Support assembly for flexible medical assemblies
The elongated support assembly addresses the issue of tissue nuclei release by providing a sliding support mechanism for flexible medical assemblies, ensuring safe and reliable access to the left atrium during transseptal puncture.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- BOSTON SCI MEDICAL DEVICE LTD
- Filing Date
- 2021-06-01
- Publication Date
- 2026-05-22
AI Technical Summary
Existing radiofrequency needles used for transseptal puncture lack a hollow lumen, leading to the release of free-floating tissue nuclei into the bloodstream, posing risks such as stroke or pulmonary embolism, and fail to provide immediate access to the left atrium after puncture.
An elongated support assembly is introduced, which can be positioned in a sliding relationship with a flexible medical assembly, providing support and enabling secure access to the left atrium by maintaining a hollow lumen and preventing the release of tissue nuclei.
The elongated support assembly ensures safe and reliable access to the left atrium by supporting the flexible medical assembly, preventing the release of tissue nuclei into the bloodstream and enhancing procedural control.
Smart Images

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Abstract
Description
Technical Field
[0001] This document relates to (but is not limited to) the technical field of (A) an elongated support assembly for an elongated flexible medical assembly and an elongated auxiliary medical assembly, and methods therefor, and / or (B) an elongated auxiliary medical assembly for an elongated flexible medical assembly, and methods therefor, and / or (C) a synergistic combination of an elongated support assembly, an elongated flexible medical assembly, and an elongated auxiliary medical assembly, and methods therefor.
Background Art
[0002] Known medical devices are configured to facilitate medical procedures and assist medical personnel in diagnosing and / or treating the medical conditions of sick patients.
Summary of the Invention
[0003] It will be appreciated that there is a need to (at least partially) mitigate at least one problem associated with existing (known) flexible medical assemblies (also referred to as the prior art). After much research and experimentation regarding existing (known) flexible medical 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] Puncture of the atrial septum (a biological characteristic of the patient) may occur during a transseptal catheterization procedure in which access to the left atrium (of the heart) is achieved from the right atrium. Known rigid needle assemblies (such as mechanical needles) may be used to puncture a desired portion of cardiac tissue. Known needle assemblies with radiofrequency emitters may be used when it is advantageous to avoid the application of mechanical force to form a puncture through the tissue. Radiofrequency-capable needles may offer a safer and more reliable alternative to mechanical needles, as the lack of required input force reduces the risk of inadvertently damaging tissue (such as the heart) by providing the user with greater procedural control. Radiofrequency energy may be used to vaporize tissue from an active electrode positioned at the distal tip of the needle (once the electrode is positioned proximal to or in contact with the tissue). However, once a transseptal puncture via a radiofrequency needle is achieved, the user may not be able to instantaneously secure access to the left atrium (of the heart). Securing access may involve implanting guidewires into the left atrium and pulmonary veins through the transseptal puncture site.
[0005] Known mechanical transseptal puncture needles have a hollow lumen from which a guidewire can be loaded and deployed immediately after crossing the atrial septum (of the heart). However, known radiofrequency needles do not have a hollow lumen because the closure of the electrically active and conductive material around the lumen can have the erroneous function of a puncturer, which can vaporize tissue circumferentially around the distal profile of the lumen, thereby releasing unwanted free-floating tissue nuclei into the bloodstream. These free-floating tissue nuclei are considered highly undesirable if they are allowed to float freely in the patient's bloodstream, given that the nuclei may pose a significant risk of stroke or pulmonary embolism.
[0006] It is desirable to provide a device or system that combines the reliability and safety of known radiofrequency aspiration, enabling access to the patient's left atrium after transseptal puncture has been achieved.
[0007] An apparatus is provided (according to a primary embodiment) to mitigate, at least in part, one problem associated with existing technologies. The apparatus is intended for use with elongated flexible medical assemblies and elongated auxiliary medical assemblies. The apparatus includes, but is not limited to, an elongated support assembly that can be positioned at least partially in a sliding relationship with the elongated flexible medical assembly. The elongated support assembly is configured to support the elongated flexible medical assembly, which is preferably done after the elongated support assembly has been positioned at least partially in a sliding relationship with the elongated flexible medical assembly. The elongated support assembly is at least partially selectively operable toward the distal portion of the elongated auxiliary medical assembly via the elongated auxiliary medical assembly.
[0008] An apparatus is provided (according to a primary embodiment) to mitigate, at least in part, one problem associated with existing technologies. The apparatus is intended for use with elongated flexible medical assemblies and elongated auxiliary medical assemblies. The apparatus includes, but is not limited to, an elongated support assembly that can be positioned at least partially proximal to the elongated flexible medical assembly. The elongated support assembly is operable, together with the elongated flexible medical assembly positioned proximal to the elongated support assembly, at least partially along the elongated auxiliary medical assembly toward the distal portion of the elongated auxiliary medical assembly. The elongated support assembly is at least partially selectively extendable, and the elongated flexible medical assembly is positioned proximal to the elongated support assembly in a direction away from the distal portion of the elongated auxiliary medical assembly. The elongated support assembly is configured to at least partially support the elongated flexible medical assembly while the elongated flexible medical assembly and the elongated support assembly are extended (coincidentally) in a direction at least partially away from the distal portion of the elongated auxiliary medical assembly.
[0009] A method is provided (according to a major embodiment) to mitigate, at least in part, at least one problem associated with existing technologies. The method is for using an elongated flexible medical assembly, an elongated auxiliary medical assembly, and an elongated support assembly. The method includes, but is not limited to, positioning the elongated support assembly in at least part of a sliding relationship with the elongated flexible medical assembly. The method also includes at least part of supporting the elongated flexible medical assembly via the elongated support assembly which is at least part of a sliding relationship with the elongated flexible medical assembly. The method also includes at least part selectively manipulating the elongated support assembly via the elongated auxiliary medical assembly toward the distal portion of the elongated auxiliary medical assembly.
[0010] A method is provided (according to a primary embodiment) to mitigate, at least in part, at least one problem associated with existing technologies. The method is for use with elongated flexible medical assemblies, elongated auxiliary medical assemblies, and elongated support assemblies. The method includes, but is not limited to, positioning the elongated support assembly at least partially proximal to the elongated flexible medical assembly. The method also includes operating the elongated support assembly toward the distal portion of the elongated auxiliary medical assembly, at least partially along the elongated auxiliary medical assembly, together with the elongated flexible medical assembly positioned proximal to the elongated support assembly. The method also includes selectively stretching the elongated support assembly at least partially, so that the elongated flexible medical assembly is positioned proximal to the elongated support assembly in a direction away from the distal portion of the elongated auxiliary medical assembly. This method also includes supporting the elongated flexible medical assembly at least partially with the elongated support assembly while the elongated flexible medical assembly and the elongated support assembly are extended (coincidentally) in a direction at least partially away from the distal portion of the elongated auxiliary medical assembly.
[0011] 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]
[0012] 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 1] A side view of an embodiment of an elongated support assembly (for use with elongated flexible medical assemblies and elongated auxiliary medical assemblies) is shown. [Figure 2] A side view of an embodiment of an elongated support assembly (for use with elongated flexible medical assemblies and elongated auxiliary medical assemblies) is shown. [Figure 3] Figure 1 shows a schematic cross-sectional side view of an embodiment of the elongated support assembly. [Figure 4] Figure 1 shows a schematic cross-sectional side view of an embodiment of the elongated support assembly. [Figure 5] Figure 1 shows a schematic cross-sectional side view of an embodiment of the elongated support assembly. [Figure 6] Figure 1 shows a schematic cross-sectional side view of an embodiment of the elongated support assembly. [Figure 7] Figure 1 shows a schematic cross-sectional side view of an embodiment of the elongated support assembly. [Figure 8] Figure 1 shows a schematic cross-sectional side view of an embodiment of the elongated support assembly. [Figure 9] Figure 1 shows a schematic cross-sectional side view of an embodiment of the elongated support assembly. [Figure 10] Figure 1 shows axial cross-sectional side views (Figures 10-13A, 14A, 14B, and 15A-19B), radial cross-sectional side views (Figures 13B and 13C), and a top view (Figure 14C) of an embodiment of the elongated support assembly 102 shown in Figure 1. [Figure 11A] Figure 1 shows axial cross-sectional side views (Figures 10-13A, 14A, 14B, and 15A-19B), radial cross-sectional side views (Figures 13B and 13C), and a top view (Figure 14C) of an embodiment of the elongated support assembly 102 shown in Figure 1. [Figure 11B] Figure 1 shows axial cross-sectional side views (Figures 10-13A, 14A, 14B, and 15A-19B), radial cross-sectional side views (Figures 13B and 13C), and a top view (Figure 14C) of an embodiment of the elongated support assembly 102 shown in Figure 1. [Figure 12A] Figure 1 shows axial cross-sectional side views (Figures 10-13A, 14A, 14B, and 15A-19B), radial cross-sectional side views (Figures 13B and 13C), and a top view (Figure 14C) of an embodiment of the elongated support assembly 102 shown in Figure 1. [Figure 12B] Figure 1 shows axial cross-sectional side views (Figures 10-13A, 14A, 14B, and 15A-19B), radial cross-sectional side views (Figures 13B and 13C), and a top view (Figure 14C) of an embodiment of the elongated support assembly 102 shown in Figure 1. [Figure 13A] Figure 1 shows axial cross-sectional side views (Figures 10-13A, 14A, 14B, and 15A-19B), radial cross-sectional side views (Figures 13B and 13C), and a top view (Figure 14C) of an embodiment of the elongated support assembly 102 shown in Figure 1. [Figure 13B] Figure 1 shows axial cross-sectional side views (Figures 10-13A, 14A, 14B, and 15A-19B), radial cross-sectional side views (Figures 13B and 13C), and a top view (Figure 14C) of an embodiment of the elongated support assembly 102 shown in Figure 1. [Figure 13C]Axial cross-sectional side view (Figs. 10 to 13A, Figs. 14A, Figs. 14B, and Figs. 15A to 19B), radial cross-sectional side view (Figs. 13B and 13C), and top view (Fig. 14C) of an embodiment of the elongated support assembly 102 of FIG. 1 are shown. [Figure 14A] Axial cross-sectional side view (Figs. 10 to 13A, Figs. 14A, Figs. 14B, and Figs. 15A to 19B), radial cross-sectional side view (Figs. 13B and 13C), and top view (Fig. 14C) of an embodiment of the elongated support assembly 102 of FIG. 1 are shown. [Figure 14B] Axial cross-sectional side view (Figs. 10 to 13A, Figs. 14A, Figs. 14B, and Figs. 15A to 19B), radial cross-sectional side view (Figs. 13B and 13C), and top view (Fig. 14C) of an embodiment of the elongated support assembly 102 of FIG. 1 are shown. [Figure 14C] Axial cross-sectional side view (Figs. 10 to 13A, Figs. 14A, Figs. 14B, and Figs. 15A to 19B), radial cross-sectional side view (Figs. 13B and 13C), and top view (Fig. 14C) of an embodiment of the elongated support assembly 102 of FIG. 1 are shown. [Figure 15A] Axial cross-sectional side view (Figs. 10 to 13A, Figs. 14A, Figs. 14B, and Figs. 15A to 19B), radial cross-sectional side view (Figs. 13B and 13C), and top view (Fig. 14C) of an embodiment of the elongated support assembly 102 of FIG. 1 are shown. [Figure 15B] Axial cross-sectional side view (Figs. 10 to 13A, Figs. 14A, Figs. 14B, and Figs. 15A to 19B), radial cross-sectional side view (Figs. 13B and 13C), and top view (Fig. 14C) of an embodiment of the elongated support assembly 102 of FIG. 1 are shown. [Figure 16A] Axial cross-sectional side view (Figs. 10 to 13A, Figs. 14A, Figs. 14B, and Figs. 15A to 19B), radial cross-sectional side view (Figs. 13B and 13C), and top view (Fig. 14C) of an embodiment of the elongated support assembly 102 of FIG. 1 are shown. [Figure 16B] Axial cross-sectional side view (Figs. 10 to 13A, Figs. 14A, Figs. 14B, and Figs. 15A to 19B), radial cross-sectional side view (Figs. 13B and 13C), and top view (Fig. 14C) of an embodiment of the elongated support assembly 102 of FIG. 1 are shown. [Figure 17A] Axial cross-sectional side view (Figs. 10 to 13A, Figs. 14A, Figs. 14B, and Figs. 15A to 19B), radial cross-sectional side view (Figs. 13B and 13C), and top view (Fig. 14C) of an embodiment of the elongated support assembly 102 of FIG. 1 are shown. [Figure 17B] Axial cross-sectional side view (Figs. 10 to 13A, Figs. 14A, Figs. 14B, and Figs. 15A to 19B), radial cross-sectional side view (Figs. 13B and 13C), and top view (Fig. 14C) of an embodiment of the elongated support assembly 102 of FIG. 1 are shown. [Figure 18A] Axial cross-sectional side view (Figs. 10 to 13A, Figs. 14A, Figs. 14B, and Figs. 15A to 19B), radial cross-sectional side view (Figs. 13B and 13C), and top view (Fig. 14C) of an embodiment of the elongated support assembly 102 of FIG. 1 are shown. [Figure 18B] Axial cross-sectional side view (Figs. 10 to 13A, Figs. 14A, Figs. 14B, and Figs. 15A to 19B), radial cross-sectional side view (Figs. 13B and 13C), and top view (Fig. 14C) of an embodiment of the elongated support assembly 102 of FIG. 1 are shown. [Figure 19A] Axial cross-sectional side view (Figs. 10 to 13A, Figs. 14A, Figs. 14B, and Figs. 15A to 19B), radial cross-sectional side view (Figs. 13B and 13C), and top view (Fig. 14C) of an embodiment of the elongated support assembly 102 of FIG. 1 are shown. [Figure 19B] Axial cross-sectional side view (Figs. 10 to 13A, Figs. 14A, Figs. 14B, and Figs. 15A to 19B), radial cross-sectional side view (Figs. 13B and 13C), and top view (Fig. 14C) of an embodiment of the elongated support assembly 102 of FIG. 1 are shown.
[0013] The drawings are not necessarily to scale and may be represented by dashed lines, schematics, and partial drawings. In certain cases, details that are unnecessary for understanding the embodiment (and / or details that make other details difficult to perceive) may be omitted. Corresponding reference numerals indicate corresponding components through several drawings. Elements in various drawings are shown for simplicity and clarity and are not drawn to scale. Some dimensions of elements in the drawings may be emphasized relative to other elements to facilitate understanding of the various embodiments disclosed. In addition, common and well-understood elements that are useful in commercially viable embodiments are often omitted to provide an obstructed view of the embodiments of this disclosure.
[0014] List of reference numbers used in drawings Elongated support assembly 102 Support lumen 104 700 Biological Characteristics Pulmonary vein 702 Medical Assistance Assembly 800 Distal portion 802 Auxiliary lumen 804 Flexible medical assembly 900 Distal puncture device 902 Rotatable device 1000 Arrow 1002 Thread 1004 Arrow 1006 Handle 1100 Portal 1102 Arrow 1104 Proximal hub 1200 Arrow 1202 Rotatable element 1300 Arrow 1301 flexible element 1302 Slidable element 1400 Arrow 1402 Proximal tapered section 1500 Arrow 1502 Flexible area 1600 Arrow 1602 Arrow 1604 Block device 1700 Arrow 1702 Biasing device 1800 Stopper 1802 Press device 1804 Arrow 1806 Arrow 1808 Operable plunger 1900 Arrow 1902 [Modes for carrying out the invention]
[0015] 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 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.
[0016] Figures 1 and 2 show side views of an embodiment of the elongated support assembly 102 (for use with the elongated flexible medical assembly 900 and the elongated auxiliary medical assembly 800).
[0017] Figures 3 to 9 show schematic cross-sectional side views of an embodiment of the elongated support assembly 102 shown in Figure 1.
[0018] Referring to the embodiments shown in Figures 1 and 2, the elongated support assembly 102 preferably includes a hollow tube, a hypo tube, a guide wire defining the lumen, a hollow member, and any equivalent thereof. The elongated support assembly 102 includes an elongated hollow tube having a curved outer surface. The elongated support assembly 102 preferably defines a support lumen 104 (also called an elongated support lumen) that extends at least partially along the longitudinal length of the elongated support assembly 102. The support lumen 104 is configured to at least partially receive (slidably receive) an elongated flexible medical assembly 900. The elongated support assembly 102 preferably includes a material containing a stainless steel alloy and / or a nitinol alloy.
[0019] The elongated support assembly 102 may have two regions of different stiffness. The region of the elongated support assembly 102 that is received in the auxiliary lumen 804 adjacent to the curved portion at the distal end of the auxiliary medical assembly 800 may be more rigid than the curved portion of the auxiliary medical assembly 800 and the region of the elongated support assembly 102 beyond it. This is to prevent distortion or disturbance of the curvature present at the distal end of the auxiliary medical assembly 800. The elongated support assembly 102 includes a first region having a first stiffness. The first region of the elongated support assembly 102 is configured to be positioned in the auxiliary lumen 804 located proximal to the curved portion at the distal end of the auxiliary medical assembly 800. The elongated support assembly 102 includes a second region having a second stiffness. The second region of the elongated support assembly 102 is configured to be positioned in and beyond the curved portion of the auxiliary medical assembly 800. The first region of the elongated support assembly 102 is relatively more rigid than the second region of the elongated support assembly 102 so as to prevent distortion of any curvature at the distal end of the auxiliary medical assembly 800 after (A) the first region of the elongated support assembly 102 is positioned within the auxiliary lumen 804 located proximal to the curved portion at the distal end of the auxiliary medical assembly 800, and (B) the second region of the elongated support assembly 102 is positioned in and beyond the curved portion of the auxiliary medical assembly 800.
[0020] Referring to the embodiments shown in Figures 1 and 2, the elongated support assembly 102 may include laser-cut features extending along the longitudinal length of the elongated body of the elongated support assembly 102. The laser-cut features are formed by removing material from the sidewalls of the hypo tube and may result in lower rigidity or higher flexibility of the elongated support assembly 102.
[0021] Laser-cut features can help increase or decrease the degree of flexibility of the elongated support assembly 102.
[0022] Referring to the embodiments shown in Figures 1 and 2, the elongated support assembly 102 may include a helically wound metal strand surrounding the support lumen 104. The helically wound metal strand may provide greater flexibility compared to a single continuous piece of material.
[0023] Referring to the embodiments shown in Figures 1 and 2, the elongated support assembly 102 may have a maximum outer diameter of approximately 0.032 inches to approximately 0.035 inches. The elongated support assembly 102 may have a minimum outer diameter of approximately 0.014 inches to approximately 0.024 inches. The elongated support assembly 102 is configured to be (preferably) received (slidably received) within the auxiliary medical assembly 800. The elongated support assembly 102 may contain any suitable material that can conform to the (internal shape) of the auxiliary medical assembly 800 without excessive geometric deformation of the elongated support assembly 102. The auxiliary medical assembly 800 is configured to be inserted into a closed space defined by the patient.
[0024] Referring to the embodiments shown in Figures 1 and 2, the elongated support assembly 102 preferably includes biocompatible material properties suitable for sufficient performance (such as dielectric strength, thermal performance, electrical insulation, corrosion resistance, water resistance, and heat resistance) to comply with industrial and regulatory safety standards (or to be suitable for medical use). For considerations in selecting a suitable material, 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] .
[0025] Referring to the embodiments shown in Figures 1 and 2, the elongated support assembly 102 may include a shape memory material, which is configured to recover its original shape (before manipulation) even after being manipulated and / or deformed. Since shape memory material (SMM) is well known, further details are omitted. The 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. This is known as the shape memory effect (SME). Superelasticity (in alloys) can be observed when the shape memory material is deformed in the presence (application) of a stimulating force.
[0026] Referring to the embodiments shown in Figures 1 and 2, the elongated support assembly 102 is configured to be used in cooperation with the elongated auxiliary medical assembly 800. The elongated support assembly 102 may include a metal alloy configured to impart to the auxiliary medical assembly 800 a degree of overall rigidity that can improve the manner of the workflow of a given procedure. Preferably, the elongated support assembly 102 can conform to the minimum characteristics of the auxiliary medical assembly 800.
[0027] Referring to the embodiments shown in Figures 1 and 2, the elongated auxiliary medical assembly 800 may include transseptal accessory devices, sheath assemblies, dilator assemblies, and any equivalents thereof. Preferably, the elongated auxiliary medical assembly 800 defines an auxiliary lumen 804 that extends at least partially along the longitudinal length of the elongated auxiliary medical assembly 800.
[0028] Referring to the embodiments shown in Figures 1 and 2, the elongated flexible medical assembly 900 may include a distal puncture device 902 configured to puncture a biological feature 700 (such as the atrial septum of the patient's heart). The elongated flexible medical assembly 900 may include an elongated needle assembly and any equivalent thereof. The distal puncture device 902 may include a radiofrequency puncture device. After performing a medical function (such as forming a puncture through a biological feature or wall), the elongated flexible medical assembly 900 may advance through an elongated support assembly 102 (for various purposes such as securing access to the left atrium of the patient's heart). Thus, according to one embodiment, the elongated support assembly 102 may be used to perform a medical function such as puncturing the atrial septum (of the patient's heart) during a transseptal catheterization procedure. It will be understood that any configuration and / or construct of the elongated support assembly 102 may be used to facilitate implantation into the left atrium immediately after puncture and securing access.
[0029] Referring to the embodiments shown in Figures 1 and 2, the elongated flexible medical assembly 900 may include (but is not limited to) a high-frequency puncture device such as a BAYLIS® POWERWIRE® high-frequency guidewire manufactured by BAYLIS MEDICAL COMPANY (headquartered in Canada). According to another embodiment, the flexible medical assembly 900 may include (but is not limited to) an elongated guidewire having a distal tip portion that presents a mechanically cut portion.
[0030] Referring to the embodiments shown in Figures 1 and 2, the elongated support assembly 102 has an outer diameter that matches the inner diameter of the auxiliary medical assembly 800. The outer diameter of the flexible medical assembly 900 (and / or distal puncture device 902) has a maximum outer diameter that does not exceed the inner diameter of the elongated support assembly 102.
[0031] Referring to the embodiments shown in Figures 1 and 2, the distal puncture device 902 preferably has a stainless steel core and / or a nitinol core and a polytetrafluoroethylene (PTFE) heat-shrinkable insulating jacket. The distal puncture device 902 includes a dome-shaped distal electrode. The distal puncture device 902 preferably has a maximum outer diameter of about 0.014 inches to about 0.24 inches. The distal puncture device 902 may include any suitable conductive material as part of the core of the radiofrequency puncture device. The distal puncture device 902 may include any suitable electrical insulating material for insulating the conductive core of the radiofrequency puncture device. The distal puncture device 902 preferably has a maximum outer diameter that fits the minimum inner diameter of the elongated support assembly 102.
[0032] Referring to the embodiments shown in Figures 1 and 2, the distal puncture device 902 may be usable by articulating the distal elements (known and not shown). The flexible medical assembly 900 may be used to puncture the atrial septum, and then, while advancing further into the left atrium (of the heart) after tissue puncture, the articulating elements may be used to change the distal conformation of the flexible medical assembly 900 from a linear and continuous shape to a non-linear and continuous shape so that the flexible medical assembly 900 can be bent at various joint sites (as needed).
[0033] Referring to the embodiments shown in Figures 1 and 2, the flexible medical assembly 900 may include an expandable structure (e.g., a cage, balloon, etc., and any equivalent thereof) positioned (attached) to the distal part of the flexible medical assembly 900. The expandable structure is configured to contact (at least partially) a biological feature (e.g., an atrial septum). The expandable structure is configured to compress tightly against the body of the flexible medical assembly 900. After crossing into the left atrium, the expandable structure is configured to expand to prevent (at least partially) loss of access.
[0034] Referring to the embodiments shown in Figures 1 and 2, the elongated support assembly 102 receives the flexible medical assembly 900. The inner diameter of the elongated support assembly 102 matches the outer diameter of the flexible medical assembly 900.
[0035] Referring to the embodiments shown in Figures 3 to 6, the elongated support assembly 102 and the flexible medical assembly 900 are positioned inside the auxiliary medical assembly 800. The external shape of the elongated support assembly 102 conforms to the internal diameter of the auxiliary medical assembly 800.
[0036] Referring to the embodiment shown in Figure 3, the elongated support assembly 102 can be positioned at least partially in a sliding relationship with the elongated flexible medical assembly 900. The sliding relationship can allow selective relative sliding between the elongated support assembly 102 and the elongated flexible medical assembly 900. The sliding relationship can allow (or include) stopping the relative sliding between the elongated support assembly 102 and the elongated flexible medical assembly 900. Stopping can be achieved by embodiments shown in Figures 13, 14, 15, 16, 17, 18, or 19. The elongated support assembly 102 is configured to at least partially support (at least partially increase the rigidity of) the elongated flexible medical assembly 900 (and the elongated auxiliary medical assembly 800) after the elongated support assembly 102 is positioned at least partially in a sliding relationship with the elongated flexible medical assembly 900. The elongated support assembly 102 is at least partially selectively operable toward the distal portion 802 of the elongated auxiliary medical assembly 800 via the elongated auxiliary medical assembly 800. The elongated flexible medical assembly 900 may include a puncture device, a radiofrequency puncture device configured to puncture the atrial septum, and any equivalent thereof. The elongated auxiliary medical assembly 800 may include medical accessory devices such as sheaths, dilators, and any equivalent thereof.
[0037] Referring to the embodiment shown in Figure 3, a method is provided for using an elongated flexible medical assembly 900, an elongated auxiliary medical assembly 800, and an elongated support assembly 102. This method includes positioning the elongated support assembly 102 in a sliding relationship with the elongated flexible medical assembly 900. The method also includes at least partially supporting the elongated flexible medical assembly 900 via the elongated support assembly 102 which is at least partially positioned in a sliding relationship with the elongated flexible medical assembly 900. The method also includes at least partially selectively manipulating the elongated support assembly 102 toward the distal portion 802 of the elongated auxiliary medical assembly 800 via the elongated auxiliary medical assembly 800. The elongated support assembly may be held in place by embodiments shown in Figures 10, 11, or 12.
[0038] Referring to the embodiment shown in Figure 3, the elongated support assembly 102 is preferably configured to at least partially increase the rigidity of the elongated flexible medical assembly 900 and the elongated auxiliary medical assembly 800.
[0039] Referring to the embodiment shown in Figure 3, the elongated support assembly 102 (preferably) defines a support lumen 104 extending along it. The support lumen 104 is configured to receive the elongated flexible medical assembly 900.
[0040] Referring to the embodiments shown in Figures 3 and 4, the elongated support assembly 102, together with the elongated flexible medical assembly 900 supported by the elongated support assembly 102 (in conjunction and in a cooperative relationship), is (preferably) at least partially selectively operable toward the distal portion 802 via the elongated auxiliary medical assembly 800.
[0041] Referring to the embodiments shown in Figures 3 and 4, the elongated flexible medical assembly 900 and the elongated support assembly 102 are at least partially (preferably) extendable outward in a direction toward and toward the distal portion 802, coinciding with it.
[0042] Referring to the embodiments shown in Figures 5 and 6, while the elongated flexible medical assembly 900 remains stationary relative to the elongated support assembly 102, and while the elongated support assembly 102 continues to support the elongated flexible medical assembly 900 at least partially during use, the elongated support assembly 102 is at least partially and (preferably) at least partially selectively operable along and toward the distal portion 802.
[0043] Referring to the embodiments shown in Figures 5 and 6, the elongated flexible medical assembly 900 is preferably configured to remain stationary relative to the elongated flexible medical assembly 900 while the elongated flexible medical assembly 900 is selectively maneuverable toward the distal portion 802 during use, and while the elongated support assembly 102 continues to at least partially support the elongated flexible medical assembly 900 during use.
[0044] Referring to the embodiment shown in Figure 6, the elongated flexible medical assembly 900 is selectively extended outward away from the distal portion 802 during use, while the elongated support assembly 102 is (preferably) at least partially configured to remain within the elongated auxiliary medical assembly 800. The elongated support assembly 102 can be held within the elongated auxiliary medical assembly 800 by the embodiments shown in Figures 10, 11, or 12.
[0045] Referring to the embodiment shown in Figure 7, the flexible medical assembly 900 (or distal puncture device 902) is used to probe and / or identify a desired biological location on a biological feature 700 (such as the atrial septum) through which to puncture (to form a puncture). The flexible medical assembly 900 and the elongated support assembly 102 are used in conjunction with an auxiliary medical assembly 800 (such as a sheath and / or dilator). The flexible medical assembly 900 (or distal puncture device 902) is positioned inside the elongated support assembly 102.
[0046] Referring to the embodiment shown in Figure 8, the flexible medical assembly 900 punctures the biological feature 700 (atrial septum) when the distal puncture device 902 is activated (for example, once radiofrequency energy is applied) during use, and when the distal puncture device 902 (distal tip electrode) is positioned accordingly. With the distal puncture device 902 of the flexible medical assembly 900 positioned in the biological feature 700 (left atrium of the heart), the distal puncture device 902 may be further extended to provide access to the left atrial zone, etc.
[0047] Referring to the embodiment shown in Figure 9, the flexible medical assembly 900 having a distal puncture device 902 is implanted in a biological feature (such as one of the pulmonary veins 702) to secure left atrial access.
[0048] The following workflow steps may be used in conjunction with the elongated support assembly 102. Referring to the embodiment in Figure 3, the first step includes inserting the elongated support assembly 102 into the auxiliary medical assembly 800. Referring to the embodiment in Figure 3, the second step includes inserting the flexible medical assembly 900 into the elongated support assembly 102 while the elongated support assembly 102 is positioned inside the auxiliary medical assembly 800. Referring to the embodiment in Figure 7, the third step includes bringing a biological feature 700 (such as an atrial septum) into contact with the flexible medical assembly 900 at a desired biological site to be crossed (i.e., punctured). Referring to embodiments in Figures 7 and 8, the fourth step includes applying radiofrequency energy to the distal puncture device 902 of the flexible medical assembly 900. Referring to the embodiment in Figure 8, the fifth step includes advancing the flexible medical assembly 900 (from the elongated auxiliary medical assembly 800) into a biological feature 700 (e.g., the left atrium and secure access thereto).
[0049] Referring to the embodiment shown in Figure 10 (axial cross-sectional side view), the rotatable device 1000 is configured to control (adjust, stop, prevent) movement (sliding movement or sliding relationship) between the elongated support assembly 102 and the elongated flexible medical assembly 900. The rotatable device 1000 is located (positioned) at the proximal end of the elongated auxiliary medical assembly 800. The rotatable device 1000 is configured to rotate (along the direction indicated by arrow 1002). The rotatable device 1000 is configured to screw into (screwably coupled, screwwise engaged) the contact portion of the elongated support assembly 102. The rotatable device 1000 includes a thread 1004 configured to screwwise engage with the outer surface of the elongated support assembly 102. The rotatable device 1000 is configured to facilitate selective movement of the elongated support assembly 102 (i.e., movement relative to the elongated auxiliary medical assembly 800). Selective movement is understood to include forward and / or backward movement along the direction of arrow 1006. The rotatable device 1000 is preferably configured to facilitate a screw-driven forward and backward movement (reciprocating motion) of the elongated support assembly 102 relative to the elongated auxiliary medical assembly 800. The elongated support assembly 102 may begin moving in a position proximal to the distal portion 802, as shown in Figure 3 or Figure 5. Following the rotation of the rotatable device 1000 (relative to the auxiliary medical assembly 800), the elongated support assembly 102 moves forward until the elongated support assembly 102 emerges from the auxiliary lumen 804. This is done so that the elongated support assembly 102 may be positioned beyond the distal portion 802 (as shown in Figure 4) or stop at the distal portion 802 (as shown in Figure 6). The rotation of the rotatable device 1000 facilitates the forward and backward movement of the elongated support assembly 102, so that the elongated support assembly 102 does not slide linearly against the elongated auxiliary medical assembly 800 (after the rotatable device 1000 is disabled or when the rotatable device 1000 is not rotating).The elongated support assembly 102 is configured to slide against the elongated auxiliary medical assembly 800 after the rotatable device 1000 has rotated (i.e., in response to the rotation of the rotatable device 1000).
[0050] Referring to the embodiments shown in Figures 11A and 11B, the handle 1100 is configured to control (stop, prevent) movement (sliding movement or sliding relationship) between the elongated support assembly 102 and the elongated flexible medical assembly 900. Figures 11A and 11B show axial cross-sectional side views. The handle 1100 is attached to the proximal end of the elongated support assembly 102. The handle 1100 extends axially from the elongated support assembly 102. The handle 1100 protrudes from a portal 1102 defined by the elongated auxiliary medical assembly 800. The portal 1102 is in fluid communication with the interior of the elongated auxiliary medical assembly 800. The handle 1100 is configured to move (push or pull) to control the movement of the elongated support assembly 102 relative to the elongated auxiliary medical assembly 800 (along the direction of arrow 1104). It is understood that movement or linear movement may include forward and / or backward movement, etc. Movement of the elongated support assembly 102 may begin at a position proximal to the distal portion 802 (as shown in Figure 3 or Figure 5, and Figure 11A). Following the forward movement (movement) of the handle 1100 along the direction of arrow 1104 (as shown in Figure 11A) (as illustrated in Figure 11B), the elongated support assembly 102 moves forward (preferably until the elongated support assembly 102 emerges from the end of the auxiliary lumen 804). This is done so that the elongated support assembly 102 may be positioned beyond the distal portion 802 (as shown in Figure 4) or may stop at the distal portion 802 (as shown in Figure 6). A quantity of static friction interaction (static friction force) exists between the outer surface of the elongated support assembly 102 and the elongated auxiliary medical assembly 800. This occurs when there is no relative movement between the elongated support assembly 102 and the elongated auxiliary medical assembly 800. The amount of static friction interaction is configured to maintain the relative position between the elongated support assembly 102 and the elongated auxiliary medical assembly 800 (unless the handle 1100 is prompted to move).The amount of static friction interaction is configured to maintain the relative position between the elongated support assembly 102 and the elongated auxiliary medical assembly 800 (in response to the handle 1100 not prompting movement of the elongated support assembly 102). In response to the handle 1100 receiving a moving force, the moving force prompts the handle 1100 to overcome the amount of static friction interaction (therefore enabling movement of the elongated support assembly 102 or relative movement). The moving force (applied to the handle 1100 by the user) is configured to overcome the amount of static friction interaction (static friction force) between the elongated support assembly 102 and the elongated auxiliary medical assembly 800. This is done so that movement can be initiated or permitted for the elongated support assembly 102 (i.e., movement relative to the elongated auxiliary medical assembly 800). It will be understood that the sliding friction force (between the elongated support assembly 102 and the elongated auxiliary medical assembly 800) is lower than the static friction force (between the elongated support assembly 102 and the elongated auxiliary medical assembly 800). If necessary, an appropriate lubricant may be positioned between the elongated support assembly 102 and the elongated auxiliary medical assembly 800 (to achieve the desired effect).
[0051] Referring to the embodiments shown in Figures 12A and 12B, the proximal hub 1200 is configured to control (stop, prevent) movement (sliding movement or sliding relationship) between the elongated support assembly 102 and the elongated flexible medical assembly 900. Figures 12A and 12B show axial cross-sectional side views. The elongated support assembly 102 includes (has) the proximal hub 1200. The proximal hub 1200 extends from the outer surface of the elongated support assembly 102. The proximal hub 1200 is configured to (at least partially) abut the entrance of the elongated auxiliary medical assembly 800 that leads into the auxiliary lumen 804 (after the elongated support assembly 102 has moved toward the entrance that leads into the auxiliary lumen 804). When the proximal hub 1200 moves so that it (at least partially) abuts against or contacts the entrance leading into the auxiliary lumen 804 (as a result of the movement of the elongated support assembly 102), the elongated support assembly 102 is stopped from moving further along the auxiliary lumen 804. The proximal hub 1200 is configured to be movable toward the auxiliary lumen 804 but not to enter it. The proximal hub 1200 is movable together with the elongated support assembly 102 along the direction of arrow 1202. The proximal hub 1200 is (preferably) sized to be larger than the size of the entrance to the auxiliary lumen 804 (of the elongated auxiliary medical assembly 800). The elongated support assembly 102 may begin moving, for example, at a position proximal to the distal portion 802 (as shown in Figure 3 or Figure 5, and Figure 12A).
[0052] Referring to the embodiment shown in Figure 12B, following the advancement (movement) of the proximal hub 1200, the elongated support assembly 102 is moved (forward by the user) until the elongated support assembly 102 emerges from the auxiliary lumen 804. This is done so that the elongated support assembly 102 can be positioned beyond the distal portion 802 (as shown in Figure 4) or can be stopped (further movement) at the position that becomes the distal portion 802 (as shown in Figure 6). There is a quantity of static friction interaction (static friction force) between the elongated support assembly 102 and the elongated auxiliary medical assembly 800. The quantity of static friction interaction is configured to maintain the relative position between the elongated support assembly 102 and the elongated auxiliary medical assembly 800 (for example, when the proximal hub 1200 is not being given movement or is not being prompted to move). The moving force applied by the user (to the proximal hub 1200) is configured to overcome the amount of static friction interaction (static friction force) between the elongated support assembly 102 and the elongated auxiliary medical assembly 800. This is done so that the elongated support assembly 102 is allowed to move (or may initiate movement relative to the elongated auxiliary medical assembly 800). It will be understood that the sliding friction force (between the elongated support assembly 102 and the elongated auxiliary medical assembly 800) is lower than the static friction force (between the elongated support assembly 102 and the elongated auxiliary medical assembly 800).
[0053] Referring to the embodiments shown in Figures 13A, 13B, and 13C, the rotatable element 1300 is configured to control (stop, prevent) movement (sliding movement or sliding relationship) between the elongated support assembly 102 and the elongated flexible medical assembly 900. Figure 13A shows an axial cross-sectional side view. Figures 13B and 13C show radial cross-sectional side views taken along the cross-sectional line AA as shown in Figure 13A. An example of the rotatable element 1300 is a toybost adapter. Toybost adapters are known to those skilled in the art. A toybost adapter may include a body, a gasket, and a cap. A toybost adapter is configured to prevent backflow of fluid. A toybost adapter is also configured to facilitate catheter introduction (a silicone valve and cap torque around the tube or instrument holds the tube in place). The elongated support assembly 102 includes the rotatable element 1300. The rotatable element 1300 is positioned at the proximal end of the elongated support assembly 102. The rotatable element 1300 includes a flexible element 1302 (such as silicone) positioned proximal to (adjacent to) the support lumen 104 (of the elongated support assembly 102). The rotatable element 1300 is configured to change (decrease or increase) the amount of compression applied to the flexible element 1302. The rotatable element 1300 is configured to change the amount of compression applied from the flexible element 1302 to the support lumen 104 of the elongated support assembly 102. The change in compression (applied to the flexible element 1302) causes a change (increase or decrease) in the effective size (inner diameter) of the support lumen 104 (of the elongated support assembly 102). The flexible element 1302 is configured to change the effective size of the support lumen 104 of the elongated support assembly 102.
[0054] Referring to the embodiment shown in Figure 13A, the support lumen 104 is opened (preferably completely opened) in response to a lower amount (or no application) of compressive force on the flexible element 1302. The rotatable element 1300 does not apply compressive force to the flexible element 1302. In response to the absence of compressive force on the flexible element 1302, the elongated flexible medical assembly 900 is allowed to move forward (freely) along the axial length of the support lumen 104 (extending through the elongated support assembly 102) (at least partially). The direction of rotation of the rotatable element 1300 (indicated by the direction of arrow 1301) is the direction in which the compressive force is applied to the flexible element 1302. After the compressive force is applied to the flexible element 1302, the diameter (inner diameter) of the support lumen 104 is reduced (at least partially).
[0055] Referring to the embodiment shown in Figure 13B, the flexible element 1302 is not compressed (is in an uncompressed state). If the rotatable element 1300 does not compress the flexible medical assembly 900, the inner diameter of the support lumen 104 is larger than the diameter of the elongated flexible medical assembly 900. This is done so that the elongated flexible medical assembly 900 can move freely within (along) the elongated support assembly 102.
[0056] Referring to the embodiment shown in Figure 13C, the rotatable element 1300 is actuated to compress the flexible element 1302. The rotatable element 1300 is configured to apply a compressive force to the flexible element 1302. As a result of (the application of compressive force from the rotatable element 1300), the inner diameter of the support lumen 104 becomes relatively smaller (in the fragment or portion located adjacent to the flexible element 1302). This is done so that the support lumen 104 restricts the movement of the elongated flexible medical assembly 900 during use (preferably achieving a halt to any movement). This is done so that the flexible medical assembly 900 no longer slides against the elongated support assembly 102 (its sliding is stopped).
[0057] Referring to the embodiments shown in Figures 14A, 14B, and 14C, the sliding element 1400 is configured to control (stop, prevent) movement (sliding movement or sliding relationship) between the elongated support assembly 102 and the elongated flexible medical assembly 900. Figures 14A and 14B show axial cross-sectional side views. Figure 14C shows an overhead or top view. The elongated support assembly 102 includes the sliding element 1400. The sliding element 1400 is preferably integrated with the proximal end of the elongated support assembly 102. The sliding element 1400 is configured to selectively contact (friction contact) the elongated flexible medical assembly 900 (after the elongated flexible medical assembly 900 has been received within the elongated support assembly 102). This is done so that the sliding element 1400 contacts (abuts against) the outer surface of the elongated flexible medical assembly 900 (during use). The sliding element 1400 is also configured to selectively move the elongated flexible medical assembly 900 (this is done after the sliding element 1400 selectively contacts or frictionally contacts the elongated flexible medical assembly 900 during use, as shown along the direction of arrow 1402 in Figure 14A). The sliding element 1400 is configured to move (by the user) along the axial length of the elongated support assembly 102 (while the user maintains contact with the sliding element 1400). The elongated flexible medical assembly 900 moves in response to the sliding element 1400 moving (forward, backward, etc.) along or on the elongated support assembly 102 (while the elongated flexible medical assembly 900 and the sliding element 1400 remain in contact with each other).
[0058] Referring to the embodiment shown in Figure 14A, the elongated flexible medical assembly 900 is fully retracted (in response to the movement of the sliding element 1400). This state may correspond to a distal configuration (as shown in Figure 5). The movement of the sliding element 1400 (along the direction of arrow 1402) is performed so that the elongated flexible medical assembly 900 moves forward or forward (as shown in Figure 14B).
[0059] Referring to the embodiment shown in Figure 14B, the complete forward movement of the elongated flexible medical assembly 900 via a sliding element is shown. This configuration may correspond to a distal configuration (as shown in Figure 6).
[0060] Referring to the embodiment shown in Figure 14C, an overhead view of the sliding element 1400 is shown. The sliding element 1400 is forward-facing and thereby can advance (move) the elongated flexible medical assembly 900. Since the elongated flexible medical assembly 900 cannot move without the movement of the sliding element 1400, the cessation of relative sliding between the elongated support assembly 102 and the elongated flexible medical assembly 900 is achieved when the sliding element 1400 is not being operated.
[0061] Referring to the embodiments shown in Figures 15A and 15B, the proximal tapered portion 1500 is configured to control (stop, prevent) movement (sliding movement or sliding relationship) between the elongated support assembly 102 and the elongated flexible medical assembly 900. Figures 15A and 15B show axial cross-sectional side views. The elongated flexible medical assembly 900 includes (has) the proximal tapered portion 1500. The proximal tapered portion 1500 is located on and extends from the outer surface (outer diameter) of the elongated flexible medical assembly 900. The outer diameter of the proximal tapered portion 1500 is greater than (exceeds) the inner diameter of the elongated support assembly 102 (of the support lumen 104).
[0062] Referring to the embodiment shown in Figure 15A, the elongated flexible medical assembly 900 moves forward through the elongated support assembly 102 along arrow 1502 (moves along the direction of arrow 1502).
[0063] Referring to the embodiment shown in Figure 15B, the proximal tapered portion 1500 (of the elongated flexible medical assembly 900) moves to (finally) abut (interact with or contact) the proximal end of the elongated support assembly 102. When the proximal tapered portion 1500 contacts (moves to contact) or abuts against the end of the elongated support assembly 102 (in use), further advancement of the elongated flexible medical assembly 900 is stopped. This is done so that the elongated flexible medical assembly 900 cannot advance further along the direction of arrow 1502, as shown in Figure 15A. When the proximal tapered portion 1500 moves to abut or contact the elongated support assembly 102, further advancement (of the elongated flexible medical assembly 900 into the elongated support assembly 102) is not possible. This is done so that there is a cessation of relative sliding (movement) between the elongated support assembly 102 and the elongated flexible medical assembly 900.
[0064] Referring to the embodiments shown in Figures 16A and 16B, the flexible region 1600 is configured to control (stop, prevent) movement (sliding movement or sliding relationship) between the elongated support assembly 102 and the elongated flexible medical assembly 900. Figures 16A and 16B show axial cross-sectional side views. The flexible region 1600 is positioned above (within) the proximal portion of the elongated support assembly 102. The elongated support assembly 102 is configured to support the flexible region 1600. The flexible region 1600 is configured to be pressed (or compressed by the user, etc.).
[0065] Referring to the embodiment shown in Figure 16A, the elongated flexible medical assembly 900 is movable within the elongated support assembly 102 (freely moving along the direction of arrow 1602). The flexible region 1600 is configured to remain uncompressed when no pressing force is applied to it by the user (as shown in Figure 16A). While the flexible region 1600 remains uncompressed, the elongated flexible medical assembly 900 is movable within or along the elongated support assembly 102 (along the direction indicated by arrow 1602), as shown in Figure 16A. The elongated flexible medical assembly 900 cannot move within or along the elongated support assembly 102 while the flexible region 1600 remains compressed (as shown in Figure 16B) because the user is applying a pressing force to the flexible region 1600.
[0066] Referring to the embodiment shown in Figure 16B, the flexible region 1600 is being pushed or moved (along the direction of arrow 1604), and the flexible region 1600 is in a compressed state. In the compressed state, the flexible region 1600 interacts with (selectively contacts) the elongated flexible medical assembly 900, which is positioned inside the lumen (support lumen 104) of the elongated support assembly 102. This is done so as to prevent further movement of the elongated flexible medical assembly 900 along the support lumen 104. Static friction (contact friction) is generated between the elongated flexible medical assembly 900 and the elongated support assembly 102 (if there is no relative movement between them). The static friction is configured to prevent further movement of the elongated flexible medical assembly 900 (along the direction of arrow 1602, for example, as shown in Figure 16A). The static friction between the elongated flexible medical assembly 900 and the elongated support assembly 102 is configured to prevent further movement of the elongated flexible medical assembly 900 after the flexible region 1600 has not been pressed. The static friction provided by the activation (pressure) of the flexible region 1600 achieves the cessation of relative sliding between the elongated support assembly 102 and the elongated flexible medical assembly 900.
[0067] Referring to the embodiments shown in Figures 17A and 17B, the block device 1700 is configured to control (stop, prevent) movement (sliding movement or sliding relationship) between the elongated support assembly 102 and the elongated flexible medical assembly 900. Figures 17A and 17B show axial cross-sectional side views. The block device 1700 is fixed (attached) to a portion of the elongated flexible medical assembly 900. The outer diameter of the block device 1700 is larger than the inner diameter of the elongated support assembly 102 (of the support lumen 104). The block device 1700 is configured not to be inserted into the support lumen 104.
[0068] Referring to the embodiment shown in Figure 17A, the elongated flexible medical assembly 900 advances into the support lumen 104 of the elongated support assembly 102, and the elongated flexible medical assembly 900 is movable (along the direction of arrow 1702).
[0069] Referring to the embodiment shown in Figure 17B, the block device 1700 moves (along the direction of arrow 1702, as shown in Figure 17A). This is done so that the block device 1700 reaches (contacts, abuts) the proximal end of the elongated support assembly 102. After the block device 1700 has moved to contact (abuts) the elongated support assembly 102, the elongated flexible medical assembly 900 is prevented from advancing further into the elongated support assembly 102 (because the block device 1700 cannot move into the elongated support assembly 102). The block device 1700 is configured to stop relative sliding movement between the elongated support assembly 102 and the elongated flexible medical assembly 900.
[0070] Referring to the embodiments shown in Figures 18A and 18B, the biasing device 1800 (e.g., a spring device) is configured to control (stop, prevent) movement (sliding movement or sliding relationship) between the elongated support assembly 102 and the elongated flexible medical assembly 900. Figures 18A and 18B show axial cross-sectional side views. The biasing device 1800 is positioned proximal to the elongated flexible medical assembly 900. The biasing device 1800 is configured to abut against the end of the elongated flexible medical assembly 900. The elongated support assembly 102 includes a stopper 1802 positioned within the support lumen 104 (of the elongated support assembly 102). The elongated support assembly 102 also includes a depressing device 1804 positioned on the outer surface of the elongated support assembly 102. The stopper 1802 is coupled to the depressing device 1804. The biasing device 1800 is configured to contact the stopper 1802 and be compressed by the stopper 1802 (in response to the application of a compressive force to the biasing device 1800). The stopper 1802 is configured to selectively move away from the biasing device 1800 (in response to activation of the push device 1804 by the user).
[0071] Referring to the embodiment shown in Figure 18A, the biasing device 1800 is in a compressed state, and the elongated flexible medical assembly 900 is fully retracted. This case may correspond to a distal configuration (as shown in Figure 5).
[0072] Referring to the embodiment shown in Figure 18B, the user applies an activation force to the push device 1804 (along the direction of arrow 1806). This is done so that the stopper 1802 is moved so that the biasing device 1800 can be released (to decompress the biasing device 1800) after the stopper 1802 has been removed (or moved aside). The release of the biasing device 1800 (from its compressed state) thereby prompts the elongated flexible medical assembly 900 to move forward (preferably until the biasing device 1800 reaches its equilibrium length, as shown in Figure 18B). The activation of the push device 1804 by the user (for the activation of the stopper 1802) causes the release of the biasing device 1800. After the stopper 1802 is released from the biasing device 1800, the biasing device 1800 imparts forward movement to the elongated flexible medical assembly 900 until the biasing device 1800 reaches its equilibrium length (and preferably until no further forward movement occurs). This case may correspond to a distal configuration (as shown in Figure 6). The biasing device 1800 moves forward until it reaches its equilibrium length (because the elongated flexible medical assembly 900 cannot move without the biasing device 1800 being released). The biasing device 1800 extends along the direction of arrow 1808 when the biasing device 1800 is released. The cessation of relative sliding between the elongated support assembly 102 and the elongated flexible medical assembly 900 occurs (preferably) after the biasing device 1800 has reached its equilibrium length.
[0073] Referring to the embodiments shown in Figures 19A and 19B, the actuated plunger 1900 is configured to control (stop, prevent) movement (sliding movement or sliding relationship) between the elongated support assembly 102 and the elongated flexible medical assembly 900. Figures 19A and 19B show axial cross-sectional side views. The actuated plunger 1900 is located at the proximal end of the elongated support assembly 102. The actuated plunger 1900 is located proximal to the elongated flexible medical assembly 900. The actuated plunger 1900 is (preferably) configured to function in the same way as a known click pen (writing instrument).
[0074] Referring to the embodiment shown in Figure 19A, the operable plunger 1900 is in a fully retracted position. The elongated flexible medical assembly 900 is fully retracted into the elongated support assembly 102 in this configuration. This may correspond to the distal configuration shown in Figure 5.
[0075] Referring to the embodiment shown in Figure 19B, the actuariable plunger 1900 can be activated by moving it along the direction of arrow 1902. Pressing the actuariable plunger 1900 pushes the elongated flexible medical assembly 900 proximal. This is done so that the elongated flexible medical assembly 900 can move (forward relative to the elongated support assembly 102). This may correspond to the distal configuration shown in Figure 6. Preferably, the elongated flexible medical assembly 900 does not move without pressing the actuariable plunger 1900. Preferably, the elongated flexible medical assembly 900 is configured to move in response to pressing the actuariable plunger 1900. The actuariable plunger 1900 can move a predetermined distance. The relative sliding between the elongated support assembly 102 and the elongated flexible medical assembly 900 stops when the actuariable plunger 1900 is fully pressed.
[0076] 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. The technical concepts included in this disclosure are described below. (Note 1) A device for use with elongated flexible medical assemblies and elongated auxiliary medical assemblies, wherein the device is The system includes an elongated support assembly that can be positioned at least partially in a sliding relationship with the aforementioned elongated flexible medical assembly, The elongated support assembly is configured to at least partially support the elongated flexible medical assembly after the elongated support assembly is at least partially positioned in a sliding relationship with the elongated flexible medical assembly. A device wherein the elongated support assembly is at least partially and selectively operable toward the distal portion of the elongated assistive medical assembly via the elongated assistive medical assembly. (Note 2) The apparatus according to Appendix 1, wherein the elongated support assembly, together with the elongated flexible medical assembly supported by the elongated support assembly, is at least partially and selectively operable toward the distal portion via the elongated auxiliary medical assembly. (Note 3) The apparatus according to Appendix 1, wherein the elongated flexible medical assembly remains stationary relative to the elongated support assembly, and the elongated support assembly continues to support the elongated flexible medical assembly at least partially during use, the elongated support assembly is at least partially and at least partially selectively operable along the distal portion, toward the distal portion. (Note 4) The apparatus according to Appendix 1, wherein the elongated support assembly remains stationary relative to the elongated flexible medical assembly while the elongated flexible medical assembly is selectively operable toward the distal portion during use, and while the elongated support assembly continues to support the elongated flexible medical assembly at least partially during use. (Note 5) The apparatus according to Appendix 1, wherein the elongated support assembly is at least partially configured to remain within the elongated auxiliary medical assembly while the elongated flexible medical assembly is selectively extended outward in a direction away from the distal portion during use. (Note 6) The apparatus according to Appendix 1, wherein the elongated flexible medical assembly and the elongated support assembly are at least partially extendable outward in a direction toward and away from the distal portion. (Note 7) The apparatus according to Appendix 1, wherein the elongated support assembly is configured to at least partially increase the rigidity of the elongated flexible medical assembly and the rigidity of the elongated auxiliary medical assembly. (Note 8) The elongated support assembly defines a support lumen that extends along the elongated support assembly, The apparatus according to Appendix 1, wherein the support lumen is configured to receive the elongated flexible medical assembly. (Note 9) The aforementioned elongated support assembly includes a hollow tube, as described in Appendix 1. (Note 10) The apparatus according to Appendix 1, wherein the elongated support assembly is configured to at least partially receive the elongated flexible medical assembly. (Note 11) The elongated support assembly defines a support lumen that extends at least partially along the longitudinal length of the elongated support assembly, The apparatus according to Appendix 1, wherein the support lumen is configured to at least partially receive the elongated flexible medical assembly. (Note 12) The device described in Appendix 1, which includes the elongated auxiliary medical assembly, including the dilator assembly. (Note 13) The apparatus according to Appendix 1, wherein the elongated auxiliary medical assembly is configured to receive the elongated support assembly. (Note 14) The elongated auxiliary medical assembly defines an auxiliary lumen that extends at least partially along the longitudinal length of the elongated auxiliary medical assembly, The apparatus according to Appendix 1, wherein the auxiliary lumen is configured to receive the elongated support assembly. (Note 15) The aforementioned elongated flexible medical assembly is The apparatus described in Appendix 1, including a distal puncture device configured to puncture a biological feature. (Note 16) A device for use with an elongated auxiliary medical assembly, the device being, A long, slender, flexible medical assembly, The system comprises an elongated support assembly that can be positioned at least partially in a sliding relationship with the aforementioned elongated flexible medical assembly, The elongated support assembly is configured to at least partially support the elongated flexible medical assembly after the elongated support assembly is at least partially positioned in a sliding relationship with the elongated flexible medical assembly. A device wherein the elongated support assembly is at least partially and selectively operable toward the distal portion of the elongated assistive medical assembly via the elongated assistive medical assembly. (Note 17) It is a device, A long, slender, flexible medical assembly, A long, slender medical assemblies, The system comprises an elongated support assembly that can be positioned at least partially in a sliding relationship with the aforementioned elongated flexible medical assembly, The elongated support assembly is configured to at least partially support the elongated flexible medical assembly after the elongated support assembly is at least partially positioned in a sliding relationship with the elongated flexible medical assembly. A device wherein the elongated support assembly is at least partially and selectively operable toward the distal portion of the elongated assistive medical assembly via the elongated assistive medical assembly. (Note 18) A method using an elongated flexible medical assembly, an elongated auxiliary medical assembly, and an elongated support assembly, the method being: To position the elongated support assembly in a sliding relationship with the elongated flexible medical assembly, The elongated flexible medical assembly is at least partially supported via the elongated support assembly, which is at least partially positioned in a sliding relationship with the elongated flexible medical assembly. A method comprising at least partially selectively manipulating the elongated support assembly toward the distal portion of the elongated medical support assembly via the elongated medical support assembly. (Note 19) A method using an elongated flexible medical assembly, an elongated auxiliary medical assembly, and an elongated support assembly, the method being: Inserting the elongated support assembly into the elongated auxiliary medical assembly, While the elongated support assembly is positioned inside the elongated auxiliary medical assembly, the elongated flexible medical assembly is inserted into the elongated support assembly. To bring a biological feature into contact with the elongated, flexible medical assembly at the desired biological site to be punctured, Applying high-frequency energy to the distal puncture device of the aforementioned elongated flexible medical assembly, A method comprising advancing the elongated flexible medical assembly from the elongated auxiliary medical assembly. (Note 20) The rotatable device is configured to control the movement between the elongated support assembly and the elongated flexible medical assembly. The rotatable device is located at the proximal end of the elongated auxiliary medical assembly, The rotatable device is configured to rotate, The rotatable device is configured to engage screwably with the outer surface of the elongated support assembly, The apparatus according to Appendix 1, wherein the rotatable device is configured to facilitate the selective movement of the elongated support assembly. (Note 21) The handle is configured to control the movement between the elongated support assembly and the elongated flexible medical assembly. The handle is attached to the proximal end of the elongated support assembly. The handle extends axially from the elongated support assembly 102, The handle protrudes from the portal of the elongated auxiliary medical assembly, The portal is in fluid communication with the interior of the elongated auxiliary medical assembly. The handle is configured to move in order to control the linear movement of the elongated support assembly, In order that there is no relative movement between the elongated support assembly and the elongated auxiliary medical assembly 800, there is a static friction interaction between the outer surface of the elongated support assembly and the inner surface of the elongated auxiliary medical assembly. The apparatus according to Appendix 1, wherein the amount of static friction interaction is configured to maintain the relative position between the elongated support assembly and the elongated auxiliary medical assembly in response to the handle not facilitating the movement of the elongated support assembly, and the handle receiving a moving force enabling the movement of the elongated support assembly, the moving force overcoming the amount of static friction interaction. (Note 22) The proximal hub is configured to control the movement between the elongated support assembly and the elongated flexible medical assembly. The elongated support assembly includes the proximal hub, The proximal hub extends from the outer surface of the elongated support assembly, The proximal hub is configured to at least partially abut the entrance leading to the auxiliary lumen in response to the elongated support assembly moving toward the entrance leading to the auxiliary lumen, such that, as a result of the movement of the elongated support assembly, the proximal hub abuts at least partially abuts the entrance leading to the auxiliary lumen of the elongated auxiliary medical assembly, and then the elongated support assembly is stopped from moving further along the auxiliary lumen. The proximal hub is configured to be movable toward the auxiliary lumen but unable to enter it. The apparatus according to Appendix 1, wherein the proximal hub is sized to be larger than the entrance of the auxiliary lumen of the elongated auxiliary medical assembly. (Note 23) The rotatable element is configured to control the movement between the elongated support assembly and the elongated flexible medical assembly. The elongated support assembly includes the rotatable element, The rotatable element is positioned at the proximal end of the elongated support assembly, The rotatable element includes a flexible element positioned proximal to the support lumen of the elongated support assembly, The rotatable element is configured to change the amount of compression applied from the flexible element to the support lumen of the elongated support assembly, The apparatus according to Appendix 1, wherein the flexible element is configured to change the effective size of the support lumen of the elongated support assembly. (Note 24) The sliding element is configured to control the movement between the elongated support assembly and the elongated flexible medical assembly. The elongated support assembly includes the sliding element, After the elongated flexible medical assembly is received within the elongated support assembly, the sliding element is configured to selectively frictionally contact the elongated flexible medical assembly, and the sliding element contacts the outer surface of the elongated flexible medical assembly during use. The sliding element is also configured to selectively move the elongated flexible medical assembly after selectively frictionally contacting the elongated flexible medical assembly during use. The sliding element is configured to be movable along the axial length of the elongated support assembly, The apparatus according to Appendix 1, wherein the elongated flexible medical assembly moves in response to the movement of the sliding element along the elongated support assembly while the elongated flexible medical assembly and the sliding element remain in contact with each other. (Note 25) The proximal tapered portion is configured to control the movement between the elongated support assembly and the elongated flexible medical assembly. The elongated flexible medical assembly includes the proximal tapered portion, The proximal tapered portion is located on the outer surface of the elongated flexible medical assembly and extends therefrom, The outer diameter of the proximal tapered portion is larger than the inner diameter of the support lumen of the elongated support assembly. The apparatus according to Appendix 1, wherein the proximal tapered portion is movable to abut against the proximal end of the elongated support assembly so that, during use, the proximal tapered portion contacts the end of the elongated support assembly, thereby preventing further advancement of the elongated flexible medical assembly, and as a result, preventing the elongated flexible medical assembly from advancing any further. (Note 26) The flexible region 1600 is configured to control the movement between the elongated support assembly and the elongated flexible medical assembly. The flexible region is located within the proximal portion of the elongated support assembly, The elongated support assembly is configured to support the flexible region, The aforementioned flexible region is configured to be pressed, After the flexible region is no longer pressed, the elongated flexible medical assembly is movable within the elongated support assembly. In the compressed state of the flexible region, the flexible region interacts with the elongated flexible medical assembly positioned inside the support lumen so that the elongated flexible medical assembly is prevented from moving further along the support lumen of the elongated support assembly. The apparatus according to Appendix 1, wherein static friction is generated during the interaction between the elongated flexible medical assembly and the elongated support assembly while the flexible region remains in a non-compressed state, thereby preventing further movement of the elongated flexible medical assembly. (Note 27) The block device is configured to control the movement between the elongated support assembly and the elongated flexible medical assembly. The block device is fixed to a portion of the elongated flexible medical assembly. The outer diameter of the block device is larger than the inner diameter of the support lumen of the elongated support assembly. The block device is configured so as not to be inserted into the support lumen. The apparatus as described in Appendix 1, wherein the block device is movable so as to contact the proximal end of the elongated support assembly, and the elongated flexible medical assembly is prevented from advancing further into the elongated support assembly after the block device 1700 has been moved to contact the elongated support assembly. (Note 28) The biasing device is configured to control the movement between the elongated support assembly and the elongated flexible medical assembly. The biasing device is positioned proximal to the elongated flexible medical assembly. The biasing device is configured to abut against the end of the elongated flexible medical assembly. The elongated support assembly includes a stopper positioned within the support lumen of the elongated support assembly, The elongated support assembly also includes a pressing device 1804 positioned on the outer surface of the elongated support assembly. The stopper is coupled to the pressing device, The biasing device is configured to contact the stopper and be compressed by the stopper in response to the application of a compressive force to the biasing device. The stopper is configured to selectively move away from the biasing device when activated by the user of the pressing device. The user activation of the pressing device is performed such that the stopper moves so that the biasing device is released. The apparatus according to Appendix 1, wherein the release of the biasing device from its compressed state prompts the elongated flexible medical assembly to move forward, and after the stopper is released from the biasing device, the biasing device imparts forward motion to the elongated flexible medical assembly. (Note 29) The movable plunger is configured to control the movement between the elongated support assembly and the elongated flexible medical assembly. The operable plunger is located at the proximal end of the elongated support assembly, The operable plunger is located proximal to the elongated flexible medical assembly, The apparatus according to Appendix 1, wherein pressing the actuated plunger pushes the elongated flexible medical assembly proximal, causing the elongated flexible medical assembly to advance. (Note 30) The elongated support assembly includes a first region having a first rigidity, The first region of the elongated support assembly is configured to be positioned within the auxiliary lumen located proximal to the curved portion at the distal end of the auxiliary medical assembly. The elongated support assembly includes a second region having a second rigidity, The second region of the elongated support assembly is configured to be positioned in and beyond the curved region of the auxiliary medical assembly. The apparatus according to Appendix 1, wherein the first region of the elongated support assembly is relatively more rigid than the second region of the elongated support assembly so as to prevent distortion of any curvature at the distal end of the auxiliary medical assembly after (A) the first region of the elongated support assembly is positioned in the auxiliary lumen located proximal to the curved portion at the distal end of the auxiliary medical assembly, and (B) the second region of the elongated support assembly is positioned in and beyond the curved portion of the auxiliary medical assembly.
Claims
1. A device for use in transseptal procedures, wherein the device is An elongated auxiliary medical assembly having an auxiliary lumen and a distal end having a curved portion, An elongated support assembly that can be positioned inside the auxiliary lumen of the elongated auxiliary medical assembly, comprising an elongated support assembly having a hollow tube defining the support lumen, The elongated support assembly includes a first region having a first rigidity, The first region of the elongated support assembly is positioned within the auxiliary lumen and is configured to be located proximal to the curved portion of the auxiliary medical assembly. The elongated support assembly includes a second region having a second rigidity, The second region of the elongated support assembly is configured to be located distal to the curved portion of the auxiliary medical assembly. The first region of the elongated support assembly is relatively more rigid than the second region of the elongated support assembly so as to prevent distortion of the curved portion when the second region of the elongated support assembly is positioned distal to the curved portion of the auxiliary medical assembly. The apparatus further comprises an elongated, flexible medical assembly including a distal puncture device, The elongated support assembly is in a sliding relationship with the elongated flexible medical assembly, and the support lumen is configured to receive the elongated flexible medical assembly. The elongated support assembly is configured to support the elongated flexible medical assembly after it has been positioned in a sliding relationship with the elongated flexible medical assembly by providing rigidity to the elongated flexible medical assembly through the hollow tube, The elongated support assembly is selectively operable toward the distal portion of the elongated assistive medical assembly via the elongated assistive medical assembly. The aforementioned device further, A device configured to control movement between the elongated support assembly and the elongated auxiliary medical assembly, wherein the elongated support assembly is selectively operable toward the distal portion of the elongated auxiliary medical assembly while the elongated flexible medical assembly remains stationary relative to the elongated support assembly. An apparatus comprising: a device configured to control movement between the elongated support assembly and the elongated flexible medical assembly, wherein the elongated support assembly is at least partially held within the elongated auxiliary medical assembly while the elongated flexible medical assembly is extended outward from the distal portion of the elongated auxiliary medical assembly.
2. The apparatus according to claim 1, wherein the elongated flexible medical assembly is configured to remain stationary relative to the elongated flexible medical assembly while the elongated flexible medical assembly is selectively operable toward the distal portion during use, and while the elongated support assembly continues to support the elongated flexible medical assembly during use.
3. The apparatus according to claim 1, wherein the elongated support assembly is configured to increase the rigidity of the elongated flexible medical assembly and the rigidity of the elongated auxiliary medical assembly.
4. The apparatus according to claim 1, wherein the elongated auxiliary medical assembly includes a dilator assembly.
5. The apparatus according to claim 1, wherein the distal puncture device is a high-frequency puncture device configured to puncture biological features.
6. The proximal hub is the device configured to control the movement between the elongated support assembly and the elongated assistive medical assembly, The elongated support assembly includes the proximal hub, The proximal hub extends from the outer surface of the elongated support assembly, The proximal hub is configured to at least partially abut the entrance leading to the auxiliary lumen in response to the movement of the elongated support assembly toward the entrance leading to the auxiliary lumen, such that, as a result of the movement of the elongated support assembly, the proximal hub abuts the entrance leading to the auxiliary lumen of the elongated auxiliary medical assembly, and then the elongated support assembly is stopped from moving further along the auxiliary lumen. The proximal hub is configured to be movable toward the auxiliary lumen but unable to enter it. The apparatus according to claim 1, wherein the proximal hub is sized to be larger than the entrance of the auxiliary lumen of the elongated auxiliary medical assembly.
7. The rotatable element is the device configured to control the movement between the elongated support assembly and the elongated flexible medical assembly, The elongated support assembly includes the rotatable element, The rotatable element is located at the proximal end of the elongated support assembly and is rotatable about the longitudinal axis of the elongated support assembly. The rotatable element includes a flexible element positioned proximal to the support lumen of the elongated support assembly, The rotatable element is configured to change the amount of compression applied from the flexible element to the support lumen of the elongated support assembly, The apparatus according to claim 1, wherein the flexible element is configured to change the effective size of the support lumen of the elongated support assembly.
8. The sliding element is the device configured to control the movement between the elongated support assembly and the elongated flexible medical assembly, The elongated support assembly includes the sliding element, After the elongated flexible medical assembly is received within the elongated support assembly, the sliding element is configured to selectively frictionally contact the elongated flexible medical assembly, and the sliding element contacts the outer surface of the elongated flexible medical assembly during use. The sliding element is also configured to selectively move the elongated flexible medical assembly after selectively frictionally contacting the elongated flexible medical assembly during use. The sliding element is configured to be movable along the axial length of the elongated support assembly, The apparatus according to claim 1, wherein the elongated flexible medical assembly moves in response to the movement of the sliding element along the elongated support assembly while the elongated flexible medical assembly and the sliding element are in frictional contact with each other.
9. The proximal tapered portion is the device configured to control movement between the elongated support assembly and the elongated flexible medical assembly, The elongated flexible medical assembly includes the proximal tapered portion, The proximal tapered portion is located on the outer surface of the elongated flexible medical assembly and extends therefrom, The outer diameter of the proximal tapered portion is larger than the inner diameter of the support lumen of the elongated support assembly. The apparatus according to claim 1, wherein the proximal tapered portion is movable to abut against the proximal end of the elongated support assembly so that, during use, the proximal tapered portion contacts the end of the elongated support assembly, thereby preventing further advancement of the elongated flexible medical assembly, and as a result, the elongated flexible medical assembly does not advance any further.
10. The flexible region is the device configured to control movement between the elongated support assembly and the elongated flexible medical assembly, The flexible region is located within the proximal portion of the elongated support assembly, The elongated support assembly is configured to support the flexible region, The flexible region is configured to be pressed, When the flexible region is not being pressed, the elongated flexible medical assembly is movable within the elongated support assembly. The apparatus according to claim 1, wherein, in the compressed state of the flexible region, the flexible region interacts with the elongated flexible medical assembly positioned inside the support lumen so that the elongated flexible medical assembly is prevented from moving further along the support lumen of the elongated support assembly.
11. The block device is the device configured to control the movement between the elongated support assembly and the elongated flexible medical assembly, The block device is fixed to a portion of the elongated flexible medical assembly. The outer diameter of the block device is larger than the inner diameter of the support tube lumen of the elongated support assembly. The block device is configured so as not to be inserted into the support lumen. The apparatus according to claim 1, wherein the block device is movable so as to contact the proximal end of the elongated support assembly, and the elongated flexible medical assembly is prevented from advancing further into the elongated support assembly after the block device has been moved to contact the elongated support assembly.
12. The biasing device is configured to control the movement between the elongated support assembly and the elongated flexible medical assembly, The biasing device is positioned proximal to the elongated flexible medical assembly. The biasing device is configured to abut against the end of the elongated flexible medical assembly. The elongated support assembly includes a stopper positioned within the support lumen of the elongated support assembly, The elongated support assembly also includes a pressing device positioned on the outer surface of the elongated support assembly. The stopper is coupled to the pressing device, The biasing device is configured to contact the stopper and be compressed by the stopper in response to the application of a compressive force to the biasing device. The stopper is configured to selectively move away from the biasing device when activated by the user of the pressing device. The user activation of the pressing device is performed such that the stopper moves so that the biasing device is released. The apparatus according to claim 1, wherein the release of the biasing device from a compressed state prompts the elongated flexible medical assembly to move forward, and after the stopper is released from the biasing device, the biasing device imparts forward movement to the elongated flexible medical assembly.