Dual Arm Hemostasis Valve Hub for Sheath

Abstract

A hemostatic valve hub for a sheath (e.g., an introducer sheath) includes a hub base having a first arm defining a first lumen and having a distal end and a proximal end, and a second arm extending from the first arm and defining a second lumen and having a distal end and a proximal end, a seal disposed within the first lumen and adjacent a locking nut, the locking nut engaged to the proximal end of the first arm and at least partially disposed within the first lumen, a primary seal disposed adjacent the proximal end of the first arm, and a secondary seal disposed adjacent the proximal end of the second arm.

Description

[Technical field]

[0001] The present disclosure relates to a hub for an introducer sheath. More particularly, the present disclosure relates to a dual arm hemostasis valve hub for 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 (e.g., femoral artery) and a medical device is inserted into the introducer sheath for introduction into the blood vessel. In various examples, the medical device may include a catheter or other medical device (e.g., blood pump). In various examples, multiple medical devices need to be simultaneously introduced into or through a blood vessel. 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 passage of multiple devices into an introducer sheath toward a single vascular access site while simultaneously facilitating passage of the devices through the introducer sheath while minimizing blood leakage and inhibiting axial displacement of the medical device within the valve hub. Summary of the Invention

[0003] In Example 1, a hemostatic valve hub for a sheath includes a hub base having a first arm defining a first lumen and having a distal end and a proximal end, and a second arm extending from the first arm and defining a second lumen and having a distal end and a proximal end, a seal disposed within the first lumen and adjacent a locking nut, the locking nut engaged to the proximal end of the first arm and at least partially disposed within the first lumen, a primary seal disposed adjacent the proximal end of the first arm, and a secondary seal disposed adjacent the proximal end of the second arm.

[0004] In Example 2, the hemostasis valve hub of Example 1 further includes where the hemostasis valve hub further comprises a locking mechanism engaged with the hub base to lock the hemostasis valve hub to the sheath. In Example 3, the hemostasis valve hub of Example 2 further includes where the fixation mechanism is a ferrule disposed within the hub base.

[0005] In Example 4, the hemostasis valve hub of Example 2 further includes where the hub base includes a narrowed portion and includes a threaded cap that engages the narrowed portion and the sheath as the locking mechanism. In Example 5, the hemostasis valve hub of any one of the preceding examples further includes where the locking nut is configured to threadably engage the first arm, further comprising an inner portion configured to engage the seal.

[0006] In Example 6, the hemostasis valve hub of Example 5 further includes where the inner portion of the locking nut is configured to axially compress the seal to reduce a lumen size of the seal. In Example 7, the hemostasis valve hub of any one of the preceding examples further includes where the hub further comprises a primary cap that engages the locking nut and a secondary cap that engages the proximal end of the second arm.

[0007] In Example 8, the hemostasis valve hub of any one of the preceding examples further includes where the primary seal has a diameter and the secondary seal has a diameter, the diameter of the primary seal being greater than the diameter of the secondary seal.

[0008] In Example 9, a delivery system for multiple medical devices into a blood vessel includes a sheath for insertion into a blood vessel, the sheath having a proximal end and a distal end, and a hemostasis valve hub for attachment to the proximal end of the sheath, the hemostasis valve hub including a hub base including a first arm defining a first lumen and having a distal end and a proximal end, a second arm extending from the first arm and defining a second lumen and having a distal end and a proximal end, a seal disposed within the first lumen and adjacent a locking nut, the locking nut engaged to the proximal end of the first arm and at least partially disposed within the first lumen, a primary seal disposed adjacent the proximal end of the first arm and a primary cap engaged to the locking nut, and a secondary seal disposed adjacent the proximal end of the second arm.

[0009] In Example 10, the hemostasis valve hub of Example 9 further includes where the primary seal has a first diameter and the secondary seal has a second diameter, and the first diameter is greater than the second diameter.

[0010] In Example 11, the hemostasis valve hub of Example 9 or Example 10 includes a case where the hub base includes a fixing mechanism for fixing to the proximal end of a sheath. In Example 12, the hemostasis valve hub of Example 11 further includes where the fixation mechanism is a ferrule disposed within a hub base of the hemostasis valve hub.

[0011] In Example 13, a method of assembling a sheath and hub includes placing a hub base over a proximal end of a sheath, the hub base having a first arm and a second arm, the first arm defining a first lumen and the second arm defining a second lumen, attaching a locking mechanism to the hub base and the proximal end of the sheath, and inserting a seal into the first lumen of the first arm. The method further includes engaging a locking nut, a primary seal, and a primary cap to the first arm, and engaging a secondary seal to the second arm.

[0012] In Example 14, the method of Example 13 further includes where the seal comprises a lumen configured to receive a medical instrument. In Example 15, the method of Example 13 or Example 14 further includes where the locking mechanism is a ferrule disposed within the hub base.

[0013] In Example 16, a hemostatic valve hub for a sheath includes a hub base including a first arm defining a first lumen and having a distal end and a proximal end, and a second arm extending from the first arm and defining a second lumen and having a distal end and a proximal end, a seal disposed within the first lumen adjacent a locking nut, the locking nut engaged to the proximal end of the first arm and at least partially disposed within the first lumen, a primary seal disposed adjacent the proximal end of the first arm and a primary cap engaged with the locking nut, and a secondary seal disposed adjacent the proximal end of the second arm.

[0014] In Example 17, the hemostasis valve hub of Example 16 further includes where the hemostasis valve hub further comprises a locking mechanism engaged with the hub base to lock the hemostasis valve hub to the sheath. In Example 18, the hemostasis valve hub of Example 17 is where the fixation mechanism is a ferrule disposed within the base of the hub.

[0015] In Example 19, the hemostasis valve hub of Example 17 further includes where the hub base includes a narrowed portion and includes a threaded cap engaged with the narrowed portion and the sheath as the locking mechanism. In Example 20, the hemostasis valve hub of Example 16 further includes where the locking nut comprises an inner portion configured to engage the seal.

[0016] In Example 21, the hemostasis valve hub of Example 20 further includes where the inner portion of the locking nut is configured to axially compress the seal to reduce the size of its seal lumen. In Example 22, the hemostasis valve hub of Example 16 further includes where the locking nut is configured to threadably engage the first arm.

[0017] In Example 23, the hemostasis valve hub of Example 16 further includes where the primary seal has a diameter and the secondary seal has a diameter, the diameter of the primary seal being greater than the diameter of the secondary seal.

[0018] In Example 24, the hemostasis valve hub of Example 16 further includes where the primary seal has a thickness and the secondary seal has a thickness, the thickness of the primary seal being greater than the thickness of the secondary seal.

[0019] In Example 25, a system for delivering multiple medical devices into a blood vessel includes a sheath for insertion into a blood vessel having a proximal end and a distal end and a hemostasis valve hub for attachment to the proximal end of the sheath, the hemostasis valve hub including a hub base having a first arm defining a first lumen and having a distal end and a proximal end and a second arm extending from the first arm and defining a second lumen and having a distal end and a proximal end, a seal disposed within the first lumen and adjacent a locking nut, the locking nut engaged to the proximal end of the first arm and at least partially disposed within the first lumen, a primary seal disposed adjacent the proximal end of the first arm and a primary cap engaged to the locking nut, and a secondary seal disposed adjacent the proximal end of the second arm.

[0020] In Example 26, the delivery system of Example 25 further includes where the primary seal has a first diameter and the secondary seal has a second diameter, and the first diameter is greater than the second diameter.

[0021] In Example 27, the delivery system of Example 25 further includes where the hub base comprises a fixation mechanism for fixing to a proximal end of the sheath. In Example 28, the delivery system of Example 27 further includes where the fixation mechanism is a ferrule disposed within a hub base of the hemostasis valve hub.

[0022] In Example 29, the delivery system of Example 27 further includes where the locking mechanism is formed from a narrowed portion of the hub base having a threaded portion and a threaded cap configured to attach to the threaded portion.

[0023] In Example 30, the delivery system of Example 25 further includes where engagement of the lock nut with the seal reduces the size of the lumen of the seal. In Example 31, a method of assembling a sheath and a hub includes placing a hub base over a proximal end of a sheath, the hub base having a first arm and a second arm, the first arm defining a first lumen and the second arm defining a second lumen, attaching a locking mechanism to the hub base and the proximal end of the sheath, and inserting a seal into the first lumen of the first arm. The method further includes engaging a locking nut, a primary seal, and a primary cap to the first arm, and engaging a secondary seal to the second arm.

[0024] In Example 32, the method of Example 31 further includes where the seal comprises a lumen configured to receive a medical instrument. In Example 33, the method of Example 31 further includes where the securing mechanism is a ferrule disposed within the hub base.

[0025] In Example 34, the method of Example 31 further includes where the fixation mechanism comprises a threaded cap configured to engage a proximal end of the sheath and a narrowed portion of the hub base. In Example 35, the method of Example 31 further includes where the locking nut comprises an inner portion configured to engage the seal and axially compress the seal to reduce a size of the seal lumen.

[0026] 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]

[0027] [Figure 1] FIG. 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] FIG. 2 illustrates a cross-sectional view of an introducer sheath after insertion into a blood vessel and after insertion of a medical device into the introducer sheath, according to an embodiment of the present disclosure. [Diagram 3] FIG. 3 illustrates a side view of a hemostasis valve hub for use with an introducer sheath according to an embodiment of the present disclosure. [Figure 4] FIG. 4 illustrates a cross-sectional view of a hemostasis valve hub as shown in FIG. 3 according to an embodiment of the present disclosure. [Diagram 5] FIG. 5 illustrates an exploded view of a hemostasis valve as shown in FIGS. 3-4, according to an embodiment of the present disclosure. [Figure 6] FIG. 6 illustrates an exploded view of a hemostasis valve hub for use with an introducer sheath according to an embodiment of the present disclosure. [Figure 7] FIG. 7 shows an enlarged view of a main cap for use with a hemostasis valve hub according to an embodiment of the present disclosure. [Figure 8] FIG. 8 shows a close-up view of a locking nut for use with a hemostasis valve hub according to an embodiment of the present disclosure. [Figure 9] FIG. 9 shows an enlarged view of a seal for use with a hemostasis valve hub according to an embodiment of the present disclosure. [Figure 10A] FIG. 10A shows an enlarged view of an additional seal for use with a hemostasis valve hub according to an embodiment of the present disclosure. [Figure 10B] FIG. 10B shows a cross-sectional view of the seal of FIG. 10A according to an embodiment of the present disclosure. [Figure 10C] FIG. 10C shows an additional cross-sectional view of the seal of FIG. 10A according to an embodiment of the present disclosure. [Figure 10D] FIG. 10D shows a close-up view of an additional seal for use with a hemostasis valve hub according to an embodiment of the present disclosure. [Figure 10E] FIG. 10E illustrates a cross-sectional view of the seal of FIG. 10D according to an embodiment of the present disclosure. [Figure 10F] FIG. 10F shows an additional cross-sectional view of the seal of FIG. 10D according to an embodiment of the present disclosure. [Figure 11] FIG. 11 illustrates a flow chart for a method of assembling an introducer sheath and hub in accordance with an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] FIG. 1 illustrates a side cross-sectional view of a blood vessel V with a sheath 100 (e.g., introducer sheath 100) at least partially inserted therein. In some embodiments, introducer sheath 100 is used to facilitate passage of various relatively large medical instruments (e.g., a vascular pump, as described further herein, etc.) through introducer sheath 100 and into blood vessel V. Here, introducer sheath 100 may be referred to as a large bore introducer sheath. Specifically, introducer sheath 100 includes a proximal end 106 and a distal end 108 opposite proximal end 106. Introducer sheath 100 includes a proximal opening (not shown) adjacent proximal end 106 and a distal opening 109 adjacent distal end 108. A body portion 110 of introducer sheath 100 extends between proximal end 106 and distal end 108, with body portion 110 defining a lumen 112 of introducer sheath 100. The introducer sheath 100 may be formed from a variety of polymeric or metallic materials. In further embodiments, the introducer sheath 100 may include additional surface coatings, including but not limited to silicone, PET, or any other applicable polymer. A hub 120 is generally provided 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 100 during use. In various instances, it may be desirable to pass multiple medical instruments through the introducer sheath 100 at one time. As such, in some embodiments, as disclosed with further reference to FIGS. 3-8, the hemostasis valve hub 120 includes at least two arms with multiple openings, thereby allowing at least two instruments to be inserted into the introducer sheath 100 at one time without requiring removal of the first instrument and subsequent insertion of the second instrument. The dual arm configuration allows for the insertion of two instruments while maintaining hemostasis and reducing blood leakage from the introducer sheath 100 and / or hub 120 during insertion, use, or removal of various medical instruments. In some embodiments, two catheters are inserted into the hub 120, and various other medical instruments may be inserted into at least one of the catheters for delivery into the blood vessel V.1, the hub 120 may be used to receive a catheter 170. The catheter 170 may be coupled to a proximal end of a blood pump that may be inserted through the hub 120 and the introducer sheath 100 and into the introducer sheath 100, as may be further described herein.

[0029] In some embodiments, the sheath 100 may be a repositioned sheath. 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 comprises an impeller assembly housing 140 and a motor housing 142. In some embodiments, the impeller assembly housing 140 and the motor housing 142 may be integral or one-piece. The impeller assembly housing 140 carries an impeller assembly 144. The impeller assembly 144 comprises 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 allows blood to flow from a blood inlet 151 formed on the impeller assembly housing 140, through the impeller assembly housing 140, and out a blood outlet 152 formed on the impeller assembly housing 140. In some embodiments, the impeller shaft 146 and the impeller 148 may be integrated, and 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 on one end portion of the impeller assembly housing 140, and the outlet 152 may be formed on one side portion of the impeller assembly housing 140. In other embodiments, the inlet 151 and / or the outlet 152 may be formed on other portions of the impeller assembly housing 140. In some embodiments, the impeller housing 140 may be coupled to a distally extending cannula (not shown), and the cannula may receive and deliver blood to the inlet 151.

[0030] 2, the motor housing 142 carries a motor 154 that is configured to drive the impeller 148 to rotate relative to the impeller assembly housing 140. In the illustrated embodiment, the motor 154 rotates a drive shaft 156 that is coupled to a drive magnet 158. Rotation of the drive magnet 158 ​​causes rotation of a driven magnet 160 that is 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 may be coupled to the impeller assembly housing 140 via other components. Additionally, as illustrated in FIG. 2, a catheter 170 extends from the proximal end of the blood pump 150. In some embodiments, the catheter 170 may be coupled to the motor housing 142 through a tapered connection lug and / or various other connection methods. The catheter 170 may have a flexible construction to facilitate delivery of the blood pump 150. While the introducer sheath 100 is illustrated above in conjunction with use with the blood pump 150, various other medical devices may be used in conjunction with the introducer sheath 100 and hemostasis valve hub 120. For example, modified blood pumps may be used in conjunction with the introducer sheath 100. In other examples, devices other than blood pumps may be incorporated.

[0031] With reference to Figures 3-5, an embodiment of a hemostasis valve hub is described in further detail. Specifically, Figures 3-5 illustrate a hemostasis valve hub 220 having a distal end 222 and a proximal end 224, and a longitudinal axis L extending between the distal end 222 and the proximal end 224. Additionally, the hemostasis valve hub 220 includes a hub base 221 with a first arm 226 and a second arm 228, the second arm 228 extending outwardly from the first arm 226 at an angle relative to the longitudinal axis L. The angle relative to the longitudinal axis L may be greater than zero. Additionally, as illustrated, the second arm 228 also includes an access port 230 extending from the second arm 228. The access port 230 may be used for the insertion of a liquid or an instrument configured for irrigation.

[0032] The distal end 222 of the hemostasis valve hub 220 is configured for attachment to the proximal end 106 (FIG. 1) of the introducer sheath 100 (FIG. 1), more specifically, to the proximal opening of the introducer sheath 100. As best illustrated in FIG. 4, the distal end 222 of the hemostasis valve hub 220 includes a securing mechanism for securing the introducer sheath 100 within the distal end 222 of the hemostasis valve hub 220. For example, in the exemplary embodiment of FIGS. 4-5, the hemostasis valve hub 220 includes a ferrule 231 disposed within its distal end 222 that is configured for securing the proximal flared opening of the introducer sheath 100 within the hemostasis valve hub 220. The proximal end 224 of the hemostasis valve hub 220 is configured for receiving a number of medical instruments for insertion through the hemostasis valve hub 220 and the introducer sheath 100 (FIG. 1). In other words, the configuration of the proximal end 224, and more particularly the configuration of the first arm 226 and the second arm 228, allows at least two medical instruments to be inserted simultaneously into one access port in the patient. In various embodiments, as previously described, the two medical instruments may be two catheters or other medical instruments, such as the blood pump 150 as previously disclosed with reference to FIG. 2, for insertion into the blood vessel V. The configuration of the hemostasis valve hub 220 allows for the reduction of blood loss or inflammation at the access site that might otherwise occur if the first instrument needs to be removed and the second instrument needs to be subsequently removed. The hemostasis valve hub 220 also reduces the need for additional access ports for the insertion of multiple medical instruments into the blood vessel V.

[0033] The dual arm configuration of the hemostasis valve hub 220 will now be described further. The first arm 226 includes a first lumen 232 defined therein and extending generally parallel to its longitudinal axis L (FIG. 3). The second arm 228 includes a second lumen 234 extending therethrough and generally angled relative to the longitudinal axis L. The first lumen 232 extends from a proximal end 236 of the first arm 226 (corresponding to the proximal end 224 of the hemostasis valve hub 220) to a distal end 238 of the first arm 226 (corresponding to the distal end 222 of the hemostasis valve hub 220). Additionally, the second lumen 234 extends between a distal end 240 of the second arm 228 and a proximal end 242 of the second arm 228.

[0034] 4-5, the first arm 226 will now be described in further detail. As illustrated, the first lumen 232 includes a first diameter D1 that extends from a distal end 238 and meets a proximal end 236 of the first lumen 232. Towards the proximal end 236 of the first lumen 232, the first lumen 232 includes a diameter D2 that extends to a second proximal end 236, the diameter D2 being larger than the diameter D1 at the proximal end 236. As illustrated, the first lumen 232 includes a seal 250 disposed adjacent a transition point of the first lumen 232 where the diameter increases from the first diameter D1 to a second diameter D2. As will be described further herein, the seal 250 defines a seal lumen 251 that extends therethrough for receiving at least one medical instrument. Adjacent to the seal 250 is a locking nut 244 having an inner portion 246 that extends at least partially toward the first lumen 232 and is engageable with the seal 250. The locking nut 244 further comprises an outer portion 248 that is disposed at least partially about an outer surface of the first arm 226. More specifically, an inner surface 249 of the outer portion 248 of the locking nut 244 may be threaded and at least a portion of the outer surface of the first arm 226 may be threaded such that the locking nut 244 threadably engages the proximal end 236 of the first arm 226 to adjust and / or maintain a desired position of the locking nut 244. In other words, an operator may rotate or thread the locking nut 244 until it engages the hemostasis valve hub 220, which in turn causes engagement with the seal 250. As will be further described with reference to Figure 9, engagement of seal 250 with locknut 244 causes inner portion 246 to engage seal 250 and apply an axial compressive force to seal 250. As seal 250 is axially compressed, initial diameter D3' (Figure 9) of lumen 251 is reduced such that lumen 251 decreases in size and is defined by compressed diameter D3. As the diameter of lumen 251 decreases in size, seal 250 contacts and fits tightly against a medical instrument (e.g., a catheter) passing therethrough, thereby stabilizing the axial position of the medical instrument.Additionally, when lock nut 244 axially compresses seal 250, seal 250 expands radially inward to provide a partial or total fluid-tight seal against the outer surface of the catheter, and expands radially outward to provide a partial or total fluid-tight seal against the inner surface of hub base 221. Additionally, seal 250 may form various other radial and / or axial seals within hub 220 as a result of the axial compressive deformation and application of an axial force thereto.

[0035] 3-5, adjacent to the locking nut 244 and spaced proximally from the proximal end 236 of the first arm 226 is a primary seal 252. The primary seal 252 is configured to have a diameter less than a diameter of the locking nut 244 but greater than a first diameter D1 of the first lumen 232. As described with further reference to FIG. 10A, the primary seal 252 is configured to provide a fluid-tight seal around a medical instrument passing through the hemostasis valve hub 220. The primary seal 252 at least partially engages the locking nut 244, as shown in FIG. 4. Additionally, a primary cap 260 is disposed adjacent to the primary seal 252 and engaged with the locking nut 244 such that the primary seal 252 is sandwiched between the locking nut 244 and the primary cap 260. More specifically, the locking nut 244 may have a detent 257 configured to receive a protrusion 258 of the primary cap 260. This coupling ensures that the primary seal 252 is securely engaged and maintains a hemostatic seal after a medical instrument is inserted into the hemostatic valve hub 220 and introducer sheath 100 (FIG. 1). In some embodiments, the primary cap 260 may be configured to couple to a sealing port (not shown) used to secure the axial movement of a medical instrument (e.g., a catheter) passing through the hub 220.

[0036] The second arm 228 will now be described further with continued reference to Figures 4-5. As previously described, the second arm 228 includes a proximal end 242 and a distal end 240. The distal end 240 is configured to engage the first arm 226 such that the first lumen 232 and the second lumen 234 merge into a single lumen upon passing through the distal end 222 of the hemostasis valve hub 220 toward the introducer sheath 100 (Figure 1). The proximal end 242 of the second arm 228 is configured to maintain a hemostatic seal upon insertion of additional medical instruments into the second lumen 234. Specifically, adjacent the proximal end 242 of the second arm 228, the second arm 228 includes a secondary seal 254 configured to extend across the entire diameter of the second lumen 234. Additionally, disposed adjacent to the secondary seal 254 and engaged with the second arm 228 is a secondary cap 262. The secondary cap 262 is configured to maintain the position of the secondary seal 254 relative to the second arm 228 of the hemostasis valve hub 220.

[0037] FIG. 6 illustrates an exploded view of an alternative embodiment of a hemostasis valve hub, illustratively hemostasis valve hub 320. Hemostasis valve hub 320 may be similar or the same as hemostasis valve hub 220 described with reference to FIGS. 3-5, except for the locking mechanism for introducer sheath 100 at the distal end 321 of hemostasis valve hub 320. Specifically, hemostasis valve hub 320 includes a first arm 326 engaged with a primary cap 360 disposed adjacent to primary seal 352. Both primary seal 352 and primary cap 360 engage a locking nut 344, which may engage a seal 350 disposed within a first lumen 332 of hemostasis valve hub 320 to axially secure a medical device, such as a catheter. Similar to seal 250 described with reference to FIG. 4, seal 350 may have a lumen 351 with a diameter that decreases after an axial compressive force is exerted on seal 350. The locking nut 344 includes an inner portion 346 and an outer portion 348, with the inner portion 346 configured for engagement with a seal 350. The hemostasis valve hub 320 additionally includes a second arm 328 that defines a second lumen 334 having a secondary seal 354 engaged with the second arm 328 and a secondary cap 362. However, the hemostasis valve hub 320 differs from the hemostasis valve hub 220 in that the distal end 321 of the hemostasis valve hub 320 includes a narrowed portion 370 that is threaded and can engage a securing feature of the sheath shaft, illustratively a threaded cap 372. The threaded cap 372 serves to engage the proximal end 106 (FIG. 1). Among other things, the threaded cap 372 is used to connect the introducer sheath 100 to the hemostasis valve hub 320. However, a variety of other suitable fixation mechanisms may be used to secure the introducer sheath 100 within the hemostasis valve hub 320. With reference to Figures 7-10, some of the above-referenced elements will be described in further detail.

[0038] Specifically, FIG. 7 illustrates an enlarged view of the primary cap 260 described above with reference to the hemostasis valve hub 220. The primary cap 260 includes a first portion 264 and a second portion 266. The second portion 266 includes an outer cylinder 267 and a plurality of inner engaging members 269 configured to engage an external instrument (e.g., a sealing port, a sealing instrument, a sealing instrument, and / or a sterile sleeve for placement over the hemostasis valve hub 220). In some embodiments, the primary cap 260 may be configured to mate with a sealing port (not shown) and may be used to secure a medical instrument, such as a catheter, passing through the hub 220, for example, to prevent axial movement of the catheter. The primary cap 260 may be formed from polycarbonate or polypropylene. The primary cap 260 may be formed from a variety of other materials, and the above materials are presented as examples. Although described with reference to the primary cap 260, the above features may also be applied to the primary cap 360 illustrated with reference to the hemostasis valve hub 320.

[0039] FIG. 8 illustrates an enlarged view of the locking nut 244. As previously described, the locking nut 244 includes an inner portion 246 and an outer portion 248 for threadedly engaging with the first arm 226 of the hemostasis valve hub 220 (FIG. 4), which may have a linear contoured configuration that allows the locking nut 244 to be firmly grasped by an operator, thereby tightly securing and coupling the locking nut 244 onto the first arm 226. The locking nut 244 may further include a threaded surface on an inner surface 249 of the outer portion 248 for threadedly engaging with the first arm 226. The locking nut 244 may also include an engagement surface (not shown) on an inner or outer surface of the outer portion 248 for engaging with the primary cap 260 in a secure connection. For example, a friction fit type connection may be used to connect the locking nut 244 and the primary cap 260. Additionally, the inner portion 246 may be configured to engage the seal 250 (FIG. 5) when the locking nut 244 is inserted into the first lumen 232 (FIG. 4) of the first arm 226. When an operator inserts the locking nut 244 into the first arm 226 to couple the locking nut 244 and the first arm 226, the inner portion 246 compresses the seal 250 and axially compresses the seal 250 through the base 221 until the seal 250 contacts the portion of the base 221 transitioning from the second diameter D2 to the first diameter D1. Once the seal 250 is positioned against the transition between the second diameter D2 and the first diameter D1, the continued axial compression of the seal 250 by the inner portion 246 results in axial compression of the seal 250. The axial compression of the seal 250 then results in a reduction in the size of the lumen 251 of the seal 250, as described herein.

[0040] FIG. 9 illustrates a close-up view of the seal 250. As illustrated, the seal 250 has an initial diameter D4 and an initial thickness T1, and the lumen 251 has an initial diameter D3'. After being axially forced toward the smaller lumen section of the first lumen, continued axial compression of the seal 250 reduces the initial diameter D3' of the lumen 251 to a compressed diameter D3 as shown in FIG. 4. This ability of the lumen 251 of the seal 250 to shrink radially inwardly allows for axial fixation of a medical instrument (e.g., a catheter within the first lumen 232) passing through the seal lumen. In other words, when an operator compresses the seal 250 by axially moving the lock nut 244, the corresponding reduction in size of the lumen 251 causes or furthers contact and / or sealing between the seal 250 and the catheter. Additionally, the seal 250 may be pressed outwardly against the inner surface of the first arm 226. Thus, seal 250 may further contribute to providing a hemostatic seal of introducer sheath 100 and hemostatic valve hub 220. Primary seal 252 (FIG. 4) and secondary seal 254 (FIG. 4) further contribute to the ability of introducer sheath 100 and hemostatic valve hub 220 to provide a hemostatic seal. Primary seal 252 and secondary seal 254 are described in further detail herein with reference to FIGs. 10A and 10B.

[0041] 10A and 10D, the primary seal 252 and the secondary seal 254 are illustrated and described in further detail. For example, as illustrated, the primary seal 252 may have a diameter D5 that is greater than the diameter D6 of the secondary seal 254. For example, the diameter D5 of the primary seal 252 may have a value between about 9 mm and about 11 mm, while the diameter D6 of the secondary seal 254 may have a value between about 5 mm and about 8.5 mm. In addition, the primary seal 252 may have a thickness T2 (FIG. 6) that is greater than the thickness T3 (FIG. 6) of the secondary seal 254. For example, the thickness T2 of the primary seal 252 may have a value in a range between about 1.5 mm and about 2.5 mm. The thickness T3 of the secondary seal 254 may be in a range between about 1.25 mm and about 2.0 mm. The primary seal 252 and the secondary seal 254 may each be a cylindrical seal such that the primary seal 252 and the secondary seal 254 have a circular cross-section. Additionally, each of the primary seal 252 and the secondary seal 254 has a partially intersecting cut in the center of the primary seal 252 and the secondary seal 254. With specific reference to the primary seal 252 and FIGS. 10A-10C, the primary seal 252 may have a partially intersecting cut having a length L2 of about 4.5 mm. With reference to the secondary seal 254 shown in FIG. 10D, the secondary seal 254 may have a partially intersecting cut having a length L3 of about 1.5 mm. However, the lengths L2 and L3 may be varied. For example, the length L2 may range from about 3.0 mm to about 4.5 mm. The length L3 may range from about 1.5 mm to about 3.0 mm. FIG. 10B illustrates a cross-sectional view of the primary seal 252 of FIG. 10A taken along line CC, and FIG. 10C illustrates a cross-sectional view of the primary seal 252 taken along line BB. As illustrated, a partially cross cut is formed when cut at a 90° orientation on opposing faces with a specified cut depth d and overlap O. For example, the partially cross cut of primary seal 252 may have overlap O1 having a value of about 0.4 mm and a cut depth d1 of about 0.9 mm. Figure 10E illustrates a cross-sectional view of secondary seal 254 of Figure 10D taken along line CC, and Figure 10C illustrates a cross-sectional view of primary seal 252 taken along line BB.As illustrated, the partially intersecting cuts of the secondary seal 254 may have an overlap O2 having a value of about 0.25 mm and a cut depth d2 of about 0.8 mm. However, the overlap O1 and overlap O2 and the depth d1 and depth d2 may vary. For example, the overlap O1 may range from 0.3 mm to 0.5 mm, the depth d1 may range from 0.7 mm to 1.1 mm, the overlap O2 may range from 0.15 mm to 0.35 mm, and the depth d2 may range from 0.6 mm to 1.0 mm. However, the primary seal 252 and the secondary seal 254 may have a variety of other configurations. For example, the primary seal 252 and the secondary seal 254 may have an oval cross-sectional shape. The primary seal 252 and the secondary seal 254 may each be made of silicone or may be formed of a variety of other suitable materials, such as a polymer, a thermoset, a rubber, a thermoset elastomer (TSE), or a silicone rubber.

[0042] 11, a method 400 of assembling an introducer sheath and hub, for example introducer sheath 100 and hub 220, is described. At block 402, the method 400 first includes placing the hub base 221 over the proximal end 106 of the introducer sheath 100. More specifically, the introducer sheath 100 is placed toward the hub base 221 until the proximal end 106 of the introducer sheath 100 is located at the distal end 222 of the base 221. At block 404, the method 400 further includes attaching a fixation mechanism to the hub base 221 and the proximal end 106 of the introducer sheath 100. In various embodiments, the fixation mechanism may be a ferrule 231 disposed within the hub base 221 at the distal end 222 of the hemostasis valve hub 220. After inserting the introducer sheath 100 into the base 221 in this manner, the ferrule 231 may be inserted into the base 221 to hold the introducer sheath 100 in place. In other embodiments, the distal end 222 of the hemostasis valve hub 220 may include a narrowed portion 370, and the locking mechanism comprises a threaded cap 372 configured to engage the narrowed portion 370.

[0043] At block 406 , the method 400 further includes inserting the seal 250 into the first lumen 232 of the first arm 226 . At block 408, the method then includes engaging the locking nut 244, the primary seal 252, and the primary cap 260 with the first arm 226 of the hemostasis valve hub 220. This step may include placing the locking nut 244 at least partially within the hub base 221 without fully seating it. This step further includes engaging the secondary seal 254 and the secondary cap 262 with the second arm of the hemostasis valve hub 220. As previously described, the configuration of the primary seal 252 and secondary seal 254 contribute to a hemostatic seal between the introducer sheath 100 and the hemostasis valve hub 220.

[0044] In various embodiments, the introducer sheath 100 and hub 220 may be used by a physician or operator to insert at least one medical instrument into a blood vessel. For example, the introducer sheath 100 and hub 220 may be used to insert at least one catheter into a blood vessel V. For example, in use, a method of inserting at least one medical instrument may include first inserting the introducer sheath 100 into the blood vessel V. The method may then include inserting the medical instrument into the first arm 226 of the hemostasis valve hub 220. In various embodiments, the medical instrument is a blood pump 150 (FIG. 2) and a catheter 170 (FIG. 2) attached to the blood pump 150. Inserting the blood pump 150 and catheter 170 may include inserting the blood pump 150 and catheter 170 into the first lumen 232 and through the primary seal 252, such that the partially intersecting cut surrounds and seals the catheter 170 after the blood pump 150 is pushed distally through the hub 220 and into the introducer sheath 100. To further seal and maintain the axial position of the catheter within the hemostasis valve hub 220 during use, the method may further include fixing the axial position of the medical device by adjusting the locking nut 244 of the first arm 226. For example, tightening the locking nut 244 causes axial compression of the seal 250, which can then cause the seal 250 to expand, thereby compressing radially against the medical device (i.e., the catheter) and radially and / or axially against the inner surface of the first arm 226. In various embodiments, a second, smaller medical instrument may be inserted into the second arm 228 of the hemostasis valve hub 220. For example, the second medical instrument may be a guide catheter for receiving a guiding tool and / or any other applicable tool that may be desired for use with the hemostasis valve hub 220. This allows the second medical instrument to be simultaneously inserted into the second arm 228 even as the first medical instrument is inserted through the first arm 226 of the hub 220.Specifically, once the second medical instrument is inserted through the second arm 228, the second medical instrument passes through the secondary seal 254 to maintain a fluid-tight seal between the second medical instrument and the hub 220. The second medical instrument may then extend through the hub 220 and into the introducer sheath 100. In other embodiments, a sealing port (not shown) may be coupled to the primary cap 260 to facilitate securing the medical instrument relative to the hub 220, for example, by preventing axial movement of the instrument relative to the hub 220.

[0045] 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 embodiments described above refer to particular features, the scope of the present invention also includes embodiments having various combinations of features and embodiments that do not include all of the features described above.

Claims

1. A hemostatic valve hub for a sheath, comprising: a hub base including a first arm defining a first lumen and having a distal end and a proximal end, and a second arm extending from the first arm and defining a second lumen and having a distal end and a proximal end; a seal disposed within the first lumen adjacent a locking nut, the locking nut engaged to the proximal end of the first arm and at least partially disposed within the first lumen; and a primary seal disposed adjacent the proximal end of the first arm; a secondary seal disposed adjacent the proximal end of the second arm; and A hemostasis valve hub for a sheath comprising:

2. The hemostasis valve hub of claim 1 , further comprising a locking mechanism engaged with the hub base to lock the hemostasis valve hub to the sheath.

3. The hemostasis valve hub of claim 2 , wherein the fixation mechanism is a ferrule disposed within the hub base.

4. The hemostasis valve hub of claim 2 , wherein the hub base includes a narrowed portion, and the locking mechanism includes a threaded cap that engages the narrowed portion and the sheath.

5. A hemostasis valve hub according to any one of the preceding claims, wherein the locking nut is configured to threadably engage the first arm and further comprises an inner portion configured to engage the seal.

6. The hemostasis valve hub of claim 5 , wherein the inner portion of the locking nut is configured to axially compress the seal to reduce a lumen size of the seal.

7. A hemostasis valve hub according to any one of the preceding claims, wherein the hub further comprises a primary cap that engages the locking nut and a secondary cap that engages the proximal end of the second arm.

8. A hemostasis valve hub according to any one of the preceding claims, wherein the primary seal has a diameter and the secondary seal has a diameter, the diameter of the primary seal being larger than the diameter of the secondary seal.

9. 1. A delivery system for multiple medical devices into a blood vessel, comprising: a sheath for insertion into a blood vessel, the sheath having a proximal end and a distal end; a hemostasis valve hub for attachment to the proximal end of the sheath, a hub base including a first arm defining a first lumen and having a distal end and a proximal end, and a second arm extending from the first arm and defining a second lumen and having a distal end and a proximal end; a seal disposed within the first lumen adjacent a locking nut, the locking nut engaged to the proximal end of the first arm and at least partially disposed within the first lumen; and a primary seal disposed adjacent the proximal end of the first arm and a primary cap engaged with the lock nut; a secondary seal disposed adjacent the proximal end of the second arm; and Equipped with the hemostasis valve hub; A delivery system comprising:

10. 10. The delivery system of claim 9, wherein the primary seal has a first diameter, the secondary seal has a second diameter, and the first diameter is greater than the second diameter.

11. 11. A delivery system according to claim 9 or claim 10, wherein the hub base comprises a securing mechanism for securing to the proximal end of the sheath.

12. The delivery system of claim 11 , wherein the fixation mechanism is a ferrule disposed within the hemostasis valve hub and spaced from the hub.

13. A method of assembling a sheath and a hub, comprising the steps of: placing a hub base over the proximal end of the sheath, the hub base having a first arm and a second arm, the first arm defining a first lumen and the second arm defining a second lumen; attaching a fixation mechanism to the hub base and the proximal end of the sheath; inserting a seal into the first lumen of the first arm; engaging a lock nut, a primary seal, and a primary cap with the first arm and engaging a secondary seal with the second arm; Including, an assembly method.

14. The method of claim 13 , wherein the seal comprises a lumen configured to receive a medical instrument.

15. The method of claim 13 or claim 14, wherein the locking mechanism is a ferrule disposed within the hub base.

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