Dual-cavity hemostatic valve hub for introducer sheath

Abstract

A hemostasis valve hub for an introducer sheath includes a hub base, a hub cap having a first wall with a first opening and a second opening and configured to engage the hub base, the hub cap having the first and second openings extending through the first wall, a manifold located within the hub cap adjacent the hub base, a primary seal located adjacent the first opening of the hub cap, and a secondary seal located adjacent the second opening of the hub cap, the primary seal and secondary seal configured to provide a fluid seal between the first opening and the hub base and between the second opening and the hub base, respectively.

Description

Technical Field

[0001] The present disclosure relates to a hub for an introducer sheath. Specifically, the present disclosure relates to a dual cavity hemostatic valve hub for a large bore introducer sheath. This application claims the benefit of priority to Provisional Application No. 63 / 314,096, filed Feb. 25, 2022, the entire disclosure of which is incorporated herein by reference.

Background Art

[0002] In various procedures for delivering intravascular medical devices, an introducer sheath is inserted into a patient's blood vessel, such as the femoral artery, and the medical device is inserted into the introducer sheath for introduction into the blood vessel. In various cases, the medical device includes other medical devices such as a catheter or a blood pump. In various cases, it is necessary to simultaneously introduce multiple medical devices into the blood vessel or insert them through the blood vessel. A hemostatic valve hub can be incorporated at the proximal end of a large bore introducer sheath to reduce blood leakage when the device is inserted, positioned, and removed. There is a need for an optimized hemostatic valve hub that allows passage of multiple devices into the introducer sheath while minimizing blood leakage and facilitating passage of the device into the introducer sheath.

Summary of the Invention

[0003] In Embodiment 1, the hemostatic valve hub for an introducer sheath includes a hub base, a hub cap having a first wall with a first opening and a second opening and configured to engage with the hub base, the hub cap having the first wall and the second opening extending through the first wall, a manifold located within the hub cap adjacent to the hub base, a primary seal located adjacent to the first opening of the hub cap, and a secondary seal located adjacent to the second opening of the hub cap, wherein the primary seal and the secondary seal are configured to provide a fluid seal between the first opening and the hub base and between the second opening and the hub base, respectively.

[0004] In Example 2, the hemostatic valve hub of Example 1 includes the first opening having a first diameter, the second opening having a second diameter, and the first diameter being larger than the second diameter.

[0005] In Example 3, the hemostatic valve hub of Example 1 or 2 further comprises the primary seal having a first thickness, the secondary seal having a second thickness, and the first thickness being greater than the second thickness.

[0006] In Example 4, the hemostatic valve hub of any one of Examples 1 to 3 further comprises a hub base including a distal end and a proximal end, and the hub base having a ferrule located within the distal end of the hub base.

[0007] In Example 5, the hemostatic valve hub of Example 4 further includes the configuration in which the ferrule is configured to secure the introducer sheath to the hub base. In Example 6, the hemostatic valve hub of any one of Examples 1 to 3 further includes the hub base comprising a distal end and a proximal end, and a threaded cap for attaching to the distal end of the hub base to secure the introducer sheath to the hub base.

[0008] In Example 7, the hemostatic valve hub of any one of Examples 1 to 6 further comprises the primary seal and the secondary seal each being composed of a cylindrical seal having a partially intersecting slit in the center of each of the primary seal and the secondary seal.

[0009] In Example 8, the hemostatic valve hub of any one of Examples 1 to 7 further includes the hub base comprising at least one ring configured to receive a suture for fixing the position of the hemostatic valve hub.

[0010] In Example 9, a delivery system for multiple medical devices into a blood vessel comprises an introducer sheath having a proximal end and a distal end for insertion into the blood vessel, and a hemostatic valve hub for attachment to the proximal end of the introducer sheath, wherein the hemostatic valve hub includes a hub base, a hub cap having a first surface having a first opening and a second opening and configured to engage with the hub base, the hub cap having the first and second openings extending through the first surface, a manifold located within the hub cap adjacent to the hub base, a primary seal located adjacent to the first opening of the hub cap, and a secondary seal located adjacent to the second opening of the hub cap. The primary seal and the secondary seal are configured to provide a fluid seal between the first opening and the hub base and between the second opening and the hub base, respectively.

[0011] In Example 10, the delivery system of Example 9 further includes the first opening having a first diameter, the second opening having a second diameter, and the first diameter being larger than the second diameter.

[0012] In Example 11, the delivery system of Example 9 or Example 10 further includes the hub base having at least one ring for receiving sutures. In Example 12, any one of the delivery systems from Examples 9 to 11 further comprises the hub base including a distal end and a proximal end, and the hub base having a ferrule located within the distal end of the hub base.

[0013] In Embodiment 13, a method for assembling an introducer sheath and a hub includes: positioning a hub base on the proximal end of the introducer sheath; attaching a fixing mechanism to the hub base and the proximal end of the introducer sheath; and engaging a hub cap with the hub base, wherein the hub cap has a seal manifold located inside the hub cap and a first surface having a first opening and a second opening, with a primary seal located between the seal manifold and the first opening, and a secondary seal located between the seal manifold and the second opening.

[0014] In Example 14, the method of Example 13 further includes engaging the hub cap with the hub base by aligning the first opening of the seal manifold with the primary seal and aligning the second opening of the seal manifold with the secondary seal.

[0015] In Example 15, the method of Example 14 further includes the fact that the first opening of the seal manifold and the first opening of the hub cap define a first lumen, and the second opening of the seal manifold and the second opening of the hub cap define a second lumen.

[0016] In Embodiment 16, the hemostatic valve hub for an introducer sheath includes a hub base, a hub cap having a first wall with a first opening and a second opening and configured to engage with the hub base, the hub cap having the first and second openings extending through the first wall, a manifold located within the hub cap adjacent to the hub base, a primary seal located adjacent to the first opening of the hub cap, and a secondary seal located adjacent to the second opening of the hub cap, wherein the primary seal and the secondary seal are configured to provide a fluid seal between the first opening and the hub base and between the second opening and the hub base, respectively.

[0017] In Example 17, the hemostatic valve hub of Example 16 includes the first opening having a first diameter, the second opening having a second diameter, and the first diameter being larger than the second diameter.

[0018] In Example 18, the hemostatic valve hub of Example 16 further includes the fact that the primary seal has a first thickness, the secondary seal has a second thickness, and the first thickness is greater than the second thickness.

[0019] In Example 19, the hemostatic valve hub of Example 16 further comprises a hub base including a distal end and a proximal end, and the hub base having a ferrule located within the distal end of the hub base.

[0020] In Example 20, the hemostatic valve hub of Example 19 further includes the configuration in which the ferrule secures the introducer sheath to the hub base. In Example 21, the hemostatic valve hub of Example 16 further includes the hub base comprising a distal end and a proximal end, and a threaded cap for attaching to the distal end of the hub base to secure the introducer sheath to the hub base.

[0021] In Example 22, the hemostatic valve hub of Example 16 further comprises the primary seal and the secondary seal, each composed of a cylindrical seal having a partially intersecting slit within the center of the primary seal and the secondary seal, respectively.

[0022] In Example 23, the hemostatic valve hub of Example 16 further includes the hub base comprising at least one ring configured to receive a suture for fixing the position of the hemostatic valve hub.

[0023] In Example 24, the hemostatic valve hub of Example 16 further includes an access port that extends radially outward from the hub base. In Example 25, the intravascular delivery system for multiple medical devices includes an introducer sheath having a proximal end and a distal end for insertion into the blood vessel, and a hemostatic valve hub for attachment to the proximal end of the introducer sheath, wherein the hemostatic valve hub includes a hub base, a hub cap having a first surface having a first opening and a second opening and configured to engage with the hub base, the hub cap having the first and second openings extending through the first surface, a manifold located within the hub cap adjacent to the hub base, a primary seal located adjacent to the first opening of the hub cap, and a secondary seal located adjacent to the second opening of the hub cap, wherein the primary and secondary seals are configured to provide a fluid seal between the first opening and the hub base and between the second opening and the hub base, respectively.

[0024] In Example 26, the delivery system of Example 25 further includes the first opening having a first diameter, the second opening having a second diameter, and the first diameter being larger than the second diameter.

[0025] In Example 27, the delivery system of Example 25 further includes that the hub base has at least one ring for receiving the suture thread. In Example 28, the delivery system of Example 25 further includes that the hub base includes a distal end and a proximal end, and the hub base has a ferrule located within the distal end of the hub base.

[0026] In Example 29, the delivery system of Example 25 further includes that the hub base includes a distal end and a proximal end, and a threaded cap is configured to be attached to the distal end of the hub base for fixing the introducer sheath to the hub base.

[0027] In Example 30, a method of assembling an introducer sheath and a hub includes placing a hub base on the proximal end of the introducer sheath, attaching a fixing mechanism to the hub base and the proximal end of the introducer sheath, and engaging a hub cap with the hub base. The hub cap has a seal manifold located within the hub cap and a first surface having a first opening and a second opening. A primary seal is located between the seal manifold and the first opening, and a second seal is located between the seal manifold and the second opening.

[0028] In Example 31, the method of Example 30 further includes that the fixing mechanism is a ferrule and the ferrule is located within the hub base. In Example 32, the method of Example 30 further includes that the fixing mechanism is a threaded cap engaged with the distal end of the hub base.

[0029] In Example 33, the method of Example 30 further includes that engaging the hub cap with the hub base includes aligning the first opening of the seal manifold with the primary seal and aligning the second opening of the seal manifold with the secondary seal.

[0030] In Example 34, the method of Example 33 further includes the fact that the first opening of the seal manifold and the first opening of the hub cap define a first lumen, and the second opening of the seal manifold and the second opening of the hub cap define a second lumen.

[0031] In Example 35, the method of Example 30 further comprises the primary seal being a cylindrical seal having a partially intersecting slit in the center of the primary seal. While numerous embodiments are disclosed, further embodiments of the present invention may become apparent to those skilled in the art from the following detailed description, which illustrates exemplary embodiments of the invention. Therefore, the drawings and detailed description should be considered illustrative and not limiting. [Brief explanation of the drawing]

[0032] [Figure 1] Figure 1 shows a cross-sectional view of the introducer sheath after insertion into a blood vessel according to an embodiment of the present disclosure. [Figure 2] Figure 2 shows a cross-sectional view of the introducer sheath after the medical device has been inserted into the introducer sheath following intravascular insertion, 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 introducer sheath according to an embodiment of the present disclosure. [Figure 4] Figure 4 shows a cross-sectional view of the hemostatic valve hub of Figure 3 according to an embodiment of the present disclosure. [Figure 5] Figure 5 is an enlarged view of a portion of the hemostatic valve hub according to an embodiment of the present disclosure. [Figure 6] Figure 6 is an exploded view of a hemostatic valve hub according to an embodiment of the present disclosure. [Figure 7A] Figure 7A is a top view of a seal for use with a hemostatic valve hub according to an embodiment of the present disclosure. [Figure 7B]Figure 7B is a cross-sectional view of the seal shown in Figure 7A according to an embodiment of the present disclosure. [Figure 7C] Figure 7C is a further cross-sectional view of the seal shown in Figure 7A according to this embodiment. [Figure 7D] Figure 7D is a top view of a seal for use with a hemostatic valve hub according to an embodiment of the present disclosure. [Figure 7E] Figure 7E is a cross-sectional view of the seal shown in Figure 7D according to an embodiment of the present disclosure. [Figure 7F] Figure 7F is a further cross-sectional view of the seal shown in Figure 7D according to this embodiment. [Figure 8] Figure 8 is an exploded view of a hemostatic valve hub according to an embodiment of the present disclosure. [Figure 9] Figure 9 is a flowchart showing a method for assembling the introducer sheath and hub according to an embodiment of the present disclosure. [Modes for carrying out the invention]

[0033] Figure 1 shows a side cross-sectional view of a blood vessel V having an introducer sheath 100 at least partially inserted into the blood vessel V. In some embodiments, the introducer sheath 100 is used to assist various relatively large medical devices, such as blood pumps, as further described herein, in entering the blood vessel V through the introducer sheath 100. The introducer sheath 100 includes a proximal end 106 and a distal end 108 opposite to the proximal end 106. The introducer 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 body portion 110 of the introducer sheath 100 extends between the proximal end 106 and the distal end 108, and the body portion 110 defines the lumen 112 of the introducer sheath 100. The introducer sheath 100 may be formed from various polymer or metallic materials. In further embodiments, the introducer sheath 100 may include an additional surface coating. The surface coating may include, but is not limited to, silicone, PET, or any other applicable polymer. The hub 120 is generally included in the proximal opening (not shown). The hub 120, also referred to herein as the hemostatic valve hub, is configured for hemostasis, i.e., to prevent blood from leaking out of the introducer sheath during use. In various cases, it may be desirable for multiple medical devices to pass through the introducer sheath 100 at once. Therefore, in some embodiments, as further disclosed with reference to Figures 3 to 8, the hemostatic valve hub 120 may include at least two openings and a manifold to allow at least two devices to be inserted into the introducer sheath 100 at once without requiring the insertion of a second device after the removal of a first device. Hub 120 provides a manifold structure for enabling the insertion of two medical devices while maintaining hemostasis and reducing blood leakage from the introducer sheath 100 and / or Hub 120 during insertion, use, or removal of various medical devices.In some embodiments, two catheters are inserted into the hub 120 at a time, and various other medical devices may be inserted into at least one of those catheters for delivery into the blood vessel V. As shown in Figure 1, the hub 120 may be used to receive a catheter 170. The catheter 170 extends through the hub 120 and the introducer sheath 100 and may be coupled to the proximal end of a blood pump which can be inserted into the introducer sheath 100, as further described herein.

[0034] Figure 2 shows a cross-sectional view of the introducer sheath 100 of Figure 1 after a medical device, an example of a blood pump 150, has been inserted into the introducer sheath 100. The blood pump 150 generally includes an impeller assembly housing 140 and a motor housing 142. In some embodiments, the impeller assembly housing 140 and the motor housing 142 may be constructed integrally or monolithically. The impeller assembly housing 140 houses an impeller assembly 144 inside. The impeller assembly 144 includes an impeller shaft 146 and an impeller 148 for transporting blood through the blood pump 150 by rotating relative to the impeller assembly housing 140. Specifically, the impeller 148 flows blood from a blood inlet 151 formed on the impeller assembly housing 140, through the impeller assembly housing 140, to 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. 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 at the end of the impeller assembly housing 140. The outlet 152 may be formed on the side of the impeller assembly housing 140. In other embodiments, the inlet 151 and / or the outlet 152 may be formed on other parts of the impeller assembly housing 140. In some embodiments, the impeller assembly housing 140 may be coupled to a distally extending cannula (not shown). The cannula may receive blood and deliver it to the inlet 151.

[0035] Continuing to refer to Figure 2, the motor housing 142 houses the motor 154. The motor 154 is configured to rotatably drive the impeller 148 relative to the impeller assembly housing 140. In the illustrated embodiment, the motor 154 rotates a drive shaft 156 coupled to a drive magnet 158. This rotation of the drive magnet 158 ​​causes the driven magnet 160, which is connected to the impeller assembly housing 140, to rotate. 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. Also, as shown 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 by tapered connectors and / or various other connecting means. The catheter 170 may have a flexible structure to facilitate delivery by the blood pump 150. Although the introducer sheath 100 is shown in conjunction with the use of the blood pump 150, various other medical devices may be used in combination with the introducer sheath 100 and the hemostatic valve hub 120. For example, other blood pumps may be used in combination with the introducer sheath 100. In other embodiments, devices other than blood pumps may be incorporated.

[0036] Figure 3 shows one embodiment of the hemostatic valve hub 220. The hemostatic valve hub 220 includes a proximal end 222 and a distal end 224 located opposite the proximal end 222. The hemostatic valve hub 220 includes a hub cap 226 configured to be coupled to a hub base 228. As shown, the hub cap 226 has a first projection 236 extending from a surface 238 of the hub cap 226. The first projection 236 is configured to be coupled to a clamping port (not shown) and can be used to fix a medical device such as a catheter 170 (Figure 2) passing through the hub 220, for example, to prevent axial movement of the catheter 170. The hub base 228 also includes an access port 230 extending from the hub base 228. The access port 230 can be used to receive further fluid and / or medical devices. The hub base 228 includes at least one flange 232 that can be used to grip the hemostatic valve hub 220. In some embodiments, the hemostatic valve hub 220 comprises two or more flanges 232. The hemostatic valve hub 220 may further include one or more suture rings 234, as will be described in more detail with respect to Figure 5.

[0037] Figure 4 shows a cross-sectional view of the hemostatic valve hub 220 shown in Figure 3. As shown, the hub cap 226 engages with the hub base 228. Specifically, the hub cap 226 comprises a plurality of engagement mechanisms 227 (a plurality of retaining parts, exemplify) for engaging with a plurality of engagement mechanisms 229 (a plurality of projections, exemplify) of the hub base 228. The surface 238 includes a first cavity, i.e., a first opening 248, and a second cavity, i.e., a second opening 250. The first opening 248 extends into the first projection 236 and defines the first lumen 252 of the hemostatic valve hub 220. The second opening 250 defines the second lumen 254 of the hemostatic valve hub 220. Each of the first lumen 252 and the second lumen 254 is configured to receive a medical device for insertion into a blood vessel V (Figure 1). As will be described in more detail below, the first opening 248 may be configured to receive a relatively larger medical device, such as a blood pump 150 with a catheter 170 (Figure 2), while the second opening 250 is configured to receive a relatively smaller medical device, such as a catheter.

[0038] The first opening 248 includes a primary seal 256 positioned to extend radially across the first lumen 252, and the second lumen 254 includes a secondary seal 258 positioned to extend radially across the second lumen 254. A seal manifold 260 is adjacent to the primary seal 256 and the secondary seal 258. The seal manifold 260 includes a first opening 262 aligned with the first opening 248 of the hub cap 226 and a second opening 264 aligned with the second opening 250 of the hub cap 226, allowing the first lumen 252 and the second lumen 254 to extend through the hub cap 226 and the hub base 228. Each of the first lumen 252 and the second lumen 254 also extends into the main cavity 255 of the valve hub 220. Therefore, once one or more medical devices are inserted through the first lumen 252 and / or the second lumen 254, the medical devices may extend through the main cavity 255 of the hub 220. Specifically, the first opening 262 and the first lumen 252 may be larger than the second opening 264 and the second lumen 254, and are configured to accommodate relatively large medical devices such as a blood pump 150 (Figure 1). The second opening 264 and the second lumen 254 may be used to accommodate other relatively small medical devices such as a guide catheter.

[0039] Continuing to refer to Figure 4, toward the distal end 224 of the hub base 228, the hub base 228 includes a constriction 240 that includes or engages with a fixing element for securing the hemostatic valve hub 220 to the introducer sheath 100. The introducer sheath 100 (Figure 1) is located around or engages with the fixing element. Specifically, the proximal end 106 (Figure 1) of the introducer sheath 100, which has a flared portion, is fixed by the fixing element to maintain the position of the introducer sheath 100. In the exemplary embodiment of Figure 4, the fixing element is a ferrule 244 configured to fix the hemostatic valve hub 220 to the flared portion of the proximal end 106 of the introducer sheath 100. However, in other embodiments, various other fixing mechanisms may be used, as will be described with reference to Figure 8.

[0040] Figure 5 shows an enlarged view of the hub base 228, specifically showing the stenosis 240. As shown, the stenosis 240 includes at least one suture ring 234 extending from the stenosis 240. The at least one suture ring 234 may be used to receive sutures and secure the hemostatic valve hub 220 to the patient. As shown in Figure 5, the at least one suture ring 234 includes a first suture ring 234a and a second suture ring 234b, but any number of suture rings may be incorporated. Also, although the suture ring 234 is shown as a substantially semicircular or semi-elliptical ring, various shapes may be employed.

[0041] Figure 6 shows an exploded view of the hemostatic valve hub 220 shown in Figures 3 to 6. As shown, during assembly, after the introducer sheath 100 (Figure 1) is inserted into the hub base 228, the ferrule 244 may be positioned within the constricted portion 240 of the hub base 228. The seal manifold 260 may then be positioned adjacent to the hub base 228 such that the first opening 262 of the seal manifold 260 is aligned with the primary seal 256 and the second opening 264 of the seal manifold 260 is aligned with the secondary seal 258. The first opening 262 of the seal manifold 260 has a larger diameter than the second opening 264 of the seal manifold 260. As further shown with reference to Figures 7A to 7B, the primary seal 256 has a first diameter D1 (Figure 7A), which is larger than the second diameter D2 (Figure 7B) of the secondary seal 258. Furthermore, the first opening 248 of the hub cap 226 may have a larger diameter than the diameter of the second opening 250. According to the above configuration, the first opening 248 of the hub cap 226 and the first opening 262 of the seal manifold 260 are configured to be completely radially covered by the primary seal 256 so that a fluid seal exists between the seal manifold 260 and the hub base 228. Similarly, the second opening 264 of the seal manifold 260 and the second opening 250 of the hub cap 226 are configured to be completely radially covered by the secondary seal 258 so that a fluid sealing seal exists between the seal manifold 260 and the hub base 228.

[0042] Furthermore, the above configuration and arrangement allow the first and second lumens 252, 254 to extend continuously through the hemostatic valve hub 220. Thus, a medical device, for example, a blood pump 150 (Figure 2) having a catheter 170 (Figure 2) attached to the blood pump 150, can be inserted into the first lumen 252, extend through the main cavity 255 of the hub base 228, enter the proximal opening (not shown) of the introducer sheath 100, and pass beyond the distal end 224 of the hub base 228 within the lumen 112 of the introducer sheath 100. Similarly, an additional medical device, for example, an additional catheter, can be inserted into the second lumen 254, extend through the main cavity 255 of the hub base 228, enter the proximal opening of the introducer sheath 100, and pass beyond the distal end 224 of the hub base 228 within the introducer sheath 100. When the medical device is inserted into the hemostatic valve hub 220, it extends through the partial cross slits of the primary and secondary seals 256, 258, thereby contributing to the liquid-tight and hemostatic seal of the introducer sheath 100 (Figure 1) and the hemostatic valve hub 220.

[0043] Referring to Figures 6 to 7F, the primary seal 256 and secondary seal 258 are shown in enlarged view and will be described in more detail. Specifically, Figure 7A shows a top view of the primary seal 256, and Figure 7D shows a top view of the secondary seal 258. As disclosed above, the primary seal 256 may have a diameter D1 that is larger than the diameter D2 of the secondary seal 258. For example, the diameter D1 of the primary seal 256 may be approximately 11 mm, while the diameter D2 of the secondary seal 258 may be approximately 8 mm. Also, the primary seal 256 may have a thickness T1 (Figure 6) that is larger than the thickness T2 (Figure 6) of the secondary seal 258. In various embodiments, the thickness T1 may be approximately 2.0 mm, while the thickness T2 may be approximately 1.5 mm. However, the above dimensions of the primary seal 256 and secondary seal 258 may be modified. For example, the diameter D1 may be in the range of 9 mm to 11 mm, and the diameter D2 may be in the range of 5 mm to 8.5 mm. Furthermore, the thickness T1 may be in the range of 1.5 mm to 2.5 mm, and the thickness T2 may be in the range of 1.25 mm to 2.00 mm.

[0044] As shown in Figures 7A and 7D, respectively, the primary seal 256 and the secondary seal 258 may each be cylindrical seals having a circular cross-section. However, the configuration of seals 256 and 258 may be modified. For example, seals 256 and 258 may have an elliptical cross-section. Furthermore, each of the primary seal 256 and the secondary seal 258 has a partial cross slit in the center of the seal 256 or 258. The partial cross slit of the primary seal 256 may have a length L1 with a value of approximately 4.5 mm. The partial cross slit of the secondary seal 258 may have a length L2 with a value of approximately 2.5 mm. However, the lengths L1 and L2 may be modified. For example, length L1 may be in the range of 3.0 mm to 4.5 mm, and length L2 may be in the range of 1.5 mm to 3.0 mm. Figure 7B shows a cross-sectional view of the primary seal 256 of Figure 7A along line CC, and Figure 7C shows a cross-sectional view of the primary seal 256 along line BB. As shown in Figures 7B and 7C, the partial cross slit is formed by slitting the primary seal 256 at a 90-degree orientation on opposing surfaces with a specified slit cutting depth d and a specified overlap O. As shown, the partial cross slit of the primary seal 256 may have an overlap O1 of approximately 0.4 mm and a slit depth d1 of approximately 0.9 mm. Figure 7E shows a cross-sectional view of the secondary seal 258 of Figure 7D along line CC, and Figure 7F shows a cross-sectional view of the secondary seal 258 of Figure 7D along line BB. The partial cross slit of the secondary seal 258 may be formed by slitting the secondary seal 258 at a 90-degree orientation on opposing surfaces with a slit cutting depth d2 and a specified overlap O2. For example, the partial cross slit of the secondary seal 258 may have an overlap O2 of approximately 0.2 mm. The value of the slit depth d2 may be approximately 0.80 mm. However, the values ​​of the overlaps O1, O2 and depths d1, d2 may be changed. 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.The partial cross slits are configured so that when a catheter or other medical device is inserted through the seals 256, 258, the partial slits maintain a fluid seal around the outer circumference of the device. The primary seal 256 and the secondary seal 258 may each be formed from silicone, or from a variety of other suitable materials including polymers, thermosetting resins, rubber, thermosetting elastomers (TSEs), or silicone rubber.

[0045] Due to the aforementioned features of the hub cap 226, seal manifold 260, and primary seal 256 and secondary seal 258, the first lumen 252 has a larger diameter than the second lumen 254. Therefore, the first lumen 252 can be configured to receive a larger medical device. For example, the first lumen 252 can be configured to receive a blood pump 150 or other suitable medical device, while the second lumen 254 can be configured to receive a smaller medical device for inserting a navigation tool, such as a guide catheter or any other suitable device.

[0046] Figure 8 shows an exploded view of a further embodiment of the 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 to 7, except for the fixing mechanism. For example, the hemostatic valve hub 320 comprises a hub cap 326, a primary seal 356, a secondary seal 358, and a seal manifold 360, similar to those described with reference to Figures 3 to 7. However, the hemostatic valve hub 320 includes a hub base 328 as an example of a modified hub base. The hub base 328 includes a constricted portion 340 having a distal end portion 372 configured to engage with the fixing mechanism. The distal end portion 372 may be threaded for engagement with the fixing mechanism. Specifically, the hemostatic valve hub 320 shows a threaded cap 370 that engages with the distal end portion 372 of the hemostatic valve hub 320. The threaded cap 370 engages with the proximal end 106 (Figure 1) of the introducer sheath 100 to secure the introducer sheath 100 within the hemostatic valve hub 320. The threaded cap 370 is used, in particular, to prevent axial movement of the introducer sheath 100 relative to the hemostatic valve hub 320. In these cases, the proximal end 106 (Figure 1) of the introducer sheath may have a flared configuration to better engage with the stenosis 340 and the fixing mechanism.

[0047] Figure 9 is a flowchart of method 400 for assembling the introducer sheath and hub, showing, for example, the flowchart for assembling the introducer sheath 100 and hemostatic valve hub 220 of Figure 1, as described with reference to Figures 3 to 7. However, method 400 may also be used with a hemostatic valve hub 320, as described with reference to Figure 8.

[0048] In block 402, method 400 includes positioning the hub base 228 on the proximal end 106 of the introducer sheath 100 by inserting the introducer sheath 100 into the main cavity 255 of the hub base 228. Specifically, the introducer sheath 100 is positioned within the hub base 228 until the proximal end 106 (Figure 1) of the introducer sheath 100 is located within the stenosis 240 of the hub base 228. As described above, the proximal opening (not shown) of the introducer sheath 100 may be on the flared portion of the proximal end 106 of the introducer sheath 100. Thus, the proximal end 106 of the introducer sheath 100 can extend into the vessel V (Figure 1) through the distal end of the hub base 228 during use. In block 404, method 400 further includes engaging a fixing mechanism between the hub base 228 and the proximal end 106 of the introducer sheath 100. In some embodiments, the fixing mechanism is a ferrule 244. In these embodiments, after the introducer sheath 100 is positioned within the constriction 240 of the hub 220, the ferrule 244 is inserted into the constriction 240 of the hub base 228 to fix the introducer sheath 100 against the inner surface of the hub base 228. However, as described above, method 400 may be used with a hemostatic valve hub 320. Thus, the fixing mechanism may be a threaded cap 370, as described with reference to Figure 8.

[0049] In block 406, method 400 further includes engaging the hub cap 226 with the hub base 228. This step of engaging the hub cap 226 with the hub base 228 may further include aligning the first opening 262 of the seal manifold 260 with the primary seal 256 and the second opening 264 of the seal manifold 260 with the secondary seal 258. This may further include aligning the first opening 248 of the hub cap 226 with the primary seal 256 and the second opening 250 of the hub cap 226 with the secondary seal 258. This arrangement of the components described above allows the first and second lumens to extend through the hemostatic valve hub 220 to accommodate various medical devices.

[0050] After the introducer sheath 100 and hub 220 are assembled, the introducer sheath 100 and hub 220 can be used for the delivery of at least one medical device into a blood vessel. Specifically, the introducer sheath 100 and hub 220 can be used to insert at least one catheter into a blood vessel V. Specifically, a physician or operator can insert the introducer sheath 100 into a blood vessel V. The physician or operator can then insert a medical device, such as a catheter, into the hub base 228 through the first opening 248 of the hub cap 226, i.e., through the first lumen 252 of the hemostatic valve hub 220. This allows the catheter to extend into the primary seal 256 through the first lumen 252. The catheter can then fully penetrate the hemostatic valve hub 220, exit from the distal end 224 of the hemostatic valve hub 220, and enter the introducer sheath 100. The configuration of the hub 220, specifically having both a first opening 248 with a primary seal 256 and a second opening 250 with a secondary seal 258, allows the second medical device to be inserted together with the first medical device into the hub 220 and introducer sheath 100 and into the blood vessel 100. For example, the second medical device may be inserted through the second opening 250 of the hub cap 226 and extend through the second lumen 254 of the hemostatic valve hub 220. This ensures a hemostatic seal between the device and the hub 220 by allowing the second medical device to extend through the secondary seal 258. The second medical device may then extend through the hemostatic valve hub 220, exit from the distal end 224 of the hemostatic valve hub 220, and be inserted into the introducer sheath 100.

[0051] 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 certain features, the scope of the present invention also includes embodiments having different combinations of features, and embodiments that do not include all of the features described above.

Claims

1. A hemostatic valve hub for an introducer sheath, Hub base and A hub cap having a first surface and a first opening and a second opening extending through the first surface, configured to engage with the hub base, wherein the first surface has a projection extending proximal to the first surface, and the first opening extends further through the projection, A seal manifold located adjacent to the hub base and within the hub cap, A primary seal located adjacent to the first opening of the hub cap, A secondary seal located adjacent to the second opening of the hub cap, Equipped with, The primary seal and the secondary seal are configured to provide a fluid seal between the first opening and the hub base and between the second opening and the hub base, respectively. The seal manifold is arranged adjacent to the primary seal and the secondary seal, The primary seal is located between the seal manifold and the hub cap. A hemostatic valve hub in which the secondary seal is located between the seal manifold and the hub cap.

2. The hemostatic valve hub according to claim 1, wherein the first opening has a first diameter, the second opening has a second diameter, and the first diameter is greater than the second diameter.

3. The hemostatic valve hub according to claim 1 or 2, wherein the primary seal has a first thickness, the secondary seal has a second thickness, and the first thickness is greater than the second thickness.

4. The hemostatic valve hub according to claim 1 or 2, wherein the hub base includes a distal end and a proximal end, and the hub base includes a ferrule located within the distal end of the hub base.

5. The hemostatic valve hub according to claim 4, wherein the ferrule is configured to fix the introducer sheath to the hub base.

6. The hemostatic valve hub according to claim 1 or 2, wherein the hub base includes a distal end and a proximal end, and a threaded cap is provided for attachment to the distal end of the hub base to secure the introducer sheath to the hub base.

7. The hemostatic valve hub according to claim 1 or 2, wherein the primary seal and the secondary seal are each composed of a cylindrical seal having a partially intersecting slit in the center of the primary seal and the secondary seal, respectively.

8. The hemostatic valve hub according to claim 1 or 2, wherein the hub base includes at least one ring configured to receive sutures for fixing the position of the hemostatic valve hub.

9. A delivery system for multiple medical devices into blood vessels, An introducer sheath having a proximal end and a distal end, for insertion into the blood vessel, A hemostatic valve hub for attachment to the proximal end of the introducer sheath, comprising the hemostatic valve hub according to claim 1 or 2, A delivery system equipped with the following features.

10. A method for assembling an introducer sheath and a hub, The hub base is positioned on the proximal end of the introducer sheath. A fixing mechanism is attached to the hub base and the proximal end of the introducer sheath, and Engaging the hub cap with the hub base, The hub cap comprises a first surface, a first opening, and a second opening, the first surface having a projection extending proximal to the first surface, the first opening extending further through the projection, and a seal manifold located inside the hub cap adjacent to the hub base. A method wherein the seal manifold is arranged adjacent to a primary seal and a secondary seal, the primary seal is located between the seal manifold and the first opening, and the secondary seal is located between the seal manifold and the second opening.

11. The method according to claim 10, wherein engaging the hub cap with the hub base includes aligning the first opening of the seal manifold with the primary seal and aligning the second opening of the seal manifold with the secondary seal.

12. The method according to claim 11, wherein the first opening of the seal manifold and the first opening of the hub cap define a first lumen, and the second opening of the seal manifold and the second opening of the hub cap define a second lumen.

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