Methods and device for puncturing tissue

Abstract

To provide a system and methods for forming a puncture in tissue.SOLUTION: A method and device are disclosed for puncturing tissue, comprising a puncture device for puncturing tissue and a support member for supporting the puncture device. The puncture device is capable of being insertable within the supporting member in co-operation with the support member during a portion of a procedure for puncturing tissue, where the puncture device is usable independently of the support member during another portion of the procedure. The puncture device comprises visual or tactile markers for determining the relative positioning between puncture device and supporting member.SELECTED DRAWING: Figure 5A

Description

Technical Field

[0001] The present disclosure relates to systems and methods for forming a puncture within a tissue. More specifically, the present disclosure relates to systems and methods for forming a puncture using an assembly that includes a puncture device and a support member.

Brief Description of the Drawings

[0002] To facilitate understanding of the present invention, embodiments of the present invention will be described by way of examples in the accompanying drawings.

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DETAILED DESCRIPTION OF THE INVENTION

[0017] To perform a transseptal procedure, it is necessary to gain access to the heart. Access can be obtained from a superior approach (specifically to the right atrium of the heart) (by obtaining access to the heart from an access point above the heart, for example, from the jugular vein through the superior vena cava), or access can be obtained from the femoral bone or an inferior approach (from an access point below the heart, for example, by accessing the heart through the inferior vena cava from the femoral vein). Once access to the right atrium is obtained, a puncture device is utilized to puncture through tissue across the septum of the heart, for example, to obtain access from the right atrium to the left atrium of the heart.

[0018] Some conventional transseptal procedures, for example, some transseptal procedures that use a subcostal approach to gain access to the heart, use a needle to perform a transseptal puncture. Certain limitations may be associated with the use of prior art devices for performing transseptal puncture procedures.

[0019] During a transseptal puncture procedure, there is a risk that other tissues of the heart may be inadvertently punctured before and after a perforation is formed, resulting in general tissue damage within the heart, damage to accessory devices (e.g., damage to a pacemaker lead located in the atrium), or potentially serious complications such as cardiac tamponade. Cardiac tamponade is a life-threatening complication of transseptal puncture that occurs when a perforation is formed in the left atrial wall, left atrial roof, or left atrial appendage. This perforation of the atrial wall results in the accumulation of fluid within the cardiac chambers surrounding the heart. This fluid accumulation compresses the heart and reduces the amount of blood that can enter the heart. Inadvertent aortic puncture is a rare life-threatening complication where the puncture device enters the aorta and may require surgical repair. Also, with some puncture devices, it is difficult to confirm the relative positioning between the puncture device and the support member. In some cases, visualization or mapping techniques can be used to confirm such positioning. However, visualization or mapping is not always readily available or desired.

[0020] In view of these potential complications associated with inadvertent puncture and the difficulties associated with determining the relative positioning between the puncture device and the support member, there is a need to provide a novel high-frequency puncture method and device that uses visual or tactile markers at the proximal end of the puncture device to evaluate the relative positioning between the puncture device (such as a high-frequency puncture device) and the reinforcement member (such as a sheath or dilator). In one embodiment, visual or tactile markers can be used for macro-positioning, while the radiopaque marker at the distal end can provide the ability to confirm or fine-tune the positioning by visualization or mapping techniques.

[0021] In one broad aspect, the inventors have discovered a system and method for providing an RF wire and a device for supporting it to facilitate transseptal puncture, for example, using a sub-apical approach.

[0022] In one broad aspect, the inventors of the present invention have developed various embodiments of a novel system and method that includes providing a puncture device having two components, namely (1) a puncture component or member that includes a marker at its proximal end, and (2) a substantially rigid and / or sturdy support member that is removable or independent from the puncture component or member and that enables the support member to be selectively used with the puncture device. In one embodiment, the puncture component or member includes a substantially flexible tissue puncture component or member. The substantially flexible tissue puncture component or member can be substantially non-traumatic. Additionally, the substantially flexible tissue puncture component or member may have a radiopaque marker at its distal end, a visual or tactile marker at its proximal end, or both. In one embodiment, the substantially flexible tissue puncture component or member is a radiofrequency (RF) wire.

[0023] Accordingly, in some embodiments, the puncture component or member can be separated from the substantially rigid and / or sturdy support member. The two components are operable independently and form an assembly, thereby providing two distinct and independent functions, namely, (i) the function of puncturing tissue with a substantially flexible and / or non-traumatic component (such as, but not limited to, a flexible energy delivery device), and (ii) the function of supporting the substantially non-traumatic puncture component using a substantially rigid or sturdy component. Additionally, visual or tactile markers may be provided to determine the relative positioning between the puncture component and the support member. These markers can be used alone or in combination with a radiopaque marker provided at the distal tip of the puncture component.

[0024] The advantages of the embodiments described herein can include one or more of the following.

[0025] -Enable the user to visually or tactually identify the relative positioning between a substantially flexible puncture device and a substantially rigid support member by using a marker at the proximal end of the substantially flexible puncture device.

[0026] -Use a combination of visual / tactile markers and visualization / mapping techniques to enable both macro-adjustment and micro-adjustment of the positioning between a substantially flexible puncture device and a substantially rigid support member.

[0027] -Enable the substantially flexible puncture device to function as an exchange wire by enabling it to be used separately from the substantially rigid support member.

[0028] -Enable the substantially flexible puncture device to be used in cooperation with the substantially rigid support member, allowing sufficient force transmission and / or torque to be transmitted to the distal tip of the assembly (e.g., facilitating a dropping procedure and identifying the position of a cavity as described below), and providing appropriate support to facilitate puncture (using the substantially flexible puncture device and facilitating intersection with the substantially flexible puncture device).

[0029] -Enable the use of the substantially flexible puncture device separately from the substantially rigid support member as a guide wire.

[0030] -Enable the substantially flexible puncture device to be used separately from the substantially rigid support member, providing a non-invasive tip and reducing the amount of force required to puncture tissue, for example, by using energy delivery instead of mechanical force, thereby minimizing the risk of damage to tissue on the left side of the heart.

[0031] - Remove or retract a substantially rigid support member to enable repositioning of the assembly relative to the target tissue site, thereby enabling the substantially rigid support member to be advanced again onto a substantially flexible energy delivery device, for example, to repeat a drop-off procedure in a transseptal puncture for positioning the assembly relative to a cavity.

[0032] - Enable removal of a substantially rigid support member such as a needle shaft after puncture, and enable a substantially flexible and atraumatic energy delivery device to remain positioned on the left side of the heart to maintain access to the left side of the heart, thereby enabling it to be used as an anchor after puncture and further enabling tracking of an additional device through a puncture device for guiding to the left side of the heart.

[0033] In one embodiment, an assembly for a transseptal puncture procedure and for improving treatment efficiency by facilitating exchange and positioning is provided. The assembly includes a puncture device for puncturing tissue and a support member for supporting the puncture device. The puncture device includes at least one proximal marker positioned at the proximal end of the puncture device and at least one distal tip marker visible under an imaging system. The support member includes a lumen for receiving the puncture device and a distal tip marker visible under the imaging system. The puncture device is insertable into the lumen of the support member and is selectively usable in cooperation with the support member during a portion of a procedure for puncturing tissue. Also, the puncture device is usable independently of the support member during another portion of the procedure. When the puncture device is inserted into the lumen, the at least one proximal marker enables positioning of the puncture device relative to the proximal end of the support member. At the same time, the at least one distal tip marker of the puncture device and the at least one distal tip marker of the support member enable positioning of the puncture device relative to the support member by using the imaging system.

[0034] In one embodiment, the imaging system is a fluoroscopy system, and the distal tip marker and the distal marker are visible under fluoroscopy.

[0035] In a further embodiment, the puncture device includes a conductive mandrel, and at least one proximal marker covers the proximal portion of the mandrel. In some such embodiments, a transparent or translucent insulating layer covers the mandrel and at least one proximal marker, but does not cover the distal end of the mandrel such that the distal end of the mandrel is electrically exposed to define a distal tip electrode. In some such embodiments, the portion of the elongate puncture device at and adjacent to at least one proximal marker has a constant diameter.

[0036] In yet a further embodiment, the mandrel is surrounded by an oxide coating covered by a transparent insulating layer, and at least one proximal marker includes a portion of the mandrel that is not covered by the oxide coating such that the portion defines a visible marker. In some such embodiments, the visible marker is formed by mechanical grinding of the oxide coating. In some such embodiments, the oxide coating is composed of titanium oxide.

[0037] In another embodiment, the mandrel is surrounded by a PTFE coating, and at least one proximal marker includes at least one pad-printed marker on the PTFE coating that defines a visible marker, and the PTFE coating and at least one pad-printed marker are beneath a transparent or translucent insulating layer.

[0038] In yet another embodiment, at least one proximal marker includes a pad-printed marker on the mandrel that defines a visible marker. In some such embodiments, the pad-printed marker is beneath a transparent or translucent insulating layer.

[0039] The transparent or translucent layer may include a heat-shrinkable layer. In some such embodiments, the layer is composed of polytetrafluoroethylene.

[0040] The mandrel may be composed of a composite structure of nitinol, stainless steel, or a distal portion composed of nitinol and a proximal portion composed of stainless steel.

[0041] In some embodiments, the puncture device can include one or more of the following. - Non-traumatic distal tip - A radiopaque coil extending around the curve of the distal end portion having a J-shaped outer profile - The end of the radiopaque coil that can be used as a distal tip marker - A radiopaque coil having echo characteristics that enables visualization of the guide wire tip using ultrasound

[0042] In one embodiment, at least one proximal marker is an elongated marker including a leading edge and a trailing edge. In some such embodiments, when the leading edge is aligned at a predetermined distance from the proximal end of the support member, the distal tip of the puncture device is within the lumen of the support member. When the trailing edge of the proximal marker is aligned at a predetermined distance from the proximal end of the support member, the distal tip of the puncture device is exposed from the distal end of the support member. In some such embodiments, the elongated marker further includes a midpoint, and the distal tip of the puncture device is substantially aligned with the distal tip of the support member when the midpoint is aligned at a predetermined distance from the proximal end of the support member. In some such embodiments, the predetermined distance is from about 0 cm to about 5 cm. In other such embodiments, the predetermined distance is from about 0 cm to about 1 cm. In some embodiments, the elongated marker includes a midpoint marker for identifying the midpoint.

[0043] In some embodiments, the puncture device is an energy-based puncture device. In some such embodiments, the puncture device is a high-frequency wire.

[0044] In yet another embodiment, a method for confirming the position of the distal tip of a transseptal puncture device relative to a support member is provided. The transseptal puncture device has at least one proximal marker visible to the naked eye and a distal tip marker visible under an imaging system, and the support member has a distal end marker visible under the imaging system. In this embodiment, the following steps are provided. (i) In a macro-positioning step, without using the imaging system, use the proximal marker to position the elongate transseptal puncture device relative to the proximal end of the support member (ii) Turn on the imaging system (iii) Use the imaging system in a micro-positioning step to position the distal tip of the elongate transseptal puncture device relative to the end of the introducer by viewing the distal tip marker and the distal end marker.

[0045] In some such embodiments, the imaging system is a fluoroscopy system, and the distal tip marker and the distal end marker are visible under fluoroscopy.

[0046] In some embodiments, a method for puncturing a target tissue with a puncture device including at least one proximal marker is provided. In this embodiment, the following steps are provided. (i) Access a region of tissue within a patient's body by advancing the puncture device into the region of tissue (ii) Advance a support device over the puncture device to support the puncture device, the support device including a lumen for receiving the puncture device (i) In a macro-positioning step, without using the imaging system, use the proximal marker to position the puncture device relative to the proximal end of the support member (iv) Position the distal end of the puncture device and the distal end of the support member at the target tissue site (v) Puncture the target tissue site using the puncture device, the support member supporting the puncture device through the puncture.

[0047] In some embodiments, step (iii) further includes using a proximal marker to determine that the distal tip of the puncture device is exposed from the distal end of the support device. In other embodiments, step (iii) further includes using a proximal marker to determine that the distal tip of the puncture device is within the lumen of the support device.

[0048] In some embodiments, the method for puncturing tissue is a method for performing a transseptal procedure. The puncture device is a transseptal puncture device and the target tissue is the fossa ovalis of the heart. In this embodiment, - Step (i) includes advancing the transseptal puncture device into the superior vena cava. - Step (iv) includes dropping the transseptal puncture device and the support device from the superior vena cava into the patient's heart to identify the location of the fossa ovalis along the septum of the heart and position the device in the fossa ovalis. - The puncture step (v) includes puncturing the fossa ovalis to gain access to the left side of the heart.

[0049] In some embodiments, the method for puncturing tissue further includes positioning the puncture device relative to the support member using a proximal marker such that the distal tip of the puncture device is exposed from the distal end of the support member. In some such embodiments, the method may also include turning on an imaging system and using the imaging system in a micropositioning step to position the distal tip of the elongate transseptal puncture device relative to the end of the introducer by viewing a distal tip marker and a distal end marker. In this way, the proximal marker may be used in a macropositioning step and the imaging system may be used in a micropositioning step.

[0050] In some such methods as described above, the puncture device is an energy-based puncture device. The energy-based puncture device may be a high-frequency wire.

[0051] In some embodiments of the above method, the assembly used to implement the method may further include a stylet. The stylet and the puncture device may be connected together to provide a needle assembly, and this assembly is used as a more rigid puncture device.

[0052] In another embodiment of the method for puncturing tissue, the method comprises - advancing a flexible puncture device including a proximal marker into the tissue area; - advancing a sheath and a support member over the flexible puncture device into the tissue area; - removing the flexible puncture device from the support member by using the proximal marker to determine the relative position between the flexible puncture device and the support member; - positioning the flexible puncture device, the sheath, and the support member as an assembly at a target tissue site within the tissue area; - applying pressure to the target tissue site using the support member; - advancing the flexible puncture device to the puncture position using the proximal marker and determining the relative position between the flexible puncture device and the support member; - forming a puncture at the target tissue site and advancing the flexible puncture device through the puncture; - advancing the sheath and the support member over the flexible puncture device and crossing them through the puncture.

[0053] In another embodiment of the method for performing a transseptal procedure, the method comprises - advancing an RF guide wire including a proximal marker into the superior vena cava; - advancing a sheath and a dilator into the superior vena cava via the RF guide wire to form an assembly; - removing the RF guide wire from the dilator by using the proximal marker to determine the relative position between the flexible puncture device and the support member; - Drop the assembly from the superior vena cava into the heart to identify the position of the fossa ovalis on the septum of the heart, and - Use an expander to tent the fossa ovalis, and - By using a proximal marker, advance the RF guide wire to the puncture position for puncturing the fossa ovalis to determine the relative position between the flexible puncture device and the support member, and - Use the energy delivered by the RF guide wire to puncture the fossa ovalis, and - Advance the RF guide wire through the puncture, and - Advance the sheath and expander through the RF guide wire to cross the sheath and expander through the puncture, including.

[0054] Referring specifically to the drawings in detail here, it is emphasized that the details shown are exemplary and are only for the purpose of an exemplary consideration of specific embodiments of the present invention. Before explaining at least one embodiment of the present invention in detail, it should be understood that the present invention is not limited to the details of the construction and arrangement of the components described in the following description or shown in the drawings in its application. The present invention is capable of other embodiments or can be implemented or executed in various ways. Also, it should be understood that the expressions and terms used herein are for the purpose of explanation and should not be regarded as limiting.

[0055] Some embodiments of the system provide a two-part assembly including a flexible RF component and a rigid support member to improve the system's usability. Rigid members, such as stiffening members, are separate and removable from the flexible RF component (such as the RF wire), allowing them to be introduced independently of the flexible RF wire. This provides flexibility in a manner that allows the use of two components and a combination of RF wire and stiffening member. Initial advancement of the flexible RF wire in the absence of the stiffening member eliminates the need for a separate exchange wire or guidewire used for initial access into the SVC (superior vena cava). The stiffening member can be advanced into the SVC to provide rigidity to the assembly and facilitate a drop procedure to locate the cavity. If the initial pass to locate the cavity is not successful, the two-part assembly allows partial removal or withdrawal of the rigid support member to allow the RF wire to be repositioned. The rigid support member can then be re-advanced to provide sufficient rigidity and force transmission to repeat the drop procedure to locate the cavity and provide sufficient support to facilitate puncturing and crossing tissue using the RF wire. Thus, the rigid support member functions to facilitate transseptal puncture using the RF wire and further facilitate crossing to the left side after the puncture is complete. The reinforcing member can then leave the flexible RF wire on the left side of the heart. The flexible RF wire can be used independently of the reinforcing member to facilitate fixation of the left atrium of the heart and to facilitate tracking of additional devices. This reduces the number of exchanges required (i.e., no separate exchange or guidewire needs to be used to fix or track other devices) and minimizes the risk of embolism and / or trauma. Thus, the reinforcing member can be selectively introduced for portions of the procedure requiring rigidity and then removed (partially or completely) to facilitate the remainder of the procedure. Furthermore, because the reinforcing component is provided separately from the flexible RF wire, the reinforcing component may be re-advanced or reinserted as needed to complete aspects of the procedure.

[0056] According to some embodiments of the present invention, details of the RF wire are disclosed in International Application No. IB2013 / 060287 and International Publication No. 2015019132, which are hereby incorporated by reference in their entirety. Additionally, according to some embodiments of the present invention, details of a support member that can be used with a piercing device such as an RF guide wire are disclosed in International Application No. ib2017 / 056777 and International Publication No. 2018083599, which are hereby incorporated by reference in their entirety.

[0057] In some embodiments of the present invention, the assembly is provided for piercing tissue, and the assembly includes a substantially flexible piercing device (such as an energy-based piercing device that is substantially non-invasive) for piercing tissue via delivery of energy. The assembly further includes a support member for supporting a substantially flexible piercing device such as a rigid needle shaft. In some such examples, the support member includes a reinforcing member (which may form the needle shaft). The support member can be selectively used with the substantially flexible piercing device and is removable or detachable from the substantially flexible piercing device. Additionally, the substantially flexible piercing device is operable to pierce tissue independently of the support member. In some such examples, the substantially flexible piercing device is an energy-based device for delivering energy to pierce tissue.

[0058] The assembly enables a substantially flexible energy-based puncture device to be used independently from a support member and to be used in cooperation during a portion of the procedure. This allows a flexible energy-based puncture device to be used for tissue puncture and as an exchange wire, reducing the number of exchanges required. The puncture device advantageously includes a non-invasive tip for puncturing tissue when utilizing RF energy to puncture the tissue. Separating the energy delivery portion of the assembly from the support member enables removal of the support member if the flexible energy-based puncture device is not positioned at the desired target location, enables repositioning of the substantially flexible energy-based puncture device, enables the support member to be advanced again over the substantially flexible energy-based puncture device, facilitates positioning of the energy delivery portion of the flexible puncture device relative to the desired target tissue location, further reduces the complexity of the procedure, and improves the procedure efficiency. Example 1 An assembly including a puncture device and a support member

[0059] In some embodiments, as shown in FIGS. 1A and 1B, the present invention provides an assembly 100 for puncturing tissue, such as for forming a transseptal puncture through a cardiac septum. The assembly provides a tissue puncture or puncture device 110 and a separate support member 130 that can be selectively used with the tissue puncture device 110 to support the puncture device 110. The puncture device 110 can be selectively used in cooperation with the support member 130 during one or more portions or steps of the procedure, and the puncture device 110 can be used independently from the support member 130 during another one or more portions or steps of the procedure for puncturing tissue. In some such embodiments, providing a separate puncture device 110 and a support member 130 selectively chosen therefor further improves the procedure efficiency by facilitating exchange and positioning.

[0060] Referring again to FIGS. 1A and 1B, in some embodiments, an assembly 100 for piercing tissue is provided, the assembly 100 including a substantially flexible piercing device 112 for piercing tissue, as further contemplated below, and a support member 130 for supporting the substantially flexible piercing device. A substantially flexible piercing device 112 similar to the embodiments contemplated above herein is selectively insertable within the support member 130 and is selectively usable in cooperation with the support member 130 during a portion of the procedure, and the substantially flexible piercing device 112 is usable independently of the support member 130 during another portion of the procedure to facilitate piercing, exchanging, and positioning of the tissue. In some such examples, the substantially flexible piercing device 112 includes an energy delivery device operable to deliver energy to pierce the tissue. In some such examples, the support member 130 includes a reinforcing member 34, as described in further detail below.

[0061] In one such example, the assembly 100 includes a needle assembly for piercing tissue, the needle assembly including a piercing device 110 and a support member 130. In some such embodiments of the needle assembly, the piercing device includes a substantially flexible piercing device 112, as shown in FIGS. 1A and 1B.

[0062] In a particular example of the needle assembly as shown in FIG. 1A, the piercing device 110 includes a substantially atraumatic distal tip 112d and the piercing device 110 is substantially atraumatic. Referring again to FIG. 1A, in some embodiments, the piercing device 110 includes an energy-based piercing device 114, such as a substantially flexible energy-based piercing device 114 having an energy delivery portion or component 114d at its distal tip for delivering energy to pierce the tissue. In a particular example of this embodiment, the piercing device 110 includes a flexible (high-frequency) RF guide wire 10 having a distal electrode tip 10d for delivering high-frequency energy to pierce the tissue.

[0063] In some cases, the RF guide wire 10 is a flexible wire that is generally electrically insulated for a selected distal region such as the distal electrode tip 10d.

[0064] In a particular embodiment of the needle assembly as shown in FIG. 1A, the piercing device includes a mechanical piercing device 118. In some such embodiments of the needle assembly, the mechanical piercing device 118 includes a relatively sharp distal tip 118d for piercing tissue.

[0065] As shown in FIGS. 1A and 1B, in some such embodiments of an assembly 100 such as a needle assembly, the support member includes a reinforcing member. In some such embodiments, as shown, the support member 130 includes a needle shaft 132 that includes a reinforcing member 34 for supporting the piercing device 110. In some such embodiments, the needle shaft 132 can provide or have the characteristics of a mechanical needle. In a particular example, a reinforcing member [such as a metal hypodermic tube] having one or more polymer layers is structured to form the needle shaft 132. Support member including needle shaft / reinforcing expander

[0066] In one broad aspect, embodiments of the present invention provide an assembly 100 for piercing tissue, the assembly 100 including a substantially flexible energy-based (or energy delivery) piercing device 114 for piercing tissue via energy delivery and a support member 130 for supporting the substantially flexible energy delivery piercing device 114. The substantially flexible energy delivery piercing device 114 is selectively insertable within the support member 130 and is selectively usable in cooperation with the support member 130 during a portion of the procedure, and the substantially flexible energy delivery piercing device 114 is usable independently of the support member 130 during another portion of the procedure, facilitating exchange and positioning while providing a substantially non-invasive piercing of the tissue. In one example, the support member 130 includes a reinforcing member 34.

[0067] In such an embodiment, referring now to the embodiment shown in FIG. 1A, the assembly 100 includes a substantially flexible energy delivery piercing device or component 114 that is provided separately from and is operable independently of the support member 130. In such an example, the flexible energy delivery piercing device or component 114 (also referred to as a flexible energy-based delivery device or a flexible energy delivery piercing device) includes a radio frequency (RF) guide wire 10. Also, a separate support member 130 includes a needle shaft 132 that includes a reinforcing member 34 and one or more polymer layers 38 that form the polymer shaft 39 of the dilator 30A, and the reinforcing member 34 is substantially surrounded by one or more polymer layers. Piercing device including a modified electrode tip

[0068] In the illustrated embodiment, the RF guide wire 10 includes an electrode for delivering radio frequency energy. In a particular example, as shown, the RF guide wire 10 has a distal electrode tip 10d for delivering radio frequency energy to pierce tissue. In some such embodiments, the distal electrode tip 10d is substantially non-invasive to reduce the pressure applied to the tissue. In such an example, the distal electrode tip of the RF guide wire 10 includes a substantially dome-shaped electrode tip that is substantially non-invasive to reduce the pressure applied to the tissue.

[0069] In some such embodiments, referring to FIG. 1A, the RF guide wire 10 may include a hemispherical electrode tip 10d that, in some embodiments, is formed distal to and adjacent to the cylinder 10c and can form a cap. In other words, the electrode tip 10d may be defined by a dome such as a substantially complete circular dome over the cylinder 10c. In some such embodiments, the outer diameter of the dome may be substantially the same as the outer diameter of the cylinder 10c. This can help provide a substantially atraumatic distal interface with the tissue to minimize the risk of trauma and / or damage at the desired target tissue site. In some such embodiments, the dome-shaped distal electrode tip 10d of the RF guide wire 10 reduces the amount of pressure applied by the tissue's distal tip, making the tip more atraumatic and spreading the force applied by the distal tip over a larger area. In some such embodiments, the RF guide wire 10 is provided as a 0.035-inch wire.

[0070] More specifically, referring to FIGS. 1A and 1C, the assembly further includes a sheath 10 and a support member including a reinforcing dilator such as dilator 30A that can be used with a flexible RF wire, the dilator 30A including a reinforcing member 34 and one or more polymer layers 38 that define a polymer shaft 39 of the dilator 30A, the reinforcing member 34 being substantially surrounded by the one or more polymer layers 38.

[0071] In some such embodiments of the present invention, the assembly 100 is provided for piercing tissue, and the support member 130 includes a needle shaft 132, the needle shaft 132 includes a reinforcing member 34 and one or more polymer layers 38, and the reinforcing member 34 is substantially surrounded by the one or more polymer layers 38. In some such embodiments, the needle shaft 132 is provided within the dilator 30A. Thus, in some embodiments, the support member is provided as part of the dilator 30A or includes the needle shaft 132 defined by the dilator 30A, and the needle shaft 132 is embedded within or surrounded by the one or more polymer layers 38 of the dilator 130.

[0072] Details of the reinforcing member 34 are shown in FIG. 1C. More specifically, FIG. 1C shows a support member 130 including a reinforcing dilator 30A having a needle shaft 132, the support member 130 being provided separately from a substantially flexible tissue piercing device or member 112, such as an energy-based tissue piercing device 114, such as an RF guide wire 10. In one example, the needle shaft 132 is provided as part of the dilator 30A or, in other words, is defined by the dilator 30A. In some such examples, the needle shaft 132 (and thus the dilator 30A defining the support member 130) is provided as a non-piercing component for supporting the tissue piercing device or member. In some such examples, the dilator 30A including the needle shaft 132 includes a proximal portion 31 that terminates at the distal tip 41. In some such embodiments, the reinforcing member 34 provides sufficient rigidity substantially similar to that of a rigid needle.

[0073] In some such embodiments, the expander shaft 32 extends along the proximal portion 31 and includes a reinforcement member 34. In the particular embodiment shown, the reinforcement member 34 is substantially surrounded by one or more polymer layers 38. In some such embodiments, the reinforcement member 34 is embedded within one or more polymer layers 38 that include an inner polymer layer and an outer polymer layer. In some such embodiments, the inner polymer layer and the outer polymer layer include an inner tubular member 35 and an outer tubular member 37 of the expander shaft 32. In some such embodiments, it can be interpreted that the reinforcement member 34 is substantially surrounded on its outside or externally by one or more polymer layers 38 that form a polymer shaft 39 (forming the expander shaft 32) around the reinforcement member 34. In some embodiments, the expander 30A may further include a radiopaque marker 42 at the distal tip 41. In one example, the reinforcement member 34 includes a hypo tube such as a metal hypo tube. In such an example, the reinforcement member 34 includes a stainless steel hypo tube and the inner tubular member 35 and the outer tubular member 37 include HDPE. The support member includes a hypo tube that defines an inner lumen

[0074] In such an example, the reinforcement member 34, such as a stainless steel hypo tube, extends longitudinally within one or more polymer layers, for example, within the inner tubular member 35 and within the outer tubular member 37 as shown in FIG. 1C. Thus, the reinforcement member 34 (e.g., the hypo tube) defines the inner lumen of the support member 130.

[0075] In one embodiment, referring again to FIG. 1C, the support member 130 has one or more polymer layers 38 that include an inner polymer layer and an outer polymer layer, and in some embodiments, may include an inner tubular member 35 and an outer tubular member 37. In a particular example, the reinforcement member 34 is substantially surrounded by one or more polymer layers 38 along its exterior as described above. In other embodiments, the reinforcement member 34 is substantially surrounded by one or more polymer layers 38 such that, for example, as defined by the inner tubular member 35 and the outer tubular member 37 shown in FIG. 1D, the reinforcement member 34 is positioned between the inner polymer layer and the inner polymer layer (in some embodiments, the hypotube is positioned between or sandwiched between two layers of polymer). In other words, the reinforcement member 34 is substantially surrounded by the inner polymer layer and the outer polymer layer and is embedded in both the inner polymer layer and the outer polymer layer. In other words, the reinforcement member 34 is sandwiched between or positioned between the inner and outer polymer layers 38 and thus the polymer shaft 39 that forms the dilator shaft 32. In some such embodiments, the inner tubular member 35 and the outer tubular member 37 include high density polyethylene (HDPE).

[0076] In some embodiments of the transseptal assembly 100, the sheath 10 includes a standard transseptal sheath, the needle shaft 132 (provided as part of the dilator 30A or defined by the dilator 30A) includes a reinforcement member 34, and the RF guide wire or RF wire is provided as a 0.035-inch wire. In some such embodiments, the RF wire includes a J-tip wire, or in another embodiment, the RF wire includes a pigtail wire.

[0077] In some such embodiments of the present invention, the reinforcement member 34 includes a distal end 34D and a proximal end 34P, and the reinforcement member 34 extends into the inner lumen of the dilator 30A as shown in FIG. 1C. In some such embodiments, the assembly 100 provides a substantially gapless interface at the junction between the reinforcement member between the distal end and the proximal end and the one or more polymer layers. In some such examples, the reinforcement member 34 is fixed within one or more polymer layers 38 that form the polymer shaft 39 of the dilator 30A. In such an example, the reinforcement member 34 is substantially fixed to the one or more polymer layers 38 of the dilator 30A at its distal and proximal ends (in other words, the reinforcement member distal end and the reinforcement member proximal end), and provides a substantially gapless interface at the junction between the reinforcement member 34 and the one or more polymer layers 38 reinforcement members at the distal and proximal ends. The drawing shows the interface at the distal end of the reinforcement member 34. A similar interface is provided at the proximal end of the reinforcement member 34. In some such embodiments of the present invention, the reinforcement member 34 is substantially sealed to the one or more polymer layers 38 of the dilator 30A at its distal and proximal ends (in other words, the reinforcement member distal end and the reinforcement member proximal end). In some such embodiments, by substantially eliminating the gap between the reinforcement member 34 and the polymer shaft 39 of the dilator 30A, blood or other liquids can be prevented from entering between the reinforcement member 34 and the polymer shaft 39. Support member that provides force transmission / torque

[0078] The support member 130 provides rigidity to a piercing device, such as an RF wire, to enable force transmission such that force is transmitted to the distal end of the assembly 100. The support member 130 provides the piercing device with sufficient rigidity to enable torque to be transmitted to the distal end of the assembly. Reinforcement member that provides force transmission / torque

[0079] In some such embodiments, the reinforcement member 34 provides sufficient rigidity to the support member 130 to enable sufficient force transfer to transmit a force to the distal end of the assembly 100. More specifically, the reinforcement member 34 enables sufficient force transfer such that a substantially flexible piercing device 112 (such as a substantially flexible energy-based piercing device 114 like the RF wire 10) and the support member 130 together provide sufficient rigidity to the assembly 100 to enable a force to be transmitted to the distal end of the assembly 100 (and thus to enable a force to be transmitted to the distal end of the substantially flexible piercing device 112).

[0080] Accordingly, the reinforcement member 34 can impart force transfer capability to the substantially flexible RF wire 10, and the substantially flexible RF wire 10, when used with the support member 130, enables a force to be transmitted to the distal end of the assembly 100, for example, to engage tissue at a target tissue site. Accordingly, the reinforcement member 34 functions as a force transfer portion of the assembly 100.

[0081] In some such embodiments, the assembly 100 further includes a sheath 20 as shown in FIG. 1A, the sheath 20 being usable with the support member 130 and providing rigidity to the assembly 100 to facilitate the force transmitted to the distal end of the assembly 100.

[0082] In some such embodiments of the present invention, the reinforcement member 34 provides sufficient rigidity to enable torque to be transmitted to the distal end of the assembly 100. Accordingly, the reinforcement member 34 provides sufficient rigidity to the assembly, and a substantially flexible piercing device 112 such as a substantially flexible energy-based piercing device 114 and the support member 130 together provide sufficient rigidity to the assembly 100 to enable torque to be transmitted to the distal end of the assembly 100 (and thus to enable torque to be transmitted to the distal end of the substantially flexible piercing device 112).

[0083] Some such embodiments of the present invention facilitate diaphragmatic puncture, with the reinforcement member 34 providing sufficient rigidity to the assembly 100 to allow sufficient force transmission to engage a desired tissue site (such as the cardiac septum). In some such examples, the support member 130 provides the substantially flexible puncture device 112 with force transmission capabilities that allow for force transmission when the substantially flexible puncture device 112 is used with the support member 130.

[0084] In some such embodiments, the assembly 100 further includes a sheath 20, as shown in FIG. 1A, which can be used with the support member 130 to provide rigidity to the assembly 100 and allow torque to be transmitted to the distal end of the assembly 100.

[0085] In some such embodiments, the sheath 20 may be coupled to the dilator 30A, thereby enabling force and / or torque transmission using one or more of the components (i.e., the sheath 20 or the dilator 30A). In other words, the user may not need to manipulate the sheath 20 and the dilator 30A (the user may simply manipulate the sheath 20 or the dilator 30A), and the RF guidewire 10 will follow the guidance and / or direction of the sheath 20 and / or the dilator 30A. In some such embodiments, the sheath 20 has some contribution to the overall torque. In some such embodiments, torquing the sheath 20 and / or the dilator 30A allows the stiffening member 34 to be torqued along with it. Strength of reinforcement members

[0086] In some embodiments of the present invention, the force transmitting portion of the assembly 100 has a resistance of at least about 0.0085 Nm 2 , for example, about 0.0115 Nm 2 In some embodiments of the invention, the force transfer portion of the assembly has a bending stiffness of at least about 0.0115 Nm to allow sufficient force transfer to allow the force to be transmitted to the distal end of the assembly 100. 2It is a support member 130 having firmness or rigidity with a bending stiffness value. In some such embodiments, the support member has a bending stiffness of about 0.0085 Nm 2 to about 0.0145 Nm 2 In one such embodiment, the support member 130 has a bending stiffness of at least about 0.0085 Nm 2 , for example, about 0.0115 Nm 2 and is a reinforcing expander 30A having a bending stiffness of about 0.0085 Nm 2 to about 0.0145 Nm 2 In one such embodiment, the reinforcing expander 30A is, for example, as provided in Example 1, as provided with respect to FIGS. 2A-2G

[0087] In some such embodiments, the support member 130 imparts rigidity or firmness to an assembly 100 that includes a piercing device, such as a substantially flexible piercing device, and functions to provide a force transmission ability to an assembly that includes a piercing device, such as a substantially flexible piercing device

[0088] In some embodiments, the bending stiffness value provided to the support member 130 can also be used in Example 2 provided herein with respect to FIGS. 4A-4G

[0089] In some embodiments of the present invention, the force transmission portion of the assembly is a support member 130 that is a reinforcing member including a stylet. The stylet has firmness or rigidity with a bending stiffness value of at least about 0.008 Nm 2 , for example, about 0.015 Nm 2 and enables sufficient force transmission to transmit force to the distal end of the assembly 100. In some such embodiments, the support member has a bending stiffness of about 0.008 Nm 2 to about 0.024 Nm 2 Firmness of the Piercing Device

[0090] ​In some embodiments of the present invention, the distal portion of a piercing device, such as a substantially flexible piercing device, has a distal portion or distal region bending stiffness. In some such examples, a substantially flexible RF guide wire 10 is provided, and the substantially flexible RF guide wire 10 has a distal portion [including along the distal electrode tip 10d], and the RF guide wire 10 has a distal portion stiffness defined by a bending stiffness of at least about 3.57×10 -6 Nm 2 , for example about 4.76×10 -6 Nm 2 . In some embodiments of the present invention, the RF guide wire 10 has a distal portion stiffness or rigidity with a bending stiffness of about 3.57×10 -6 Nm 2 to about 5.95×10 -6 Nm 2 .

[0091] In some such examples, the distal region of the RF guide wire 10 tapers from the proximal region of the RF guide wire 10 over a distance of about 12 cm to 15 cm. In other words, the distal portion of the RF guide wire 10 has a length of about 12 cm to about 15 cm. In some such examples, the distal portion of the RF guide wire 10 is the thinnest point of the RF guide wire 10.

[0092] In some such embodiments, the substantially flexible RF guide wire 10 has a proximal portion with a proximal portion bending stiffness of less than about 0.00179 Nm, for example about 0.00143 Nm 2 . In some embodiments of the present invention, the RF guide wire 10 has a proximal portion stiffness or rigidity with a bending stiffness of about 0.00107 Nm 2 to about 0.00179 Nm 2 2 .

[0093] In some embodiments of the present invention, for the substantially flexible piercing device, the RF guide wire 10 has a bending stiffness of about 2.0×10 -6 to about 1.4×10 -3 Nm 2 ​It has a certain bending stiffness. In some such embodiments, the RF guide wire 10 has a wire diameter of from about 0.127 mm to about 0.635 mm. Shape capabilities of the support member / reinforcement member

[0094] The reinforcement member 34 is shaped such that the support member 130 (e.g., provided as part of the reinforcement expander 30A or including the needle shaft 132 defined by the reinforcement expander 30A) can be removed from a substantially flexible energy delivery piercing device 110 (such as the RF wire 10) and reshaped so that the curve of the support member 130 can be reinserted to optimize the position of the assembly 100 relative to a target tissue site such as the fossa ovalis of the heart septum. In other embodiments, the support member 130 includes a stylet 60 provided separately from the expander 30A (which imparts shapeability to the assembly 100 as described in embodiments further described hereinbelow). In other words, the stylet 60 functions to impart a desired curvature and rigidity to the assembly 100 when used with the assembly 100. The stylet 60 is removable from the assembly, reshaped to provide a desired curvature to the assembly 100, and can be reinserted into the assembly 100. Connection between the expander and the sheath (locking feature)

[0095] In some embodiments of the present invention, referring now to FIG. 1C, an assembly 100 is provided that includes a sheath 20 as shown in FIG. 1A for use therewith during a portion of the procedure in conjunction with a reinforcement expander 30a for use therewith during a portion of the procedure. In some such embodiments, the assembly 100 includes a locking mechanism that allows for axial and rotational connection between the expander 30A and the sheath 20 for a portion of the procedure. In some embodiments of the present invention, the locking mechanism allows for a cooperative engagement between the sheath 20 and the expander 30A to provide rotational and axial connection. This can help minimize the risk of rotational misalignment between the sheath 20 and the expander 30A, and thus can reduce the risk of confusion resulting from misalignment.

[0096] Referring now to FIG. 1E, a support member 130 including a needle shaft 132 (provided as part of the dilator 30A or defined by the dilator 30A) includes a dilation hub 51 that is operable to be coupled to the sheath hub 21 for a portion of the procedure. In one embodiment, as shown in FIG. 1F, a locking mechanism is provided that includes one or more keys 52 for cooperatively engaging corresponding features (such as key receiving features) on the sheath hub 21 that allow for axial and rotational locking of the dilation hub 51 with the sheath 20. Thus, in some embodiments of the present invention, a locking mechanism is provided that allows for axial and rotational connection of the dilator and the sheath for a portion of the procedure. In some embodiments, a steerable sheath is provided, and the steerable sheath 20 may be an 8Fr steerable sheath. Alternatively, an 8.5Fr steerable sheath 20 may be provided. In some such embodiments, the steerable sheath 20 may have different curvatures. In a particular embodiment, the steerable sheath 20 may be provided at different curvatures, specifically, at angles of 37, 45, 55, 90, or 135 degrees. In a particular example of this embodiment, the sheath tube includes an inner PTFE liner, a braid, and a Pebax outer jacket. In some such embodiments, a support member 130 including a needle shaft 132 that is compatible with an 8Fr sheath (e.g., provided as part of an 8Fr dilator 30A or defined by an 8Fr dilator 30A) is provided. Alternatively, the support member 130 including the needle shaft 132 may be provided as part of an 8.5Fr dilator 30A that is compatible with an 8Fr steerable sheath 20, or may be defined by an 8.5Fr dilator 30A. The support member 130 including the needle shaft 132 (e.g., provided as part of the dilator 30A or defined by the dilator 30A) may have a curvature of 50 degrees or 86 degrees. In some embodiments, the material may include HDPE and a metal hypo tube that form a reinforcing member 34. In some such embodiments, the RF wire may include a 0.035 inch OD wire and may be a J tip wire or a pigtail wire. In a particular example of this embodiment, the wire may include a stainless steel core having a PTFE coating. Markers along the length of the puncture device

[0097] The markers may be disposed at discrete positions along the length of the puncture device. Various embodiments are described below. In embodiments where the puncture device does not have a handle or hub, the markers are particularly advantageous. Some RF puncture devices, for example, do not have a handle or hub. This is similar to an exchange wire or a guide wire. However, during certain procedures, macropositioning of the puncture device relative to the support member may be required. Thus, visual or tactile markers may be provided to assist in determining such relative positioning. Visual markers are visible to the user without using an imaging system. That is, they are visible to the naked eye. Tactile markers may be visible to the user and may be identifiable by touch.

[0098] In some embodiments, as shown in FIG. 1G, the puncture member includes a proximal marker 116. Laser etching can be used to form the proximal marker 116 such that it cannot be removed during use or sterilization. The use of the proximal marker 116 is described below.

[0099] FIG. 1H shows different examples of marker 117. FIG. 1H-i shows a distal end marker 117. FIG. 1H-ii shows a distal end marker 117 and an intermediate marker 117. FIG. 1H-iii shows two intermediate markers 117. The proximal marker 116 of FIG. 1G or FIGS. 5A-5C can be formed by removing oxides and coating the wire with a transparent layer as described below.

[0100] In one embodiment, the marker may be constructed by making the marker a different color from the rest of the piercing device body. This can be achieved by many means. In one embodiment, the piercing device 112 is stainless steel. The piercing device 112 is masked at discrete locations along the body (i.e., where the marker is to be present), and the remaining wire is coated with a first PTFE layer that is a different color from the underlying stainless steel surface. The PTFE coating may be applied using sprayable PTFE. After the coating process is complete, the masking is removed. For example, an additional layer of transparent PTFE can be applied using a heat shrink process to bond the layer to the piercing device. The previously masked portion then becomes a marker visible to the naked eye. Depending on the thickness of the first PTFE layer, the marker can also be a "tactile" marker. In other words, the user may touch the marker to detect the narrower portion of the wire.

[0101] Other means of creating the marker include the following. a. Apply a layer of PTFE coating in a first color. The marker may then be pad printed at discrete locations where the marker is desired. b. Apply a layer of PTFE coating in a color. At discrete locations where the marker is desired, mechanically abrade the PTFE coating. In this embodiment, another layer of transparent PTFE coating can be applied (e.g., by heat shrink). c. Pad print the marker onto the piercing device body. Next, apply a transparent or translucent PTFE heat shrink layer on top. The layer of transparent or translucent PTFE must be translucent enough to allow the underlying pad printed marker to be visible.

[0102] In an alternative embodiment, the piercing device 112 includes one or more markers 117 formed by mechanical grinding of an oxide coating of the wire formed during heat treatment of the wire. Some embodiments of the piercing device 112 include one or more markers 117 formed by mechanical grinding of an oxide coating of the wire formed during heat treatment of the wire. The marker 117 can be a proximal marker, an intermediate marker, or a distal marker. The formation of this marker will be described with reference to FIGS. 1H and 1I. FIG. 1I shows a cross-section of the wire at point "A" of FIG. 1H after the wire has been heat treated. FIG. 1I shows a piercing device 112 including a solid mandrel surrounded by an oxide coating 119 and covered by a transparent heat shrink 115 (transparent layer). In a typical embodiment, the mandrel 108 is composed of nitinol, but in some alternative embodiments, it is stainless steel. In one embodiment, the oxide coating 119 on the piercing device is composed of titanium dioxide. This coating is typically stable and acts as a barrier to ion exchange. After heat treatment, the oxide coating 119 expands along the entire length of the piercing device. Typically, a portion of the coating at the proximal end is removed to enable electrical connection to the overwire cable connector, and at least one other portion of the coating is removed to form a marker that is visible without imaging, i.e., visible to the naked eye. The oxide coating 119 can be removed by grinding the surface of the piercing device into a desired glyph shape, thereby forming the marker 117. The transparent heat shrink 115 typically includes transparent PTFE formed from an extruded tube heat shrunk onto the piercing device. Alternative embodiments of the heat shrink 115 are composed of a transparent layer formed from alternative materials known to those skilled in the art. The RF guide wire 100 is electrically insulated by a transparent heat shrink that makes the marker 117 visible. In some examples, the transparent layer has a thickness in the range of about 0.086 mm to 0.118 mm.

[0103] FIG. 5 is a schematic cross-sectional view of a support member 130 having a piercing device 112 (such as an RF guide wire) installed therein. In the embodiment of FIG. 5, the support member 130 has a distal marker 142 at its distal end to indicate the position of the distal end of the support member 130 under imaging, and the piercing device 112 has a radiopaque marker 104 at its distal end to indicate the position of the distal end of the piercing device under imaging. FIGS. 5A-5C show the steps of a method of advancing the piercing device 112 through the support member 130. In FIG. 5A, the piercing device 112 is positioned such that the distal end of a proximal marker 116 is at the proximal end of the hub / handle of the support member, while the tip of the distal end of the piercing device is still inside the lumen of the support member. The piercing device is advanced to the configuration of FIG. 5B where the center of the proximal marker 116 at the proximal end of the hub / handle of the support member and the tip of the distal end of the piercing device are above the tip of the support member 130. The piercing device is further advanced to the configuration of FIG. 5C where the proximal end of the proximal marker 116 is at the proximal end of the hub / handle of the support member and the distal end of the piercing device 112 extends beyond the tip of the support member 130. The configuration of FIG. 5C further includes a distal marker 142 of the support member 130 lined up with the radiopaque marker 104 at the distal end of the support member 130, which confirms the relative positioning of the piercing device and the support member under imaging. Thus, FIGS. 5A-5C show an elongated proximal marker 116 such that the leading edge of the marker represents a first relative position between the piercing device and the support member (i.e., where the piercing device is within the lumen of the support member), the middle (or midpoint) of the marker represents a second relative position between the piercing device and the support member (i.e., where the distal tip of the piercing device is aligned with the distal tip of the support member), and the trailing edge of the marker represents a third relative position between the piercing device and the support member (i.e., where the distal tip of the piercing device extends beyond and is exposed from the support member). In an alternative embodiment, each relative position may be marked by a separate marker. In an alternative embodiment, a plurality of separate proximal markers may be provided to identify the first relative position, the second relative position, and the third relative position, respectively.

[0104] In some embodiments, the shaft of the puncture device 112 has a radiopaque marker 104, and the proximal marker 116 has an outer diameter ≤ 0.035 inches. The radiopaque marker 104 is composed of platinum and iridium (Pt / Ir) and has an inner diameter ≥ 0.01 inches. In one embodiment, the mandrel of the puncture device 112 is made of stainless steel. In an alternative embodiment, the mandrel of the puncture device 112 is a composite of a distal portion composed of a superelastic material such as nitinol designed to be twist-resistant and a proximal portion composed of a more rigid alloy such as stainless steel. In yet another embodiment, the mandrel is composed of nitinol to improve flexibility and resistance to twist along the entire length of the puncture device. In embodiments where a composite structure exists, these materials can be welded, press-fitted, or adhered together. The body of the puncture device may be completely insulated with polytetrafluoroethylene (PTFE). A typical embodiment of the puncture device 112 has an outer diameter ≤ 0.035 inches of any size of the puncture device as long as it fits within the dilator used for transseptal procedures. An alternative embodiment of the radiopaque marker 104, which is a component of a smaller diameter RF guidewire, has an inner diameter less than 0.01 inches. A typical embodiment of the introducer 130 has an inner diameter ≥ 0.035 inches, but other inner diameter sizes of the introducer are possible as long as the RF guidewire 100 used in the procedure can pass through.

[0105] In one embodiment, the piercing device may include a number of markers along its length. These markers may be spaced apart to correspond to a particular length of the support member. Support members such as dilators, sheaths, and stylets may be of various lengths. For example, the sheath may be longer or shorter depending on the requirements of a particular procedure. By providing a number of markers spaced along the length of the piercing device, the piercing can be used with support members of various lengths by matching a particular support member length with a marker. For greater clarity, the markers may comprise distinct visual or tactile features to distinguish which marker is to be used with which device. With regard to visual markers, different colors, shades, surface features (reflective metal coils, indented bands, etchings, etc.) or symbols can be used to distinguish different markers. In the case of markers having visual features, a transparent coating is provided over the top to secure the features and ensure that the piercing device has a consistent outer surface. Radiopaque marker

[0106] In some embodiments, as shown in FIGS. 1C and 1D, the support member 130 includes one or more radiopaque markers such as the support member radiopaque marker 42. In some examples as described above, the assembly 100 provides a support member 130 (e.g., provided as part of the reinforced dilator 30A or including the needle shaft 132 defined by the reinforced dilator 30A) and includes a radiopaque marker 42 such as at the distal tip of the support member 130. In some such examples, the support member 130 includes a radiopaque marker 42 embedded within the polymer at its distal tip as shown.

[0107] In certain embodiments, the radiopaque marker 42 is embedded within a polymer of the support member 130, such as within one or more polymer layers 38 (forming the polymer shaft 39, which in turn forms the dilator shaft 32), for example, within its distal tip (of the support member 130), and includes a radiopaque coil (such as provided as part of the reinforcing dilator 30A or including the needle shaft 132 defined by the reinforcing dilator 30A). In more particular embodiments, the radiopaque coil is embedded within one or more polymer layers such that one or more polymer layers extend distally beyond the radiopaque coil. Alignment Using Radiopaque Markers

[0108] In some embodiments of the present invention, for example, as shown in FIGS. 3B and 3C, a substantially flexible energy-based puncture device 114 (such as an RF guide wire) is provided that includes one or more device-side radiopaque markers (or, in other words, one or more device radiopaque markers) at its distal end. In some such embodiments, as described above, the support member 130 also includes a support member radiopaque marker at the distal end of the support member 130 (as shown in FIGS. 1C and 1D). In some such embodiments, similar to the embodiments shown in FIGS. 3B and 3C, one or more device radiopaque markers 12 are configured to cooperate with the support member radiopaque marker 42 to indicate the relative position of the substantially flexible energy-based puncture device 114 (such as the RF guide wire 10). The embodiments shown in FIGS. 3B and 3C show a dilator 30B provided separately from the stylet 64. However, in alternative embodiments currently described, the stylet 64 may be the reinforcing member 34 provided within the dilator 30A.

[0109] In some such embodiments, the assembly 100 includes an initial configuration 100A in which a substantially flexible energy-based piercing device 114 (such as the RF guide wire 10) can be positioned within the support member 130, whereby one or more device radiopaque markers 12 are not aligned with the radiopaque marker 42 of the support member 130, as shown in FIG. 3A. In some such examples, a number of radiopaque markers, including one or more device radiopaque markers 12 and support member radiopaque markers 42, may be visible under imaging.

[0110] In some such embodiments, the assembly 100 includes a first configuration 100B in which a substantially flexible energy-based piercing device 114 (such as the RF guide wire 10) can be positioned within the support member 130, as shown in FIG. 3B, whereby one or more device radiopaque markers 12 are aligned with the radiopaque marker 42 of the support member 130, as shown in FIG. 3B. In some such examples, a single radiopaque marker [including one or more device radiopaque markers 12 and support member radiopaque markers 42 that may be arranged in proximity to each other] may be visible under imaging.

[0111] Assembly 100 further has a second configuration 100B in which a substantially flexible energy-based piercing device 114 (such as RF guide wire 10) is positionable / advancable within support member 130, whereby one or more device radiopaque markers 12 are misaligned or out of alignment with support member radiopaque marker 42. In some such embodiments, the misalignment between one or more device radiopaque markers 12 and support member radiopaque marker 42 indicates the positioning of the energy delivery portion 114d of the flexible energy-based piercing device 114 (such as the RF electrode tip 10d of RF guide wire 10) beyond the support member (e.g., the distal tip of support member 130 or distal of the end) for positioning relative to the target tissue site for tissue piercing. In some such embodiments, as in FIG. 3A, a number of radiopaque markers [including one or more device radiopaque markers 12 and support member radiopaque marker 42] may be visible under imaging, and one or more device radiopaque markers 12 are positioned distally relative to support member radiopaque marker 42, indicating that the distal electrode tip 10d is positioned relative to the target tissue site (such as the septum of the heart) to pierce the tissue.

[0112] In some such embodiments, the sheath 20, the dilator 30A, and the reinforcement member 34 are all radiopaque and have radiopaque properties so as to be visible under imaging. In some such embodiments, one or more of the sheath 20, the dilator 30A, and the reinforcement member 34, such as a metal hypo tube, include a radiopaque material in addition to the radiopaque marker

[42] . The reinforcement member 34, such as a metal shaft or hypo tube, is also radiopaque. In some such embodiments, the polymer forming the sheath 20 and / or the dilator 30A may include a polymer radiopaque filler, such as 20% barium sulfate, and thus is contrasted with one or more markers [12, 42] at the distal tip. In other words, this can provide visibility under imaging and further provide contrast with one or more markers [42, 12], whereby the user can see the dilator 30A in relation to the RF guidewire 10 during imaging and determine whether the RF guidewire 10 is positioned inside or outside the dilator 30A [i.e., whether the distal segment of the RF guidewire 10 is distal to the dilator 30A]. In other embodiments, the puncture device 114 (such as the RF guidewire 10), the sheath 20, the dilator 30A, and the reinforcement member 34 are also visible using an ultrasonic imaging system, a radiopaque coil 106, and the marker 12. Support member having a blunt distal tip

[0113] In some embodiments of the present invention, the support member 130 includes a substantially sharp distal tip 143 in order to provide a substantially atraumatic distal tip 143, while providing the advantages of a substantially rigid or stiff support member 130 inside (such as by providing the reinforcement member 34).

[0114] In such an embodiment, an overall method / workflow is provided that shows a method of performing a transseptal puncture procedure using the assembly 100 as described above herein. The method disclosed herein provides one or more advantages associated with an assembly that includes an energy delivery component provided separately from a rigid component. Details of the method are provided herein below. Method of using Example 1

[0115] As a general overview, in one major embodiment, referring again to FIGS. 2A-2G, a method for performing a transseptal puncture is provided, the method comprising: (i) advancing an RF wire into the superior vena cava as shown in FIG. 2B; (ii) advancing a sheath and dilator into the superior vena cava via the wire as shown in FIG. 2C; (iii) removing the RF wire from the dilator as shown in FIG. 2D; (iv) dropping from the SVC into the heart to find the fossa ovalis as further shown in FIG. 2D; (v) tenting using the dilator; (vi) advancing the RF wire to the puncture location with reference to FIG. 2D; (vii) puncturing and advancing the RF wire as shown in FIG. 2E; and (viii) crossing the sheath and dilator via the RF wire as shown in FIG. 2F.

[0116] More specifically, in certain embodiments of the method of the present invention, referring again to FIG. 2A, a method for performing a transseptal puncture procedure using an assembly 100 including a flexible RF wire 10, a sheath 20, and an expander 30A is provided. The method includes, in step 202, advancing the RF wire into the superior vena cava (SVC) to obtain access, as further shown in FIG. 2B. In some such embodiments, by providing the energy delivery component (flexible RF wire) separately from the reinforcement member, it becomes possible to use the energy delivery component as an access wire. More specifically, the expander 30A can be advanced later, enabling the flexible RF wire to provide access to the SVC without using an additional access wire. This can help reduce the number of steps and streamline the procedure, thus reducing the procedure time and complexity.

[0117] The method further includes, in step 204, advancing the sheath 20 and the expander 30A into the SVC via the flexible RF wire. Thus, the flexible RF wire 10 functions as an access wire, enabling the sheath 20 and the expander 30A (e.g., as an assembly) to be tracked into the SVC via the flexible RF wire 10, as shown in FIG. 2C.

[0118] The method further provides for removing the RF wire within the dilator 30A in step 206. The method may optionally include step 207 of determining the relative positioning between the RF wire and the sheath / dilator using a proximal marker on the RF wire. For example, in the embodiment of the puncture device shown in FIGS. 5A-5C, the proximal marker may be used to determine whether the active tip of the puncture device is fully within the dilator / sheath or exposed from the dilator / sheath. This positioning may optionally be verified or further adjusted using visualization or mapping techniques. After confirming the relative positioning of the wire (e.g., the wire is fully within the sheath / dilator), the user may proceed to step 208. In step 208, the method includes performing a drop from the SVC into the heart to identify the location of the cavity in order to perform the step of positioning the assembly 100, as shown in FIG. 2D. In one such example, having the reinforcing member 34 (within the dilator 30A) operable separately and independently from the flexible RF wire provides the added benefit of allowing for repeated drop-off if the cavity is lost on the first pass. More specifically, it eliminates the need to reinsert the access wire, in other words, remove the access wire, and then re-advance a rigid puncture device, such as a needle, into the SVC to repeat the drop-off. More specifically, in one embodiment of the present application, the dilator 30A (and thus the reinforcing member 34) may be partially removed or retracted along with the sheath 20, and the flexible RF wire 10 may be re-advanced into the SVC. The sheath 20 and dilator 30 may then be re-advanced over the flexible RF wire 10, as shown in FIG. 2C, and drop-off may be repeated to allow the RF wire 10 to engage the cavity. This may help reduce procedure time and improve safety, as additional exchanges are not necessary. Adding additional exchanges can add more time and unnecessary risk. Thus, the current embodiment, in which the energy delivery component and the rigid component are separated, can reduce procedure time and risks.

[0119] The reinforcing member 34 [within the dilator 30A] provides the additional benefit of providing sufficient rigidity to the assembly 100 to facilitate dropout in step 208. Thus, the reinforcing member 34 allows for sufficient force transmission and torque to allow the assembly 100 to engage the septum, as shown in FIG. 2D . The method further includes tenting the dilator 30A in step 212, with reference to FIG. 2D . The reinforcing member 34 provides sufficient rigidity to the assembly 100 to apply force to the distal end of the assembly 100, thus allowing for tenting with the dilator 30A. In some embodiments, having the reinforcing member 34 in the dilator 30A allows it to be removed and reshaped to allow for optimization of its position relative to the cavity. In some such embodiments, prior to the tenting step, in step 210, the physician can evaluate whether the angle of the dilator 30A and / or the assembly 100 is sufficient. If the angle is not deemed sufficient, the physician can withdraw the dilator 30A and reshape the curve in step 211. The dilator may then be reinserted as indicated by step 213. The procedure may then be repeated beginning at step 208, and the drop may be performed again using assembly 100. Once the cavity is located, the physician may proceed to tenting with the dilator in step 212. In some cases, it may be necessary to repeat the procedure by starting at a previous step, such as step 202, 204, or 206, before step 208 can be performed. This is because the RF wire may not be properly positioned to allow the drop (step 208) to be performed without repositioning the assembly.

[0120] This method further includes, in step 214, advancing the RF wire 10 to the puncture position, and in step 216, as shown in FIG. 2E, [4] further including the step of puncturing and advancing the RF wire 10. In step 214, when the RF wire is advanced to the puncture position (i.e., located outside the sheath / dilator), the user may optionally visually or tactilely monitor the proximal marker on the RF wire to determine the relative positioning between the RF wire and the dilator / sheath. In one embodiment (see, for example, FIGS. 5A - 5C), since the proximal marker is not visible within the handle / hub of the dilator / sheath, the user knows that the active tip of the RF wire is exposed (i.e., at the puncture position). This positioning may optionally be verified or further adjusted using visualization or mapping techniques. In step 216, the RF wire punctures the tissue and advances through the tissue. Advancing the RF wire 10 into the left side of the heart 500 enables fixation of the RF wire 10 on the left side of the heart and maintains access to the left side of the heart. Since the flexible RF wire is more flexible, the flexible RF wire 10 can provide the further advantage of allowing the operator to push hard without causing damage. This method further includes, in step 218, as further shown in FIG. 2F, [5] crossing the sheath and dilator through the RF wire 10. The flexible RF wire 10 may further protect the open end of the sheath 20 / dilator 30A, thereby not strongly pressing into the tissue. In step 218, the sheath 20 and dilator 30A [including the reinforcing component 34] can be removed.

[0121] As outlined herein, the energy delivery component is provided as a flexible RF wire 10 separate from a robustness component such as a reinforcing member 34 [provided within the expander 30A], and the reinforcing member 34 [having the expander 30A] is separable from and removable from the flexible RF wire 10. This provides the added advantage of enabling immediate fixation of the flexible RF wire within the left atrium by providing steps that allow the reinforcing member 34 [within the expander 30A] to be removable after transseptal puncture and access and that allow the flexible RF wire 10 to remain positioned within the left atrium as shown in FIG. 2G. In such an embodiment, the RF wire may be positioned within the left superior pulmonary vein for fixation. This enables the RF wire to maintain access to the left atrium and allows the reinforcing member 34 [along with the expander 30A] to be removed to facilitate device exchange to the left atrium using the flexible RF wire. This eliminates the need for the physician to advance another wire after puncture to maintain access to the left side to track additional devices to the left side, thereby further reducing additional exchanges on the left side. In addition to reducing the treatment time and the number of steps required, a further benefit of minimizing left-sided exchanges is minimizing the risk of infection, embolism, and stroke. In another embodiment, the RF wire 10 may have a pigtail curve at the distal end. This may enable fixation of the RF wire 10 within the left atrium instead of the pulmonary vein. Alternatively, the RF wire 10 may be used for fixation within the pulmonary vein. In some such embodiments, the former method of fixation to the left atrium can provide additional advantages not found in the latter method. Use of a proximal marker on a puncture device

[0122] In some embodiments of the present method, in a step that may be referred to as "macro positioning", the user positions the puncture device relative to the support member using the proximal marker 116 without using an imaging system such as fluoroscopy. Following "macro positioning", the user may utilize an imaging system (e.g., fluoroscopy) in a step that may be referred to as "micro positioning" for more accurate positioning of the introducer and the RF guide wire relative to the target tissue. By using the proximal and distal markers, the user can perform the early part of positioning the device without using fluoroscopy, thereby reducing the amount of X-rays to which the user and the patient are exposed compared to performing the entire procedure under fluoroscopy. In some alternative embodiments of the present method, a portion of the procedure involved in positioning the puncture device relative to the support member is performed without any fluoroscopy. Use of the same device for initial tracking / access and positioning

[0123] In some embodiments of the present invention, referring to FIGS. 2A - 2G, a method for puncturing tissue is disclosed. The method includes accessing a region of tissue within a patient's body by advancing a device (such as a puncture device 110 which may be an RF guide wire 10) into the region of tissue, as shown in FIG. 2B. In some such examples, the method of puncturing the region of tissue includes a method of performing a transseptal puncture, and the step of accessing the region of tissue includes advancing a device (such as a puncture device 110) into the superior vena cava (SVC) 501 adjacent to the patient's heart 500.

[0124] In some embodiments of the present invention, the method of piercing tissue includes, for example, as shown in FIG. 2D, [3] positioning the device at a target tissue site within the region of the tissue, and, for example, as shown in FIG. 2C, [2] first tracking a support member 130 (such as a reinforcing dilator 30A) through a piercing device 110 to support the device (such as the piercing device 110), and, as shown in FIG. 2D, [3] enabling advancement of the device (such as the piercing device 110) toward the target tissue site to position the device at the target tissue site for piercing.

[0125] In some such embodiments, the step of positioning the piercing device 110 at the target tissue site includes [3] performing a drop from the superior vena cava (SVC) into the patient's heart 500 to identify the location of the fossa ovalis (or, in other words, the fossa fenestra) 504 along the septum 502 of the heart 500, for example, first (2) tracking or advancing a support member 130 (such as a dilator 30A) through the device (such as the piercing device 110) into the SVC to (3) facilitate the drop and position the piercing device 110 at the fossa fenestra 504.

[0126] In some such embodiments, as shown in FIGS. 2B - 2D, the steps of [1] accessing, as shown in FIG. 2B, and [3] positioning, as shown in FIG. 2D, are performed using the same device such as the piercing device 110, and the piercing device 110 can be used without the support member 130 during the [1] accessing step, and the device can be used with the support member 130 during the [3] positioning step. Use of a Piercing Device for Initial Access and Positioning

[0127] In some such embodiments of the present invention, as shown in FIGS. 2B - 2D, the steps of accessing and positioning using the piercing device 110 are performed. Use of the Same Device for Initial Access, Positioning, and Piercing

[0128] In some such embodiments of the present invention, as shown in FIG. 2E, after the step of positioning as shown in FIG. 2D, the method further includes the step of using a device (such as the puncture device 110) to puncture the target tissue site. The support member 130 supports the device (such as the puncture device 110) during the puncture, and the steps of [1] accessing, [3] positioning, and [4] puncturing are performed using the same device.

[0129] In some embodiments of the present invention, the step of puncturing the target tissue site includes the step of puncturing through the cavity 504 to obtain access to the left side of the heart 500. Thereby, one or more devices of the assembly 100, such as the support member 130 (such as the dilator 30A) and the sheath 20 of the assembly 100, can be tracked to the left side of the heart via the RF guide wire 10. Use of a puncture device for initial access, positioning, and puncture

[0130] In some such examples, as shown in FIGS. 2B-2E, the steps of accessing, positioning, and puncturing are performed using the puncture device 110. Use of the same device for initial access, positioning, puncture, and fixation

[0131] According to one embodiment of the present invention, the method further includes a fixing step, as shown in FIG. 2E. The fixing step is performed using a device (such as the puncture device 110) to maintain access to the other side of the target tissue site after the step of puncturing the target tissue site, and as shown in FIG. 2F, enables one or more additional devices [such as the support member 130 including the sheath 20 and the dilator 30A] to be tracked to the other side of the target tissue site via the device (such as the puncture device 110). The steps of accessing, positioning, puncturing, and fixing are performed using the same device. A puncture device 110 such as the RF guide wire 10 may be left in place to maintain access to the left side of the heart, as shown in FIG. 2G. For example, the support member 130 including the dilator 30A may be removed or retracted to enable fixing using the RF guide wire 10. The RF guide wire 10 functions as a rail for guiding one or more devices to the left side of the heart. In some such embodiments, the RF guide wire 10 is substantially non-invasive to minimize damage to the tissue while providing a substantially rigid rail for guiding one or more devices to the left side of the heart.

[0132] In some such embodiments of the present invention, the fixing step for maintaining access through the target tissue site includes advancing a device (such as the puncture device 110) through the fossa to the left side of the heart to maintain access to the left side of the heart. This step further includes removing the support member 130 [such as the dilator 30A] and leaving the puncture device 110 [such as the RF guide wire 10] in place to maintain access to an area of tissue such as the left side of the heart.

[0133] Thus, in some embodiments, the fixing step includes removing the support member 130 including the dilator 30A to enable the RF guide wire 10 to remain positioned to maintain access to the left side of the heart for fixing. Additionally, the sheath 20 may be further removed. Substitutions for devices used for initial access, positioning, and / or puncture - based on the base claim, these subordinations depend on

[0134] In some such embodiments of the invention, the device includes a flexible puncturing device 112, and one or more of the accessing, positioning, puncturing, and anchoring steps are performed using the flexible puncturing device 112. In some such examples, each of the accessing, positioning, puncturing, and anchoring steps is substantially performed using the flexible puncturing device 112.

[0135] In some such embodiments of the invention, the device includes a substantially flexible guidewire (such as mechanical guidewire 118 or RF guidewire 10), in which case one or more of the accessing, positioning, puncturing, and anchoring steps are performed using the substantially flexible guidewire (such as mechanical guidewire 118 or RF guidewire 10). In some such examples, each of the accessing, positioning, puncturing, and anchoring steps is substantially performed using a substantially flexible guidewire (such as mechanical guidewire 118 or RF guidewire 10).

[0136] In some such embodiments of the invention, the device includes a flexible energy-based lancing device 114, and one or more of the accessing, positioning, lancing, and anchoring steps are performed using the flexible energy-based lancing device 114. In some such examples, each of the accessing, positioning, lancing, and anchoring steps is performed substantially using the flexible energy-based lancing device 114.

[0137] In some such embodiments of the present invention, the device includes a flexible RF guide wire 10, and one or more of the steps of accessing, positioning, puncturing, and fixing are performed using the flexible RF guide wire 10. In some such examples, each of the steps of accessing, positioning, puncturing, and fixing is substantially performed using a substantially flexible flexible RF guide wire 10.

[0138] In some such embodiments of the present invention, the device includes a flexible mechanical guide wire 118 having a relatively sharp distal tip 118d, and one or more of the steps of accessing, positioning, puncturing, and fixing are performed using the flexible mechanical guide wire 118. In some such examples, each of the steps of accessing, positioning, puncturing, and fixing is substantially performed using a substantially flexible mechanical guide wire 118. The step of repeating the steps of accessing and positioning

[0139] In some such embodiments of the present invention, the method further includes repeating the steps of [1] accessing as shown in FIG. 2B and [3] positioning as shown in FIG. 2D until the [4] device (such as the puncture device 110) is positioned at the desired target tissue site before the puncture step, as shown in FIG. 2E. Reforming of the support member

[0140] In some such examples, repeating the step of [3] positioning as shown in FIG. 2D further includes reforming the curvature of the support member 130 after removing the support member 130 and re-tracking the support member 130 through a device (such as the puncture device 110 repositioned [1] within the SVC as shown in FIG. 2B) as shown in FIG. 2C before repeating the step of positioning as shown in FIG. 2D, and in the example shown, includes a dropping procedure to find the cavity 504. In a particular example, the support member 130 includes a reinforcing member 34, and the step of positioning is performed using the reinforcing member 34.

[0141] In some such embodiments of the present invention, the method includes reshaping a support member 130 (such as the reinforcement expander 30A). In some such examples, the method includes withdrawing an expansion element or expander 30A and reshaping it. In other examples, the method includes withdrawing both the expansion element 30A and the sheath 20 and reshaping them. The support member includes a reinforcement expander

[0142] In some such examples, the reshaping is performed using the support member 130 that includes the reinforcement expander 30A, the reinforcement expander 30A includes a reinforcement member 34, and the positioning step is performed using the re - shapeable reinforcement expander 30A. The support member includes a stylet

[0143] In some embodiments, alternatively, as further discussed herein below and described in connection with FIGS. 4A - 4E, the reshaping step can be performed using the support member 130 that includes the stylet 60, the stylet 60 is the reinforcement member 34, and the positioning step is performed using the stylet 60.

[0144] In some such examples, the stylet element 60 can be removed and reshaped. In other examples, the stylet element 60 can be withdrawn and reshaped together with the sheath 20 and / or the expander 30B to see what the net shape would be and then re - inserted into it.

[0145] The method described above herein may also be used in embodiments further discussed below that have a removable stylet 60 as shown in FIGS. 4A - 4E. A mapping system for visualizing initial access tracking and positioning

[0146] In some such embodiments, referring to FIGS. 2A-2G and in addition thereto, referring to the embodiments shown in FIGS. 4A-4E, the positioning step is performed using the flexible RF guide wire 10. In some such examples, the positioning and puncturing steps are performed using the flexible RF guide wire 10. Further, in some such examples, the positioning, puncturing, and fixing steps are performed using the flexible RF guide wire 10. In some such examples, the mapping system provided below can be used to visualize the positioning and fixing steps. In some such examples, as provided in FIGS. 2A-2G and FIGS. 4A-4E, the accessing step may be further performed using the RF guide wire 10. Thus, in some such examples, the mapping system provided below can be used to visualize the flexible RF guide wire 10 during the positioning and fixing steps using the mapping system. In some such examples, the method further includes the step of visualizing the flexible RF guide wire 10 using the mapping system during the accessing and positioning steps.

[0147] Such an embodiment of the present invention provides a mapping system that can be used to visualize the RF guide wire 10 during a method of puncturing tissue during one or more of the accessing, positioning, and fixing steps.

[0148] In some cases, the mapping device may include an electroanatomical mapping system that can be magnetic or impedance based on the electroanatomical mapping system creating a virtual volume. In some examples, the electroanatomical mapping system can be used in conjunction with other echocardiographic methods that can be ultrasound. The echocardiographic imaging modality may be used as an overlay in the map, in other words, they can be used to provide additional information to the mapping system. The echocardiographic method may include intracardiac examination or TEE echocardiography.

[0149] In some embodiments, the method includes switching the mapping mode used for each of the access, positioning, and fixation used in the piercing step, as well as the piercing mode.

[0150] In some such embodiments, the method of mapping the RF guidewire 10 and visualizing it using an imaging modality may be used with a flexible wire having electrodes that may or may not deliver energy that can be used to record a target. In some cases, it may be a passive electrode for recording a target. Alternatively, as discussed above, when the RF guidewire 10 is used, the mapping system may be used with an active electrode such as the distal electrode tip 10d of the RF guidewire 10. Thus, the recording and mapping characteristics of the mapping system can be used with a guidewire having passive or active electrodes. In certain embodiments, if the wire is provided with a passive electrode for mapping, the wire may include a piercing means or means for piercing tissue. In one example, the wire may include a mechanical guidewire 118 that may have a sharp distal tip 118d for piercing tissue.

[0151] In some such embodiments, the reinforcement member is a stylet 60 that can be used independently of a substantially flexible energy-based piercing device 114 such as the RF wire 10. Example 2

[0152] In another embodiment, an embodiment of the present invention provides an assembly 300 for piercing tissue (e.g., forming a transseptal puncture through the septum of the heart) as shown in FIG. 3A. Similar to the embodiments described above herein, the assembly 300 provides a piercing device such as a substantially flexible energy delivery piercing device 114 for piercing tissue via energy delivery (such as a flexible RF guidewire 10 and a support member for supporting a substantially flexible energy delivery piercing device such as a separate reinforcing member 34). In some such embodiments, the support member includes a reinforcing member 34. In some such embodiments, the substantially flexible energy delivery piercing device 114 (such as the RF guidewire 10) is selectively insertable within the support member 130 and is selectively usable in cooperation with the support member 130 during a portion of the procedure, and the substantially flexible energy delivery piercing device 114 (such as the RF guidewire 10) is usable independently of the support member 130 during another portion of the procedure, facilitating exchange and positioning while providing a substantially non-invasive piercing of the tissue. Overall assembly

[0153] In one such example, as shown in FIG. 3A, the assembly 300 includes a flexible energy delivery component 114 provided separately from and operable independently of the support member. In one such example, the flexible energy delivery component includes an RF wire 10 and the separate support member 130 includes a stylet 60 that defines a reinforcing member 34. In other words, as described later herein, the support member 130 is a reinforcing member 34 provided as a stylet 60 that can be used independently of a piercing device 110 such as a flexible piercing device 112. Stated yet another way, the support member 130 is defined by the reinforcing member 34, and in one example, the reinforcing member 34 includes a stylet 60. The assembly 300 further includes a sheath 20 and a dilator 30B that can be used with the flexible RF wire 10. In a particular example, the reinforcing member 64 is also provided separately from and removable from the dilator 30B, which is provided as a flexible dilator in this embodiment.

[0154] Some such embodiments can be used with a support member 130 and include an expander 30B that forms a support member assembly 134 that is selectively used during a portion of a procedure, as shown in FIG. 3B. In some such embodiments, as described above, the support member 130 includes a stylet 60 that defines a reinforcement member 34. In some examples, an expander 30B is provided that can be used with the stylet 60 to form a stylet assembly 164 as shown in FIG. 3C.

[0155] In some such embodiments, the puncture device 110 includes a substantially flexible energy-based puncture device 114. In a particular example of this embodiment, the substantially flexible energy-based puncture device 114 includes a flexible RF guidewire or wire 10. In some embodiments, the RF guidewire 10 can be selectively used in cooperation with the stylet 60 (e.g., by being selectively coupled thereto) during a portion of a procedure, and the RF guidewire 10 can be used independently of the stylet 60 during another portion of the procedure. The ability to selectively use the RF guidewire 10, in combination with and without the stylet 60, facilitates the puncture of tissue. Shape capabilities of the support member / reinforcement member

[0156] In some such embodiments of the present invention where the support member 130 is provided separately from the dilator 30B, the assembly 300 provides a support member 130 that is moldable to allow removal from a puncture device 110 (e.g., a flexible tissue puncture device 112 for a substantially flexible energy-based tissue puncture device 114), and allows the curve of the support member 130 to be remolded and reinserted therewith. For example, the remolded support member 130 is substantially flexible energy-based tissue puncture device 114 and / or one or more other components of the assembly 300, such as the dilator 30B and / or the sheath 20, to optimize the position of the assembly 300 relative to the target tissue site (to facilitate puncture, such as the cardiac fossa to facilitate transseptal puncture). It is reinsertable and / or usable with.

[0157] In certain embodiments, the stylet 60 is moldable to allow removal of the stylet 60 from a substantially flexible puncture device and remolding and reinsertion of the curve of the stylet 60 to optimize the position of the assembly relative to the target tissue site. In some such embodiments, the stylet 60 is removable from one or more components or members of the assembly 300, remolded and reinserted therewith to position the assembly 300 at the target tissue site.

[0158] Details of the stylet 60 that defines the reinforcement member 34 used with the expander 30B and the flexible RF wire 10 are shown in FIGS. 3B and 3C. More specifically, FIGS. 3B and 3C show, in some embodiments, an expander 30B that does not have an embedded reinforcement member internally, or in other words, is a flexible expander such as a standard transseptal expander separate from the expander 30B, and the expander 30B includes a proximal portion 31 that terminates at the distal tip 41. In some embodiments, the expander 30B may further include a radiopaque marker 42 at the distal tip 41. Similar to the embodiments disclosed herein, the expander 30B includes an expander shaft 32 that extends along the proximal portion 31. However, unlike the embodiments discussed above herein, the assembly 300 provides a reinforcement member or component 34 defined by the stylet 60 that is provided separately from the expander 30B and functions as a removable reinforcement member removable from the expander 30B. Thus, the reinforcement member 34 is provided separately from the flexible RF wire 10 and the expander 30B and is removable from both the flexible RF wire 10 and the expander 30B. FIG. 3B shows the position of the assembly 300 for dropping, while FIG. 3C shows the position of the assembly 300 for arc generation to enable transseptal puncture. Atraumatic stylet

[0159] In some embodiments, the stylet 60 is provided as a substantially atraumatic stylet 68 as shown in FIG. 5F to prevent damage to the expander 30A from being inserted. In some such examples, the stylet 68 includes a tapered distal tip 69 that helps prevent and / or minimize skiving and provides a smoother feel to the user when inserted into the expander during use.

[0160] In some embodiments, alternatively, or in addition to providing the tapered distal tip 69, the stylet 60 is made substantially atraumatic by providing a lubricating coating 67 on the stylet 60, preventing and / or minimizing skiving, and providing a smoother feel to the user when inserted into the expander during use.

[0161] In some such embodiments, the lubricating coating 67 includes a PTFE coating. The PTFE coating may be spray-coated onto the stylet 60 or may be provided as a heat shield. Alignment Using Radiopaque Markers

[0162] In some embodiments of the present invention, similar to the embodiments previously discussed with respect to assembly 100, assembly 300 includes a substantially flexible energy-based piercing device 114 (such as RF guide wire 10) having one or more device radiopaque markers 12 at its distal end. Additionally, the support member assembly includes one or more support assembly radiopaque markers 42 at the distal end of the support member assembly 134 (including, for example, a separate reinforcing member 34 such as stylet 60 and a piercing device 110 such as a substantially flexible energy-based piercing device 114). In such an example, the support assembly radiopaque marker 42 is provided on the dilator 30B of the support member assembly 134. In some such embodiments, one or more device radiopaque markers 12 are configured to cooperate with the support assembly radiopaque marker 42 to indicate the relative position of the substantially flexible energy-based piercing device 114.

[0163] In some such embodiments, assembly 300 includes an initial configuration 100A in which a substantially flexible energy-based piercing device 114 (such as RF guide wire 10) is positionable within the support member assembly 134, whereby one or more device radiopaque markers 12 are not aligned with the support assembly radiopaque marker 42 as shown in FIG. 3A. In some such embodiments, a number of radiopaque markers, including one or more device radiopaque markers 12 and support member radiopaque markers 42, may be visible under imaging.

[0164] Assembly 300 further has a first configuration 100B in which a substantially flexible energy-based piercing device 114 can be positioned within a support member assembly 134, whereby one or more device radiopaque markers 12 are aligned with support assembly radiopaque markers 42. In some such embodiments, a single radiopaque marker [including one or more device radiopaque markers 12 and support member radiopaque markers 42 that can be disposed in proximity to each other] may be visible under imaging.

[0165] Assembly 300 further has a second configuration 100B in which a substantially flexible energy-based piercing device 114 (such as RF guide wire 10) can be positioned / advanced within a support member assembly 134, whereby one or more device radiopaque markers 12 are not aligned or are misaligned with support assembly radiopaque markers 42. In some such embodiments, the misalignment between one or more device radiopaque markers 12 and support assembly radiopaque markers 42 indicates the positioning of the energy delivery portion 114 (also referred to as the electrode distal tip 10d or distal electrode tip 10d) of the flexible energy-based piercing device 114 (such as RF guide wire 10) beyond the support member assembly 134 (e.g., the distal tip of support member 130 or the distal end of the end) for positioning relative to the target tissue site for tissue piercing.

[0166] Referring now to FIG. 3A, as shown in FIG. 3A and similar to the previously discussed embodiments, a number of radiopaque markers including one or more device radiopaque markers 12 and support member radiopaque markers 42 may be visible under imaging, and one or more device radiopaque markers 12 are positioned distally relative to the support member radiopaque markers 42, indicating that the distal electrode tip 10d is positioned relative to the target tissue site (such as the septum of the heart) for piercing the tissue.

[0167] In some embodiments of the present invention, one or more members or components of the assembly 300 may be radiopaque to facilitate visualization of the assembly 300. In such an example, the sheath 20 and / or the dilator 30B includes a radiopaque polymer, and the stylet 60 (e.g., including a metal shaft) is radiopaque. Thus, in some embodiments, the stylet 60, the sheath 20, and / or the dilator 30B are all radiopaque and thus have radiopacity. In a particular embodiment, the polymer forming the sheath 20 and / or the dilator 30B includes a radiopaque filler such as 20% barium sulfate to enable the user to view the sheath 20 and / or the dilator 30B and provide contrast with one or more markers 12, 42 at the distal tip. Thus, this configuration can improve visibility and make it possible to confirm whether the RF guide wire 10 (more specifically, the electrode distal tip 10d of the RF guide wire 10) is positioned inside at any time, or whether it extends outside or beyond the distal tip of the dilator 30B.

[0168] In some embodiments of the transseptal assembly 300, the sheath 20 includes a standard transseptal sheath, the dilator 30B includes a standard flexible dilator, and the flexible RF wire 10 is provided as a 0.035-inch wire. In some such embodiments, the flexible RF wire 10 may be a J-tip wire or a pigtail wire. In a particular example, the dilator 30 includes HDPE. The dilator 30 defines an inner diameter sufficient to accommodate the stylet 60. In one embodiment, the stylet 60 defining the reinforcing member 34 includes a hypo tube such as a metal hypo tube. In a particular embodiment, the stylet 60 includes a metal hypo tube including a stainless steel hypo tube. In such an embodiment, the stainless steel hypo tube has an ID greater than about 0.035 inches.

[0169] In some embodiments, the steerable sheath 20 may be an 8 French (Fr) steerable sheath. Alternatively, an 8.5 Fr steerable sheath 20 may be provided. In some such embodiments, the steerable sheath 20 may have different curvatures. In certain embodiments, the steerable sheath 20 may be provided with different curvatures, specifically, at angles of 37, 45, 55, 90 or 135 degrees. In a particular example of this embodiment, the sheath tube includes an inner PTFE liner, a braid, and a Pebax outer jacket. In some such embodiments, an 8 French (Fr) dilator 30B is provided, which is compatible with an 8 French (Fr) sheath. Alternatively, an 8.5 (Fr) dilator 30B compatible with an 8 French (Fr) steerable sheath 20 may be provided. Some such dilators may have a 64 degree curvature and an HDPE shaft. The stylet 60 may be provided as a metal hypo tube. In such an example, the stylet 60 may have an ID greater than about 0.038 inches and an OD less than about 0.060 inches. The dilator 30A may have a 50 degree or 86 degree curvature. In some embodiments, the material may include HDPE and a metal hypo tube forming the reinforcing member 34. In some such embodiments, the RF wire 10 includes a 0.035 inch OD wire and may be a J-tip wire or a pigtail wire. In a particular example of this embodiment, the RF wire 10 may include a stainless steel core with a PTFE coating. Method [Example 2 - Removable Stylet] Use of the same device for initial tracking / access and positioning

[0170] In some embodiments of the present invention, referring to FIGS. 4A-4G, a method for puncturing tissue is disclosed. As shown in FIG. 4B, the method includes accessing a region of tissue within a patient's body by advancing a device (such as a puncture device 110 like an RF guide wire 10) into the region of the tissue. In some such examples, as shown in FIG. 4B, the method of puncturing a region of tissue includes a method of performing a transseptal puncture, and the step of accessing the region of the tissue includes advancing a device (such as a puncture device 110) into the superior vena cava (SVC) 501 adjacent to the patient's heart 500.

[0171] In some embodiments of the present invention, the method of puncturing tissue includes, for example, as shown in FIG. 4D, [4] positioning the device at a target tissue site within the region of the tissue, and as shown in FIG. 4C, [3] first tracking a support member 130 through a puncture device 110 to support the device (such as a puncture device 110), and as shown in FIG. 4D, to position the device at the target tissue site for puncture, allowing [4] the device (such as a puncture device 110) to advance toward the target tissue site.

[0172] In some such examples, the step of positioning the puncture device 110 at the target tissue site includes [4] performing a fall from the superior vena cava (SVC) into the patient's heart 500 to identify the location of the fossa ovalis structure (or fossa ovalis) 504 along the septum 502 of the heart 500. For example, first (3) tracking or advancing a support member 130 (such as a stylet) through a device (such as a puncture device 110) into the SVC to facilitate, as shown in FIG. 4D, the fall procedure and position the puncture device 110 at the fossa ovalis. For example, this involves dropping the assembly 300 from the superior vena cava into the heart to find the fossa ovalis.

[0173] In some embodiments, the [4] positioning step may include tracking and advancing a support member 130 that, as shown in FIG. 4C, may first include advancing, for example, a sheath 20 and an expander 30B into the superior vena cava via a device (such as an RF guide wire 10) before inserting a stylet 60 into the expander 30B until it reaches a stop. In some such embodiments, the [4] positioning step is performed after the step of removing the RF guide wire from the stylet 60.

[0174] In some such embodiments, as shown in FIGS. 4B - 4D, the [1] access as shown in FIG. 4B and the [4] positioning step as shown in FIG. 4D are performed using the same device, such as a puncture device 110 as shown in FIG. 2D, which can be used without a support member 130 (including a stylet 60) during the [1] access step and can be used with a support member 130 (including a stylet 60) during the [4] positioning step. Use of a Puncture Device for Initial Access and Positioning

[0175] In some such embodiments of the present invention, as shown in FIGS. 4B - 4D, the steps of accessing and positioning are performed using a puncture device 110 (such as an RF guide wire 10). Use of the Same Device for Initial Access, Positioning, and Puncture

[0176] In some such embodiments of the present invention, as shown in FIG. 4E, the method further includes, after the [5][4] positioning step as shown in FIG. 4D, puncturing a target tissue site using a device (such as a puncture device 110). A support member 130 (including a stylet 60) supports the device (such as a puncture device 110) during the [5] puncture, and the [1] access, [4] positioning, and [5] puncture steps are performed using the same device.

[0177] In some embodiments of the present invention, the step of puncturing the [5] target tissue site includes the step of puncturing through the cavity 504 to obtain access to the left side of the heart 500. Thereby, one or more devices of the assembly 100, such as the support member 130 (such as the dilator 30A) and the sheath 20 of the assembly 100, can be tracked to the left side of the heart via the RF guide wire 10.

[0178] In some such embodiments, the step of puncturing [5] is performed by first advancing a device (such as the RF guide wire 10) and tenting with the dilator 30B as shown in FIG. 4D, enabling the RF guide wire 10 to be advanced to the puncture position to puncture the septum 502 with the cavity 504. Use of a puncture device for initial access, positioning, and puncture

[0179] In some such examples, as shown in FIGS. 2B - 2E, the steps of accessing, positioning, and puncturing are performed using the puncture device 110. Use of the same device for initial access, positioning, and puncturing and fixation

[0180] According to one embodiment of the present invention, the method further includes a step of fixing, as shown in FIG. 4E. The fixing step is performed using a device (such as the puncture device 110) after the step of puncturing the target tissue site to maintain access to the other side of the target tissue site through the target tissue site. As shown in FIG. 4F, one or more additional devices [such as the sheath 20 and the dilator 30B] are enabled to be advanced or tracked through a device (such as the puncture device 110, for example, the RF guide wire 10) to enable the intersection of the sheath 20 and the dilator 30B on the other side of the target tissue site, for example, the left side of the heart. The steps of [1] access, [4] positioning, [5] puncturing, and fixing are performed using the same device. The RF guide wire 10 may be left in place to maintain access to the left side of the heart, as shown in FIG. 4G. The RF guide wire 10 functions as a rail for guiding one or more devices to the left side of the heart. In some such embodiments, the RF guide wire 10 is substantially non-invasive to minimize damage to the tissue while providing a substantially rigid rail for guiding one or more devices to the left side of the heart.

[0181] In some such embodiments of the present invention, the fixing step for maintaining access through the target tissue site includes advancing a device (such as the puncture device 110) through a cavity to the left side of the heart to maintain access to the left side of the heart.

[0182] In some such examples, the fixing step further includes removing the stylet 60 to enable fixation by allowing the RF guide wire 10 to remain positioned to maintain access to the left side of the heart. The sheath 20 and / or the dilator 30B may also be removed in addition.

[0183] In some such embodiments, wires such as the RF guide wire and the removable stylet 60 are used to substantially perform the steps of access, positioning, puncturing, and fixing. Use of a puncture device for initial access, positioning, and puncture

[0184] In some such embodiments of the present invention, steps of accessing, positioning, puncturing, and fixing are performed using a puncture device (such as a wire including RF guide wire 10) and a removable stylet 60. Alternative to devices used for initial access, positioning, and / or puncture - Based on the basic patent claims, these dependent claims are dependent below

[0185] In some such embodiments of the present invention, the device includes a flexible puncture device 112, and using the flexible puncture device 112, one or more of the steps of accessing, positioning, puncturing, and fixing are performed. In some such examples, each of the steps of accessing, positioning, puncturing, and fixing is substantially performed using the flexible puncture device 112.

[0186] In some such embodiments of the present invention, the device includes a substantially flexible guide wire (such as mechanical guide wire 118 or RF guide wire 10), in which case one or more of the steps of accessing, positioning, puncturing, and fixing are performed using the substantially flexible guide wire (such as mechanical guide wire 118 or RF guide wire 10). In some such examples, each of the steps of accessing, positioning, puncturing, and fixing is substantially performed using the substantially flexible guide wire (such as mechanical guide wire 118 or RF guide wire 10).

[0187] In some such embodiments of the present invention, the device includes a flexible energy-based piercing device 114, and one or more of the steps of accessing, positioning, piercing, and securing are performed using the flexible energy-based piercing device 114. In some such examples, each of the steps of accessing, positioning, piercing, and securing is substantially performed using a substantially flexible energy-based piercing device 114.

[0188] In some such embodiments of the present invention, the device includes a flexible RF guidewire 10, and one or more of the steps of accessing, positioning, piercing, and securing are performed using the flexible RF guidewire 10. In some such examples, each of the steps of accessing, positioning, piercing, and securing is substantially performed using a substantially flexible flexible RF guidewire 10.

[0189] In some such embodiments of the present invention, the device includes a flexible mechanical guidewire 118 having a relatively sharp distal tip 118d, and one or more of the steps of accessing, positioning, piercing, and securing are performed using the flexible mechanical guidewire 118. In some such examples, each of the steps of accessing, positioning, piercing, and securing is substantially performed using a substantially flexible mechanical guidewire 118. Step of repeating the steps of accessing and positioning

[0190] In some such embodiments of the present invention, the method further includes repeating the steps of [1] accessing as shown in FIG. 4B and [4] positioning as shown in FIG. 4D until the [5] device (such as the piercing device 110) is positioned at the desired target tissue site prior to the piercing step, as shown in FIG. 4E. Reforming of the support member

[0191] In some such embodiments, repeating the positioning step as shown in FIG. 4D further includes reshaping the curvature of the support member 130 after removing the support member 130 [stylet 60] and before repeating the positioning step as shown in FIG. 4D, and re-tracking the support member 130 [stylet 60] via a device as shown in FIG. 4C (such as the puncture device 110 repositioned [1] within the SVC as shown in FIG. 4B), and in the illustrated embodiment, includes a dropping procedure to find the cavity 504. In certain embodiments, the support member 130 includes a stylet 60, and the positioning step is performed using the stylet 60.

[0192] In some such embodiments of the present invention, the method includes reshaping the support member 130 (by pulling out and reshaping the stylet 60). The support member includes a stylet

[0193] In some embodiments, referring to FIGS. 4A-4E, the reshaping step can be performed using the support member 130 that includes the stylet 60, the stylet 60 being the reinforcement member 34, and the positioning step is performed using the stylet 60.

[0194] In some such examples, the stylet element 60 can be removed and reshaped. In other examples, the stylet element 60 can be pulled out and reshaped with the sheath 20 and / or the dilator 30B to see what the net shape would be and then reinserted therein.

[0195] Similar to the embodiments described above herein, an overall method / workflow is provided that shows a method of performing a transseptal puncture procedure using an assembly 300 as described above herein. The methods disclosed herein provide one or more advantages associated with an assembly that includes an energy delivery component provided separately from a rigid component. Details of the method are provided hereinbelow.

[0196] As a general overview, in one broad embodiment, as shown in FIGS. 4A-4G, a method for performing a transseptal puncture is provided, the method comprising: (i) advancing an RF wire into the superior vena cava; (ii) advancing a sheath and a dilator through the wire into the superior vena cava; (iii) inserting a stylet until the stylet within the dilator reaches a stop; (iv) withdrawing the RF wire from the stylet; (v) dropping from the SVC into the heart to find the fossa ovalis; (vi) tenting using the dilator; (vii) advancing the RF wire to the puncture position; (viii) puncturing and advancing the RF wire; (ix) crossing the sheath and the dilator through the RF wire; and (x) removing the stylet.

[0197] More specifically, referring again to FIG. 4A, a method for performing a transseptal puncture procedure is provided using an assembly 100 that includes a flexible RF wire 10 or RF guide wire 10, a sheath 20, a standard transseptal dilator 30B, and a stylet 60. The method includes, at step 402, as further shown in FIG. 4B, [1] advancing the RF wire into the superior vena cava (SVC) to obtain access. As outlined above, in some such embodiments, by providing the energy delivery component (flexible RF wire 10) separately from the reinforcement member 34, the energy delivery component can be used as an access wire or a starter wire. More specifically, the stylet 60 that defines the reinforcement member 34 can be advanced later, enabling the flexible RF wire 10 to provide access to the SVC without using an additional access wire. This can help reduce the number of steps and streamline the procedure, thus reducing the procedure time and complexity.

[0198] The method further includes, in step 404, advancing [2] the sheath 20 and the flexible dilator 30B into the SVC via a flexible RF wire. Thus, in this embodiment, the flexible RF wire 10 also functions as an access wire, enabling the sheath 20 and the dilator 30B (e.g., as an assembly) to be tracked into the SVC via the flexible RF wire 10, as shown in FIG. 4C. Further, in such an example, the standard transseptal dilator 30B may be provided without an embedded reinforcing member. This can help enable initial tracking of the sheath 20 and the dilator 30B and provide the physician with a feel similar to that of a standard transseptal.

[0199] This method further provides, at step 406, an additional step of inserting the stylet 60 until it reaches the stop within the dilator 30B. At step 408, in order to position the assembly 300 at a target tissue site such as a fossa along the septum 502 of the heart 500, a step of removing the RF wire in the dilator 30B and step 410, as shown in FIG. 4D, provide a step of positioning the assembly 300 by performing a fall from the SVC to the heart to identify the location of the fossa 504. The reinforcing member 34 [defined by the stylet 60] provides sufficient rigidity to the assembly 100 to facilitate the fall. Thus, the reinforcing member 34 allows sufficient force transmission and torque to enable the assembly 100 to engage the septum 502, as shown in FIG. 4D. The method may optionally provide step 409 of using a proximal marker on the RF wire to determine the relative positioning between the RF wire and the dilator / sheath. For example, the RF wire may include at least one proximal marker to determine whether the active tip of the RF wire is within the relative positioning between the RF wire and the dilator / sheath. In one embodiment, the marker is positioned at the proximal end of the RF wire such that when the proximal marker is fully exposed from the handle / hub of the assembly (some combination of the stylet, dilator, and sheath), the active tip of the RF wire is completely within the lumen of the dilator / sheath. In this embodiment, when the proximal marker is no longer in sight (i.e., within the handle / hub of the fully assembled assembly), the active tip of the RF wire is exposed from the dilator / sheath. This allows at least a macro adjustment of the relative positioning between the RF wire and the dilator / sheath. In other embodiments, separate proximal markers may be provided to indicate various states of relative positioning (i.e., exposed from or just inside the sheath / dilator). This positioning may optionally be verified or further adjusted using visualization or mapping techniques.

[0200] In such an embodiment, making the reinforcement member 34 (as defined by the stylet 60) operable independently and separately from the flexible RF wire 10 may further assist in repeatability if one or more steps of the procedure need to be repeated. If the initial placement of the flexible RF wire 10 relative to the septum 502 is not sufficient after a drop, the sheath 20 and the dilator 30B may be partially removed or partially withdrawn together with the stylet 60 [and thus the reinforcement member 34], and the flexible RF wire 10 may be repositioned within the superior vena cava (SVC). The sheath 20, the dilator 30B and the stylet 60 [and thus the reinforcement member 34] may advance forward again via the RF wire 10 and provide appropriate force transmission and torque to reposition the RF wire 10 relative to the septum upon a drop, as shown in FIG. 4D, for example, positioning the assembly 300 at a target tissue site such as the cavity 504 during the step of positioning the cavity 504 prior to RF delivery. Thus, the reinforcement member 34 and the RF wire 10 can help minimize device exchange by reducing the need to reinsert an exchange wire. This can help shorten the treatment time and improve safety by eliminating the exchange. Thus, the current embodiment in which the energy delivery component and the rigid component are separated can reduce the treatment time and risk.

[0201] Furthermore, in the embodiments described herein, a removable reinforcing member is provided in that the stylet 60, and thus the reinforcing member 34, is removable from and separable from the dilator 30B. By providing a removable rigidity element by the removable stylet 60, the stylet can impart different curvatures. A variable system is provided where the position of the stylet 60 within the dilator 30B can be adjusted to utilize a more preferred position for positioning relative to the cavity 504 with respect to the dilator 30B. Additionally, the stylet 60 may be re-formable and may be withdrawn and manually re-shaped. In some such embodiments, after the drop is performed in step 410, the physician can evaluate whether the angle of the stylet 60 and / or the assembly 300 is sufficient in step 412 prior to tenting. If the angle is not considered sufficient, in step 422, the physician can withdraw the stylet 60 and re-form the curve. Then, starting from step 406 to step 412, the procedure can be repeated.

[0202] If the angle is considered sufficient, in step 412, the method further includes step 414 of tenting with the dilator 30B with reference to FIG. 4D. The reinforcing member 34 provides sufficient rigidity to the assembly 100 to enable applying a force to the distal end of the assembly 100 and thus enable tenting with the dilator 30B.

[0203] This method further includes, at step 416, advancing the RF wire 10 to the puncture position. When the RF wire is advanced to the puncture position (i.e., located outside the sheath / dilator), the user may optionally visually or tactilely monitor the proximal marker on the RF wire to determine the relative positioning between the RF wire and the dilator / sheath. In one embodiment, since the proximal marker is combined in an assembly (i.e., some combination of the stylet, dilator, and sheath) and is not visible within the handle / hub, the user knows that the active tip of the RF wire is exposed (i.e., at the puncture position). This positioning may optionally be verified or further adjusted using visualization or mapping techniques.

[0204] At step 418, as shown in [5] FIG. 4E, the RF wire 10 is punctured and advanced such that the RF wire 10 can puncture through the septum 502 at the cavity 504 and access the left side of the heart, thereby providing a step of fixing using the RF wire 10. In some such embodiments, the positioned RF wire 10 functions as an anchor to maintain access to the left side of the heart after puncture. Since the flexible RF wire 10 is more flexible, the flexible RF wire 10 can provide the further advantage of allowing the operator to push hard without damage.

[0205] This method further includes, at step 420, as further shown in FIG. 4F, [6] crossing the sheath 10 and the dilator 30B with the internal stylet 60 through the RF wire 10. The flexible RF wire 10 may further protect the open end of the sheath 20 / dilator 30B, thereby not strongly pressing into the tissue. At step 422, the sheath 20 and the dilator 30 and the stylet 60 [and thus the reinforcing member 34 defined thereby] may be removed.

[0206] As outlined herein, the energy delivery component is provided as a flexible RF wire 10 separate from a rigidity component such as the reinforcement member 34 [provided by stylet 60], and the stylet 60 is separable and removable from the flexible RF wire 10. This provides the additional advantage that the reinforcement member 34 [defined by stylet 60] can be removable after transseptal puncture and access, for example, as shown in Figure 4G, allowing the flexible RF wire 10 to be immediately secured within the left atrium by providing steps that allow the flexible RF wire 10 to remain positioned within the left atrium. In such an embodiment, the RF wire 10 may be positioned within the left superior pulmonary vein for fixation. This allows the RF wire 10 to maintain access to the left atrium and allows removal of the stylet 60 [and thus the reinforcement member 34] to facilitate device exchange to the left atrium using the flexible RF wire 10. This can eliminate the need for the physician to advance another wire after puncture to maintain access to the left side in order to track an additional device to the left side, further reducing additional exchanges on the left side. As outlined above, this embodiment also provides the further benefit of minimizing the risk of infection, embolism, and stroke by minimizing left-sided exchanges in addition to reducing treatment time and the number of steps required. Lockable Stylet and Flexible Puncture Device

[0207] In some embodiments of the present invention, the assembly 100 or 300 further includes a locking feature that allows a flexible energy-based puncture device 114 (such as an RF guide wire 10) to be coupled to a reinforcement member 34 (such as a stylet 60) to form a needle assembly, making the flexible energy-based puncture device 114 (such as an RF guide wire 10) selectively usable with the reinforcement member 34 and providing the feel of a needle while allowing the use of the RF guide wire.

[0208] In some such embodiments, the locking feature may be capable of axially locking the piercing device 114 and the reinforcement member 34 such that the piercing device 114 and the reinforcement member 34 can be moved together axially. In further embodiments, the locking feature may further provide rotational locking. The locking feature enables a combination that provides the feel of a rigid RF needle while allowing the use of the RF wire 10. The combination further provides the advantages provided hereinabove in the context of a separate energy delivery system where a flexible energy delivery component such as the RF wire 10 is provided separately from a support member 130 such as the reinforcement member 34.

[0209] In embodiments having a locking feature, the method associated with Example 2 above may further include the step of locking the reinforcement member 34 and the RF wire 10 together. This may be desirable at various points in the procedure to a) drop the device onto the cavity structure or b) provide the RF wire 10 with sufficient stiffness and pushability to pierce the septum.

[0210] Accordingly, in some embodiments, the system of the present invention provides a workflow that can reduce the number of device exchanges, facilitate reproducibility, provide proper fixation, and improve safety.

[0211] The above-described embodiments of the present invention are for illustrative purposes only. Accordingly, the scope of the present invention is intended to be limited only by the appended claims.

[0212] It is understood that, for clarity, certain features of the invention that are described in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, for brevity, various features of the invention that are described in the context of a single embodiment may be provided separately or in any suitable partial combination.

[0213] The present invention has been described with reference to specific embodiments thereof, but many alternative forms, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternative forms, modifications, and variations that fall within the broad scope of the appended claims. All publications, patents, and patent applications mentioned herein are hereby incorporated by reference in their entirety as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference herein. In addition, any reference citation or identification in this application should not be construed as an admission that such reference is available as prior art to the present invention.

Claims

**Claim 1** An assembly for a transseptal puncture procedure and for improving treatment efficiency by facilitating exchange and positioning, the assembly comprising a puncture device for puncturing tissue, the puncture device including at least one proximal marker positioned at the proximal end of the puncture device and at least one distal end marker visible under an imaging system, a puncture device; a support member for supporting the puncture device, the support member including a lumen for receiving the puncture device and a distal tip marker visible under the imaging system; the puncture device is insertable into the lumen of the support member and is selectively usable in cooperation with the support member during a portion of a procedure for puncturing tissue, and the puncture device is usable independently of the support member during another portion of the procedure; when the puncture device is inserted into the lumen, the at least one proximal marker enables positioning of the puncture device relative to the proximal end of the support member, and the at least one distal tip marker and the at least one distal end marker enable positioning of the puncture device relative to the support member by using the imaging system. An assembly. **Claim 2** The assembly according to claim 1, wherein the imaging system is a fluoroscopy system, and the distal tip marker and the distal end marker are visible under fluoroscopy. **Claim 3** The puncture device is a conductive mandrel, wherein the at least one proximal marker covers a proximal portion of the mandrel, a conductive mandrel; a transparent or translucent insulating layer covering the mandrel and the at least one proximal marker, the transparent layer not covering the distal end of the mandrel such that the distal end of the mandrel is electrically exposed to define a distal tip electrode, a transparent or translucent insulating layer; and The assembly according to claim 1 or 2, wherein the portion of the elongated puncture device at and adjacent to the at least one proximal marker has a constant diameter. **Claim 4** The mandrel is surrounded by an oxide coating that is coated by the transparent insulating layer, and the at least one proximal marker includes a portion of the mandrel that is not coated by the oxide coating such that the portion defines a visible marker. The assembly according to claim 3.

5. The assembly according to claim 4, wherein the visible marker is formed by mechanical grinding of the oxide coating.

6. The mandrel is surrounded by a PTFE coating, and the at least one proximal marker includes at least one pad-printed marker on the PTFE coating that defines a visible marker, and the PTFE coating and the at least one pad-printed marker are under the transparent or translucent insulating layer. The assembly according to claim 3.

7. The assembly according to claim 3, wherein the at least one proximal marker includes a pad-printed marker on the mandrel that defines a visible marker, and the pad-printed marker is under the transparent or translucent insulating layer.

8. The assembly according to any one of claims 3 to 7, wherein the transparent or translucent layer includes a heat-shrinkable layer.

9. The assembly according to claim 8, wherein the heat-shrinkable layer is composed of polytetrafluoroethylene.

10. The assembly according to any one of claims 3 to 9, wherein the mandrel is composed of nitinol.

11. The assembly according to any one of claims 3 to 9, wherein the mandrel is composed of stainless steel.

12. The assembly according to any one of claims 3 to 9, wherein the mandrel has a composite structure of a distal portion composed of nitinol and a proximal portion composed of stainless steel.

13. The assembly according to any one of claims 4, 5, 8, 9, 10, and 11, wherein the oxide coating is composed of titanium dioxide.

14. The assembly according to any one of claims 1 to 13, wherein the puncture device is flexible.

15. The assembly according to any one of claims 1 to 14, wherein the puncture device includes a non-traumatic tip.

16. The assembly according to any one of claims 1 to 15, further comprising a radiopaque coil extending around a curve of the distal end portion having a J-shaped outer profile.

17. The assembly according to any one of claims 1 to 16, wherein an end portion of the radiopaque coil can be used as the distal tip marker.

18. The assembly according to any one of claims 1 to 17, wherein the radiopaque coil has echo characteristics when using ultrasound to enable visualization of the distal tip of the guide wire.

19. The at least one proximal marker is an elongated marker including a leading edge and a trailing edge, and the distal tip of the puncture device is within the lumen of the support member when the leading edge is aligned at a predetermined distance from the proximal end of the support member, and the distal tip of the puncture device is exposed from the distal end of the support member when the trailing edge of the proximal marker is aligned at the predetermined distance from the proximal end of the support member. The assembly according to any one of claims 1 to 18.

20. The elongated marker further includes a midpoint, and the distal tip of the puncture device is substantially aligned with the distal tip of the support member when the midpoint is aligned at the predetermined distance from the proximal end of the support member. The assembly according to any one of claims 1 to 19.

21. The assembly according to any one of claims 19 to 20, wherein the predetermined distance is from about 0 cm to about 5 cm.

22. The assembly according to any one of claims 19 to 20, wherein the predetermined distance is from about 0 cm to about 1 cm.

23. The assembly according to any one of claims 20 to 22, wherein the elongated marker includes a midpoint marker for identifying the midpoint.

24. The assembly according to any one of claims 1 to 23, wherein the puncture device is a high-frequency wire.

25. A transseptal puncture device, the transseptal puncture device including a lumen for puncturing tissue and receiving the puncture device and a distal tip marker visible under an imaging system, and used with a support member for supporting the puncture device, the assembly including a conductive elongated mandrel, at least one proximal marker positioned at a proximal portion of the mandrel, at least one distal end marker positioned at a distal portion of the mandrel, the at least one distal end marker being visible under an imaging system. A transparent insulating layer covering the mandrel and the at least one proximal marker, wherein the transparent layer does not cover the distal end of the mandrel such that the distal end of the mandrel is electrically exposed to define a distal tip electrode, and includes, The portion of the transseptal puncture device at and adjacent to the at least one proximal marker has a constant diameter, The puncture device is insertable into the lumen of the support member and is selectively usable in cooperation with the support member during a portion of a procedure for puncturing tissue, and the puncture device is usable independently of the support member during another portion of the procedure, When the puncture device is inserted into the lumen, the at least one proximal marker enables positioning of the puncture device relative to the proximal end of the support member, and the at least one distal tip marker and the at least one distal end marker enable positioning of the puncture device relative to the support member by using the imaging system. A transseptal puncture device. **Claim 26** The transseptal puncture device according to claim 25, wherein the imaging system is a fluoroscopy system, and the distal tip marker and the distal end marker are visible under fluoroscopy. **Claim 27** The mandrel is surrounded by an oxide coating covered by the transparent insulating layer, and the at least one proximal marker includes a portion of the mandrel not covered by the oxide coating such that the portion defines a visible marker. The transseptal puncture device according to any one of claims 25 to 26. **Claim 28** The transseptal puncture device according to claim 27, wherein the visible marker is formed by mechanical grinding of the oxide coating. **Claim 29** The mandrel is surrounded by a PTFE coating, the at least one proximal marker includes at least one pad printed marker on the PTFE coating that defines a visible marker, and the PTFE coating and the at least one pad printed marker are under the transparent or translucent insulating layer. The transseptal puncture device according to any one of claims 25 to 26. **Claim 30** At least one proximal marker includes a pad-printed marker on the mandrel that defines a visible marker, the pad-printed marker being under the transparent or translucent insulating layer, the transseptal puncture device according to any one of claims 25-26.

31. The transseptal puncture device according to any one of claims 25-30, wherein the transparent layer includes a heat-shrinkable layer.

32. The transseptal puncture device according to claim 31, wherein the heat-shrinkable layer is composed of polytetrafluoroethylene.

33. The transseptal puncture device according to any one of claims 25-32, wherein the mandrel is composed of nitinol.

34. The transseptal puncture device according to any one of claims 25-32, wherein the mandrel is composed of stainless steel.

35. The transseptal puncture device according to any one of claims 25-32, wherein the mandrel is a composite structure of a distal portion composed of nitinol and a proximal portion composed of stainless steel.

36. The transseptal puncture device according to any one of claims 27-28 and 31-35, wherein the oxide coating is composed of titanium dioxide.

37. The transseptal puncture device according to any one of claims 25-36, wherein the puncture device is flexible.

38. The transseptal puncture device according to any one of claims 25-37, wherein the puncture device includes a non-traumatic tip.

39. The transseptal puncture device according to any one of claims 25-38, further comprising a radiopaque coil extending around a curve of the distal end portion having a J-shaped outer profile.

40. The transseptal puncture device according to any one of claims 25-39, wherein an end of the radiopaque coil can be used as the distal tip marker.

41. The transseptal puncture device according to any one of claims 25-40, wherein the radiopaque coil has echo characteristics when using ultrasound to enable visualization of the guide wire tip.

42. The at least one proximal marker is an elongated marker including a leading edge and a trailing edge, and the distal tip of the puncture device is within the lumen of the support member when the leading edge is aligned at a predetermined distance from the proximal end of the support member, and the distal tip of the puncture device is exposed from the distal end of the support member when the trailing edge of the proximal marker is aligned at the predetermined distance from the proximal end of the support member. The transseptal puncture device according to any one of claims 25 to 41.

43. The elongated marker further includes a midpoint, and the distal tip of the puncture device is substantially aligned with the distal tip of the support member when the midpoint is aligned at the predetermined distance from the proximal end of the support member. The transseptal puncture device according to any one of claims 25 to 42.

44. The transseptal puncture device according to any one of claims 42 to 43, wherein the predetermined distance is from about 0 cm to about 5 cm.

45. The transseptal puncture device according to any one of claims 42 to 43, wherein the predetermined distance is from about 0 cm to about 1 cm.

46. The transseptal puncture device according to any one of claims 43 to 45, wherein the elongated marker includes a midpoint marker for identifying the midpoint.

47. The assembly according to any one of claims 25 to 46, wherein the transseptal puncture device is a high-frequency wire.

48. A method for confirming the position of the tip of a transseptal puncture device relative to a support member, the transseptal puncture device having at least one proximal marker visible to the naked eye and a distal tip marker visible under an imaging system, the support member having a distal end marker visible under the imaging system, the method comprising: (i) In a macro positioning step, positioning the elongated transseptal puncture device relative to the proximal end of the support member using the proximal marker without using the imaging system; (ii) Turning on the imaging system; (iii) Using the imaging system in a micro positioning step to position the distal tip of the elongated transseptal puncture device relative to the end of the introducer by viewing the distal tip marker and the distal end marker.

49. The method according to claim 47, wherein the imaging system is a fluoroscopic system, and the distal tip marker and the distal end marker are visible under fluoroscopy.

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