Sheath hub with built-in clamping port for catheter position fixation

Abstract

A valve hub assembly for use with a sheath includes a valve hub having a proximal end opposite a distal end, a first arm defining a first lumen, and a second arm defining a second lumen. A clamping port is disposed at the proximal end of the valve hub. The clamping port includes a hub cap that engages the clamping port, a radially expandable seal disposed within the lumen of the hub cap, a pusher that engages with the radially expandable seal and is disposed at least partially within the hub cap, and a locking nut disposed around the pusher and configured to press the pusher against the radially expandable seal.

Description

[Technical Field]

[0001] The present disclosure relates to sheath hubs, and more particularly to hubs having built-in clamping ports that can be used to secure a medical device, such as a catheter, within the hub, thereby fixing the position of the catheter relative to the hub and sheath. [Background technology]

[0002] In various procedures for delivering an intravascular medical device, a sheath is inserted into a patient's blood vessel, e.g., the femoral artery, and the medical device extends through the sheath and into the patient's vasculature. In various examples, the medical device includes a catheter or other device, such as a blood pump. A hub may be incorporated into the proximal portion of the sheath to reduce blood leakage as the device is inserted, positioned, and removed. In various examples, it may be desirable to secure the positioning of the medical device within the sheath and vasculature, and in addition, it may be desirable to reposition the medical device within the vasculature. Therefore, there is a need for an improved fastening mechanism that secures a medical device, such as a catheter, within the sheath and vasculature while also allowing for repositioning of the medical device within the vasculature. SUMMARY OF THE DISCLOSURE

[0003] In Example 1, the valve hub assembly includes a valve hub and a clamping port. The valve hub includes a proximal end opposite a distal end, a first arm defining a first lumen, and a second arm defining a second lumen. The clamping port is disposed at the proximal end of the valve hub and includes a hubcap engaged with the clamping port, the hubcap defining a third lumen for receiving the radially expandable seal, a pusher engaged with the radially expandable seal and at least partially disposed within the hubcap, and a locknut disposed around the pusher and configured to clamp the pusher against the radially expandable seal.

[0004] In Example 2, in the valve hub assembly of Example 1, the fastening port further includes a sleeve holder engaged with the pusher. In Example 3, in the valve hub assembly of Example 2, the fastening port further includes a sleeve gripper engageable with the sleeve holder.

[0005] In Example 4, the valve hub assembly of any of the preceding examples further includes a suture pad engaged with the distal end of the valve hub. In Example 5, the valve hub assembly of any of the preceding Examples, wherein the clamping port further includes a primary seal disposed in the hub cap and positioned adjacent the first lumen.

[0006] In Example 6, in the valve hub assembly of any of the preceding examples, the hub cap includes a first portion, a second portion, and a transition wall defining a transition between the first portion and the second portion, and the radially expandable seal is disposed within the first portion and adjacent to the transition wall.

[0007] In Example 7, the valve hub assembly of Example 6, wherein the lock nut is configured to axially compress the pusher against the radially expandable seal such that the radially expandable seal radially expands to seal against the inner surface of the hub cap.

[0008] In Example 8, the valve hub assembly of any of the preceding Examples, wherein the radially expandable seal is a Toohey seal. In Example 9, in the valve hub assembly of any of the preceding examples, the hub cap has a plurality of protrusions extending from a proximal end of the hub cap, the valve hub has a collar with a plurality of openings, and the plurality of protrusions on the hub cap are engaged with the plurality of openings so as to prevent rotation of the hub cap relative to the valve hub.

[0009] In Example 10, a method for positioning and securing a medical device comprises assembling a valve hub having a proximal end and a distal end onto a sheath, the method comprising disposing a clamping port at the proximal end of the valve hub, the clamping port including a hub cap defining a first lumen for receiving a radially expandable seal, a pusher engaged with the radially expandable seal and at least partially disposed within the hub cap, and a locking nut disposed around the pusher and the hub cap to compress the pusher against the radially expandable seal, the method comprising delivering the medical device through the valve hub and sheath, the method comprising confirming the position of the medical device, clamping the clamping port, and securing a sterile sleeve using the clamping port.

[0010] In Example 11, the method of Example 10, wherein tightening the tightening port includes actuating a lock nut to move a pusher against the radially expandable seal.

[0011] In Example 12, the method of Example 11, wherein the pusher radially expands the radially expandable seal to form a sealing engagement between the radially expandable seal and the hubcap.

[0012] In Example 13, in any one of Examples 10-12, the hub cap has a plurality of protrusions extending from a proximal end of the hub cap, the valve hub has a collar with a plurality of openings, and the plurality of protrusions of the hub cap are engaged with the plurality of openings so as to prevent rotation of the hub cap relative to the valve hub.

[0013] In Example 14, the method of any one of Examples 10-13, wherein the confirmation of the position of the medical device is performed using fluoroscopy. In Example 15, in the method of any one of Examples 10 to 14, securing the sterile sleeve to the clamping port further includes placing the sterile sleeve over a sleeve holder of the clamping port and placing a sleeve gripper over the sterile sleeve and sleeve holder.

[0014] In Example 16, a valve hub assembly for use with a sheath includes a valve hub and a clamping port, the valve hub including a proximal end opposite a distal end, a first arm defining a first lumen, and a second arm defining a second lumen. The assembly includes a clamping port disposed at the proximal end of the valve hub, the clamping port including a hub cap engaged with the proximal end of the valve hub and defining a third lumen for receiving a radially expandable seal, a pusher engaged with the radially expandable seal and at least partially disposed within the hub cap, and a locking nut disposed around the pusher to tighten the pusher against the radially expandable seal.

[0015] In Example 17, the valve hub assembly of Example 16 further includes a sleeve holder for engaging the pusher without engaging the lock nut, and engagement between the sleeve holder and the pusher is configured such that rotation of the lock nut does not cause rotation of the sleeve holder.

[0016] In Example 18, in the valve hub assembly of Example 17, the clamping port further includes a sleeve gripper engageable with the sleeve holder. In Example 19, the valve hub assembly of Example 16 further includes a suture pad engaged with the distal end of the valve hub.

[0017] In Example 20, the valve hub assembly of Example 16, wherein the clamping port further includes a primary seal disposed in the hub cap and positioned adjacent to the first lumen.

[0018] In Example 21, the valve hub assembly of Example 16, wherein the hub cap includes a first portion, a second portion, and a transition wall defining a transition between the first portion and the second portion, and the radially expandable seal is disposed within the first portion and adjacent to the transition wall.

[0019] In Example 22, the valve hub assembly of Example 21, wherein the lock nut is configured to axially move the pusher relative to the radially expandable seal such that the radially expandable seal radially expands to seal against the inner surface of the hub cap.

[0020] In Example 23, the valve hub assembly of Example 16, wherein the radially expandable seal is a Tuohy seal. In Example 24, in the valve hub assembly of Example 16, the hub cap has multiple protrusions extending from a proximal end of the hub cap, the valve hub has a collar with multiple openings, and the multiple protrusions of the hub cap engage with the multiple openings so as to prevent rotation of the hub cap relative to the valve hub.

[0021] In Example 25, a delivery system includes a sheath and a hemostasis valve hub assembly. The sheath has a proximal end and a distal end and is configured to be inserted into a blood vessel. The hemostasis valve hub assembly includes a clamping port engaged with the proximal end of the sheath and disposed at the proximal end of the hemostasis valve hub. The clamping port includes a hub cap engaged with the proximal end of the hemostasis valve hub, the hub cap having a first portion and a second portion and defining a lumen. The clamping port includes a pusher engaged with a radially expandable seal disposed on the first portion and at least partially disposed within the hub cap, and a locking nut disposed around the pusher and the hub cap and configured to press the pusher against the radially expandable seal.

[0022] In Example 26, in the delivery system of Example 25, the hubcap further includes a transition wall defining a transition between the first portion and the second portion, and the radially expandable seal is disposed adjacent to the transition wall.

[0023] In Example 27, the delivery system of Example 25, wherein the locking nut is configured to axially urge the pusher against the radially expandable seal. In Example 28, in the delivery system of Example 25, the hemostasis valve hub includes a first arm and a second arm, the safety cap is engaged with the second arm, and the clamping port is engaged with the first arm.

[0024] In Example 29, in the delivery system of Example 25, the hub cap has multiple protrusions extending from the proximal end of the hub cap, the hemostasis valve hub has a collar with multiple openings, and the multiple protrusions of the hub cap are engaged with the multiple openings so as to prevent rotation of the hub cap relative to the hemostasis valve hub.

[0025] In Example 30, a method for positioning a medical device and securing the positioning of the medical device includes assembling a hemostasis valve hub onto a sheath. The method further includes disposing a clamping port on a proximal end of the hemostasis valve hub, the clamping port including a hubcap engaged with the proximal end of the hemostasis valve hub, the hubcap defining a lumen for receiving a radially expandable seal, the clamping port including a pusher engaged with the radially expandable seal and at least partially disposed within the hubcap, and a locking nut disposed around the pusher and the hubcap. The method further includes delivering the medical device through the hemostasis valve hub and the sheath, confirming the position of the medical device, clamping the clamping port of the hemostasis valve hub to press the pusher against the radially expandable seal, and securing a sterile sleeve using the clamping port.

[0026] In Example 31, the method of Example 30, wherein tightening the tightening port of the hemostasis valve hub includes actuating a lock nut to press a pusher against the radially expandable seal.

[0027] In Example 32, in the method of Example 31, pressing the pusher against the radially expandable seal radially expands the radially expandable seal and creates a sealing engagement between the radially expandable seal and the hub cap.

[0028] In Example 33, in the method of Example 30, the hub cap has multiple protrusions extending from the proximal end of the hub cap, the hemostasis valve hub has a collar with multiple openings, and the multiple protrusions of the hub cap are engaged with the multiple openings so as to prevent rotation of the hub cap relative to the hemostasis valve hub.

[0029] In Example 34, the method of Example 30, wherein the confirmation of the position of the medical device is performed via fluoroscopy. In Example 35, in the method of Example 30, securing the sterile sleeve to the clamping port further includes placing the sterile sleeve over a sleeve holder of the clamping port and placing a sleeve gripper over the sterile sleeve and sleeve holder.

[0030] While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. [Brief explanation of the drawings]

[0031] [Figure 1] 1 is a side view of an introducer sheath extending into a blood vessel according to an embodiment of the present disclosure; [Figure 2] 1 is a cross-sectional view of a medical device positioned within a blood vessel according to an embodiment of the present disclosure. [Figure 3]FIG. 10 is a side view of a valve hub assembly coupled to a clamping port according to an embodiment of the present disclosure. [Figure 4] 4 is a cross-sectional view of a valve hub assembly coupled to the clamping port of FIG. 3 in accordance with an embodiment of the present disclosure. [Figure 5] FIG. 4 is a close-up view of the valve hub assembly of FIG. 3 in accordance with an embodiment of the present disclosure. [Figure 6A] FIG. 4 is a close-up view of a seal for use with the valve hub assembly of FIG. 3 in accordance with an embodiment of the present disclosure. [Figure 6B] FIG. 6B is a side view of the seal of FIG. 6A according to an embodiment of the present disclosure. [Figure 7] FIG. 4 is an enlarged perspective view of a hub cap for use with the valve hub assembly of FIG. 3 according to an embodiment of the present disclosure. [Figure 8] FIG. 4 is an enlarged perspective view of a seal for use with the valve hub assembly of FIG. 3 according to an embodiment of the present disclosure. [Figure 9] FIG. 4 is an enlarged perspective view of a pusher for use with the valve hub assembly of FIG. 3 in accordance with an embodiment of the present disclosure. [Figure 10A] FIG. 4 is an enlarged front perspective view of a locking nut for use with the valve hub assembly of FIG. 3 in accordance with an embodiment of the present disclosure. [Figure 10B] FIG. 10B is an enlarged rear perspective view of the locking nut of FIG. 10A according to an embodiment of the present disclosure. [Figure 11] FIG. 4 is an enlarged side perspective view of a sleeve holder for use with the valve hub assembly of FIG. 3 in accordance with an embodiment of the present disclosure. [Figure 12] FIG. 4 is an enlarged side view of a suture pad for use with the valve hub assembly of FIG. 3 in accordance with an embodiment of the present disclosure. [Figure 13] 4 is a flowchart of a method of securing a medical device positioning through use of the valve hub assembly of FIG. 3 according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0032] Hemostatic valve hub assemblies facilitate the insertion and positioning of one or more medical devices (e.g., catheters, guidewires) while also helping to prevent blood leakage during a procedure. Certain embodiments of the present disclosure feature assemblies having components that help secure the position of one or more medical devices while maintaining a seal. Additionally, certain embodiments of the present disclosure also provide devices that allow for easy repositioning of one or more medical devices.

[0033] FIG. 1 shows a side cross-sectional view of a blood vessel V with an introducer sheath 100 at least partially inserted into the blood vessel V. While the disclosure herein is primarily made with reference to the introducer sheath 100, as described further herein, the disclosure may also be applied to repositioning sheaths. In some embodiments, the introducer sheath 100 is used to facilitate the passage of various relatively large medical devices, such as a blood pump, as described further herein, that are threaded through the introducer sheath 100 and into the blood vessel V. Accordingly, the introducer sheath 100 may be referred to as a large-bore introducer sheath. 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 introducer sheath 100 extends between proximal end 106 and distal end 108, and body portion 110 defines a lumen 112 of introducer sheath 100. Introducer sheath 100 may be formed from a variety of polymeric or metallic materials, and in further embodiments, introducer sheath 100 may include additional surface coatings.

[0034] A hemostatic valve hub 120 (hereinafter referred to as "hub 120" for simplicity) is generally included at the proximal end 106 of the introducer sheath 100 and fits over a proximal opening of the introducer sheath 100. The hub 120 is configured to achieve hemostasis, for example, by helping to prevent blood from leaking out of the introducer sheath 100 during use. A medical device, such as a catheter 170, can be inserted into the blood vessel V through the hub 120 and introducer sheath 100, and the hub 120 can maintain hemostasis between the catheter 170, the introducer sheath 100, and the external environment. In some embodiments, the catheter 170 can be coupled to a medical device, such as the blood pump 150 shown in FIG. 2. After insertion of the catheter 170, it may be desirable to secure the axial and radial position of the catheter 170 to ensure that the catheter 170 (and any coupled medical device) remains in the proper position during use. It may also be desirable for the operator to reposition the catheter 170 (and any associated medical devices) after insertion. Accordingly, the hub 120 may include a multi-component clamping port 130 within the hub 120 that provides fixation of the catheter 170 relative to the hub 120 and the vessel V, as described further herein. The hub 120 and the clamping port 130 may also allow for repositioning of the catheter 170 relative to the hub 120 and the vessel V.

[0035] FIG. 2 shows a cross-sectional view of the introducer sheath 100 of FIG. 1 after a medical device, such as blood pump 150, has been inserted into the introducer sheath 100. As described above, a catheter, such as catheter 170, may be coupled to a proximal portion of the blood pump 150 and extend outside of the blood vessel V and 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 integral or unitary. The impeller assembly housing 140 houses an impeller assembly 144 therein. The impeller assembly 144 includes an impeller shaft 146 and an impeller 148 that rotates relative to the impeller assembly housing 140 to drive blood through the blood pump 150. More specifically, impeller 148 directs blood to flow from a blood inlet 151 formed on impeller assembly housing 140, through impeller assembly housing 140, and out a blood outlet 152 formed on impeller assembly housing 140. In some embodiments, impeller shaft 146 and impeller 148 may be integrally formed, while in other embodiments, impeller shaft 146 and impeller 148 may be separate components. As shown in FIG. 2 , inlet 151 may be formed at an end of impeller assembly housing 140, and outlet 152 may be formed at a side of impeller assembly housing 140. In other embodiments, inlet 151 and / or outlet 152 may be formed in other portions of impeller assembly housing 140. In some embodiments, impeller assembly housing 140 may be coupled to a distally extending cannula that may receive and deliver blood to blood inlet 151.

[0036] 2 , motor housing 142 carries motor 154, which is configured to rotatably drive impeller 148 relative to impeller assembly housing 140. In the illustrated embodiment, motor 154 rotates drive shaft 156, which is coupled to drive magnet 158, and rotation of drive magnet 158 ​​rotates driven magnet 160, which is connected to impeller assembly housing 140. More particularly, in embodiments incorporating impeller shaft 146, impeller shaft 146 and impeller 148 are configured to rotate with driven magnet 160. In other embodiments, motor 154 can be coupled to impeller assembly housing 140 via other components. While introducer sheath 100 is illustrated above in conjunction with use with blood pump 150, various other medical devices can be used in conjunction with introducer sheath 100 and hemostasis valve hub 120.

[0037] 3 and 4 illustrate an embodiment of a hemostasis valve hub assembly having a hemostasis valve hub 220 (hereinafter "hub 220" for simplicity), a port 240 (e.g., clamping port 240), and a suture pad 326 coupled together. Illustratively, hub 220 is comprised of multiple components, including a safety cap 242 and a primary seal 244 (shown in FIG. 4). Clamping port 240 is comprised of multiple components, including a radially expandable seal or Toohey seal 270 (FIG. 4), a hub cap 248, a pusher 276 engaged with hub cap 248, a lock nut 292 engaged with pusher 276, a sleeve holder 308 positioned at least partially over pusher 276, and a sleeve gripper 320 positioned around sleeve holder 308. The hub 220 will be further described with reference to Figures 3 and 4 and the enlarged view of Figure 5. As shown, the hub 220 includes a proximal end 222 and a distal end 224. The hub 220 further includes a first arm 226 having a first lumen 228 extending between the proximal end 222 and the distal end 224, and a second arm 230 having a second lumen 232 extending between the proximal end 222 and the distal end 224. As shown, the first lumen 228 and the second lumen 232 are radially separated from one another along most of the length of the hub 220, although the first and second lumens 228, 232 may join together at the distal end 224 of the hub 220. In other embodiments, the first and second lumens 228, 232 may remain separate and connect to separate lumens within a sheath, for example, a dual-lumen sheath. Thus, hub 220 allows separate tools to be simultaneously inserted through first lumen 228 and second lumen 232 of hub 220 and then through hub 220 into blood vessel V. For example, first lumen 228 may be used to receive a larger medical device (e.g., a sheath, catheter, blood pump), while second lumen 232 may be used to receive a smaller tool, such as a guidewire.

[0038] 3, the hub 220 includes a collar 258 extending from the proximal end 222 and having at least one notch 259 extending therein. The collar 258 and the at least one notch 259 can be configured to engage with the hub cap 248, as described further herein.

[0039] The components of the hub 220 and the fastening port 240 are further described with reference to FIGS. 3, 4, and 6-12. For example, as shown in FIGS. 3 and 4, the safety cap 242 is engaged with the proximal end of the second arm 230 of the hub 220. In some embodiments, the safety cap 242 is threadedly engaged with the second arm 230, although various other fastening mechanisms may be incorporated. For example, as shown in FIG. 4, the safety cap 242 may have a plurality of threads 246 on its inner surface to assist in engaging the second arm 230 and forming a fluid-tight seal between the second lumen 232 and the safety cap 242. Additionally, as shown in FIG. 3, the safety cap 242 may have a plurality of ribs 247 on its outer surface to assist an operator in gripping the safety cap 242 during removal from or insertion into the second arm 230.

[0040] The primary seal 244 is shown disposed against the first lumen 228 of the first arm 226 at the proximal end 222 of the hub 220. The primary seal 244 is configured to help provide a fluid-tight seal around the clamping port 240 and a medical device passing through the hub 220, as described further herein. Referring to the enlarged view of FIG. 6A , the primary seal 244 has a generally circular shape and a diameter D1. The diameter D1 may have a value between about 8 mm and about 11 mm, and for example, in some embodiments, the value may be about 9 mm. Additionally, as best shown in FIG. 6A , the primary seal 244 may have a thickness T1. The thickness T1 may have a value between about 1.5 mm and 2.5 mm, and for example, in some embodiments, the thickness T1 is about 2 mm. With particular reference to FIG. 6A , the primary seal 244 may have a partial cross slit 238 having a length L1 of about 4.5 mm. The primary seal 244 may be constructed from a variety of other suitable materials, such as silicone or a polymer (eg, a thermoset elastomer (TSE) polymer, such as a thermosetting polymer, or a rubber, such as silicone rubber).

[0041] As shown in FIGS. 3 and 4 , the hub cap 248 may engage the proximal end 222 of the hub 220. With particular reference to the enlarged view of FIG. 7 , the hub cap 248 may include a first portion 250 having a diameter D2 and a second portion 252 having a diameter D3 that is larger than the diameter D2. For example, the diameter D2 may be between about 9 mm and about 11 mm, and the diameter D3 may be between about 12.5 mm and about 15 mm. The hub cap 248 may also include a transition wall 249 that defines a transition between the first portion 250 and the second portion 252. The second portion 252 of the hub cap 248 is positioned over the proximal end 222 of the hub 220 and configured to radially engage the hub 220 and receive the primary seal 244.

[0042] More specifically, as shown in FIG. 4 , the second portion 252 has a rib 256 extending from an inner surface 254 of the second portion 252 that can engage with the groove 234 of the hub 220. The engagement between the rib 256 and the groove 234 can be facilitated by a press fit between the hub 220 and the hub cap 248. Additionally, as shown in the enlarged view of FIG. 7 , the hub cap 248 can include at least one protrusion 260 extending from an end face of the second portion 252 that can be received in a notch 259 in the collar 258 of the hub 220. For example, as shown in FIG. 3 , the protrusion 260 is shown engaging with the notch 259. In this manner, after the second portion 252 and the hub 220 are engaged, the hub cap 248 is prevented from rotating relative to the hub 220. As described below, preventing the hub cap 248 from rotating helps prevent rotation of the medical device from rotating the fastening port 240 during assembly.

[0043] 7, first portion 250 includes a plurality of threaded features 262 that may be configured for engagement with locking nuts 292 (FIG. 4), as described further herein. Additionally, hubcap 248 includes a lumen 264, as described further herein. Lumen 264 extends through both first portion 250 and second portion 252 to allow for reception of primary seal 244 within second portion 252 and radially expandable seal 270 (FIG. 4) within first portion 250. Additionally, first portion 250 of hubcap 248 may include an opening 266 that may be configured to receive a protrusion of pusher 276, as described further herein.

[0044] Referring again to FIGS. 3 and 4, the clamping port 240 includes a radially expandable seal 270 disposed within the first portion 250 (FIG. 3) of the hubcap 248. FIG. 8 shows a close-up perspective view of the radially expandable seal 270. The radially expandable seal 270 is defined in a generally cylindrical shape and has a lumen 272 extending therethrough. The radially expandable seal 270 may be a Toohey seal. In this case, axial compression of the seal 270 causes the seal 270 to radially expand and engage with an abutting surface. In these embodiments, this forms a fluid-tight seal around a medical device passing through the clamping port 240 in the hubcap 248. Thus, the seal 270 also secures the position of the medical device relative to the hub 220 and the clamping port 240.

[0045] As previously referenced, the first portion 250 of the hubcap 248 may be engaged with a pusher 276. Referring to FIGS. 3, 4, and 9, the pusher 276 may be at least partially received within the hubcap 248 and engaged with the radially expandable seal 270. FIG. 9 shows a perspective view of the pusher 276. As shown, the pusher 276 has a cylindrical configuration with a proximal portion 278, a distal portion 280, and a lumen 282 extending therethrough. The pusher 276 has a body shaped or coupled to various components to provide various functions described herein, including engaging other components of the valve hub assembly to help provide a seal. The body of the pusher 276 is defined by an outer surface 284 having a plurality of ribs 286 and a plurality of protrusions 288 extending therefrom. More specifically, the plurality of ribs 286 includes a first rib 286a disposed toward the proximal portion 278 of the pusher 276 and a second rib 286b disposed toward the distal end 280 of the pusher 276. The plurality of protrusions 288 extend radially outward from the outer surface 284 and include a first protrusion 288a and a second protrusion 288b positioned opposite one another along the circumference of the pusher 276. In other words, the first and second protrusions 288a, 288b may be circumferentially spaced apart by approximately 180 degrees. The first and second protrusions 288a, 288b may be circumferentially spaced apart by approximately 180 degrees. The plurality of protrusions 288 further includes a third protrusion 288c that is disposed distally of the second rib 286b and positioned circumferentially offset relative to the first and second protrusions 288. As described further herein, the plurality of ribs 286 and the plurality of protrusions 288 may be configured to engage and secure the pusher 276 with the hubcap 248, the locknut 292, and the sleeve holder 308.

[0046] Lock nut 292 will be further described herein with reference to FIG. 4 and the enlarged views in FIGS. 10A and 10B. As shown, lock nut 292 has a generally cylindrical exterior with a lumen 294 extending therethrough. Additionally, lock nut 292 includes a plurality of ribs 291 disposed about the exterior surface of lock nut 292. The plurality of ribs 291 allow an operator to grip or grasp lock nut 292 and make it easier to rotate lock nut 292 during use. Furthermore, lock nut 292 includes a plurality of threaded features 296, or ribs, extending from an interior surface 301 of lock nut 292, which may be used for engagement with pusher 276 and / or hub cap 248, as further described herein. Additionally, with particular reference to FIG. 10A, lock nut 292 includes a collar 298 extending radially inward from interior surface 301 of lock nut 292. The collar 298 may have at least one notch 302, or illustratively two notches 302a, 302b, which may be used for engagement between the lock nut 292 and the pusher 276.

[0047] 3 and 4, the sleeve holder 308 may also be fitted over a portion of the pusher 276, illustratively the proximal portion 278 of the pusher 276. As shown, the sleeve holder 308 does not engage the locking nut 292, such that the sleeve holder 308 and the locking nut 292 can move independently of one another. The sleeve holder 308 will be further described with reference to the enlarged view of FIG. 11. The sleeve holder 308 is defined by an engagement portion 310 configured to engage the pusher 276 and a second portion 312 extending proximally from the engagement portion 310 and having a lumen 314 extending therethrough. More specifically, the engagement portion 310 is defined by a collar 316 extending outward from the second portion 312. The collar 316 includes two notches 318a and 318b that may extend into openings 319a and 319b, respectively, defined by a wall of the collar 316. As shown, each of the openings 319a and 319b has a generally rectangular shape, although various other configurations may be incorporated. As described further herein, the openings 319a and 319b are configured to receive protrusions of the pusher 276 and facilitate engagement between the sleeve holder 308 and the pusher 276. Additionally, the sleeve holder 308 includes a rib 336 extending circumferentially around the second portion 312. The second portion 312 may be configured to receive the sleeve gripper 320. The sleeve gripper 320 is cylindrical and defines a lumen 322 extending therethrough. The sleeve gripper 320 may further include a groove 338 ( FIG. 4 ). The groove 338 may engage the sleeve holder 308 when the second portion 312 of the sleeve holder 308 is received within the lumen 322 of the sleeve gripper 320. In this manner, the second portion 312 is received within the lumen 322 of the sleeve gripper 320 upon engagement.

[0048] The suture pad 326 is configured to engage the distal end 224 of the hub 220 and includes a main portion 328 having a cylindrical configuration and a lumen 330 extending through the cylindrical configuration to receive the proximal end 222 of the hub 220. Additionally, the suture pad 326 includes at least two extensions 332 extending radially outward from the main portion 328. The two extensions 332 define a plane having a plurality of openings 334 extending therethrough. The two extensions 332 and the openings 334 extending therethrough enable the suture pad 326 to be secured on the patient. For example, the openings 334 may be used to suture the suture pad 326 to the patient's skin. However, various other mechanisms for securing the hub 220 to the patient may be incorporated.

[0049] Assembly and engagement of the suture pad 326 and clamping port 240 components to the hub 220 will be further described herein with reference to Figures 3 and 4. As shown, the suture pad 326 is engaged with the distal end 224 of the hub 220. More specifically, a main portion 328 of the suture pad 326 is disposed over the distal end 224 of the hub 220 such that the distal end 224 is received within the lumen 330 of the suture pad 326. Additionally, a safety cap 242 is shown engaged with the second arm 230 of the hub 220. As previously mentioned, the safety cap 242 includes a plurality of threads 246 for engaging the second arm 230 such that a portion of the safety cap 242 is disposed around the second arm 230 and another portion is disposed within the lumen 232 of the second arm 230. This engagement of the safety cap 242 with the hub 220 allows for a hemostatic seal within the second arm 230 . 3 and 4 , primary seal 244 is disposed relative to proximal end 222 of hub 220, and more specifically, relative to first arm 226. Furthermore, partial cross slit 238 aligns with first lumen 228 of first arm 226 such that a continuous lumen is formed through first arm 226 and primary seal 244, allowing a medical device to be inserted through hub 220 and partial cross slit 238 of primary seal 244. Furthermore, hub cap 248 is disposed over primary seal 244 and engaged with proximal end 222 of hub 220. As previously described, groove 234 of hub 220 engages with rib 256 of hub cap 248 to secure the connection between hub 220 and hub cap 248. Thus, a hemostatic seal can be formed between catheter 170 and primary seal 244, and thereby between catheter 170 and primary seal 244. Additionally, protrusion 260 of hubcap 248 may be disposed within notch 259 formed in collar 258 that extends around first arm 226 of hub 220. In this manner, when hubcap 248 is engaged with hub 220, rotation of hubcap 248 is prevented because protrusion 260 is positioned on the edge of notch 259 in collar 258. In other words, protrusion 260 engages notch 259, preventing hubcap 248 from rotating or being removed from hub 220 when tightening or loosening locknut 292 or when repositioning any medical device extending through hub 220.

[0050] 3 and 4 , radially expandable seal 270 is disposed within first portion 250 of hubcap 248 and against transition wall 249 of hubcap 248. During assembly, radially expandable seal 270 may be disposed within first portion 250 of hubcap 248, and pusher 276 may be used to axially compress radially expandable seal 270 against transition wall 249 while pusher 276 is engaged with hubcap 248. More specifically, distal end 224 of pusher 276 may be disposed within first portion 250 of hubcap 248, and third protrusion 288 c may engage opening 266 of hubcap 248 to limit rotation of pusher 276 relative to hubcap 248. The pusher 276 may be pressed into the hubcap 248 until the second rib 286b is disposed adjacent the proximal end 222 of the hubcap 248. Once the pusher 276 is engaged with the hubcap 248 in this manner, the engagement of the pusher 276 with the radially expandable seal 270 and the hubcap 248 may be secured by a locking nut 292. The locking nut 292 may be disposed over the pusher 276 until the locking nut 292 is disposed distally relative to the rib 286a toward the proximal end 278 of the pusher 276. More specifically, when locking nut 292 is placed over pusher 276, first and second protrusions 288a, 288b of pusher 276 can be inserted through notches 302a, 302b of collar 298, with first and second protrusions 288a, 288b located proximally relative to notches 302a, 302b. As previously mentioned, locking nut 292 is positioned such that rib 268a is located proximally relative to notches 302a, 302b and, therefore, collar 298. When placed over pusher 276, threads 294 of hubcap 248 engage threaded feature 262 of hubcap 248.In this manner, locking nut 292 is rotatable into engagement with hubcap 248 such that hubcap 248 moves distally and thereby actuates pusher 276 distally, further forcing pusher 276 against radially expandable seal 270. This allows radially expandable seal 270 to expand and seal against the inner surface of hubcap 248 and, in turn, against a medical device passing through seal 270. However, engagement of third protrusion 288c within opening 266 of hubcap 248 helps ensure that rotation of locking nut 292 only pushes pusher 276 distally to a predetermined extent. In other words, distal movement of pusher 276 relative to expandable seal 270 continues until protrusion 288c abuts the surface of opening 266.

[0051] In this manner, a hemostatic seal may be created between a medical device extending into radially expandable seal 270 and hub cap 248. Additionally, expandable seal 270 may secure the position of the medical device relative to hub 220. For example, it may help prevent the medical device from moving axially or radially within hub 220. In one embodiment, expansion of expandable seal 270 as described herein may secure catheter 170 within hub 220, which helps prevent axial movement of the catheter within hub 220. In another embodiment, expansion of expandable seal 270 as described herein may secure catheter 170 within hub 220, which helps prevent axial movement of the catheter within hub 220, which in turn secures the position of blood pump 150 coupled to catheter 170 within the patient's vasculature.

[0052] To reposition the medical device, lock nut 292 is loosened by rotating lock nut 292 so that it moves proximally relative to pusher 276, releasing the engagement between pusher 276 and lock nut 292. This releases at least some compression between pusher 276 and expandable seal 270, moving pusher 276 away from expandable seal 270 and releasing expandable seal 270 from pressing against the inner surface of hub cap 248 and against a medical device passing through seal 270, allowing the medical device to be repositioned. After repositioning is complete, lock nut 292 can be retightened to secure the medical device in place again.

[0053] 3 and 4, sleeve holder 308 is positioned over proximal end 278 of pusher 276 such that engagement portion 310 can engage first and second protrusions 288a, 288b of pusher 276. After first and second protrusions 288a, 288b are inserted through opening 319 of sleeve holder 308, sleeve holder 308 can be rotated to engage first and second protrusions 288a, 288b with the wall of collar 316 of engagement portion 310.

[0054] Finally, the sleeve gripper 320 may then be positioned over the second portion 312 of the sleeve holder 308. As shown, the ribs 336 of the sleeve holder 308 may engage with the grooves 338 (FIG. 4) of the sleeve gripper 320 to ensure a secure coupling between the sleeve gripper 320 and the sleeve holder 308. This engagement may occur after positioning the sterile sleeve over the sleeve gripper 320 to secure the positioning of the sleeve holder 308.

[0055] As described throughout, various medical devices may be inserted through the hub 220 for insertion into the introducer sheath 100. For example, the catheter 170, the blood pump 150, and / or various other medical devices may be inserted through the hub 220 for positioning within the blood vessel V. In some embodiments, it may be desirable to remove the introducer sheath 100 and replace it with a repositioning sheath. In these embodiments, the hub 220 and clamping port 240 may be located at the proximal end of the repositioning sheath, even though the dimensions of the hub 220 and clamping port 240 or their components may be different when used with the repositioning sheath compared to the introducer sheath. In particular, the clamping port 240 may provide the advantage of allowing for repositioning of the catheter 170, the blood pump 150, and / or various other medical devices that may be inserted through the hub 220 and accompanying sheath by allowing for loosening and re-clamping of the clamping port 240 after initial positioning of the medical device. In particular, the clamping port 204 may allow for repositioning of the medical device while avoiding concomitant twisting of the sterile sleeve due to the sleeve holder 308 being independent of the locking nut 292. This allows the user to tighten or loosen the locking nut 292, allowing for repositioning of the medical device, and then retighten the locking nut 292. The overall process is further described with reference to FIG.

[0056] 13 is a flow chart illustrating a method 400 for locking the placement of a medical device extending through the hub 220 and the clamping port 240, such as a catheter 170. Although the description is given herein with reference to a catheter 170, various other medical devices may be used with the methods described herein. For example, the method 400 may be adapted for use with a catheter 170 coupled to a blood pump 150.

[0057] At block 402, the method 400 first includes assembling the hub 220 having the fastening port 240 onto the sheath. In some embodiments, the sheath may be the introducer sheath 100, while in other embodiments, the sheath may be a repositioning sheath. The method 400 is described herein with reference to the introducer sheath 100. When the hub 220 is assembled onto the sheath 100, the fastening port 240 may be fully assembled, as shown in FIG. 3, but the locking nut 292 may be in a loosened configuration.

[0058] At block 404, the method 400 further includes delivering a medical device, such as a catheter 170, through the hub 220, i.e., through the clamping port 240 and the introducer sheath 100. This step additionally includes verifying the position of the catheter 170 within the patient. This verification may be accomplished using fluoroscopy or various other imaging modalities. Although described herein as a catheter 170, in some embodiments, the blood pump 150 may be delivered through the hub 220 and the introducer sheath 100, and the position of the blood pump 150 within the patient may be verified.

[0059] Further, at block 406, the method 400 includes tightening the clamping port 240. In some embodiments, this step may further include actuating the locking nut 292 to engage the pusher 276 and axially compress the pusher 276 against the radially expandable seal 270. The radially expandable seal 270 therefore expands into sealing engagement with the inner surface of the hub cap 248. In this manner, a fluid-tight seal is formed around the catheter 170 within the hub cap 248, in addition to the fluid-tight seal provided by the primary seal 244 at the proximal end 222 of the hub 220. As described above, actuation of the expandable seal 270 fixes the position of the medical device relative to the hub 220 and the sheath 100. Additionally, the method 400 may also include repositioning the catheter 170 and / or blood pump 150 until the catheter 170 and / or blood pump 150 are in the desired position. Once the blood pump 150 is in the proper position, the lock nut 292 can be rotated as described above to push the pusher 276 distally into engagement with the expandable seal 270 and secure the position of the catheter 170. Due to the independent arrangement between the sleeve holder 308 and the lock nut 292, rotation of the lock nut 292 does not cause rotation of the sleeve holder 308; therefore, the sleeve holder 308 and sterile sleeve remain in place and do not need to be adjusted by the operator. Additionally, the method 400 may also include the step of repositioning the catheter 170 and / or blood pump 150 until the catheter 170 and / or blood pump 150 are in the desired position. Once the blood pump 150 is in the proper position, the lock nut 292 can be rotated as described above to push the pusher 276 distally and engage the expandable seal 270 to secure the position of the catheter 170. Due to the independent arrangement between the sleeve holder 308 and the lock nut 292, rotation of the lock nut 292 does not cause rotation of the sleeve holder 308, and therefore the sleeve holder 308 and sterile sleeve remain in place and do not need to be adjusted by the operator.

[0060] At block 408, method 400 further includes securing a sterile sleeve using clamping port 240. Prior to this step, the sterile sleeve was pre-secured between sleeve gripper 320 and sleeve holder 308, and sleeve gripper 320, sleeve holder 308, and sterile sleeve are a pre-assembled assembly. Thus, the step at block 408 includes mounting the pre-assembled sleeve gripper 320, sleeve holder 308, and sterile sleeve onto clamping port 240. As noted above, sleeve holder 308 does not engage locking nut 292, which means that locking nut 292 can be manipulated without manipulating sleeve holder 308. In other words, locking nut 292 can be tightened or loosened, and catheter 170 and / or blood pump 150 can be repositioned without affecting sleeve holder 308 or the attached sterile sleeve. Similarly, the lock nut 292 can be retightened after repositioning the catheter 170 and / or blood pump 150 without affecting the sleeve holder 308 or the attached sterile sleeve.

[0061] The ability to tighten the clamping port 240, and more specifically the radially expandable seal 270, and then secure the sleeve to the clamping port provides the advantage of considering possible repositioning of the catheter 170 and / or introducer sheath 100 before securing the sleeve. Because movement of the catheter 170 may displace the blood pump from a desired position, or because a physician may choose to reposition the blood pump after initial placement, the ability to tighten, loosen, and re-tighten the clamping port 240 before securing the sterile sleeve to the clamping port 240 may reduce the likelihood that the sterile sleeve will be twisted or otherwise deformed, and therefore may reduce the need to remove or reposition the sterile sleeve after repositioning the catheter 170 and / or blood pump.

[0062] Although the embodiments and methods have been described with reference to a catheter 170 and a blood pump 150 for receipt within the catheter 170, various other medical devices may be incorporated. Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the invention. For example, while the above-described embodiments refer to particular features, the scope of the invention also includes embodiments having different combinations of features and embodiments that do not include all of the above-described features.

Claims

1. 1. A valve hub assembly for use with a sheath, comprising: The valve assembly includes a valve hub having a proximal end opposite a distal end, a first arm defining a first lumen, and a second arm defining a second lumen; the valve assembly including a clamping port disposed at a proximal end of the valve hub; the clamping port includes a hub cap engaged with the clamping port, the hub cap defining a third lumen for receiving a radially expandable seal; the clamping port including a pusher that engages the radially expandable seal and is at least partially disposed within the hubcap; the clamping port including a lock nut disposed about the pusher and configured to clamp the pusher against the radially expandable seal. Valve hub assembly.

2. The valve hub assembly of claim 1 , wherein the clamping port further includes a sleeve holder that engages the pusher.

3. The valve hub assembly of claim 2 , wherein the clamping port further includes a sleeve gripper engageable with the sleeve holder.

4. The valve hub assembly of any one of claims 1 to 3, further comprising a suture pad engaging a distal end of the valve hub.

5. The valve hub assembly of any one of claims 1 to 4, wherein the clamping port further includes a primary seal disposed within the hub cap and positioned adjacent the first lumen.

6. 6. The valve hub assembly of claim 1, wherein the hub cap comprises a first portion, a second portion, and a transition wall defining a transition between the first portion and the second portion, and the radially expandable seal is disposed in the first portion and located adjacent to the transition wall.

7. 7. The valve hub assembly of claim 6, wherein the lock nut is configured to axially compress the pusher against the radially expandable seal such that the radially expandable seal radially expands to seal against an inner surface of the hub cap.

8. A valve hub assembly according to any preceding claim, wherein the radially expandable seal is a Toohey seal.

9. 9. A valve hub assembly as claimed in any one of claims 1 to 8, wherein the hub cap has a plurality of protrusions extending from a proximal end of the hub cap, and the valve hub has a collar with a plurality of openings, the plurality of protrusions on the hub cap engaging with the plurality of openings so as to prevent rotation of the hub cap relative to the valve hub.

10. 1. A method of positioning and securing the position of a medical device, comprising: The method comprises assembling a valve hub having a proximal end and a distal end to a sheath; The method includes disposing a clamping port at a proximal end of the valve hub, the clamping port comprising: a hubcap defining a first lumen for receiving a radially expandable seal; a pusher engaging the radially expandable seal and disposed at least partially within the hubcap; a lock nut disposed around the pusher and the hub cap to compress the pusher against the radially expandable seal; The method comprises delivering a medical device through the valve hub and the sheath; The method comprises inspecting the position of the medical device; The method comprises clamping the clamping port; The method comprises securing a sterile sleeve with the clamping port.

11. The method of claim 10 , wherein tightening the tightening port includes actuating the lock nut to move the pusher against the radially expandable seal.

12. The method of claim 11 , wherein the pusher radially expands the radially expandable seal to create a sealed engagement between the radially expandable seal and the hubcap.

13. 13. A method according to any one of claims 10 to 12, wherein the hubcap has a plurality of protrusions extending from a proximal end thereof, and the valve hub has a collar having a plurality of openings, the plurality of protrusions on the hubcap engaging with the plurality of openings so as to prevent rotation of the hubcap relative to the valve hub.

14. The method according to any one of claims 10 to 13, wherein the confirmation of the position of the medical device is performed by fluoroscopy.

15. 15. The method of any one of claims 10 to 14, wherein securing a sterile sleeve to the clamping port further comprises placing a sterile sleeve over a sleeve holder of the clamping port and placing a sleeve gripper over the sterile sleeve and the sleeve holder.

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