Single cavity hemostatic valve hub for introducer sheath

Abstract

A hemostasis valve hub for use with an introducer sheath includes a base having a securing mechanism for securing the hemostasis valve hub to the introducer sheath, an outer shell securable to the base and defining an interior volume, a shutter spiral portion disposed within the interior volume and including a plurality of fins arranged in a spiral, a brush portion disposed within the interior volume adjacent to the disk shutter portion, the brush portion including a plurality of brushes arranged in a spiral, and a seal disposed within the base adjacent to the brush portion and having a partial cross slit configuration.

Description

[Technical field]

[0001] The present disclosure relates to a hub for use with an introducer sheath. More particularly, the present disclosure relates to a single cavity hemostatic valve hub for use with a large bore introducer sheath. [Background technology]

[0002] In various procedures for delivering intravascular medical devices, an introducer sheath is inserted into a patient's blood vessel, for example, the femoral artery, and a medical device is inserted into the introducer sheath for introduction into the blood vessel. In various examples, the medical device includes a catheter or other medical device, such as a blood pump. In various examples, multiple medical devices need to be introduced into or through a blood vessel simultaneously. A hemostatic valve hub may be incorporated into the proximal end of a large diameter introducer sheath to reduce blood leakage as the devices are inserted, positioned, and removed. There is a need for an optimized hemostatic valve hub that allows for the passage of multiple devices into the introducer sheath while still minimizing blood leakage and facilitating the passage of devices through the introducer sheath. Summary of the Invention

[0003] In Example 1, a hemostasis valve hub for use with an introducer sheath includes a base having a fixing mechanism for fixing the hemostasis valve hub to the introducer sheath, an outer shell securable to the base and defining an internal volume, a shutter spiral portion disposed within the internal volume and including a plurality of fins arranged in a spiral, a brush portion disposed within the internal volume adjacent to the shutter spiral portion, the brush portion including a plurality of brushes arranged in a spiral, and a seal disposed within the base and having a partial cross slit configuration.

[0004] In Example 2, the hemostasis valve hub described in Example 1 includes that the fixation mechanism is a ferrule disposed within the base for engaging the introducer sheath and the hemostasis valve hub. In Example 3, the hemostasis valve hub of Example 1 or Example 2 includes the outer shell comprising a top cap and a bottom cap coupled to the top cap.

[0005] In Example 4, the hemostasis valve hub of Example 3 includes a seal disposed adjacent the top cap and the brush portion. In Example 5, the hemostasis valve hub of any one of Examples 1-4 includes, wherein the seal is configured to have a diameter of at least 8.0 mm.

[0006] In Example 6, the hemostatic valve hub of any one of Examples 1-5 includes a base comprising a plurality of sewing rings for fixing the position of the device. In Example 7, the hemostasis valve hub of Example 6 includes a base, an outer shell, a seal assembly, and a hub cap longitudinally aligned to define a lumen.

[0007] In Example 8, a delivery system for inserting multiple medical devices into a blood vessel includes an introducer sheath having a proximal end and a distal end, and a hemostasis valve hub configured to engage the proximal end of the introducer sheath. The hemostasis valve hub includes a base having a securing mechanism for securing the hemostasis valve hub to the introducer sheath, an outer shell securable to the base and defining an interior volume, a shutter helix disposed within the interior volume and including a plurality of helically arranged fins, a brush portion disposed within the interior volume adjacent the shutter helix, the brush portion including a plurality of helically arranged brushes, and a seal disposed within the base and adjacent the brush portion and having a partial cross slit configuration.

[0008] In Example 9, the delivery system of Example 8 includes the outer shell comprising a top cap coupled to a bottom cap. In Example 10, the delivery system of Example 9 includes a seal disposed adjacent the top cap and the brush portion.

[0009] In Example 11, the delivery system of Example 10 includes the bottom cap comprising an O-ring seal for forming a seal between the bottom cap and the base. In Example 12, the delivery system of any one of Examples 8-11 includes the fixation mechanism being a ferrule disposed within the base of the hub for engaging the base and the introducer sheath.

[0010] In Example 13, a method of delivering at least one medical device into a blood vessel includes securing a hub base to a proximal end of an introducer sheath using a securing mechanism, securing an outer shell including at least a seal, a shutter spiral portion, and a brush portion to the hub base and securing a hub cap to the hub base, inserting the introducer sheath into the blood vessel, and inserting at least one medical device through the outer shell and the hub base into a lumen defined by the hub cap and extending the medical device into the introducer sheath.

[0011] In Example 14, the method of Example 13 includes the brush portion comprising a plurality of brushes arranged in a spiral such that the plurality of brushes are in sealing engagement with the medical device upon insertion of the medical device.

[0012] In Example 15, the method of Example 13 or Example 14 includes, the securing mechanism for securing the hub base to the introducer sheath includes a ferrule disposed within the hub base.

[0013] In Example 16, a hemostasis valve hub for use with an introducer sheath includes a base having a fixing mechanism for fixing the hemostasis valve hub to the introducer sheath, an outer shell securable to the base and defining an interior volume, a shutter spiral portion disposed within the interior volume and including a plurality of fins arranged in a spiral, a brush portion disposed within the interior volume adjacent to the shutter spiral portion, the brush portion including a plurality of brushes arranged in a spiral, and a seal disposed within the base adjacent to the brush portion and having a partial cross slit configuration.

[0014] In Example 17, the hemostasis valve hub of Example 16 includes the fixation mechanism being a ferrule disposed within the base for engaging the introducer sheath and the hemostasis valve hub. In Example 18, the hemostasis valve hub of Example 16 includes the outer shell comprising a top cap and a bottom cap coupled to the top cap.

[0015] In Example 19, the hemostasis valve hub of Example 18 includes a seal disposed adjacent the top cap and the brush portion. In Example 20, the hemostasis valve hub of Example 16 includes, wherein the seal is configured to have a diameter of at least 8.0 mm.

[0016] In Example 21, the hemostasis valve hub of Example 20 includes the seal constructed from silicone. In Example 22, the hemostasis valve hub of Example 16 includes the shutter helix comprising a plurality of fins extending radially inward from the outer ring.

[0017] In Example 23, the hemostatic valve hub of Example 16 includes a base comprising a plurality of sewing rings for fixing the position of the device. In Example 24, the hemostasis valve hub of Example 16 includes the hub comprising a hub cap configured to engage with the outer shell.

[0018] In Example 25, the hemostasis valve hub of Example 24 includes a base, an outer shell, a seal assembly, and a hub cap longitudinally aligned to define a lumen. In Example 26, a delivery system for inserting multiple medical devices into a blood vessel includes an introducer sheath having a proximal end and a distal end, and a hemostasis valve hub configured to engage the proximal end of the introducer sheath. The hemostasis valve hub includes a base having a securing mechanism for securing the hemostasis valve hub to the introducer sheath, an outer shell securable to the base and defining an interior volume, a shutter helix disposed within the interior volume and including a plurality of helically arranged fins, a brush portion disposed within the interior volume adjacent the shutter helix, the brush portion including a plurality of helically arranged brushes, and a seal disposed within the base and adjacent the brush portion and having a partial cross slit configuration.

[0019] In Example 27, the delivery system of Example 26 includes the outer shell comprising a top cap coupled to a bottom cap. In Example 28, the delivery system of Example 27 includes a seal disposed adjacent the top cap and the brush portion.

[0020] In Example 29, the delivery system of Example 26 includes the bottom cap comprising an O-ring seal for forming a seal between the bottom cap and the base. In Example 30, the delivery system of Example 26 includes the fixation mechanism being a ferrule disposed within the base of the hub for engaging the base and the introducer sheath.

[0021] In Example 31, a method of delivering at least one medical device into a blood vessel includes securing a hub base to a proximal end of an introducer sheath using a securing mechanism, securing an outer shell including at least a seal, a shutter spiral portion, and a brush portion to the hub base and securing a hub cap to the hub base, inserting the introducer sheath into the blood vessel, and inserting at least one medical device through the outer shell and the hub base into a lumen defined by the hub cap and extending the medical device into the introducer sheath.

[0022] In Example 32, the method of Example 31 further includes, the method further including inserting a second medical device through the lumen. In Example 33, the method of Example 31 further includes the brush portion comprising a plurality of brushes arranged in a spiral such that the plurality of brushes are in sealing engagement with the medical device upon insertion of the medical device.

[0023] In Example 34, the method of Example 31 further includes the securing mechanism for securing the hub base to the introducer sheath includes a ferrule disposed within the hub base. In Example 35, the method of Example 31 further includes, wherein the fixing mechanism for fixing the hub base to the introducer sheath is a threaded cap for engaging with the proximal end of the introducer sheath and the hub base.

[0024] While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. [Brief description of the drawings]

[0025] [Figure 1] 1 illustrates a cross-sectional view of an introducer sheath after insertion into a blood vessel according to an embodiment of the present disclosure. [Diagram 2] 1 illustrates a cross-sectional view of an introducer sheath after insertion into a blood vessel and insertion of a medical device into the introducer sheath in accordance with an embodiment of the present disclosure. [Diagram 3] 1 is a side view of a hemostasis valve hub for use with an introducer sheath according to an embodiment of the present disclosure. [Figure 4] 4 is an exploded view of the hemostasis valve hub of FIG. 3 in accordance with an embodiment of the present disclosure. [Diagram 5] 4 is a cross-sectional view of the hemostasis valve hub of FIG. 3 in accordance with an embodiment of the present disclosure. [Figure 6] 6 is an exploded view of a portion of the hemostasis valve hub of FIG. 5 in accordance with an embodiment of the present disclosure. [Figure 7] 13 is a close-up view of a shell cap of a hemostasis valve hub according to an embodiment of the present disclosure. [Figure 8] 13 is a close-up view of a seal of a hemostasis valve hub according to an embodiment of the present disclosure. FIG. [Figure 9A] 13 is an enlarged view of a brush portion of a hemostasis valve hub according to an embodiment of the present disclosure. FIG. [Figure 9B] FIG. 9B is a close-up view of a brush of the brush portion of FIG. 9A according to an embodiment of the present disclosure. [Figure 10] 13 shows a close-up view of a shutter spiral for use with a hemostasis valve hub according to an embodiment of the present disclosure. [Figure 11] 13 shows a close-up view of a shell cap for use with a hemostasis valve hub according to an embodiment of the present disclosure. [Figure 12] 1 illustrates an exploded view of a hemostasis valve hub according to an embodiment of the present disclosure. [Figure 13] 1 shows a flowchart of a method for inserting a medical device into a blood vessel according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] FIG. 1 illustrates a side cross-sectional view of a blood vessel V with an introducer sheath 100 at least partially inserted therein. In some embodiments, the introducer sheath 100 is used to facilitate the passage of various relatively large medical devices, such as a blood pump as described further herein, through the introducer sheath 100 and into the blood vessel V. Thus, the introducer sheath 100 may be referred to as a large bore introducer sheath. The introducer sheath 100 comprises a proximal end 106 and a distal end 108 opposite the proximal end 106. In an embodiment, the proximal end 106 is a flared proximal end. The introducer sheath 100 includes a proximal opening (not shown) adjacent the proximal end 106 and a distal opening 109 adjacent the distal end 108. The body portion 110 of the introducer sheath 100 extends between the proximal end 106 and the distal end 108, and the body portion 110 defines a lumen 112 of the introducer sheath 100. The introducer sheath 100 can be formed of various polymeric or metallic materials. In further embodiments, the introducer sheath 100 may include an additional surface coating. The surface coating may include, but is not limited to, silicone, PET, or any other applicable polymer. A hub 120 is typically included at the proximal opening. The hub 120, also referred to herein as a hemostasis valve hub, is configured for hemostasis, i.e., to prevent blood from leaking out of the introducer sheath during use. In various examples, it may be desirable for the hub 120 to be configured to allow multiple medical devices to pass through the introducer sheath 100 at one time. In these embodiments, it is beneficial to ensure that the hub 120 provides an adequate seal between multiple medical devices, such as catheters, so that blood leakage from the introducer sheath 100 is reduced during insertion, manipulation, and removal of the devices. The use of a hub inserted into the proximal end 106 of the introducer sheath 100 provides an additional method of sealing the introducer sheath 100. Exemplary embodiments of the hub 120 are described further herein. As shown in FIG. 1, the hub 120 can be used to receive a catheter 170.A catheter 170 extends through the hub 120 and the introducer sheath 100 and may be coupled to a proximal end of a blood pump that may be inserted into the introducer sheath 100, as described further herein.

[0027] 2 illustrates a cross-sectional view of the introducer sheath 100 of FIG. 1 after a medical device, illustratively a blood pump 150, has been inserted into the introducer sheath 100. The blood pump 150 generally includes an impeller assembly housing 140 and a motor housing 142. In some embodiments, the impeller assembly housing 140 and the motor housing 142 can be integrally or monolithically configured. In other embodiments, the impeller assembly housing 140 and the motor housing 142 can be separate components configured to be removably or permanently coupled.

[0028] The impeller assembly housing 140 holds the impeller assembly 144 therein. The impeller assembly 144 includes an impeller shaft 146 and an impeller 148 that rotates relative to the impeller assembly housing 140 to drive blood through the blood pump 150. More specifically, the impeller 148 directs blood from a blood inlet 151 formed in the impeller assembly housing 140 through the impeller assembly housing 140 and out a blood outlet 152 formed in the impeller assembly housing 140. In some embodiments, the impeller shaft 146 and the impeller 148 may be integrated, while in other embodiments, the impeller shaft 146 and the impeller 148 may be separate components. As shown in FIG. 2, the inlet 151 may be formed in an end portion of the impeller assembly housing 140 and the outlet 152 may be formed in a side portion of the impeller assembly housing 140. In other embodiments, the inlet 151 and / or the outlet 152 can be formed in other portions of the impeller assembly housing 140. In some embodiments, the impeller assembly housing 140 can be coupled to a distally extending cannula (not shown), which can receive blood and deliver the blood to the inlet 151.

[0029] With continued reference to FIG. 2, the motor housing 142 holds a motor 154, which is configured to rotatably drive the impeller 148 relative to the impeller assembly housing 140. In the illustrated embodiment, the motor 154 rotates a drive shaft 156 coupled to a drive magnet 158. Rotation of the drive magnet 158 ​​causes rotation of a driven magnet 160 connected to the impeller assembly housing 140. More specifically, in embodiments incorporating the impeller shaft 146, the impeller shaft 146 and the impeller 148 are configured to rotate with the driven magnet 160. In other embodiments, the motor 154 can be coupled to the impeller assembly housing 140 via other components. Additionally, as shown in FIG. 2, a catheter 170 extends from the proximal end of the blood pump 150. In some embodiments, the catheter 170 can be coupled to the motor housing 142 via a tapered connector and / or various other connection means. The catheter 170 may have a flexible structure to facilitate delivery of the blood pump 150. Although the introducer sheath 100 is described above in conjunction with the use of the blood pump 150, a variety of other medical devices may be used in conjunction with the introducer sheath 100 and hemostasis valve hub 120, with the blood pump 150 being provided as an example. For example, other variations of blood pumps may be used in conjunction with the introducer sheath 100. In other embodiments, medical devices other than blood pumps may be incorporated.

[0030] 3 and 4 show a hemostasis valve hub 220 that can be used to accept a medical device, for example, a catheter 170 coupled with a blood pump 150 (FIG. 2), for insertion into the introducer sheath 100 (FIG. 1) and blood vessel V (FIG. 1). Specifically, the hemostasis valve hub 220 has a proximal end 222, a distal end 224, and a longitudinal axis L extending between the proximal end 222 and the distal end 224. The hemostasis valve hub 220 includes a hub base 226 at the distal end 224. As shown, the hemostasis valve hub 220 also includes an access port 230 extending from the hub base 226. The access port 230 may be used to accept additional fluids and / or medical devices for irrigation within the hemostasis valve hub 220 or the introducer sheath 100. The hub base 226 further includes at least one flange 232 that can be used by a physician to grip the hemostasis valve hub 220 when securing the hemostasis valve hub 220 onto the introducer sheath 100 (FIG. 1). In some embodiments, the hemostasis valve hub 220 includes two or more flanges 232. The hemostasis valve hub 220 may also include one or more sewing rings 234. For example, as shown in FIG. 4, the one or more sewing rings 234 include a first sewing ring 234a and a second sewing ring 234b. The sewing rings 234 can be configured to receive sutures to secure the placement of the hemostasis valve hub 220.

[0031] FIG. 5 illustrates a cross-sectional view of the hemostasis valve hub 220 shown in FIGS. 3-4. As illustrated, the hub base 226 includes a fastening mechanism at the distal end 224 of the hemostasis valve hub 220 for coupling the hemostasis valve hub 220 to the proximal end 106 (FIG. 1) of the introducer sheath 100 (FIG. 1). More specifically, in the exemplary embodiment of FIG. 5, the hub base 226 includes a ferrule 228 configured to engage the proximal end 106 of the introducer sheath 100 for insertion into the hub base 226. However, various other fastening mechanisms may be used, for example, as described with reference to FIG. 12. The hub base 226 further includes an outer shell 236 that encloses an interior region 238 that includes a seal assembly 237. More specifically, the outer shell 236 includes a top cap 240 that engages with a bottom cap 242 to define the interior region 238. The seal assembly 237 includes a shutter helix 244, a brush portion 246, and a seal 250 within the outer shell 236. The components of the seal assembly 237 are further described herein with reference to Figures 6-11. As further shown in Figure 5, the hub base 226 and the top cap 240 of the outer shell 236 are engaged with a hub cap 248. The hub cap 248 includes an opening 252 for receiving a medical device, such as a catheter. The opening 252 extends into a lumen 249 that extends through the hemostasis valve hub 220. In some embodiments, the hub cap 248 can be configured to mate with a clamping port (not shown) that is used to secure a medical device, such as a catheter, through the hub 220.

[0032] 6, the outer shell 236 and the seal assembly 237 will be further described. As shown, the top cap 240 has a generally cylindrical shape with an opening 254 extending therethrough and configured to align with the opening 252 of the hub cap 248. Disposed below the top cap 240 and configured to be received therein is a seal 250. The seal 250 may be a cylindrical seal having a partial cross slit in the center of the seal 250, as will be further described with reference to FIG. 8. Additionally, a brush portion 246 is disposed below the seal 250. As will be further described with reference to FIGS. 9A-9B, the brush portion 246 comprises a plurality of brushes 256 or brush disks stacked adjacent to one another. The brush portion 246 is configured to provide a sealing engagement with a medical device. As shown, a shutter helix 244 is disposed below the brush portion 246. The shutter helix 244 is configured to provide a sealing engagement between the hemostasis valve hub 220 and various medical devices, as will be further described with reference to FIG. Additionally, below the shutter helix 244 is the bottom cap 242 of the outer shell 236. The above-described components of the seal assembly 237 and the outer shell 236 are described in further detail herein with reference to Figures 7-11.

[0033] 7 illustrates a cross-section of the top cap 240 of the outer shell 236 and a portion of the interior region 238 defined within the top cap 240. As illustrated, the top cap 240 includes an opening 254 at a top surface of the top cap 240. The top cap 240 may include an engagement feature 258 configured to engage with the hub cap 248. The top cap 240 is illustrated as being generally cylindrical in shape, but may have a variety of configurations. Additionally, the top cap 240 may be constructed from a material such as a polymer, a thermoset, a rubber or a thermoset elastomer (TSE), or a silicone rubber.

[0034] FIG. 8 illustrates a seal 250 for use in the seal assembly 237 (FIG. 6). The seal 250 is generally cylindrical in shape and has a circular cross section with a partial cross slit 260 located in the center of the seal 250. As previously described, the partial cross slit 260 is configured such that at least one medical device inserted through an opening in the top cap 240 (FIG. 7) is then received in the partial cross slit 260 of the seal 250 such that the catheter sealingly engages with the medical device. The seal 250 is constructed from silicone, although various other materials may be used. For example, materials such as polymers, thermosets, rubbers or thermoset elastomers (TSEs), or silicone rubbers may be used. The seal 250 may have a diameter D1 having a value between 8 mm and 12 mm. The configuration of the seal 250 may provide additional hemostatic benefits for longer periods of use. The partial cross slit seal 250 grips the device being passed through without absorbing fluids / blood that may pass through the device. The configuration of seal 250 allows for longer duration hemostasis during use of introducer sheath 100 within blood vessel V.

[0035] As previously mentioned, adjacent to the seal 250 is the brush portion 246. FIG. 9A shows the brush portion 246 comprised of multiple brushes 256 stacked on top of one another. As shown in both FIG. 9A and FIG. 9B, each brush, for example brush 256a, includes multiple bristles 262 extending radially inward from an outer periphery 264 of the brush 256a. Specifically, each bristles 262 has a generally triangular shape with an apex 266 at the radially innermost point of each bristles 262. When multiple brushes 256 are stacked on top of one another, the bristles 262 are offset in a helical fashion to form a fan-like arrangement. When a medical device is inserted through the top cap 240 and the seal 250, the medical device, for example a catheter, extends through the brush portion 246. When a catheter is inserted through the brush portion 246, the catheter extends through the brush portion 246 at the radial center point of the brush portion 246. The radial center point is defined as the location where the apexes 266 of each bristles 262 converge towards one another. In certain instances, when a catheter is inserted through the brush portion 246, the channel of the catheter engages the various apexes 266 of the brush portion 246. This configuration increases the seal between the catheter, the introducer sheath 100, and the hemostasis valve hub 220, as well as contributing to a stable axial position of the catheter within the hemostasis valve hub 220. Additionally, when more than one medical device is inserted through the brush portion 246, the configuration of the bristles 262 ensures that each of the multiple medical devices or catheters is sealingly engaged by the brush portion 246. Furthermore, when multiple medical devices are inserted into the hemostasis valve hub 220, the configuration of the brush portion 246 can stabilize the axial position of each medical device.

[0036] FIG. 10 shows a top cross-sectional view of the shutter helix 244. The shutter helix 244 includes a plurality of fins 245 extending radially inward from an outer ring 247 of the shutter helix 244. In a similar manner as described with reference to the brush portion 246, when a medical device, e.g., a catheter, is inserted into the hemostasis valve hub 220, the catheter extends generally through the center of the shutter helix 244. The plurality of fins 245 can deform as the catheter is inserted through the shutter helix 244, but the plurality of fins 245 are biased into contact with the catheter. In this manner, when the catheter is inserted through the shutter helix 244, the plurality of fins 245 act to maintain a hemostatic seal between the catheter, the hemostasis valve hub 220, and the introducer sheath 100 (FIG. 1). In some embodiments, a second catheter and / or a medical device may also be inserted through the hemostasis valve hub 220. In these embodiments, the plurality of fins 245 is also configured such that the shutter helix 244 maintains a hemostasis valve around the second catheter. In various embodiments, the shutter helix 244 has a thickness in the range of 2 mm to 4 mm, and the plurality of fins 245 can include at least two fins of 1 mm thickness having a tapered down profile.

[0037] FIG. 11 illustrates a cross-sectional view of the bottom cap 242 of the outer shell 236. As previously described, the bottom cap 242 is configured to engage with the top cap 240 to form the outer shell 236. More specifically, as illustrated, the bottom cap 242 includes an engagement feature 268 for coupling with the top cap 240. The bottom cap 242 further includes a circumferential groove 270 for receiving a seal (not shown), such as an O-ring seal, configured to be received within the circumferential groove 270 of the bottom cap 242. The O-ring seal can contribute to a fluid-tight seal between the bottom cap 242 when the bottom cap 242 is engaged with the hub base 226. In this manner, the above-mentioned features can be engaged with one another to form a seal assembly 237 disposed within the outer shell 236. Any of the above-mentioned features can be modified, removed, or added to the seal assembly 237 to change the sealing capabilities of the seal assembly 237. For example, the number of brushes 256 in the brush portion 246 may be increased and / or decreased, and the diameter or thickness of the seal 250 may be increased or decreased. As previously described, the seal assembly 237 and outer shell 236 are disposed between the hub base 226 and the hub cap 248. Thus, when a medical device such as a catheter is inserted through the hub cap 248, the catheter extends through the lumen 249 (FIG. 5), and thus through the seal assembly 237, and through the hub base 226 of the hemostasis valve hub 220. The catheter can then extend out of the distal end 224 of the hemostasis valve hub 220 and into the introducer sheath 100. Additionally, in various embodiments, an additional medical device (i.e., a second catheter) can be inserted through the hemostasis valve hub 220, through the lumen 249, and into the introducer sheath 100.

[0038] 12 illustrates a further embodiment of a hemostasis valve hub 320, which may be similar or the same as hemostasis valve hub 220, except for the fixation mechanism and the distal end of the hub base. Specifically, FIG. 12 illustrates a hemostasis valve hub 320 comprising a hub base 326 that engages with a seal assembly 337 that engages with a hub cap 348. The hub base 326, seal assembly 337, and hub cap 348 may be the same as the hub base 226, seal assembly 237, and hub cap 248 described with reference to FIG. 4. However, as illustrated, the hub base 326 comprises a narrowed portion 370 towards the distal end 324 of the hemostasis valve hub 320. The narrowed portion 370 is configured to engage with a threaded cap 372. In this manner, the threaded cap 372 engages both the hub base 326 and the proximal end 106 (FIG. 1) of the introducer sheath 100 (FIG. 1), securing the hemostasis valve hub 320 to the introducer sheath 100.

[0039] 13 and 1, a method 400 of delivering at least one medical device into a blood vessel V using the hemostasis valve hub 220 described with reference to FIGS. 3-10 is described. In block 402, the method 400 first includes securing the hub base 226 to the proximal end 106 of the introducer sheath 100 using a securing mechanism. In various embodiments, the securing mechanism includes placing a ferrule 228 within the hub base 226 to secure the hub base 226 to the proximal end 106 of the introducer sheath 100. In various other embodiments, the method 400 may be applied with the use of the hemostasis valve hub 320 described with reference to FIG. 12, and the securing mechanism may include a threaded cap 372 engaged with the narrowed portion 370.

[0040] At block 404, the method 400 further includes securing the outer shell 236, including the seal assembly 237, to the hub base 226 and securing the hub cap 248 to the outer shell 236. More specifically, the bottom cap 242 is secured to the hub base 226 and the top cap 240 is secured to the hub cap 248. At block 406, the method 400 further includes inserting the introducer sheath 100 into the blood vessel V.

[0041] Additionally, at block 408, the method 400 further includes inserting at least one medical device into the lumen 249 defined by the hub cap 248, the seal assembly 237, and the hub base 226. Inserting the at least one medical device may include inserting a catheter, for example, the catheter 170 (FIG. 1), through the hemostasis valve hub 220 and extending the catheter 170 out of the distal end 224 of the hemostasis valve hub 220. As previously described, inserting the catheter 170 through the seal assembly 237 creates a sealing engagement between the catheter 170 and the hemostasis valve hub 220. In some embodiments, an additional medical device, for example, a second catheter, may also be inserted into the hemostasis valve hub 220. As a result of the configuration of the various elements of the outer shell 236 and the seal assembly 237, at least two medical devices can be inserted simultaneously through the hemostasis valve hub 220. In this manner, the hemostasis valve hub 220 functions to provide a single cavity hemostasis valve hub for accepting multiple medical devices through the hemostasis valve hub 220 and into the introducer sheath 100, reducing leakage and improving axial stability of the medical devices.

[0042] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the above embodiments refer to particular features, the scope of the present invention also includes embodiments having different combinations of features and embodiments that do not include all of the features described above.

Claims

1. 1. A hemostasis valve hub for use with an introducer sheath, comprising: a base having a securing mechanism for securing the hemostasis valve hub to the introducer sheath; an outer shell securable to the base and defining an interior volume; a shutter spiral disposed within the interior volume, the shutter spiral including a plurality of fins arranged in a spiral; a brush portion disposed within the interior volume adjacent the shutter helix, the brush portion including a plurality of brushes arranged in a helical configuration; a seal disposed within the base, the seal having a partial cross slit configuration; A hemostasis valve hub comprising:

2. The hemostasis valve hub of claim 1 , wherein the fixation mechanism is a ferrule disposed within the base for engaging the introducer sheath and the hemostasis valve hub.

3. The hemostasis valve hub of claim 1 or claim 2, wherein the outer shell comprises a top cap and a bottom cap coupled to the top cap.

4. The hemostasis valve hub of claim 3 , wherein the seal is disposed adjacent to the top cap and the brush portion.

5. The hemostasis valve hub of any preceding claim, wherein the seal is configured to have a diameter of at least 8.0 mm.

6. The hemostasis valve hub of any one of claims 1 to 5, wherein the base comprises a plurality of sewing rings for fixing the position of the device.

7. The hemostasis valve hub of claim 6 , wherein the base, the outer shell, the seal assembly, and the hub cap are longitudinally aligned to define a lumen.

8. 1. A delivery system for inserting a plurality of medical devices into a blood vessel, comprising: an introducer sheath having a proximal end and a distal end; a hemostasis valve hub configured to engage the proximal end of the introducer sheath, a base having a securing mechanism for securing the hemostasis valve hub to the introducer sheath; an outer shell securable to the base and defining an interior volume; a shutter spiral disposed within the interior volume, the shutter spiral including a plurality of fins arranged in a spiral; a brush portion disposed within the interior volume adjacent the shutter helix, the brush portion including a plurality of brushes arranged in a helical configuration; a seal disposed within the base adjacent the brush portion, the seal having a partial cross slit configuration; a hemostasis valve hub comprising: A delivery system comprising:

9. The delivery system of claim 8 , wherein the outer shell comprises a top cap coupled to a bottom cap.

10. The delivery system of claim 9 , wherein the seal is disposed adjacent the top cap and the brush portion.

11. The delivery system of claim 10 , wherein the bottom cap includes an O-ring seal for forming a seal between the bottom cap and the base.

12. The delivery system of any one of claims 8 to 11, wherein the fixation mechanism is a ferrule disposed within the base of the hub for engaging the base and the introducer sheath.

Images