Support device for medical devices

Abstract

A positioning device may be provided to maintain the positioning of an introducer hub relative to a reconfigured sheath or catheter. The positioning device may include a first coupler, a second coupler configured to be removably coupled to a portion of the reconfigured sheath or catheter proximal to the first coupler, and a portion extending between the first coupler and the second coupler, the extension bridge being configured to maintain a constant axial distance between the introducer hub and the proximal end of the reconfigured sheath or catheter. A flexible hinge may be incorporated and the medical device is configured to pass through the second coupler, the flexible hinge, and the first coupler.

Description

Technical Field

[0001] Cross - Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 390,554, filed on July 19, 2022, and U.S. Provisional Patent Application No. 63 / 447,963, filed on February 24, 2023. The entire content of the applications referenced above is incorporated herein by reference.

[0002] Technical Field

[0002] The present disclosure relates to a support structure for a medical device that can extend outward from a patient's body, such as a positioning device configured to position a medical device, a catheter, and / or a sheath at an access site and relative to a patient and / or relative to a part of a medical device or a support structure, such as an introducer hub.

Background Art

[0003] Background

[0003] In a clinical environment, a medical device can be inserted into a patient at an access point via an access device or the like. After such treatment, the patient may need to leave the medical device and / or sheath in place. For example, a patient may be transported to an intensive care unit with a blood pump in place and a positioning sheath exposed at the access site.

[0004]

[0004] Current practice includes, for example, slightly inserting the end of a repositioning sheath into the hemostatic valve of the hub of an introducer sheath inserted through an access site.

Summary of the Invention

Means for Solving the Problems

[0005] Summary

[0005] In various aspects, a positioning device may be provided for maintaining axial positioning of an introducer hub relative to a repositioning sheath or catheter. The positioning device may include a first coupler configured to be removably coupled to the proximal end of the introducer hub. The positioning device may include a second coupler configured to be removably coupled to a portion of the repositioning sheath or catheter proximal to the first coupler. The positioning device may be configured to maintain a constant axial distance between the introducer hub and the proximal end of the repositioning sheath or catheter.

[0006]

[0006] In some embodiments, the positioning device may include an extension bridge extending between the first coupler and the second coupler.

[0007]

[0007] In some embodiments, the first coupler may include a first surface including a threaded portion configured to interact with one or more threads on the outer surface of the introducer hub to prevent axial movement of the first coupler relative to the introducer hub. In some embodiments, the first coupler may include at least one recess or aperture configured to interact with a tab or overhang portion on the outer surface of the introducer hub to prevent axial movement of the first coupler relative to the introducer hub. In some embodiments, the first coupler may include at least one fixture configured to interact with a corresponding fixture on the outer surface of the introducer hub to maintain the position of the introducer hub relative to the first coupler.

[0008]

[0008] In some embodiments, the first coupler may include a rotatable portion and a non-rotatable portion, the rotatable portion being located distally from the non-rotatable portion, and the rotatable portion being configured to interact with a thread, tab, or overhang portion on the outer surface of the introducer hub. In some embodiments, the first coupler may have an outer diameter larger than the outer diameter of the introducer hub.

[0009]

[0009] In some embodiments, the first coupler may have a constant outer diameter between the first end and the second end. In some embodiments, the outer diameter of the first end of the first coupler may be smaller than the outer diameter of the second end of the first coupler. In some embodiments, the outer diameter of the first coupler may decrease in a direction from a middle portion between the first end and the second end of the first coupler toward the first end of the coupler.

[0010]

[0010] In some embodiments, the positioning device may include an adjustable arm coupled to the first coupler. The adjustable arm may be configured to support the repositioning sheath or catheter when the repositioning sheath or catheter extends proximally from the first coupler.

[0011]

[0011] In some embodiments, the extension bridge may be configured to avoid contacting the repositioning sheath or catheter. In some embodiments, the extension bridge may circumferentially surround the repositioning sheath or catheter. In some embodiments, the extension bridge may partially circumferentially surround the repositioning sheath or catheter.

[0012]

[0012] In some embodiments, the extension bridge may be configured to allow only a portion of the repositioning sheath or catheter to be slidably inserted into the extension section. In some embodiments, the extension bridge may be configured to prevent the repositioning sheath from extending into the introducer hub.

[0013]

[0013] In some embodiments, the extension bridge may have a rigidity greater than the rigidity of the repositioning sheath or catheter.

[0014]

[0014] In some embodiments, the second connector may be configured to allow only a portion of the repositioning sheath or catheter to be slidably inserted into the connection section. In some embodiments, the second connector may include a shaped portion shaped such that the inner surface of the shaped portion substantially conforms to the outer surface of the repositioning sheath or catheter. In some embodiments, the shaped portion may be configured to surround at least a portion of the suture pad. In some embodiments, the shaped portion may be configured to surround at least a portion of the connector at the proximal end of the repositioning sheath.

[0015]

[0015] In some embodiments, the positioning device may include a hinge that hinge - connects a first section of the positioning device to a second section of the positioning device, and at least a portion of the introducer hub and at least a portion of the repositioning sheath or catheter can be at least partially disposed within the first section before the second section closes hingedly. In some embodiments, the positioning device may include a locking mechanism configured to prevent the positioning device from opening hingedly. In some embodiments, the locking mechanism includes a snap - hinge in the first section, and the snap - hinge includes a handle and a locking portion configured to slidably connect to a recessed portion or an overhanging portion in the second section.

[0016]

[0016] In some embodiments, at least a portion of the introducer hub may be at least partially disposed within a portion of a first section that forms a portion of the first connector, and at least a portion of the repositioning sheath or catheter is disposed within a portion of the first section that forms a portion of the second connector of the first section.

[0017]

[0017] In some embodiments, the inner surface of the first section and / or the second section may include an indicator representing the exact positioning of the repositioning sheath.

[0018]

[0018] In some embodiments, each of the first section and the second section may include a length having one or more ribs extending into a channel formed between the first section and the second section, the channel being configured to receive at least a portion of the repositioning sheath and / or the catheter.

[0019]

[0019] In some embodiments, the first connector may include a clam shell, and the second connector may be attached to the clam shell via a ball joint fixed within the clam shell.

[0020]

[0020] In some embodiments, the extension bridge may include a hinge section configured to allow the proximal end of the extension bridge to rotate about the hinge section relative to the distal end of the extension bridge. In some embodiments, the hinge section can be unlocked to allow the hinge section to rotate or locked to prevent the hinge section from rotating.

[0021]

[0021] In some embodiments, a kit may be provided, the kit including an introducer hub, a repositioning sheath, and a positioning device as disclosed herein.

[0022]

[0022] In some embodiments, a positioning device may be provided that is configured for adjustable positioning of a medical device, a repositioning sheath, or both, relative to the introducer hub. The positioning device may include a first connector configured to be removably coupled to the proximal end of the introducer hub. The second connector may be configured to receive a medical device, a repositioning sheath, and / or a catheter. The positioning device may include a hinge section configured to allow an adjustable lock portion to rotate about the hinge section relative to the first connector.

[0023]

[0023] In some embodiments, the second coupler may be configured to allow or prevent axial adjustment of the medical device and / or the repositioning sheath relative to the introducer hub based on an adjustable lock position, and the positioning device is configured to slidably receive the medical device through an adjustable lock portion and through the first coupler.

[0024]

[0024] In some embodiments, the hinge section can be unlocked to allow the hinge section to rotate or locked to prevent the hinge section from rotating.

[0025]

[0025] In some embodiments, a positioning device configured for adjustable positioning of the catheter device, the repositioning sheath, or both relative to the introducer hub may be provided. The positioning device may include a first coupler configured to be removably coupled to the proximal end of the introducer hub. The first coupler may be configured to slidably receive the medical device to allow the medical device to enter the introducer hub. The positioning device may include a proximal end configured to slidably receive the medical device. The positioning device may include a flexible hinge connecting the first coupler and the second coupler, and the flexible hinge may be configured to allow the medical device to be slidably received therethrough.

[0026]

[0026] In some embodiments, the flexible hinge can be unlocked to allow the flexible hinge to rotate or locked to prevent the flexible hinge from rotating.

[0027]

[0027] In some embodiments, the flexible hinge may include an outer housing having a distal end, a proximal end, and an inner surface defining a first volume of space extending through the outer housing. In some embodiments, the flexible hinge may include a joint (which may be a ball joint) having a distal end, a proximal end, and an inner surface defining a second volume of space extending through the joint. The distal end of the joint may be at least partially positioned within the first volume of space. The joint may be configured to rotate about a first axis relative to the outer housing, the first axis being orthogonal to a path from a first end of the outer housing to a second end of the outer housing. The second volume of space may be configured to enable a medical device to be slidably received and guided from the proximal end of the joint to the distal end of the outer housing.

[0028]

[0028] In various aspects, a positioning device may be provided. The positioning kit may include a first coupler. The first coupler may have a housing. The first coupler may have means for locking the first coupler to an introducer sheath. The first coupler may include an alignment tab. The first coupler may include one or more indicators of the locked state of the first coupler.

[0029]

[0029] The positioning device may include a second coupler. The second coupler may be connected to the first coupler. The second coupler may be configured to receive a tubular member. The first coupler may be pivotally attached to the second coupler.

[0030]

[0030] In various aspects, a kit may be provided. The kit may include a medical device, a positioning device as disclosed herein, and optionally a repositioning sheath.

[0031]

[0031] In various aspects, a method of adjusting the positioning of a medical device, a repositioning sheath, or both, relative to an introducer hub may be provided. The method may include adjusting the positioning of the medical device, the repositioning sheath, or both. Adjusting may include rotating the proximal end of the positioning device relative to the distal end of the positioning device, axially moving the medical device, the repositioning sheath, or both, or a combination thereof. The method may include locking a locking mechanism in the positioning device to prevent the medical device, the repositioning sheath, or both from axially moving relative to the locking mechanism.

[0032]

[0032] In some embodiments, the method may include unlocking a locking mechanism in the positioning device. In some embodiments, the method may include attaching a first coupler to the hub prior to adjustment. In some embodiments, the method may include attaching a second coupler to the repositioning sheath and / or catheter after adjustment.

[0033]

[0033] In some embodiments, locking a locking mechanism in the positioning device may include locking a first locking mechanism to prevent the medical device, the repositioning sheath, or both from axially moving relative to the locking mechanism, and locking a second locking mechanism to prevent the proximal end of the positioning device from rotating relative to the distal end of the positioning device.

[0034]

[0034] In some embodiments, the flexible hinge may include an outer housing having a distal end, a proximal end, and an inner surface defining a first volume that extends through the outer housing. In some embodiments, the flexible hinge may include a joint having a distal end, a proximal end, and an inner surface defining a second volume that extends through the joint. The distal end of the joint may be at least partially positioned within the first volume. The joint may be configured to rotate about a first axis relative to the outer housing, the first axis being orthogonal to a path from a first end of the outer housing to a second end of the outer housing. The second volume may be configured to enable a medical device to be slidably received and guided from the proximal end of the joint to the distal end of the outer housing.

[0035]

[0035] In various aspects, a system may be provided. The system may include a flexible hinge operably coupled to an introducer hub and a medical device configured to pass through the flexible joint and into the introducer hub. The flexible hinge may include an outer housing having a distal end, a proximal end, and an inner surface defining a first volume that extends through the outer housing. In some embodiments, the flexible hinge may include a joint having a distal end, a proximal end, and an inner surface defining a second volume that extends through the joint. The distal end of the joint may be at least partially positioned within the first volume. The joint may be configured to rotate about a first axis relative to the outer housing, the first axis being orthogonal to a path from a first end of the outer housing to a second end of the outer housing. The second volume may be configured to enable a medical device to be slidably received and guided from the proximal end of the joint to the distal end of the outer housing.

[0036]

[0036] In various aspects, a method of coupling and / or separating a coupler and a hub may be provided (e.g., to prevent axial movement of a medical device, a repositioning sheath, or both relative to the hub, or to enable movement of the medical device and / or repositioning sheath). The method may include aligning and engaging a first coupler with the hub, as disclosed herein. In some embodiments, the medical device and / or repositioning sheath may be introduced before the first coupler is aligned and engaged. In some embodiments, the medical device and / or repositioning sheath may be introduced after the first coupler is aligned and engaged. The method may include moving at least a portion of the first coupler or the hub from a first position to a second position. In some embodiments, this movement may be from an unlocked position to a locked position. In some embodiments, this movement may be from a locked position to an unlocked position.

Brief Description of the Drawings

[0037] Brief Description of the Drawings

Figure 1A

[0037] FIG. is a diagram of an embodiment of a positioning device.

Figure 1B

[0038] FIG. is a partial cutaway view of a first coupler of a positioning device.

Figure 1C

[0038] FIG. is a partial cutaway view of a first coupler of a positioning device.

Figure 1D

[0039] FIG. is a diagram of an embodiment of a positioning device.

Figure 1E

[0039] FIG. is a diagram of an embodiment of a positioning device.

Figure 1F

[0040] FIG. is a diagram of a positioning device aligned and locked on a hub.

Figure 1G

[0040] FIG. is a diagram of a positioning device aligned and locked on a hub.

Figure 1H

[0041] Shows a positioning device and an introducer hub according to an embodiment.

Figure 1I

[0042] Shows a positioning device according to another embodiment of the present disclosure.

Figure 1J

[0042] Shows a positioning device according to another embodiment of the present disclosure.

Figure 1K

[0042] Shows a positioning device according to another embodiment of the present disclosure.

Figure 1L

[0042] Shows a positioning device according to another embodiment of the present disclosure.

Figure 1M

[0043] Shows a part of a positioning device according to an embodiment.

Figure 2A

[0044] It is a diagram of an embodiment of a positioning device in an open configuration having a clam shell design.

Figure 2B

[0045] It is a diagram of an embodiment of a positioning device in a closed configuration having a clam shell design.

Figure 2C

[0046] It is a diagram of an embodiment of a positioning device in an open configuration having a clam shell design.

Figure 2D

[0047] It is a diagram of the positioning device of FIG. 2C in a closed configuration.

Figure 3A

[0048] It is a diagram of an embodiment of a positioning device having a flexible hinge design.

Figure 3B

[0049] It is a cross-sectional explanatory diagram focusing on the hinge part of an embodiment having a flexible hinge design.

Figure 3C

[0050] It is a diagram of an embodiment of the positioning device of FIG. 3B in which the hinge is adjusted downward toward the patient's skin.

Figure 3D

[0051] It is a diagram of a positioning device according to an embodiment.

Figure 3E

[0052] It is a diagram of the positioning device of FIG. 3D in the locked position.

Figure 3F

[0053] A diagram of a positioning device according to another embodiment.

Figure 3G

[0054] A diagram of a positioning device according to another embodiment.

Figure 3H

[0055] A diagram of a positioning device according to another embodiment.

Figure 3I

[0056] A diagram of the positioning device of FIG. 3D in the locked position.

Figure 4

[0057] A flowchart of the method.

Figure 5A

[0058] A diagram of an embodiment with a graft.

Figure 5B

[0058] A diagram of an embodiment with a graft.

Mode for Carrying Out the Invention

[0038] Detailed Description

[0059] As is well known, a medical device can be inserted into a patient at an access point via an access device or the like for performing a medical procedure or treatment. After such a procedure or treatment, the patient may need to leave the medical device and / or sheath in place. For example, a patient may be transported to an intensive care unit with the blood pump in place and the positioning sheath exposed at the access site.

[0039]

[0060] In some embodiments, the end of the repositioning sheath can be inserted slightly into the hemostatic valve of the hub of the introducer sheath inserted into the access site. To avoid contamination, bleeding from, and / or occlusion of the side port, the inventors recognize the advantages of a device that can enable proper positioning and fixation of a contamination prevention barrier at the medical device (e.g., a pump), the repositioning sheath, and / or the access site. For example, the inventors recognize the advantages of a device that can minimize and / or prevent movement of the introducer hub and / or relative to the patient. In some examples, the device can be configured to minimize and / or prevent axial and / or radial movement of the introducer hub relative to the patient. In some embodiments, a positioning device can be provided to maintain axial positioning of the introducer hub relative to the repositioning sheath or catheter.

[0040]

[0061] Turning now to the figures, FIG. 1A shows an embodiment of a positioning device according to an embodiment of the present disclosure. In some embodiments, as shown in this figure, the positioning device 10 can include a first coupler 20 (e.g., a distal coupler or distal end coupler) configured to be removably coupled, for example, to the hub body 81 of an access device, such as an introducer 80, at the proximal end of the hub body. In some cases, the introducer can have a sheath 82 coupled to the distal end of the hub body 81 and can have a side port 83 extending away from the side of the hub body 81.

[0041]

[0062] In some embodiments, the positioning device can include a second coupler 30 configured to be removably coupled to a portion of the repositioning sheath 90 or catheter proximal to the first coupler.

[0042]

[0063] The positioning device may include a bridge extension 40 that extends between a first coupler 20 (e.g., a distal end coupler) and a second coupler 30. The bridge extension may be configured to maintain a constant distance (e.g., an axial distance) between the proximal end of the introducer hub 81 and the proximal end of the repositioning sheath 90 or the catheter.

[0043]

[0064] In some embodiments, the first coupler, the second coupler, and the bridge extension may be permanently attached to each other, such as being integrally formed. In other embodiments, one or both of the first coupler and the second coupler may be removably attachable to the bridge extension. In this regard, the positioning device may include a modular system that may be set by a clinician.

[0044]

[0065] Any suitable method for connecting the first coupler 20 to the introducer hub and for maintaining the desired position of the first coupler relative to the introducer hub is envisioned.

[0045]

[0066] For example, referring briefly to FIG. 1B, in some embodiments, the first coupler may be configured to threadably engage the hub. For example, the first coupler 20 may include a chamber having a first surface 28 that includes a threaded portion (e.g., including a recess 29) configured to interact with one or more threads 86 on the outer surface of the introducer hub 81 to prevent the first coupler from moving (e.g., axially) relative to the introducer hub. As will be appreciated, other suitable engagement methods may be used to attach the coupler to the hub. For example, in some embodiments, the coupler may be press fit or snap fit onto the hub.

[0046]

[0067] As will be appreciated, in some embodiments, the engagement of the coupler and the hub may be sufficient to lock the coupler to the hub and maintain the position of the coupler relative to the hub. In other embodiments, as described herein, the coupler may include one or more locking features to lock and prevent movement between the coupler and the hub. For example, in some embodiments, the first coupler may also include at least one recess or opening 23 configured to interact with a tab or overhang 84 on the outer surface of the introducer hub 81 to prevent the first coupler from moving (e.g., axially) relative to the introducer hub. As will be appreciated, the hub may also include an opening configured to engage one or more tabs or overhangs in the first coupler. In this regard, the coupler may be locked to the hub by threading and tabs.

[0047]

[0068] In other embodiments, as shown by way of example in FIGS. 1F and 1G, the proximal surface of the coupler may include one or more fixtures that interact with corresponding fixtures on the distal surface of the hub to lock the distal hub to the coupler when the coupler is rotated to a locked position (see the arrow in FIG. 1G). For example, as shown in these figures, the coupler may include first and second arms 87a, 87b that are slidably received within first and second fixtures 88a, 88b (e.g., locking bumps) on the hub. In such embodiments, the contact portions 89a (e.g., distal portions) of the first and second arms may be configured to contact corresponding contact portions 98a (e.g., contact edges) of the corresponding fixtures to lock the position of the arms relative to the fixtures and, thus, the position of the hub relative to the coupler. As will be appreciated, the corresponding contact portions may have any suitable shape and size for engaging each other.

[0048]

[0069] Although shown with two arms and four corresponding fixtures, it will be recognized that the hub and the first coupler may have any suitable number of corresponding fixtures. Further, although the hub is shown with fixtures for slidably receiving the arms in the coupler, in other embodiments the coupler may include one or more fixtures for receiving the arms on the hub. In yet other embodiments, other cantilever arrangements may be used to lock the coupler to the hub. As will be recognized, in all such embodiments, the first coupler may be unlocked from the hub, such as after completion of a treatment or procedure.

[0049]

[0070] Referring briefly to FIG. 1C, in some embodiments, the first coupler may include a rotatable portion 25 and a non-rotatable portion 26, with the rotatable portion being located distally from the non-rotatable portion. In some embodiments, the rotatable portion 25 may be configured to interact with threads, tabs, and / or overhangs on the outer surface of the introducer hub to prevent the first coupler from moving (e.g., axially) relative to the introducer hub (in FIG. 1C, the rotatable portion includes recesses intended to interact with threads located on the outer surface of the hub). As will be recognized, the shape, size, and / or pitch of the threads in the first coupler may correspond to the shape, size, and / or pitch of the threads in the hub such that the first coupler can be coupled to the hub.

[0050]

[0071] In some embodiments, as shown in FIGS. 1H and 1I, the first coupler 20 may include a gripping region 27 to assist a clinician in moving the coupler relative to the hub. As will be appreciated, the gripping region may extend around the entire circumference of the coupler (see FIG. 1H) or only around a portion of the outer circumference of the coupler (see FIG. 1I). In some embodiments, the gripping region may include a plurality of axially extending protrusions (e.g., ribs) and / or depressions (e.g., channels) that may be alternately positioned around the outer circumference of the coupler. As will be appreciated, the protrusions may be different from each other, but each of the protrusions may be the same size. Similarly, each of the depressions may be the same size or the depressions may be different from each other.

[0051]

[0072] In some embodiments, as shown in FIG. 1I, for example, the coupler may include an alignment tab 45a that may be used by a clinician to properly align the coupler on the hub. For example, in some embodiments, as shown in FIG. 1I, the user may align the alignment tab 45a of the coupler with a corresponding alignment tab 45b on the hub and then engage the coupler with the hub. In some embodiments, when aligned and engaged, the coupler may be locked to the hub such that the position of the coupler relative to the hub is maintained. In other embodiments, when the coupler is aligned and engaged with the hub, the coupler may not be locked to the hub. Instead, the coupler may have a first position, i.e., a "set" position, and a second position, i.e., a "lock" position, when aligned and engaged. In some embodiments, the clinician may use the coupler to lock the coupler relative to the hub from the first position to the second position.

[0052]

[0073] In some embodiments, the coupler may include an indicator (e.g., visual and / or auditory) to indicate when the coupler has moved between the first position and the second position 46 and also to indicate when the coupler is in the locked position 47. As will be appreciated, in other embodiments, other suitable indicators may also be used.

[0053]

[0074] In some embodiments, the first coupler may have an outer diameter that is larger than the outer diameter of the introducer hub. For example, in FIG. 1B, the threads on the hub are shown on the outward-facing surface (e.g., extending away from the central axis), and the recess in the first coupler is shown on the inward-facing surface (e.g., the recess is located on the surface facing the central axis). However, those skilled in the art will understand that the threads can be located on the inward-facing surface, in which case the recess for receiving the threads will be located on the outward-facing surface of the first coupler. Similarly, it will be understood that the relevant components involved in connecting the hub to the first coupler (e.g., threads, openings, etc.) can be located on the hub or the first coupler. For example, when the threads are located on the first coupler, the recess is located on the hub.

[0054]

[0075] In some embodiments, the first coupler may have a generally cylindrical outer wall (e.g., having a constant diameter between the first end and the second end). In other embodiments, as shown in FIGS. 1J and 1K, a portion of the coupler may have a tapered wall. For example, as shown in these figures, the outer diameter of the coupler may decrease in the direction toward the first end, e.g., away from the hub. In some embodiments, the outer diameter may decrease from a position intermediate the first end and the second end (e.g., the middle between the first end and the second end) toward the second end (e.g., away from the side of the coupler that engages the hub). In some embodiments, the coupler may include one or more notches or windows for visually identifying a locking state of the coupler with respect to the hub (e.g., see the lock icon 47 in FIG. 1K).

[0055]

[0076] In some embodiments, as also shown in FIGS. 1J and 1K, the coupler may include a housing 331 that functions as a socket as described herein and may provide the clinician with freedom in adjusting the position of the hub and / or medical device relative to the patient.

[0056]

[0077] As will be appreciated, the coupler can be attached to the housing in any suitable manner. For example, in some embodiments, as shown in FIG. 1L, the coupler can include a first portion 20a and a second portion 20b with a portion of the housing sandwiched between the first portion 20a and the second portion 20b. For example, the first coupler portion and the second coupler portion can be threaded together around the housing to attach the coupler to the housing. The first coupler portion and the second coupler portion can also be snap-fitted together by one or more fasteners. As will be appreciated, the coupler can then be attached to the hub (e.g., by threading and / or fasteners).

[0057]

[0078] Although shown as having two coupler portions, it will be appreciated that the coupler can have three or more coupler portions. Also, the coupler portions are shown as having different lengths, each defining an outer perimeter of the coupler and attached to each other to form the complete length of the coupler. However, in other embodiments, each coupler portion can be attached to each other such that the first coupler portion and the second coupler portion form only a portion of the outer perimeter of the coupler (having the same length but) and can form only a portion of the outer perimeter of the coupler (see, e.g., FIG. 1M). As will be appreciated, in addition to engaging in a snap-fit manner, the coupler can be pressed to remove it from the hub.

[0058]

[0079] Although shown as attachable to the housing, it will be appreciated that the coupler can also be formed integrally with the coupler.

[0059]

[0080] Referring back to FIG. 1A, in some embodiments, the bridge extension 40 may circumferentially surround at least a portion of the repositioning sheath 90 or the catheter. In such embodiments, the repositioning sheath or catheter may include a flexible tubular member 91 that extends proximally away from the connection portion 92. The connection portion may have one or more fixtures 93 configured to interact with the second coupler 30, for example, to increase friction, and may provide slots or ridges with which a portion of the second coupler may interact to prevent (e.g., axial) movement of the repositioning sheath or catheter relative to the second coupler 30. In some embodiments, the suture hub 94 may be present on the repositioning sheath or catheter and may be connected (e.g., rotatably connected) to the connection portion 92. Additional components 95 of the repositioning sheath or catheter, including other fixtures or tubular members, may extend proximally away from the positioning device.

[0060]

[0081] In some embodiments, the bridge extension 40 may circumferentially surround a portion of the flexible tubular member 91 that is between the first coupler 20 and the connection portion 92.

[0061]

[0082] Referring to FIG. 1D, in some embodiments, the bridge extension may circumferentially surround the repositioning sheath or catheter in part. As seen in FIG. 1D, in some embodiments, there may be a pattern of recesses or openings 43 axially positioned along the extension bridge. In some embodiments, the extension portion may include sidewalls that extend only partially around the repositioning sheath or catheter. For example, in some embodiments, at a first location in the axial direction, one edge 42 of the extension portion may be circumferentially spaced from a second edge (not shown) by a distance greater than zero. In some embodiments, the circumferential distance is less than half of the full circumference of the repositioning sheath or catheter.

[0062]

[0083] Referring to FIG. 1E, in some embodiments, the bridge extension 40 may be configured to avoid contacting the repositioning sheath or catheter. In some embodiments, the bridge extension may be configured to not be coaxial with the repositioning sheath or catheter. In some embodiments, the bridge extension is not parallel to the repositioning sheath or catheter. For example, in some embodiments, the wall 41 that defines the shape of the bridge extension 40 may be configured to form a handle and / or have an ergonomic shape. In some embodiments, the bridge extension may be configured such that at least one wall 41 abuts at least partially against the patient's skin.

[0063]

[0084] In some embodiments, the bridge extension is directly connected to the first connector. In some embodiments, the bridge extension may be indirectly connected to the first connector 20. For example, in some embodiments, the hinge 43 may connect the bridge extension to the first connector (see FIG. 1E). In such embodiments, the clinician may be able to adjust the position of the bridge extension relative to the first connector.

[0064]

[0085] In some embodiments, the bridge extension may be directly connected to the second connector 30. In some embodiments, the bridge extension may be indirectly connected to the second connector. For example, in some embodiments, the hinge 44 may also connect the bridge extension to the second connector 30. Similarly to the above, in such embodiments, this may enable the clinician to adjust the position of the bridge extension relative to the second connector.

[0065]

[0086] In some embodiments, the second connector 30 may include a rotatable portion 34 and a non-rotatable portion 35. The rotatable portion may be configured to rotate about the central axis of the non-rotatable portion. In some embodiments, the hinge 44 may be connected to the rotatable portion.

[0066]

[0087] Referring to FIG. 1E, in some embodiments, the positioning device 10 may include an adjustable arm 70 coupled to the first coupler 20. The adjustable arm 70 may be configured to support the repositioning sheath 90 and / or catheter (and in particular the flexible tubular member 91) when the repositioning sheath or catheter extends proximally from the first coupler.

[0067]

[0088] In some embodiments, the first coupler 20 may include a proximal surface 21 and a side surface 22 that define a slot 24 (or an opening, etc.) that extends through a portion of the first coupler 20. The slot 24 may be configured to allow the device to be attached after the repositioning sheath or catheter is properly positioned. For example, in such embodiments, the flexible tubular member 91 may be slidable through the slot 24 when the first coupler 20 is coupled to the hub. As described herein and as will be appreciated in view of FIGS. 1H - 1L and FIGS. 3A and 3B, the coupler may be coupled to a housing and / or joint through which the tubular member may be slidable.

[0068]

[0089] In some embodiments, the extension bridge may have a rigidity greater than the rigidity of the repositioning sheath and / or catheter. In some embodiments, the bridge extension may have a rigidity greater than a predetermined rigidity sufficient to prevent the bridge extension from flexing under the weight of the repositioning sheath or catheter during use. In some embodiments, the bridge extension may also be formed of a flexible material.

[0069]

[0090] Referring again to FIG. 1A, in some embodiments, the second coupler 30 may be configured to allow only a portion of the repositioning sheath 90 or catheter to be slidably inserted into the coupling section. For example, in some embodiments, the flexible tubular member and the first portion 93 of the connection portion may be configured to be slidably received by the second coupler. The second portion 96 of the connection portion cannot be further inserted into the coupling section.

[0070]

[0091] In some embodiments, the second coupler may include a molded portion 31 configured to surround at least a portion of the connection portion.

[0071]

[0092] Referring to FIG. 1D, in some embodiments, the second coupler 30 may include a molded portion 31 molded such that the inner surface 34 of the molded portion substantially coincides with a portion of the outer surface 97 of the repositioning sheath or catheter.

[0072]

[0093] In some embodiments, the molded portion of the second coupler may include a section 32 configured to surround at least a portion of the suture pad 94. In some embodiments, the section 32 may define one or more openings 33 to allow direct access to the suture pad.

[0073]

[0094] In some embodiments, the molded portion of the second coupler 30 may be configured to surround at least a portion of an additional component 95 (e.g., a connector, a tube, etc.) at the proximal end of the repositioning sheath.

[0074]

[0095] In some embodiments, the second coupler is configured to be disposed over or around a portion of the repositioning sheath or catheter, and that portion of the sheath or catheter is not slidably inserted into the second coupler. For example, in some embodiments, the molded portion of the second coupler may be pressed onto the connection portion of the repositioning sheath or catheter until a portion of the connection portion is fixed within the second coupler. In that regard, in some embodiments, the second coupler may be configured to snap onto at least a portion of the repositioning sheath in a state that results in a press fit or snap fit engagement of the second coupler with the repositioning sheath and / or catheter.

[0075]

[0096] Figures 2A and 2B illustrate another embodiment of a positioning device according to the present disclosure. As shown in these figures, the positioning device may include a clam shell design and may be configured to engage a hub to hold a tubular member with respect to the positioning device and the hub. In this regard, the clam shell may be configured to function as both a first coupler 20 and a second coupler 30. As shown in these figures, the positioning device 100 is generally divided into two sections 110, 111 connected via a hinge 112.

[0076]

[0097] As seen in FIGS. 2A and 2B, some embodiments may include only a first coupler and a second coupler and may not include an extension bridge.

[0077]

[0098] As seen in FIG. 2A, the first coupler (e.g., the distal coupler) may include a first surface 132 that defines an opening 131 that extends through the first surface 132 during use (e.g., when the two sections 110, 111 are configured in a closed position such that the two inner surfaces 144 of the device contact each other). The first coupler 20 may have side walls 134 that define one or more recesses 133 for interacting with threads, tabs, etc. on the outer surface of the introducer hub 81 (e.g., see the first coupler of FIGS. 1A - 1E). As shown in FIG. 2B, the introducer 80 may include a suturing hub portion 85 that is rotatably attached.

[0078]

[0099] In some embodiments, as shown in FIG. 2A, the first coupler may have a raised portion 135 on one of the two sections 110, 111 that is configured to fit into a recessed portion 136 in the other of the two sections.

[0079]

[0100] The second connector 30 may include the length of the positioning device proximal to the first connector. For example, the second connector and the first connector may be adjacent to each other. In some embodiments, the second connector 30 may include a proximal surface 160 that defines a proximal opening 121 that extends through the proximal surface 160 in use. In some embodiments, the proximal opening 121 may have a diameter larger than that of the distal opening 131. As will be appreciated, a portion of the repositioning sheath may be configured to extend outwardly through the proximal opening 121.

[0080]

[0101] In some embodiments, the length of each section 110, 111 of the positioning device of the second connector 30 may include an opening that extends through each section 110, 111 in use to receive a portion of the repositioning hub (or other tubular structure). In some embodiments, the length may be one or more ribs 145, each rib axially spaced from the other ribs, and each rib shaped to enable the repositioning sheath or catheter to be slidably received. In some embodiments, the ribs may maintain the position of the sheath or catheter relative to the positioning device 100.

[0081]

[0102] In some embodiments, the second coupler 30 may be configured to allow only a relocation sheath or a portion of the catheter to be slidably inserted into the second coupler. For example, in some embodiments, the second coupler may include an opening 141 having a diameter that narrows in the distal direction, the diameter of the opening being narrower than the proximal opening and also narrower than the outer diameter of the relocation sheath and / or catheter such that the opening serves as a stopper for the relocation sheath. In that regard, the most distal end of the relocation sheath cannot extend beyond the distal end of the opening 141. In some embodiments, the most distal end of the relocation sheath cannot extend beyond a proximal surface 143 that defines a proximal inlet to the opening 141. In this regard, the proximal surface of the opening can serve as a stopper protrusion. In some embodiments, the positioning device (e.g., an extension bridge or an extension bridge in combination with the first coupler) may be configured to prevent the relocation sheath from extending into the introducer hub.

[0082]

[0103] As will be appreciated, although shown as having a smaller diameter opening 141 to serve as a stopper for the relocation sheath and / or protrusion, it will be appreciated that the second coupler may simply have a stopper protrusion that extends into the channel (similar to the protrusion of the rib) to prevent the relocation sheath and / or catheter from extending beyond the protrusion, notwithstanding the positioning closer to the central axis of the channel.

[0083]

[0104] In some embodiments, the positioning device may include a hinge 112 that hinge-connects a first section 110 of the positioning device to a second section 111 of the positioning device. In this way, in an open configuration (such as the configuration seen in FIG. 2A), at least a portion of the introducer hub and at least a portion of the relocation sheath or catheter can be at least partially disposed within the first section 110 before the second section hinges closed to a closed configuration (such as the configuration seen in FIG. 2B).

[0084]

[0105] In some embodiments, the positioning device may include an indicator 146 on the inner surface 144 of the first section 110 and / or the second section 111 that represents the exact positioning of the repositioning sheath. The indicator may include one or more icons, lines, or other means detectable by a person indicating where and / or how the repositioning sheath or catheter should be positioned within the device. In some embodiments, the positioning device may include a window through which a clinician can visually inspect the repositioning sheath and / or catheter within the positioning device to determine the appropriate position.

[0085]

[0106] In some embodiments, the positioning device may include a lock 150 configured to prevent the positioning device from opening in a hinged manner after the positioning device is in a closed configuration. In some embodiments, the lock may include a snap hinge in one of the clam shell sections, such as the first section 110. In some embodiments, the snap hinge may include a handle 152 and a lock portion 154 configured to slidably couple to a recessed portion 156 and / or an overhanging portion 155 in the second section. The snap hinge may rotate about a hinge pin 153.

[0086]

[0107] As seen in FIG. 2A, the lock is in a first position, i.e., an open position, allowing the positioning device to be freely opened and closed. In FIG. 2B, the lock is moved (here, rotated) to a second position, i.e., a closed position, thereby locking the positioning device in a closed configuration until the lock is returned to the first position, i.e., the open position.

[0087]

[0108] In some embodiments, the locking hinge pin 153 extends in a direction orthogonal to the hinge pin of the hinge 112 that connects the first section 110 and the second section 111 of the positioning device. In some embodiments, the locking hinge pin 153 extends orthogonally to the direction of the hinge pin of the hinge pin 112 that connects the first section and the second section of the positioning device. In this regard, the lock moves in a direction different from the direction in which the first and second sections open and close relative to each other.

[0088]

[0109] According to other embodiments, certain additional elements may be added to the positioning device to provide further control over the positioning and movement of the repositioning sheath or catheter. For example, in some embodiments, a positioning device may be provided that is configured for adjustable positioning of a medical device, a repositioning sheath, or both, relative to an introducer hub. In some embodiments, the first coupler and the second coupler may be movable relative to each other such that the position of the repositioning sheath and / or catheter may be adjustable relative to the hub.

[0089]

[0110] Figures 2C and 2D illustrate another exemplary positioning device. Similar to Figures 2A and 2B, the positioning device 100 in Figures 2C and 3D also includes a clam shell design that can be hinged open and closed and locked (see lock 150). However, in Figures 2C and 2D, the clam shell may be attached to the hub and the ball joint 241 rather than directly connected to the flexible tubular member. In this regard, the positioning device may also function here in a manner similar to the first coupler described herein and may be configured to maintain the position of the hub relative to the medical device, and the ball joint may be attached to a second coupler for receiving the tubular member. The first coupler may be pivotally attached to the second coupler. As will be appreciated in view of Figures 2C and 2D, the ball joint may allow rotation of the tubular member that may be slidable through the ball joint and through the hemostatic valve of the hub, thus allowing the position of the hub relative to the patient to be adjusted.

[0090]

[0111] Referring to FIG. 3A, in some embodiments, the positioning device may include a hinge 230 that connects the first coupler 20 and the second coupler 30. In such embodiments, the hinge 230 (which may also be referred to as a "flexible hinge") may be configured to allow the second coupler to rotate relative to the first coupler about a hinge (see hinge axis 299 in FIG. 3A). In such embodiments, the hinge axis may extend orthogonally to the longitudinal central axis 298 of the positioning device.

[0091]

[0112] In some embodiments, the hinge may include a lock 235 that can be moved to an unlocked position to allow the hinge section to rotate or to a locked position to prevent the hinge section from rotating. The lock may include a visual indicator, such as an icon 236 or other visual display, indicating whether the hinge section is locked or unlocked.

[0092]

[0113] Similarly to the above, the first coupler 20 of FIG. 3A may be configured to be removably coupled to the proximal end of the introducer hub. The first coupler may also be configured to slidably receive a medical device to allow the medical device to enter the introducer hub.

[0093]

[0114] The second coupler 30 of the positioning device may include a proximal end 220 configured to slidably receive a medical device. The proximal end may include a first section 221 and a second section 222, and the second section may have an outer diameter smaller than that of the first section. The proximal end of the second section may define an opening 260 configured to slidably receive a medical device.

[0094]

[0115] In some embodiments, the second coupler may include a proximal end 220 and an adjustable lock 250. The adjustable lock may be configured to allow or prevent axial adjustment of the medical device and / or the repositioning sheath relative to the second coupler 30 and the introducer hub based on the position of the adjustable lock.

[0095]

[0116] Referring to FIG. 3B, an enlarged view of the hinge having a ball joint can be seen. In some embodiments, the hinge 240 may include an outer housing 231 having a distal end 262, a proximal end 261, and an inner surface 263 that defines a first volumetric space 244 extending through the outer housing 231. The outer housing may also define a portion of the first coupler 20 (see also FIGS. 1H-1M). As seen in FIG. 3B, the first coupler may include a ring 211 that is rotatably coupled to the outer housing of the hinge 231. In some embodiments, a portion of the ring 211 may be configured to interact with the outer surface of the introducer hub 81. For example, the ring 211 may be threaded onto the hub in some embodiments. As will be appreciated, the ring may also be fixedly attached to the outer housing of the ring 231.

[0096]

[0117] As shown in FIG. 3B, the flexible hinge may include a ball 241 having a distal end 265, a proximal end 266, and an inner surface 267 that defines a second volumetric space 268 extending through the ball 241. In some embodiments, the distal end 265 of the ball 241 may be at least partially positioned within the first volumetric space 244 of the outer housing. In some embodiments, the ball 241 may include one or more raised portions 242 configured to prevent the ball from rotating beyond a specified amount. As will be appreciated, the shape and size of the ball may correspond to the shape and size of the first volumetric space 244.

[0097]

[0118] The proximal end 266 of the ball (e.g., ball 241) may be coupled to the first section 221 of the second coupler 220 of the device.

[0098]

[0119] In some embodiments, the ball joint may allow rotation of the second coupler in any direction with respect to the first coupler 20. In some embodiments, the joint may be configured to allow rotation within a single plane. For example, in some embodiments, the joint may be configured to rotate about a first axis (e.g., the central axis of the hinge pin 243 or the like) with respect to the outer housing, and the first axis is orthogonal to the path 249 passing through the positioning device.

[0099]

[0120] The path 249 may represent the path of the medical device through a lumen extending through the second coupler from the proximal opening 260, through the lumen within the proximal end 248 of the flexible joint, through the second space volume 268, through the first space volume 244, through the distal end 262 of the outer housing, and through the first coupler 20. After passing through the distal end of the outer housing, the medical device then enters the contamination prevention means 270 of the introducer hub before entering the third space volume 275 defined by the hub. The contamination prevention means may include a hemostatic valve 271, a foam 272, and / or a cap 273.

[0100]

[0121] Thus, the second space volume may be configured to allow the medical device to be slidably received and guided from the proximal end 266 of the joint to the distal end 262 of the outer housing.

[0101]

[0122] In some embodiments, the second volume 268 within the ball 241 is configured to have two branch paths 245, 246. The first branch path 245 can be utilized when the device is configured such that the path 249 at the proximal end 266 of the joint is substantially parallel to the path when the device passes through the distal end 262 of the outer housing. That is, the first branch path can be used when the joint is in a generally "straight" position. Conversely, the second branch path 246 can be utilized when the device is configured such that the path 249 at the proximal end 266 of the joint forms an angle with the path when the device passes through the distal end 262 of the outer housing. In this regard, the medical device (and / or another accessory) can be passed through the hinge at a desired angle. In some embodiments, the angle can be between 30 and 90 degrees.

[0102]

[0123] The flexible hinge can be positioned between the first connector 20 and the second connector 220 and can be configured to allow the medical device to be slidably received through the flexible hinge.

[0103]

[0124] The hinge section can be configured to allow an adjustable locking portion to rotate about the hinge section relative to the first connector.

[0104]

[0125] The positioning device can be configured to slidably receive the medical device through the adjustable locking portion and through the first connector.

[0105]

[0126] Figure 3C shows a perspective view of the positioning device of FIG. 3B with the medical device and catheter inserted into the positioning device. As shown in this figure, the positioning device is adjusted so that the desired positioning of the medical device, the repositioning sheath, or both, relative to the introducer hub, can be achieved by the clinician. As shown in this figure, the first coupler 20 is configured to be removably coupled to the proximal end of the introducer hub 81. The first coupler may also be configured to slidably receive a medical device (which may include catheter 280) and allow the medical device to enter the introducer hub 81. After entering the introducer hub, the medical device then enters the introducer sheath 82 and can then enter the patient through an access point 291 on the surface of the patient's skin 290.

[0106]

[0127] In some embodiments, the positioning device may include a lock 250 that may include an adjustable button 251 (e.g., a push button) coupled to the second coupler 30. In some embodiments, the lock may be configured to allow or prevent the medical device and / or the repositioning sheath from being axially adjusted relative to the second coupler 30 and the hub based on the position of the medical device and / or the repositioning sheath relative to the second coupler.

[0107]

[0128] The positioning device may be configured to slidably receive a medical device (which may include catheter 280) through the lock 250 and through the first coupler 20 when the adjustable locking portion is in the unlocked configuration. When the adjustable locking portion is in the locked configuration, the medical device and / or the repositioning sheath cannot move axially relative to the adjustable locking portion.

[0108]

[0129] The positioning device may include a hinge configured to allow the lock to rotate about a hinge relative to the first coupler.

[0109]

[0130] The positioning device may include a proximal end 222 configured to slidably receive a medical device (or a repositioning sheath).

[0110]

[0131] The medical device may include one or more markings 285 on the outer surface of the catheter 280. In some embodiments, the markings may be radiopaque. In some embodiments, the markings are visible markings. In some embodiments, at least one marking is disposed proximal to the positioning device.

[0111]

[0132] In some embodiments, the positioning device may include a fixture 295. The fixture may be configured to hold a transparent flexible sterile member 296 (such as a bag, etc.) positioned around at least a portion of the catheter 280. The fixture 295 may be connected to the proximal end 222 via the transparent flexible sterile member 296.

[0112]

[0133] In some embodiments, a kit may be provided, which may include an introducer hub, a repositioning sheath, and the positioning device disclosed herein.

[0113]

[0134] In some embodiments, a kit may be provided. The kit may include a medical device, the positioning device disclosed herein, and optionally a repositioning sheath.

[0114]

[0135] Referring to FIG. 3D, another embodiment of the housing 231 is shown. As shown in this figure, the housing may include a two-piece socket with first and second housing members 233a, 233b that are attached to each other to form a housing and a ring (similar to the housing and the first coupler shown in FIG. 1J). As will be appreciated in view of FIG. 3D, a clinician may rotate the second housing portion 233b about the hub flange to lock and close the interface between the housing and the hub (see the arrow in FIG. 3D). In FIG. 3E, a closed interface between the housing and the hub can be seen.

[0115]

[0136] Referring to FIG. 3F, another multi-component housing is shown. As shown in this figure, after aligning the housing with the hub by corresponding alignment tabs, the fastener 237 of the housing can be axially slid on the hub, for example, on the hub flange (see the arrow in FIG. 3F) to lock the hub relative to the housing. As will be appreciated, the shape and size of the fastener can correspond to the shape and size of the hub (e.g., the hub flange). Further, as will be appreciated, although shown as having two fasteners, the housing can be configured to have a single fastener or three or more fasteners.

[0116]

[0137] FIG. 3G shows yet another method of attaching the housing 231 to the hub. As shown in this figure, the housing can include first and second tabs 238a, 238b that can engage the hub. In such an embodiment, the tabs are splayed outwardly in a direction away from the hub while sliding on the hub flange, after which point the tabs snap back into place and can hold the hub to the housing. For removal, the user can apply pressure to the tabs to splay them outwardly again to allow the clinician to remove the hub from the housing.

[0117]

[0138] FIGS. 3H and 3I show yet another method of attaching the housing 231 to the hub 81. As shown in this figure, the housing can include a hinged clamp that can be snap-fastened onto the hub (e.g., the hub flange). Similar to other embodiments, the clamp can be attached after the housing has been aligned with the hub.

[0118]

[0139] As will be appreciated, other ways of attaching the housing to the hub may be used. For example, the user may push forward (e.g., toward the hub) such that a protrusion (e.g., on the hub) slides within a ring on the housing, or a protrusion on the housing slides within a ring on the hub, to lock and unlock. In yet another embodiment, the user may rotate the ring until the ring of the housing engages the hub. Next, when the ring and hub engage and lock, the ring and housing also engage and lock.

[0119]

[0140] Referring to FIG. 4, in some embodiments, a method for adjusting the positioning of a medical device, a repositioning sheath, or both, relative to an introducer hub may be provided. In embodiments having a lock, method 300 may include unlocking the lock in the positioning device 310. In some embodiments, the method may include adjusting the positioning of the medical device, the repositioning sheath, or both 320. The adjustment step may include (1) rotating a second coupler of the positioning device relative to a first coupler of the positioning device 321, (2) axially moving the medical device, the repositioning sheath, or both 322, or (3) a combination thereof.

[0120]

[0141] The method may include locking the locking mechanism in the positioning device 330. In some embodiments, locking the locking mechanism in the positioning device may include locking the locking mechanism to prevent the medical device, the repositioning sheath, or both from moving axially relative to the locking mechanism. In some embodiments, locking the locking mechanism may include locking the locking mechanism to prevent the proximal end of the positioning device from rotating relative to the distal end of the positioning device. In some embodiments, at least two locking mechanisms are adjusted, namely, one to prevent axial movement and one to prevent rotational movement.

[0121]

[0142] The disclosed system can be used for various applications. For example, currently, in certain conventional non-percutaneous (surgical) insertions, a physician typically exposes a blood vessel (e.g., the axillary artery), attaches a graft, then inserts a peel-away sheath into the graft and secures the graft to the peel-away sheath. The peel-away sheath supports a medical device (such as a catheter-based pump) that is passed through the graft. The sheath also includes a hemostatic valve. At the end of the procedure, the graft is clamped and the sheath is removed, peeled away, and then a repositioning unit that includes a butterfly portion pre-positioned on the proximal portion of the catheter is slid within the graft and attached to the graft before the clamp is released, thereby allowing the medical device to remain inserted through the graft into the blood vessel.

[0122]

[0143] The disclosed system can eliminate the need for a peel-away sheath in the above procedure, thereby simplifying the insertion procedure for non-percutaneous applications. Referring to FIG. 5A, the graft 410 can be seen with an inner surface 412 that defines a lumen extending through the graft. A suture hub 420 (e.g., a butterfly) is seen in a state connected to a hub body 81. The suture hub can be rotatably connected to the hub body. The distal end 421 of the suture hub has an outer surface 422 configured to be removably connected to the inner surface 412 of the graft.

[0123]

[0144] Referring to the conventional procedure, after attaching and clamping the graft to the blood vessel, the distal end of the suture hub can be directly attached to the graft using the disclosed system. Next, since the hub body includes a hemostatic valve, the clamp on the graft can be released.

[0124]

[0145] Next, a medical device can be passed through. Referring to FIG. 5B, when the graft and the repositioning butterfly are properly connected, it can be seen that a medical device (such as a catheter-connected medical device such as a catheter-type heart pump) can be passed through the second coupler 30, the hinge 230, the first coupler 20, the hub body 81, the suture hub 420, and the graft 410. Thus, the hub and the suture hub can sufficiently support the medical device through the graft.

[0125]

[0146] It will be understood that the inner dimensions of the hub (including the hub body 81) and the suture hub 420 can be appropriately selected, for example, based on the outer diameter of the medical device intended to be inserted through the hub and the suture hub.

[0126]

[0147] Embodiments of the present disclosure will be described in detail with reference to the drawings, in which like reference numerals identify like or identical elements. It should be understood that the embodiments of the disclosure are merely examples of the present disclosure and can be embodied in various forms. Well-known functions or structures are not described in detail in order to avoid obscuring the present disclosure with unnecessary details. Therefore, the specific structural and functional details disclosed herein should be construed not as limiting but merely as a basis for the claims and as a representative basis for teaching those skilled in the art.

[0127]

[0148] Those skilled in the art will recognize or be able to confirm many equivalents to the specific embodiments of the invention described below using only routine experimentation. Such equivalents are intended to be encompassed by the following claims.

Claims

**Claim 1** A positioning device, a first coupler configured to be removably coupled to the proximal end of an introducer hub; a second coupler configured to be removably coupled to a portion of a repositioning sheath or catheter proximal to the first coupler, wherein the first coupler is attached to the second coupler; comprising the positioning device is configured to maintain the axial position of the repositioning sheath or catheter relative to the introducer hub. Positioning device. **Claim 2** The positioning device according to claim 1, further comprising an extension bridge extending between the first coupler and the second coupler and configured to maintain a constant axial distance between the introducer hub and the proximal end of the repositioning sheath or catheter. **Claim 3** The positioning device according to claim 2, wherein the extension bridge is configured to avoid contacting the repositioning sheath or catheter. **Claim 4** The positioning device according to claim 2, wherein the extension bridge circumferentially surrounds at least a portion of the repositioning sheath or catheter. **Claim 5** The positioning device according to claim 2, wherein the extension bridge partially circumferentially surrounds the repositioning sheath or catheter. **Claim 6** The positioning device according to claim 2, wherein the extension bridge is configured to allow only a portion of the repositioning sheath or catheter to be slidably inserted through the extension section. **Claim 7** The positioning device according to claim 2, wherein the extension bridge is configured to prevent the repositioning sheath from extending into the introducer hub. **Claim 8** The positioning device according to claim 2, wherein the extension bridge has a rigidity greater than that of the repositioning sheath or catheter. **Claim 9** The positioning device according to claim 2, wherein the second coupler is configured to allow only a portion of the repositioning sheath or catheter to be slidably inserted through the connection section. **Claim 10** The first connector according to claim 1 includes a first surface including a threaded portion configured to interact with one or more threads on the outer surface of the introducer hub to prevent axial movement of the first connector relative to the introducer hub.

11. The positioning device according to claim 1, wherein the first connector includes at least one fixture configured to interact with a corresponding fixture on the outer surface of the introducer hub to maintain the position of the introducer hub relative to the first connector.

12. The positioning device according to claim 11, wherein the first connector includes at least one recess or opening configured to interact with a tab or an overhang on the outer surface of the introducer hub.

13. The positioning device according to claim 1, wherein the first connector includes a rotatable portion and a non-rotatable portion, the rotatable portion being located distally from the non-rotatable portion, the rotatable portion being configured to interact with a thread, a tab, or an overhang on the outer surface of the introducer hub to prevent axial movement of the first connector relative to the introducer hub.

14. The positioning device according to claim 1, wherein the first connector has an outer diameter larger than the outer diameter of the introducer hub.

15. The positioning device according to claim 1, wherein the first connector has a constant outer diameter between a first end and a second end.

16. The positioning device according to claim 1, wherein the outer diameter of the first end of the first connector is smaller than the outer diameter of the second end of the first connector.

17. The positioning device according to claim 16, wherein the outer diameter of the first connector decreases in a direction from a portion between the first end and the second end of the first connector towards the first end of the connector.

18. The positioning device according to claim 1, further comprising an adjustable arm coupled to the first connector and configured to support the repositioning sheath or catheter when the repositioning sheath or catheter extends proximally from the first connector.

19. The positioning device according to claim 1, wherein the second connector includes the molded portion molded such that an inner surface of the molded portion substantially coincides with an outer surface of the repositioning sheath or the catheter.

20. The positioning device according to claim 19, wherein the molded portion is configured to surround at least a part of the suture pad.

21. The positioning device according to claim 19, wherein the molded portion is configured to surround at least a part of a connector at a proximal end of the repositioning sheath.

22. The positioning device according to claim 1, wherein the positioning device includes a hinge that hinge-connects a first section of the positioning device to a second section of the positioning device, and at least a part of the introducer hub and at least a part of the repositioning sheath or the catheter can be at least partially disposed within the first section before the second section closes in a hinged manner.

23. At least a part of the introducer hub is at least partially disposed within a part of the first section that forms a part of the first connector, and at least a part of the repositioning sheath or the catheter is disposed within a part of the first section that forms a part of the second connector of the first section. The positioning device according to claim 22.

24. The positioning device according to claim 22, further comprising a locking mechanism configured to prevent the positioning device from opening in a hinged manner.

25. The locking mechanism includes a snap hinge in the first section, and the snap hinge includes a handle and a locking portion configured to slidably connect to a concave portion or an overhanging portion in the second section. The positioning device according to claim 24.

26. The hinge section can be unlocked to allow the hinge section to rotate, or can be locked to prevent the hinge section from rotating. The positioning device according to claim 24.

27. The inner surface of the first section and / or the second section includes an indicator representing the exact positioning of the repositioning sheath. The positioning device according to claim 22.

28. Each of the first section and the second section includes a length having one or more ribs extending into a channel formed between the first section and the second section, the channel being configured to receive at least a portion of the repositioning sheath and / or the catheter. The positioning device according to claim 22.

29. The positioning device according to claim 1, wherein the first connector includes a clam shell, and the second connector is attached to the clam shell via a ball joint fixed within the clam shell.

30. The positioning device according to claim 1, wherein the extension bridge includes the hinge section configured such that a proximal end of the extension bridge is rotatable about the hinge section with respect to a distal end of the extension bridge.

31. A positioning device, comprising a housing and the first connector having means for locking the first connector to an introducer sheath, a second connector connected to the first connector, the second connector being configured to receive a tubular member The positioning device includes.

32. The positioning device according to claim 31, wherein the first connector includes alignment tabs.

33. The positioning device according to claim 31, wherein the first connector includes one or more indicators of a locked state of the first connector.

34. The positioning device according to claim 31, wherein the first connector is pivotally attached to the second connector.

35. A kit, an introducer hub, a repositioning sheath, the positioning device according to any one of claims 1 to 34 The kit includes.

36. A positioning device configured for adjustable positioning of a medical device, a repositioning sheath, a catheter, or a combination thereof relative to an introducer hub, a first connector configured to be removably coupled to a proximal end of the introducer hub, a second connector configured to slidably receive the medical device, the repositioning sheath, the catheter, or a combination thereof, the hinge section configured such that an adjustable locking portion is rotatable about the hinge section with respect to the first connector The positioning device includes.

37. The second coupler is configured to enable or prevent the medical device and / or the repositioning sheath from being axially adjusted relative to the introducer hub based on an adjustable lock position, and the positioning device is configured to slidably receive the medical device through the adjustable lock portion and through the first coupler. The positioning device according to claim 36.

38. The hinge section can be unlocked to allow the hinge section to rotate or locked to prevent the hinge section from rotating. The positioning device according to claim 36.

39. A positioning device configured for adjustable positioning of a medical device, a repositioning sheath, or both relative to an introducer hub, A first coupler configured to be removably coupled to the proximal end of the introducer hub and configured to slidably receive the medical device to allow the medical device to enter the introducer hub, A second coupler configured to slidably receive a portion of the repositioning sheath and / or the catheter device, A flexible hinge connecting the first coupler and the second coupler, the flexible hinge being configured to allow the medical device to be slidably received therethrough, Comprising a positioning device.

40. The flexible hinge includes a lock configured to prevent the flexible hinge from rotating, and in the unlocked configuration, the flexible hinge can rotate. The positioning device according to claim 39.

41. The flexible hinge An outer housing having a distal end, a proximal end, and an inner surface defining a first volume extending through the outer housing, The joint having a distal end, a proximal end, and an inner surface defining a second spatial volume that passes through the joint, wherein the distal end of the joint is at least partially positioned within the first spatial volume, the joint is configured to rotate about a first axis relative to the outer housing, and the first axis is orthogonal to a path from the first end of the outer housing to the second end of the outer housing, the joint and comprising the second spatial volume is configured to enable a medical device to be slidably received and guided from the proximal end of the joint to the distal end of the outer housing, The positioning device according to claim 39.

42. The positioning device according to claim 41, wherein the joint is a ball joint.

43. A kit comprising a medical device, the positioning device according to any one of claims 36 to 42, and optionally a repositioning sheath The kit comprising.

44. A method of adjusting the positioning of a medical device, a repositioning sheath, or both, relative to an introducer hub, comprising rotating a first coupler of the positioning device relative to a second coupler of the positioning device, axially moving the medical device, the repositioning sheath, or both, or a combination thereof to adjust the positioning of the medical device, the repositioning sheath, or both, and optionally locking the locking mechanism in the positioning device to prevent the medical device, the repositioning sheath, or both from moving axially relative to the locking mechanism The method comprising.

45. The method according to claim 44, further comprising unlocking the locking mechanism in the positioning device.

46. The method according to claim 44, further comprising attaching the first coupler to the hub prior to adjustment.

47. The method according to claim 44, further comprising attaching the second coupler to the repositioning sheath and / or catheter after adjustment.

48. Locking the locking mechanism in the positioning device comprises locking a first lock to prevent the medical device, the repositioning sheath, or both from moving axially relative to the locking mechanism, Locking a second lock to prevent the proximal end of the positioning device from rotating relative to the distal end of the positioning device The method of claim 44, comprising: **Claim 49** The positioning device comprises The outer housing having a distal end, a proximal end, and an inner surface defining a first volume extending through the outer housing; The joint having a distal end, a proximal end, and an inner surface defining a second volume extending through the joint, wherein the distal end of the joint is at least partially positioned within the first volume, and the joint is configured to rotate about a first axis relative to the outer housing, the first axis being orthogonal to a path from the first end of the outer housing to the second end of the outer housing; a joint Including a flexible hinge; The method of claim 44, wherein the second volume is configured to allow a medical device to be slidably received and guided from the proximal end of the joint to the distal end of the outer housing. **Claim 50** The method of claim 49, wherein the joint is a ball joint. **Claim 51** A system comprising A flexible hinge operably coupled to an introducer hub; A medical device configured to pass through the flexible hinge and enter the introducer hub Including The flexible hinge comprises The outer housing having a distal end, a proximal end, and an inner surface defining a first volume extending through the outer housing; The joint having a distal end, a proximal end, and an inner surface defining a second volume extending through the joint, wherein the distal end of the joint is at least partially positioned within the first volume, and the joint is configured to rotate about a first axis relative to the outer housing, the first axis being orthogonal to a path from the first end of the outer housing to the second end of the outer housing; a joint Including The second volume is configured to allow a medical device to be slidably received and guided from the proximal end of the joint to the distal end of the outer housing. A system. **Claim 52** A method of connecting a coupler to a hub, comprising Aligning and engaging a first coupler with the hub Moving at least a portion of the first coupler or the hub from a first position to a second position A method comprising.

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