Sheath hub with built-in fastening port for catheter position locking

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 lumen, and a second arm defining a lumen. A fastening port is disposed at the proximal end of the valve hub. The fastening port includes a hub cap that engages the fastening port, a radially expandable seal located in a lumen of the hub cap, a push rod that engages the radially expandable seal and is at least partially disposed within the hub cap, and a lock nut that locks the radially expandable seal in the lumen of the hub cap. The lock nut is disposed about the pushrod and is configured to press the pushrod against the radially expandable seal.

Description

Cross Reference to Related Applications

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 447,707, filed on February 23, 2023, which is incorporated herein by reference. Technical Field

[0002] The present disclosure relates to a hub for a sheath. More particularly, the present disclosure relates to a hub having a built-in fastening port that can be used to secure a medical device, such as a catheter, within the hub and thereby fix the position of the catheter relative to the hub and sheath. BACKGROUND

[0003] In various procedures for delivering intravascular medical devices, a sheath is inserted into a patient's blood vessel, such as the femoral artery, and the medical device extends through the sheath and into the patient's vessel. In various cases, the medical device includes a catheter or other medical device, such as a blood pump. A hub can be incorporated into the proximal end of the sheath to reduce blood leakage as the device is inserted, positioned, and removed. In various cases, there may be a need to secure the position of the medical device within the sheath and vessel. In addition, there may be a need to reposition the medical device within the vessel. Therefore, there is a need for an improved fastening mechanism for securing a medical device, such as a catheter, to a sheath and vessel, which also allows for repositioning of the medical device within the vessel. Summary of the Invention

[0004] In Example 1, a valve hub assembly includes a valve hub and a securing port. The valve hub includes a proximal end opposite the distal end, a first arm portion defining a first lumen, and a second arm portion defining a second lumen. The securing port is disposed at the proximal end of the valve hub and includes a hub cap, a push rod, and a locking nut. The hub cap engages the securing port and defines a third lumen for receiving a radially expandable seal. The push rod engages the radially expandable seal and is at least partially disposed within the hub cap. The locking nut is disposed about the push rod and is configured to secure the push rod against the radially expandable seal.

[0005] In Example 2, the valve hub assembly of Example 1, wherein the fastening port further comprises a sleeve retainer that engages the push rod.

[0006] In Example 3, the valve hub assembly of Example 2, wherein the fastening port further comprises a sleeve gripper engageable with the sleeve retainer.

[0007] In Example 4, the valve hub assembly of any of the preceding examples further includes a suture pad that engages a distal end of the valve hub.

[0008] In Example 5, the valve hub assembly of any of the preceding examples, wherein the securement port further comprises a primary seal disposed within the hub cap and positioned adjacent to the first lumen.

[0009] In Example 6, the valve hub assembly of any of the preceding examples, 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 wherein the radially expandable seal is disposed within the first portion and adjacent to the transition wall.

[0010] In Example 7, the valve hub assembly of Example 6, wherein the locking nut is configured to axially compress the pushrod against the radially expandable seal such that the radially expandable seal radially expands to seal the inner surface of the hub cap.

[0011] In Example 8, the valve hub assembly of any of the preceding examples, wherein the radially expandable seal is a toriconical seal.

[0012] In Example 9, the valve hub assembly of any of the preceding examples, wherein the hub cap has a plurality of protrusions extending from a proximal end of the hub cap, the valve hub has a collar having a plurality of openings, and the plurality of protrusions of the hub cap engage the plurality of openings such that rotation of the hub cap relative to the valve hub is inhibited.

[0013] In Example 10, a method for positioning and securing a position of a medical device, comprising: assembling a valve hub on a sheath, the valve hub having a proximal end and a distal end; disposing a securement port at the proximal end of the valve hub, the securement port comprising a hub cap defining a first lumen for receiving a radially expandable seal, a pushrod engaging the radially expandable seal and at least partially disposed within the hub cap, and a locking nut disposed about the pushrod and hub cap for compressing the pushrod against the radially expandable seal; delivering a medical device through the valve hub and sheath; verifying a position of the medical device; securing the securement port; and securing a sterile sleeve with the securement port.

[0014] In Example 11, the method of Example 10, wherein securing the securement port comprises actuating the locking nut to move the pushrod against the radially expandable seal.

[0015] In Example 12, the method of Example 11, wherein the pushrod causes radial expansion of the radially expandable seal to cause a sealing engagement between the radially expandable seal and the hub cap.

[0016] In Example 13, the method of any of Examples 10-12, wherein the hub cap has a plurality of protrusions extending from a proximal end of the hub cap, the valve hub has a collar having a plurality of openings, and the plurality of protrusions of the hub cap engage the plurality of openings such that rotation of the hub cap relative to the valve hub is inhibited.

[0017] In Example 14, the method of any of Examples 10-13, wherein verification of the position of the medical device is via fluoroscopy.

[0018] In Example 15, the method of any of Examples 10-14, wherein securing the sterile sleeve to the fastening port further comprises placing the sterile sleeve on a sleeve holder of the fastening port and disposing a sleeve gripper on the sterile sleeve and the sleeve holder.

[0019] In Example 16, a valve hub assembly for use with a sheath includes a valve hub and a fastening port. The valve hub includes a proximal end opposite a distal end, a first arm portion defining a first lumen, and a second arm portion defining a second lumen. The fastening port is disposed at the proximal end of the valve hub and includes a hub cap, a push rod, and a locking nut; the hub cap engages the proximal end of the valve hub, the hub cap defining a third lumen for receiving a radially expandable seal; the push rod engages the radially expandable seal and is at least partially disposed within the hub cap; the locking nut is disposed about the push rod and is configured to secure the push rod against the radially expandable seal.

[0020] In Example 17, the valve hub assembly of Example 16, further comprising a sleeve holder for engaging the push rod without engaging the locking nut, wherein engagement of the sleeve holder and the push rod is configured such that rotation of the locking nut does not cause rotation of the sleeve holder.

[0021] In Example 18, the valve hub assembly of Example 17, wherein the fastening port further comprises a sleeve gripper that is capable of engaging the sleeve holder.

[0022] In Example 19, the valve hub assembly of Example 16, comprising a suture pad that engages the distal end of the valve hub.

[0023] In Example 20, the valve hub assembly of Example 16, wherein the fastening port further comprises a primary seal disposed within the hub cap and positioned adjacent to the first lumen.

[0024] 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 wherein the radially expandable seal is disposed within the first portion and adjacent to the transition wall.

[0025] In Example 22, the valve hub assembly of Example 21, wherein the locking nut is configured to axially move the push rod against the radially expandable seal such that the radially expandable seal radially expands to seal against an inner surface of the hub cap.

[0026] In Example 23, the valve hub assembly of Example 16, wherein the radially expandable seal is a toriconical seal.

[0027] In Example 24, the valve hub assembly of Example 16, wherein the hub cap has a plurality of protrusions extending from a proximal end of the hub cap, the valve hub has a collar having a plurality of openings, and the plurality of protrusions of the hub cap engage the plurality of openings such that rotation of the hub cap relative to the valve hub is inhibited.

[0028] In Example 25, a delivery system comprises: a sheath and a hemostatic valve assembly. The sheath has a proximal end and a distal end and is configured for insertion through a blood vessel. The hemostatic valve hub assembly engages the proximal end of the sheath and includes a securement port disposed at a proximal end of the hemostatic valve hub. The securement port includes: a hub cap engaging the proximal end of the hemostatic valve hub, the hub cap having a first portion and a second portion and defining a lumen; a radially expandable seal within the first portion; a push rod engaging the radially expandable seal and at least partially disposed within the hub cap; and a locking nut disposed about the push rod and the hub cap and configured to press the push rod against the radially expandable seal.

[0029] In Example 26, the delivery system of Example 25, wherein the hub cap further includes a transition wall defining a transition between the first portion and the second portion, wherein the radially expandable seal is positioned adjacent to the transition wall.

[0030] In Example 27, the delivery system of Example 25, wherein the locking nut is configured to axially press the push rod against the radially expandable seal.

[0031] In Example 28, the delivery system of Example 25, wherein the hemostatic valve hub includes a first arm and a second arm, and wherein the safety cap engages the second arm and the securement port engages the first arm.

[0032] In Example 29, the delivery system of Example 25, wherein the hub cap has a plurality of protrusions extending from a proximal end of the hub cap, and the hemostatic valve hub has a collar having a plurality of openings, and the plurality of protrusions of the hub cap engage the plurality of openings such that rotation of the hub cap relative to the hemostatic valve hub is inhibited.

[0033] In Example 30, a method for positioning and securing a medical device includes assembling a hemostatic valve hub onto a sheath. The method further includes placing a fastening port at a proximal end of the hemostatic valve hub, the fastening port comprising: a hub cap engaging the proximal end of the hemostatic valve hub and defining a lumen for receiving a radially expandable seal; the push rod engaging the radially expandable seal and being at least partially disposed within the hub cap; and the locking nut disposed about the push rod and the hub cap. The method further includes delivering the medical device through the hemostatic valve hub and the sheath, verifying the position of the medical device, tightening the fastening port of the hemostatic valve hub to press the push rod against the radially expandable seal, and securing a sterile sleeve with the fastening port.

[0034] In Example 31, the method of Example 30 wherein tightening of the tightening port of the hemostatic valve hub comprises actuating a locking nut to cause compression of the pushrod against the radially expandable seal.

[0035] In Example 32, the method of Example 31, wherein pressing the push rod against the radially expandable seal causes radial expansion of the radially expandable seal to cause sealing engagement between the radially expandable seal and the hub cover.

[0036] In Example 33, the method according to Example 30 is described, wherein the hub cap has a plurality of protrusions extending from a proximal end of the hub cap, the hemostasis valve hub has a collar having a plurality of openings, and the plurality of protrusions of the hub cap engage the plurality of openings such that rotation of the hub cap relative to the hemostasis valve hub is inhibited.

[0037] In Example 34, the method of Example 30, wherein verification of the position of the medical device is performed via fluoroscopy.

[0038] In Example 35, the method of Example 30 wherein securing the sterile sleeve to the securing port further comprises placing the sterile sleeve on a sleeve holder of the securing port and arranging a sleeve gripper on the sterile sleeve and the sleeve holder.

[0039] Although multiple embodiments are disclosed, other embodiments of the present invention will be apparent to those skilled in the art from the following detailed description, which shows and describes exemplary embodiments of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative and not restrictive. BRIEF DESCRIPTION OF DRAWINGS

[0040] Figure 1 A side view of an introducer sheath extended into a blood vessel is shown in accordance with an embodiment of the present disclosure.

[0041] Figure 2A cross-sectional view of a medical device positioned within a blood vessel is shown according to an embodiment of the present disclosure.

[0042] Figure 3 A side view of a valve hub assembly coupled to a securing port is shown according to an embodiment of the present disclosure.

[0043] Figure 4 According to an embodiment of the present disclosure, a device connected to Figure 3 sectional view of the valve hub assembly with the fastening port.

[0044] Figure 5 According to the embodiment of the present disclosure, Figure 3 Magnified view of the valve hub assembly.

[0045] Figure 6A According to an embodiment of the present disclosure, a method for Figure 3 An enlarged view of the seal used with the valve hub assembly.

[0046] Figure 6B According to the embodiment of the present disclosure, Figure 6A Side view of the seal.

[0047] Figure 7 According to an embodiment of the present disclosure, a method for Figure 3 An enlarged perspective view of a hub cover used with a valve hub assembly.

[0048] Figure 8 According to an embodiment of the present disclosure, a method for Figure 3 An enlarged perspective view of a seal used with a valve hub assembly.

[0049] Figure 9 According to an embodiment of the present disclosure, a method for Figure 3 An enlarged perspective view of a push rod used with a valve hub assembly.

[0050] Figure 10A According to an embodiment of the present disclosure, a method for Figure 3 An enlarged front perspective view of a locking nut used with a valve hub assembly.

[0051] Figure 10B According to the embodiment of the present disclosure, Figure 10A An enlarged perspective view of the locking nut.

[0052] Figure 11 According to an embodiment of the present disclosure, a method for Figure 3 An enlarged side perspective view of a sleeve retainer used with a valve hub assembly.

[0053] Figure 12 According to an embodiment of the present disclosure, a method for Figure 3An enlarged side view of a suture pad used with a valve hub assembly.

[0054] Figure 13 According to an embodiment of the present disclosure, Figure 3 Flowchart of a method for securing a position of a medical device using a valve hub assembly. DETAILED DESCRIPTION

[0055] The hemostatic valve hub assembly facilitates the insertion and positioning of one or more medical devices (e.g., catheters, guidewires) while also helping to prevent blood leakage during surgery. Certain embodiments of the present disclosure feature an assembly having components that assist in securing the position of one or more medical devices while maintaining a seal. Additionally, certain embodiments provide devices that facilitate the convenient repositioning of one or more medical devices.

[0056] Figure 1 A side cross-sectional view of a blood vessel V and an introducer sheath 100 is shown, with the introducer sheath 100 at least partially inserted into the blood vessel V. Although the disclosure herein is largely described with reference to the introducer sheath 100, the present disclosure may also be applicable to repositioning sheaths, as will be discussed further herein. In some embodiments, the introducer sheath 100 is used to facilitate insertion of various larger medical devices (such as a blood pump, such as will be described further herein) through the introducer sheath 100 and into the blood vessel V. Therefore, 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, which is opposite the proximal end 106. The introducer sheath 100 includes a proximal opening (not shown) adjacent to the proximal end 106 and a distal opening 109 adjacent to the distal end 108. The body portion 110 of the introducer sheath 100 extends between the proximal end 106 and the distal end 108, and the body portion 110 defines a lumen 112 of the introducer sheath 100. The introducer sheath 100 can be formed from various polymers or metal materials. In other embodiments, the introducer sheath 100 can include an additional surface coating. The surface coating can include, but is not limited to, silicone, PET, or an applicable polymer.

[0057] A hemostasis valve hub 120 (hereinafter referred to as "hub 120") is generally included at the proximal end 106 and is located on the proximal opening of the introducer sheath 100. The hub 120 is configured to provide hemostasis, for example by helping to prevent blood from leaking out of the introducer sheath 100 during use. For example, a medical device (such as a catheter 170) can be inserted through the hub 120 and the introducer sheath 100 and into the blood vessel V; 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 Figure 21 and 2. The blood pump 150 is shown. After insertion of the catheter 170, it may be necessary to fix the axial and radial position of the catheter 170 to ensure that the catheter 170 (and any attached medical device) remains in the proper position during use. It may also be desirable for the operator to reposition the catheter 170 (and any attached medical device) after insertion. Therefore, the hub 120 may include a fastening port 130, which includes several components within the hub 120 and provides for fixation of the catheter 170 relative to the hub 120 and the blood vessel V, as will be further described herein. The hub 120 and the fastening port 130 may also allow for repositioning of the catheter 170 relative to the hub 120 and the blood vessel V.

[0058] Figure 2 Shown is the medical device (such as blood pump 150) after being inserted into the introducer sheath 100. Figure 1 1. A cross-sectional view of the introducer sheath 100 is shown. As described above, a catheter (such as catheter 170) can be coupled to the proximal end 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 can be integrally or unitarily constructed. The impeller assembly housing 140 carries 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, the impeller 148 causes blood to flow from a blood inlet 151 formed on the impeller assembly housing 140, through the impeller assembly housing 140, and out of a blood outlet 152. In some embodiments, impeller shaft 146 and impeller 148 may be integrally formed; and in other embodiments, impeller shaft 146 and impeller 148 may be separate components. Figure 2 As shown, inlet 151 may be formed on an end portion of impeller assembly housing 140, and outlet 152 may be formed on a side portion of impeller assembly housing 140. In other embodiments, inlet 151 and / or outlet 152 may be formed on other portions of impeller assembly housing 140. In some embodiments, impeller assembly housing 140 may be coupled to a distally extending cannula, and the cannula may receive blood and deliver it to inlet 151.

[0059] Continue to refer Figure 2, the motor housing 142 carries a motor 154, and 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, which is coupled to a drive magnet 158. Rotation of the drive magnet 158 ​​causes rotation of a driven magnet 160, which is coupled to the impeller assembly housing 140. More specifically, in embodiments incorporating the impeller shaft 146, the impeller shaft 146 and the impeller 148 are configured to rotate together with the driven magnet 160. In other embodiments, the motor 154 may be coupled to the impeller assembly housing 140 via other components. Although the introducer sheath 100 is illustrated above using the blood pump 150, various other medical devices may be used in conjunction with the introducer sheath 100 and the hemostasis valve hub 120.

[0060] Figure 3 and Figure 4 An embodiment of a hemostatic valve hub assembly is shown having a hemostatic valve hub 220 (hereinafter referred to as "hub 220"), a port 240 (e.g., a fastening port 240), and a suture pad 326 coupled together. Illustratively, the hub 220 includes a plurality of components including a safety cap 242 and a primary seal 244 ( Figure 4 The fastening port 240 includes a plurality of components including a radially expandable seal or Tuohy seal 270 ( Figure 4 ), hub cap 248, push rod 276 (engaging hub cap 248), locking nut 292 (engaging push rod 276), sleeve retainer 308 (at least partially disposed on push rod 276), and sleeve gripper 320 (disposed about sleeve retainer 308).

[0061] refer to Figure 3 and Figure 4 as well as Figure 522 and 23. The hub 220 is further described herein and is an enlarged view of the hub 220. As shown, the hub 220 includes a proximal end 222 and a distal end 224. The hub 220 also 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 spaced apart from each other for most of the length of the hub 220; however, the first lumen 228 and the second lumen 232 can be joined together at the distal end 224 of the hub 220. In other embodiments, the first lumen 228 and the second lumen 232 can remain separate and connect the separate lumens in a sheath (e.g., a dual-lumen sheath). Thus, the hub 220 allows separate tools to be simultaneously inserted through the first lumen 228 and the second lumen 232 of the hub 220 , and then simultaneously inserted through the hub 220 and into the blood vessel V. For example, the first lumen 228 may be used to receive a larger medical device (e.g., a sheath, a catheter, a blood pump), while the second lumen 232 may be used to receive a smaller tool, such as a guidewire.

[0062] In addition, if Figure 3 As shown, hub 220 includes a collar 258 extending from proximal end 222 and having at least one cutout 259 extending within collar 258. Collar 258 and at least one cutout 259 may be configured to engage hub cap 248, as will be further described herein.

[0063] refer to Figure 3 、 Figure 4 and Figures 6 to Figure 12 , the components of the hub 220 and the fastening port 240 will be further described. For example, Figure 3 and Figure 4 As shown, the safety cap 242 engages the proximal end of the second arm portion 230 of the hub 220. In some embodiments, the safety cap 242 threadably engages the second arm portion 230; however, various other securing mechanisms may be incorporated. For example, Figure 4 As shown, the safety cap 242 may have a plurality of threads 246 on an inner surface of the safety cap 242 for engaging the second arm 230 and helping to form a fluid tight seal between the second lumen 232 and the safety cap 242. Figure 3 As shown, the safety cover 242 may have a plurality of ribs 247 on an outer surface of the safety cover 242 for assisting an operator in gripping the safety cover 242 on the second arm 230 during removal or insertion of the safety cover 242 .

[0064] A primary seal 244 is shown positioned 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 assist in providing a fluid tight seal around a medical device that passes through the fastening port 240 and the hub 220, as will be further described herein. Figure 6A In the enlarged view of FIG, the main seal 244 is defined by a generally circular shape having a diameter D1. The diameter D1 may have a value between about 8 mm and about 11 mm. For example, in some embodiments, the diameter D1 may have a value of about 9 mm. In addition, as Figure 6A As best shown, the primary seal 244 can have a thickness T1. The thickness T1 can have a value between approximately 1.5 mm and 2.5 mm. For example, in some embodiments, the thickness T1 is approximately 2 mm. Specifically referring to Figure 6A , the primary seal 244 can have a partial cross slit 238 having a length L1 of approximately 4.5 mm. The primary seal 244 can include silicone, or various other suitable materials, such as polymers (e.g., thermosetting polymers such as thermosetting elastomer (TSE) polymers, and rubbers such as silicone rubber).

[0065] like Figure 3 and Figure 4 As shown, the hub cap 248 can snap fit the proximal end 222 of the hub 220. Figure 7 As shown in the enlarged view of FIG, 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 diameter D2. For example, diameter D2 may have a value between approximately 9 mm and approximately 11 mm, and diameter D3 may have a value between approximately 12.5 mm and approximately 15 mm. Hub cap 248 may also include a transition wall 249 that defines a transition between first portion 250 and second portion 252. Second portion 252 of hub cap 248 is configured to be positioned over proximal end 222 of hub 220, to radially engage hub 220, and to receive primary seal 244.

[0066] More specifically and as Figure 4 As shown, the second portion 252 has a rib 256 extending from the inner surface 254 of the second portion 252, and the rib 256 can engage 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. Figure 7 As shown in the enlarged view of FIG, the hub cap 248 may include at least one protrusion 260 extending from the end surface of the second portion 252, and the protrusion 260 may be received in the cutout 259 of the collar 258 of the hub 220. For example, this is shown in FIG. Figure 325 , wherein the protrusion 260 is shown as a snap-fit ​​notch 259. Thus, after the second portion 252 and the hub 220 are snap-fitted, the hub cap 248 is inhibited from rotating relative to the hub 220. As will be described below, inhibiting the rotation of the hub cap 248 helps inhibit the rotation of the medical device to avoid causing the fastening port 240 to rotate during assembly.

[0067] Continue to refer Figure 7 The first portion 250 includes a plurality of threaded features 262 that can be configured to engage a locking nut 292 ( Figure 4 ), as will be further described herein. In addition, the hub cap 248 includes a lumen 264 extending through both the first portion 250 and the second portion 252, which allows the primary seal 244 to be received within the second portion 252 and the radially expandable seal 270 ( Figure 4 ) is received within the first portion 250, as will be further described herein. Additionally, the first portion 250 of the hub cap 248 can include an opening 266 that can be configured to receive a protrusion of the push rod 276, as will be further described herein.

[0068] Reference again Figure 3 and Figure 4 , the fastening port 240 includes a radially expandable seal 270 disposed within the first portion 250 of the hub cover 248 ( Figure 3 ). Figure 8 An enlarged perspective view of a radially expandable seal 270 is shown. The radially expandable seal 270 is defined by a generally cylindrical shape and has a lumen 272 extending therethrough. The radially expandable seal 270 can be a Toshi seal, such that axial compression of the seal 270 causes radial expansion of the seal 270 to engage a surface against which the seal 270 is positioned. In these embodiments, this creates a fluid-tight seal around a medical device that passes through the fastening port 240 within the hub cap 248. Thus, the seal 270 also secures the position of the medical device relative to the hub 220 and the fastening port 240.

[0069] As previously referenced, the first portion 250 of the hub cap 248 can engage the push rod 276. Figure 3 、 Figure 4 and Figure 9 The push rod 276 is further described herein. The push rod 276 can be at least partially received within the hub cap 248 and engage the radially expandable seal 270. Figure 9A perspective view of a push rod 276 is shown. As shown, the push rod 276 has a cylindrical configuration with a proximal end 278 and a distal end 280 and a lumen 282 extending therethrough. The push rod 276 has a body that is shaped to (or coupled to various components) provide the various functions described herein, including engaging other components of the valve hub assembly to assist in providing a seal. The body of the push rod 276 is defined by an outer surface 285, which has a plurality of ribs 286 and a plurality of protrusions 288 extending therefrom. More specifically, the plurality of ribs 286 include a first rib 286a disposed toward the proximal end 278 of the push rod 276 and a second rib 286b disposed toward the distal end 280 of the push rod 276. The plurality of projections 288 include a first projection 288a and a second projection 288b that extend radially outward from the outer surface 284 and are positioned opposite each other along the circumference of the push rod 276. In other words, the first projection 288a and the second projection 288b may be circumferentially spaced approximately 180 degrees apart. The first projection 288a and the second projection 288b are disposed proximally relative to the first rib 286a.

[0070] The plurality of protrusions 288 also includes a third protrusion 288c disposed distally from the second rib 286b and positioned circumferentially offset relative to the first and second protrusions 288. As will be further described herein, the plurality of ribs 286 and the plurality of protrusions 288 can be configured to engage and secure the push rod 276 with the hub cap 248, the locking nut 292, and the sleeve retainer 308.

[0071] refer to Figure 10A and Figure 10B A magnified view of Figure 4 , the locking nut 292 will be further described herein. As shown, the locking nut 292 has a generally cylindrical outer shape with a lumen 294 disposed therein. In addition, the locking nut 292 includes a plurality of ribs 291 arranged about an outer surface of the locking nut 292, the plurality of ribs 291 increasing the ease with which an operator can grip or grasp the locking nut 292 and rotate the locking nut 292 during use. Additionally, the locking nut 292 includes a plurality of threaded features 296 or ribs extending from an inner surface 301 of the locking nut 292, which can be used to engage the push rod 276 and / or the hub cap 248, as will be further described herein. Additionally, with specific reference to Figure 10A , the locking nut 292 includes a collar 298 that extends radially inward from an inner surface 301 of the locking nut 292. The collar 298 can have at least one cutout 302, or illustratively two cutouts 302a, 302b, that can be used for engagement between the locking nut 292 and the push rod 276.

[0072] In addition, reference Figure 3 and Figure 4 , the sleeve retainer 308 may also be received on a portion of the push rod 276, illustratively on the proximal end 278 of the push rod 276. Note that, as shown, the sleeve retainer 308 does not engage the locking nut 292, thereby allowing the sleeve retainer 308 and the locking nut 292 to move independently of each other. Figure 11 , sleeve holder 308 will be described further herein. The sleeve holder 308 is defined by an engagement portion 310 configured to engage the push rod 276 and a second portion 312 extending proximally from the engagement portion 310 and having a lumen 314 extending therethrough. More particularly, the engagement portion 310 is defined by a collar 316 extending outwardly from the second portion 312. The collar 316 includes two cutouts 318a and 318b, each of which can extend into openings 319a, 319b defined by the walls of the collar 316. As shown, each of the openings 319a and 319b is generally rectangular in shape, however, various other configurations may be incorporated. As will be described further herein, the openings 319a and 319b are configured to receive a protrusion of the push rod 276 to facilitate engagement of the sleeve holder 308 with the push rod 276. Furthermore, the sleeve holder 308 includes a rib 336 that extends circumferentially around the second portion 312. The second portion 312 can be configured to receive a gripper 320. The sleeve gripper 320 is cylindrical and defines a lumen 322 extending therethrough. The sleeve gripper 320 can additionally include a groove 338 ( Figure 4 ); when the second portion 312 of the sleeve holder 308 is received within the lumen 322 of the sleeve gripper 320, the groove 338 can engage the sleeve holder 308. Thus, when engaged, the second portion 312 is received within the lumen 322 of the sleeve gripper 320.

[0073] 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 suture pad 326 and for receiving the proximal end 222 of the hub 220. In addition, the suture pad 326 includes at least two extensions 332 extending radially outward from the main portion 328. The two extensions 332 define a flat surface having a plurality of openings 334 extending therethrough. The two extensions 332 and the openings 334 extending therethrough allow the suture pad 326 to be secured to a subject. For example, the openings 334 can be used to sew the suture pad 326 to the patient's skin. However, various other mechanisms for securing the hub 220 to the patient may be incorporated.

[0074] refer to Figure 3 andFigure 4 , the assembly and engagement of the suture pad 326 and the components of the fastening port 240 onto the hub 220 will be described herein. As shown, the suture pad 326 engages the distal end 224 of the hub 220. More specifically, the main portion 328 of the suture pad 326 is disposed on the distal end 224 of the hub 220 such that the distal end 224 of the hub 220 is received within the lumen 330 of the suture pad 326. Additionally, the safety cap 242 is shown engaging the second arm 230 of the hub 220. As previously described, the safety cap 242 includes a plurality of threads 246 for engaging the second arm 230 of the hub 220 such that a portion of the safety cap 242 is disposed around the second arm 230 and a portion of the safety cap 242 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.

[0075] Still refer to Figure 3 and Figure 4 , the primary seal 244 is positioned against the proximal end 222 of the hub 220, and more particularly, against the first arm 226 of the hub 220. Additionally, the partial cross slit 238 is aligned with the first lumen 228 of the first arm 226, such that a continuous lumen is formed through the first arm 226 and the primary seal 244, allowing a medical device to be inserted through the hub 220 and the partial cross slit 238 of the primary seal 244. Additionally, the hub cap 248 is disposed over the primary seal 244 and engages the proximal end 222 of the hub 220. As previously described, the groove 234 of the hub 220 engages the rib 256 of the hub cap 248 to secure the coupling between the hub 220 and the hub cap 248. Thus, a hemostatic seal can be formed between the catheter 170 and the primary seal 244 (and, therefore, the hub 220). Additionally, the protrusion 260 of the hub cap 248 can be disposed within a cutout 259 formed by the collar 258 extending around the first arm portion 226 of the hub 220. In this manner, once the hub cap 248 engages the hub 220, any rotation of the hub cap 248 is inhibited because the protrusion 260 will be positioned against the edge of the cutout 259 of the collar 258. In other words, the protrusion 260 engages the cutout 259 to ensure that the hub cap 248 cannot be rotated and / or removed from the hub 220 during tightening or loosening of the locking nut 292 or during repositioning of any medical device extending through the hub 220.

[0076] Still refer to Figure 3 and Figure 4, the radially expandable seal 270 is disposed within the first portion 250 of the hub cap 248 and against the transition wall 249 of the hub cap 248. During assembly, the radially expandable seal 270 can be positioned within the first portion 250 of the hub cap 248, and the pusher rod 276 can be used to axially compress the radially expandable seal 270 against the transition wall 249 during engagement of the pusher rod 276 with the hub cap 248. More specifically, the distal end 224 of the pusher rod 276 can be placed within the first portion 250 of the hub cap 248, and the third protrusion 288c can engage the opening 266 of the hub cap 248 to limit rotation of the pusher rod 276 relative to the hub cap 248. The pusher rod 276 can be pushed into the hub cap 248 until the second rib 286b is disposed adjacent the proximal end 222 of the hub cap 248. Once pusher rod 276 engages hub cap 248 in this manner, the engagement of pusher rod 276, radially expandable seal 270, and hub cap 248 can be secured using locking nut 292. Locking nut 292 can be positioned on pusher rod 276 until locking nut 292 is positioned distally relative to rib 286a, which is positioned toward proximal end 278 of pusher rod 276. More specifically, when locking nut 292 is positioned on pusher rod 276, first and second protrusions 288a, 288b of pusher rod 276 can be inserted through cutouts 302a, 302b of collar 298, such that first and second protrusions 288a, 288b extend proximally relative to cutouts 302a, 302b. As previously described, locking nut 292 is positioned such that rib 268a is also positioned proximally relative to cutouts 302a, 302b and, therefore, collar 298. Once positioned on push rod 276, threads 294 of hub cap 248 engage threaded features 262 of hub cap 248. Consequently, screw nut 292 can be rotated to engage hub cap 248, causing hub cap 248 to move distally and thereby actuating push rod 276 distally and causing push rod 276 to push radially expandable seal 270. This can cause radially expandable seal 270 to expand and seal against the inner surface of hub cap 248 and against a medical device passing through seal 270. However, engagement of third protrusion 288c within opening 266 of hub cap 248 helps ensure that rotation of locking nut 292 only pushes push rod 276 distally to a predetermined extent. In other words, distal movement of push rod 276 against expandable seal 270 can continue until protrusion 288c abuts a surface of opening 266.

[0077] Thus, a hemostatic seal can be formed between the medical device, which extends within the radially expandable seal 270, and the hubcap 248. Furthermore, the expandable seal 270 can secure the position of the medical device relative to the hub 220, for example, helping to inhibit axial or radial movement of the medical device within the hub 220. In one example, expansion of the expandable seal 270 as described herein can secure the catheter 170 within the hub 220, thereby helping to prevent axial movement of the catheter within the hub 220. In another example, expansion of the expandable seal 270 as described herein can secure the catheter 170 within the hub 220, thereby helping to prevent axial movement of the catheter 170 within the hub 220, and, in turn, secure the position of the blood pump 150 within the patient's vasculature, to which the blood pump 150 is coupled.

[0078] To reposition the medical device, the locking nut 292 is loosened by rotating it so that the locking nut 292 moves proximally relative to the push rod 276 to release the engagement between the push rod 276 and the locking nut 292. This releases at least some of the compressive force between the push rod 276 and the expandable seal 270, which causes the push rod 276 to move away from the expandable seal 270, thereby releasing the expandable seal 270 against the inner surface of the hub cap 248 and against the medical device passing through the seal 270, and thereby allowing the medical device to be repositioned. After repositioning is complete, the locking nut 292 can be re-tightened to once again secure the medical device in place.

[0079] In addition, still refer to Figure 4 and Figure 13 , the sleeve holder 308 is positioned on the proximal end 278 of the push rod such that the engagement portion 310 can engage the first and second protrusions 288a, 288b of the push rod 276. After the first and second protrusions 288a, 288b are inserted through the opening 319 of the sleeve holder 308, the sleeve holder 308 can be rotated to cause the first and second protrusions 288a, 288b to engage the wall of the collar 316 of the engagement portion 310.

[0080] Finally, the sleeve gripper 320 can then be positioned on the second portion 312 of the sleeve holder 308. As shown, the ribs 336 of the sleeve holder 308 can engage the grooves 338 ( Figure 13 ), to ensure the fixed connection of sleeve gripper 320 and sleeve retainer 308. This engagement can be performed after the sterile sleeve is positioned on the sleeve gripper 320 to fix the position of sleeve retainer 308.

[0081] As described throughout, a variety of medical devices can be inserted through the hub 220 for insertion into the introducer sheath 100. For example, a catheter 170, a blood pump 150, and various other medical devices can be inserted through the hub 220 for positioning within a blood vessel V. In some embodiments, it can be desirable for the introducer sheath 100 to be removed or replaced with a repositioning sheath. In these embodiments, the previously described hub 220 and securement port 240 can be disposed on a proximal end of a repositioning sheath, but the dimensions of the hub 220 and securement port 240 or components thereof can be different when used with a repositioning sheath (as compared to an introducer sheath). In particular, the securement port 240 can provide advantages that allow for repositioning of the catheter 170, the blood pump 150; and / or various other medical devices can be inserted through the hub 220 and associated sheath by allowing the securement port 240 to be loosened and re-secured after the initial positioning of the medical device. In particular, the securement port 204 can allow for repositioning of the medical device while avoiding twisting of the associated sterile sleeve due to the sleeve retainer 308 being independent of the locking nut 292. This allows a user to loosen and re-secure the locking nut 292, allowing for repositioning of the medical device, and then re-secure the locking nut 292. The overall process will be described with reference to Figure 3 Further described.

[0082] ​ For purposes of illustration, a method 400 of locking the position of a medical device (e.g., the catheter 170) extending through the hub 220 and securement port 240 is shown as a flowchart. While the DETAILED DESCRIPTION is described herein with reference to the catheter 170, various other medical devices can be used with the methods described herein. For example, the method 400 can be adapted for use with the catheter 170 coupled to the blood pump 150.

[0083] At block 402, the method 400 first includes assembling the hub 220 having the securement port 240 on a sheath. In some embodiments, the sheath can be the introducer sheath 100; however, in other embodiments, the sheath can be a repositioning sheath. The method 400 will be described herein with reference to the introducer sheath 100. When the hub 220 is assembled on the sheath 100, the securement port 240 can be fully assembled as shown; however, the locking nut 292 can be in a loosened configuration. ​

[0084] ​At block 404, method 400 further includes delivering a medical device (e.g., catheter 170) through hub 220, and thus through fastening port 240 and introducer sheath 100. This step additionally includes verifying the position of catheter 170 within the patient. This can be accomplished by utilizing fluoroscopy or various other imaging mechanisms. Although described herein as catheter 170, in some embodiments, blood pump 150 can be delivered through hub 220 and introducer sheath 100, and the position of blood pump 150 within the patient can be verified.

[0085] Additionally, at block 406, method 400 includes securing port 240. In various embodiments, this step may further include actuating locking nut 292 to engage pushrod 276, thereby axially compressing pushrod 276 against radially expandable seal 270. Consequently, radially expandable seal 270 expands into sealing engagement with the inner surface of hub cap 248. Thus, in addition to the fluid-tight seal provided by primary seal 244 at proximal end 222 of hub 220, a fluid-tight seal is also formed around catheter 170 within hub cap 284. As described above, actuation of expandable seal 270 secures the position of the medical device relative to hub 220 and sheath 100. Furthermore, method 400 may further include repositioning catheter 170 and / or blood pump 150 until catheter 170 and / or blood pump 150 are in a desired position. Once the blood pump 150 is in position, the locking nut 292 can be rotated as previously described to push the push rod 276 distally and into engagement with the expandable seal 270 to secure the position of the catheter 170. Due to the independent arrangement between the sleeve holder 308 and the locking nut 292, rotation of the locking nut 292 does not cause rotation of the sleeve holder 308; and therefore, the sleeve holder 308 and the sterile sleeve remain in position and no operator adjustment is required.

[0086] At frame 408, method 400 further comprises securing the sterile sleeve with the fastening port 240. Prior to this step, the sterile sleeve has been secured between the sleeve gripper 320 and the sleeve holder 308, such that the sleeve gripper 320, sleeve holder 308, and sterile sleeve are a preassembled assembly. Thus, the step at frame 408 comprises attaching the preassembled sleeve gripper 320, sleeve holder 308, and sterile sleeve to the fastening port 240. As described above, the sleeve holder 308 is not engaged with the locking nut 292, meaning that the locking nut 292 can be manipulated without manipulating the sleeve holder 308. In other words, the locking nut 292 can be tightened, loosened, and the catheter 170 and / or blood pump 150 can be repositioned without affecting the sleeve holder 308 or the attached sterile sleeve. Likewise, after repositioning of the catheter 170 and / or blood pump 150, the locking nut 292 may be re-tightened without affecting the sleeve holder 308 or the attached sterile sleeve.

[0087] The ability to tighten the securing port 240 (and more specifically, the radially expandable seal 270) and then secure the sleeve to the securing port in turn provides the advantage of accounting for possible repositioning of the catheter 170 and / or introducer sheath 100 before securing the sleeve. Because movement of the catheter 170 may cause the blood pump to shift from its desired position, or because the physician may choose to change the position of the blood pump after initial placement, the ability to tighten, loosen, and re-tighten the securing port 240 before securing the sterile sleeve to the securing port 240 reduces the likelihood that the sterile sleeve will twist or otherwise deform, and thus may reduce the need to remove or reposition the sterile sleeve after repositioning the catheter 170 and / or blood pump.

[0088] While the embodiments and methods are described with reference to a catheter 170 and a blood pump 150 for insertion into the catheter 170, various other medical devices may be incorporated. Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to specific features, the scope of the present invention also includes embodiments having different combinations of features and embodiments that do not include all of the features described above.

Claims

1. A valve hub assembly for use with a sheath, the valve hub assembly comprising: a valve hub having a proximal end opposite the distal end, a first arm portion defining a first lumen, and a second arm portion defining a second lumen; and a fastening port disposed at the proximal end of the valve hub, the fastening port comprising: a hub cap engaging the fastening port, the hub cap defining a third lumen for receiving a radially expandable seal, a push rod engaging the radially expandable seal and disposed at least partially within the hubcap, and A locking nut is disposed about the push rod and is configured for tightening the push rod against the radially expandable seal. 2 . The valve hub assembly of claim 1 , wherein the fastening port further comprises a sleeve retainer that engages the push rod. 3 . The valve hub assembly of claim 2 , wherein the fastening port further comprises a sleeve gripper, the sleeve gripper being engageable with the sleeve retainer.

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

5. The valve hub assembly of any one of the preceding claims, wherein the fastening port further comprises a primary seal disposed within the hub cap and positioned adjacent to the first lumen.

6. The valve hub assembly of any one of the preceding claims, wherein the hub cover comprises a first portion, a second portion, and a transition wall, the transition wall defining a transition portion between the first portion and the second portion, and wherein the radially expandable seal is disposed within the first portion and adjacent to the transition wall.

7. The valve hub assembly of claim 6, wherein the locking nut is configured to axially compress the pushrod against the radially expandable seal such that the radially expandable seal radially expands to seal against the inner surface of the hub cover.

8. The valve hub assembly according to any one of the preceding claims, wherein the radially expandable seal is a Tosch seal.

9. The valve hub assembly of any one of the preceding claims, wherein the hub cover has a plurality of protrusions extending from a proximal end of the hub cover, the valve hub has a collar having a plurality of openings, and the plurality of protrusions of the hub cover engage the plurality of openings such that rotation of the hub cover relative to the valve hub is inhibited.

10. A method for locating and fixing the position of a medical device, the method comprising: Assembling a valve hub on the sheath, the valve hub having a proximal end and a distal end; disposing a fastening port at the proximal end of the valve hub, the fastening port comprising a hub cap defining a first lumen for receiving a radially expandable seal, a push rod engaging the radially expandable seal and being at least partially disposed within the hub cap, and a locking nut disposed about the push rod and the hub cap for compressing the push rod against the radially expandable seal; delivering the medical device through the valve hub and the sheath; verifying the position of the medical device; tightening the fastening port; and The sterile sleeve is fixed using the fastening port.

11. The method of claim 10, wherein the tightening of the tightening port comprises actuating the locking nut to move the pushrod against the radially expandable seal.

12. The method of claim 11, wherein the push rod causes radial expansion of the radially expandable seal to cause sealing engagement between the radially expandable seal and the hub cap.

13. The method of any one of claims 10 to 12, wherein the hub cap has a plurality of protrusions extending from a proximal end of the hub cap, the valve hub has a collar having a plurality of openings, and the plurality of protrusions of the hub cap engage the plurality of openings such that rotation of the hub cap relative to the valve hub is inhibited.

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

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

Images