Multi-component medical device with locking mechanism

Abstract

Various medical procedures utilize two or more medical device components, including medical device components in which a first medical device component 34 is advanced within a second medical device component 32. One example is an elongate dilator 34 for use in conjunction with a guide catheter 32. The guide catheter and the elongate dilator may be adapted to provide a rotational locking mechanism that allows the guide catheter and the elongate dilator to be locked together such that rotation of one of the components causes rotation of both components. In some examples, the guide catheter and elongate dilator may cooperate to also provide relative axial locking between the two components.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 445,090, filed on February 13, 2023, the disclosure of which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to medical devices and, more particularly, to medical devices having a locking mechanism that releasably provides a lock between components. Background Art

[0004] Various medical procedures utilize two or more medical device components, including those in which a first medical device component is advanced within a second medical device component. An example is an elongated dilator used in conjunction with a guide catheter. In some instances, it may be desirable to control the movement of the first and second medical device components without having to physically touch both components simultaneously. For example, in some instances, it may be desirable to provide a rotational lock between the two components so that when a physician or other professional rotates one component, the other component also rotates. There is a continuing need for improved medical devices and medical device systems. Summary of the Invention

[0005] The present disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example can be found in a medical device assembly. The medical device assembly includes a first elongated medical device having a first elongated shaft and a first proximal hub, the first elongated shaft having a first proximal region and a first distal region, the first proximal hub being secured to the first proximal region. The medical device assembly includes a second elongated medical device having a second elongated shaft and a second proximal hub, the second elongated shaft having a second proximal region and a second distal region, the second proximal hub being secured to the second proximal region. The first elongated medical device is adapted to form a releasable axial and / or rotational lock with the second elongated medical device.

[0006] Alternatively or additionally, the second elongate shaft may be adapted to fit within a lumen extending through the first elongate shaft.

[0007] Alternatively or additionally, the second proximal hub can be adapted to releasably couple to the first proximal hub when the second elongated shaft is disposed within a lumen extending through the first elongated shaft.

[0008] Alternatively or additionally, the second proximal hub may be adapted to form a releasable rotational lock with the first proximal hub.

[0009] Alternatively or additionally, the second proximal hub may be adapted to form a releasable axial lock with the first proximal hub.

[0010] Alternatively or additionally, the first elongate medical device may be adapted to be advanced over a guidewire in order to reach the atrial septum.

[0011] Alternatively or additionally, a second elongate medical device may be adapted to be advanced over the guidewire in combination with the first elongate medical device to create or enlarge a hole formed in the atrial septum.

[0012] Alternatively or additionally, the first elongate medical device may comprise a guide catheter.

[0013] Alternatively or additionally, the second elongate medical device may comprise an elongate dilator.

[0014] Alternatively or additionally, the second proximal hub may include a grippable profile.

[0015] Another example can be found in a medical device assembly for accessing the left atrial appendage. The medical device assembly includes a guide catheter having a guide catheter shaft and a guide catheter hub secured to a proximal region of the guide catheter shaft. The medical device assembly includes an elongated dilator having an elongated dilator shaft including a distal region adapted to create and / or enlarge a hole in tissue and a dilator hub secured to a proximal region of the elongated dilator shaft. The guide catheter and the elongated dilator are adapted to form a releasable lock therebetween.

[0016] Alternatively or additionally, the elongate dilator shaft may be adapted to fit within a lumen extending through the guide catheter shaft.

[0017] Alternatively or additionally, the dilator hub can be adapted to releasably couple to the guide catheter hub when the elongated dilator shaft is disposed within a lumen extending through the guide catheter shaft.

[0018] Alternatively or additionally, the dilator hub may be adapted to form a releasable rotational lock with the guide catheter hub.

[0019] Alternatively or additionally, the dilator hub may be adapted to form a releasable axial lock with the guide catheter hub.

[0020] Alternatively or additionally, the guide catheter may be adapted to be advanced over a guidewire in order to reach the atrial septum.

[0021] Alternatively or additionally, the elongate dilator may be adapted to be advanced over a guidewire in conjunction with a guide catheter to create or enlarge a hole formed in the atrial septum.

[0022] Alternatively or additionally, the second proximal hub may include a grippable profile.

[0023] Another example can be found in a medical device assembly for implanting a left atrial appendage closure (LAAC) device. The medical device assembly includes a guide catheter having a guide catheter shaft and a guide catheter hub secured to a proximal region of the guide catheter shaft. The medical device assembly includes an elongated dilator having an elongated dilator shaft and a dilator hub, the elongated dilator shaft including a distal region adapted to create and / or enlarge a hole in tissue, the dilator hub secured to a proximal region of the elongated dilator shaft. The guide catheter and the elongated dilator are adapted to form a releasable lock therebetween.

[0024] Alternatively or additionally, the medical device assembly may further comprise a LAAC device delivery catheter adapted to be advanced through the guide catheter after the elongate dilator has been removed.

[0025] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The figures and detailed description that follow more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The present disclosure may be more fully understood upon consideration of the following detailed description taken in conjunction with the accompanying drawings, in which:

[0027] Figure 1 An example of a portion of a procedure for implanting an LAAC (left atrial appendage closure) device comprising a guide catheter used in conjunction with an elongated dilator is provided;

[0028] Figure 2A is a side view of an exemplary assembly including a guide catheter and an elongated dilator, wherein the elongated dilator is inserted into the guide catheter but not coupled thereto;

[0029] Figure 2B yes Figure 2A a side view of an illustrative assembly of wherein the elongated dilator is temporarily coupled to the guide catheter;

[0030] Figures 3 to 11B is a view of Example A providing a rotational lock between a guide catheter and an elongated dilator;

[0031] Figures 12 to 20 is a view of Example B providing a rotational lock between a guide catheter and an elongated dilator;

[0032] 21 to 26C are views of Example C providing rotational and axial locking between a guide catheter and an elongated dilator;

[0033] Figures 27A to 32B is a view of Example D providing a rotational lock between a guide catheter and an elongated dilator; and

[0034] Figures 33 to 36B is a view of Example E providing a rotational lock between a guide catheter and an elongated dilator.

[0035] Although the present disclosure is susceptible to various modifications and alternative forms, details thereof have been shown by way of example in the accompanying drawings and will be described in detail. However, it should be understood that it is not intended to limit the present invention to the particular embodiments described. On the contrary, the present disclosure encompasses all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0036] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, in which similar reference numerals indicate similar elements throughout the multiple views. The detailed description and the accompanying drawings are intended to illustrate, not to limit, the present disclosure. Those skilled in the art will recognize that the various elements described and / or shown can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and the accompanying drawings illustrate exemplary embodiments of the present disclosure for which protection is claimed. However, for clarity and ease of understanding, although each feature and / or element may not be shown in each drawing, unless otherwise specified, the features and / or elements may be understood to be present.

[0037] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0038] All numerical values ​​assumed herein are modified by the term "about", whether or not explicitly stated. The term "about" generally refers to a range of numbers that one skilled in the art would consider equivalent to the stated value (i.e., having the same function or result). In many instances, the term "about" can include numbers rounded to the nearest significant figure.

[0039] The recitations of numerical ranges by endpoints include all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0040] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the content clearly dictates otherwise.

[0041] As used in this specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in a sense that includes "and / or" unless the content clearly dictates otherwise. It should be noted that, for ease of understanding, certain features of the present disclosure may be described in the singular, even though these features may be plural or repeated in the disclosed embodiments. Each example of a feature may be included and / or contained in a single disclosure unless expressly provided to the contrary. For purposes of simplicity and clarity, not all elements of the present disclosure must be shown in every drawing or discussed in detail below. However, it should be understood that the discussion below may apply equally to any and / or all components having multiple parts, unless expressly provided to the contrary. In addition, for clarity, not all instances of certain elements or features are shown in every drawing.

[0042] Related terms such as "proximal," "distal," "advance," "retraction," and variations thereof may generally be considered relative to the positioning, orientation, and / or operation of various elements of a user / operator / manipulator of the device, where "proximal" and "retraction" mean or refer to being closer to or toward the user, and "distal" and "advance" mean or refer to being farther away from or away from the user. In some instances, the terms "proximal" and "distal" may be arbitrarily designated to aid in understanding the present disclosure, and these instances will be clear to one skilled in the art. Other related terms, such as "upstream," "downstream," "inflow," and "outflow," refer to the direction of fluid flow in a lumen (such as within a body lumen, a blood vessel, or a device). Still other related terms, such as "axial," "circumferential," "longitudinal," "transverse," "radial," and / or variations thereof, generally refer to a direction and / or orientation relative to a central longitudinal axis of the disclosed structure or device.

[0043] The terms "monolithic" and "unitary" generally refer to one or more components that are made or composed of a single structural or basic unit / element. Monolithic components and / or unitary components shall exclude structures and / or features formed by assembling or otherwise coupling together multiple discrete components.

[0044] It should be noted that references in the specification to "an embodiment," "some embodiments," "other embodiments," etc. indicate that the described embodiments may include a particular feature, structure, or characteristic, but not every embodiment necessarily includes a particular feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in conjunction with an embodiment, it will be within the scope of one skilled in the art to use the particular feature, structure, or characteristic in conjunction with other embodiments, whether or not explicitly described, unless expressly indicated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, are considered to be combinable or arrangable with each other to form other additional embodiments, or to supplement and / or enrich the described embodiments, as understood by one of ordinary skill in the art.

[0045] For the sake of clarity, certain identifying digital nomenclatures (e.g., first, second, third, fourth, etc.) can be used to name and / or distinguish the features of the various descriptions and / or claims throughout the specification and / or claims. It should be understood that the digital nomenclature is not restrictive, but merely exemplary. In certain embodiments, for the sake of brevity and clarity, the previously used digital nomenclatures can be changed and deviated from. That is, the feature identified as a "first" element can be referred to as a "second" element, a "third" element, etc., later, or can be omitted completely, and / or different features can be referred to as a "first" element. The meaning and / or name in each case are clear to a skilled practitioner.

[0046] Many medical procedures can involve the combined use of two different medical devices. For example, a first medical device can be used in combination with a second medical device to gain access to a specific treatment site, where appropriate treatment can then be performed. In some cases, a guidewire can be advanced through the vasculature to reach the specific treatment site. The first medical device can be advanced over the guidewire, and then the second medical device can be advanced through the first medical device. In some instances, it may be desirable to be able to advance and control the first and second medical devices as a single assembly, meaning that both the first and second medical devices can be moved, advanced, or retracted axially without requiring the user to simultaneously hold both the first and second medical devices. In some instances, the first and second medical devices can be rotated as a single assembly, meaning that the first and second medical devices can be rotated together without requiring the user to simultaneously hold both the first and second medical devices. In some instances, being able to advance or rotate the first and second medical devices together can be advantageous, particularly when the first and second medical devices have curved distal regions and / or are steerable.

[0047] An illustrative, but non-limiting, example of a medical procedure in which the first and second medical devices may be used in combination may include accessing the left atrium for implantation of a left atrial appendage closure (LAAC) device. In particular, a first medical device, such as a guide catheter, may be used in combination with a second medical device, such as an elongated dilator. It should be understood that two such medical devices may be used in combination to perform any of a variety of different medical procedures. Gaining access to the left atrium for delivery and implantation of a LAAC is merely an example of using a first medical device in combination with a second medical device.

[0048] Figure 1 A schematic diagram of a portion of a human heart 10 is provided, including a superior vena cava 12, an inferior vena cava 14, a septum 16, an atrial septum 18, a right atrium 20, and a left atrium 22. In some cases, the left atrium 22 may include a left atrial appendage (LAA) 23. A composite medical device including a guide catheter 24 may be advanced over a guidewire 26. In some cases, the guidewire 26 may be an RF guidewire adapted for cauterization using a cautery tip 27 using RF (radio frequency) energy. For example, in some cases, the RF guidewire may be used to form a small hole in or near the atrial septum 18. In some cases, the guidewire may have a sharp distal end that may be used to form a puncture.

[0049] The puncture through the atrial septum 18 can be made from a location within the right atrium 20. By forming a hole through the atrial septum 18, the left atrium 22 can be reached from the relatively safe right side of the heart. In some cases, an elongated medical device including an elongated dilator 28 can be advanced over a guidewire 26 and within a guide catheter 24. Once the hole is formed in the atrial septum, the elongated dilator 28 can be advanced over the guidewire and through the hole to widen the hole. The elongated dilator 28 and guidewire 26 can be removed from the hole to allow a delivery device carrying a LAAC (left atrial appendage closure) device to be advanced through the guide catheter 24. A variety of devices can be advanced through the guide catheter 24 to reach the LAA 23. Illustrative examples of suitable LAAC devices include the Watchman FLX available from Boston Scientific Corporation. TM LAAC device.

[0050] In some cases, the assembly comprising the guide catheter 24 and the elongated dilator 28 can be advanced through the inferior vena cava 14 to reach the right atrium 20. It should be understood that this can represent a tortuous path through the vascular system. In some cases, the guide catheter 24 and / or the elongated dilator 28 can be adapted to have a curved distal end for ease of manipulation. It should be understood that being able to maintain relative rotation between the guide catheter 24 and the elongated dilator 28 may be beneficial for manipulating the device through anatomical structures. This article describes multiple examples of mechanical rotation locking mechanisms that can be used to releasably provide rotational locking between the guide catheter 24 and the elongated dilator 28. These devices can also provide axial locking between the guide catheter 24 and the elongated dilator 28.

[0051] Figure 2A 3 is a side view of an exemplary assembly 30 including a guide catheter 32 and an elongated dilator 34. The guide catheter 32 can be considered an example of the guide catheter 24, while the elongated dilator 34 can be considered an example of the elongated dilator 28. As will be discussed, the guide catheter 32 and the elongated dilator 34 can be adapted so that the guide catheter 32 and the elongated dilator 34 can be coupled together to provide a releasable rotational lock therebetween.

[0052] The guide catheter 32 includes an elongated shaft 36 that terminates at its proximal end in a proximal hub 38. In some instances, a strain relief 40 extends distally from the proximal hub 38 a short distance on the elongated shaft 36. For example, in some cases, the proximal hub 38 may include one or more fittings, such as a Luer fitting, to allow for the introduction of various fluids. As shown, the proximal hub 38 includes a fitting 42 disposed on an upper portion of the proximal hub 38. In some instances, as will be discussed, the position of the fitting 42 relative to the proximal hub 38 provides an indication of the direction of curvature of the distal region (not shown) of the elongated shaft 36. In some instances, when the proximal hub 38 (and therefore the elongated shaft 36) is oriented so that the fitting 42 points upward (as shown), the distal region of the elongated shaft 36 can bend in an upward direction. A nut 44 is threadedly engaged with the proximal hub 38. In some examples, nut 44 may be manipulated by rotating nut 44 in a clockwise or counterclockwise direction to open or close a valve disposed within proximal hub 38 .

[0053] The elongated dilator 34 includes a dilator hub 46 adapted to serve as a handle. It will be appreciated that, for example, the dilator hub 46 is adapted to be easily gripped between the thumb and index finger of a user. The elongated dilator 34 includes a shaft 48 extending proximally from the dilator hub 46. Although not shown, the distal end of the shaft 48 can be pointed or otherwise adapted to penetrate tissue. In some cases, the distal end of the shaft 48 can be adapted to create a hole in tissue without requiring any initial hole to be formed, for example, by a guidewire. In some cases, the distal end of the shaft 48 can be adapted to enlarge an existing hole.

[0054] The dilator hub 46 can be adapted to be releasably secured to the proximal hub 38 of the guide catheter 32. By doing so, this provides a connection between the guide catheter 32 and the elongated dilator 34. In some instances, such a connection can provide a releasable rotational lock between the guide catheter 32 and the elongated dilator 34. In some instances, the dilator hub 46 can include an indicator 50 extending away from the dilator hub 46. In some instances, particularly when the shaft 48 of the dilator 34 includes a curved distal region, the orientation of the indicator 50 relative to the dilator hub 46 provides an indication of the direction of curvature of the curved distal region. In some instances, aligning the indicator 50 on the dilator hub 46 with the fitting 42 on the proximal hub 38 provides a corresponding directional alignment between the curved distal region of the elongated shaft 36 and the curved distal region of the shaft 48.

[0055] exist Figure 2A , the shaft 48 of the elongated dilator 34 has been inserted into the lumen extending through the proximal hub 38 and the elongated shaft 36 of the guide catheter 32, but the dilator hub 46 has not yet contacted and secured relative to the proximal hub 38. Figure 2B , the dilator hub 46 is shown fixed relative to the proximal hub 38. In some examples, the fixed connection between the proximal hub 38 and the dilator hub 46 can provide a releasable rotational lock between the guide catheter 32 and the elongated dilator 34, so that the guide catheter 32 and the elongated dilator 34 can be rotated together using only a single hand, i.e., the user only needs to hold one of the proximal hub 38 and the dilator hub 46. In some examples, this can provide advantages in maneuvering the assembly 30 through the vasculature, particularly when both the guide catheter 32 and the elongated dilator 34 include distal curvatures. This can be particularly useful when the user is only grasping the dilator hub 46, as the dilator hub 46 is adapted to be easily grasped.

[0056] In some instances, the secure connection between the proximal hub 38 and the dilator hub 46 can provide a releasable axial lock between the guide catheter 32 and the elongated dilator 34, such that the guide catheter 32 and the elongated dilator 34 can be axially advanced or retracted together using only a single hand, i.e., the user would only need to hold one of the proximal hub 38 and the dilator hub 46. This can be particularly useful when the user is only grasping the dilator hub 46, as the dilator hub 46 is adapted to be easily grasped.

[0057] In some examples, the secure connection between the proximal hub 38 and the dilator hub 46 can provide a releasable axial lock and a releasable rotational lock between the guide catheter 32 and the elongated dilator 34, so that the guide catheter 32 and the elongated dilator 34 can be axially advanced or retracted together using only a single hand, i.e., the user will only need to hold one of the proximal hub 38 and the dilator hub 46. The user can advance and rotate both the guide catheter 32 and the elongated dilator 34 with a single hand. This can be particularly useful when the user is only grasping the dilator hub 46, as the dilator hub 46 is adapted to be easily grasped.

[0058] Various mechanisms for providing a releasable rotational lock between a guide catheter, such as guide catheter 32, and an elongated dilator, such as elongated dilator 34, are described herein. Figures 3 to 11B Views are provided of an example A for providing a releasable rotational lock between a guide catheter and an elongated dilator. Figures 12 to 20 Figures 21 through 26C provide views of an example B for providing a releasable rotational lock between a guide catheter and an elongated dilator. Figures 21 through 26C provide views of an example C for providing a releasable rotational lock between a guide catheter and an elongated dilator. Figure 27A to Figure 3 2C provides a view of Example D providing a releasable rotational lock and a releasable axial lock between a guide catheter and an elongated dilator. Figures 33 to 35B A view of Example E providing a releasable rotational lock between a guide catheter and an elongated dilator is provided.

[0059] Example A

[0060] The goal of Example A is to provide a releasable rotational lock between the guide catheter and the elongated dilator so that the user does not have to hold both the dilator and the guide catheter for rotational alignment. In some instances, this can include a rotational lock between the valve nut and the guide catheter hub, and between the elongated dilator and the valve nut. Figure 3 is a perspective view of the proximal hub 138 of the guide catheter 132 and a valve nut 144 adapted to be secured relative to the proximal hub 138 of the guide catheter 132 .

[0061] The guide catheter 132 includes a proximal hub 138, one or more ports or fittings 142 (one shown) extending from the proximal hub 138, and a strain relief 140 extending proximally from the proximal hub 138. The elongated shaft 136 extends proximally from the proximal hub 138, passing through the strain relief 140. The proximal hub 138 and the valve nut 144 can each include features that provide a releasable rotational lock between the proximal hub 138 (and therefore the guide catheter 132) and the valve nut 144.

[0062] Figure 4 1 is a perspective view of a valve nut 144 illustrating features that allow for a releasable rotational lock between the valve nut and the proximal hub. The valve nut 144 includes a knurled outer surface 146 to make it easier for a user to manipulate the valve nut 144. A distal region 148 of the valve nut 144 is adapted to fit over a proximal region 150 of the proximal hub 138. The distal region 148 of the valve nut 144 includes a plurality of notches 152 cut into or otherwise formed within the distal region 148 of the valve nut 144. In some cases, the distal region 148 of the valve nut 144 may include a total of six notches 152, each circumferentially spaced about the distal region 148 of the valve nut 144 such that each notch 152 has a center point that is approximately 60 degrees circumferentially spaced from an adjacent notch 152. In some cases, there may be more than six equally spaced notches 152 about the distal region 148 of the valve nut 144. In some cases, the distal region 148 surrounding the valve nut 144 may have fewer than six equally spaced notches 152. In some instances, each of the six notches 152 has sidewalls that are angled at approximately 60 degrees, although other angles are contemplated. As will be discussed, these notches accommodate corresponding raised sections (e.g., Figure 5 ). The distal region 148 of the valve nut 144 includes a recessed area 154 that is adapted to fit over the proximal region 150 of the proximal hub 138.

[0063] Figure 5 1 is a perspective view of the proximal hub 138 illustrating features that allow for a releasable rotational lock between the valve nut 144 and the proximal hub 138. The proximal region 150 of the proximal hub 138 includes an externally threaded surface 156 adapted to engage a corresponding internally threaded surface ( Figure 6 The engagement between the outer threaded surface 156 and the inner threaded surface of the valve nut 144 means that rotating the valve nut 144 relative to the proximal hub 138 can cause the valve nut 144 to move axially relative to the proximal hub 138.

[0064] In some examples, the proximal region 150 of the proximal hub 138 includes a plurality of tabs 158 affixed to an outer surface 160 of the proximal region 158. In some cases, the tabs 158 can be integrally molded as part of the proximal hub 138. In some cases, the tabs 158 can be formed separately and subsequently affixed to the outer surface 160. For example, the tabs 158 can be adhesively affixed. In some cases, there can be a total of six tabs 158 spaced circumferentially around the outer surface 160. In some cases, there can be more than six tabs 158. In some cases, there can be fewer than six tabs 158.

[0065] In observation Figure 4 and Figure 5 When, it is understandable, Figure 5 The tab 158 shown is suitable for use with Figure 4 The proximal hub 132 and the distal region 148 of the valve nut 144 interact with each other. In some cases, the tabs 158 have sides that are angled at approximately 60 degrees. In some cases, the tabs 158 may have sides that are generally angled to match, or at least substantially match, the angled sides of the recesses 152. In some cases, the number of tabs 158 will match the number of recesses 152. While a total of six tabs 158 are shown on the proximal hub 132 and a total of six recesses 158 are shown on the distal region 148 of the valve nut 144, this is merely illustrative. In some cases, there may be fewer than six tabs 158 and fewer than six recesses 152. In some cases, there may be more than six tabs 158 and more than six recesses 152. In some cases, there may be two tabs 158 and four recesses 152, or perhaps three tabs 158 and six recesses 152, as long as the circumferential spacing between the tabs 158 is a multiple of the circumferential spacing between the recesses 152. In any event, the tabs 158 and the notches 152 may cooperate to provide a releasable rotational lock between the proximal hub 138 and the valve nut 144 .

[0066] Figure 6 is a schematic cross-sectional view. Figure 6 As shown, when the user retracts the valve nut 144, the notch 152 formed in the proximal region 148 of the valve nut 144 will engage with the tab 158 on the proximal region 150 of the proximal hub 132. In some cases, the user will feel a rotational locking engagement. Because both the notch 152 and the tab 158 have sides that are angled at approximately 60 degrees in some cases, the notch 152 and the tab 158 will together provide a rotational lock.

[0067] like Figure 6As shown, the internal threaded surface 162 within the valve nut 144 has not yet reached and engaged the corresponding external threaded surface 156 of the proximal hub 138. The valve nut 144 includes an inner protruding segment 164 extending distally from the internal threaded surface 162. Depending on the relative position of the valve nut 144 relative to the proximal hub 138, the inner protruding segment 164 can engage a valve 166 disposed within the proximal hub 138. For example, the rotational lock can resist an applied torque of approximately 4.67 N-cm (0.41 lb-in). In some cases, applying sufficient torque to the valve nut 144 relative to the proximal hub 138 can be sufficient to overcome the rotational lock, if desired. Figure 6 The valve nut 144 is shown retracted from the valve 166. In some examples, for example, the valve 166 can be a resilient member.

[0068] exist Figure 7A In the embodiment, the user has pushed the valve nut 144 far enough to disengage the notch 152 from the tab 158. Once the notch 152 is disengaged from the tab 158, the user can feel a smooth rotation. Figure 7A In the embodiment, the notch 152 and the tab 158 have reached the limit of engagement. The valve 166 just contacts the inner protruding section 164 of the valve nut 144, but the inner protruding section 164 of the valve nut 144 has not yet begun to compress the valve 166. Figure 7B , the valve nut 144 has moved further and the internal threaded surface 164 of the valve nut 144 has engaged the corresponding internal threaded surface 156 of the proximal hub 138. It can be seen that the tabs 158 on the proximal hub 130 do not interfere with normal valve function. It can be seen that the inner protruding section 164 of the valve nut 144 has substantially compressed the valve 166.

[0069] The previous figures illustrate a releasable rotational lock between the proximal hub 138 and the valve nut 144. In order to provide a releasable rotational lock between the guide catheter 132 and the elongated dilator, it is useful to also provide a releasable rotational lock between the valve nut 144 and the elongated dilator. Figure 8 1 is a perspective view illustrating the connection between the valve nut 144 and a snap fitting 170 forming the distal region of the elongated dilator. The snap fitting 170 is adapted to receive an elongated shaft extending therethrough and may be adapted to fit into a dilator hub.

[0070] In particular, Figure 9 Shown is a proximal end view of the valve nut 144, which includes a hole 172 adapted to receive a portion of an elongated dilator. In some cases, the hole 172 is sized to receive a portion of an elongated dilator hub (e.g., Figure 2A and Figure 2B172 . Figure 9 Also visible is the knurled outer surface 146 of the valve nut 144.

[0071] Figure 10A is a perspective view of a snap fitting 170. A distal region 178 of the snap fitting 170 includes a plurality of ribs 180 adapted to fit within slots 174 formed around the bore 172 of the valve nut 144. In some cases, the distal region 178 of the snap fitting 170 may include a plurality of ribs 180 equally spaced around the distal region 178 of the snap fitting 170. For example, if there are four ribs 180, the four ribs 180 may be spaced approximately 90 degrees apart around the circumference of the bore 172. In some cases, there may be more than four ribs 180. In some cases, there may be fewer than four ribs 180. It should be understood that in some examples, the number and distribution of the slots 174 formed in the proximal end surface 176 of the valve nut 144 may be identical to the corresponding ribs 180 formed in the distal region 178 of the snap fitting 170. In some cases, there may be one rib 180 and four slots 174, or possibly two ribs 180 and four slots 174, as long as the circumferential spacing between tabs 158 is a multiple of the circumferential spacing between notches 152. As shown, a total of four slots 174 are added without interfering with the snap-fit ​​geometry of valve nut 144. Figure 10A The snap fitting 170 is shown to include a fully circular snap profile 182 .

[0072] Figure 10BFIG2 is an exploded view of an exemplary dilator hub 184, illustrating how the snap-fit ​​fitting 170 forms part of the dilator hub 184. The dilator hub 184 can be used as part of an elongated dilator adapted to provide a releasable rotational lock with the valve nut 144. The dilator hub 184 includes a luer fitting 186 having a distal region 188 that provides a luer fit and a proximal region 190 that includes a plurality of apertures 190a. The dilator hub 184 includes a first clamshell structure 192a and a second clamshell structure 192b that together form a grippable portion of the dilator hub 184. The first clamshell structure 192a includes a plurality of protrusions 194 adapted to extend through the apertures 190a formed in the luer fitting 186 and into corresponding apertures (not visible in this view) formed in the second clamshell structure 192b. In some examples, the protrusions 194 form a snap-fit ​​with corresponding apertures formed in the second clamshell structure 192b. When the first clamshell structure 192a is assembled to the second clamshell structure 192b, the snap fitting 170 and the luer fitting 186 are clamped between the first clamshell structure 192a and the second clamshell structure 192b. The elongated shaft forming part of the elongated dilator is not shown, but is housed by a lumen 196 extending through the snap fitting 170. The lumen 196 can be considered to be in fluid communication with a corresponding lumen 198 extending through the luer fitting 186. The second clamshell structure 192b includes an extension 200 that is adapted to provide an indication of the direction of curvature of the distal region of the elongated shaft.

[0073] Figure 11A is a schematic cross-sectional view illustrating the engagement of the circular snap profile 182 . Figure 11B Indicating a relatively small rotation of the snap fitting 170 relative to the valve nut 144, a plurality of ribs 180 are shown that fit into corresponding slots 174, thereby providing a releasable rotational lock between the valve nut 144 and the snap fitting 170 (and therefore between the valve nut 144 and the dilator hub 184). With four tabs and four notches, the valve nut 144 can be locked into any one of four positions, each approximately 90 degrees apart. This works in conjunction with the four ribs 180 formed on the snap fitting 170 and can be used to consistently orient the bend indicator to a specific position that aligns with the side port tube. Since there are other possible positions, it is up to the user to determine whether proper alignment is achieved when the snap is inserted into the elongated dilator. As mentioned above, in some cases, there may be fewer than four positions, but a minimum of two or three positions to accommodate the thread length.

[0074] Example B

[0075] The goal of Example B is to provide a rotational lock between the guide catheter and the elongated dilator so that the user does not have to hold the two components separately. Figure 12is a perspective view showing the valve nut 244 attached to the proximal hub 238 of the guide catheter 232. As will be discussed, the valve compressor 246 that fits within the valve nut 244 includes features that provide a smooth funnel for housing and receiving an elongated dilator and provide a releasable rotational lock with the elongated dilator.

[0076] like Figure 12 As shown, guide catheter 232 includes a proximal hub 238, one or more ports or fittings 242 (one shown) extending from proximal hub 238, and a strain relief 240 extending proximally from proximal hub 238. Elongated shaft 236 extends proximally from proximal hub 238 through strain relief 240. Figure 13 2 is an exploded view showing the proximal hub 238 of the guide catheter 232 and a number of components that together form part of the valve nut 244 and the dilator hub 250. The dilator hub 250 can be combined with an elongated dilator shaft (not shown) to form an elongated dilator that can be used in conjunction with the guide catheter 232. Additional components include a valve 248, a valve compressor 246, a valve nut 244, a snap-fit ​​tip 270 (which can be considered similar to the snap-fit ​​fitting 170), a universal luer 286, a first clamshell structure 292a, and a second clamshell structure 292b. The valve 248, which can be a resilient element, fits into the aperture 220 formed in the proximal region 222 of the proximal hub 238.

[0077] The luer fitting 286 includes a distal region 288 that provides a luer fit and a proximal region 290 that includes a plurality of apertures 290a. The dilator hub 250 includes a first clamshell structure 292a and a second clamshell structure 292b that together form a grippable portion of the dilator hub 250. The first clamshell structure 292a includes a plurality of protrusions 294 that are adapted to extend through the apertures 290a formed in the luer fitting 186 and into corresponding apertures (not visible in this view) formed in the second clamshell structure 292b. In some examples, the protrusions 294 form a snap fit with corresponding apertures formed in the second clamshell structure 292b. When the first clamshell structure 292a is assembled to the second clamshell structure 292b, the snap tip 270 and the luer fitting 286 are clamped between the first clamshell structure 292a and the second clamshell structure 292b. An elongated shaft forming part of the elongated dilator is not shown, but is housed by a lumen 296 extending through the snap tip 270. The lumen 296 can be considered to be in fluid communication with a corresponding lumen 298 extending through the Luer fitting 286. The second clamshell structure 292b includes an extension 300 adapted to provide an indication of the direction of curvature of the distal region of the elongated shaft.

[0078] Figure 14is a perspective view showing the valve compressor 246 disposed within the valve nut 244 . Figure 15A is an exploded side view of the valve compressor 246 and the valve nut 244, and Figure 15B 2 is a cross-sectional view thereof. The valve compressor 246 includes a raised ridge 246a and an outer profile 246b, which together provide a snap fit between the valve compressor 246 and the annular shoulder 244a of the valve nut 244. This allows the valve compressor 246 to snap into the valve nut 244. The annular shoulder 244a is adapted to resist the forces generated by the torque applied to the valve nut 244. It should be understood that the proximal portion 246c is adapted to engage the valve 248 and, therefore, can be considered to have a similar function to the inner protruding section 164 described with respect to the valve nut 144.

[0079] The valve compressor 246 includes a plurality of ribs 246d that engage corresponding slots 224 formed in the proximal region 222 of the proximal hub 238. In some cases, the valve compressor 246 may include two ribs 246d approximately 180 degrees apart, and the proximal hub 238 may have two corresponding slots 224. In some examples, the valve compressor 246 may include three or more ribs 246d spaced about the valve compressor 246, with a corresponding number of slots 224 in the proximal hub 238.

[0080] 222 of the proximal hub 238.

[0081] like Figure 16A As shown, the valve compressor 246 includes ears 245 and ears 247 that accommodate the rotational lock. Due to the ears 245 and ears 247 forming part of the valve compressor 246 and corresponding recesses 241 and 243 formed in the valve nut 244, the snap fit spans two areas, each area is approximately 100 degrees. Figure 16B As shown, during assembly, after the assembled parts are free to rotate, the ears 245 and 247 need to be aligned with the notches 241 and 243 in the outer nut 244.

[0082] Figure 17FIG2 is a perspective view of the valve compressor 246 relative to the proximal hub 238, providing another view of the rib 246d engaging the corresponding slot 224 formed in the proximal region 222 of the proximal hub 238. In some examples, the rib 246d and slot 224 cooperate to provide a specific orientation of the valve compressor 246 relative to the proximal hub 238 and the fitting 242. It should be understood that the relative position of the rib 246d and slot 224 is approximately 90 degrees apart from the position of the fitting 242. This same spacing is achieved through the valve compressor 246 by the relative position of the ears 245 and 247 (of the valve compressor 246) and the notches 241 and 243 (of the valve nut 244). Thus, the expander hub 250 will be positioned so that the extension 300 of the clamshell structure 292a will be aligned with the fitting 242. This means that the curved distal region of the elongated dilator including the dilator hub 250 will align with a corresponding curved distal region of the elongated shaft 236 forming part of the guide catheter 232 .

[0083] Figure 18 and Figure 19 is a cross-sectional view showing how the valve nut 244 (with the valve compressor therein) snaps onto the proximal hub 238. In some examples, the proximal hub 238 includes an annular ridge 238a adapted to engage a corresponding annular snap 244b formed on the valve nut 244. Figure 18 , the annular catch 244b is positioned adjacent to the annular ridge 238a, but has not yet been pushed onto the annular ridge 238a. Figure 19 , the annular catch 244b has been pushed onto the annular ridge 238a.

[0084] exist Figure 18 and Figure 19 The rib 246d and the slot 224 can also be seen. Figure 18 The position of the proximal hub 238 shown is pushed relative to Figure 19 Prior to the position of the proximal hub 238 as shown, the rib 246d needs to be aligned with the slot 224. Figure 18 In FIG, the internal threaded surface 262 of the valve nut 244 has not yet engaged with the external threaded surface 264 formed on the proximal hub 238. Figure 19 , the internal threaded surface 262 of the valve nut 244 just engages the external threaded surface 264 formed on the proximal hub 238. As can be seen, the slot 224 ends before the position of the valve 248, so that the valve function is not affected by the slot 224.

[0085] Figure 20FIG2 is a perspective view of an exemplary elongated dilator 234 including a dilator hub 250. The elongated dilator shaft 237 extends proximally from clamshell structures 292a and 292b, which snap together to form the dilator hub 250. The dilator hub 250 includes a plurality of ribs 302 adapted to fit within ears 245 and 247 formed within the valve compressor 246. In some cases, for example, the ribs 302 are formed as part of the snap tip 270. As shown, the valve compressor 246 includes two ears 245 and 247, and the snap tip 270 includes two corresponding ribs 302. In some cases, the valve compressor 246 may include three or more ears, and the snap tip 270 may correspondingly include three or more ribs 302. In some cases, the valve compressor 246 may include a single ear, and the snap tip 270 may include a single rib 302.

[0086] Example C

[0087] The goal of Example C is to provide both rotational and axial locking between the guide catheter and the elongated dilator so that the user does not have to hold the two components separately. Figure 21A is an exploded view illustrating assembly 320 including proximal hub 322. A fitting 324 extends from proximal hub 322 and can be used to supply fluid to the interior of proximal hub 322. An elongated shaft 326 extends proximally from proximal hub 322 and includes a strain relief 328 extending a short distance along elongated shaft 326. In some instances, when elongated shaft 326 includes a curved distal region (not shown), the position of fitting 324 can provide an indication of the direction of the curvature. Proximal region 340 of proximal hub 322 does not include an externally threaded surface. A hole 342 is formed within proximal region 340 of proximal hub 322.

[0088] Assembly 320 includes a valve 344, which may be, for example, an elastic member, and is mounted in bore 342. A compressor 346 is adapted to translate relative to valve 344 to reversibly compress valve 344. A clip 348 is adapted to fit within a bore 350 formed in compressor 346. Clip 348 includes a bore 352 adapted to accommodate an elongated expander. Assembly 320 includes a first nut half 354a and a second nut half 354b. A nut sleeve 356 is mounted on first and second nut halves 354a, 354b to hold them together. The first and second nut halves 354a, 354b together define an internally threaded surface 358 adapted to engage a corresponding externally threaded surface 360 ​​formed on compressor 346. This allows compressor 346 to translate relative to the first and second nut halves 354a, 354b.

[0089] Figure 21B and Figure 21C is a cross-sectional view showing how the compressor 346 translates to compress the valve 344 while the catch 348 remains stationary. Figure 21B , compressor 346 has contacted valve 344, but has not translated far enough to compress valve 344. Figure 21C , compressor 346 has translated further and has substantially compressed valve 344. The distal end 346a of compressor 346 is adapted to have a shape that is complementary to the shape of valve 344. In some instances, this may mean that a washer is not required. As can be seen, the internal threaded surface 358 defined by the first nut half 354a and the second nut half 354b engages the external threaded surface 360 ​​formed on compressor 346 to allow the nut assembly including the first nut half 354a, the second nut half 354b, and the nut sleeve 356 to rotate, thereby causing compressor 346 to translate.

[0090] Figure 22 FIG3 is a perspective view showing a compressor 346 aligned for insertion into a bore 342 formed in the proximal region 340 of the proximal hub 322. The compressor 346 includes a plurality of ribs 362 adapted to extend into a plurality of corresponding slots 364 formed in the bore 342. It should be understood that the engagement of the ribs 362 with the slots 364 allows the compressor 346 to translate relative to the proximal hub 322, but does not allow the compressor 346 to rotate relative to the proximal hub 322. In some cases, the ribs 362 extend only a fraction of the length of the compressor 346. While two ribs 362 and two slots 364 are shown, in some cases, there may be three or more ribs 362 and correspondingly three or more slots 364. In some cases, the compressor 346 may include a single rib 362, and the bore 342 may include a single slot 364.

[0091] Figure 233 is a perspective view showing the buckle 348 aligned for insertion into the aperture 350 formed in the compressor 346. The buckle 348 includes a plurality of ribs 366 adapted to extend into a plurality of corresponding slots 368 formed in the aperture 350. It should be understood that the engagement of the ribs 366 with the slots 368 allows the compressor 346 to translate relative to the buckle 348, but does not allow the compressor 346 to rotate relative to the buckle 348. In some cases, the ribs 362 extend only a small portion of the length of the compressor 346. While two ribs 362 and two slots 364 are shown, in some cases there may be three or more ribs 362 and corresponding three or more slots 364. In some cases, there may be a single rib 362 and a single slot 364. Because the compressor 346 is not allowed to rotate relative to the proximal hub 322, and because the buckle 348 is not allowed to rotate relative to the compressor 346, rotational alignment between the proximal hub 322 and the buckle 348 is maintained.

[0092] It should be understood that the aperture 352 formed in the buckle 352 includes an ear 370 adapted to receive a rib on the dilator hub of the elongated dilator to maintain a rotational orientation between the proximal hub 322 and the elongated dilator. In some instances, this rotational orientation extends to align a curved distal region of the elongated dilator with a corresponding curved distal region of the elongated shaft 326 of the guide catheter.

[0093] Figure 24A 376 is a side view illustrating how the first nut half 354a and the second nut half 354b interact with the proximal portion 340 of the proximal hub 322. The first nut half 354a and the second nut half 354b each define a portion of an annular flange 372 adapted to engage a narrowed portion 374 of the proximal portion 340 of the proximal hub 322. The narrowed portion 374 is defined only proximal to the increased diameter portion 376. The first nut half 354a and the second nut half 354b are able to freely rotate about the proximal hub 322. The engagement between the annular flange 372 and the narrowed portion 374 provides an axial lock between the first nut half 354a, the second nut half 354b, and the proximal hub 322.

[0094] Figure 24B 348. FIG3 is a side view showing how the buckle 348 interacts with the first nut half 354a and the second nut half 354b. The first nut half 354a and the second nut half 354b together define an annular flange 378 that is adapted to engage an annular recess 380 formed in the buckle 348. The engagement between the annular flange 378 and the annular recess 380 axially constrains the buckle 348, but allows the first nut half 354a and the second nut half 354b to rotate freely relative to the buckle 348.

[0095] Figure 25 FIG3 is an end view of a valve nut assembly 382. The valve nut assembly 382 includes a first nut half 354a and a second nut half 354b constrained within a nut sleeve 356. In some cases, the nut sleeve 356 can be pressed onto the first and second nut halves 354a, 354b. In some instances, the nut sleeve 356 can snap onto the first and second nut halves 354a, 354b. In some cases, the nut sleeve 356 can be glued to the first and second nut halves 354a, 354b. The nut sleeve 356 prevents the first and second nut halves 354a, 354b from separating. A plurality of flat surfaces 384 formed on the outer surfaces of the first and second nut halves 354a, 354b interact with corresponding flat surfaces 386 formed on the inner surface of the nut sleeve 356 to provide torque transmission between the nut sleeve 356 and the first and second nut halves 354a, 354b. This means that rotating the nut sleeve 356 will cause corresponding rotation of the first nut half 354a and the second nut half 354b.

[0096] Figure 26A The WATCHMAN TruSteer is shown in combination with the valve nut assembly 382. TM Perspective view of access sheath hub 388. TruStee is a steerable access device described, for example, in U.S. Provisional Application Serial No. 63 / 316,208, which is incorporated herein by reference. Figure 26B Shown in an exploded view thereof, the hub 388 includes a proximal portion 390 similar to the proximal portion of the proximal hub 322. A bore 392 formed in the proximal portion 390 of the hub 388 includes a slot 394 adapted to receive the rib 362 formed on the compressor 346.

[0097] Discussion of Example D

[0098] The goal of Example D is to provide both rotational and axial locking between the guide catheter and the elongated dilator so that the user does not have to hold the two components separately. Figure 27A FIG4 is an exploded view of assembly 400, illustrating proximal hub 402 of guide catheter 404. Guide catheter 404 includes an elongated shaft 406 extending proximally from proximal hub 402. A strain relief 408 extends proximally a short distance from proximal hub 402 on elongated shaft 406. Proximal hub 402 includes a proximal portion 412. Proximal portion 412 includes a side window 414, an externally threaded surface 416, and an end aperture 418.

[0099] Assembly 400 also includes a valve 420, a compressor 422, a buckle 424, and a valve nut 426. In some cases, Example D does not require a gasket. Valve 420 can be placed within end hole 418, and compressor 422 can be added behind valve 420 by inserting it through side hole 414. In some examples, proximal region 412 of proximal hub 402 includes a plurality of slots 418a that interact with corresponding ribs 424b formed on buckle 424 to provide rotational alignment between proximal hub 402 and buckle 424.

[0100] Figure 27B and Figure 27C 4 is a schematic cross-sectional view showing a compressor 422 positioned adjacent to a valve 420. A clip 424 fits into an aperture 418 formed in the proximal region 412 of the proximal hub 402. The clip 424 includes a plurality of raised segments 424a (one visible in this view) that interact with the distal edge of the proximal hub 402 to secure the clip 424 in place. As can be seen, the clip 424 remains stationary while the compressor 422 translates distally to compress the valve 420 (and translates proximally to allow the valve 420 to relax). The externally threaded surface 416 of the proximal hub 402 engages a correspondingly internally threaded surface 426c of the valve nut 426. The distal end 424c of the clip is adapted to contact the compressor 422.

[0101] Figure 28A 4 is a schematic cross-sectional view showing how the compressor 422 is inserted into the proximal hub 402 through the side window 414. The side window 414 can have a height that matches the ID (inside diameter) of the proximal hub 402 to accommodate a full diameter compressor. In some cases, the compressor 422 includes a concave diameter section 422a and a full diameter section 422b. Figure 28B As shown, compressor 422 is advanced distally to actuate valve 420 .

[0102] Figure 29A 4 is a schematic cross-sectional view showing the valve nut 426 positioned relative to the proximal region 412 of the proximal hub 402. As shown, no undercut snap is formed in the valve nut 426 to retain the valve nut 426 on the proximal hub 402. Instead, the proximal flange of the snap 424 retains the valve nut 426. The valve nut 426 can be radially constrained at both ends to prevent tilting, which could result in cross-threading if not prevented. Figure 29B As shown, the figure is along Figure 29A The cross-sectional view taken along line 29B-29B of FIG. 1 shows a cross-sectional view taken along line 29B-29B of FIG. 1 , when the valve nut is in the proximal position (eg, Figure 29B ), the outer threaded surface 416 of the proximal hub 402 does not engage the inner threaded surface 426 c of the valve nut 426. Therefore, this allows the valve nut 426 to rotate freely when the valve 420 is open.

[0103] Figure 30 and Figure 31 4 is another cross-sectional view. Valve nut 426 contacts compressor 422. When valve nut 426 is advanced and rotated to close valve 420, outer threaded surface 416 of proximal hub 402 engages inner threaded surface 426c of valve nut 426 before valve nut 426 engages compressor 422. Thus, the user does not need to apply force to compress valve 420. Valve nut 426 advances compressor 422 as it rotates. Compressor 422 returns to its proximal position through valve 420, rather than through valve nut 426.

[0104] FIG. 32 a is a diagram showing the WATCHMAN TruSteer in combination with component 428. TM Entering the perspective view of the sheath hub 388, the assembly includes the combination of the valve 420, the compressor 422, the buckle 424 and the valve nut 426. Figure 32B Shown in an exploded view thereof, the hub 388 includes a proximal portion 390 similar to the proximal portion of the proximal hub 322. A bore 392 formed in the proximal portion 390 of the hub 388 includes a slot 394 adapted to receive the rib 362 formed on the compressor 346.

[0105] Discussion of Example E

[0106] The goal of Example E is to provide a rotational lock between the guide catheter and the elongated dilator. Figure 33 506. An elongated dilator 504 is shown in FIG. 504. FIG. 505 is a side view of an exemplary assembly 500 comprising a guide catheter 502 and an elongated dilator 504. The guide catheter 502 comprises a proximal hub 506. An elongated shaft 508 extends proximally from the proximal hub 506. A strain relief 510 extends proximally from the proximal hub 506. A fitting 512 enables fluid to be delivered to the interior of the proximal hub 506. In some instances, the orientation of the fitting 512 relative to the proximal hub 506 can provide an indication of the direction of curvature for a curved distal region (not shown) of the elongated shaft 508. The elongated dilator 504 can be considered to represent a portion of the elongated dilator 504 relative to the proximal hub 506. Figure 6 The dilator hub 184 is augmented with an elongated dilator shaft 514 .

[0107] Expander hub 184.

[0108] Figure 34 506. The proximal hub 506 includes a proximal region 520. The proximal region 520 includes an annular flange 522, an externally threaded surface 524, and an elongated slot 526 cut into the proximal region 520. The elongated slot 526 is adapted to accommodate a plurality of additional components, such as Figure 35A and Figure 35B Additional components include valve 528 , pusher 530 , internal member 532 , and valve nut 534 .

[0109] Figure 35A 5 is a schematic cross-sectional view showing the seal open, free to rotate counterclockwise and without thread engagement. As shown, the pusher 530 is also not compressing the valve 528. The valve nut 534 includes an internal threaded surface 540 that engages the external threaded surface 524 of the proximal hub 506. Figure 35B , pusher 530 has moved distally and thereby compressed valve 528. Figure 35A and Figure 35B , it can be seen that the valve nut 534 has moved distally, causing the pusher 530 to contact the valve 528 and compress the valve. Figure 36A and Figure 35A Same, but indicates that Figure 35A Cross section after 90-degree rotation of the orientation. Figure 36B and Figure 35B Same, but indicates that Figure 35B 90 degrees after the orientation in FIG. As can be seen, the internal threaded surface 540 extends only a portion of the length of the valve nut 534.

[0110] Materials that can be used in the devices described herein may include those commonly associated with medical devices. The devices described herein or components thereof may be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials. Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steel; low carbon steel; nickel titanium alloys, such as linear elastic and / or superelastic nitinol; other nickel alloys, such as nickel chromium molybdenum alloys (e.g., UNS: N06625, such as 625, UNS: N06022, such as UNS: N10276, such as other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as alloy ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (for example, UNS: R30003, such as platinum-rich stainless steel, titanium, combinations thereof, or any other suitable material.

[0111] As mentioned herein, within the family of commercially available nickel-titanium, or Nitinol, alloys, there is a class known as "linear elastic" or "non-superelastic" alloys that, while chemically similar to traditional shape memory and superelastic alloys, can exhibit unique and effective mechanical properties. Linear elastic and / or non-superelastic Nitinol differs from superelastic Nitinol in that linear elastic and / or non-superelastic Nitinol does not exhibit a distinct "superelastic plateau" or "landmark zone" in its stress / strain curve, as does superelastic Nitinol. Instead, in linear elastic and / or non-superelastic Nitinol, as recoverable strain increases, stress continues to increase in a substantially linear, or somewhat, but not necessarily completely, linear, relationship until plastic deformation begins, or at least in a more linear relationship than the superelastic plateau and / or landmark zone seen in superelastic Nitinol. Therefore, for the purposes of this disclosure, linear elastic and / or non-superelastic Nitinol may also be referred to as "substantially" linear elastic and / or non-superelastic Nitinol.

[0112] In some cases, linear elastic and / or non-superelastic nitinol can also be distinguished from superelastic nitinol in that linear elastic and / or non-superelastic nitinol can accept strains up to about 2-5% while remaining substantially elastic (e.g., before plastic deformation), whereas superelastic nitinol can accept strains up to about 8% before plastic deformation. Both of these materials can be distinguished from other linear elastic materials, such as stainless steel (which can also be distinguished based on its composition), which can only accept strains of about 0.2% to 0.44% before plastic deformation.

[0113] In some embodiments, a linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not exhibit any detectable martensite / austenite phase transformations by differential scanning calorimetry (DSC) and dynamic metallographic thermal analysis (DMTA) analysis over a wide temperature range. For example, in some embodiments, within a range of approximately -60 degrees Celsius (°C) to approximately 120°C, there may be no detectable martensite / austenite phase transformations by DSC and DMTA analysis in a linear elastic and / or non-superelastic nickel-titanium alloy. Consequently, over this very wide temperature range, the mechanical bending properties of such a material are generally inert to the effects of temperature. In some embodiments, the mechanical bending properties of the linear elastic and / or non-superelastic nickel-titanium alloy at ambient or room temperature are substantially the same as their mechanical properties at body temperature, for example, because they do not exhibit a superelastic plateau and / or signature region. In other words, over a wide temperature range, the linear elastic and / or non-superelastic nickel-titanium alloy maintains its linear elastic and / or non-superelastic characteristics and / or properties.

[0114] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy can be in the range of about 50% to about 60% (by weight) nickel, with the remainder being substantially titanium. In some embodiments, the nickel content of the composition is in the range of about 54% to about 57% (by weight). An example of a suitable nickel-titanium alloy is FHP-NT alloy available from Furukawa Techno Material Co. of Kanagawa, Japan. Some examples of nickel-titanium alloys are disclosed in U.S. Patent Nos. 5,238,004 and 6,508,803, which are incorporated herein by reference. Other suitable materials may include ULTANIUM TM (available from Neo-Metrics) and GUM METAL TM (Available from Toyota.) In some other embodiments, superelastic alloys (eg, superelastic Nitinol) may be used to achieve the desired properties.

[0115] In at least some embodiments, the device described herein, or its components may also be doped with, made of, or otherwise include radiopaque materials. Radiopaque materials are understood to be materials that can produce relatively bright images on a fluoroscopic examination screen or another imaging technique during a medical procedure. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, etc. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the design of guidewire 10 to achieve the same result.

[0116] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the devices disclosed herein or components thereof. For example, the devices disclosed herein or components thereof can be made of materials that do not substantially distort the image and do not produce a large number of artifacts (i.e., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in MRI images. The devices disclosed herein or components thereof can also be made of materials that can be imaged by MRI machines. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), Nitinol, etc., and other similar ones.

[0117] A sheath or covering (not shown) may be disposed over some or all of the devices described herein to define a generally smooth outer surface. However, in other embodiments, no such sheath or covering may be present. The sheath may be made of a polymer or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., available from DuPont), or a combination thereof. ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM Engineering Plastics), ), ether or ester based copolymers (e.g., butene / poly(alkylene ether) phthalate and / or other polyester elastomers such as those available from DuPont ), polyamides (e.g., available from Bayer Or available from Elf Atochem ), elastic polyamides, block polyamide / ether, polyether block amide (PEBA, such as can be Trademark), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), High-density polyethylene, Low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., ), polysulfone, nylon, nylon-12 (e.g., available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc. thereof. In some embodiments, the sheath can be blended with a liquid crystal polymer (LCP). For example, the blend can contain up to about 6% LCP.

[0118] In some embodiments, the external surface of device described herein can be sandblasted, beaded sandblasted, sodium bicarbonate blasted, electropolished, etc. In these and some other embodiments, a coating can be applied, such as a smooth, hydrophilic, protective or other type of coating. Alternatively, the sheath can include a smooth, hydrophilic, protective or other type of coating. Hydrophobic coatings (such as fluoropolymers) provide dry lubricity, which improves the handling of guidewires and the replacement of devices. Smooth coatings improve maneuverability and improve lesion penetration ability. Suitable lubricating polymers are well known in the art and can include silicones, hydrophilic polymers such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinyl pyrrolidone, polyvinyl alcohol, hydroxyalkyl cellulose, alginates, saccharides, caprolactones, etc., and mixtures and combinations thereof. Hydrophilic polymers can be mixed with each other or mixed with a formulated amount of water-insoluble compounds (including some polymers) to produce a coating with suitable lubricity, adhesion and solubility. Some other examples of such coatings and materials and methods for producing such coatings can be found in US Pat. Nos. 6,139,510 and 5,772,609, which are incorporated herein by reference.

[0119] The portion of the device as described herein can be formed by, for example, coating, extruding, coextruding, intermittent layer coextrusion (ILC) or end-to-end fusing multiple sections. The layer can have a uniform hardness or gradually decrease from its proximal end to the distal end hardness. The gradual reduction in stiffness can be continuous (as by ILC), or can be stepped (as by fusing separate extruded tube sections together). The outer layer can be impregnated with a radiopaque filler material for ease of radiographic visualization. Those skilled in the art will recognize that these materials can be widely varied without departing from the scope of this disclosure.

[0120] It should be understood that the present disclosure is in many respects illustrative only. Without exceeding the scope of the present disclosure, changes may be made in the details, particularly in the shape, size, and arrangement of steps. To the extent appropriate, this may include any feature used in one exemplary embodiment being used in other embodiments. Of course, the scope of the present invention is defined in the language of the appended claims.

Claims

1. A medical device assembly comprising: A first elongated medical device comprising: a first elongated shaft having a first proximal region and a first distal region; and a first proximal hub secured to the first proximal region; and A second elongated medical device comprising: a second elongated shaft having a second proximal region and a second distal region; and a second proximal hub secured to the second proximal region; Wherein, the first elongated medical device is adapted to form a releasable axial lock and / or rotational lock with the second elongated medical device.

2. The medical device assembly of claim 1, wherein: The second elongated shaft is adapted to fit within a lumen extending through the first elongated shaft.

3. The medical device according to claim 2, wherein The second proximal hub is adapted to releasably couple to the first proximal hub when the second elongated shaft is disposed within the lumen extending through the first elongated shaft.

4. The medical device according to any one of claims 1 to 3, wherein The second proximal hub is adapted to form a releasable rotational lock with the first proximal hub.

5. The medical device assembly of claim 1, wherein: The first elongated medical device is adapted to be advanced over a guidewire to reach the atrial septum.

6. The medical device assembly of claim 5, wherein: The second elongate medical device is adapted to be advanced over the guidewire in combination with the first elongate medical device to create or enlarge a hole formed in the atrial septum.

7. The medical device assembly according to any one of claims 1 to 6, wherein: The first elongated medical device comprises a guide catheter.

8. The medical device assembly according to any one of claims 1 to 7, wherein: The second elongated medical device comprises an elongated dilator.

9. A medical device assembly for accessing a left atrial appendage, comprising: A guide catheter, comprising: a guide catheter shaft; and a guide catheter hub secured to a proximal region of the guide catheter shaft; and An elongated dilator, comprising: an elongated dilator shaft comprising a distal region adapted to create and / or enlarge a hole in tissue; and a dilator hub secured to a proximal region of the elongated dilator shaft; Wherein, the guide catheter and the elongate dilator are adapted to form a releasable lock therebetween.

10. The medical device assembly of claim 9, wherein: The elongated dilator shaft is adapted to fit within a lumen extending through the guide catheter shaft.

11. The medical device according to claim 10, wherein: The dilator hub is adapted to releasably couple to the guide catheter hub when the elongated dilator shaft is disposed within the lumen extending through the guide catheter shaft.

12. The medical device according to any one of claims 9 to 11, wherein The dilator hub is adapted to form a releasable rotational lock with the guide catheter hub.

13. The medical device assembly according to any one of claims 9 to 12, wherein: The second proximal hub includes a grippable profile.

14. A medical device assembly for implanting a left atrial appendage closure (LAAC) device, comprising: A guide catheter, comprising: a guide catheter shaft; and a guide catheter hub secured to a proximal region of the guide catheter shaft; and An elongated dilator, comprising: an elongated dilator shaft comprising a distal region adapted to create and / or enlarge a hole in tissue; and a dilator hub secured to a proximal region of the elongated dilator shaft; Wherein, the guide catheter and the elongate dilator are adapted to form a releasable lock therebetween.

15. The medical device assembly of claim 14, further comprising a LAAC device delivery catheter adapted to be advanced through the guide catheter after the elongate dilator has been removed.

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