Medical device support device

Abstract

A positioning device may be provided for maintaining the positioning of a guide hub relative to a repositioning sheath or catheter. The positioning device may include a first coupler, a second coupler configured to be removably coupled to a portion of a repositioning sheath or catheter proximate the first coupler, and a portion extending between the first coupler and the second coupler, the extension bridge is configured to maintain a fixed axial distance between the guide hub and the proximal end of the repositioning sheath or catheter. A flexible hinge may be incorporated, where the medical device is to be configured through the second coupler, the flexible hinge, and the first coupler.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] 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 contents of the above applications are incorporated herein by reference. Technical Field

[0003] The present disclosure relates to support structures for medical devices that can extend outward from a patient's body, such as positioning devices, which are configured to allow the medical device, catheter and / or sheath to be positioned at an access point and relative to the patient and / or relative to a portion of the medical device or support structure, such as a guide hub. Background Art

[0004] In a clinical setting, a medical device may be inserted into a patient at an access point, for example, via an access device. After such treatment, the patient may need to leave the medical device and / or sheath in place. For example, the patient may be transported to an intensive care unit with a blood pump in place and a positioning sheath exposed at the access point.

[0005] Current practice involves, for example, slightly inserting the end of a repositioning sheath into a hemostatic valve of a hub of an introducer sheath inserted through the access site. Summary of the invention

[0006] In various aspects, a positioning device for maintaining the axial positioning of a guide hub relative to a repositioning sheath or catheter can be provided. The positioning device can include a first coupler configured to be removably coupled to a proximal end of the guide hub. The positioning device can 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 can be configured to maintain a fixed axial distance between the guide hub and the proximal end of the repositioning sheath or catheter.

[0007] In some embodiments, the positioning arrangement may include an extension bridge extending between the first coupler and the second coupler.

[0008] In some embodiments, the first coupler may include a first surface including a threaded portion configured to interact with one or more threads on an outer surface of the guide hub to prevent the first coupler from axially moving relative to the guide hub. In some embodiments, the first coupler may include at least one recess or aperture configured to interact with a tab or extrusion on an outer surface of the guide hub to prevent the first coupler from axially moving relative to the guide hub. In some embodiments, the first coupler may include at least one fastener configured to interact with a corresponding fastener on an outer surface of the guide hub to maintain a position of the guide hub relative to the first coupler.

[0009] In some embodiments, the first coupling may include a rotatable portion and a non-rotatable portion, the rotatable portion being located distally of the non-rotatable portion, the rotatable portion being configured to interact with a thread, a lug, or an extruded portion of an outer surface of the guide hub. In some embodiments, the outer diameter of the first coupling may be greater than the outer diameter of the guide hub.

[0010] 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 portion between the first end and the second end of the first coupler to the first end of the coupler.

[0011] In some embodiments, the positioning device can include an adjustable arm coupled to the first coupler. The adjustable arm can be configured to support the repositioning sheath or catheter as it extends proximally from the first coupler.

[0012] In some embodiments, the extension bridge can be configured to avoid contact with the repositioning sheath or catheter. In some embodiments, the extension bridge can circumferentially surround the repositioning sheath or catheter. In some embodiments, the extension bridge can partially circumferentially surround the repositioning sheath or catheter.

[0013] In some embodiments, the extension bridge can be configured to allow only a portion of the repositioning sheath or catheter to be slidably inserted through the extension section. In some embodiments, the extension bridge can be configured to prevent the repositioning sheath from extending into the guide hub.

[0014] In some embodiments, the extension bridge can have a stiffness greater than the stiffness of the repositioning sheath or catheter.

[0015] In some embodiments, the second coupler can be configured to allow only a portion of the repositioning sheath or catheter to be slidably inserted through the coupling section. In some embodiments, the second coupler can include a molded portion that is molded so that the inner surface of the molded portion substantially matches the outer surface of the repositioning sheath or catheter. In some embodiments, the molded portion can be configured to surround at least a portion of the suture pad. In some embodiments, the molded portion can be configured to surround at least a portion of the connector at the proximal end of the repositioning sheath.

[0016] In some embodiments, the positioning device can include a hinge that hingedly connects a first section of the positioning device to a second section of the positioning device, wherein at least a portion of the guide hub and at least a portion of the repositioning sheath or catheter can be at least partially placed into the first section before the second section is hingedly closed. In some embodiments, the positioning device can include a locking mechanism that is configured to prevent the positioning device from hingedly opening. In some embodiments, the locking mechanism includes a snap hinge on the first section, the snap hinge including a handle and a locking portion that is configured to be slidably coupled to a recessed or extruded portion on the second section.

[0017] In some embodiments, at least a portion of the guide hub can be at least partially placed in a portion of the first section forming a portion of the first connector, and at least a portion of the repositioning sheath or catheter can be placed in a portion of the first section forming a portion of the second connector of the first section.

[0018] In some embodiments, the inner surface of the first section and / or the second section may include indicators indicating proper positioning of the repositioning sheath.

[0019] In some embodiments, each of the first and second segments can include a length having one or more ribs extending into a channel formed between the first and second segments, the channel configured to receive at least a portion of a repositioning sheath and / or catheter.

[0020] In some embodiments, the first coupler may include a clamshell, and the second coupler may be attached to the clamshell via a ball joint secured within the clamshell.

[0021] In some embodiments, the extension bridge may include an articulation section configured to allow the proximal end of the extension bridge to rotate about the articulation section relative to the distal end of the extension bridge. In some embodiments, the articulation section may be unlocked to allow the articulation section to rotate, or locked to prevent the articulation section from rotating.

[0022] In some embodiments, a kit may be provided that may include a guide hub, a repositioning sheath, and a positioning device as disclosed herein.

[0023] In some embodiments, a positioning device can be provided that can be configured for adjustable positioning of a medical device, a repositioning sheath, or both relative to a guide hub. The positioning device can include a first coupler configured to be removably coupled to the proximal end of the guide hub. A second coupler can be configured to receive a medical device, a repositioning sheath, and / or a catheter. The positioning device can include an articulated section configured to allow an adjustable locking portion to rotate about the articulated section relative to the first coupler.

[0024] In some embodiments, the second connector can be configured to allow or prevent the medical device and / or the repositioning sheath from being axially adjusted relative to the guide hub based on the position of the adjustable lock, wherein the positioning device is configured such that the medical device can be slidably received through the adjustable locking portion and through the first connector.

[0025] In some embodiments, the articulating section may be unlocked to allow the articulating section to rotate, or locked to prevent the articulating section from rotating.

[0026] In some embodiments, a positioning device can be provided that is configured for adjustable positioning of a catheter device, a repositioning sheath, or both relative to a guide hub. The positioning device can include a first coupler that can be configured to be removably coupled to the proximal end of the guide hub. The first coupler can be configured to slidably receive a medical device and allow the medical device to enter the guide hub. The positioning device can include a proximal end that is configured to slidably accommodate the medical device. The positioning device can include a flexible hinge connecting the first coupler and the second coupler, wherein the flexible hinge can be configured to allow the medical device to be slidably received by the flexible hinge.

[0027] 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.

[0028] In some embodiments, the flexible hinge may include an outer shell having a distal end, a proximal end, and an inner surface that defines a first spatial volume extending therethrough. 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 that defines a second spatial volume extending therethrough. The distal end of the joint may be at least partially positioned within the first spatial volume. The joint may be configured to rotate relative to the outer shell about a first axis that is orthogonal to a path from the first end of the outer shell to the second end of the outer shell. The second spatial volume may be 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 shell.

[0029] 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 a device for locking the first coupler to the guide sheath. The first coupler may include an alignment tab. The first coupler may include one or more markings of a locked state of the first coupler.

[0030] 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 the tubular member. The first coupler may be pivotally attached to the second coupler.

[0031] In various aspects, a kit can be provided. The kit can include a medical device, a positioning device as disclosed herein, and an optional repositioning sheath.

[0032] In various aspects, a method for adjusting the positioning of a medical device, a repositioning sheath, or both relative to a guide hub can be provided. The method can include adjusting the positioning of the medical device, the repositioning sheath, or both. The adjusting can include: rotating a proximal end of the positioning device relative to a distal end of the positioning device; moving the medical device, the repositioning sheath, or both in an axial direction; or a combination thereof. The method can include locking a locking mechanism on the positioning device to prevent axial movement of the medical device, the repositioning sheath, or both relative to the locking mechanism.

[0033] In some embodiments, the method may include unlocking a locking mechanism on the positioning device. In some embodiments, the method may include attaching the first coupler to the hub prior to adjusting. In some embodiments, the method may include attaching the second coupler to the repositioning sheath and / or catheter after adjusting.

[0034] In some embodiments, locking the locking mechanism on the positioning device may include: locking a first locking mechanism to prevent axial movement of the medical device, the repositioning sheath, or both 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.

[0035] In some embodiments, the flexible hinge may include an outer shell having a distal end, a proximal end, and an inner surface defining a first spatial volume extending therethrough. In some embodiments, the flexible hinge may include a joint having a distal end, a proximal end, and an inner surface defining a second spatial volume extending therethrough. The distal end of the joint may be at least partially positioned within the first spatial volume. The joint may be configured to rotate relative to the outer shell about a first axis, the first axis being orthogonal to a path from the first end of the outer shell to the second end of the outer shell. The second spatial volume may be 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 shell.

[0036] In various aspects, a system may be provided. The system may include a flexible hinge operably connected to a guide hub, and a medical device configured to pass through a flexible joint and enter the guide hub. The flexible hinge may include an outer shell having a distal end, a proximal end, and an inner surface defining a first spatial volume extending therethrough. In some embodiments, the flexible hinge may include a joint having a distal end, a proximal end, and an inner surface defining a second spatial volume passing therethrough. The distal end of the joint may be at least partially positioned within the first spatial volume. The joint may be configured to rotate relative to the outer shell around a first axis, the first axis being orthogonal to a path from the first end of the outer shell to the second end of the outer shell. The second spatial volume may be 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 shell.

[0037] In various aspects, a method for coupling and / or decoupling a connector and a hub (e.g., for preventing a medical device, a repositioning sheath, or both from axially moving relative to a hub, or for allowing a medical device and / or a repositioning sheath to move) can be provided. The method can include aligning and engaging a first connector to a hub, as disclosed herein. In some embodiments, the medical device and / or the repositioning sheath can be introduced before the first connector is aligned and engaged. In some embodiments, the medical device and / or the repositioning sheath can be introduced after the first connector is aligned and engaged. The method can include moving at least a portion of the first connector or the hub from a first position to a second position. In some embodiments, this can be from an unlocked position to a locked position. In some embodiments, this can be from a locked position to an unlocked position. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1A is a diagram of an embodiment of a positioning device.

[0039] Figure 1B and 1C It is a partial cross-sectional view of the first connector of the positioning device.

[0040] Figure 1D and 1E is a diagram of an embodiment of a positioning device.

[0041] Figure 1F and 1G Illustration of the locating device aligned and locked to the hub respectively.

[0042] Figure 1H A positioning device and a guide hub according to one embodiment are shown.

[0043] Figures 1I-1L A positioning device according to other embodiments of the present disclosure is shown.

[0044] Figure 1M A portion of a positioning device according to one embodiment is shown.

[0045] Figure 2A is an illustration of an embodiment of a positioning device having a clamshell design in an open configuration.

[0046] Figure 2B is an illustration of an embodiment of a positioning device having a clamshell design in a closed configuration.

[0047] Figure 2C is an illustration of an embodiment of a positioning device having a clamshell design in an open configuration.

[0048] Figure 2D is in a closed configuration Figure 2C Illustration of the positioning device.

[0049] Figure 3A is an illustration of an embodiment of a positioning device having a flexible hinge design.

[0050] Figure 3B is an illustration of a cross-sectional view focusing on the hinge portion of an embodiment having a flexible hinge design.

[0051] Figure 3C yes Figure 3B Illustration of an embodiment of a positioning device in which the hinge is adjusted downward toward the patient's skin.

[0052] Figure 3D is a diagram of a positioning device according to one embodiment.

[0053] Figure 3E is in locked position Figure 3D Illustration of the positioning device.

[0054] Figure 3F is a diagram of a positioning device according to another embodiment.

[0055] Figure 3G is a diagram of a positioning device according to another embodiment.

[0056] Figure 3H is a diagram of a positioning device according to another embodiment.

[0057] Fig. 3I is in locked position Figure 3D Illustration of the positioning device.

[0058] Figure 4 is a flow chart of the method.

[0059] Figure 5A and 5Bis a diagram of an embodiment with a graft. DETAILED DESCRIPTION

[0060] As is known, a medical device can be inserted into a patient at an access point, for example, via an access device, to perform a medical surgical procedure or treatment. After such surgery or treatment, the patient may need to leave the medical device and / or sheath in place. For example, the patient can be transported to an intensive care unit with a blood pump in place and a positioning sheath exposed at the access point.

[0061] In some embodiments, the end of the repositioning sheath can be slightly inserted into the hemostatic valve of the hub of the guide sheath inserted through the entry point. In order to avoid problems with contamination, bleeding and / or clogging of the side port, the inventors have recognized the benefits of a device that can allow proper positioning and fixation of a medical device (e.g., a pump), a repositioning sheath and / or an anti-contamination barrier at the entry point. For example, the inventors have recognized the benefits of a device that can minimize and / or prevent movement relative to the guide 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 relative to the guide hub and / or the patient. In some embodiments, a positioning device can be provided for maintaining the axial positioning of the guide hub relative to the repositioning sheath or catheter.

[0062] Now turning to the attached figure, Figure 1A An embodiment of a positioning device according to an embodiment of the present disclosure is shown. In some embodiments, as shown in the figure, the positioning device 10 may include a first coupler 20 (e.g., a distal coupler or distal end coupler) configured to be removably coupled to a hub body 81 of an access device (such as an introducer 80), for example, coupled to the proximal end of the hub body. In some cases, the introducer may have a sheath 82 coupled to the distal end of the hub body 81, and may have a side port 83 extending away from the side surface of the hub body 81.

[0063] In some embodiments, the positioning device can include a second coupler 30 configured to removably couple to a portion of a repositioning sheath 90 or catheter proximate the first coupler.

[0064] The positioning device can include an extension bridge 40 extending between the first coupler 20 (e.g., distal coupler) and the second coupler 30. The extension bridge can be configured to maintain a fixed distance (e.g., axial distance) between the proximal end of the guide hub 81 and the proximal end of the repositioning sheath 90 or catheter.

[0065] In some embodiments, the first coupler and the second coupler and the extension bridge can be permanently attached to each other, such as integrally formed. In other embodiments, one or both of the first coupler and the second coupler can be removably attached to the extension bridge. In this regard, the positioning device can include a modular system that can be configured by a clinician.

[0066] Any suitable method for connecting the first coupling 20 to the guide hub and for maintaining a desired position of the first coupling relative to the guide hub is contemplated.

[0067] For example, briefly refer to Figure 1B In some embodiments, the first coupler can be configured to threadedly engage with the hub. For example, the first coupler 20 can include a chamber having a first surface 28, the first surface 28 including a threaded portion (e.g., including a recess 29), the threaded portion configured to interact with one or more threads 86 on the outer surface of the guide hub 81 to prevent the first coupler from moving relative to the guide hub (e.g., axially). As will be appreciated, other suitable engagement methods can be used to attach the coupler to the hub. For example, in some embodiments, the coupler can be press-fit or snap-fit ​​to the hub.

[0068] As will be appreciated, in some embodiments, the engagement between the connector and the hub may be sufficient to lock the connector to the hub and maintain the position of the connector relative to the hub. In other embodiments, as described herein, the connector may include one or more locking features to lock the movement between the connector and the hub. For example, in some embodiments, the first connector may also include at least one recess or orifice 23 configured to interact with a lug or extruded portion 84 on the outer surface of the guide hub 81 so as to prevent the first connector from moving relative to the guide hub (e.g., axially). As will be appreciated, the hub may also include an orifice configured to engage with one or more lugs or extruded portions on the first connector. In this regard, the connector may be locked relative to the hub via threaded engagement and lugs.

[0069] In other embodiments, Figure 1F and 1G As shown by way of example in FIG. 1 , the proximal face of the coupler may include one or more fasteners that interact with corresponding fasteners on the distal face of the hub to lock the distal hub to the coupler when the coupler is rotated into a locked position (see FIG. 1 ). Figure 1G). For example, as shown in these views, the coupler can include a first arm 87a and a second arm 87b that are slidably received within a first fastener 88a and a second fastener 88b (e.g., locking tabs) on the hub, respectively. In such an embodiment, the contact portions 89a (e.g., distal portions) of the first and second arms can be configured to contact corresponding contact portions 98a (e.g., contact edges) of the corresponding fasteners to lock the position of the arms relative to the fasteners, and thereby lock the position of the hub relative to the coupler. As will be appreciated, the corresponding contact portions can have any suitable shape and size for engaging with each other.

[0070] Although shown as having two arms and four corresponding fasteners, it should be understood that the hub and the first coupler can have any suitable number of corresponding fasteners. In addition, although the hub is shown as having fasteners for slidably receiving arms on the coupler, in other embodiments, the coupler can include one or more fasteners for receiving arms on the hub. In other embodiments, other cantilever arrangements can be used to lock the coupler relative to the hub. As will be appreciated, in all such embodiments, the first coupler can be unlocked from the hub, for example, after completion of a treatment or procedure.

[0071] Brief reference Figure 1C In some embodiments, the first coupling can include a rotatable portion 25 and a non-rotatable portion 26, the rotatable portion being located distal to the non-rotatable portion. In some embodiments, the rotatable portion 25 can be configured to interact with threads, tabs, and / or extrusions on an outer surface of the guide hub to prevent the first coupling from moving (e.g., axially) relative to the guide hub. Figure 1C As will be appreciated, the shape, size and / or pitch of the threads on the first coupling may correspond to the shape, size and / or pitch of the threads on the hub such that the first coupling may be coupled to the hub.

[0072] In some embodiments, Figure 1H and Fig. 1I As shown, the first connector 20 may include a gripping area 27 to assist the clinician in moving the connector relative to the hub. As will be appreciated, the gripping area may extend around the entire circumference of the connector (see FIG. Figure 1H ) or extends only around a portion of the circumference of the coupling (see Fig. 1I). In some embodiments, the gripping area may include a plurality of axially extending protrusions (e.g., ribs) and / or recesses (e.g., channels) that may alternate around the circumference of the coupler. As will be appreciated, each of the protrusions may be the same size, but they may also vary from protrusion to protrusion. In a similar manner, each recess may have the same size, or they may vary from recess to recess.

[0073] In some embodiments, Fig. 1I As shown, for example, the coupler can include an alignment tab 45a that a clinician can use to properly align the coupler on the hub. Fig. 1I As shown, the user can align the alignment tab 45a of the coupling with the corresponding alignment tab 45b on the hub, and then the coupling can be engaged with the hub. In some embodiments, once aligned and engaged, the coupling can be locked to the hub so that the position of the coupling relative to the hub can be maintained. In other embodiments, when the coupling is aligned and engaged with the hub, the coupling may not be locked to the hub. Instead, the coupling may have a first or "original" position when aligned and engaged and a second "locked" position. In some embodiments, the clinician can use the coupling from the first position to the second position to lock the coupling relative to the hub.

[0074] In some embodiments, the coupler may include indicia (e.g., visual and / or audible) to indicate when the coupler is moved between the first position 46 and the second position 46, and also to indicate when the coupler is in the locked position 47. As will be appreciated, other suitable indicia may be utilized in other embodiments.

[0075] In some embodiments, the outer diameter of the first coupling can be larger than the outer diameter of the guide hub. In some embodiments, the outer diameter of the first coupling can be larger than the outer diameter of the guide hub. Figure 1B In the embodiment of the present invention, the threads on the hub are shown as being on the outward facing surface (e.g., extending away from the central axis), and the recess on the first coupler is on the inward facing surface (e.g., the recess is on the surface facing the central axis). However, those skilled in the art will understand that the threads can be on the inward facing surface, where the recess for receiving the threads will be on the outward facing surface of the first coupler. Similarly, it should be understood that the relevant components involved in coupling the hub to the first coupler (e.g., threads, apertures, etc.) can be on the hub or on the first coupler. For example, if the threads are on the first coupler, the recess will be on the hub.

[0076] In some embodiments, the first coupling can have a substantially cylindrical outer wall (e.g., having a constant diameter between the first end and the second end). In other embodiments, such as Figure 1J and Figure 1KAs shown, a portion of the coupler can have a tapered wall. For example, as shown in these views, the outer diameter of the coupler can decrease in a direction toward the first end, e.g., in a direction away from the hub. In some embodiments, the outer diameter can decrease from a position between the first end and the second end (e.g., midway between the first end and the second end) toward the second end (e.g., in a direction away from the side of the coupler that engages the hub). In some embodiments, the coupler can include one or more cutouts or windows for visually indicating a locked state of the coupler relative to the hub (see, e.g., Figure 1K 47).

[0077] In some embodiments, Figure 1J and Figure 1K As shown, the coupler can include a housing 331 that can function as a receptacle and allow a clinician to flexibly adjust the position of the hub and / or medical device relative to the patient, as described herein.

[0078] As will be appreciated, the coupler may be attached to the housing in any suitable manner. For example, in some embodiments, Figure 1L As shown, the coupler can include a first section 20a and a second section 20b, with a portion of the housing sandwiched between them. For example, the first coupler portion and the second coupler portion can be threaded together and around the housing to attach the coupler to the housing. The first coupler portion and the second coupler portion can also snap together via one or more fasteners. As will be appreciated, the coupler can thereafter be attached to the hub (e.g., via threaded engagement and / or fasteners).

[0079] Although shown as having two coupling parts, it should be understood that the coupling can have more than two coupling parts. In addition, although the coupling parts are shown as each defining the circumference of the coupling and having different lengths attached together to form the full length of the coupling, in other embodiments, each coupling part can only form a portion of the circumference of the coupling (while having the same length), wherein the first coupling part and the second coupling part are attached together to form the full circumference of the coupling (see, e.g. Figure 1M ). As will be appreciated, in addition to snapping to engage, the coupling may be pressed to release from the hub.

[0080] Although shown as being attachable to the housing, it will be appreciated that the coupler may be integrally formed with the housing.

[0081] Reference again Figure 1AIn some embodiments, the extension bridge 40 can circumferentially surround at least a portion of the repositioning sheath 90 or catheter. In such embodiments, the repositioning sheath or catheter can include a flexible tubular member 91 extending proximally away from the coupling 92. The coupling can have one or more fasteners 93 configured to interact with the second coupling 30, such as to increase friction, provide a slot or ridge with which a portion of the second coupling can interact to prevent (e.g., axial) movement of the repositioning sheath or catheter relative to the second coupling 30. In some embodiments, a suture hub 94 can be present on the repositioning sheath or catheter and can be coupled (e.g., rotatably coupled) to the coupling 92. Additional components 95 of the repositioning sheath or catheter, including other accessories or tubular members, can extend proximally away from the positioning device.

[0082] In some embodiments, the extension bridge 40 may circumferentially surround a portion of the flexible tubular member 91 between the first coupler 20 and the coupling 92 .

[0083] refer to Figure 1D In some embodiments, the extension bridge may partially circumferentially surround the repositioning sheath or catheter. Figure 1D As shown, in some embodiments, there can be a pattern of recesses or apertures 43 positioned axially along the extension bridge. In some embodiments, the extension portion can include a sidewall that extends only partially around the repositioning sheath or catheter. For example, in some embodiments, at a first point in the axial direction, one edge 42 of the extension portion can be circumferentially separated from a second edge (not shown) by a distance greater than zero. In some embodiments, the circumferential distance is less than half of the total circumference of the repositioning sheath or catheter.

[0084] refer to Figure 1E In some embodiments, the extension bridge 40 can be configured to avoid contact with the repositioning sheath or catheter. In some embodiments, the extension bridge can be configured to be non-coaxial with the repositioning sheath or catheter. In some embodiments, the extension bridge is not parallel to the repositioning sheath or catheter. For example, in some embodiments, the wall 41 defining the shape of the extension bridge 40 can be configured to form a handle, and / or have an ergonomic shape. In some embodiments, the extension bridge can be configured so that at least one wall 41 at least partially rests against the patient's skin.

[0085] In some embodiments, the extension bridge is directly coupled to the first coupler. In some embodiments, the extension bridge can be indirectly coupled to the first coupler 20. For example, in some embodiments, the hinge 43 can connect the extension bridge to the first coupler (see Figure 1E ). In such an embodiment, the clinician can adjust the position of the extension bridge relative to the first coupler.

[0086] In some embodiments, the extension bridge can be directly coupled to the second coupler 30. In some embodiments, the extension bridge is indirectly coupled to the second coupler. For example, in some embodiments, the hinge 44 can also connect the extension bridge to the second coupler 30. As described above, in such embodiments, this can allow the clinician to adjust the position of the extension bridge relative to the second coupler.

[0087] In some embodiments, the second coupling 30 may include a rotatable portion 34 and a non-rotatable portion 35. The rotatable portion may be configured to rotate around a central axis of the non-rotatable portion. In some embodiments, a hinge 44 may be connected to the rotatable portion.

[0088] refer to Figure 1E In some embodiments, the positioning device 10 can include an adjustable arm 70 coupled to the first coupler 20. The adjustable arm 70 can be configured to support the repositioning sheath 90 and / or catheter (particularly the flexible tubular member 91) as the repositioning sheath or catheter extends proximally from the first coupler.

[0089] 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 aperture, etc.) extending through a portion of the first coupler 20. The slot 24 may be configured to allow a device to be attached after the repositioning sheath or catheter is in place. For example, in such an embodiment, when the first coupler 20 is coupled to the hub, the flexible tubular member 91 may slide through the slot 24. As described herein, and in view of Figures 1H-1L as well as Figure 3A and 3B It will be appreciated that the coupler may also be coupled to a housing and / or a fitting through which the tubular member may slide.

[0090] In some embodiments, the extension bridge may have a stiffness greater than the stiffness of the repositioning sheath and / or catheter. In some embodiments, the extension bridge may have a stiffness greater than a predetermined stiffness sufficient to prevent the extension bridge from deflecting due to the weight of the repositioning sheath or catheter when in use. In such embodiments, the extension bridge may still be formed of a flexible material.

[0091] Reference again Figure 1A In some embodiments, the second coupler 30 can be configured to allow only a portion of the repositioning sheath 90 or catheter to be slidably inserted through the coupling segment. For example, in some embodiments, the first segment 93 of the flexible tubular member and the coupler can be configured to be slidably received by the second coupler. The second segment 96 of the coupler may not be able to be further inserted through the coupling segment.

[0092] In some embodiments, the second coupler can include a molded portion 31 configured to surround at least a portion of the coupling.

[0093] refer to Figure 1D In some embodiments, the second coupler 30 can include a molded portion 31 that is molded such that an inner surface 34 of the molded portion substantially matches a portion of an outer surface 97 of a repositioning sheath or catheter.

[0094] 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 apertures 33 to allow direct access to the suture pad.

[0095] In some embodiments, the molded portion of the second coupler 30 can be configured to surround at least a portion of an additional component 95 (eg, a connector, a tube, etc.) at the proximal end of the repositioning sheath.

[0096] In some embodiments, the second coupler is configured to be placed over or around a portion of a repositioning sheath or catheter, wherein the portion of the sheath or catheter is non-slidably inserted into the second coupler. For example, in some embodiments, a molded portion of the second coupler can be pressed onto a coupler of the repositioning sheath or catheter until the portion of the coupler is secured in the second coupler. In this regard, in embodiments, the second coupler can be configured to snap onto at least a portion of the repositioning sheath, wherein the second coupler has a press fit or snap fit engagement with the repositioning sheath and / or catheter.

[0097] Figure 2A and Figure 2B Another embodiment of a positioning device according to the present disclosure is shown. As shown in these views, the positioning device can include a clamshell design and can be configured to engage with the hub and hold the tubular member relative to the positioning device and relative to the hub. In this regard, the clamshell can be configured to serve as both a first coupling 20 and a second coupling 30. As shown in these views, the positioning device 100 will generally be divided into two sections 110, 111 connected via a hinge 112.

[0098] like Figure 2A and Figure 2B As shown, some embodiments may include only the first coupler and the second coupler, and no extension bridge.

[0099] like Figure 2AAs shown, the first coupling (e.g., the distal coupling) includes a first surface 132, which can define an opening 131 extending through the first surface 132 when in use (e.g., when the two sections 110, 111 are configured to be in a closed position, so that the two inner surfaces 144 of the device contact each other). The first coupling 20 can have a side wall 134, which defines one or more recesses 133 for interacting with threads, tabs, etc. on the outer surface of the guide hub 81 (see, for example, Figures 1A-1E The first connector in Figure 2B As shown, introducer 80 may include a suturing hub portion 85 that is rotatably attached.

[0100] In some embodiments, Figure 2A As shown, the first coupler may have a raised portion 135 on one of the two sections 110 , 111 , the raised portion 135 being configured to fit into a recessed portion 136 on the other of the two sections.

[0101] The second coupler 30 may include a length of the positioning device proximal to the first coupler. For example, the second coupler and the first coupler may be adjacent to each other. In some embodiments, the second coupler 30 may include a proximal surface 160 that defines a proximal opening 121 extending therethrough when in use. In some embodiments, the proximal opening 121 may have a larger diameter than 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.

[0102] In some embodiments, the length of each section 110, 111 of the positioning device of the second coupler 30 may include an opening extending therethrough when in use to receive a portion of a repositioning hub (or another tubular structure). In some embodiments, the length may include one or more ribs 145, each rib axially separated from the other ribs, and each rib is molded to allow slidable reception of a repositioning sheath or catheter. In some embodiments, the ribs may maintain the position of the sheath or catheter relative to the positioning device 100.

[0103] In some embodiments, the second connector 30 can be configured to allow only a portion of the repositioning sheath or catheter to be slidably inserted through the second connector. For example, in some embodiments, the second connector may include an opening 141 whose diameter 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 repositioning sheath and / or catheter, so that the opening serves as a stopper for the repositioning sheath. In this regard, the distal end of the repositioning sheath cannot extend beyond the distal end of the opening 141. In some embodiments, the distal end of the repositioning sheath cannot extend beyond the proximal surface 143 that defines the proximal entrance of the opening 141. In this regard, the proximal surface of the opening can serve as a stopper flange. In some embodiments, a positioning device (e.g., an extension bridge or a combination of an extension bridge and a first connector) can be configured to prevent the repositioning sheath from extending into the guide hub.

[0104] As will be appreciated, while opening 141 is shown as having a smaller diameter to serve as a stop for the repositioning sheath and / or flange, it will be appreciated that the second connector may simply have a stop flange extending into the channel (similar to a stop flange of a rib, although positioned closer to the central axis of the channel) to prevent the repositioning sheath and / or catheter from extending through the flange.

[0105] In some embodiments, the positioning device may include a hinge 112 that hingedly connects the first section 110 of the positioning device to the second section 111 of the positioning device. In this way, when in an open configuration (such as Figure 2A ), at least a portion of the guide hub and at least a portion of the repositioning sheath or catheter can be hingedly closed at the second section to be in a closed configuration (such as Figure 2B ) is at least partially placed into the first section 110 before.

[0106] 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 indicating the correct positioning of the repositioning sheath. The indicator may include one or more icons, lines, or other human detectable means indicating where and / or how the repositioning sheath or catheter should be placed in the device. In some embodiments, the positioning device may include a window through which a clinician can view the repositioning sheath and / or catheter in the positioning device to determine the proper position.

[0107] In some embodiments, the positioning device may include a lock 150 configured to prevent the positioning device from hingedly opening after it is placed in a closed configuration. In some embodiments, the lock may include a snap hinge on one of the clamshell segments, such as on the first segment 110. In some embodiments, the snap hinge may include a handle 152 and a locking portion 154 configured to be slidably coupled to a recessed portion 156 and / or an extruded portion 155 on the second segment. The snap hinge may rotate about a hinge pin 153.

[0108] like Figure 2A As shown, the lock is in a first open position, allowing the positioning device to be freely opened or closed. Figure 2B In the embodiment of the present invention, the lock has been moved (here, rotated) to the second closed position, thereby locking the positioning device in the closed configuration until the lock is moved back to the first open position.

[0109] In some embodiments, the hinge pin 153 of the lock extends in a direction perpendicular to the hinge pin of the hinge 112 that connects the first and second sections 110, 111 of the positioning device. In some embodiments, the hinge pin 153 of the lock extends perpendicular to the hinge pin 112 that connects the first and second sections of the positioning device. In this regard, the lock moves in a direction that is different from the direction in which the first and second sections open and close relative to each other.

[0110] According to other embodiments, in order to provide even further control over the positioning and movement of the repositioning sheath or catheter, certain additional elements can be added to the positioning device. For example, in some embodiments, a positioning device can be provided that can be configured for adjustable positioning of the medical device, the repositioning sheath, or both relative to the guide hub. In such embodiments, the first coupler and the second coupler can be moved relative to each other so that the position of the repositioning sheath and / or catheter can be adjustable relative to the hub.

[0111] Figure 2C and 2D Another exemplary positioning device is shown. Figure 2A and Figure 2B , Figure 2C and Figure 3D The positioning device 100 in also includes a clamshell design that can be hingedly opened, closed and locked (see lock 150). Figure 2C and 2DIn the embodiment of the present invention, the clamshell can be attached to the hub and ball joint 241, rather than being directly coupled to the flexible tubular member. In this regard, the positioning device can again function similarly to the first coupler described herein, and can be configured to maintain the position of the hub relative to the medical device, and the ball joint can be attached to the second coupler for receiving the tubular member. The first coupler can be pivotally attached to the second coupler. As shown in FIG. Figure 2C and 2D As will be appreciated, the ball joint may allow for adjustment of the position of the hub relative to the patient, as the ball joint may allow for rotation of a tubular member into which the tubular member may slide and through the hemostatic valve of the hub.

[0112] refer to Figure 3A In some embodiments, the positioning device can include a hinge 230 connecting the first connector 20 and the second connector 30. In such an embodiment, the hinge 230 (sometimes referred to as a "flexible hinge") can be configured to allow the second connector to move around the hinge (see Figure 3A The hinge axis 299 in the positioning device) and rotates relative to the first coupling. In such an embodiment, the hinge axis can extend perpendicular to the central longitudinal axis 298 of the positioning device.

[0113] In some embodiments, the hinge may include a lock 235 that can be moved to an unlocked position to allow the articulated section to rotate, or to a locked position to prevent the articulated section from rotating. The lock may include a visual marker, such as an icon 236 or other visual representation, which indicates whether the articulated section is locked or unlocked.

[0114] As mentioned above, Figure 3A The first coupling 20 can be configured to be removably coupled to the proximal end of the guide hub. The first coupling can also be configured to slidably receive a medical device and allow the medical device to enter the guide hub.

[0115] The second coupling 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 segment 221 and a second segment 222, wherein the second segment has a smaller outer diameter than the first segment. The proximal end of the second segment may define an opening 260, which is configured to slidably receive a medical device.

[0116] In some embodiments, the second coupler can include a proximal end 220 and an adjustable lock 250. The adjustable lock can be configured to allow or prevent the medical device and / or repositioning sheath from being axially adjusted relative to the second coupler 30 and the guide hub based on the position of the adjustable lock.

[0117] refer to Figure 3B, a close-up of a hinge having a ball joint can be seen. In some embodiments, hinge 240 may include an outer shell 231 having a distal end 262, a proximal end 261, and an inner surface 263 that defines a first spatial volume 244 extending therethrough. The outer shell may also define a portion of first coupler 20 (see also Figures 1H-1M ).like Figure 3B As shown, the first coupler can include a ring 211 that can be rotatably coupled to the outer housing 231 of the hinge. In some embodiments, a portion of the ring 211 can be configured to interact with the outer surface of the guide hub 81. For example, in some embodiments, the ring 211 can be threaded onto the hub. As will be understood, the ring can also be fixedly attached to the outer housing 231 of the ring.

[0118] like Figure 3B As shown, the flexible hinge may include a ball 241 having a distal end 265, a proximal end 266, and an inner surface 267 defining a second spatial volume 268 therethrough. In some embodiments, the distal end 265 of the ball 241 may be at least partially positioned within the first spatial volume 244 of the outer shell. In some embodiments, the ball 241 may include one or more raised portions 242 configured to prevent the ball from rotating beyond a predetermined amount. As will be appreciated, the shape and size of the ball may correspond to the shape and size of the first spatial volume 244.

[0119] The proximal end 266 of the ball (eg, ball 241) may be coupled to the first section 221 of the second coupler 220 of the device.

[0120] In some embodiments, the ball joint can allow the second coupler to rotate in any direction relative to the first coupler 20. In some embodiments, the joint can be configured to allow rotation within a single plane. For example, in some embodiments, the joint can be configured to rotate relative to the outer housing about a first axis (e.g., a central axis of a hinge pin 243 or the like), the first axis being orthogonal to the path 249 through the positioning device.

[0121] Path 249 can represent the path of the medical device from the proximal opening 260 through the lumen extending through the second coupler, through the lumen in the proximal end 248 of the flexible joint, through the second spatial volume 268, through the first spatial volume 244 and to the distal end 262 of the outer shell, and through the first coupler 20. After passing through the distal end of the outer shell, the medical device will then enter the anti-contamination measure 270 of the guide hub before entering the third spatial volume 275 defined by the hub. The anti-contamination measure can include a hemostatic valve 271, a foam 272, and / or a cover 273.

[0122] Thus, the second volume of space can be configured to allow a medical device to be slidably received and guided from the proximal end 266 of the hub to the distal end 262 of the outer housing.

[0123] In some embodiments, the second spatial volume 278 within the ball 241 is configured to have two forks 245, 246. The first fork 245 can be utilized when the device is configured so that the path 249 at the proximal end 266 of the joint is substantially parallel to its path when passing through the distal end 262 of the outer shell. That is, the first fork can be used when the joint is normally in a "straight" position. Conversely, the second form 246 can be utilized when the device is configured so that the path 249 at the proximal end 266 of the joint is angled relative to its path when passing through the distal end 262 of the outer shell. In this regard, the medical device (and / or another accessory) can pass through the hinge at a desired angle. In some embodiments, the angle can be between 30-90 degrees.

[0124] A flexible hinge may be positioned between the first coupler 20 and the second coupler 220 , wherein the flexible hinge may be configured to allow a medical device to be slidably received through the flexible hinge.

[0125] The articulation section may be configured to allow the adjustable locking portion to rotate about the articulation section relative to the first coupler.

[0126] The positioning device may be configured such that the medical device may be slidably received through the adjustable locking portion and through the first coupling.

[0127] Figure 3C Shows Figure 3B 81 , wherein the medical device and the catheter are inserted into the positioning device. As shown in this view, the positioning device has been adjusted so that the clinician has achieved the desired positioning of the medical device, the repositioning sheath, or both relative to the guide hub. As shown in this view, the first coupler 20 is configured to be removably coupled to the proximal end of the guide hub 81. The first coupler can also be configured to slidably receive the medical device (which can include a catheter 280) and allow the medical device to enter the guide hub 81. After entering the guide hub, the medical device can then enter the guide sheath 82 and then pass through the entry point 291 on the surface of the patient's skin 290 and enter the patient's body.

[0128] In some embodiments, the positioning device can include a lock 250, which can include an adjustable button 251 (e.g., a push button) coupled to the second coupler 30. In some embodiments, the lock can 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.

[0129] The positioning device can be configured such that when the adjustable locking portion is in the unlocked configuration, a medical device (which can include a catheter 280) can be slidingly received by the lock 250 and by the first coupler 20. 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.

[0130] The positioning arrangement may include a hinge configured to allow the lock to rotate about the hinge relative to the first coupler.

[0131] The positioning device may include a proximal end 222 configured to slidably receive a medical device (or repositioning sheath).

[0132] The medical device can include one or more markers 285 on the outer surface of the catheter 280. In some embodiments, the marker can be radiopaque. In some embodiments, the marker is a visible marker. In some embodiments, at least one marker is close to the positioning device.

[0133] In some embodiments, the positioning device can include a fitting 295. The fitting can be configured to hold a transparent flexible sterile member 296 (eg, a bag, etc.) positioned around at least a portion of the catheter 280. The fitting 295 can be coupled to the proximal end 222 via the transparent flexible sterile member 296.

[0134] In some embodiments, a kit may be provided that may include a guide hub, a repositioning sheath, and a positioning device as disclosed herein.

[0135] In some embodiments, a kit may be provided. The kit may include a medical device, a positioning device as disclosed herein, and an optional repositioning sheath.

[0136] refer to Figure 3D , showing another embodiment of a housing 231. As shown in this view, the housing may include a two-piece socket having a first housing member 233a and a second housing member 233b that are attached together to form a housing and a ring (e.g., similar to Figure 1J As will be Figure 3D As will be appreciated from the examples of the invention, the clinician can rotate the second housing portion 233b about the hub flange (see Figure 3D ) to lock and close the housing-hub interface. Figure 3E The closed housing-hub interface can be seen in the figure.

[0137] refer to Figure 3F, another multi-piece housing is shown. As shown in this view, after the housing and the hub are aligned via corresponding alignment tabs, the hub can be locked relative to the housing by axially sliding a clip 237 of the housing on the hub (e.g., on the hub flange) (see Figure 3F ). As will be appreciated, the shape and size of the clips can correspond to the shape and size of the hub (e.g., the hub flange). As will be further appreciated, although shown as having two clips, the housing can be configured with a single clip or more than two clips.

[0138] Figure 3G Yet another way to attach the housing 231 to the hub is shown. As shown in this view, the housing can include a first tab 238a and a second tab 238b that can engage with the hub. In such an embodiment, the tabs can be flared outward and away from the hub while sliding over the hub flange, after which the tabs can snap back into place and hold the hub to the housing. To release, the user can squeeze the tabs to flare the tabs outward again to allow the clinician to disengage the hub from the outer housing.

[0139] Figure 3H and Fig. 3I Still another way of attaching the housing 231 to the hub 81 is shown. As shown in this view, the housing can include a hinged clamp that can snap onto the hub (e.g., the hub flange). As with other embodiments, the clamp can be attached after the housing is first aligned with the hub.

[0140] As will be appreciated, other methods of attaching the housing to the hub may be used. For example, a user may push forward (e.g., toward the hub) to lock and unlock when a protrusion (e.g., a protrusion on the hub) slides into a ring on the housing or when a protrusion on the housing slides into a ring on the hub. In yet another embodiment, a user may rotate the ring of the housing until it engages with the hub. Then, when the ring and the hub engage and lock, the ring and the housing also engage and lock.

[0141] refer to Figure 4 In some embodiments, a method for adjusting the positioning of a medical device, a repositioning sheath, or both relative to a guide hub can be provided. In embodiments having a lock, the method 300 can include unlocking 310 a lock on a positioning device. In some embodiments, the method can include adjusting 320 the positioning of the medical device, the repositioning sheath, or both. The adjusting step can include: (1) rotating 321 a second coupler of the positioning device relative to a first coupler of the positioning device; (2) moving 322 the medical device, the repositioning sheath, or both in an axial direction; or (3) a combination thereof.

[0142] The method may include locking 330 a locking mechanism on the positioning device. In some embodiments, locking the locking mechanism on the positioning device may include locking the locking mechanism to prevent axial movement of the medical device, the repositioning sheath, or both relative to the locking mechanism. In some embodiments, locking the locking mechanism may include locking the locking mechanism to prevent rotation of the proximal end of the positioning device relative to the distal end of the positioning device. In some embodiments, at least two locking mechanisms are adjusted, one for preventing axial movement and one for preventing rotational movement.

[0143] The disclosed system can be used for a variety of applications. For example, currently, for certain conventional non-percutaneous (surgical) insertions, a physician will typically expose a blood vessel (e.g., an axillary artery) and attach a graft, then insert a peeling sheath into the graft and secure the graft to the peeling sheath. The peeling sheath provides support for a medical device (e.g., a catheter-based pump) to be passed through the graft. The sheath also includes a hemostatic valve. At the end of the procedure, the graft is clamped, the sheath is removed and peeled away to allow removal of the sheath while leaving the catheter in place in the graft, and then a repositioning unit comprising a butterfly portion pre-mounted on the proximal portion of the catheter is slid in and attached to the graft, then released, allowing the medical device to remain inserted into the blood vessel via the graft.

[0144] The disclosed system can eliminate the use of a peel-away sheath in the above-mentioned procedures, thereby simplifying the insertion procedure for non-percutaneous applications. Figure 5A , a graft 410 is seen, with an inner surface 412 defining an inner cavity extending through the graft. A suturing hub 420 (e.g., a butterfly) is seen coupled to the hub body 81. The suturing hub can be rotatably coupled to the hub body. The distal end 421 of the suturing hub has an outer surface 422 that is configured to removably couple to the inner surface 412 of the graft.

[0145] With reference to conventional surgery, after attaching the graft to the blood vessel and clamping the graft, using the disclosed system, the distal end of the suture hub can be directly attached to the graft. The graft can then be released because the hub body includes a hemostatic valve.

[0146] The medical device can then be passed through. Figure 5B , it can be seen that once the graft and repositioning butterfly are properly connected, a medical device (such as a medical device coupled to catheter 280, such as a catheter-based heart pump) can be passed through the second coupler 30, hinge 230, first coupler 20, hub body 81, suture hub 420, and graft 410. In this manner, the hub and suture hub can provide adequate support for the medical device through the graft.

[0147] It should be understood that the interior dimensions of the hub (including the hub body 81) and the suturing hub 420 may be appropriately selected based on, for example, the outer diameter of a medical device intended to be inserted through the hub and the suturing hub.

[0148] Embodiments of the present disclosure are described in detail with reference to the accompanying drawings, wherein the same reference numerals identify similar or identical elements. It should be understood that the disclosed embodiments are merely examples of the present disclosure, which may be implemented in various forms. Well-known functions or configurations are not described in detail to avoid obscuring the present disclosure with unnecessary details. Therefore, the specific structural and functional details disclosed herein should not be interpreted as restrictive, but only as the basis for the claims and as a representative basis for teaching those skilled in the art.

[0149] Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be encompassed by the following claims.

Claims

1. A positioning device, comprising: a first coupler configured to be removably coupled to a proximal end of the guide hub; a second coupler configured to removably couple to a portion of a repositioning sheath or catheter proximate to the first coupler, the first coupler being attached to the second coupler, Wherein, the positioning device is configured to maintain the axial position of the repositioning sheath or catheter relative to the guide hub.

2. The positioning device according to claim 1 further includes an extension bridge extending between the first connector and the second connector, and the extension bridge is constructed to maintain a fixed axial distance between the guide hub and the proximal end of the repositioning sheath or catheter.

3. The positioning device according to claim 2, wherein: The extension bridge is configured to avoid contact with the repositioning sheath or catheter.

4. The positioning device according to claim 2, wherein: The extension bridge circumferentially surrounds at least a portion of the repositioning sheath or catheter.

5. The positioning device according to claim 2, wherein: The extension bridge partially circumferentially surrounds the repositioning sheath or catheter.

6. The positioning device according to claim 2, wherein: The extension bridge is configured to allow only a portion of a repositioning sheath or catheter to be slidably inserted through the extension section.

7. The positioning device according to claim 2, wherein: The extension bridge is configured to prevent the repositioning sheath from extending into the guide hub.

8. The positioning device according to claim 2, wherein: The extension bridge has a stiffness greater than the stiffness of the repositioning sheath or catheter.

9. The positioning device according to claim 2, wherein: The second coupling is configured to allow only a portion of a repositioning sheath or catheter to be slidably inserted through the coupling section.

10. The positioning device according to claim 1, wherein: The first coupling includes a first surface including a threaded portion configured to interact with one or more threads on an outer surface of the guide hub to prevent axial movement of the first coupling relative to the guide hub.

11. The positioning device according to claim 1, wherein: The first coupler includes at least one fastener configured to interact with a corresponding fastener on an outer surface of the guide hub to maintain a position of the guide hub relative to the first coupler.

12. The positioning device according to claim 11, wherein: The first coupling includes at least one recess or aperture configured to interact with a tab or extrusion of an outer surface of the guide hub.

13. The positioning device according to claim 1, wherein: The first connector includes a rotatable portion and a non-rotatable portion, wherein the rotatable portion is located distal to the non-rotatable portion, and the rotatable portion is configured to interact with a thread, a protrusion or an extruded portion of an outer surface of the guide hub to prevent the first connector from moving axially relative to the guide hub.

14. The positioning device according to claim 1, wherein: The first coupling has an outer diameter greater than an outer diameter of the guide hub.

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

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

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

19. The positioning device according to claim 1, wherein: The second coupler includes a molded portion that is molded such that an inner surface of the molded portion substantially matches an outer surface of the repositioning sheath or catheter.

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

21. The positioning device according to claim 19, wherein: The molded portion is configured to surround at least a portion 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 hingedly connects a first section of the positioning device to a second section of the positioning device, wherein at least a portion of the guide hub and at least a portion of the repositioning sheath or catheter can be at least partially placed into the first section before the second section is hingedly closed.

23. The positioning device according to claim 22, wherein: At least a portion of the guide hub is at least partially disposed in a portion of the first segment forming a portion of the first coupler, and at least a portion of the repositioning sheath or catheter is disposed in a portion of the first segment forming a portion of the second coupler of the first segment.

24. The positioning device of claim 22, further comprising a locking mechanism configured to prevent the positioning device from hingedly opening.

25. The positioning device according to claim 24, wherein: The locking mechanism includes a snap hinge on the first section, the snap hinge including a handle and a locking portion configured to slidably couple to a recessed or extruded portion on the second section.

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

27. The positioning device according to claim 22, wherein: An inner surface of the first section and / or the second section includes an indicator indicating proper positioning of the repositioning sheath.

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

29. The positioning device according to claim 1, wherein: The first coupler includes a clamshell, and the second coupler is attached to the clamshell via a ball joint secured within the clamshell.

30. The positioning device according to claim 1, wherein: The extension bridge includes an articulation section configured to allow a proximal end of the extension bridge to rotate about the articulation section relative to a distal end of the extension bridge.

31. A positioning device, comprising: a first coupler having a housing and means for locking the first coupler to the introducer sheath; and A second coupler is connected to the first coupler, the second coupler being configured to receive a tubular member.

32. The positioning device according to claim 31, wherein: The first coupler includes an alignment tab.

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

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

35. A kit comprising: Guide hub; repositioning sheath; and A positioning device according to any one of claims 1 to 34.

36. A positioning device configured to adjustably position a medical device, a repositioning sheath, a catheter, or a combination thereof relative to a guide hub, the positioning device comprising: a first coupler configured to be removably coupled to a proximal end of the guide hub; a second coupler configured to slidably receive the medical device, repositioning sheath, catheter, or a combination thereof; and An articulation section is configured to allow the adjustable locking portion to rotate about the articulation section relative to the first coupler.

37. The positioning device according to claim 36, wherein: The second connector is configured to allow or prevent the medical device and / or repositioning sheath from being axially adjusted relative to the guide hub based on the position of the adjustable lock, wherein the positioning device is configured to enable the medical device to be slidably received through the adjustable locking portion and through the first connector.

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

39. A positioning device configured to adjustably position a medical device, a repositioning sheath, or both relative to a guide hub, the positioning device comprising: a first coupler configured to be removably coupled to a proximal end of the guide hub, the first coupler being configured to slidably receive a medical device and allow the medical device to enter the guide hub; a second coupler configured to slidably receive a portion of a repositioning sheath and / or a catheter device; and A flexible hinge connects the first coupler and the second coupler, the flexible hinge being configured to allow the medical device to be slidably received by the flexible hinge.

40. The positioning device according to claim 39, wherein: The flexible hinge comprises a lock configured to prevent the flexible hinge from rotating, wherein in an unlocked configuration the flexible hinge is able to rotate.

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

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

43. A kit comprising: Medical devices; A positioning device according to any one of claims 36 to 42; and Optionally, reposition the sheath.

44. A method for adjusting the positioning of a medical device, a repositioning sheath, or both relative to a guide hub, comprising: Adjust the positioning of the medical device, repositioning sheath, or both by: rotating the first coupler of the positioning device relative to the second coupler of the positioning device; moving the medical device, the repositioning sheath, or both in an axial direction; or its combination; and Optionally, the locking mechanism is locked to the positioning device to prevent axial movement of the medical device, the repositioning sheath, or both relative to the locking mechanism.

45. The method of claim 44, further comprising unlocking a locking mechanism on the positioning device.

46. ​​The method of claim 44, further comprising attaching the first coupler to the hub prior to adjusting.

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

48. The method of claim 44, wherein: Locking the locking mechanism on the positioning device comprises: locking a first lock to prevent axial movement of the medical device, the repositioning sheath, or both relative to the locking mechanism; and The second lock is locked to prevent the proximal end of the positioning device from rotating relative to the distal end of the positioning device.

49. The method of claim 44, wherein: The positioning device comprises a flexible hinge, and the flexible hinge comprises: an outer shell having a distal end, a proximal end, and an inner surface defining a first spatial volume extending through the outer shell; a joint having a distal end, a proximal end, and an inner surface defining a second spatial volume therethrough, the distal end of the joint being at least partially positioned within the first spatial volume, the joint being configured to rotate relative to the outer shell about a first axis, the first axis being orthogonal to a path from the first end of the outer shell to the second end of the outer shell; Wherein the second spatial volume is configured to allow a medical device to be slidably received and guided from the proximal end of the hub to the distal end of the outer housing.

50. The positioning device according to claim 49, wherein: The joint is a ball and socket joint.

51. A system comprising: a flexible hinge operably coupled to the guide hub; and a medical device configured to pass through the flexible joint and into the guide hub, The flexible hinge comprises: an outer shell having a distal end, a proximal end, and an inner surface defining a first spatial volume extending through the outer shell; a joint having a distal end, a proximal end, and an inner surface defining a second spatial volume therethrough, the distal end of the joint being at least partially positioned within the first spatial volume, the joint being configured to rotate relative to the outer shell about a first axis, the first axis being orthogonal to a path from the first end of the outer shell to the second end of the outer shell, The second spatial volume is configured to allow a medical device to be slidably received and guided from a proximal end of the joint to a distal end of the outer housing.

52. A method for coupling a coupling and a hub, comprising: aligning and engaging the first coupling to the hub; and The first coupler or at least a portion of the hub is moved from a first position to a second position.

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