Tightening port of Tooy valve for repositioning and axial locking of percutaneous circulatory support device

Abstract

It provides a tightening port for a Tooey valve for repositioning and axial locking of a percutaneous circulatory support device. [Solution] A tightening port 130 for use with the hub 120 of the introducer sheath 100 includes a cartridge that reversibly engages with 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 seal disposed within the lumen of the cartridge; and a lock 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, wherein the inner portion of the lock nut is configured to press against the seal, thereby reducing the size of the opening of the seal.

Description

Technical Field

[0001] The present disclosure relates to a lock attachment to a hub of an introducer sheath. More specifically, the present disclosure relates to a tightening port attachment of a Tuohy valve that enables repositioning and axial locking of a medical device disposed within a hub of an introducer sheath.

Background Art

[0002] In various procedures for delivering intravascular medical devices, an introducer sheath is inserted into a patient's blood vessel, such as the femoral artery, and the medical device is inserted into the introducer sheath and introduced into the blood vessel. In various cases, the medical device includes other medical devices such as a catheter or a blood pump. A hemostatic valve hub is incorporated at the proximal end of the introducer sheath and can reduce blood leakage when 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. It is necessary to enhance the axial stability of the medical device inserted into the valve hub and the introducer sheath while facilitating the passage of the device through the introducer sheath and enabling repositioning of the device.

Summary of the Invention

[0003] In Example 1, a tightening port for use with a hub of a sheath is a cartridge that reversibly engages with 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 seal disposed within the lumen of the cartridge, and a lock 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 lock nut being configured to press against the seal to reduce the size of the opening of the seal.

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

[0005] In Example 3, the clamping port of Example 2 further includes the first portion of the cartridge having at least one post extending radially from the first portion. In Example 4, the clamping port of Example 3 further includes the fact that at least one post is configured to engage with at least one opening in the hub in order to secure the clamping port to the hub.

[0006] In Example 5, any one of the tightening ports in Examples 2-4 further includes having a plurality of threads on the outer surface of the second part of the cartridge that at least partially extend around the outer surface.

[0007] In Example 6, the tightening port of Example 5 further includes a threaded surface configured such that the outer portion of the lock nut engages with multiple threads on the outer surface of a second portion of the cartridge in order to secure the lock nut to the cartridge.

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

[0009] In Example 8, one of the tightening ports from Examples 1-7 further includes lumens extending through the cartridge, seal, and lock nut, which are aligned with the longitudinal axis of the tightening 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 to be inserted through a blood vessel, a hub engaging with the proximal end of the sheath, and a clamping port engaging with the proximal end of the hub. The clamping port includes a cartridge reversibly engaging with 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 a 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 with the proximal end of the cartridge, wherein the inner portion of the locking nut is configured to press against the seal and engage the seal with the medical device.

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

[0012] In Example 11, the delivery system of Example 10 further includes the fact that the seal is located adjacent to the transition area between the first and second parts of the cartridge. In Example 12, the delivery system of Example 11 is further configured such that the lock nut is configured to compress the seal axially to reduce the size of the seal opening.

[0013] Example 13 provides a method for delivering at least one medical device into a blood vessel, comprising the steps of: inserting a sheath having a proximal end, a distal end, and a hub on the proximal end into a blood vessel; inserting a catheter through the proximal end of the hub; providing a pre-assembled clamping port having a cartridge covering the catheter, wherein the cartridge includes a seal disposed within the cartridge and a lock nut for the clamping port, which is at least partially within the cartridge and engages the clamping port with the proximal end of the hub; and engaging the lock nut with the cartridge to axially press the seal so that the seal engages with the inner surface of the catheter and the cartridge.

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

[0015] In Example 15, the method of Example 13 or Example 14 further includes the fact that a portion of the cartridge includes an outer surface having multiple threads, the lock nut includes a threaded portion, and engaging the lock nut with the cartridge further includes engaging the threaded portion of the lock nut with the multiple threads of the cartridge.

[0016] In Example 16, a tightening port for use with a hemostatic valve hub of a sheath includes a cartridge that reversibly engages with the proximal end of the hemostatic 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 lock 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, wherein the inner portion of the lock nut is configured to press against the seal to reduce the size of the seal's opening; and a sleeve holder engaged with the lock nut.

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

[0018] In Example 18, the clamping port of Example 17 further includes a first portion of the cartridge having at least one post extending radially from the first portion. In Example 19, the clamping port of Example 18 further includes the fact that at least one post is configured to engage with at least one opening of the hemostatic valve hub in order to secure the clamping port to the hemostatic valve hub.

[0019] In Example 20, the tightening port of Example 17 further includes having a plurality of threads on the outer surface of the second portion of the cartridge that at least partially extend around the outer surface. In Example 21, the tightening port of Example 20 further includes a threaded surface configured such that the outer portion of the lock nut engages with a plurality of threads on the outer surface of a second portion of the cartridge in order to secure the lock nut to the cartridge.

[0020] In Example 22, the seal is a Tooey seal in the clamping port of Example 16. In Example 23, the clamping port of Example 16 further includes lumens extending through the cartridge, seal, and lock nut, which are aligned with the longitudinal axis of the clamping port.

[0021] In Example 24, the clamping port of Example 16 further includes a lock nut that includes an extension, a sleeve holder that defines a lumen, and the extension being received within the lumen of the sleeve holder.

[0022] In Example 25, the clamping port of Example 16 further includes the fact that the seal is made of silicone. In Example 26, a delivery system for at least one medical device into a blood vessel includes a sheath having a proximal and distal end and configured to be inserted through a blood vessel; a hemostatic valve hub engaging with the proximal end of the sheath; and a clamping port engaging with the proximal end of the hemostatic valve hub. The clamping port includes a cartridge reversibly engaging with 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 a medical device; a seal disposed within the lumen of the cartridge; a lock 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 lock nut being configured to press against the seal to engage the seal with the medical device; and a sleeve holder engaged with the lock nut.

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

[0024] In Example 28, the delivery system of Example 27 further includes the fact that the seal is located adjacent to the transition area between the first and second parts. In Example 29, the delivery system of Example 28 is further configured such that the lock nut is configured to compress the seal axially to reduce the size of the seal opening.

[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, and providing a pre-assembled clamping port having a cartridge covering the catheter, the cartridge including a seal disposed within the cartridge and a lock nut of the clamping port at least partially within the cartridge and engaging the clamping port with the proximal end of the valve hub, engaging the lock nut with the cartridge to axially press the seal so that the seal engages against the catheter and the inner surface of the cartridge.

[0026] In Example 31, the method of Example 20 further includes that 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 axially pressed within the first portion, resulting in a reduction in the size of the opening of the seal.

[0027] In Example 32, the method of Example 30 further includes that a part of the cartridge includes an outer surface having a plurality of threads, the lock nut includes a threaded portion, and engaging the lock nut with the cartridge further includes engaging the threaded portion of the lock nut with the plurality of threads of the cartridge.

[0028] In Example 33, the method of Example 30 further includes that 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 of 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 lock nut and the cartridge and repositioning the catheter.

[0030] Although several embodiments are disclosed, further embodiments of the present invention will become apparent to those skilled in the art from the following detailed description illustrating and describing exemplary embodiments of the invention. Accordingly, the drawings and detailed description should be considered as illustrative and not limiting in nature. [Brief explanation of the drawing]

[0031] [Figure 1] This is a cross-sectional view of an introducer sheath extending to the introducer sheath according to an embodiment of the present disclosure. [Figure 2] This is a cross-sectional view of a medical device placed inside a blood vessel according to an embodiment of the present disclosure. [Figure 3] This is a side view of a tightening port for use with a valve hub according to an embodiment of the present disclosure. [Figure 4] Figure 3 is an exploded view of a tightening port according to an embodiment of the present disclosure. [Figure 5] This is a side view of a portion of a tightening port according to an embodiment of the present disclosure. [Figure 6] This is a perspective view of the tightening port shown in Figure 3 according to an embodiment of the disclosure. [Figure 7] This is a cross-sectional view of the clamping port shown in Figure 3 according to an embodiment of the present disclosure. [Figure 8] This is a flowchart of a method for delivering at least one medical device into a blood vessel according to an embodiment of the present disclosure. [Modes for carrying out the invention]

[0032] Figure 1 shows a cross-sectional view of a blood vessel V in which a sheath 100, such as an introducer sheath 100, is inserted at least partially into the blood vessel V. In some embodiments, the introducer sheath 100 is used to facilitate the entry of various relatively large medical devices, such as blood pumps, into the blood vessel V through the introducer sheath 100, as will be further described herein. Thus, the introducer sheath 100 may be called a large-bore introducer sheath. The introducer sheath 100 includes a proximal end 106 and a distal end 108 opposite to 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 main body portion 110 of the introducer sheath 100 extends between the proximal end 106 and the distal end 108, and the main body portion 110 defines the lumen 112 of the introducer sheath 100. The introducer sheath 100 may be formed from various polymer 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. The hub 120 is generally included in the proximal opening 107. The hub 120, also referred to herein as the hemostatic 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 the hemostatic valve hub, hubs of other embodiments may be incorporated. A medical device, such as a catheter 170, may be inserted through a hub 120 and an introducer sheath 100, the hub 120 being able to maintain hemostasis between the catheter 170, the introducer sheath 100, and the external environment. In some embodiments, the catheter 170 may be coupled to a distally extending medical device, such as a blood pump 150 as shown in Figure 2. After insertion of the catheter 170, axial stabilization of the catheter 170 may be desired to ensure that the catheter 170 (and the coupled medical device) does not shift axially during use.Furthermore, in these examples, the operator may wish to reposition the catheter 170 (and the attached medical device) after insertion in order to position the catheter 170 in a desired location throughout the surgery. For this purpose, a clamping port 130 may be located 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 may be a repositionable sheath. Figure 2 shows a cross-sectional view of the introducer sheath 100 of Figure 1 after a medical device, exemplary a blood pump 150, has been inserted into the introducer sheath 100. As described above, in some embodiments, a catheter, such as a catheter 170, may be coupled to the proximal end of the blood pump 150 and extend outside 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 constructed integrally or monolithically. The impeller assembly housing 140 houses an impeller assembly 144 within the impeller assembly housing 140. 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, the impeller 148 causes blood to flow out from a blood inlet 151 formed on the impeller assembly housing 140, through the impeller assembly housing 140, and out from a blood outlet 152 formed on the impeller assembly housing 140. In some embodiments, the impeller shaft 146 and the impeller 148 may be a single unit, and in other embodiments, the impeller shaft 146 and the impeller 148 may be separate components. As shown in Figure 2, the inlet 151 may be formed at the end of the impeller assembly housing 140, and the outlet 152 may be formed on the side of the impeller assembly housing 140. In other embodiments, the inlet 151 and / or the outlet 152 may be formed on other parts of the impeller assembly housing 140. In some embodiments, the impeller assembly housing 140 may be coupled to a distally extending cannula (not shown) that can receive blood and deliver it to the inlet 151.

[0034] Continuing to refer to Figure 2, the motor housing 142 houses a motor 154, which is configured to rotatably drive an 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. The rotation of the drive magnet 158 ​​causes a driven magnet 160 connected to the impeller assembly housing 140 to rotate. More specifically, in embodiments incorporating an 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. As described above, in some embodiments, as shown in Figure 2, a catheter 170 may extend from the proximal end of the blood pump 150 and be coupled to the motor housing 142 via tapered connectors and / or various other connecting means. While the introducer sheath 100 is illustrated above in conjunction with the use of the blood pump 150, various other medical devices may be used with the introducer sheath 100 and the hemostatic valve hub 120. For example, another variation of the blood pump may be used in combination with the introducer sheath 100. In other examples, medical devices other than the blood pump may be incorporated.

[0035] Figures 3 and 4 show embodiments of a clamping port 230 configured for attachment to the hub 120. The clamping port 230 includes a proximal end 232 and a distal end 233 and extends along the longitudinal axis L. The clamping port 230 includes a cartridge 234 adjacent to the distal end 233, which is configured to engage with a lock nut 250 that can engage with a sleeve holder 270. As shown, at the distal end 233, the cartridge 234 includes an opening 242. The opening 242 may form part of a lumen 244 (Figure 7) for receiving a medical device, such as a catheter 170 (Figure 1), as will be further described herein. In addition, the cartridge 234 includes a first portion 236 defined by a first diameter D1 (Figure 7) and a second portion 238 defined by a second diameter D2 (Figure 7). The first portion 236 comprises at least one post 240 extending radially outward from the 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 comprises a plurality of threads 246 extending radially outward from the outer surface of the second portion 238. As illustrated, the threads 246 may be configured to engage with a mating threaded portion 252 of a lock nut 250. More specifically, the lock nut 250 includes an outer portion 254 having an inner surface that forms a threaded portion 252 configured to engage with the outer surface of the second portion 238, as further described herein with reference to Figures 6 and 7. The lock nut 250 further includes an inner portion 256 configured to extend at least into the second portion 238 of the cartridge 234 after engagement, as further described herein with reference to Figure 7.

[0036] Furthermore, the clamping port 230 includes a seal 280 that is received within the cartridge 234. More specifically, during assembly, the seal 280 is positioned within the second portion 238 and adjacent to the first portion 236. The seal 280 is substantially cylindrical with an opening 282, the opening 282 extending through the center of the seal 280 and defining a lumen that can be aligned with the opening 242 of the cartridge 234 to extend the lumen 244. In various embodiments, the seal 280 is a two-way seal. In some embodiments, the seal 280 is made of silicone, or a variety of other suitable materials such as polymers, thermosetting resins, rubber, or thermosetting elastomers (TSEs), silicone rubber. The seal 280 is described further herein with reference to Figure 7.

[0037] Referring further to Figures 3 and 4, the lock nut 250 includes an extension portion 258 that extends proximal to the outer portion 254. The extension portion 258 is configured to receive a sleeve holder 270. The sleeve holder 270 has a substantially 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 lock nut 250 and to position and secure a sterile sleeve placed on the lock nut 250 within the lumen 272 of the sleeve holder 270.

[0038] As described above, the cartridge 234 may be configured to engage with the hub 120 (Figure 1) to secure the clamping port 230 onto the hub 120. Figure 5 shows the cartridge 234 engaged with the hub 120. More specifically, as shown, the hub 120 includes an extension 122 extending from the 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 that extends aligned with the longitudinal axis L (Figure 1) of the clamping port 230 and a second portion 129 that is aligned substantially perpendicular to the longitudinal axis L. Therefore, when the cartridge 234 is inserted into the extension 122 of the hub 120, the cartridge 234 can be rotated so that at least one post 240 is received in the first portion 127 of the hub 120 and at least one post 240 is received in the second portion 129 of the opening 126, securing the cartridge 234 to the hub 120. This couples the cartridge 234 within the hub 120 (Figure 1) and covers the medical device inserted through the introducer sheath 100 (Figure 1). After the insertion of the cartridge 234, the lock nut 250 can be engaged with the cartridge 234, as further described with reference to Figure 6.

[0039] Figure 6 shows an embodiment of the cartridge 234 in engagement with the lock nut 250. More specifically, in order to engage the cartridge 234 with the lock nut 250, the lock nut 250 is positioned at the proximal end 248 of the cartridge 234, and the threaded portion 252 of the lock nut 250 engages with the cartridge 234. In other words, the threaded portion 252 is screwed into the threads 246, and the lock nut 250 is rotated by an operator to tighten the lock nut 250 onto the cartridge 234. Once the lock nut 250 is tightened onto the cartridge 234, the seal 280 can be axially pressed by the inner portion 256 of the lock nut 250, as will be further described herein with reference to Figure 7.

[0040] Figure 7 shows the tightening port 230 after the engagement of the cartridge 234, lock nut 250, and sleeve holder 270. The seal 280 is located within the lumen 244 of the tightening port 230, and more specifically, within the cartridge 234. As shown, the seal 280 is located at the transition point of the cartridge 234, where the first portion 236 transitions into the second portion 238, and the diameter increases from the first diameter D1 to the second diameter D2. As described above, during the engagement of the lock nut 250 with the cartridge 234, the inner portion 256 is located within the cartridge 234, and the threaded portion 252 is located around the outer surface of the cartridge 234. As shown in Figure 7, when the lock nut 250 is tightened to engage with the cartridge 234, the inner portion 256 may come into direct contact with the seal 280. During engagement and further distal displacement of the inner portion 256 into the cartridge 234, the inner portion 256 presses the seal 280 axially. Because the seal 280 is located near the transition point between the first portion 236 and the second portion 238 of the cartridge 234, the axial pressing of the seal 280 causes it to move adjacent to the first portion 236, which has a smaller diameter D1. Once the seal 280 is positioned adjacent to the first portion 236, further axial pressing of the seal 280 results in axial compression of the seal 280. As a result, the size of the opening 282 of the seal 280 is reduced during and after the axial compression of the seal 280. The reduction in the size of the opening 282 of the seal 280 causes engagement between the seal 280 and a medical device extending through the clamping port 230, such as a catheter 170 (Figure 1), and axial compression of the seal 280 causes engagement between the seal 280 and the inner surface of the cartridge 234. In other words, axial compression of the seal 280 reduces the opening 228, and thus the lumen, while the seal 280 also expands outward to contact the inner surface of the cartridge 234.More specifically, the reduction in the size of the opening 282, and thus the size of the lumen of the seal 280, causes the seal 280 to constrict around the catheter 170, and the seal 280 expands, for example radially and / or axially, relative to the inner surface of the cartridge 234 for engagement with the cartridge 234. In this way, the catheter 170 is fixed and stabilized such that radial or axial movement of the catheter 170 (and the coupled medical device) is substantially reduced or eliminated. The lock nut 250 can then be loosened by the operator by rotating it, thereby reducing the engagement between the catheter 170 and the seal 280 and allowing the axial position of the catheter 170 to be adjusted. Once the catheter 170 (and the coupled medical device) is in the desired position, the lock nut 250 can be tightened again to fix the axial position of the catheter 170. In this way, the clamping port 230 provides a method for axially stabilizing a medical device, such as a catheter 170 (and a coupled medical device), without requiring the removal of the introducer sheath 100, the hub 120, and / or the clamping port 230.

[0041] Furthermore, a method 300 for delivering a medical device into a blood vessel V will be described with reference to the above figures and Figure 8. 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 a blood vessel V. However, while the delivery of the catheter 170 will be described with reference, various other devices may be used.

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

[0043] In block 306, method 300 may include the step of inserting the tightening port 230 so as to cover the catheter 170 and engaging the cartridge 234 with the extension 122 of the hub 120. However, in other embodiments, the tightening port 230 may be pre-assembled on the introducer sheath 100 or on a medical device such as the catheter 170 before the medical device is inserted through the hub 120. In such embodiments, the tightening port 230 may already be positioned on the introducer sheath or hub 120 when the catheter 170 is inserted through the introducer sheath 100 and hub 120. In block 308, method 300 further includes the step of using the cartridge 234 to tighten the lock nut 250 to press the seal 280, compressing the seal axially and reducing the radial size of the opening 282 of the seal 280. In some embodiments, this step includes engaging the threaded portion 252 of the lock nut 250 with the threads 246 of the cartridge 234 so that the inner portion 256 is compressed axially against the seal 280. As described above, this causes the seal 280 to expand and engage with the outer surface of the catheter 170 and the inner surface of the cartridge 234. In this way, the catheter 170 is axially fixed within the tightening port 230 after the lock nut 250 and cartridge 234 are engaged. Method 300 may also include a step of loosening the engagement between the lock nut 250 and cartridge 234. In other words, the lock nut 250 can be rotated to disengage the threaded portion 252 and the threads 246 of cartridge 234. In this way, the operator can reposition the catheter 170 and re-fix the axial position of the catheter 170 before repeating the engagement between the lock nut 250 and cartridge 234. In various embodiments, the method further includes the step of inserting a blood pump 150, which is coupled to a catheter 170, through an introducer sheath 100 for delivery to a blood vessel V.

[0044] While embodiments and methods are 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. A tightening port for use with the sheath hub, A cartridge that reversibly engages with the 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 tightening port comprising: a lock 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, wherein the inner portion of the lock nut is configured to press against the seal and reduce the size of the opening of the seal.

2. The tightening port according to 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 clamping port according to claim 2, wherein the first portion of the cartridge includes at least one post extending radially from the first portion.

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

5. The tightening port according to any one of claims 2 to 4, wherein the outer surface of the second portion of the cartridge has a plurality of threads that at least partially extend around the outer surface.

6. The tightening port according to claim 5, wherein the outer portion of the lock nut includes a threaded surface configured to engage with the plurality of threads on the outer surface of the second portion of the cartridge in order to secure the lock nut to the cartridge.

7. The clamping port according to any one of claims 1 to 6, wherein the hub is a hemostatic valve hub, the clamping port includes a sleeve holder, and the seal is a Tooy seal.

8. The tightening port according to any one of claims 1 to 7, wherein the tightening port includes lumens extending through the cartridge, the seal, and the lock nut, and lumens aligned with the longitudinal axis of the tightening port.

9. A system for delivering at least one medical device into a blood vessel, A sheath having a proximal end and a distal end, and configured to be inserted through a blood vessel, A hub that engages with the proximal end of the sheath, A clamping port that engages with the proximal end of the hub, A cartridge that reversibly engages with the 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 aforementioned medical device, A seal disposed within the lumen of the cartridge, A delivery system comprising a tightening port, the 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, wherein the inner portion of the locking nut is configured to press the seal and engage the seal with the medical device.

10. The delivery system according to claim 9, wherein the cartridge comprises 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 according to claim 10, wherein the seal is located adjacent to the transition area between the first and second portions of the cartridge.

12. The delivery system according to claim 11, wherein the lock nut is configured to compress the seal in the axial direction to reduce the size of the opening of the seal.

13. A method for delivering at least one medical device into a blood vessel, The steps include inserting a sheath having a proximal end, a distal end, and a hub on the proximal end into the blood vessel, The steps include inserting a catheter through the proximal end of the hub, A step of providing a pre-assembled clamping port having a cartridge covering the catheter, wherein the cartridge includes a seal disposed within the cartridge and a lock nut for the clamping port, which is at least partially within the cartridge and engages the clamping port with the proximal end of the hub; A method comprising the step of engaging the lock nut with the cartridge and pressing the seal axially so that the seal engages with the inner surfaces of the catheter and the cartridge.

14. The method according to 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 pressed axially into the first portion, causing a reduction in the size of the opening of the seal.

15. The method according to claim 13 or 14, wherein a portion of the cartridge includes an outer surface having a plurality of screw threads, the lock nut includes a threaded portion, and engaging the lock nut with the cartridge further includes engaging the threaded portion of the lock nut with the plurality of screw threads of the cartridge.

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