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 priority to Provisional Application No. 63 / 314,096, filed February 25, 2022, which is incorporated herein by reference in its entirety. [Background technology]

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

[0003] In Example 1, 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 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, the primary seal and the 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.

[0004] In Example 2, the hemostasis 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 hemostasis valve hub of Examples 1 or 2 further includes, the primary seal having a first thickness and the secondary seal having a second thickness, the first thickness being greater than the second thickness.

[0006] In Example 4, the hemostasis valve hub of any one of Examples 1 to 3 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.

[0007] In Example 5, the hemostasis valve hub of Example 4 further includes the ferrule 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 that the hub base includes a distal end and a proximal end, and a threaded cap is configured for attachment 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 includes that the primary seal and the secondary seal are each comprised of a cylindrical seal having a partial cross slit within 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 that the hub base includes at least one ring configured to receive a suture to fix the position of the hemostatic valve hub.

[0010] In Example 9, a delivery system for multiple medical devices into a blood vessel includes an introducer sheath having a proximal end and a distal end for insertion into the blood vessel, and a hemostasis valve hub for attachment to the proximal end of the introducer sheath, the hemostasis valve hub including a hub base, a hub cap having a first surface with a first opening and a second opening, the hub cap configured to engage with the hub base, the first opening and the second opening extending through the first surface, 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 the 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.

[0011] In Example 10, the delivery system of Example 9 further includes the first opening having a first diameter and the second opening having a second diameter, the first diameter being greater 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 a suture. In Example 12, the delivery system of any one of Examples 9 to 11 further includes, the hub base including a distal end and a proximal end, the hub base having a ferrule located within the distal end of the hub base.

[0013] In Example 13, a method of assembling an introducer sheath and a hub includes positioning a hub base on a 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 to the hub base, the hub cap having a seal manifold positioned within the hub cap and a first surface having a first opening and a second opening, a primary seal positioned between the seal manifold and the first opening, and a secondary seal positioned between the seal manifold and the second opening.

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

[0015] In Example 15, the method of Example 14 further includes the first opening of the seal manifold and the first opening of the hubcap defining a first lumen, and the second opening of the seal manifold and the second opening of the hubcap defining a second lumen.

[0016] In Example 16, 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 with the hub base, the hub cap having the first opening 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, the primary seal and the 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.

[0017] In Example 17, the hemostasis 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 greater than the second diameter.

[0018] In Example 18, the hemostasis valve hub of Example 16 further includes, the primary seal having a first thickness and the secondary seal having a second thickness, the first thickness being greater than the second thickness.

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

[0020] In Example 20, the hemostasis valve hub of Example 19 further includes the ferrule configured to secure the introducer sheath to the hub base. In Example 21, the hemostasis valve hub of Example 16 further includes that the hub base includes a distal end and a proximal end, and a threaded cap is configured for attachment 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 includes, wherein the primary seal and the secondary seal each comprise a cylindrical seal having a partial cross slit within a center of each of the primary seal and the secondary seal.

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

[0023] In Example 24, the hemostasis valve hub of Example 16 further includes the hub base including an access port extending radially outward from the hub base. In Example 25, a delivery system for multiple medical devices into a blood vessel includes an introducer sheath having a proximal end and a distal end for insertion into the blood vessel, and a hemostasis valve hub for attachment to the proximal end of the introducer sheath, the hemostasis valve hub including a hub base, a hub cap having a first surface having a first opening and a second opening, the hub cap configured to engage with the hub base, the first opening and the second opening 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 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.

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

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

[0026] In Example 29, the delivery system of Example 25 further includes the hub base including a distal end and a proximal end, and a threaded cap configured for attachment to the distal end of the hub base to secure 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 a 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 to the hub base, the hub cap having a seal manifold positioned within the hub cap and a first surface having a first opening and a second opening, a primary seal positioned between the seal manifold and the first opening, and a second seal positioned between the seal manifold and the second opening.

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

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

[0030] In Example 34, the method of Example 33 further includes the first opening of the seal manifold and the first opening of the hubcap defining a first lumen, and the second opening of the seal manifold and the second opening of the hubcap defining a second lumen.

[0031] In Example 35, the method of Example 30 further includes the primary seal being a cylindrical seal having a partial cross slit in a center of the primary seal. While multiple embodiments are disclosed, still other embodiments of the present invention may 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]

[0032] [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. [Diagram 2] FIG. 2 illustrates a cross-sectional view of an introducer sheath after insertion of a medical device into the introducer sheath after insertion into a blood vessel, according to an embodiment of the present disclosure. [Diagram 3] FIG. 3 shows 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 shows a cross-sectional view of the hemostasis valve hub of FIG. 3 according to an embodiment of the present disclosure. [Diagram 5] FIG. 5 is an enlarged view of a portion of a hemostasis valve hub according to an embodiment of the present disclosure. [Figure 6] FIG. 6 is an exploded view of a hemostasis valve hub according to an embodiment of the present disclosure. [Figure 7A] FIG. 7A is a top view of a seal for use with a hemostasis valve hub according to an embodiment of the present disclosure. [Figure 7B]FIG. 7B is a cross-sectional view of the seal of FIG. 7A according to an embodiment of the present disclosure. [Figure 7C] FIG. 7C is a further cross-sectional view of the seal of FIG. 7A, according to this embodiment. [Figure 7D] FIG. 7D is a top view of a seal for use with a hemostasis valve hub according to an embodiment of the present disclosure. [Figure 7E] FIG. 7E is a cross-sectional view of the seal of FIG. 7D according to an embodiment of the present disclosure. [Figure 7F] FIG. 7F is a further cross-sectional view of the seal of FIG. 7D, according to this embodiment. [Figure 8] FIG. 8 is an exploded view of a hemostasis valve hub according to an embodiment of the present disclosure. [Figure 9] FIG. 9 is a flow chart illustrating a method of assembling an introducer sheath and hub according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] FIG. 1 illustrates a side cross-sectional view of a blood vessel V having an introducer sheath 100 at least partially inserted therein. In some embodiments, the introducer sheath 100 is used to assist various relatively large medical devices, such as a blood pump as further described herein, in passing through the introducer sheath 100 and into the blood vessel V. The introducer sheath 100 includes a proximal end 106 and a distal end 108 opposite the proximal end 106. The introducer sheath 100 includes a proximal opening (not shown) adjacent the proximal end 106 and a distal opening 109 adjacent the distal end 108. A body portion 110 of the introducer sheath 100 extends between the proximal end 106 and the distal end 108, the body portion 110 defining a lumen 112 of the 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. The surface coatings may include, but are not limited to, silicone, PET, or any other applicable polymer. A hub 120 is generally included at the proximal opening (not shown). The hub 120, also referred to herein as a hemostasis valve hub, is configured for hemostasis, i.e., to prevent blood from leaking out of the introducer sheath during use. In various instances, it may be desirable for multiple medical devices to pass through the introducer sheath 100 at one time. Thus, in some embodiments, as further disclosed with reference to FIGS. 3-8, the hemostasis valve hub 120 may include at least two openings and a manifold to allow for the insertion of at least two devices into the introducer sheath 100 at one time without requiring the insertion of a second device after removal of the first device. The hub 120 provides a manifold structure to allow insertion of two devices while maintaining hemostasis and reducing blood leakage from the introducer sheath 100 and / or the 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 the catheters for delivery into the blood vessel V. As shown in FIG. 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 a proximal end of a blood pump that may be inserted into the introducer sheath 100, as described further herein.

[0034] FIG. 2 illustrates a cross-sectional view of the introducer sheath 100 of FIG. 1 after a medical device, illustratively a blood pump 150, has been inserted into the introducer sheath 100. The blood pump 150 generally includes an impeller assembly housing 140 and a motor housing 142. In some embodiments, the impeller assembly housing 140 and the motor housing 142 may be integrally or monolithically constructed. The impeller assembly housing 140 houses an impeller assembly 144 therein. The impeller assembly 144 includes an impeller shaft 146 and an impeller 148 for rotating relative to the impeller assembly housing 140 to transport blood through the blood pump 150. Specifically, the impeller 148 drives blood 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. 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 at an end of the impeller assembly housing 140. The outlet 152 may be formed in a side of the impeller assembly housing 140. In other embodiments, the inlet 151 and / or the outlet 152 may be formed in other portions of the impeller assembly housing 140. In some embodiments, the impeller assembly housing 140 may be coupled with a distally extending cannula (not shown). The cannula may receive and deliver blood to the inlet 151.

[0035] 2, the motor housing 142 houses a 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 that is coupled to a drive magnet 158. This rotation of the drive magnet 158 ​​causes rotation of a driven magnet 160 that is connected to the impeller assembly housing 140. Specifically, in embodiments incorporating an 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. Also shown in FIG. 2 is a catheter 170 that 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 a tapered connector and / or various other connection means. The catheter 170 may have a flexible structure to facilitate delivery of the blood pump 150. It is noted that although the introducer sheath 100 is shown in conjunction with the use of the blood pump 150, a variety of other medical devices may be used in conjunction with the introducer sheath 100 and hemostasis valve hub 120. For example, other blood pumps may be used in conjunction with the introducer sheath 100. In other embodiments, devices other than blood pumps may be incorporated.

[0036] FIG. 3 illustrates one embodiment of a hemostasis valve hub 220. The hemostasis valve hub 220 includes a proximal end 222 and a distal end 224 opposite the proximal end 222. The hemostasis 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 protrusion 236 extending from a face 238 of the hub cap 226. The first protrusion 236 is configured to couple to a clamping port (not shown) and may be used to secure a medical device, such as a catheter 170 (FIG. 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 may be used to receive additional fluids and / or medical devices. The hub base 228 includes at least one flange 232 that may be used to grip the hemostasis valve hub 220. In some embodiments, the hemostasis valve hub 220 includes two or more flanges 232. The hemostasis valve hub 220 may further include one or more sewing rings 234, as described in more detail with respect to FIG.

[0037] FIG. 4 illustrates a cross-sectional view of the hemostasis valve hub 220 shown in FIG. 3. As illustrated, the hub cap 226 is engaged with the hub base 228. Specifically, the hub cap 226 includes a plurality of engagement features 227 (illustratively a plurality of detents) for engaging with a plurality of engagement features 229 (illustratively a plurality of protrusions) of the hub base 228. The face 238 includes a first cavity or opening 248 and a second cavity or opening 250. The first opening 248 extends into the first protrusion 236 to define a first lumen 252 of the hemostasis valve hub 220. The second opening 250 defines a second lumen 254 of the hemostasis valve hub 220. Each of the first lumen 252 and the second lumen 254 is configured to receive a medical device for insertion into the blood vessel V (FIG. 1). As described in more detail below, the first opening 248 can be configured to receive a relatively larger medical device, such as a blood pump 150 with a catheter 170 (FIG. 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 through the second lumen 254. Adjacent to the primary seal 256 and the secondary seal 258 is a seal manifold 260. 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. Additionally, each of the first lumen 252 and the second lumen 254 extends into a main cavity 255 of the valve hub 220. Thus, when one or more medical devices are inserted through first lumen 252 and / or second lumen 254, the medical devices may extend through main cavity 255 of hub 220. In particular, first opening 262 and first lumen 252 may be larger than second opening 264 and second lumen 254 and are configured to be capable of receiving a relatively large medical device, such as blood pump 150 (FIG. 1). Second opening 264 and second lumen 254 may be used to receive other relatively smaller medical devices, such as a guide catheter.

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

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

[0041] FIG. 6 shows an exploded view of the hemostasis valve hub 220 shown in FIGS. 3-6. As shown, during assembly, after the introducer sheath 100 (FIG. 1) is inserted into the hub base 228, the ferrule 244 may be placed within the constriction 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 diameter larger than the diameter of the second opening 264 of the seal manifold 260. As further shown with reference to FIGS. 7A-7B, the primary seal 256 has a first diameter D1 (FIG. 7A), which is larger than the second diameter D2 (FIG. 7B) of the secondary seal 258. Additionally, the first opening 248 of the hub cap 226 may have a diameter greater 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 such 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 such that a fluid-tight seal exists between the seal manifold 260 and the hub base 228.

[0042] The above-described configurations and arrangements also allow the first and second lumens 252, 254 to extend continuously through the hemostasis valve hub 220. Thus, a medical device, for example, a blood pump 150 (FIG. 2) having a catheter 170 (FIG. 2) attached thereto, may be inserted into the first lumen 252, extend through the main cavity 255 of the hub base 228, enter a 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, may be inserted into the second lumen 254, extend through the main cavity 255 of the hub base 228, enter a 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 a medical device is inserted into the hemostasis valve hub 220 , it extends through the partial intersecting slits of the primary and secondary seals 256 , 258 , thereby contributing to a fluid-tight and hemostatic seal of the introducer sheath 100 ( FIG. 1 ) and the hemostasis valve hub 220 .

[0043] 6-7F, the primary seal 256 and the secondary seal 258 are shown enlarged and will be described in further detail. Specifically, FIG. 7A shows a top view of the primary seal 256, and FIG. 7D shows a top view of the secondary seal 258. As disclosed above, the primary seal 256 may have a diameter D1 larger than the diameter D2 of the secondary seal 258. For example, the diameter D1 of the primary seal 256 may have a value of about 11 mm, while the diameter D2 of the secondary seal 258 may have a value of about 8 mm. Also, the primary seal 256 may have a thickness T1 (FIG. 6) larger than the thickness T2 (FIG. 6) of the secondary seal 258. In various embodiments, the thickness T1 may have a value of about 2.0 mm, while the thickness T2 may have a value of about 1.5 mm. However, the above-mentioned dimensions of the primary seal 256 and the secondary seal 258 may be changed. For example, the diameter D1 may range from 9 mm to 11 mm, and the diameter D2 may range from 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 FIG. 7A and FIG. 7D, respectively, the primary seal 256 and the secondary seal 258 may each be a cylindrical seal such that the primary seal 256 and the secondary seal 258 have a circular cross section. However, the configuration of the seals 256, 258 may be modified. For example, the seals 256, 258 may be elliptical in cross section. Additionally, each of the primary seal 256 and the secondary seal 258 has a partial cross slit in the center of the seal 256, 258. The partial cross slit of the primary seal 256 may have a length L1 having a value of about 4.5 mm. The partial cross slit of the secondary seal 258 may have a length L2 having a value of about 2.5 mm. However, the lengths L1, L2 may be modified. For example, the length L1 may range from 3.0 mm to 4.5 mm, and the length L2 may range from 1.5 mm to 3.0 mm. FIG. 7B shows a cross-sectional view of the primary seal 256 of FIG. 7A along line CC, and FIG. 7C shows a cross-sectional view of the primary seal 256 along line BB. As shown in FIG. 7B and FIG. 7C, the partial cross slits are formed by slit cutting the primary seal 256 at a 90 degree orientation on the opposing sides with a prescribed slit cut depth d and a prescribed overlap O. As shown, the partial cross slits of the primary seal 256 may have an overlap O1 value of about 0.4 mm and a slit depth d1 of about 0.9 mm. FIG. 7E shows a cross-sectional view of the secondary seal 258 of FIG. 7D along line CC, and FIG. 7F shows a cross-sectional view of the secondary seal 258 of FIG. 7D along line BB. The partial cross slits of the secondary seal 258 may be formed by slit cutting the secondary seal 258 at a 90 degree orientation on the opposing sides with a slit cut depth d2 and a prescribed overlap O2. For example, the partial cross slit of the secondary seal 258 may have an overlap O2 value of about 0.2 mm. The value of the slit depth d2 may be about 0.80 mm. However, the values ​​of the overlap O1, O2 and the depths d1, d2 may be varied. 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.The partial cross slits are configured such that when a catheter or other medical device is inserted through seals 256, 258, the partial slits maintain a fluid-tight seal around the circumference of the device. Primary seal 256 and secondary seal 258 may each be formed from silicone or a variety of other suitable materials, including a polymer, a thermoset, a rubber, a thermoset elastomer (TSE), or a silicone rubber.

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

[0046] FIG. 8 shows an exploded view of a further embodiment of a hemostasis valve hub 320. The hemostasis valve hub 320 may be similar or identical to the hemostasis valve hub 220 described with reference to FIGS. 3-7, except for the fixation mechanism. For example, the hemostasis valve hub 320 includes a hub cap 326, a primary seal 356, a secondary seal 358, and a seal manifold 360, similar to those described with reference to FIGS. 3-7. However, the hemostasis valve hub 320 includes a hub base 328, as an example of a modified hub base. The hub base 328 includes a constriction 340 having a distal end portion 372 configured to engage with the fixation mechanism. The distal end portion 372 may be threaded for engagement with the fixation mechanism. Specifically, the hemostasis valve hub 320 shows a threaded cap 370 that engages with the distal end portion 372 of the hemostasis valve hub 320. The threaded cap 370 may engage the proximal end 106 (FIG. 1) of the introducer sheath 100 to secure the introducer sheath 100 within the hemostasis valve hub 320. The threaded cap 370 is used, among other things, to prevent axial movement of the introducer sheath 100 relative to the hemostasis valve hub 320. In these cases, the proximal end 106 (FIG. 1) of the introducer sheath may have a flared configuration to better engage the stenosis 340 and the fixation mechanism.

[0047] Figure 9 shows a flow chart of a method 400 for assembling an introducer sheath and hub, for example, the introducer sheath 100 of Figure 1 and the hemostasis valve hub 220 as described with reference to Figures 3-7. However, the method 400 may also be used with the hemostasis valve hub 320 as described with reference to Figure 8.

[0048] At block 402, the 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 ( FIG. 1 ) of the introducer sheath 100 is located within the stenosis 240 of the hub base 228. As mentioned above, a proximal opening (not shown) of the introducer sheath 100 can be on a flared portion of the proximal end 106 of the introducer sheath 100. Thus, the proximal end 106 of the introducer sheath 100 can extend through the distal end of the hub base 228 into the blood vessel V ( FIG. 1 ) during use. At block 404, the method 400 further includes engaging a locking mechanism with the hub base 228 and the proximal end 106 of the introducer sheath 100. In some embodiments, the locking mechanism is a ferrule 244. In these embodiments, after the introducer sheath 100 is positioned within the constriction 240 of the hub base 228, the ferrule 244 is inserted into the constriction 240 of the hub base 228 to lock the introducer sheath 100 against the inner surface of the hub base 228. However, as discussed above, the method 400 may also be used with a hemostasis valve hub 320. Thus, the locking mechanism may be a threaded cap 370 as described with reference to FIG. 8.

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

[0050] After assembly of the introducer sheath 100 and the hub 220, the introducer sheath 100 and the hub 220 may be used for delivery of at least one medical device into a blood vessel. Specifically, the introducer sheath 100 and the hub 220 may be used for inserting at least one catheter into the blood vessel V. Specifically, a physician or operator may insert the introducer sheath 100 into the blood vessel V. The physician or operator may then insert a medical device, for example a catheter, through the first opening 248 of the hub cap 226, i.e., through the first lumen 252 of the hemostasis valve hub 220 and into the hub base 228. This causes the catheter to extend through the first lumen 252 into the primary seal 256. The catheter may then pass completely through the hemostasis valve hub 220 and out the distal end 224 of the hemostasis valve hub 220 and into the introducer sheath 100. This 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 a second medical device to be inserted into the hub 220 and introducer sheath 100 and into the blood vessel 100 along with a first medical device. 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 hemostasis valve hub 220, thereby ensuring a hemostasis seal between the device and the hub 220 as the second medical device extends through the secondary seal 258. The second medical device may then be inserted through the hemostasis valve hub 220 and out the distal end 224 of the hemostasis valve hub 220 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 particular features, the scope of the present invention also includes embodiments having different combinations of features and embodiments that do not include all of the features described above.

Claims

1. 1. A hemostasis valve hub for an introducer sheath, comprising: A hub base and a hub cap configured to engage the hub base, the hub cap having a first wall with a first opening and a second opening, the first opening and the second opening extending through the first wall; a manifold located within the hub cap adjacent the hub base; a primary seal located adjacent the first opening in the hubcap; a secondary seal located adjacent the second opening in the hubcap; and Equipped with A hemostasis valve hub, 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.

2. The hemostasis valve hub of claim 1 , wherein the first opening has a first diameter and the second opening has a second diameter, the first diameter being greater than the second diameter.

3. The hemostasis valve hub of claim 1 or 2, wherein the primary seal has a first thickness and the secondary seal has a second thickness, the first thickness being greater than the second thickness.

4. The hemostasis valve hub of any one of claims 1 to 3, wherein the hub base includes a distal end and a proximal end, the hub base including a ferrule located within the distal end of the hub base.

5. The hemostasis valve hub of claim 4 , wherein the ferrule is configured to secure the introducer sheath to the hub base.

6. A hemostasis valve hub according to any one of claims 1 to 3, wherein the hub base includes a distal end and a proximal end, and a threaded cap is configured for attachment to the distal end of the hub base to secure the introducer sheath to the hub base.

7. A hemostasis valve hub according to any one of claims 1 to 6, wherein the primary seal and the secondary seal each comprise a cylindrical seal having a partial cross slit within the center of each of the primary seal and the secondary seal.

8. The hemostasis valve hub of any one of claims 1 to 7, wherein the hub base includes at least one ring configured to receive a suture to secure the position of the hemostasis valve hub.

9. 1. A delivery system for multiple medical devices into a blood vessel, comprising: an introducer sheath having a proximal end and a distal end for insertion into the blood vessel; a hemostasis valve hub for attachment to the proximal end of the introducer sheath; wherein the hemostasis valve hub comprises: A hub base and a hub cap configured to engage the hub base, the hub cap having a first surface with a first opening and a second opening, the first opening and the second opening extending through the first surface; a manifold located within the hub cap adjacent the hub base; a primary seal located adjacent the first opening in the hubcap; a secondary seal located adjacent the second opening in the hubcap; and Including, 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.

10. 10. The delivery system of claim 9, wherein the first opening has a first diameter and the second opening has a second diameter, the first diameter being greater than the second diameter.

11. The delivery system of claim 9 or 10, wherein the hub base has at least one ring for receiving a suture.

12. The delivery system of any one of claims 9 to 11, wherein the hub base includes a distal end and a proximal end, the hub base including a ferrule located within the distal end of the hub base.

13. 1. A method of assembling an introducer sheath and a hub, comprising: disposing a hub base over a proximal end of the introducer sheath; attaching a fixation mechanism to the hub base and the proximal end of the introducer sheath; and engaging a hub cap with the hub base; wherein the hubcap has a seal manifold located within the hubcap and a first surface having a first opening and a second opening, 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.

14. 14. The method of claim 13, wherein engaging the hub cap with the hub base includes aligning a first opening of the seal manifold with the primary seal and aligning a second opening of the seal manifold with the secondary seal.

15. 15. The method of claim 14, wherein the first opening in the seal manifold and the first opening in the hubcap define a first lumen, and the second opening in the seal manifold and the second opening in the hubcap define a second lumen.

Images