Dual-arm hemostatic 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 specifically, the present disclosure relates to a hemostatic valve hub with a dual arm for a large-diameter introducer sheath.

Background Art

[0002] In various procedures for delivering medical devices within blood vessels, an introducer sheath is inserted into a patient's blood vessel (e.g., the femoral artery), and a medical device is inserted into this introducer sheath for introduction into the blood vessel. In various examples, such medical devices include catheters or other medical devices (such as blood pumps). In various examples, a number of medical devices need to be introduced into the blood vessel simultaneously or inserted through the blood vessel. To reduce blood leakage when the device is inserted, positioned, and removed, a hemostatic valve hub may be incorporated at the proximal end of the large-diameter introducer sheath. There is a need for an optimized hemostatic valve hub that allows multiple devices to pass through the introducer sheath towards a single vascular access site, minimizes blood leakage while facilitating the passage of the device through the introducer sheath, and suppresses 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 comprising 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 to a lock nut, the lock nut being engaged with the proximal end of the first arm and at least partially disposed within the first lumen, a primary seal disposed adjacent to the proximal end of the first arm, and a secondary seal disposed adjacent to the proximal end of the second arm.

[0004] In Example 2, the hemostatic valve hub of Example 1 further includes a fixing mechanism engaged with the hub base to fix the hemostatic valve hub to the sheath when the hemostatic valve hub further includes such a fixing mechanism. In Example 3, the hemostatic valve hub of Example 2 further includes the case where the fixing mechanism is a ferrule located within the base of the hub.

[0005] In Example 4, the hemostatic valve hub of Example 2 further includes a case where the hub base includes a narrow portion and includes a threaded cap as a fixing mechanism that engages with the narrow portion and the sheath. In Example 5, the hemostatic valve hub of any one of the preceding examples further comprises an inner portion configured such that a lock nut is screwed into a first arm and engages with a seal.

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

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

[0008] In Example 9, a system for delivering multiple medical devices into a blood vessel comprises a sheath for insertion into the blood vessel, the sheath having a proximal end and a distal end, and a hemostatic valve hub for attachment to the proximal end of the sheath. The hemostatic valve hub comprises 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 defining a second lumen and having a distal end and a proximal end; a seal disposed in the first lumen and adjacent to a lock nut, the lock nut engaging with the proximal end of the first arm and at least partially disposed in the first lumen; a primary seal disposed adjacent to the proximal end of the first arm and a primary cap engaging with the lock nut; and a secondary seal disposed adjacent to the proximal end of the second arm.

[0009] In Example 10, the hemostatic valve hub of Example 9 further includes the case 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 hemostatic valve hub of Example 9 or Example 10 includes a case where the hub base is provided with a fixing mechanism for fixing it to the proximal end of the sheath. In Example 12, the hemostatic valve hub of Example 11 further includes the case where the fixing mechanism is a ferrule located within the hub base of the hemostatic valve hub.

[0011] In Example 13, the method for assembling the sheath and hub includes the steps of: placing the hub base on 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 fixing 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 the steps of engaging a lock nut, a primary seal and a primary cap with the first arm and engaging a secondary seal with the second arm.

[0012] In Example 14, the method of Example 13 further includes the case 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 the case where the fixing mechanism is a ferrule located within the hub base.

[0013] In Example 16, the hemostatic valve hub for the sheath comprises 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 positioned adjacent to a lock nut in the first lumen, the lock nut engaging with the proximal end of the first arm and the seal at least partially positioned in the first lumen; a primary seal positioned adjacent to the proximal end of the first arm and a primary cap engaging with the lock nut; and a secondary seal positioned adjacent to the proximal end of the second arm.

[0014] In Example 17, the hemostatic valve hub of Example 16 further includes a case in which the hemostatic valve hub further comprises a fixing mechanism that engages with the hub base to fix the hemostatic valve hub to the sheath. In Example 18, the hemostatic valve hub of Example 17 is a ferrule in which the fixing mechanism is located within the hub base.

[0015] In Example 19, the hemostatic valve hub of Example 17 further includes a case where the hub base includes a narrow portion and a threaded cap that engages with the narrow portion and the sheath as a fixing mechanism. In Example 20, the hemostatic valve hub of Example 16 further includes the case where the lock nut has an inner portion configured to engage with a seal.

[0016] In Example 21, the hemostatic valve hub of Example 20 further includes the case where the inner portion of the lock nut is configured to compress the seal axially to reduce the size of the seal lumen. In Example 22, the hemostatic valve hub of Example 16 further includes the case where the lock nut is configured to screw into the first arm.

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

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

[0019] In Example 25, the intravascular delivery system for multiple medical devices includes a sheath for insertion into a blood vessel, the sheath having a proximal end and a distal end and a hemostatic valve hub for attachment to the proximal end of the sheath. The hemostatic valve hub comprises 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 in the first lumen and adjacent to a lock nut, the lock nut engaging with the proximal end of the first arm and at least partially disposed in the first lumen; a primary seal and primary cap engaged with the lock nut, disposed adjacent to the proximal end of the first arm; and a secondary seal disposed adjacent to the proximal end of the second arm.

[0020] In Example 26, the delivery system of Example 25 further includes the case 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 a case where the hub base is secured to the proximal end of the sheath. In Example 28, the delivery system of Example 27 further includes the case where the fixing mechanism is a ferrule located within the hub base of the hemostatic valve hub.

[0022] In Example 29, the delivery system of Example 27 further includes the case where the fixing mechanism is formed of a narrow portion of a hub base having a threaded portion and a threaded cap configured to be attached to this threaded portion.

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

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

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

[0026] While numerous embodiments have been disclosed, other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description which illustrates and describes exemplary 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 shows a cross-sectional view of an introducer sheath after insertion into a blood vessel according to an embodiment of the present disclosure. [Figure 2] FIG. 2 shows 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. [Figure 3] Figure 3 shows a side view of a hemostatic valve hub for use with an introduction sheath, according to an embodiment of the present disclosure. [Figure 4] Figure 4 shows a cross-sectional view of a hemostatic valve hub as shown in Figure 3, according to an embodiment of the present disclosure. [Figure 5] Figure 5 shows an exploded view of a hemostatic valve according to an embodiment of the present disclosure, as shown in Figures 3-4. [Figure 6] Figure 6 shows an exploded view of a hemostatic valve hub for use with an introduction sheath, according to an embodiment of the present disclosure. [Figure 7] Figure 7 shows a magnified view of the main cap for use with a hemostatic valve hub according to an embodiment of the present disclosure. [Figure 8] Figure 8 shows an enlarged view of a lock nut for use with a hemostatic valve hub according to an embodiment of the present disclosure. [Figure 9] Figure 9 shows an enlarged view of a seal for use with a hemostatic valve hub according to an embodiment of the present disclosure. [Figure 10A] Figure 10A shows a magnified view of an additional seal for use with a hemostatic valve hub, according to an embodiment of the present disclosure. [Figure 10B] Figure 10B shows a cross-sectional view of the seal shown in Figure 10A, according to an embodiment of the present disclosure. [Figure 10C] Figure 10C shows an additional cross-sectional view of the seal in Figure 10A, according to an embodiment of the present disclosure. [Figure 10D] Figure 10D shows a magnified view of an additional seal for use with a hemostatic valve hub, according to an embodiment of the present disclosure. [Figure 10E] Figure 10E shows a cross-sectional view of the seal of Figure 10D according to an embodiment of the present disclosure. [Figure 10F] Figure 10F shows an additional cross-sectional view of the seal in Figure 10D, according to an embodiment of the present disclosure. [Figure 11] Figure 11 shows a flowchart illustrating a method for assembling the introduction sheath and hub according to an embodiment of the present disclosure. [Modes for carrying out the invention]

[0028] Figure 1 shows a lateral cross-sectional view of a blood vessel V, with a sheath 100 (e.g., an introduction sheath 100) at least partially inserted into the blood vessel V. In some embodiments, the introduction sheath 100 is used to facilitate the passage of various relatively large medical instruments (e.g., vascular pumps, as further described herein) through the introduction sheath 100 into the blood vessel V. Here, the introduction sheath 100 may be referred to as a large-bore introduction sheath. Specifically, the introduction sheath 100 includes a proximal end 106 and a distal end 108 opposite the proximal end 106. The introduction sheath 100 includes a proximal opening (not shown) adjacent to the proximal end 106 and a distal opening 109 adjacent to the distal end 108. The main body portion 110 of the introduction sheath 100 extends between the proximal end 106 and the distal end 108, and the main body portion 110 defines the lumen 112 of the introduction sheath 100. The introduction sheath 100 may be formed from various polymer or metallic materials. In a further embodiment, the introduction sheath 100 may have an additional surface coating. Examples of surface coatings include, but are not limited to, silicone, PET, or any other applicable polymer. A hub 120 is generally provided at the proximal opening. The hub 120 is configured for hemostasis, i.e., to prevent blood from leaking out of the introduction sheath 100 during use, as is also referred herein as a hemostatic valve hub. In various examples, it may be desirable for multiple medical instruments to pass through the introduction sheath 100 at once. Thus, in some embodiments disclosed with further reference to Figures 3-8, the hemostatic valve hub 120 comprises at least two arms having multiple openings, thereby allowing at least two instruments to be inserted into the introduction sheath 100 at once without requiring the removal of a first instrument and subsequent insertion of a second instrument. The dual-arm configuration allows for the insertion of two medical devices while maintaining hemostasis during insertion, use, or removal of various medical devices and reducing blood leakage from the introduction sheath 100 and / or hub 120. In some embodiments, two catheters may be inserted into the hub 120, and various other medical devices may be inserted into at least one of the delivery catheters into the blood vessel V.As shown in Figure 1, the hub 120 may be used to receive the catheter 170. As may be further described herein, the catheter 170 may be connected to the proximal end of a blood pump that penetrates the hub 120 and the introduction sheath 100 and is inserted into the introduction sheath 100.

[0029] In some embodiments, the sheath 100 may be a repositioned sheath. Figure 2 shows a cross-sectional view of the introduction sheath 100 after the medical device (exemplary, a blood pump 150) has been inserted into the introduction sheath 100 as shown in Figure 1. The blood pump 150 typically 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 manufactured integrally or as a single unit. The impeller assembly housing 140 supports 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 of 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 Figure 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), which may receive blood and deliver it to the inlet 151.

[0030] Continuing with reference to Figure 2, the motor housing 142 supports a motor 154, which is configured to drive an impeller 148 to rotate relative to the impeller assembly housing 140. In the illustrated embodiment, the motor 154 rotates a drive shaft 156, which is coupled to a drive magnet 158. The rotation of the drive magnet 158 ​​causes the rotation of a driven magnet 160, which is connected to the impeller assembly housing 140. More specifically, in embodiments incorporating an impeller shaft 146, the impeller shaft 146 and the impeller 148 are configured to rotate together with the driven magnet 160. In other embodiments, the motor 154 may be coupled to the impeller assembly housing 140 via other components. In addition, as illustrated in Figure 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 tapered connectors and / or various other connection methods. The catheter 170 may have a flexible construction to facilitate delivery of the blood pump 150. While the introduction sheath 100 is illustrated above in conjunction with the use of the blood pump 150, various other medical devices may be used in connection with the introduction sheath 100 and the hemostatic valve hub 120. For example, a modified blood pump may be used in connection with the introduction sheath 100. In other examples, devices other than the blood pump may be incorporated.

[0031] Embodiments of the hemostatic valve hub are described in more detail with reference to Figures 3-5. Specifically, Figures 3-5 illustrate a hemostatic 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. In addition, the hemostatic valve hub 220 has a hub base 221 comprising a first arm 226 and a second arm 228, the second arm 228 extending outward from the first arm 226 at an angle with respect to the longitudinal axis L. The angle with respect to the longitudinal axis L may be greater than 0. Furthermore, 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 inserting a liquid or instrument configured for irrigation.

[0032] The distal end 222 of the hemostatic valve hub 220 is configured to attach to the proximal end 106 (Figure 1) of the introduction sheath 100 (Figure 1), more specifically, to the proximal opening of the introduction sheath 100. As best illustrated in Figure 4, the distal end 222 of the hemostatic valve hub 220 includes a fixing mechanism for securing the introduction sheath 100 within the distal end 222 of the hemostatic valve hub 220. For example, in the exemplary embodiments shown in Figures 4-5, the hemostatic valve hub 220 includes a ferrule 231 located within its distal end 222, which is configured to secure the proximal flared opening of the introduction sheath 100 within the hemostatic valve hub 220. The proximal end 224 of the hemostatic valve hub 220 is configured to receive multiple medical instruments for insertion through the hemostatic valve hub 220 and the introduction sheath 100 (Figure 1). In other words, the configuration of the proximal end 224, more specifically the configuration of the first arm 226 and the second arm 228, allows at least two medical devices to be inserted simultaneously into one access port of a patient. In various embodiments, as described herein, the two medical devices may be two catheters or several other medical devices, for example, a blood pump 150 for insertion into blood vessel V, as disclosed herein with reference to Figure 2. The configuration of the hemostatic valve hub 220 allows for the suppression of blood loss or inflammation at the access site that might otherwise occur if the first device needs to be removed and the second device subsequently needs to be removed. The hemostatic valve hub 220 also reduces the need for additional access ports for inserting multiple medical devices into blood vessel V.

[0033] The dual-arm configuration of the hemostatic valve hub 220 is described further here. The first arm 226 comprises a first lumen 232 defined within the first arm 226 and typically extending parallel to its longitudinal axis L (Figure 3). The second arm 228 comprises a second lumen 234 that penetrates the second arm 228 and is typically angled with respect to the longitudinal axis L. The first lumen 232 extends from the proximal end 236 of the first arm 226 (corresponding to the proximal end 224 of the hemostatic valve hub 220) to the distal end 238 of the first arm 226 (corresponding to the distal end 222 of the hemostatic valve hub 220). Furthermore, the second lumen 234 extends between the distal end 240 and the proximal end 242 of the second arm 228.

[0034] Referring to Figures 4-5, the first arm 226 will now be described in more detail. As illustrated, the first lumen 232 includes a first diameter D1, which extends from the distal end 238 and contacts the 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 extending 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 positioned adjacent to the transition point of the first lumen 232, where the diameter increases from the first diameter D1 to the second diameter D2. As further described here, the seal 250 defines a seal lumen 251 that passes through the seal 250 to receive at least one medical instrument. Adjacent to the seal 250 is a lock nut 244 having an inner portion 246, which extends at least partially toward the first lumen 232 and is engageable with the seal 250. The lock nut 244 further comprises an outer portion 248 that is at least partially positioned around the outer surface of the first arm 226. More specifically, the inner surface 249 of the outer portion 248 of the lock nut 244 may be threaded, and at least a portion of the outer surface of the first arm 226 may also be threaded so that the lock nut 244 can screw onto the proximal end 236 of the first arm 226 to adjust and / or maintain the desired position of the lock nut 244. In other words, an operator may rotate or screw the lock nut 244 until it engages with the hemostatic valve hub 220, which also causes engagement with the seal 250. As further described with reference to Figure 9, the engagement of the seal 250 with the lock nut 244 causes the inner portion 246 to engage with the seal 250, thereby applying an axial compressive force to the seal 250. When the seal 250 is compressed axially, the initial diameter D3' (Figure 9) of the lumen 251 decreases, and as a result, the size of the lumen 251 is reduced and its lumen is defined by the compressed diameter D3. As the diameter of the lumen 251 decreases, the seal 250 comes into contact with and becomes tight against the medical device (e.g., a catheter) passing through the seal 250, thereby stabilizing the axial position of the medical device.In addition, when the lock nut 244 compresses the seal 250 axially, the seal 250 expands radially inward, providing a partial or complete fluid seal to the outer surface of the catheter, and expands radially outward, providing a partial or complete fluid seal to the inner surface of the hub base 221. Furthermore, as a result of axial compressive deformation and the application of axial forces to the seal 250, the seal 250 may form various other radial and / or axial seals within the hub 220.

[0035] Continuing with reference to Figures 3-5, the primary seal 252 is located adjacent to the lock nut 244 and positioned at a distance proximal to the proximal end 236 of the first arm 226. The primary seal 252 is configured to have a diameter smaller than the diameter of the lock nut 244, but larger than the first diameter D1 of the first lumen 232. As described with further reference to Figure 10A, the primary seal 252 is configured to provide a fluid-tight seal around the medical device passing through the hemostatic valve hub 220. The primary seal 252 engages with the lock nut 244 at least partially, as shown in Figure 4. Furthermore, the primary cap 260 is positioned adjacent to the primary seal 252 such that the primary seal 252 is sandwiched between the lock nut 244 and the primary cap 260, and engages with the lock nut 244. More specifically, the lock nut 244 may have a retaining element 257 configured to receive a projection 258 of the primary cap 260. This coupling ensures that the primary seal 252 is securely engaged and maintains hemostatic sealing after the medical device is inserted into the hemostatic valve hub 220 and introduction sheath 100 (Figure 1). In some embodiments, the primary cap 260 may be configured to couple to a tightening port (not shown) used to fix the axial movement of the medical device (e.g., a catheter) passing through the hub 220.

[0036] The second arm 228 will now be described with further 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 with the first arm 226 so that the first lumen 232 and the second lumen 234 merge to form a single lumen when passing through the distal end 222 of the hemostatic valve hub 220 toward the introduction sheath 100 (Figure 1). The proximal end 242 of the second arm 228 is configured to maintain the hemostatic seal when an additional medical device is inserted into the second lumen 234. Specifically, adjacent to the proximal end 242 of the second arm 228, the second arm 228 is provided with a secondary seal 254 configured to extend across the entire diameter of the second lumen 234. In addition, a secondary cap 262 is positioned adjacent to the secondary seal 254 and engages with the second arm 228. This secondary cap 262 is configured to maintain the position of the secondary seal 254 relative to the second arm 228 of the hemostatic valve hub 220.

[0037] Figure 6 shows an exploded view of an alternative embodiment of the hemostatic valve hub (exemplary hemostatic valve hub 320). The hemostatic valve hub 320 may be similar to or identical to the hemostatic valve hub 220 described with reference to Figures 3-5, except for the fixing mechanism for the introduction sheath 100 located at the distal end 321 of the hemostatic valve hub 320. Specifically, the hemostatic valve hub 320 comprises a first arm 326 engaged with a primary cap 360 positioned adjacent to a primary seal 352. Both the primary seal 352 and the primary cap 360 engage with a lock nut 344, which can engage with a seal 350 positioned in a first lumen 332 of the hemostatic valve hub 320, for axially securing a medical device, such as a catheter. Similar to the seal 250 described with reference to Figure 4, the seal 350 may have a lumen 351 with a diameter that decreases after an axial compressive force is applied to the seal 350. The lock nut 344 comprises an inner portion 346 and an outer portion 348, the inner portion 346 being configured to engage with the seal 350. The hemostatic valve hub 320 also comprises a second arm 328 defining a second lumen 334 having a secondary seal 354 that engages with a secondary cap 362. However, the hemostatic valve hub 320 differs from the hemostatic valve hub 220 in that its distal end 321 includes a narrow portion 370, which is threaded and can engage with a fixing mechanism for the sheath shaft (exemplarily a threaded cap 372). The threaded cap 372 works to engage with the proximal end 106 (Figure 1). In particular, the threaded cap 372 is used to connect the introduction sheath 100 to the hemostatic valve hub 320. However, various other suitable fastening mechanisms may be used to secure the introduction sheath 100 within the hemostatic valve hub 320. Some of the elements referred to above are described in more detail with reference to Figures 7-10.

[0038] Specifically, Figure 7 illustrates an enlarged view of the primary cap 260 described above with reference to the hemostatic valve hub 220. The primary cap 260 includes a first portion 264 and a second portion 266. The second portion 266 includes a plurality of internal engaging members 269 configured to engage with an outer cylinder 267 and an external device (e.g., a sealing port, a sealing device, a sealing device, and / or a sterile sleeve for placement on the hemostatic valve hub 220). In some embodiments, the primary cap 260 may be configured to connect to a sealing port (not shown) and may be used to secure a medical device passing through the hub 220, such as a catheter, 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, the above materials being presented as examples. Although described with reference to the primary cap 260, the above features may also apply to the primary cap 360 illustrated with reference to the hemostatic valve hub 320.

[0039] Figure 8 illustrates an enlarged view of the lock nut 244. As previously described, the lock nut 244 comprises an inner portion 246 and an outer portion 248 for screwing onto the first arm 226 of the hemostatic valve hub 220 (Figure 4) (Figure 4). The outer portion 248 may have a linear ridged configuration that allows the lock nut 244 to be firmly grasped by an operator, thereby tightly fixing and connecting the lock nut 244 to the first arm 226. The lock nut 244 may further include a threaded surface on the inner surface 249 of the outer portion 248 for screwing onto the first arm 226. The lock nut 244 may also include an engaging surface (not shown) on the 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 lock nut 244 to the primary cap 260. In addition, the inner portion 246 may be configured to engage with the seal 250 (Figure 5) when the lock nut 244 is inserted into the first lumen 232 (Figure 4) of the first arm 226. When the operator inserts the lock nut 244 into the first arm 226 and connects the lock nut 244 with the first arm 226, the inner portion 246 pushes the seal 250 in and pushes the seal 250 axially through the base 221 until the seal 250 contacts the portion of the base 221 that transitions from the second diameter D2 to the first diameter D1. Once the seal 250 is positioned relative to the transition portion between the second diameter D2 and the first diameter D1, the continued axial push of the seal 250 by the inner portion 246 results in axial compression of the seal 250. Subsequently, as described herein, the axial compression of the seal 250 results in a reduction in the size of the lumen 251 of the seal 250.

[0040] Figure 9 illustrates an enlarged 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 pushed toward the smaller lumen compartment 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 Figure 4. This ability of the seal 250's lumen 251 to shrink radially inward allows for axial fixation of a medical instrument (e.g., an intra-catheter in the first lumen 232) passing through the seal lumen. In other words, when an operator compresses the seal 250 by axial movement of the lock nut 244, the corresponding reduction in the size of the lumen 251 causes or further causes contact and / or sealing between the seal 250 and the catheter. In addition, the seal 250 may be pressurized outward against the inner surface of the first arm 226. Therefore, the seal 250 can further contribute to providing hemostatic sealing of the introduction sheath 100 and the hemostatic valve hub 220. The primary seal 252 (Figure 4) and the secondary seal 254 (Figure 4) further contribute to the ability to provide hemostatic sealing of the introduction sheath 100 and the hemostatic valve hub 220. The primary seal 252 and the secondary seal 254 are described in further detail herein with reference to Figures 10A and 10B.

[0041] Referring to Figures 10A and 10D, the primary seal 252 and secondary seal 254 are illustrated and described in more detail. For example, as illustrated, the primary seal 252 may have a diameter D5 that is larger than the diameter D6 of the secondary seal 254. For example, the diameter D5 of the primary seal 252 may be between approximately 9 mm and 11 mm, while the diameter D6 of the secondary seal 254 may be between approximately 5 mm and 8.5 mm. In addition, the primary seal 252 may have a thickness T2 (Figure 6) that is larger than the thickness T3 (Figure 6) of the secondary seal 254. For example, the thickness T2 of the primary seal 252 may be in the range of approximately 1.5 mm and 2.5 mm. The thickness T3 of the secondary seal 254 may be in the range of approximately 1.25 mm and 2.0 mm. The primary seal 252 and the secondary seal 254 may each be cylindrical seals, such that they have a circular cross-section. Furthermore, each of the primary seal 252 and the secondary seal 254 has a partially intersecting notch within the center of the primary seal 252 and the secondary seal 254. Referring specifically to the primary seal 252 and Figures 10A to 10C, the primary seal 252 may have a partially intersecting notch with a length L2 of approximately 4.5 mm. Referring to the secondary seal 254 shown in Figure 10D, the secondary seal 254 may have a partially intersecting notch with a length L3 of approximately 1.5 mm. However, lengths L2 and L3 may be modified. For example, length L2 may be in the range of approximately 3.0 mm to approximately 4.5 mm. Length L3 may be in the range of approximately 1.5 mm to approximately 3.0 mm. Figure 10B illustrates a cross-sectional view of the primary seal 252 of Figure 10A taken along line CC, and Figure 10C illustrates a cross-sectional view of the primary seal 252 taken along line BB. As illustrated, when cuts are made on opposing surfaces at a 90° orientation to have a specified cut depth d and overlap O, a partially intersecting cut is formed. For example, the partially intersecting cut of the primary seal 252 may have an overlap O1 with a value of approximately 0.4 mm and a cut depth d1 with a value of approximately 0.9 mm. Figure 10E illustrates a cross-sectional view of the secondary seal 254 of Figure 10D taken along line CC, and Figure 10C illustrates a cross-sectional view of the primary seal 252 taken along line BB.As illustrated, the partially intersecting cuts of the secondary seal 254 may have an overlap O2 with a value of approximately 0.25 mm and a cut depth d2 of approximately 0.8 mm. However, the overlaps O1 and O2 and the depths d1 and d2 may be modified. For example, the overlap O1 may be in the range of 0.3 mm to 0.5 mm, the depth d1 may be in the range of 0.7 mm to 1.1 mm, the overlap O2 may be in the range of 0.15 mm to 0.35 mm, and the depth d2 may be in the range of 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 polymer, thermosetting material, rubber, thermosetting elastomer (TSE), or silicone rubber.

[0042] Referring to Figure 11, a method 400 for assembling an introduction sheath and hub, for example, an introduction sheath 100 and a hub 220, is described. In block 402, the method 400 first includes placing the hub base 221 on the proximal end 106 of the introduction sheath 100. More specifically, the introduction sheath 100 is placed toward the hub base 221 until the proximal end 106 of the introduction sheath 100 is located toward the distal end 222 of the base 221. In block 404, the method 400 further includes attaching a fixing mechanism to the hub base 221 and the proximal end 106 of the introduction sheath 100. In various embodiments, the fixing mechanism may be a ferrule 231 located within the hub base 221 at the distal end 222 of the hemostatic valve hub 220. After inserting the introduction sheath 100 into the base 221 in this manner, the ferrule 231 may be inserted into the base 221 to support the introduction sheath 100 in the appropriate position. In another embodiment, the distal end 222 of the hemostatic valve hub 220 may include a narrow portion 370, and the fixing mechanism comprises a threaded cap 372 configured to engage with this narrow portion 370.

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

[0044] In various embodiments, the introduction sheath 100 and hub 220 may be used by a physician or operator to insert at least one medical device into a blood vessel. For example, the introduction sheath 100 and hub 220 may be used to insert at least one catheter into a blood vessel V. For example, a method of inserting at least one medical device during use may first include inserting the introduction sheath 100 into the blood vessel V. This method may then include inserting the medical device into the first arm 226 of the hemostatic valve hub 220. In various embodiments, the medical device is a blood pump 150 (Figure 2) and a catheter 170 (Figure 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 through the primary seal 252, thereby pushing the blood pump 150 distally through the hub 220 and into the introduction sheath 100, after which the partially intersecting notches surround and seal the catheter 170. During use, in order to further seal and maintain the axial position of the catheter within the hemostatic valve hub 220, this method may further include fixing the axial position of the medical device by adjusting the lock nut 244 of the first arm 226. For example, tightening the lock nut 244 may cause axial compression of the seal 250, which can therefore cause expansion of the seal 250, thereby compressing radially with respect to the medical device (i.e., the catheter) and radially and / or axially with respect to the inner surface of the first arm 226. In various embodiments, a second small medical device may be inserted into the second arm 228 of the hemostatic valve hub 220. For example, the second medical device may be a guide catheter for receiving a guide tool and / or any other applicable tool, which is preferable to use with the hemostatic valve hub 220. This allows the second medical device to be inserted into the second arm 228 at the same time as the first medical device is inserted through the first arm 226 of the hub 220.Specifically, once the second medical device is inserted through the second arm 228, it passes through the secondary seal 254 to maintain a liquid-tight seal between the second medical device and the hub 220. The second medical device may then extend through the hub 220 into the introduction sheath 100. In other embodiments, a tight-fitting port (not shown) may be coupled to the primary cap 260 to facilitate securing the medical device to the hub 220, for example, by preventing axial movement of the device 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 specific features, the scope of the present invention also includes embodiments having various combinations of multiple features and embodiments that do not include all of the features described above.

Claims

1. A hemostatic valve hub for sheaths, A hub base comprising 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 to a lock nut, wherein the lock nut engages with the proximal end of the first arm and is at least partially disposed within the first lumen and has a plurality of retaining elements, A primary seal positioned adjacent to the proximal end of the first arm, A secondary seal positioned adjacent to the proximal end of the second arm, A primary cap that engages with the lock nut and a secondary cap that engages with the proximal end of the second arm A hemostatic valve hub for a sheath, comprising a primary cap having a plurality of projections configured to engage with the plurality of return retainers of the lock nut.

2. The hemostatic valve hub according to claim 1, further comprising a fixing mechanism that engages with the hub base for fixing the hemostatic valve hub to the sheath.

3. The hemostatic valve hub according to claim 2, wherein the fixing mechanism is a ferrule disposed within the hub base.

4. The hemostatic valve hub according to claim 2, wherein the hub base includes a narrow portion, and the fixing mechanism includes a threaded cap that engages with the narrow portion and the sheath.

5. The hemostatic valve hub according to any one of claims 1 to 4, wherein the lock nut further comprises an inner portion configured to screw into the first arm and to engage with the seal.

6. The hemostatic valve hub according to claim 5, wherein the inner portion of the lock nut is configured to compress the seal in the axial direction to reduce the lumen size of the seal.

7. The hemostatic valve hub according to any one of claims 1 to 4, wherein the primary seal has a diameter, the secondary seal has a diameter, and the diameter of the primary seal is greater than the diameter of the secondary seal.

8. A system for delivering multiple medical devices into blood vessels, A sheath for insertion into a blood vessel, wherein the sheath has a proximal end and a distal end, A hemostatic valve hub for attachment to the proximal end of the sheath, A hub base comprising 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 to a lock nut, wherein the lock nut engages with the proximal end of the first arm and is at least partially disposed within the first lumen, A primary seal positioned adjacent to the proximal end of the first arm and a primary cap that engages with the lock nut, the primary cap having a plurality of projections configured to engage with a plurality of return stoppers on the lock nut, A secondary seal positioned adjacent to the proximal end of the second arm, Equipped with, The hemostatic valve hub, A delivery system equipped with the following features.

9. The delivery system according to claim 8, 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.

10. The delivery system according to claim 8 or 9, wherein the hub base is provided with a fixing mechanism for fixing it to the proximal end of the sheath.

11. The delivery system according to claim 10, wherein the fixing mechanism is a ferrule located within the hemostatic valve hub, away from the hub.

12. A method for assembling a sheath and a hub, A step of placing the hub base on the proximal end of the sheath, wherein the hub base has a first arm and a second arm, the first arm defining a first lumen, and the second arm defining a second lumen, A step of attaching the fixing mechanism to the hub base and the proximal end of the sheath, The steps include inserting the seal into the first lumen of the first arm, The steps include engaging the lock nut, primary seal, and primary cap with the first arm and engaging the secondary seal with the second arm, Includes, An assembly method wherein the primary cap comprises a plurality of projections configured to engage with a plurality of return stops on the lock nut.

13. The method according to claim 12, wherein the seal comprises a lumen configured to receive a medical instrument.

14. The method according to claim 12 or claim 13, wherein the fixing mechanism is a ferrule disposed within the hub base.

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