Sheath assembly and / or dilator assembly

Abstract

The apparatus is for an elongated sheath assembly configured to at least partially house an elongated dilator assembly. The apparatus includes a dilator receiver device configured to be mounted on the elongated sheath assembly. A dilator receiver mover is configured to be at least partially attached to the elongated sheath assembly. The dilator receiver mover is configured to be operably connected to the dilator receiver device. The dilator receiver mover is also configured to selectively move the dilator receiver device along a predetermined distance.

Description

Technical Field

[0001] This document relates to, but is not limited to, technical fields such as (A) a kit comprising an elongate sheath assembly, an elongate dilator assembly, a dilator receiver device, and a dilator receiver mover; (B) an apparatus for use with (configured to be used with) an elongate dilator assembly, wherein the apparatus comprises an elongate sheath assembly (configured to receive the elongate dilator assembly), a dilator receiver device, and a dilator receiver mover; (C) an apparatus for installation on an elongate sheath assembly (configured to receive an elongate dilator assembly), wherein the apparatus comprises a dilator receiver device and a dilator receiver mover; (D) a method of manipulating an elongate sheath assembly configured to receive an elongate dilator assembly; and (E) a kit comprising a first medical assembly, a second medical assembly, a receiver device, and a receiver mover.

Background Art

[0002] Known medical devices are configured to facilitate medical procedures and assist medical personnel in diagnosing and / or treating medical conditions.

Summary of the Invention

[0003] It will be appreciated that there exists a need to (at least partially) alleviate at least one problem associated with existing (known) sheath assemblies (also referred to as prior art). After much research and experimentation on existing (known) sheath assemblies, an (at least partial) understanding of the problems and their solutions has been (at least partially) identified and (at least partially) clearly expressed as follows.

[0004] Transseptal puncture of the fossa ovale (of the patient's heart) may first require a puncture device positioned by a guide device (e.g., a sheath / dilator combination). The sheath / dilator combination is pressed against the septum, tenting is performed, and visualization is performed by or via a medical imaging system. Controlling the pressure that may be applied to the septum is a concern. If insufficient force is applied, a visually observable tenting result may not be obtained, while if excessive force is applied, there is an increased risk that the sheath / dilator may pop out into the left atrium after puncture.

[0005] Figures 1A and 2B show side perspective views of embodiments of a known long sheath assembly and a long dilator assembly configured for use with, or in conjunction with, a known long sheath assembly (at least partially inserted).

[0006] Figures 2A and 2B are side perspective views (Figure 2A) and side view (Figure 2B) of an embodiment of the known long dilator assembly of Figure 1B, inserted into the long sheath assembly of Figure 1A.

[0007] Referring to an embodiment shown in Figure 1A, a known sheath assembly comprises a first end section defining an inlet portal. A second end section is spaced apart from the first end section. The second end section defines an outlet portal. A fixed shaft extends between the first and second end sections. The fixed shaft defines a shaft lumen that extends along the longitudinal length of the sheath assembly. The fixed shaft has a fixed length (a predetermined length). The inlet and outlet portals are in fluid communication with each other through the shaft lumen. A sheath handle assembly is located in the first end section. A sheath hub is located in the first end section. Preferably, the sheath hub is located inside the sheath handle assembly.

[0008] Referring to an embodiment shown in Figure 1B, the long dilator assembly comprises a dilator handle at one end section (of the long dilator assembly) and a dilator tip located at the opposite end section (of the long dilator assembly). The dilator hub is located on the dilator handle and is either facing or oriented toward the dilator tip. The long dilator shaft extends between the dilator hub and the dilator tip. The dilator assembly has a fixed length (a predetermined length).

[0009] Referring to an embodiment shown in Figure 2A, the sheath assembly engages with the long dilator assembly. The sheath assembly is configured to house (slidably house) the long dilator assembly within the shaft lumen of the fixed shaft (along the longitudinal length of the sheath assembly). When the sheath assembly is fully housed (fully engaged with) the long dilator assembly within the shaft lumen during use, the front section of the long dilator assembly extends outward from the front section (of the sheath assembly) to expose a fixed, exposed dilator shaft portion having a certain length (a predetermined shaft length which is the fixed portion of the dilator shaft).

[0010] Referring to embodiments such as that shown in Figure 2B, if the reach of the long dilator assembly is too long or too short, resulting in excessive or insufficient tenting of the septum (located in the right atrium of the patient's heart), the surgeon may need to adjust the curved portion (shape) (direction and / or position) of the long dilator assembly, either by manual operation and / or by using a known and not illustrated maneuvering mechanism. This presents a problem in this configuration, as it can waste or prolong valuable or time-sensitive surgical time. Generally, dilators and known sheaths can be of sufficient length for the procedure. The reach of the dilator can be controlled by its curvature within the right atrium. Adjusting the curvature (bend) of the dilator may be one solution, but this may require (A) pulling the dilator out of a known sheath and manually bending it (if the dilator is deformable), and / or (B) using a maneuverable, known sheath (known and not shown) so that the surgeon can control the curve of the dilator. Both of these methods lack precision and may depend on the surgeon's experience and skill in the procedure. It may be desirable to provide a workflow in which tenting (overtenting) is performed against the septum starting from a long reach, and then the dilator is pulled out to the appropriate extent (or amount) of the tent formed on part of the septum. It will be seen that this desired methodology may be more intuitive than changing the curve of the dilator.

[0011] Referring to an embodiment such as that shown in Figure 2A, it may be desirable to avoid the process of adjusting the curved portion of the long dilator assembly, thereby avoiding wasting valuable or time-sensitive surgical time.

[0012] Referring to an embodiment such as that shown in Figure 2A, a configuration is provided in which an additional length of the long dilator assembly is exposed during a procedure in which the length of the long dilator assembly can be adjusted by the surgeon while the sheath assembly is positioned, thereby it may be desirable to save (consequently) valuable or time-sensitive surgical time.

[0013] Referring to an embodiment such as that shown in Figure 2A, it may be desirable to provide a configuration in which, while the elongated dilator assembly remains engaged with the sheath assembly during the procedure, the elongated dilator assembly may be selectively extended (further moved) or retracted (retracted) from the sheath assembly (outside of the sheath assembly), thereby allowing the elongated dilator assembly to be selectively moved (and at least partially exposed) from the end of the sheath assembly (during the procedure). Selective movement means that the elongated dilator assembly is movable in response to the application of a moving force, and that the elongated dilator assembly does not move on its own in the absence of such a force.

[0014] A kit is provided (according to a primary embodiment) to mitigate, at least in part, at least one problem associated with existing technology. The kit includes, but is not limited to, a first medical assembly. A second medical assembly is configured to house at least partially the first medical assembly. A receiver device is configured to be attached at least partially to the second medical assembly. The receiver device is also configured to house the first medical assembly. A receiver mover is configured to be operably connected to the receiver device so that the receiver mover selectively moves the receiver device along a predetermined distance.

[0015] A kit is provided (according to a primary embodiment) to mitigate, at least in part, at least one problem associated with existing technology. The kit includes, but is not limited to, a synergistic combination of elements. The kit includes, for example, a long dilator assembly and a long sheath assembly configured to at least partially house the long dilator assembly. The kit also includes a dilator receiver device configured to at least partially mount (having a structure configured to mount) to the long sheath assembly. The kit also includes a dilator receiver mover configured to at least partially operably connect to the dilator receiver device. Preferably, the dilator receiver mover is configured to selectively move the dilator receiver device along a predetermined distance. According to a preferred embodiment, the dilator receiver mover is configured to at least partially mount to the long sheath assembly.

[0016] Apparatus is provided (according to a primary embodiment) to mitigate, at least in part, one problem associated with existing technology. The apparatus is intended for use with a long dilator assembly (configured for use with a long dilator assembly). The apparatus includes, but is not limited to, a long sheath assembly configured to at least partially house a long dilator assembly. The dilator receiver device is configured to be attached at least partially to the long sheath assembly. A dilator receiver mover is operably connected to the dilator receiver device. Preferably, the dilator receiver mover is configured to selectively move the dilator receiver device along a predetermined distance.

[0017] An apparatus is provided (according to a primary embodiment) to mitigate, at least in part, at least one problem associated with existing technology. The apparatus is usable with (for) a long sheath assembly. The long sheath assembly is configured to at least partially house a long dilator assembly. The apparatus includes, but is not limited to, a synergistic combination of a dilator receiver device and a dilator receiver mover. The dilator receiver device is configured to be at least partially mounted to the long sheath assembly. The dilator receiver mover is configured to be at least partially operably connected to the dilator receiver device. According to a preferred embodiment, the dilator receiver mover is configured to be at least partially mounted to the long sheath assembly. Preferably, the dilator receiver mover is configured to selectively move the dilator receiver device along a predetermined distance.

[0018] A method is provided (according to a primary embodiment) to mitigate, at least in part, at least one problem associated with existing technology. The method is for operating a long sheath assembly configured to accommodate at least partially a long dilator assembly. The method includes, but is not limited to, selectively accommodating and supporting a long dilator assembly, at least in part, via a dilator receiver device that is at least partially attached to the long sheath assembly. The method also includes selectively moving the dilator receiver device and the long dilator assembly along a predetermined distance, at least in part, via a dilator receiver mover operably connected to the dilator receiver device, after the long dilator assembly has been at least partially accommodated in the dilator receiver device. According to a preferred embodiment, the dilator receiver mover is configured to be at least partially attached to the long sheath assembly. Preferably, the dilator receiver mover is configured to selectively move the dilator receiver device along a predetermined distance.

[0019] Other embodiments are identified in the claims. Other aspects and features of the non-limiting embodiments may become apparent hereto those skilled in the art by considering the following detailed description of the non-limiting embodiments with reference to the accompanying drawings. This summary is provided to introduce the concepts in a simplified form, which will be further described below in the detailed description. This summary is not intended to identify any potentially important or possible essential features of the disclosed subject matter, nor is it intended to describe each disclosed embodiment or all realizations of the disclosed subject matter. Many other novel advantages, features, and relationships will become apparent as this description progresses. The figures and the following description illustrate the exemplary embodiments in more detail. [Brief explanation of the drawing]

[0020] Non-limiting embodiments can be better understood by referring to the following detailed description of non-limiting embodiments when interpreted in conjunction with the accompanying drawings. [Figure 1A] The images show a known long sheath assembly and a side perspective view of an embodiment of a long dilator assembly configured for use with, or in conjunction with, a known long sheath assembly (at least partially inserted). [Figure 1B] The images show a known long sheath assembly and a side perspective view of an embodiment of a long dilator assembly configured for use with, or in conjunction with, a known long sheath assembly (at least partially inserted). [Figure 2A] Figure 1B is a side perspective view of an embodiment of a known long dilator assembly, inserted into the long sheath assembly of Figure 1A. [Figure 2B] Figure 1B is a side view of an embodiment of a known long dilator assembly, inserted into the long sheath assembly of Figure 1A. [Figure 3A] This is a side perspective view of an embodiment of a dilator receiver device and dilator receiver mover attached to a long sheath assembly. [Figure 3B] This is a front end view of an embodiment of a dilator receiver device and a dilator receiver mover attached to a long sheath assembly. [Figure 4] Figure 3B is a cross-sectional view of the dilator receiver device and dilator receiver mover attached to the long sheath assembly. [Figure 5] Figure 3B is a cross-sectional view of the dilator receiver device and dilator receiver mover attached to the long sheath assembly. [Figure 6] Figure 3B is a cross-sectional view of the dilator receiver device and dilator receiver mover attached to the long sheath assembly. [Figure 7]FIG. 3B is a cross-sectional view of the dilator receiver device and the dilator receiver mover attached to the elongate sheath assembly of FIG. 3B.

[0021] The drawings are not necessarily to scale, and may be shown in phantom lines, schematic views, and partial views. In certain instances, details that are not necessary for an understanding of the embodiments (and / or details that make other details difficult to perceive) may be omitted. Corresponding reference characters indicate corresponding components throughout the several views of the drawings. Elements in the various figures are shown for simplicity and clarity and are not drawn to scale. The dimensions of some of the elements in the figures may be exaggerated relative to other elements to facilitate understanding of the various disclosed embodiments. In addition, well-known and commonly understood elements that are useful in commercially practicable embodiments are often not shown to provide an obstructed view of the embodiments of the present disclosure.

[0022] List of reference numbers used in the drawings Sheath Assembly 100 First End Section 102 Longitudinal Axis 103 Entry Portal 104 Second End Section 108 Exit Portal 110 Sheath Handle Assembly 114 Stationary Shaft 116 Shaft Lumen 118 Dilator Assembly 200 Insertion Direction 201 Dilator Hub 202 Dilator Shaft 204 Dilator Tip 206 Dilator Shaft Portion 207 Dilator Handle 208 Dilator Receiver Device 300 Dilator Receiver Mover 302 Input Gear 304 Rotational Direction 305 Output Gear 306 Movable Shaft 308 Sheath Hub 310 Hub Cavity 312 Designated distance 314 Designated distance 315 Round trip 316 Locking mechanism 318 Locking device 320 First locking portion 320A Second locking portion 320B Sheath assembly 400 First end section 402 Entrance Portal 404 Second end section 408 Exit Portal 409 Sheath Hub 410 Sheath handle assembly 414 Fixed shaft 416 Shaft lumen 418 First medical assembly 501 Second medical assembly 502 Receiver device 503 Receiver repositioning unit 504 [Modes for carrying out the invention]

[0023] Detailed description of non-limiting embodiments The following detailed descriptions are illustrative and not intended to limit the embodiments or uses and applications of the embodiments described. As used, the words “exemplary” or “exemplary” mean “serving as an example, case, or illustration.” Any implementation described as “exemplary” or “exemplary” should not necessarily be construed as being preferable or advantageous to other implementations. All implementations described below are illustrative implementations provided to enable a person skilled in the art to make or use embodiments of the disclosure and are not intended to limit the scope of the disclosure. The scope of the disclosure is defined by the claims. For the purposes of description, “top,” “bottom,” “left,” “rear,” “right,” “front,” “vertical,” “horizontal,” and their derivatives are related to the examples oriented in the drawings. No connection is intended by any expression or implied theory in the preceding technical field, background, abstract, or any other expression in the following detailed description. It should also be understood that the devices and processes shown in the accompanying drawings and described in the following specification are illustrative embodiments (examples), aspects and / or concepts as defined in the accompanying claims. Accordingly, dimensions and other physical characteristics relating to the disclosed embodiments should not be considered limiting unless otherwise expressly stated in the claims. The phrase “at least one” is understood to be equivalent to “one (a)”. Embodiments (examples, modifications, changes, alternatives, variations, embodiments, and / or any equivalents thereof) are described with respect to the drawings. It should be understood that this disclosure is limited to the subject matter provided by the claims and is not limited to the specific embodiments shown and described. The scope of the meaning of a device configured to be coupled to an article (i.e., connected to an article, interacting with an article, etc.) will be understood to be interpreted as the device being configured to be coupled to an article either directly or indirectly. Accordingly, “configured to be” may include the meaning of “either directly or indirectly” unless otherwise specifically stated.

[0024] Figures 3A and 3B show a side perspective view (Figure 3A) and a front view (Figure 3B) of an embodiment of a dilator receiver device 300 and a dilator receiver mover 302 attached to a long sheath assembly 100.

[0025] Figures 4, 5, 6, and 7 show cross-sectional views of the dilator receiver device 300 and the dilator receiver mover 302 attached to the long sheath assembly 100 of Figure 3B. The long dilator assembly 200 is configured for use with the long sheath assembly 100, or for use with the long sheath assembly 100 (at least partially inserted). The cross-sectional views of Figures 4, 5, 6, and 7 are taken along section line AA of Figure 3B.

[0026] A kit is shown with reference to embodiments such as those depicted in Figures 3A, 3B, and 4. The kit comprises a long dilator assembly 200 and a long sheath assembly 100 configured to at least partially house the long dilator assembly 200. A dilator receiver device 300 is configured to be at least partially mounted (installed) on the long sheath assembly 100. The dilator receiver device 300 preferably comprises a movable shaft 308 configured to be at least partially mounted on the long sheath assembly 100. The dilator receiver device 300 preferably has a receiver structure configured to be at least partially mounted on the long sheath assembly 100. A dilator receiver mover 302 is configured to be operably connected (directly or indirectly connected) to the dilator receiver device 300. This is done so that the dilator receiver mover 302 selectively moves the dilator receiver device 300 along a predetermined distance 314.

[0027] Referring to embodiments such as those shown in Figures 3A, 3B, and 4, the elongated dilator assembly 200 may comprise any type of sheath device, such as those used in transseptal puncture. The elongated dilator assembly 200 may be of different sizes, shapes, and / or materials. The elongated dilator assembly 200 may be configured to be maneuverable or fixed. The elongated sheath assembly 100 may be any type of dilator compatible with the elongated dilator assembly 200. The elongated sheath assembly 100 is preferably configured to engage with the elongated dilator assembly 200 at a proximity hub, thereby preventing unintended movement of the elongated sheath assembly 100.

[0028] Referring to embodiments such as those shown in Figures 3A, 3B, and 4, the dilator receiver mover 302 is preferably configured to selectively move the dilator receiver device 300 from a first predetermined distance 314 (as shown in Figure 6) to a second predetermined distance 315 (as shown in Figure 7). This is done so that the long dilator assembly 200 is also movable from the first predetermined distance 314 (as shown in Figure 6) to the second predetermined distance 315. Preferably, this is done so that the dilator receiver mover 302 and the long dilator assembly 200 are movable between the first predetermined distance 314 (as shown in Figure 6) and the second predetermined distance 315 (as shown in Figure 7), that is, so that a portion of the long dilator assembly 200 (e.g., the dilator hub 202) and a portion of the long sheath assembly 100 (e.g., the sheath hub 310) remain in contact with each other (a contact relationship or contact configuration).

[0029] Referring to embodiments as shown in Figures 3A, 3B, and 4, according to a preferred embodiment, the dilator receiver mover 302 is configured to be attached (installed) to (preferably) a long sheath assembly 100. This is done (preferably) so that the dilator receiver mover 302 selectively moves the dilator receiver device 300 along a predetermined distance 314 (as shown in Figure 6). Referring again to Figures 3A, 3B, and 4, the dilator receiver mover 302 may include a position control device, a translation assembly, a gear assembly, and / or any equivalent thereof. For example, the gear assembly (as shown in Figures 3A, 3B, or 4) may include (but is not limited to) a synergistic combination of an input gear 304 and an output gear 306, and / or any equivalent thereof. The input gear 304 is movable (rotatable, reciprocating) along a rotational direction 305. The output gear 306 is movable along a reciprocating path 316 (preferably a straight reciprocating path). The input gear 304 and the output gear 306 are configured to mesh with each other. The input gear 304 is operably mounted to the elongated sheath assembly 100 (preferably mounted to the sheath handle assembly 114 (or housing) of the elongated sheath assembly 100). The output gear 306 is fixedly mounted to the outer surface of the movable shaft 308 (or to the dilator receiver device 300 as a whole). Broadly speaking, the dilator receiver mover 302 has a mover structure (e.g., a gear assembly, etc.) configured to be mounted (installed) to (a section or part of) the elongated sheath assembly 100.

[0030] Referring to an embodiment shown in Figure 3A, the kit is illustrated. The kit comprises a first medical assembly 501. The first medical assembly 501 includes, but is not limited to, a long dilator assembly 200, a catheter, and / or any equivalent thereof. The first medical assembly 501 and / or the long dilator assembly 200 are configured to be inserted into a closed space defined by the living body (patient). The kit also comprises a second medical assembly 502 configured to at least partially house the first medical assembly 501. The second medical assembly 502 may include, but is not limited to, a long sheath assembly 100 and / or any equivalent thereof. The second medical assembly 502 is configured to (preferably) guide the insertion of the first medical assembly 501 into a closed space defined by the patient. The first medical assembly 501 and the second medical assembly 502 are (preferably) impermeable to the patient's bodily fluids. The first medical assembly 501 and the second medical assembly 502 each (according to a preferred embodiment) include biocompatible material properties suitable for sufficient performance characteristics (insulation strength, thermal performance, insulation and corrosion resistance, water and heat resistance) for safety performance that complies with industrial and regulatory safety standards (or is suitable for medical use). For considerations in the selection of suitable materials, refer to the following publication: Plastics in Medical Devices: Properties, Requirements, and Applications, 2nd edition, by Vinny R. Sastri, hardcover ISBN: 9781455732012, published November 21, 2013, publisher: Amsterdam [Pays-Bas]: Elsevier / William Andrew,

[2014] . The kit also includes a receiver device 503 configured to be at least partially attached to the second medical assembly 502. The receiver device 503 is configured to house the first medical assembly 501. The receiver device 503 may include, but is not limited to, the dilator receiver device 300 and any equivalent thereof.The kit also includes a receiver mover 504 configured to be operably connected to the receiver device 503. This is done so that the receiver mover 504 selectively moves the receiver device 503 along a predetermined distance 314. The receiver mover 504 includes, but is not limited to, a dilator receiver mover 302 and any equivalent thereof.

[0031] Referring to embodiments such as those shown in Figures 3A, 3B, and 4, a device is shown for use with (or configured to be installed with) a long dilator assembly 200. The device comprises a long sheath assembly 100 configured to at least partially house the long dilator assembly 200. A dilator receiver device 300 is configured to at least partially mount to the long sheath assembly 100. A dilator receiver mover 302 is operably connected to the dilator receiver device 300. Preferably, the dilator receiver mover 302 is configured to selectively move the dilator receiver device 300 along a predetermined distance 314.

[0032] Referring to embodiments such as those shown in Figures 3A, 3B, and 4, a device for (configured to be installed in) a long sheath assembly 100 configured to at least partially house a long dilator assembly 200 is shown. The device comprises a dilator receiver device 300 such as a movable shaft 308 and / or any equivalent thereof. The dilator receiver device 300 is mounted (at least partially, configured to be installed, installed, installed inside) the long sheath assembly 100. The dilator receiver device 300 comprises any preferred type of mounting structure configured to at least partially mount to the long sheath assembly 100. A dilator receiver mover 302 is configured to be operably connected (directly or indirectly connected) to the dilator receiver device 300. Preferably, the dilator receiver mover 302 is configured to selectively move the dilator receiver device 300 along a predetermined distance 314.

[0033] Referring to embodiments such as those shown in Figures 3A, 3B, and 4, the dilator receiver mover 302 has a mounting structure configured to be attached (installed) to the elongated sheath assembly 100.

[0034] Referring to embodiments such as those shown in Figures 3A, 3B, and 4, the dilator receiver device 300 is configured to selectively house and support the elongated dilator assembly 200, at least partially. This is preferably done after the elongated sheath assembly 100 has housed the elongated dilator assembly 200, at least partially, during use.

[0035] Referring to embodiments shown in Figures 3A, 3B, and 4, the dilator receiver mobile 302 is configured to be operably connected to (or has a structure configured to be connected to or linked to) the dilator receiver device 300, either directly or indirectly.

[0036] Referring to embodiments such as those shown in Figures 3A, 3B, and 4, after the long dilator assembly 200 is at least partially housed by the dilator receiver device 300 (as shown in Figures 6 and 7), the dilator receiver mover 302 is configured to selectively move (translate, linearly translate) the dilator receiver device 300 and the long dilator assembly 200, at least partially.

[0037] Referring to embodiments such as those shown in Figures 3A, 3B, and 4, the elongated sheath assembly 100 is configured to accommodate the elongated dilator assembly 200 at least partially (slidably) along at least part of the length of the elongated sheath assembly 100.

[0038] Referring to embodiments such as those shown in Figures 3A, 3B, and 4, the elongated sheath assembly 100 defines an exit portal 110. The elongated sheath assembly 100 includes a sheath hub 310 configured to be at least partially housed within a hub cavity 312. The sheath hub 310 is also configured to be at least partially movable along the hub cavity 312. The sheath hub 310 is also configured to at least partially abut against the dilator hub 202 of the elongated dilator assembly 200. This is preferably done after the dilator hub 202 has been positioned to at least partially abut against the sheath hub 310 (preferably after the sheath hub 310 has been at least partially housed within the hub cavity 312).

[0039] Referring to embodiments shown in Figures 3A, 3B, and 4, the elongated sheath assembly 100 comprises a first end section 102 (inlet end) defining an inlet portal 104 leading to a hub cavity 312. A second end section 108 (outlet end) defines an outlet portal 110. A long axis 103 extends axially between the first end section 102 and the second end section 108. The sheath hub 310 is configured to be at least partially housed within the hub cavity 312 and the inlet portal 104 of the first end section 102. The sheath hub 310 is also configured to be at least partially movable along the hub cavity 312 (along the long axis 103) after it has been at least partially housed within the hub cavity 312. The sheath hub 310 is also configured to at least partially abut the dilator hub 202 of the elongated dilator assembly 200, which is preferably done after the dilator hub 202 has been positioned to at least partially abut the sheath hub 310 (preferably after the sheath hub 310 has been at least partially housed within the hub cavity 312).

[0040] Referring to embodiments such as those shown in Figures 3A, 3B, and 4, the dilator receiver mover 302 is positioned in close proximity to the sheath hub 310 of the elongated sheath assembly 100. The dilator receiver mover 302 is configured to selectively move the sheath hub 310 and the dilator hub 202 at least partially between the first end section 102 and the second end section 108, which preferably occurs after the sheath hub 310 has at least partially contacted the dilator hub 202 during use.

[0041] Referring to embodiments such as those shown in Figures 3A and 3B, the sheath assembly 100 also comprises a sheath handle assembly 114 (or housing assembly) having a fixed shaft 116 defining the shaft lumen 118. The fixed shaft 116 is fixed and extends from the sheath handle assembly 114.

[0042] Referring to embodiments such as those shown in Figures 3A, 3B, and 4, the sheath hub 310 is configured to be movably supported by the sheath handle assembly 114. The dilator receiver device 300 is configured to selectively house and support, at least partially, the dilator shaft 204 (long dilator shaft) and the dilator hub 202 of the long dilator assembly 200. The hub cavity 312 is in fluid communication with the shaft lumen 118 of the fixed shaft 116. The shaft lumen 118 of the fixed shaft 116 is configured to house the dilator shaft 204 of the long dilator assembly 200. It will be understood that the dilator shaft 204 may include polymer-based materials and / or any suitable materials (including multiple materials). The dilator shaft 204 may include, for example, SAE (Society of Automotive Engineering) standard 304 stainless steel. SAE 304 stainless steel contains both chromium (approximately 15% to 20%) and nickel (approximately 2% to 10.5%) as its main non-ferrous components. Alternatively, the dilator shaft 204 may contain a shape memory material, which is configured to recover its original shape (before operation) even after being manipulated and / or deformed. Since shape memory material (SMM) is known, further details are omitted. Shape memory material is configured to recover its original shape from large and significant plastic deformation in response to the application of a specific stimulus to the shape memory material. This is known as the shape memory effect (SME). Superelasticity (in alloys) can be observed when shape memory material is deformed in the presence (application) of a stimulating force.

[0043] Referring to embodiments shown in Figures 3A, 3B, and 4, the dilator receiver device 300 includes a movable shaft 308. The movable shaft 308 is configured to be movable within the longitudinal length of the elongated sheath assembly 100.

[0044] Referring to embodiments such as those shown in Figures 3A, 3B, and 4 (and Figures 6 and 7), a method for operating a long sheath assembly 100 configured to at least partially accommodate a long dilator assembly 200 is provided. The method includes selectively accommodating and supporting the long dilator assembly 200 at least partially via a dilator receiver device 300 that is at least partially attached to the long sheath assembly 100. The method also includes selectively moving the dilator receiver device 300 and the long dilator assembly 200 along a predetermined distance 314 at least partially via a dilator receiver mover 302 operably connected to the dilator receiver device 300, after the long dilator assembly 200 has been at least partially accommodated by the dilator receiver device 300. The method may include having a dilator receiver mover 302 attached to the long sheath assembly 100 (according to a preferred embodiment).

[0045] Referring to embodiments shown in Figures 4 and 5, a locking device 320 (also referred to as a latch device, etc.) may be provided. The locking device 320 may include a push-button latch (which is known to those skilled in the art and will not be described or explained in further detail). The locking device 320 is configured to selectively lock the sheath hub 310 and the dilator hub 202 with respect to each other. The locking device 320 is also configured to selectively disengage the 310 and the dilator hub 202 from each other (for removal). The locking device 320 preferably comprises a first locking portion 320A and a second locking portion 320B. The first locking portion 320A is attached to the sheath hub 310 (i.e., attached to the surface of the sheath hub 310 that is exposed from the entrance portal 104 and faces outward (spaced apart)). The second locking portion 320B is attached to the dilator hub 202 (i.e., the outer surface of the dilator hub 202). When the dilator hub 202 is positioned adjacent to (near or in contact with) the sheath hub 310 (as shown in Figure 5), the first locking portion 320A and the second locking portion 320B are aligned with each other. The user can push the first locking portion 320A (of the dilator hub 202) into the second locking portion 320B (of the sheath hub 310). This action selectively latches the dilator hub 202 to the sheath hub 310 (as shown in Figures 6 and 7). Once the action is complete, the user can perform the locking operation (latching process) in reverse order (at the appropriate time). In other words, the user can, by pressing, temporarily direct or bias the first locking portion 320A (of the dilator hub 202) toward the second locking portion 320B (of the sheath hub 310), thereby selectively releasing (removing) the dilator hub 202 from the sheath hub 310, and subsequently, the long dilator assembly 200 can be removed (completely separated) from the sheath assembly 100.It will be understood that the locking device 320 is preferably mounted in a central position on the dilator hub 202 and the sheath hub 310, etc. (Although this mounting is shown off-center, this is to clearly show the function of the components of the locking device 320 and their potentially possible locations, and by placing the locking device 320 off-center to the side, the aim is to make the drawing relatively easy to understand).

[0046] Referring to an embodiment as shown in Figure 5, a long dilator assembly 200 can be inserted into the sheath assembly 100 such that the dilator hub 202 fits into (at least partially contacts) the sheath hub 310. The projection of the dilator tip 206 can be minimized (if desired, until the tip of the sheath assembly 100 is positioned when the long dilator assembly 200 is installed). The dilator assembly 200 is movable along the interior of the long sheath assembly 100 (e.g., the shaft lumen 118 and the movable shaft 308) and along an insertion direction 201 aligned within that range. The shaft lumen 118 is configured to slidably accommodate the movable shaft 308. The shaft lumen 118 is fixedly connected to the sheath handle assembly 114. The movable shaft 308 extends from the sheath hub 310. The sheath hub 310 is configured to be movable along the hub cavity 312 (defined by the sheath handle assembly 114).

[0047] Referring to the embodiment shown in Figure 5, the rotation of the input gear 304 causes the output gear 306 to move linearly, thereby causing the movable shaft 308 and the sheath hub 310 to move linearly. During use, the rotation of the input gear 304 causes the output gear 306 to move linearly, thereby causing the movable shaft 308, the sheath hub 310, and the dilator hub 202 to move linearly (after the dilator hub 202 is inserted into the sheath handle assembly 114 and the dilator hub 202 comes into contact with or abuts against the sheath hub 310).

[0048] Referring to an embodiment as shown in Figure 5, when the dilator receiver mover 302 (preferably the input gear 304) is actuated (preferably rotated), the sheath hub 310 moves forward or backward, effectively decreasing or increasing the overall length of the long dilator assembly 200 extending from the output section (e.g., the tip of the fixed shaft 116 of the long sheath assembly 100). Subsequently, the long dilator assembly 200 may extend or retract relative to the tip of the fixed shaft 116 of the long sheath assembly 100. The movable shaft 308 may slide (move) relative to the sheath hub 310 in response to the actuator receiver mover 302.

[0049] Referring to embodiments shown in Figures 5 and 6, both the sheath hub 310 and the dilator hub 202 are configured to be selectively engaged. The locking mechanism 318 (also referred to as a latch mechanism) is configured to selectively and securely engage (or lock, as shown in Figure 6) the dilator receiver mover 302 with respect to the sheath handle assembly 114 (or long sheath assembly 100). This is done so that the dilator receiver mover 302 cannot move or rotate relative to the long sheath assembly 100. The locking mechanism 318 is an optional mechanism. The locking mechanism 318 is configured to selectively disengage (as shown in Figure 5) the dilator receiver mover 302 from the sheath handle assembly 114 (or long sheath assembly 100) so that the dilator receiver mover 302 can move or rotate relative to the long sheath assembly 100. The locking mechanism 318 may include any suitable type of locking mechanism (no further details of any particular nature will be described here, as it is assumed that the design and installation of the locking mechanism 318 will be known to those skilled in the art). The locking device 320 and the locking mechanism 318 may be deployed in parallel (together) or separately (if so desired). In addition, the dilator receiver mover 302 and the dilator receiver device 300 provide a configuration that improves accuracy when the surgeon adjusts the protruding length of the elongated dilator assembly 200 (extending from the end of the elongated sheath assembly 100) (preferably after securely locking the sheath hub 310 and the dilator hub 202 together). According to another embodiment, the locking device 320 is configured to selectively lock and unlock the sheath hub 310 to the dilator hub 202. The locking device 320 may include, for example, a snap-fit ​​connector or a press-fit connector, any type of locking device, and / or any equivalent thereof.

[0050] Referring to an embodiment as shown in Figure 6, the sheath hub 310 (e.g., a port at the proximal end of the elongated sheath assembly 100) is configured to reliably engage with the proximal end of the elongated dilator assembly 200. The position of the sheath hub 310 can be adjusted by utilizing the dilator receiver mover 302 so that the elongated sheath assembly 100 can move (slide) further inward into the elongated sheath assembly 100 (preferably when engaged with the dilator hub 202), or it can be pulled out from the elongated sheath assembly 100 (from inside the elongated sheath assembly 100). A locking device 320 (a known type, which will not be described in detail) may be positioned between the dilator hub 202 and the sheath hub 310 (if necessary), and it will be understood that the locking device 320 may include any type of locking device (e.g., snap-fit, press-fit, other shapes, materials, etc.) and / or any equivalent thereof. Preferably, the range of motion of the dilator receiver device 300 or movable shaft 308 is approximately in centimeters. The dilator receiver mover 302 is configured to provide precise sub-millimeter resolution of the linear movement of the dilator receiver device 300. The dilator receiver mover 302 can be positioned anywhere on the elongated sheath assembly 100 within the reach of the surgeon.

[0051] Referring to an embodiment shown in Figure 6, the dilator hub 202 of the elongated dilator assembly 200 contacts (fits into) the sheath hub 310 of the elongated sheath assembly 100. By operating the dilator receiver mover 302, the sheath hub 310 can be moved forward (distally), thereby increasing the amount of the elongated dilator assembly 200 protruding from the tip section of the end of the elongated sheath assembly 100.

[0052] Referring to an embodiment shown in Figure 7, the dilator hub 202 of the long dilator assembly 200 remains in contact with (engaged with) the sheath hub 310 of the long sheath assembly 100.

[0053] (If desired during the procedure or when desired) the sheath hub 310 is advanced to the furthest position or furthest point so that the amount of protrusion of the long dilator assembly 200 from the tip of the long sheath assembly 100 can be maximized.

[0054] Referring to embodiments such as those shown in Figures 6 and 7, the dilator receiver mover 302 is preferably configured to selectively move the dilator receiver device 300 from a first predetermined distance 314 (as shown in Figure 6) to a second predetermined distance 315 (as shown in Figure 7). This is done so that the long dilator assembly 200 is also movable from the first predetermined distance 314 (as shown in Figure 6) to the second predetermined distance 315. Preferably, this is done so that the dilator receiver mover 302 and the long dilator assembly 200 are movable between the first predetermined distance 314 (as shown in Figure 6) and the second predetermined distance 315 (as shown in Figure 7), that is, so that a portion of the long dilator assembly 200 (e.g., the dilator hub 202) and a portion of the long sheath assembly 100 (e.g., the sheath hub 310) remain in contact with each other (a contact relationship). Advantageously, the long sheath assembly 100 may be configured to avoid (optionally during the procedure) the replacement of the long dilator assembly 200, thereby helping the surgeon avoid wasting valuable or time-sensitive surgical time. Advantageously, the long sheath assembly 100 may provide a workflow in which tenting (over-tenting) is performed against the septum 902 (shown in Figure 2B), and then the dilator assembly 200 is pulled out to the appropriate extent (or amount) of the tent formed on a portion of the septum 902. It will be seen that this methodology may be more intuitive than changing the curved portion of the dilator assembly 200. Advantageously, the additional length of the long dilator assembly 200, which can be moved or exposed (i.e., extending from the end of the long sheath assembly 100) during the procedure, allows the amount or length (reasonable length) of the exposed portion of the dilator tip 206 (extending from the end of the long sheath assembly 100) to vary. This can be done, if desired, without the need to replace the long dilator assembly 200 during the procedure (thus avoiding wasting valuable or time-sensitive surgical time).If the need to replace the long dilator assembly 200 is eliminated due to length issues, the long dilator assembly 200 can be extended to adjust the curved portion of the long dilator assembly 200. During the procedure, the dilator assembly 200 can be selectively extended or moved away from the sheath assembly 100 (output portion), while the long dilator assembly 200 remains engaged (securely engaged or in contact) with the sheath assembly 100, so that the long dilator assembly 200 can be selectively exposed from the sheath assembly 100. Between a first predetermined distance 314 and a second predetermined distance 315 (as shown in Figure 6), there exists a position range (hub position range) in which the dilator receiver device 300 (movable shaft 308) may move (it may reciprocate along the reciprocating path 316 as shown in Figures 3A and 3B). The dilator receiver device 300 and the dilator receiver transfer device 302 also advantageously provide the physician with greater confidence and / or control during transseptal puncture (procedure) so that the force applied to the septum has an appropriate level of impact on the patient's tissue.

[0055] The following are proposed as further descriptions of embodiments in which any one or more arbitrary technical features (described in the Detailed Description, Abstract, and Claims) can be combined with any one or more other arbitrary technical features (described in the Detailed Description, Abstract, and Claims). Each claim in the paragraph of Claims is understood to be a non-limiting claim unless otherwise specified. Unless otherwise specified, the terms used in these specifications should be interpreted as including certain tolerances that a person skilled in the art would recognize as providing equivalent functionality. For example, the term "perpendicular" is not necessarily limited to 90.0 degrees, but may include variations thereof that a person skilled in the art would recognize as providing equivalent functionality for the purposes described for the relevant member or element. Terms such as "about" and "substantially" in the context of configuration generally refer to an arrangement, configuration, or arrangement of the relevant element that is exactly or sufficiently close to the arrangement, configuration, or arrangement of the element in question, in order to maintain the operability of the element in the Disclosure that does not substantially alter the Disclosure. Similarly, unless otherwise made clear from its context, numerical values ​​should be interpreted as including certain tolerances that a person skilled in the art would recognize as negligible in importance because they do not substantially alter the operability of the Disclosure. It will be understood that the description and / or drawings identify and describe embodiments of the apparatus (either explicitly or essentially). The apparatus may include any preferred combination and / or rearrangement of the technical features identified in the detailed description, as required and / or desired to suit a particular technical purpose and / or technical function. It will be understood that, where possible and preferred, any one or more technical features of the apparatus may be combined with any one or more other technical features of the apparatus (in any combination and / or rearrangement). It will be understood that a person skilled in the art will know that, even if not explicitly stated above, the technical features of each embodiment may be expanded upon in other embodiments. A person skilled in the art will understand that other options are possible for the configuration of the components of the apparatus, adapting to manufacturing requirements and remaining within the scope described in at least one of the claims.This specification provides embodiments including the best mode and enables those skilled in the art to fabricate and use the embodiments. The patentable scope may be defined by the claims. Written descriptions and / or drawings may be helpful in understanding the scope of the claims. It is assumed that all essential aspects of the disclosed subject matter are provided herein. In this specification, the word “includes” is understood to be equivalent to the word “comprising,” in that both words are used to indicate presuppositions, components, parts, or other non-limiting lists. The term “comprising,” which is synonymous with the terms “including,” “containing,” or “characterized by,” is comprehensive or non-limiting and does not exclude additional, unlisted elements or method steps. “Comprising” (comprised of) is a “non-limiting” phrase and allows for the scope of application of art that employs additional, unlisted elements. When used in a claim, the word “comprising” is a temporary verb (transitional term) that separates the preamble of the claim from the technical features of the present disclosure. The foregoing outlines non-limiting embodiments. The description is made with respect to specific non-limiting embodiments. It is understood that non-limiting embodiments are merely illustrative examples.

Claims

1. It's a kit, The first medical assembly and A second medical assembly configured to at least partially house the first medical assembly, the second medical assembly defining an exit portal and including a sheath hub, the sheath hub being configured to at least partially house within a hub cavity defined by the second medical assembly and to be at least partially movable along the hub cavity, the sheath hub being configured to at least partially abut the dilator hub of the first medical assembly after it has been positioned to at least partially abut the sheath hub, A receiver device configured to be at least partially attached to the sheath hub of the second medical assembly and to house the first medical assembly, comprising a receiver device including a movable shaft, A receiver mover comprising an input gear and an output gear configured to mesh with the input gear, wherein the input gear is movable along a rotational direction, the output gear is movable along a reciprocating path, the output gear is mounted on the outer surface of the movable shaft of the receiver device, and the receiver mover is configured to move the receiver device along the reciprocating path between a state in which a first predetermined distance is formed between the tip of the dilator of the first medical assembly and the tip of the sheath of the second medical assembly, and a state in which a second predetermined distance different from the first predetermined distance is formed between the tip of the dilator and the tip of the sheath.

2. It's a kit, Long dilator assembly and A long sheath assembly configured to at least partially house the long dilator assembly, wherein the long dilator assembly defines an exit portal and includes a sheath hub, the sheath hub is configured to at least partially house within a hub cavity defined by the long sheath assembly and to be at least partially movable along the hub cavity, and the sheath hub is configured to at least partially abut the dilator hub of the long dilator assembly after it has been positioned to at least partially abut the sheath hub, A dilator receiver device configured to be at least partially attached to the sheath hub of the long sheath assembly, comprising a dilator receiver device including a movable shaft, A dilator receiver mover comprising an output gear mounted on the outer surface of the movable shaft of the dilator receiver device and an input gear configured to mesh with the output gear, wherein the input gear is movable along a rotational direction and the output gear is movable along a reciprocating path, and the dilator receiver mover is configured to move the dilator receiver device along the reciprocating path between a state in which a first predetermined distance is formed between the tip of the dilator of the long dilator assembly and the tip of the sheath of the long sheath assembly and a state in which a second predetermined distance different from the first predetermined distance is formed between the tip of the dilator and the tip of the sheath.

3. The kit according to claim 2, wherein, after the elongated sheath assembly has at least partially housed the elongated dilator assembly during use, the dilator receiver device is configured to at least partially house and support the elongated dilator assembly.

4. The kit according to claim 2, wherein, after the elongated dilator assembly has been at least partially housed by the dilator receiver device, the dilator receiver mover is configured to move the dilator receiver device and the elongated dilator assembly at least partially.

5. The aforementioned long sheath assembly is A first end section defining an entrance portal leading to the hub cavity, Includes a second end section defining the aforementioned exit portal, The sheath hub is configured to be at least partially housed within the hub cavity and the entrance portal of the first end section, After the sheath hub is at least partially housed in the hub cavity, the sheath hub is also configured to be at least partially movable along the hub cavity. The kit according to claim 2, wherein the sheath hub is configured to at least partially abut the dilator hub of the elongated dilator assembly after the dilator hub of the elongated dilator assembly is positioned to at least partially abut the sheath hub.

6. The kit according to claim 5, wherein, after the sheath hub has at least partially contacted the dilator hub during use, the dilator receiver mover is configured to selectively move the sheath hub and the dilator hub at least partially between the first end section and the second end section.

7. The aforementioned long sheath assembly also, A sheath handle assembly having a fixed shaft that defines the shaft lumen, The kit according to claim 6, further comprising the fixing shaft fixed to and extending from the sheath handle assembly.

8. The kit according to claim 7, wherein the sheath hub is configured to be movably supported by the sheath handle assembly.

9. The kit according to claim 7, wherein the dilator receiver device is configured to house and support, at least partially, the dilator shaft and the dilator hub of the elongated dilator assembly.

10. The kit according to claim 7, wherein the hub cavity is in fluid communication with the shaft lumen of the fixed shaft.

11. The kit according to claim 7, wherein the shaft lumen of the fixed shaft is configured to accommodate the dilator shaft of the long dilator assembly.

12. The kit according to claim 2, wherein the long dilator assembly is also movable between the state in which the first predetermined distance is formed and the state in which the second predetermined distance is formed, the dilator receiver mover is configured to move the dilator receiver device between the state in which the first predetermined distance is formed and the state in which the second predetermined distance is formed.

13. The kit according to claim 2, wherein the input gear is operably mounted to the sheath handle assembly of the elongated sheath assembly.

14. A locking mechanism configured to selectively lock the dilator receiver mover to the elongated sheath assembly, The kit according to claim 2, further comprising a locking mechanism configured to selectively disengage the dilator receiver mover from the elongated sheath assembly.

15. A locking device is installed on the sheath hub and the dilator hub, The kit according to claim 2, wherein the locking device is configured to selectively lock and unlock the sheath hub to the dilator hub.

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