-10) due to the slot 262 in the nut 228.

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 references 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.,) Polyester, 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) (for example,) Polysulfone, nylon-12 (such as,commercially 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 asALLOY ) 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.

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.