Dual Cavity Hemostasis Valve Hub for Large Bore Introducer Sheaths

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

TECHNICAL FIELD

The present disclosure relates to a hub for an introducer sheath. More specifically, the present disclosure relates to a dual cavity hemostasis valve hub for large bore introducer sheaths.

BACKGROUND

In various procedures for delivering intravascular medical devices, an introducer sheath is inserted into a blood vessel of a patient, for example a femoral artery, and medical devices are inserted into the introducer sheath for introduction into the blood vessel. In various instances, the medical devices include catheters or other medical devices such as a blood pump. In various instances, multiple medical devices need to be introduced into or inserted through the blood vessel at the same time. A hemostasis valve hub may be incorporated at a proximal end of the large bore introducer sheath to reduce blood leakage as devices are being inserted, positioned, and removed. There is a need for an optimized hemostasis valve hub that allows for the passage of multiple devices into the introducer sheath while still minimizing blood leakage and facilitating passage of the device through an introducer sheath.

SUMMARY

In an Example 1, a hemostasis valve hub for an introducer sheath includes a hub base, a hub cap configured for engagement with the hub base, the hub cap having a first wall with a first opening and a second opening extending through the first wall, a manifold positioned within the hub cap and adjacent the hub base, a primary seal positioned adjacent the first opening of the hub cap, a secondary seal positioned adjacent the second opening of the hub cap, and wherein the primary seal and the secondary seal are configured to provide a fluid seal between the first opening and the second opening, respectively, and the hub base.

In an Example 2, the hemostasis valve hub of Example 1 includes 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.

In an Example 3, the hemostasis valve hub of Examples 1 or 2 further includes 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.

In an Example 4, the hemostasis valve hub of any one of Examples 1-3 further includes wherein the hub base includes a distal end and a proximal end and wherein the hub base has a ferrule positioned within the distal end of the hub base.

In an Example 5, the hemostasis valve hub of Example 4 further includes wherein the ferrule is configured for securing the introducer sheath with the hub base.

In an Example 6, the hemostasis valve hub of any one of Examples 1-3 further includes wherein the hub base comprises a distal end and a proximal end and wherein a threaded cap is configured for attachment to the distal end of the hub base for securing the introducer sheath with hub base.

In an Example 7, the hemostasis valve hub of any one of Examples 1-6 further includes wherein the primary seal and the secondary seal are each composed of cylindrical seals having a partial cross slit within a center of each the first seal and the second seal.

In an Example 8, the hemostasis valve hub of any one of Examples 1-7 further includes wherein the hub base includes at least one ring configured for receiving a suture to secure the hemostasis valve hub positioning.

In an Example 9, a delivery system for a plurality of medical devices into a blood vessel includes an introducer sheath for insertion into the blood vessel, the introducer sheath having a proximal end and a distal end, 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 configured for engagement with the hub base, the hub cap having a first face with a first opening and a second opening extending through the first face, a manifold positioned within the hub cap and adjacent the hub base, a primary seal positioned adjacent the first opening of the hub cap, and a secondary seal positioned adjacent 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 second opening, respectively, and the hub base.

In an Example 10, the delivery system of Example 9 further includes 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.

In an Example 11, the delivery system of Example 9 or Example 10 further includes wherein the hub base has at least one ring for receiving a suture.

In an Example 12, the delivery system of any one of Examples 9-11 further includes wherein the hub base includes a distal end and a proximal end and wherein the hub base has a ferrule positioned within the distal end of the hub base.

In an Example 13, a method of assembling an introducer sheath and a hub includes placing a hub base onto the proximal end of the introducer sheath, attaching a securing mechanism to the hub base and the proximal end of the introducer sheath, and engaging a hub cap onto the hub base, the hub cap having a seal manifold positioned within the hub cap and a first face having a first opening and a second opening, a first seal positioned between the seal manifold and the first opening, and a second seal positioned between the seal manifold and the second opening.

In an Example 14, the method of Example 13 further includes 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 with the secondary seal.

In an Example 15, the method of Example 14 further includes 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.

In an Example 16, a hemostasis valve hub for an introducer sheath includes a hub base, a hub cap configured for engagement with the hub base, the hub cap having a first wall with a first opening and a second opening extending through the first wall, a manifold positioned within the hub cap and adjacent the hub base, a primary seal positioned adjacent the first opening of the hub cap, a secondary seal positioned adjacent the second opening of the hub cap, and wherein the primary seal and the secondary seal are configured to provide a fluid seal between the first opening and the second opening, respectively, and the hub base.

In an Example 17, the hemostasis valve hub of Example 16 includes 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.

In an Example 18, the hemostasis valve hub of Example 16 further includes 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.

In an Example 19, the hemostasis valve hub of Example 16 further includes wherein the hub base comprises a distal end and a proximal end and wherein the hub base has a ferrule positioned within the distal end of the hub base.

In an Example 20, the hemostasis valve hub of Example 19 further includes wherein the ferrule is configured for securing the introducer sheath with hub base.

In an Example 21, the hemostasis valve hub of Example 16 further includes wherein the hub base comprises a distal end and a proximal end and wherein a threaded cap is configured for attachment to the distal end of the hub base for securing the introducer sheath with hub base.

In an Example 22, the hemostasis valve hub of Example 16 further includes wherein the primary seal and the secondary seal are each composed of cylindrical seals having a partial cross slit within a center of each the first seal and the second seal.

In an Example 23, the hemostasis valve hub of Example 16 further includes wherein the hub base comprises at least one ring configured for receiving a suture to secure the hemostasis valve hub positioning.

In an Example 24, the hemostasis valve hub of Example 16 further includes wherein the hub base comprises an access port extending radially outward from the hub base.

In an Example 25, a delivery system for a plurality of medical devices into a blood vessel includes an introducer sheath for insertion into the blood vessel, the introducer sheath having a proximal end and a distal end, 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 configured for engagement with the hub base, the hub cap having a first face with a first opening and a second opening extending through the first face, a manifold positioned within the hub cap and adjacent the hub base, a primary seal positioned adjacent the first opening of the hub cap, and a secondary seal positioned adjacent 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 second opening, respectively, and the hub base.

In an Example 26, the delivery system of Example 25 further includes 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.

In an Example 27, the delivery system of Example 25 further includes wherein the hub base has at least one ring for receiving a suture.

In an Example 28, the delivery system of Example 25 further includes wherein the hub base comprises a distal end and a proximal end and wherein the hub base has a ferrule positioned within the distal end of the hub base.

In an Example 29, the delivery system of Example 25 further includes wherein the hub base comprises a distal end and a proximal end and wherein a threaded cap is configured for attachment to the distal end of the hub base for securing the introducer sheath with hub base.

In an Example 30, a method of assembling an introducer sheath and a hub includes placing a hub base onto the proximal end of the introducer sheath, attaching a securing mechanism to the hub base and the proximal end of the introducer sheath, and engaging a hub cap onto the hub base, the hub cap having a seal manifold positioned within the hub cap and a first face having a first opening and a second opening, and a first seal positioned between the seal manifold and the first opening and a second seal positioned between the seal manifold and the second opening.

In an Example 31, the method of Example 30 further includes wherein the securing mechanism is a ferrule and the ferrule is positioned within the hub base.

In an Example 32,the method of Example 30 further includes wherein the securing mechanism is a threaded cap engaged with a distal end of the hub base.

In an Example 33, the method of Example 30 further includes 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 with the secondary seal.

In an Example 34, the method of Example 33 further includes 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.

In an Example 35, the method of Example 30 further includes wherein the first seal is a cylindrical seal having a partial cross slit within a center of the first seal.

DETAILED DESCRIPTION

FIG.1illustrates a side cross sectional view of a blood vessel V with an introducer sheath100, inserted at least partially into the blood vessel V. In some embodiments, the introducer sheath100is used for facilitating the passage of various relatively large medical devices, such as a blood pump as will be described further herein, through the introducer sheath100and into the blood vessel V. Hence, the introducer sheath100may be referred to as a large bore introducer sheath. The introducer sheath100comprises a proximal end106and a distal end108that is opposite the proximal end106. The introducer sheath100includes a proximal opening (not shown) adjacent the proximal end106and a distal opening109adjacent the distal end108. A body portion110of the introducer sheath100extends between the proximal end106and the distal end108, and the body portion110defines a lumen112of the introducer sheath100. The introducer sheath100may be formed by various polymeric or metallic materials. In further embodiments, the introducer sheath100may comprise an additional surface coating. The surface coating may include, but is not limited to, silicone, PET, or any other applicable polymer. A hub120is commonly included at the proximal opening (not shown). The hub120, 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 desired for the passage of multiple medical devices through the introducer sheath100at one time. As such, in some embodiments, as will be disclosed further with reference toFIGS.3-8, the hemostasis valve hub120may include at least two openings and a manifold for allowing the insertion of at least two devices into the introducer sheath100at once, without requiring removal of the first device and subsequent insertion of the second device. The hub120provides a manifold structure for allowing the insertion of the two devices while also maintaining hemostasis and reducing the blood leakage from the introducer sheath100and/or the hub120during the insertion, use of, or removal of the various medical devices. In some embodiments, two catheters are inserted into the hub120at once, and various other medical devices may be inserted into at least one of the catheters for delivery into the blood vessel V. As shown inFIG.1, the hub120may be used to receive a catheter170. The catheter170extends through the hub120and the introducer sheath100and may couple to a proximal end of a blood pump which may be inserted into the introducer sheath100, as will be described further herein.

FIG.2illustrates a cross-sectional view of the introducer sheath100ofFIG.1after insertion of a medical device, illustratively a blood pump150, into the introducer sheath100. The blood pump150generally includes an impeller assembly housing140and a motor housing142. In some embodiments, the impeller assembly housing140and the motor housing142may be integrally or monolithically constructed. The impeller assembly housing140carries an impeller assembly144therein. The impeller assembly144includes an impeller shaft146and an impeller148that rotates relative to the impeller assembly housing140to drive blood through the blood pump150. More specifically, the impeller148causes blood to flow from a blood inlet151formed on the impeller assembly housing140, through the impeller assembly housing140, and out of a blood outlet152formed on the impeller assembly housing140. In some embodiments, the impeller shaft146and the impeller148may be integrated, and in other embodiments the impeller shaft146and the impeller148may be separate components. As shown inFIG.2, the inlet151may be formed on an end portion of the impeller assembly housing140and the outlet152may be formed on a side portion of the impeller assembly housing140. In other embodiments, the inlet151and/or the outlet152may be formed on other portions of the impeller assembly housing140. In some embodiments, the impeller assembly housing140may couple to a distally extending cannula (not shown), and the cannula may receive and deliver blood to the inlet151.

With continued reference toFIG.2, the motor housing142carries a motor154, and the motor154is configured to rotatably drive the impeller148relative to the impeller assembly housing140. In the illustrated embodiment, the motor154rotates a drive shaft156, which is coupled to a driving magnet158. Rotation of the driving magnet158causes rotation of a driven magnet160, which is connected to the impeller assembly housing140. More specifically, in embodiments incorporating the impeller shaft146, the impeller shaft146and the impeller148are configured to rotate with the driven magnet160. In other embodiments, the motor154may couple to the impeller assembly housing140via other components. Additionally, as illustrated inFIG.2, the catheter170extends from a proximal end of the blood pump150. In some embodiments, the catheter170may be coupled to the motor housing142through a tapering connector and/or various other connecting means. The catheter170may have a flexible construction to facilitate the delivery of the blood pump150. While the introducer sheath100is illustrated with the use of the blood pump150, various other medical devices may be used in conjunction with the introducer sheath100and the hemostasis valve hub120. For example, a variation of a blood pump may be used in conjunction with the introducer sheath100. In other examples, a device other than a blood pump may be incorporated.

FIG.3illustrates an embodiment of a hemostasis valve hub220. The hemostasis valve hub220includes a proximal end222and a distal end224positioned opposite the proximal end222. The hemostasis valve hub220includes a hub cap226configured to be coupled to a hub base228. As illustrated, the hub cap226has a first protruding portion236that extends from a face238of the hub cap226. The first protruding portion236may be configured to couple to a tightening port (not shown) and used to secure a medical device, such as the catheter170(FIG.2), passing through hub220, for example to inhibit axial movement of the catheter170. Additionally, the hub base228includes an access port230extending from the hub base228. The access port230may be used for receiving additional fluids and/or medical devices. The hub base228comprises at least one flange232that may be used for grasping the hemostasis valve hub220. In some embodiments, the hemostasis valve hub220comprises two or more flanges232. The hemostasis valve hub220may also include one or more suture rings234, as described in more detail with respect toFIG.5.

FIG.4illustrates a cross sectional view of the hemostasis valve hub220illustrated inFIG.3. As illustrated, the hub cap226is engaged with the hub base228. More specifically, the hub cap226comprises a plurality of engagement features227, illustratively detents, for engaging with a plurality of engagement features229of the hub base228, illustratively protrusions. The face238comprises a first cavity or opening248and a second cavity or opening250. The first opening248extends into the first protruding portion236to define a first lumen252of the hemostasis valve hub220. The second opening250defines a second lumen254of the hemostasis valve hub220. Each of the first lumen252and the second lumen254are configured for receiving a medical device for insertion into the blood vessel V (FIG.1). As described in more detail below, first opening248may be configured to receive relatively larger medical devices, such as the blood pump150with the catheter170(FIG.2), while the second opening250is configured to receive relatively smaller medical devices, such as a catheter.

The first opening248comprises a primary seal256positioned extending radially across the first lumen252, the second lumen254comprises a secondary seal258positioned extending radially the second lumen254. Adjacent the primary seal256and the secondary seal258is a seal manifold260. The seal manifold260comprises a first opening262aligned with the first opening248of the hub cap226and a second opening264aligned with the second opening250of the hub cap226to allow the first lumen252and the second lumen254to extend through the hub cap226and the hub base228. Additionally, each of the first lumen252and the second lumen254extend into a main cavity255of the valve hub220. In this way, when the one or more medical devices are inserted through the first lumen252and/or the second lumen254, the medical device may extend through the main cavity255of the hub220. Specifically, the first opening262and the first lumen252may be larger than the second opening264and the second lumen254, configured such that the first opening262and the first lumen252are capable of receiving the relatively large medical devices, such as the blood pump150(FIG.1). Additionally, the second opening264and the second lumen254may then be used for receiving other relatively smaller medical devices, such as guide catheters.

With continued reference toFIG.4, toward the distal end224of the hub base228, the hub base228comprises a narrowed portion240that includes or engages with a securing element for securing the hemostasis valve hub220to the introducer sheath100. Additionally, the introducer sheath100(FIG.1) is positioned around and engaged with the securing element. More specifically, the proximal end106(FIG.1) of the introducer sheath100, which has a flared portion, is secured by securing element to maintain the positioning of the introducer sheath100. In the illustrative embodiment ofFIG.4, the securing element is a ferrule244configured to secure the hemostasis valve hub220at the flared portion of the proximal end106of the introducer sheath100. However, in other embodiments, various other securing mechanisms may be used, as will be described with reference toFIG.8.

FIG.5illustrates an enlarged view of the hub base228, specifically illustrating the narrowed portion240. As illustrated, the narrowed portion240includes at least one suture ring234that extends from the narrowed portion240. The at least one suture ring234may be used for receiving a suture to secure the hemostasis valve hub220onto a patient. As illustrated inFIG.5, the at least one suture ring234includes a first suture ring234aand a second suture ring234b, however any number of suture rings may be incorporated. Additionally, while illustrated as generally semi-circular or semi-oval rings, the suture rings234may have a variety of shapes incorporated.

FIG.6illustrates an exploded view of the hemostasis valve hub220shown inFIGS.3-6. As illustrated, during assembly, after the introducer sheath100(FIG.1) has been inserted into the hub base228, the ferrule244may be positioned within the narrowed portion240of the hub base228. The seal manifold260may then be positioned adjacent the hub base228, such that a first opening262of the seal manifold260aligns with the primary seal256and a second opening264of the seal manifold260aligns with the secondary seal258. The first opening262of the seal manifold260has a diameter that is greater than a diameter of the second opening264of the seal manifold260. As will be illustrated further with reference toFIGS.7A-7B, the primary seal256comprises a first diameter D1(FIG.7A) that is greater than a second diameter D2(FIG.7B) of the secondary seal258. Further, the first opening248of the hub cap226may have a diameter that is greater than a diameter of the second opening250. As a result of the above-described configuration, the first opening248of the hub cap226and the first opening262of the seal manifold260are configured for complete radial coverage by the primary seal256such that there is a fluid seal between the seal manifold260and the hub base228. Similarly, the second opening264of the seal manifold260and the second opening250of the hub cap226are configured for complete radial coverage by the secondary seal258such that there is a fluid tight seal between the seal manifold260and the hub base228.

Additionally, the above-described configuration and alignment allows for the first and second lumens252,254to extend continuously through the hemostasis valve hub220. As such, a medical device, for example the blood pump150(FIG.2) with the catheter170(FIG.2) attached to the blood pump150, may be inserted into the first lumen252, extend through the main cavity255of the hub base228, enter the proximal opening (not shown) of the introducer sheath100, and pass beyond the distal end224of the hub base228within the lumen112of the introducer sheath100. Similarly, an additional medical device, for example an additional catheter, may be inserted through the second lumen254, extend through main cavity255of the hub base228, enter the proximal opening of the introducer sheath100, and pass beyond the distal end224of the hub base228within the introducer sheath100. When inserted through the hemostasis valve hub220, the medical devices extend through partial cross slits of the primary and secondary seals256,258, to contribute to the fluid tight and hemostatic seal of the introducer sheath100(FIG.1) and the hemostasis valve hub220.

With reference toFIGS.6-7F, the primary seal256and the secondary seal258are illustrated enlarged and described in further detail, respectfully. Specifically,FIG.7Aillustrates a top view of the primary seal256andFIG.7Dillustrates a top view of the secondary seal258. As previously disclosed, the primary seal256may have a diameter D1that is larger than a diameter D2of the secondary seal258. For example, the diameter D1of the primary seal256may have a value of approximately 11 mm while the diameter D2of the secondary seal258may have a value of approximately 8 mm. Additionally, the primary seal256may have a thickness T1(FIG.6) that is larger than a thickness T2(FIG.6) of the secondary seal258. In various embodiments, the thickness T1may have a value of approximately 2.0 mm while the thickness T2may have a value of approximately 1.5 mm. However, the above-described dimensions of the primary seal256and the secondary seal258may vary. For example, the diameter D1may range from 9 mm to 11 mm, and the diameter D2may range from 5 mm to 8.5 mm. Additionally, the thickness T1may range from 1.5 mm to 2.5 mm, and the thickness T2may range from 1.25 mm to 2.00 mm.

As illustrated inFIGS.7A and7D, respectfully, the primary and secondary seals256,258may each be a cylindrical seal such that the primary and secondary seals256,258have a circular cross-section. However, the configuration of the seals256,258may vary. For example, the seals256,258may be oval in cross section. Further, each of the primary seal256and the secondary seal258has a partial cross slit within the center of the seals256,258. The partial cross slit of the primary seal256may have a length L1with a value of approximately 4.5 mm while the partial cross slits of the secondary seal258may have a length L2with a value of approximately 2.5 mm. However, the lengths L1, L2may be varied. For example, length L1may range from 3.0 mm to 4.5 mm and the length L2may range from 1.5 mm to 3.0 mm.FIG.7Billustrates a cross sectional view of the primary seal256ofFIG.7Ataken along line C-C, andFIG.7Cillustrates a cross sectional view of the primary seal256take along line B-B. As illustrated inFIGS.7B and7C, the partial cross slit forms when the primary seal256is slit cut at 90 degree orientation on opposite faces with a defined slit cut depth d and a defined overlap O. As illustrated, the partial cross slit of the primary seal256may have an overlap O1with a value of approximately 0.4 mm and a slit depth d1approximately 0.9 mm.FIG.7Eillustrates a cross sectional view of the secondary seal258ofFIG.7Dtaken along line C-C andFIG.7Fillustrates a cross sectional view of the secondary seal258taken along line B-B ofFIG.7D. The secondary seal258partial cross slit may be formed from slit cutting the secondary seal258at a 90 degree orientation on opposite faces with a slit cut depth d2and a defined overlap O2. For example, the partial cross slits of the secondary seal258may have a value of the overlap O2of approximately 0.25 mm and the slit depth d2value may be approximately 0.80 mm. However, the values of the overlaps O1, O2and the depths d1, d2may be varied. For example, the overlap O1may range from 0.3 mm to 0.5 mm, the depth d1may range from 0.7 mm to 1.1 mm, the overlap O2may range from 0.15 mm to 0.35 mm and the depth d2may range from 0.6 mm to 1.0 mm. The partial cross slits are configured such that upon insertion of a catheter or other medical device through the seals256,258, the partial slits maintain a fluid tight seal around the circumference of the device. The primary seal256and the secondary seal258may each be composed of silicone, or various other suitable materials including polymer, thermoset, rubber or thermoset elastomer (TSE), or silicone rubber.

As a result of the above-described features of the hub cap226, the seal manifold260and the primary and secondary seals256,258, the first lumen252has a larger diameter than the second lumen254. As such, the first lumen252may be configured for receiving a larger medical device. For example, the first lumen252may be configured for receiving the blood pump150, or another suitable medical device, while the second lumen254is configured for receiving a smaller medical device, for example a guide catheter, for navigation tools to be inserted into, or any other suitable device.

FIG.8illustrates an exploded view of an additional embodiment of a hemostasis valve hub320. The hemostasis valve hub320may be similar to, or the same as, the hemostasis valve hub220as described with reference toFIGS.3-7, with the exception of the securing mechanism. For example, the hemostasis valve hub320comprises a hub cap326, a primary seal356, a secondary seal358, and a seal manifold360similarly to as described with reference toFIGS.3-7. However, the hemostasis valve hub320comprises a modified hub base, illustratively hub base328. The hub base328comprises a narrowed portion340with a distal end portion372that is configured for engaging with a securing mechanism. The distal end portion372may be threaded for engagement with a securing mechanism. Specifically, hemostasis valve hub320illustrates a threaded cap370that engages with the distal end portion372of the hemostasis valve hub320. The threaded cap370may then engage with the proximal end106(FIG.1) of the introducer sheath100to secure the introducer sheath100within the hemostasis valve hub320. In particular, threaded cap370is used to prevent axial movement of the introducer sheath100with respect to hemostasis valve hub320. In these instances, the proximal end106(FIG.1) of the introducer sheath may have a flared configuration to better engage with the narrowed portion340and the securing mechanism.

FIG.9illustrates a flow chart of a method400of assembling an introducer sheath and a hub, for example assembling the introducer sheath100ofFIG.1with the hemostasis valve hub220as described with reference toFIGS.3-7. However, the method400may also be used with the hemostasis valve hub320as described with reference toFIG.8.

At block402, the method400includes placing the hub base228onto the proximal end106of the introducer sheath100by inserting the introducer sheath100through the main cavity255of the hub base228. More specifically, the introducer sheath100is placed into the hub base228until the proximal end106(FIG.1) of the introducer sheath100is located within the narrowed portion240of the hub base228. As previously described, the proximal opening (not shown) of the introducer sheath100may be on the flared portion of the proximal end106of the introducer sheath100. In this way, the proximal end106of the introducer sheath100may extend though the distal end of the hub base228and into the blood vessel V (FIG.1) during use. At block404, the method400further includes engaging a securing mechanism to the hub base228and the proximal end106of the introducer sheath100. In some embodiments, the securing mechanism is the ferrule244. In these embodiments, after the introducer sheath100is positioned within the narrowed portion240of the hub220, the ferrule244is inserted into the narrowed portion240of the hub base228to secure the introducer sheath100against an inner surface of the hub base228. However, as previously described, the method400may be used with the hemostasis valve hub320and as such, the securing mechanism may be the threaded cap370as described with reference toFIG.8.

At block406, the method400further includes engaging the hub cap226onto the hub base228. This step of engaging the hub cap226onto the hub base228may further include aligning the first opening262of the seal manifold260with the primary seal256and aligning the second opening264of the seal manifold260with the secondary seal258. This may further include aligning the first opening248of the hub cap226with the primary seal256and aligning the second opening250of the hub cap226with the secondary seal258. In this way, the alignment of the above described components allows for the first lumen and the second lumen to extend through the hemostasis valve hub220to receive various medical devices.

After assembly of the introducer sheath100and the hub220, the introducer sheath100and the hub220may be used for delivery of at least one medical device into a blood vessel. More specifically, the introducer sheath100and the hub220can be used for inserting at least one catheter into the blood vessel V. Specifically, a physician or an operator may insert the introducer sheath100into the blood vessel V. The physician and the operator may then insert a medical device, for example a catheter, through the first opening248of the hub cap226and thus into the hub base228within the first lumen252of the hemostasis valve hub220. In this way, the catheter extends through the first lumen252and within the primary seal256. The catheter may then extend entirely through the hemostasis valve hub220, out of the distal end224of the hemostasis valve hub220, and into the introducer sheath100. Due to the configuration of the hub220, and more specifically the configuration of having both the first opening248with the primary seal256and the second opening250and the secondary seal258, alongside the first medical device, a second medical device may be inserted into the hub220and the introducer sheath100and into the blood vessel100. For example, the second medical device may be inserted through the second opening250of the hub cap226and extend though the second lumen254of the hemostasis valve hub220. In this way, the second medical device extends through the secondary seal258to ensure a hemostatic sealing between the device and the hub220. The second medical device can then be extended through the hemostasis valve hub220and out of the distal end224of the hemostasis valve hub220for insertion into the introducer sheath100.