Tuohy Valve Tightening Port for Repositioning and Axial Locking of Percutaneous Circulatory Assist Devices

Abstract

A fastening port for use with a hub of an introducer sheath includes a cartridge that reversibly engages with a proximal end of the hub, the cartridge having a proximal end, a distal end, and a lumen extending between the proximal and distal ends of the cartridge, a seal disposed within the lumen of the cartridge, and a locking nut having an inner portion disposed within the lumen of the cartridge and an outer portion configured to engage the proximal end of the cartridge, the inner portion of the locking nut configured to compress the seal to reduce the size of an opening in the seal.

Description

[Technical field]

[0001] The present disclosure relates to a locking attachment to a hub of an introducer sheath, and more particularly, to a Tuohy valve clamping port attachment that allows for repositioning and axial locking of a medical device disposed within the hub of the introducer sheath. [Background technology]

[0002] In various procedures for delivering intravascular medical devices, an introducer sheath is inserted into a patient's blood vessel, for example the femoral artery, and a medical device is inserted into the introducer sheath and introduced into the blood vessel. In various cases, the medical device includes a catheter or other medical device, such as a blood pump. A hemostatic valve hub may be incorporated into the proximal end of the introducer sheath to reduce blood leakage as the device is inserted, positioned, and removed. In various cases, repositioning of the medical device and stabilization of the medical device during repositioning may be desired. There is a need to increase the axial stability of the valve hub and the medical device inserted into the introducer sheath while facilitating passage of the device through the introducer sheath and allowing repositioning of the device. Summary of the Invention

[0003] In Example 1, a fastening port for use with a hub of a sheath includes a cartridge that reversibly engages with a proximal end of the hub, the cartridge having a proximal end, a distal end, and a lumen extending between the proximal and distal ends of the cartridge, a seal disposed within the lumen of the cartridge, and a locking nut having an inner portion disposed within the lumen of the cartridge and an outer portion configured to engage the proximal end of the cartridge, the inner portion of the locking nut configured to press against the seal to reduce the size of an opening in the seal.

[0004] In Example 2, the fastening port of Example 1 further includes, the cartridge having a first portion having a first diameter and a second portion having a second diameter, the first diameter being smaller than the second diameter.

[0005] In Example 3, the fastening port of Example 2 further includes: the first portion of the cartridge includes at least one post extending radially from the first portion. In Example 4, the fastening port of Example 3 further includes at least one post configured to engage at least one opening in the hub to secure the fastening port to the hub.

[0006] In Example 5, the fastening port of any one of Examples 2-4 further includes, an exterior surface of the second portion of the cartridge having a plurality of threads extending at least partially around the exterior surface.

[0007] In Example 6, the fastening port of Example 5 further includes, an outer portion of the locking nut including a threaded surface configured to engage the plurality of threads on the outer surface of the second portion of the cartridge to secure the locking nut to the cartridge.

[0008] In Example 7, the constriction port of any one of Examples 1-6 further includes, the hub is a hemostasis valve hub, the constriction port includes a sleeve holder, and the seal is a Tuohy seal.

[0009] In Example 8, the clamping port of any one of Examples 1-7 further includes a lumen extending through the cartridge, the seal, and the locking nut, the lumen being aligned with a longitudinal axis of the clamping port.

[0010] In Example 9, a delivery system for at least one medical device into a blood vessel includes a sheath having a proximal end and a distal end and configured for insertion through a blood vessel, a hub engaging the proximal end of the sheath, and a fastening port engaging the proximal end of the hub. The fastening port includes a cartridge reversibly engaging the proximal end of the hub, the cartridge having a proximal end, a distal end, and a lumen extending between the proximal and distal ends of the cartridge, a lumen for receiving the medical device, a seal disposed within the lumen of the cartridge, and a locking nut having an inner portion disposed within the lumen of the cartridge and an outer portion configured to engage the proximal end of the cartridge, the inner portion of the locking nut configured to compress the seal into engagement with the medical device.

[0011] In Example 10, the delivery system of Example 9 further includes the cartridge including a first portion having a first diameter and a second portion having a second diameter, the first diameter being smaller than the second diameter.

[0012] In Example 11, the delivery system of Example 10 further includes a seal disposed adjacent a transition area between the first portion and the second portion of the cartridge. In Example 12, the delivery system of Example 11 further includes, wherein the locking nut is configured to axially compress the seal to reduce the size of the opening in the seal.

[0013] In Example 13, a method for delivering at least one medical device into a blood vessel includes inserting a sheath having a proximal end, a distal end, and a hub on the proximal end into the blood vessel; inserting a catheter through the proximal end of the hub; providing a pre-assembled clamping port having a cartridge covering the catheter, the cartridge including a seal disposed within the cartridge and a clamping port locking nut at least partially within the cartridge and engaging the clamping port with the proximal end of the hub; and engaging the locking nut with the cartridge to axially compress the seal such that the seal engages against an inner surface of the catheter and cartridge.

[0014] In Example 14, the method of Example 13 further includes the cartridge including a first portion having a first diameter and a second portion having a second diameter larger than the first diameter, and during engagement of the lock nut, the seal is axially pressed into the first portion causing a reduction in the size of the opening in the seal.

[0015] In Example 15, the method of Example 13 or Example 14 further includes, wherein a portion of the cartridge includes an exterior surface having a plurality of threads, and the locking nut includes a threaded portion, and engaging the locking nut with the cartridge further includes engaging the threaded portion of the locking nut with the plurality of threads of the cartridge.

[0016] In Example 16, a fastening port for use with a hemostasis valve hub of a sheath includes a cartridge that reversibly engages with a proximal end of the hemostasis valve hub, the cartridge having a proximal end, a distal end, and a lumen extending between the proximal and distal ends of the cartridge, a seal disposed within the lumen of the cartridge, a locking nut having an inner portion disposed within the lumen of the cartridge and an outer portion configured to engage with the proximal end of the cartridge, the inner portion of the locking nut configured to press against the seal to reduce the size of an opening in the seal, and a sleeve holder engaged with the locking nut.

[0017] In Example 17, the fastening port of Example 16 further includes, the cartridge having a first portion having a first diameter and a second portion having a second diameter, the first diameter being smaller than the second diameter.

[0018] In Example 18, the fastening port of Example 17 further includes: the first portion of the cartridge includes at least one post extending radially from the first portion. In Example 19, the fastening port of Example 18 further includes at least one post configured to engage with at least one opening in the hemostasis valve hub to secure the fastening port to the hemostasis valve hub.

[0019] In Example 20, the fastening port of Example 17 further includes, an exterior surface of the second portion of the cartridge having a plurality of threads extending at least partially around the exterior surface. In Example 21, the fastening port of Example 20 further includes, an outer portion of the locking nut includes a threaded surface configured to engage a plurality of threads on an outer surface of the second portion of the cartridge to secure the locking nut to the cartridge.

[0020] In Example 22, the seal is a two-way seal in the clamping port of Example 16. In Example 23, the clamping port of Example 16 further includes a lumen extending through the cartridge, the seal, and the locking nut, the lumen being aligned with the longitudinal axis of the clamping port.

[0021] In Example 24, the fastening port of Example 16 further includes: the locking nut includes an extension; the sleeve holder defines a lumen; and the extension is received within the lumen of the sleeve holder.

[0022] In Example 25, the clamping port of Example 16 further includes, the seal being constructed from silicone. In Example 26, a delivery system for at least one medical device into a blood vessel includes a sheath having a proximal end and a distal end and configured for insertion through a blood vessel, a hemostasis valve hub engaging the proximal end of the sheath, and a clamping port engaging the proximal end of the hemostasis valve hub. The clamping port includes a cartridge reversibly engaging the proximal end of the hub, the cartridge having a proximal end, a distal end, and a lumen extending between the proximal and distal ends of the cartridge, a lumen for receiving the medical device, a seal disposed within the lumen of the cartridge, a locking nut having an inner portion disposed within the lumen of the cartridge and an outer portion configured to engage the proximal end of the cartridge, the inner portion of the locking nut configured to press against the seal to engage the seal against the medical device, and a sleeve holder engaged with the locking nut.

[0023] In Example 27, the delivery system of Example 26 includes the cartridge including a first portion having a first diameter and a second portion having a second diameter, the first diameter being smaller than the second diameter.

[0024] In Example 28, the delivery system of Example 27 further includes a seal disposed adjacent a transition region between the first portion and the second portion. In Example 29, the delivery system of Example 28 further includes, wherein the locking nut is configured to axially compress the seal to reduce the size of the opening in the seal.

[0025] In Example 30, a method for delivering at least one medical device into a blood vessel includes inserting a sheath having a proximal end and a distal end and a valve hub on the proximal end of the sheath into the blood vessel, inserting a catheter through the proximal end of the valve hub, providing a pre-assembled clamping port with a cartridge covering the catheter, the cartridge including a seal disposed within the cartridge and a clamping port locking nut at least partially within the cartridge and engaging the clamping port with the proximal end of the valve hub, and engaging the locking nut with the cartridge to axially compress the seal such that the seal engages against an inner surface of the catheter and cartridge.

[0026] In Example 31, the method of Example 20 further includes the cartridge including a first portion having a first diameter and a second portion having a second diameter larger than the first diameter, and during engagement of the lock nut, the seal is axially pressed into the first portion causing a reduction in the size of the opening in the seal.

[0027] In Example 32, the method of Example 30 further includes, wherein a portion of the cartridge includes an exterior surface having a plurality of threads, and the locking nut includes a threaded portion, and engaging the locking nut with the cartridge further includes engaging the threaded portion of the locking nut with the plurality of threads of the cartridge.

[0028] In Example 33, the method of Example 30 further includes, wherein engaging the cartridge with the proximal end of the valve hub includes engaging at least one post of the cartridge with at least one opening in the valve hub.

[0029] In Example 34, the method of Example 30 further includes inserting a blood pump into the catheter. In Example 35, the method of Example 30 further includes loosening the engagement between the locking nut and the cartridge and repositioning the catheter.

[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 description of the drawings]

[0031] [Figure 1] 1 is a cross-sectional view of an introducer sheath extending to the introducer sheath according to an embodiment of the present disclosure. FIG. [Diagram 2] 1 is a cross-sectional view of a medical device disposed within a blood vessel according to an embodiment of the present disclosure. [Diagram 3] FIG. 13 is a side view of a pinch port for use with a valve hub according to an embodiment of the present disclosure. [Figure 4] FIG. 4 is an exploded view of a clamping port as shown in FIG. 3 according to an embodiment of the present disclosure. [Diagram 5] 1 is a side view of a portion of a clamping port according to an embodiment of the present disclosure. FIG. [Figure 6] FIG. 4 is a perspective view of the clamping port of FIG. 3 in accordance with an embodiment of the present disclosure. [Figure 7] FIG. 4 is a cross-sectional view of the clamping port shown in FIG. 3 according to an embodiment of the present disclosure. [Figure 8] 1 is a flowchart of a method of delivering at least one medical device into a blood vessel according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] FIG. 1 illustrates a cross-sectional view of a blood vessel V with a sheath 100, such as introducer sheath 100, at least partially inserted into the blood vessel V. In some embodiments, the introducer sheath 100 is used to facilitate entry of various relatively large medical devices, such as a blood pump, through the introducer sheath 100 and into the blood vessel V, as described further herein. Thus, 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. The introducer sheath 100 has a body portion 110 extending between a proximal end 106 and a distal end 108, the body portion 110 defining a lumen 112 of the introducer sheath 100. The introducer sheath 100 may be formed of various polymeric or metallic materials. In further embodiments, the introducer sheath 100 may include an additional surface coating. The surface coating may include, but is not limited to, silicone, PET, or any other applicable polymer. A hub 120 is generally included in the proximal opening 107. The hub 120, also referred to herein as a hemostasis valve hub, is configured for hemostasis, i.e., to prevent blood from leaking out of the introducer sheath 100 during use. Although described herein as a hemostasis valve hub, alternative embodiment hubs may be incorporated. A medical device, for example, catheter 170, may be inserted through hub 120 and introducer sheath 100, and hub 120 may maintain hemostasis between catheter 170, introducer sheath 100, and the external environment. In some embodiments, catheter 170 may be coupled to a distally extending medical device, such as blood pump 150 as shown in FIG. 2. After insertion of catheter 170, axial stabilization of catheter 170 may be desirable to ensure that the axial position of catheter 170 (and coupled medical device) does not shift during use.Additionally, in these instances, the operator may wish to reposition the catheter 170 (and associated medical device) after insertion in order to position the catheter 170 in a desired location throughout the procedure. To this end, a clamping port 130 may be disposed at the proximal end of the hub 120 to provide axial fixation or stabilization of the catheter 170. The clamping port 130 may also allow for repositioning and stabilization of the catheter 170, as further described herein.

[0033] In some embodiments, the sheath 100 can be a repositioning sheath. 2 illustrates a cross-sectional view of the introducer sheath 100 of FIG. 1 after inserting a medical device, illustratively a blood pump 150, into the introducer sheath 100. As discussed above, in some embodiments, a catheter, such as catheter 170, may be coupled to a proximal end of the blood pump 150 and extend outside of the blood vessel V. The blood pump 150 generally includes an impeller assembly housing 140 and a motor housing 142. In some embodiments, the impeller assembly housing 140 and the motor housing 142 may be integrally or monolithically constructed. The impeller assembly housing 140 mounts 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 pump blood through the blood pump 150. More specifically, impeller 148 directs blood 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 integral, while in other embodiments, impeller shaft 146 and impeller 148 may be separate components. As shown in FIG. 2, inlet 151 may be formed in an end of impeller assembly housing 140 and outlet 152 may be formed in 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 (not shown), which may receive and deliver blood to inlet 151.

[0034] 2, the motor housing 142 carries a motor 154 configured to rotatably drive the impeller 148 relative to the impeller assembly housing 140. In the illustrated embodiment, the motor 154 rotates a drive shaft 156 coupled to a drive magnet 158. Rotation of the drive magnet 158 ​​causes rotation of a driven magnet 160 connected 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 with the driven magnet 160. In other embodiments, the motor 154 may be coupled to the impeller assembly housing 140 via other components. As mentioned above, in some embodiments, as shown in FIG. 2, the catheter 170 may extend from the proximal end of the blood pump 150 and be coupled to the motor housing 142 via a tapered connector and / or various other connection means. Although the introducer sheath 100 is illustrated above with the use of a blood pump 150, a variety of other medical devices may be used with the introducer sheath 100 and hemostasis valve hub 120. For example, another variation of a blood pump may be used in combination with the introducer sheath 100. In other examples, medical devices other than a blood pump may be incorporated.

[0035] 3 and 4 show an embodiment of a fastening port 230 configured for attachment to the hub 120. The fastening port 230 includes a proximal end 232 and a distal end 233 and extends along a longitudinal axis L. The fastening port 230 includes a cartridge 234 adjacent the distal end 233, the cartridge 234 configured to engage a lock nut 250 that may engage a sleeve holder 270. As shown, at the distal end 233, the cartridge 234 includes an opening 242. The opening 242 may form a portion of a lumen 244 (FIG. 7) for receiving a medical device, e.g., a catheter 170 (FIG. 1), as further described herein. In addition, the cartridge 234 includes a first portion 236 defined by a first diameter D1 (FIG. 7) and a second portion 238 defined by a second diameter D2 (FIG. 7). The first portion 236 includes at least one post 240 extending radially outward from an outer surface of the first portion 236 for engaging with the hub 120. In some embodiments, the at least one post 240 includes two posts. In other embodiments, the at least one post 240 may include three or more posts. The second portion 238 of the cartridge 234 includes a plurality of threads 246 extending radially outward from an outer surface of the second portion 238. As shown, the threads 246 may be configured to engage with a mating threads 252 of the locking nut 250. More specifically, the locking nut 250 includes an outer portion 254 having an inner surface forming a threads 252 configured to engage with an outer surface of the second portion 238, as will be further described with reference to FIGS. 6 and 7. The locking nut 250 further includes an inner portion 256 configured to extend at least into the second portion 238 of the cartridge 234 upon engagement, as will be further described with reference to FIG. 7.

[0036] Additionally, the fastening port 230 includes a seal 280 that is received within the cartridge 234. More specifically, when assembled, the seal 280 is disposed within the second portion 238 and adjacent to the first portion 236. The seal 280 is generally cylindrical with an opening 282 that extends through the center of the seal 280 and defines a lumen that may align with the opening 242 of the cartridge 234 to extend the lumen 244. In various embodiments, the seal 280 is a tow seal. In some embodiments, the seal 280 is made of silicone or various other suitable materials such as a polymer, a thermoset, a rubber, or a thermoset elastomer (TSE), a silicone rubber. The seal 280 is further described herein with reference to FIG. 7.

[0037] 3-4, the locking nut 250 includes an extension portion 258 extending proximally from the outer portion 254. The extension portion 258 is configured to receive a sleeve holder 270. The sleeve holder 270 has a generally cylindrical shape so as to define a lumen 272. The lumen 272 of the sleeve holder 270 may be configured to receive the extension portion 258 of the locking nut 250 and to position and secure a sterile sleeve disposed on the locking nut 250 within the lumen 272 of the sleeve holder 270.

[0038] As discussed above, the cartridge 234 can be configured to engage the hub 120 (FIG. 1) to secure the fastening port 230 on the hub 120. FIG. 5 shows the cartridge 234 engaged with the hub 120. More specifically, as shown, the hub 120 includes an extension 122 extending from a proximal end 124 of the hub 120. The extension 122 includes a plurality of openings 126 configured to receive the cartridge 234. The openings 126 include a first portion 127 extending in alignment with the longitudinal axis L (FIG. 1) of the fastening port 230 and a second portion 129 aligned generally perpendicular to the longitudinal axis L. Thus, upon insertion of cartridge 234 into extension 122 of hub 120, cartridge 234 may be rotated such that at least one post 240 is received within first portion 127 of hub 120 and at least one post 240 is received within second portion 129 of opening 126 to secure cartridge 234 to hub 120. Cartridge 234 is thereby coupled within hub 120 (FIG. 1) and over a medical device inserted through introducer sheath 100 (FIG. 1). After insertion of cartridge 234, a locking nut 250 may be engaged with cartridge 234, as will be further described with reference to FIG. 6.

[0039] 6 illustrates an embodiment of the cartridge 234 during engagement with the locking nut 250. More specifically, to engage the cartridge 234 with the locking nut 250, the locking nut 250 is disposed on the proximal end 248 of the cartridge 234, and a threaded portion 252 of the locking nut 250 is engaged with the cartridge 234. In other words, the threaded portion 252 is threadedly engaged with the threads 246, and the locking nut 250 is rotated by an operator to tighten the locking nut 250 onto the cartridge 234. Once the locking nut 250 is tightened onto the cartridge 234, the seal 280 may be axially pressed by an inner portion 256 of the locking nut 250, as will be further described herein with reference to FIG.

[0040] FIG. 7 illustrates the clamping port 230 after engagement of the cartridge 234, the locking nut 250, and the sleeve holder 270. The seal 280 is disposed within the lumen 244 of the clamping port 230, and more specifically, within the cartridge 234. As illustrated, the seal 280 is disposed at a transition point of the cartridge 234 where the first portion 236 transitions to the second portion 238 and increases in diameter from a first diameter D1 to a second diameter D2. As described above, during engagement of the locking nut 250 with the cartridge 234, the inner portion 256 is disposed within the cartridge 234 and the threads 252 are disposed around the outer surface of the cartridge 234. As shown in FIG. 7, when the locking nut 250 is tightened into engagement with the cartridge 234, the inner portion 256 may be in direct contact with the seal 280. During engagement and further distal displacement of inner portion 256 into cartridge 234, inner portion 256 axially presses seal 280. Because seal 280 is disposed near the transition point between first portion 236 and second portion 238 of cartridge 234, axial pressing of seal 280 moves seal 280 adjacent to first portion 236 of smaller diameter D1. Once seal 280 is disposed adjacent first portion 236, further axial pressing of seal 280 results in axial compression of seal 280. As a result, the size of opening 282 in seal 280 is reduced during and after axial compression of seal 280. The reduction in size of opening 282 in seal 280 causes engagement between seal 280 and a medical device, e.g., catheter 170 (FIG. 1), extending through clamping port 230, and the axial compression of seal 280 causes engagement of seal 280 with an inner surface of cartridge 234. In other words, while the axial compression of seal 280 reduces opening 228, and thus the lumen, seal 280 also expands outward to contact the inner surface of cartridge 234.More specifically, the reduction in the size of the opening 282, and therefore the size of the lumen of the seal 280, causes the seal 280 to tighten around the catheter 170, and expands, e.g., radially and / or axially, against the inner surface of the cartridge 234 due to engagement with the cartridge 234. In this manner, the catheter 170 is secured and stabilized such that radial or axial movement of the catheter 170 (and associated medical device) is substantially reduced or eliminated. The locking nut 250 can then be loosened by an operator by rotating the locking nut 250, resulting in reduced engagement between the catheter 170 and the seal 280, allowing the axial position of the catheter 170 to be adjusted. Once the catheter 170 (and associated medical device) is in the desired position, the locking nut 250 can be tightened again to secure the axial position of the catheter 170. In this manner, the clamping port 230 provides a method of axially stabilizing a medical device, e.g., catheter 170 (and associated medical device), without requiring removal of the introducer sheath 100, the hub 120, and / or the clamping port 230.

[0041] Further, with reference to the figures above and to Figure 8, a method 300 of delivering a medical device into a blood vessel V will be described. For example, the medical device may include a catheter 170, which may be configured to receive a blood pump 150 (Figure 1) for delivery into the blood vessel V; however, while described with reference to delivery of the catheter 170, a variety of other devices may be used.

[0042] At block 302, the method 300 includes inserting the introducer sheath 100 into the blood vessel V. At block 304, the method 300 includes inserting a medical device, for example, a catheter 170, into and through the proximal end 124 of the hub 120 such that the catheter 170 extends through the hub 120 and into the introducer sheath 100.

[0043] At block 306, the method 300 may include inserting the clamping port 230 over the catheter 170 and engaging the cartridge 234 with the extension 122 of the hub 120. However, in other embodiments, the clamping port 230 may be pre-assembled on the introducer sheath 100 or on a medical device, such as the catheter 170, prior to inserting the medical device through the hub 120. In such embodiments, the clamping port 230 may already be disposed on the introducer sheath or hub 120 when the catheter 170 is inserted through the introducer sheath 100 and hub 120. At block 308, the method 300 further includes tightening the locking nut 250 with the cartridge 234 to compress the seal 280 and axially compress the seal to reduce the radial size of the opening 282 in the seal 280. In some embodiments, this step includes engaging the threads 252 of the locking nut 250 with the threads 246 of the cartridge 234 such that the inner portion 256 axially compresses against the seal 280. As described above, this causes the seal 280 to expand and engage the outer surface of the catheter 170 and the inner surface of the cartridge 234. In this manner, the catheter 170 is axially secured within the fastening port 230 after the engagement of the locking nut 250 with the cartridge 234. The method 300 may also include the step of loosening the engagement between the locking nut 250 and the cartridge 234. In other words, the locking nut 250 may be rotated to release the engagement between the threads 252 and the threads 246 of the cartridge 234. In this manner, the operator may reposition the catheter 170 to again secure the axial positioning of the catheter 170 before repeating the engagement between the locking nut 250 and the cartridge 234. In various embodiments, the method further includes inserting a blood pump 150 coupled to a catheter 170 through the introducer sheath 100 for delivery to the blood vessel V.

[0044] Although the embodiments and methods have been described with reference to a catheter 170 and a blood pump 150 received by 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 embodiments described above refer to certain features, the scope of the invention also includes embodiments having different combinations of features and embodiments that do not include all of the features described above.

Claims

1. 1. A fastening port for use with a hub of a sheath, comprising: a cartridge reversibly engaging a proximal end of the hub, the cartridge having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end of the cartridge; a seal disposed within the lumen of the cartridge; a locking nut having an inner portion disposed within the lumen of the cartridge and an outer portion configured to engage the proximal end of the cartridge, the inner portion of the locking nut configured to compress the seal to reduce the size of an opening in the seal.

2. 2. The clamping port of claim 1, wherein the cartridge has a first portion having a first diameter and a second portion having a second diameter, the first diameter being smaller than the second diameter.

3. The fastening port of claim 2 , wherein the first portion of the cartridge includes at least one post extending radially from the first portion.

4. The clamping port of claim 3 , wherein the at least one post is configured to engage at least one opening in the hub to secure the clamping port to the hub.

5. The fastening port of claim 2 , 3 or 4 , wherein an outer surface of the second portion of the cartridge has a plurality of threads extending at least partially around the outer surface.

6. 6. The fastening port of claim 5, wherein the outer portion of the locking nut includes a threaded surface configured to engage the plurality of threads on the outer surface of the second portion of the cartridge to secure the locking nut to the cartridge.

7. The clamping port of claim 1 , wherein the hub is a hemostasis valve hub, the clamping port includes a sleeve holder, and the seal is a Toohey seal.

8. 8. The clamping port of claim 1, wherein the clamping port includes a lumen extending through the cartridge, the seal, and the lock nut, the lumen being aligned with a longitudinal axis of the clamping port.

9. 1. An intravascular delivery system for at least one medical device, comprising: a sheath having a proximal end and a distal end and configured for insertion through a blood vessel; a hub engaging the proximal end of the sheath; a fastening port engaging a proximal end of the hub, a cartridge reversibly engaging a proximal end of the hub, the cartridge having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end of the cartridge; a lumen for receiving the medical device; a seal disposed within the lumen of the cartridge; a locking nut having an inner portion disposed within the lumen of the cartridge and an outer portion configured to engage the proximal end of the cartridge, the inner portion of the locking nut configured to compress the seal to engage the seal against the medical device; and

10. 10. The delivery system of claim 9, wherein the cartridge includes a first portion having a first diameter and a second portion having a second diameter, the first diameter being smaller than the second diameter.

11. The delivery system of claim 10 , wherein the seal is disposed adjacent a transition area between the first and second portions of the cartridge.

12. The delivery system of claim 11 , wherein the locking nut is configured to axially compress the seal to reduce the size of the opening in the seal.

13. 1. A method for delivering at least one medical device into a blood vessel, comprising: inserting a sheath into the blood vessel, the sheath having a proximal end, a distal end, and a hub on the proximal end; inserting a catheter through the proximal end of the hub; providing a pre-assembled clamping port having a cartridge over the catheter, the cartridge including a seal disposed within the cartridge and a clamping port locking nut at least partially within the cartridge and engaging the clamping port with the proximal end of the hub; and engaging the locking nut with the cartridge to axially compress the seal so that the seal engages against an inner surface of the catheter and the cartridge.

14. 14. The method of claim 13, wherein the cartridge includes a first portion having a first diameter and a second portion having a second diameter larger than the first diameter, and during engagement of the lock nut, the seal is forced axially into the first portion causing a reduction in the size of the seal opening.

15. 15. The method of claim 13 or claim 14, wherein a portion of the cartridge includes an exterior surface having a plurality of threads, and the locking nut includes a threaded portion, and engaging the locking nut with the cartridge further comprises engaging the threaded portion of the locking nut with the plurality of threads of the cartridge.

Images