Method and device for puncturing tissue

Abstract

The present disclosure relates to systems and methods for creating a puncture using an assembly including a puncture device and a support member. [Solution] A method and system for puncturing tissue is disclosed, comprising a puncturing device for puncturing tissue and a support member 130 for supporting the puncturing device, the puncturing device being insertable within the support member and selectively usable in cooperation with the support member during a portion of the tissue puncturing procedure and usable independently of the support member during another portion of the procedure.

Description

Technical Field

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

[0002] To facilitate understanding of the present invention, embodiments of the present invention are shown by way of example in the accompanying drawings.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0004] To perform a transseptal procedure, access to the heart is necessary. The access may be obtained from a superior approach (in particular, access to the right atrium of the heart is obtained from a superior access point above the heart, for example, through the superior vena cava from the superior vena cava), or the access may be obtained from an inferior or inferior approach (by obtaining access to the heart from an inferior access point below the heart, for example, through the inferior vena cava from the inferior vena cava). Once access to the right atrium is obtained, a puncture device is utilized, for example, to puncture tissue across the septum of the heart to obtain access from the right atrium to the left atrium of the heart.

[0005] Some conventional transseptal procedures, for example, those applying an inferior approach to obtain access to the heart, apply a needle to perform the transseptal puncture. One limitation may be associated with the use of a needle or other rigid device to perform the transseptal puncture procedure.

[0006] These limitations include (1) the need for a separate exchange wire to gain access to the SVC, resulting in multiple device exchanges on the right side when (2) the use of a needle requires multiple device exchanges to complete the procedure, (3) the difficulty of correcting the placement of the puncture device after insertion into the dense atrium when the target position on the fossa is missed, (4) the lack of reproducibility for certain aspects of the procedure to complete the puncture effectively and timely, (5) the puncture device not providing sufficient atraumaticity and excessive force being applied to the punctured tissue causing damage to the tissue, (6) the potential risk of trauma to the structures within the left atrium after puncture by the advancing force, (7) the lack of proper fixation after puncture to maintain access, (8) the need for an additional exchange on the left side to facilitate anchoring, requiring removal of the puncture device and advancement of another wire (e.g., a pigtail wire), and / or (9) one or more of the traceability to be able to track once on the left side wire.

[0007] The inventors of the present invention have discovered systems and methods for attempting to overcome the limitations associated with prior art systems.

[0008] In some such examples, when a sharp mechanical needle is used, the device is not sufficiently atraumatic to minimize the risk of damage to the tissue, and the mechanical needle does not provide proper fixation after puncture.

[0009] In other examples, when an energy-based needle such as an RF needle is used, the RF needle may require multiple device exchanges, may lack reproducibility for one or more steps of the procedure, leading to an increase in treatment time and / or inefficiency. Further, the RF needle may not provide proper fixation after puncture.

[0010] In one broad aspect, the inventors have discovered systems and methods that provide an RF wire and a device to support it to facilitate transseptal puncture, for example using a subcostal approach. The systems and methods of the present invention attempt to overcome the limitations associated with conventional transseptal systems that utilize a needle to complete a transseptal puncture procedure. Some such conventional transseptal procedures that require the use of a needle use a subcostal approach to gain access to the heart in order to perform a transseptal puncture.

[0011] Current rigid mechanical needles provide a sharp tip for puncturing tissue. Such mechanical needles have several limitations that may include (1) the sharp mechanical needle may not provide sufficient articulation and may apply excessive force to the punctured tissue that can cause damage to the tissue, (2) there is a risk of trauma to structures within the left atrium after puncture due to the advancing force, (3) the need for additional exchange on the left side that requires removal of the needle and advancement of another wire (such as a pigtail wire) to facilitate fixation, and / or the trackability to enable tracking of additional devices on the wire once on the left side.

[0012] Furthermore, current rigid energy-based devices used to puncture tissue can also have one or more of several limitations described above herein.

[0013] 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 separate puncture component or member and (2) a substantially rigid and / or stiff support member that is removable from or independent of the puncture component or member and that enables the support member to be selectively used with the puncture device.

[0014] In some examples, (1) a separate piercing component or member comprises a substantially flexible tissue piercing component or member. In some such examples, the separate substantially flexible tissue piercing component or member can be substantially non-invasive. Further, in some examples, the separate substantially flexible tissue piercing component or member can have a relatively sharp component such as a relatively sharp distal tip component.

[0015] In some embodiments, the inventors of the present invention have developed a novel system that includes providing a rigid energy-based piercing device having two components: (1) a flexible [non-invasive] energy-based piercing device or a member such as a radio frequency (RF) wire, and (2) a rigid support member such as a rigid reinforcement member that is removable or independent from the flexible energy-based piercing device.

[0016] In another broad aspect, there is provided a novel assembly that includes a separated needle assembly comprising (1) a substantially flexible tissue piercing member or component that pierces tissue (which can be further substantially non-invasive) and (2) a substantially rigid needle shaft that supports the piercing member and can be selectively used therewith. In some such embodiments, the needle shaft is substantially rigid to provide a force transmission capability but lacks a tissue piercing capability (in other words, the needle shaft is still sufficiently non-invasive so as not to pierce tissue).

[0017] Accordingly, some embodiments of the present invention include separating the components of a piercing device into two independently operable components that form an assembly and thereby provide two separate and independent functions, the functions being (i) the function of piercing tissue with a substantially flexible and / or non-invasive component (such as, but not limited to, a flexible energy delivery device), and (ii) the function of supporting a substantially non-invasive piercing component using a substantially rigid or stiff needle shaft. Such embodiments provide one or more advantages that were not previously achieved or were not achievable using existing systems.

[0018] The advantages can include one or more of: (i) providing a substantially flexible and / or non-invasive puncture device (such as an energy delivery puncture device), and (ii) providing a substantially rigid support member, such as a rigid needle shaft, to support the substantially non-invasive puncture device.

[0019] Enable a substantially flexible puncture device to be used separately from a substantially rigid support member and enable the substantially flexible puncture device to function as an exchange wire.

[0020] Enable a substantially flexible puncture device to be used in cooperation with a substantially rigid support member, for example, by advancing the substantially rigid support member over the substantially flexible puncture device, enabling sufficient force transmission and / or torque to be transmitted to the distal tip of the assembly (e.g., facilitating a drop-down procedure and positioning a fossa as described below), and providing appropriate support to facilitate puncture (using a substantially flexible puncture device and facilitating intersection with the substantially flexible puncture device).

[0021] Enable the use of a substantially flexible puncture device separately from a substantially rigid support member, and the substantially flexible puncture device can further function as a puncture device that punctures tissue while minimizing the risk of damage to the tissue during puncture (e.g., non-punctured tissue), and facilitate intersection using the substantially flexible puncture device.

[0022] Enable a substantially flexible puncture device to be used separately from a substantially rigid support member, for example, by providing a non-invasive tip, for example, by using energy delivery to reduce the amount of force required to puncture tissue, and for example, on the left side of the heart, the risk of damage to the tissue can be minimized after access is obtained.

[0023] For example, to enable a substantially rigid support member to re-advance over a substantially flexible energy delivery device, by enabling a substantially flexible (optionally also non-invasive) energy delivery puncture device that can be used independently of the substantially rigid support member to be re-tracked into a desired vasculature, a substantially rigid support member such as a needle shaft can be removed or retracted to enable repositioning of the assembly relative to the target tissue site, repeating the drop-down procedure for transseptal puncture to position the assembly relative to the fossa.

[0024] Enabling a substantially rigid support member such as a needle shaft to be removed after puncture, enabling a substantially non-invasive energy delivery device to be used independently of the substantially rigid support member, and enabling it to remain positioned on the left side of the heart to maintain access to the left side of the heart, provides fixation after puncture using the puncture device and further enables tracking of additional devices on the puncture device for guidance to the left side of the heart.

[0025] The system of the present invention provides several advantages for addressing the above problems when providing a substantially flexible non-invasive puncture device such as an RF wire in combination with a separate or independent support member such as a substantially rigid needle shaft or a reinforcing member forming a substantially rigid needle shaft, and can be selectively used with the substantially flexible non-invasive puncture device. a) The system enables the reinforcing member to advance over the RF wire and enables the RF wire to function as a replacement wire, which can help streamline the workflow, reduce the number of device exchanges on the right side of the heart, and help reduce the time and complexity of the procedure. b) The system enables the reproducibility of the drop-down procedure by allowing partial removal or partial retraction or extraction of the reinforcement member to enable repositioning and / or re-advancement of RF piercing devices, such as RF wires within the SVC, without the need for additional replacements. c) The system further enables removal of the reinforcement member after piercing, (i) allowing the RF wire to remain positioned within the left atrium, helping to avoid the risk of trauma, and / or (ii) enabling fixation within the left side without the need for additional replacements, for example, to enhance procedural safety or efficiency, and / or (iii) allowing the RF wire to be maintained within the left atrium for traceability, in other words, to assist in the delivery and tracking of the appropriate device. The advantage of minimizing RF wire exchanges is, in addition to shortening time / steps, minimizing the risk of toxicity. This is particularly important on the left side of the heart, where unnecessary exchanges can increase the risk of complications such as embolism and stroke.

[0026] As described above, in some embodiments, a substantially flexible tissue piercing component or member can be selectively used with a substantially rigid support member. In some such examples, being selectively usable means that a substantially flexible energy-based piercing device can be removably usable within the support member, or selectively insertable within the support member, or removably attachable, for use with the support member during a portion of the procedure, and removable from the support member, or removable, during another portion of the procedure.

[0027] In one broad aspect of the present invention, there is provided a needle assembly for enhancing treatment efficiency by piercing tissue and facilitating exchange and positioning. The needle assembly includes a piercing device for piercing tissue and a support member for supporting the piercing device. The piercing device is insertable into the support member and is selectively usable in cooperation therewith during a part of the procedure of piercing tissue, and the piercing device is usable independently thereof during another part of the procedure.

[0028] In another broad aspect of the present invention, there is provided an assembly for piercing tissue. The assembly includes a substantially flexible piercing device for piercing tissue and a support member for supporting the substantially flexible piercing device. The substantially flexible piercing device is selectively insertable into the support member so as to be selectively usable in cooperation with the support member during a part of the procedure of piercing tissue while facilitating exchange and positioning, and the substantially flexible piercing device is usable independently thereof during another part of the procedure.

[0029] In another broad aspect, embodiments of the present invention include an assembly for piercing tissue. The assembly includes a substantially flexible energy delivery piercing device for piercing tissue through energy delivery and a support member for supporting the substantially flexible energy delivery piercing device. The substantially flexible energy delivery piercing device is selectively insertable into the support member during a part of the procedure of piercing tissue to facilitate exchange and positioning while providing a substantially non-invasive piercing of the tissue, and the substantially flexible energy delivery piercing device is usable independently thereof during another part of the procedure.

[0030] In another broad aspect, embodiments of the present invention include a needle assembly for piercing tissue, the needle assembly including a flexible piercing device for piercing tissue and a reinforcing member for supporting the piercing device, the piercing device being selectively usable in cooperation with the reinforcing member during a portion of a procedure to enhance treatment efficiency by facilitating exchange and positioning, and the piercing device being usable independently of the reinforcing member during another portion of the procedure.

[0031] In another broad aspect, embodiments of the present invention include a method of piercing tissue, the method comprising: (i) accessing a region of tissue within a patient's body by advancing a device into the region of tissue; and (ii) positioning the device at a target tissue site within the region of tissue by advancing the device toward the target tissue site by tracking the device over the device to support the device, the step of positioning the device at the target tissue site for piercing, the steps of accessing and positioning being performed using the same device, the device being usable without a support member during the step of accessing, and the device being usable with a support member during the step of positioning.

[0032] In yet another broad aspect, embodiments of the present invention comprise: (i) accessing a region of tissue within a patient's body using an access device; and (ii) positioning a device at a target tissue site within the region of tissue by accessing the device along a path defined by the device to support the device to advance the device toward the target tissue site for piercing, by tracking the device together with the device, the steps of accessing and positioning being performed using separate devices, the steps of accessing and positioning being performed without a support member, and the device being usable with a support member during the step of positioning.

[0033] In one broad aspect, embodiments of the present invention include a method of puncturing tissue, the method comprising advancing a flexible puncturing device into a region of tissue, advancing a sheath and a support member into the region of tissue on the flexible puncturing device, retracting the flexible puncturing device into the support member, positioning the flexible puncturing device as an assembly at a target tissue site within the region of tissue, exploring using the support member, advancing the flexible puncturing device to a puncture position, puncturing and advancing the flexible puncturing device, and crossing a sheath and a dilator on the flexible puncturing device.

[0034] In another broad aspect, embodiments of the present invention include a method of performing a transseptal puncture, the method comprising advancing an RF guide wire into the superior vena cava, advancing a sheath and a dilator into the superior vena cava on the RF guide wire, retracting the RF guide wire into the superior vena cava, dropping down from the superior vena cava into the heart to find a fossa, exploring with the dilator, advancing the RF guide wire to a puncture position, puncturing using the RF guide wire and advancing the RF guide wire, and crossing a sheath and a dilator on the RF guide wire.

[0035] In yet another broad aspect, embodiments of the present invention include a method of performing a transseptal puncture, the method comprising advancing an RF guide wire into the superior vena cava, advancing a sheath and a dilator into the superior vena cava, inserting a stylet into the dilator to reach a stop, retracting the RF guide wire into the stylet, dropping down from the superior vena cava into the heart to find a fossa, exploring with the dilator, advancing the RF wire to a puncture position, puncturing and advancing the RF wire, crossing a sheath and a dilator on the RF wire, and removing the stylet.

[0036] In yet another broad aspect, embodiments of the present invention include a method of performing a transseptal puncture, the method comprising advancing a J-wire into the superior vena cava, advancing a sheath and a dilator into the superior vena cava, removing the J-wire, inserting a needle assembly comprising a stylet and an RF guide wire into the dilator at the position of two fingers, dropping down from the superior vena cava into the heart to find a fossa, exploring using the dilator, advancing the needle assembly to the puncture position, advancing the puncture and the needle assembly to a stop in the dilator, holding the position and unlocking the RF guide wire, and advancing and fixing the RF guide wire.

[0037] In some embodiments of the method of puncturing tissue, the device includes a flexible energy-based puncturing device and substantially all steps are performed using the flexible energy-based puncturing device.

[0038] In some embodiments of the method of puncturing tissue, the device includes a flexible RF guide wire and substantially all steps are performed using the flexible RF guide wire.

[0039] In some embodiments of the method of puncturing tissue, the device includes a flexible mechanical guide wire having a relatively sharp distal tip and substantially all steps are performed using the flexible mechanical guide wire.

[0040] Here, particularly with reference to the drawings in detail, it is emphasized that the details shown are for purposes of illustration only and are only for the description of specific embodiments of the present invention. Before describing at least one embodiment of the present invention in detail, the present invention is not limited to the details of the structure and arrangement of the components described in the following description or shown in the drawings in its application. The present invention can be implemented or carried out in other embodiments or in various ways. Also, the terms and phrases used herein are for purposes of explanation and should not be regarded as limiting.

[0041] As an overview of embodiments of the present invention, some embodiments of the system provide a two-piece assembly comprising a flexible RF component and a rigid support member to enhance the utility of the system. Rigid members, such as reinforcing members, are provided separately from and removably from flexible RF components, such as RF wires, and can thus be introduced independently of the flexible RF wires. This provides flexibility in how a combination of two components, an RF wire and a reinforcing member, can be used. The RF wire can be used independently of the reinforcing member as needed, and the initial advancement of the flexible RF wire without the reinforcing member eliminates the need for a separate exchange wire used for initial access to the (superior vena cava) SVC. The reinforcing member can then be selectively used, advanced into the SVC, and provide appropriate force transmission to facilitate a dropdown procedure to locate the fossa. If the first pass in fossa positioning is unsuccessful, the two-piece assembly allows for partial removal or withdrawal of the rigid support member and repositioning of the RF wire. The rigid support member can then be advanced or repositioned again to provide appropriate rigidity and force transmission, repeat the dropdown procedure, position the fossa, facilitate puncture using the RF wire, and provide appropriate support to facilitate crossing with 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 be removed, leaving the flexible RF within the left side of the heart. Accordingly, the flexible RF wire can be used independently of the reinforcing member, facilitating fixation, facilitating tracking, minimizing left-sided exchanges, minimizing the risk of embolism, and minimizing the risk of trauma. Accordingly, the reinforcement member can be selectively introduced for some of the procedures that require rigidity and then (partially or completely) removed to facilitate the remaining part of the procedure. Furthermore, since the reinforcement component is provided separately from the flexible RF wire, the reinforcement component may be advanced or reinserted again as desired to complete the manner of the procedure.

[0042] According to some embodiments of the present invention, details of the RF wire are disclosed in application number PCT / IB2013 / 060287 and publication number WO2015019132, which are hereby incorporated by reference in their entirety. The details provided below include some embodiments of the support member that can be used with a piercing device such as an RF guide wire disclosed in the referenced application.

[0043] In some embodiments of the present invention, an assembly for piercing tissue is provided, the assembly comprising a substantially flexible piercing device (such as an energy-based piercing device, which is substantially non-invasive) that pierces tissue via energy delivery. The assembly further comprises a support member that supports a substantially flexible piercing device such as a rigid needle shaft. In some such examples, the support member includes a reinforcement member (which can form the needle shaft). The support member is operable to be selectively usable with the substantially flexible piercing device and removable or detachable therefrom. Furthermore, the substantially flexible piercing device is operable independently of the support member to pierce tissue. In some such examples, the substantially flexible piercing device is an energy-based device that delivers energy to the pierced tissue.

[0044] In some such embodiments of the present invention, a substantially flexible energy-based piercing device is selectively usable in cooperation with a substantially rigid support member during a portion of the procedure. Further, the substantially flexible energy-based piercing device is usable independently of the support member during another portion of the procedure.

[0045] In some such examples, the support member is removable from the substantially flexible energy-based piercing device during a portion of the procedure, enabling the substantially flexible energy-based piercing device to be used separately therefrom.

[0046] The assembly enables the substantially flexible energy-based piercing device to be usable independently of the support member during a portion of the procedure and to be usable in cooperation during a portion of the procedure. This facilitates exchange by enabling the flexible energy-based piercing device to be used to pierce tissue and as an exchange wire, and further provides the advantage of providing a non-invasive tip for piercing tissue since the substantially flexible energy-based piercing is substantially non-invasive. By detaching the energy delivery portion of the assembly from the support member, it becomes possible to further remove the support member if the flexible energy-based piercing device is not positioned at the desired target location, enabling the support member to be repositioned to allow it to advance again over the substantially flexible energy-based piercing device, facilitating the placement of the energy delivery portion of the flexible piercing device relative to the desired target tissue location, and further reducing the complexity of the procedure and increasing the efficiency of the procedure. Example 1 An assembly including a piercing device and a support member

[0047] In some embodiments, as shown in FIGS. 1A and 1B, the present invention provides an assembly 100 for piercing tissue, such as for generating a transseptal puncture through a septum of the heart, the assembly comprising a tissue piercing or piercing device 110 and a separate support member 130 that can be selectively used with the tissue piercing device 110 to support the piercing device 110. The piercing device 110 can be selectively used in cooperation with the support member 130 during one or more parts or steps of the procedure, and the piercing device 110 can be used independently therefrom for piercing tissue during one or more parts or steps of the procedure. In some such embodiments, providing a separate piercing device 110 and a support member 130 for selectively comprising it further improves the efficiency of the procedure by facilitating exchange and positioning.

[0048] Referring again to FIGS. 1A and 1B, in some embodiments, an assembly 100 for piercing tissue is provided, the assembly 100 comprising a support member 130 that supports a substantially flexible piercing device and a substantially flexible piercing device 112 for piercing tissue, as further described herein. The substantially flexible piercing device 112 can be selectively inserted into the support member 130 so as to be selectively usable in cooperation with the support member 130 during a part of the procedure for piercing tissue and for facilitating exchange and positioning, and the substantially flexible piercing device 112 can be used independently of the support member 130 during another part of the procedure. In some such examples, the substantially flexible piercing device 112 comprises an energy delivery device operable to deliver energy for piercing tissue. In some such examples, as further described in detail below, the support member 130 comprises a reinforcing member 34.

[0049] In one such example, the assembly 100 includes a needle assembly that pierces tissue, and the needle assembly includes 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.

[0050] In a particular example of the needle assembly, as shown in FIG. 1A, the piercing device 110 includes a substantially non-invasive distal tip 112d, and the piercing device 110 is substantially non-invasive. 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 that has an energy delivery portion or component 114d at its distal tip for delivering energy to pierce tissue. In this particular example, the piercing device 130 includes a flexible (high-frequency) RF guide wire 10 that has a distal electrode tip 10d for delivering high-frequency energy to pierce tissue.

[0051] In some cases, the RF guide wire 10 is a generally electrically insulated flexible wire, except for a selected distal region such as the distal electrode tip 10d.

[0052] In a particular example of the needle assembly, as shown in FIG. 1A, the piercing device includes a mechanical piercing device 118. In some such embodiments, the mechanical piercing device 118 of the needle assembly includes a relatively sharp distal tip 118d for piercing tissue.

[0053] In some such embodiments, as shown in the figure, there is an assembly 100, such as a needle assembly. In FIGS. 1A and 1B, the support member consists of a reinforcing member. In some such embodiments, as shown, the support member 130 includes a needle shaft 132 that includes a reinforcing member 34 that supports the piercing device 110. In some such embodiments, the needle shaft 132 can provide or have mechanical needle characteristics. In a specific example, a reinforcing member (e.g., a metal hypodermic tube having one or more polymer layers) is structured to form the needle shaft 132.

[0054] In some embodiments described herein below, an assembly 100 such as a needle assembly includes an RF wire and a separate reinforcing member. Accordingly, while some embodiments of the invention provided herein below are described with respect to RF guide wires, some such embodiments described herein may be accompanied by other piercing devices such as mechanical piercing devices such as mechanical guide wires. However, RF guide wires can provide advantages not seen in other piercing devices such as mechanical guide wires. Device Example 1 Support member including needle shaft / reinforcing expander

[0055] In one broad aspect, embodiments of the invention provide an assembly 100 for piercing tissue, the assembly 100 comprising 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 during a portion of the procedure and usable independently thereof during another portion of the procedure to facilitate 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.

[0056] In one such example, referring to the embodiment shown in FIG. 1A, the assembly 100 comprises a substantially flexible energy delivery piercing device or component 114 provided separately from and operable independently of the support member 130. In one such example, a 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, and a separate support member 130 includes a needle shaft 132 having a reinforcing member 34 and one or more polymer layers 38 that form a polymer shaft 39 of an expander 30A, and the reinforcing member 34 is substantially surrounded by one or more polymer layers. Modified electrode tip

[0057] In the illustrated example, the RF guide wire 10 includes an electrode for delivering radio frequency energy. In one particular example, as illustrated, 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 exerted on the tissue. In one such 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 exerted on the tissue.

[0058] In some such examples, referring to FIG. 1A, the RF guide wire 10 may include a cylinder 10c having a hemispherical electrode tip 10d, and in some examples, a cap may be formed distal to and adjacent to the cylinder 10c. In other words, the electrode tip 10d may be defined by a dome at the top of the cylinder 10c that is substantially completely round. In some such examples, the outer diameter of the dome may substantially match the outer diameter of the cylinder 10c. This can help provide a substantially non-traumatic distal interface with the tissue to minimize the risk of trauma and / or injury at the desired target tissue site. In some such embodiments, the dome-shaped distal electrode tip 10d of the RF guide wire 10 can reduce the amount of pressure exerted on the tissue by the tip to make the tip more non-traumatic, and thus the force exerted by the distal tip spreads over a larger area. In some such examples, the RF guide wire 10 is provided as a 0.035-inch wire.

[0059] More specifically, referring to FIGS. 1A and 1C, the assembly further comprises a sheath 10 and a support member comprising a reinforcement expander such as expander 30A that can be used with a flexible RF wire, the expander 30A comprising a reinforcement member 34 and one or more polymer layers 38 that define the polymer shaft 39 of the expander 30A, the reinforcement member 34 being substantially surrounded by the one or more polymer layers 38.

[0060] In some such embodiments of the present invention, an assembly 100 for puncturing tissue is provided, the support member 130 comprising a needle shaft 132, the needle shaft 132 comprising a reinforcement member 34 and one or more polymer layers 38, the reinforcement member 34 being substantially surrounded by the one or more polymer layers 38. In some such embodiments, the needle shaft 132 is provided within the expander 30A. Thus, in some embodiments, the support member is provided as part of the expander 30A or comprises a needle shaft 132 defined by the expander 30A, the needle shaft 132 being embedded in or surrounded by one or more polymer layers 38 of the expander 130.

[0061] The details of the reinforcement member 34 are shown in FIG. 1C. More specifically, FIG. 1C shows a support member 130 comprising a reinforced 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 put another way, 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 that supports the tissue piercing device or member. In some such examples, the dilator 30A comprising the needle shaft 132 comprises a proximal portion 31 that terminates at the distal tip 41. In some such embodiments, the reinforcement member 34 provides sufficient rigidity that is substantially similar to that of a rigid needle.

[0062] In some such examples, the dilator shaft 32 extends along the proximal portion 31 and comprises the reinforcement member 34. In the particular example shown, the reinforcement member 34 is substantially surrounded by one or more polymer layers 38. In some such examples, the reinforcement member 34 is embedded within one or more polymer layers 38 including an inner polymer layer and an outer polymer layer. In some such examples, the inner and outer polymer layers include inner and outer tubular members 35, 37 of the dilator shaft 32. In some such examples, being substantially surrounded can be interpreted to mean that the outside or exterior of the reinforcement member 34 is substantially surrounded by one or more polymer layers 38 that form a polymer shaft 39 (forming the dilator shaft 32) around the reinforcement member 34. In some embodiments, the dilator 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 one such example, the reinforcement member 34 includes a stainless steel hypo tube and the inner and outer tubular members 35, 37 include HDPE. The hypo-tube defines the inner lumen of the support member.

[0063] In such an example, a reinforcing member 34, such as a stainless steel hypo-tube, extends longitudinally within one or more polymer layers, e.g., within inner and outer tubular members 35, 37, as shown in FIG. 1C. Thus, the reinforcing member 34 (e.g., the hypo-tube) defines the inner lumen of the support member 130. A hypo-tube located between one or more polymer layers

[0064] In one example, referring again to FIG. 1C, the support member 130 includes one or more polymer layers 38, including an inner polymer layer and an outer polymer layer, and in some examples, may include inner and outer tubular members 35, 37. In a particular example, the reinforcing member 34 is substantially surrounded by one or more polymer layers 38 along its outer side, as described above. In other examples, the reinforcing member 34 is substantially surrounded by one or more polymer layers 38 such that it is located between an inner polymer layer and an inner polymer layer, as defined by, for example, inner and outer tubular members 35, 37 shown in FIG. 1D (in some examples, the hypo-tube is located between or sandwiched between two layers of polymer). In other words, the reinforcing member 34 is substantially surrounded by both an inner and an outer polymer layer and is embedded therein. In other words, the reinforcing member 34 is sandwiched between inner and outer polymer layers 38 and a polymer shaft 39 that forms the expander shaft 32. In some such examples, the inner and outer tubular members 35, 37 comprise high density polyethylene (HDPE).

[0065] In some embodiments of the transseptal assembly 100, the sheath 10 comprises a standard transseptal sheath, and the needle shaft 132 (provided as part of the dilator 30OA or defined by the dilator 30OA) comprises a reinforcing member 34 as described above herein, and the RF guide wire or RF wire is provided as a 0.035-inch wire. In some such examples, the RF wire comprises a J-tip wire, or in an alternative example, the RF wire comprises a pigtail wire. Hypotube fixed within the internal lumen of the dilator

[0066] In some such embodiments of the present invention, the reinforcing member 34 comprises a distal end 34D and a proximal end 34P, and the reinforcing member 34 extends within the internal lumen of the dilator 30A, as shown in FIG. 1C. In some such embodiments, the assembly 100 provides an interface with substantially no gap at the junction between the reinforcing member at the distal and proximal ends and the one or more polymer layers. In some such examples, the reinforcing member 34 is fixed within one or more polymer layers 38 that form the polymeric shaft 39 of the dilator 30A. Now referring to FIGS. 7A - 7C, in one such example, the reinforcing member 34 is substantially fixed to one or more polymer layers 38 of the dilator 30A at its distal and proximal ends (in other words, the distal end of the reinforcing member and the proximal end of the reinforcing member), providing an interface with substantially no gap at the junction between the reinforcing member 34 and the one or more polymer layers 38 at the distal and proximal ends. The drawings show the interface at the distal end of the reinforcing member 34. A similar interface is provided at the proximal end of the reinforcing member 34 as well. In some such embodiments of the present invention, the reinforcing member 34 is substantially sealed to one or more polymer layers 38 of the expander 30A at its distal and proximal ends (in other words, the distal end of the reinforcing member and the proximal end of the reinforcing member). In some such embodiments, by substantially eliminating the gap between the reinforcing member 34 and the polymer shaft 39 of the expander 30A, blood or other liquid can be prevented from entering between the reinforcing member 34 and the polymer shaft 39. Force transmission and / or torque transmission Support member for providing force / torque transmission

[0067] In some such embodiments of the present invention, the support member 130 provides sufficient rigidity to a piercing device such as an RF wire and enables sufficient force transmission to transmit force to the distal end of the assembly 100.

[0068] In some such embodiments, the support member 130 provides sufficient rigidity to the piercing device to enable torque to be transmitted to the distal end of the assembly. Reinforcing member for providing force transmission / torque

[0069] In some such examples, the reinforcing member 34 provides sufficient rigidity to the assembly 100 such that sufficient force transmission is possible to enable force to be transmitted to the distal end of the assembly 100. More specifically, the reinforcing member 34 enables a substantially flexible piercing device 112 (such as a substantially flexible energy-based piercing device 114 like the RF wire 10) to transmit force to the distal end of the assembly 100 together with the support member 130 (and thus enables force to be transmitted to the distal end of the substantially flexible piercing device 112).

[0070] Thus, the reinforcement member 34 can impart a force transmission ability to the substantially flexible RF wire 10, and this force transmission ability, 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 the tissue at the target tissue site, and is force transmissible. Thus, the reinforcement member 34 functions as a force transmission part of the assembly 100.

[0071] In some such examples, the assembly 100 further comprises a sheath 20, as shown in FIG. 1A, and the sheath 20 can be used with the support member 130 to provide rigidity to the assembly 100 to facilitate the force transmitted to the distal end of the assembly 100.

[0072] 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. Thus, the reinforcement member 34 provides sufficient rigidity to the assembly, and a substantially flexible puncture device 112, such as the substantially flexible energy-based puncture device 114, provides sufficient rigidity to the assembly 100 together with the support member 130 to enable torque to be transmitted to the distal end of the assembly 100 (thus enabling torque to be transmitted to the distal end of the substantially flexible puncture device 112).

[0073] Some such embodiments of the present invention facilitate transverse puncture, and the reinforcement member 34 provides sufficient rigidity to the assembly 100 to enable sufficient force transmission to engage a desired tissue site (such as the septum of the heart). In some such examples, the support member 130 provides a force transmission ability to the substantially flexible puncture device 112, and the substantially flexible puncture device 112 is force transmissible when used with the support member 130.

[0074] In some such embodiments, the assembly 100 further comprises 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 enable torque to be transmitted to the distal end of the assembly 100.

[0075] In some such examples, the sheath 20 can be coupled to an expander 30A that enables force and / or torque transmission using one or more components (i.e., the sheath 20 or the expander 30A). In other words, the user does not need to manipulate the sheath 20 and the expander 30A (the user only needs to manipulate the sheath 20 or the expander 30A), and the RF guide wire 10 follows the guidance and / or direction of the sheath 20 and / or the expander 30A. In some such examples, the sheath 20 has some contribution to the overall torque. In some such embodiments, applying torque to the sheath 20 and / or the expander 30A enables torque to be applied to the reinforcement member 34. Rigidity of the reinforcement member

[0076] In some embodiments of the present invention, the force transmission portion of the assembly 100 has a force transmission portion flexural rigidity of at least about 0.0085 Nm 2 , for example, about 0.0115 Nm 2 . In some embodiments of the present invention, the force transmission portion of the assembly has a flexural rigidity value of at least about 0.0115 Nm 2 to enable sufficient force transmission to enable force to be transmitted to the distal end of the assembly 100, and is a support member 130 having rigidity. In some such examples, the support member has a flexural rigidity of about 0.0085 Nm 2 to about 0.0145 Nm2. In such an example, the support member 130 is a reinforced expander 30A having a flexural rigidity of at least about 0.0085 Nm 2 , for example, about 0.0115 Nm 2 . In a specific example, the reinforcement extender 30A has a bending stiffness of about 0.0085 Nm 2 to about 0.0145 Nm 2 In such an embodiment, the reinforcement extender 30A is the reinforcement extender 30A provided in Example 1, as provided with respect to FIGS. 2A-2G, for example.

[0077] In some such examples, the support member 130 functions to impart rigidity to an assembly 100 that includes a piercing device, such as a substantially flexible piercing device, and to provide force transmission ability to an assembly that includes a piercing device, such as a substantially flexible piercing device.

[0078] In some embodiments, the bending stiffness values provided to the support member 130 can also be used in Example 2 and Example 3 provided herein with respect to FIGS. 4A-4G and FIGS. 6A-6H. Example 2, Example 3

[0079] In some embodiments of the present invention, the force transmission portion of the assembly is the support member 130, which is a reinforcing member with a stylet. The stylet has a rigidity with a bending stiffness value of at least about 0.008 Nm 2 , for example, about 0.015 Nm 2 and has sufficient force transmission to allow force to be transmitted to the distal end of the assembly 100. In some such examples, the support member has a bending stiffness of about 0.008 Nm 2 to about 0.024 Nm 2 In some embodiments of the present invention, the distal portion of a piercing device, such as a substantially flexible piercing device, has a bending stiffness in the distal portion or distal region. 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 the portion along the distal electrode tip 10d), and the RF guide wire 10 has at least about 3.57×10 Rigidity of the piercing device

[0080] Nm -6 Nm 2 to about 4.76×10-6 Nm 2 The distal segment stiffness is defined by a bending stiffness of In some embodiments of the present invention, the RF guidewire 10 has a diameter of about 3.57×10 -6 Nm 2 ~Approx. 5.95×10 -6 Nm 2 The distal portion has a bending stiffness of .

[0081] In some such examples, the distal region of RF guidewire 10 tapers from about 12 cm to about 15 cm from the proximal region of RF guidewire 10. In other words, the distal portion of RF guidewire 10 has a length of about 12 cm to about 15 cm. In some such examples, the distal portion of RF guidewire 10 is the thinnest point of RF guidewire 10.

[0082] In some such embodiments, the substantially flexible RF guidewire 10 has a resistance of about 0.00179 Nm 2 Less than about 0.00143 Nm 2 In some embodiments of the present invention, the RF guidewire 10 has a proximal portion having a proximal portion bending stiffness of about 0.00107 Nm 2 ~ approx. 0.00179Nm 2 The proximal portion has a bending stiffness of .

[0083] In some embodiments of the present invention, the substantially flexible puncture device includes an RF guidewire 10 and has a diameter of about 2.0×10 -6 ~Approx. 1.4×10 -3 Nm 2 The bending stiffness is between . In some such examples, the RF guidewire 10 has a wire diameter of about 0.127 mm to about 0.635 mm. Shape capability of support / reinforcement members

[0084] More specifically, to optimize the position of the assembly 100 relative to a target tissue site such as a heart septum, the reinforcement member 34 is such that the support member 130 (e.g., provided as part of a reinforced dilator 30A or comprising a needle shaft 132 as defined by the reinforced dilator 30A) is removed from a substantially flexible energy delivery piercing device 110 (such as RF wire 10), and the support member 130 is shaped to be able to be reinserted therewith such that the curvature of the support member 130 is reinserted therewith.

[0085] In some embodiments of the present invention, the support member 130 is shaped to be able to be removed from a piercing device (such as a substantially flexible piercing device 114 such as an RF guide wire 10) such that the curvature of the support member 130 is reinserted therewith to optimize the position of the assembly 100 relative to a target tissue site. In some such examples, the reinforcement member 34 further provides formability and enables the reinforcement member 34, and thus the support member 130, to be shaped. In some such embodiments, when the reinforcement member 34 is formable, to optimize the position of the assembly 100 relative to a target tissue site such as a heart septum, the support member 130 (including the reinforcement member 34) is removed from a substantially flexible piercing device (such as an RF guide wire) and the curvature of the support member is reinserted therewith.

[0086] In some such embodiments, the support member 130 is provided within a reinforced dilator 30A (such as within the needle shaft 132 of the reinforced dilator 30A) and thus comprises a reinforcement member 34 that gives the dilator 30A shapeability. In other examples, the support member 130 comprises a stylet 60 provided separately from the dilator 30A (providing shape stability to the assembly 100 as described in embodiments further described hereinbelow). In other words, when used with the assembly 100, the stylet 60 functions to impart a desired curvature and rigidity to the assembly 100. The stylet 60 is removable from the assembly and can be reshaped and reinserted relative to the assembly 100 to provide the desired curvature to the assembly 100. Connection between the dilator and the sheath Lock function of Example 1

[0087] In some embodiments of the present invention, referring to FIG. 1C, an assembly 100 is provided, the assembly 100 comprising a sheath 20 as shown in FIG. 1A for use with a reinforced dilator 30a during part of the procedure. In some such examples, the assembly 100 includes a locking mechanism that allows for axial and rotational coupling of the dilator 30A and the sheath 20 for part of the procedure. In some embodiments of the present invention, the locking mechanism enables cooperative engagement between the sheath 20 and the dilator 30A to provide rotational and axial coupling. This helps to minimize the risk of rotational misalignment between the sheath 20 and the dilator 30A, and thus the risk of confusion resulting from misalignment can be reduced.

[0088] Here, referring to FIG. 1E, a support member 130 comprising a needle shaft 132 that comprises the dilator 30A (provided as part of or defined thereby) is operable to be coupled to the sheath hub 21 for part of the procedure and comprises a dilator hub 51. In one example, as shown in FIG. 1F, a locking mechanism is provided that comprises one or more keys 52 that cooperate with a corresponding mechanism (such as a key receiving mechanism) on the sheath hub 21 that allows for axial and rotational locking of the dilator hub 51 with the sheath 20. Thus, in some embodiments of the present invention, a locking mechanism is provided to allow for axial and rotational coupling of the dilator and the sheath for part of the procedure. In some examples, a variable sheath is provided, and the variable sheath 20 may be an 8Fr variable sheath. Alternatively, an 8.5Fr variable sheath 20 may be provided. In some such examples, the variable sheath 20 can have different curvatures. In a particular example, the variable sheath 20 may be provided with different curvatures, specifically at angles of 37 degrees, 45 degrees, 55 degrees, 90 degrees or 135 degrees. In this particular example, the sheath tubing includes an inner PTFE liner, a blade and a Pebax outer jacket. In some such embodiments, a support member 130 is provided that includes a needle shaft 132 of an 8Fr dilator 30A (e.g., provided as part of or defined thereby) that is compatible with an 8Fr sheath. Alternatively, the support member 130 that includes the needle shaft 132 may be provided as part of the 8Fr variable sheath 20 or may be defined by an 8.5Fr dilator 30A. The support member 130 that includes the needle shaft 132 (e.g., provided as part of or defined by the dilator 30A) can have a curvature of 50 degrees or 86 degrees. In some examples, the material can include HDPE and a metal hypo tube that forms a reinforcing member 34. In some such examples, the RF wire includes a 0.035 inch OD wire and may be a J-tip wire or a pigtail wire. In this particular example, the wire can include a stainless steel core with a PTFE coating. Radiopaque marker

[0089] In some embodiments, as shown in FIGS. 1C and 1D, the support member 130 includes one or more radiopaque markers such as a support member radiopaque marker 42. In some examples as described above, the assembly 100 provides a support member 130 (e.g., comprising a needle shaft 132 provided as part of a reinforced expander 30A or defined by a reinforced expander 30A), and includes a radiopaque marker 42 at a distal tip of the support member 130 or the like. In some such examples, the support member 130 includes a radiopaque marker 42 embedded within the polymer at its distal tip as shown.

[0090] In certain examples, as shown in FIGS. 7A, 7B, and 7C, the radiopaque marker 42 includes a radiopaque coil 142 (e.g., provided as part of a reinforced expander 30A or comprising a needle shaft 132 defined by a reinforced expander 30A) embedded within the polymer of the support member 130, such as at its distal tip (of the support member 130) and within one or more polymer layers 38 (forming a polymer shaft 39 that in turn forms the expander shaft 32). In more specific examples, the radiopaque coil 142 is embedded within one or more polymer layers such that one or more polymer layers extend distally beyond the radiopaque coil 42. Alignment Using Radiopaque Markers

[0091] 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 alternatively, 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 a substantially flexible energy-based puncture device 114 (such as 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 as presently described, the stylet 64 may be a reinforcing member 34 provided within the dilator 30A.

[0092] In some such embodiments, the assembly 100, as shown in FIG. 3A, includes an initial configuration 100A in which a substantially flexible energy-based puncture device 114 (such as RF guide wire 10) is positionable within the support member 130 such that one or more device radiopaque markers 12 are misaligned with the support member 130 radiopaque marker 42. In some such examples, multiple radiopaque markers, including one or more device radiopaque markers 12 and support member radiopaque marker 42, may be visible during imaging.

[0093] In some such embodiments, the assembly 100, as shown in FIG. 3B, includes a first configuration 100B in which a substantially flexible energy-based puncture device 114 (such as RF guide wire 10) is positionable within the support member 130 such that one or more device radiopaque markers 12 are aligned with the support member 130 radiopaque marker 42 as shown in FIG. 3B. In some such examples, a single radiopaque marker may be visible during imaging (including one or more device radiopaque markers 12 and a support member radiopaque marker 42 that can be arranged in proximity to each other).

[0094] Assembly 100 further has a second configuration 100B, and a substantially flexible energy-based piercing device 114 (such as RF guide wire 10) is positionable / advancable within support member 130 such that there is substantially no misalignment or poor alignment with support member radiation-opaque marker 42 of one or more device radiation-opaque markers 12. As a result, misalignment between one or more device radiation-opaque markers 12 and support member radiation-opaque marker 42 is beyond the support member for positioning with respect to a target tissue site for tissue piercing (e.g., distal to the distal tip or end of support member 130), indicating the positioning of the energy delivery portion 114d of the substantially flexible energy-based piercing device 114 (such as the electrode tip 10d of RF guide wire 10). In some such examples, similar to FIG. 3A, multiple radiation-opaque markers are visible during imaging [including one or more device radiation-opaque markers 12 and support member radiation-opaque markers 42]. Here, one or more device radiation-opaque markers 12 are disposed distally with respect to support member radiation-opaque marker 42, indicating that the distal electrode tip 10d is disposed with respect to a target tissue site (such as the septum of the heart) for piercing the tissue.

[0095] In some such examples, sheath 20, dilator 30A, and reinforcement member 34 are all radiation-opaque and have radiation-opacity such that they can be seen during imaging. In some such examples, one or more of sheath 20, dilator 30A, and reinforcement member 34 such as a metal hypo tube comprise a radiation-opaque material in addition to radiation-opaque marker

[42] . Reinforcement member 34 such as a metal shaft or hypo tube is also radiation-opaque. In some such embodiments, the polymer forming sheath 20 and / or dilator 30A may include a polymer radiation-opaque filler such as 20% barium sulfate, resulting in contrast with one or more markers [12, 42] at the distal tip. In other words, this may provide visibility under imaging and may further provide contrast with one or more markers [42, 12], enabling the user to observe the dilator 30A under imaging for viewing whether the RF guide wire 10 is disposed within or outside the dilator 30A [i.e., whether the distal segment of the RF guide wire 10 is distal to the dilator 30A] as compared to the RF guide wire 10. Blunt dilator tip [Example 1]

[0096] In some embodiments of the present invention, the support member 130 comprises a substantially non-traumatic distal tip 143, and as shown in FIG. 1A, while comprising a substantially blunt distal tip or edge 143, it has the advantages of a substantially rigid support member 130 (such as by providing a reinforcing member 34). In some such embodiments, as described above and referring again to FIG. 1A, a reinforced dilator 30A is provided. In some examples, the dilator 30A comprises a substantially blunt distal tip or edge 144 to provide a substantially non-traumatic distal tip 144. In some such embodiments, the reinforced dilator 30A comprises a substantially thick distal wall along the distal tip 144, and the distal tip 144 is defined by a substantially rounded distal tip edge. In some such embodiments, in addition to enabling the use of the RF guide wire 10 for one or more of positioning, tracking device, puncture, and fixation, the dilator 30A provides the advantages associated with providing a substantially rigid body by providing substantially rigid components (such as the reinforcing member 34 therein), while providing traceability and ease of intersection, and has the advantages of a dilator by comprising a substantially non-traumatic distal tip and further a tapered shape of the distal tip.

[0097] In one such embodiment, an overall method / workflow is provided, which shows a method of performing a transseptal puncture procedure using the assembly 100 as described above herein. The methods disclosed herein provide one or more advantages associated with an assembly comprising an energy delivery component provided separately from a rigid component. Details of this method are set forth below. Method Method [Example 1] Using the same device for initial tracking / access and positioning

[0098] In some embodiments of the present invention, referring to FIGS. 2A - 2G, a method of puncturing tissue is disclosed. This method includes the step of accessing a region of tissue within a patient's body by advancing a device (such as a puncturing device 110 like RF guide wire 10) into the region of tissue as shown in FIG. 2B. In some such examples, the method of puncturing a tissue region comprises a method of performing a transseptal puncture in which the step of accessing the tissue region includes advancing a device (such as a puncturing device 110) into the superior vena cava (SVC) 501 adjacent to the patient's heart 500.

[0099] In some embodiments of the present invention, the method of puncturing tissue further includes, for example, [3] first tracking a support member 130 (such as a stiffening dilator 30A) on the puncturing device 110 as shown in FIG. 2C to support the device (such as the puncturing device 110), and [3] advancing the device (such as the puncturing device 110) toward the target tissue site to enable positioning the device at the target tissue site within the region of tissue as shown in FIG. 2D, by which the device is positioned at the target tissue site within the region of tissue as shown in FIG. 2D.

[0100] In some such examples, the step of placing the puncture device 110 at the target tissue site includes, for example, first (2) tracking or advancing a support member 130 (such as dilator 30A) within the SVC over the device (such as puncture device 110), and (3) facilitating a drop-down into the fossa 504 to place the puncture device 110, by performing a drop-down from the superior vena cava (SVC) into the patient's heart 500 to position the fossa ovalis (or in other words, fossa) 504 along the septum 502 of the heart 500.

[0101] In some such examples, as shown in FIGS. 2B - 2D, the step of accessing [1] as shown in FIG. 2B and the step of positioning [3] as shown in FIG. 2D are performed using the same device, such as puncture device 110, which can be used without the support member 130 during the step of accessing [1], and the device can be used with the support member 130 during the step of positioning [3]. Use of a Puncture Device for Initial Access and Positioning

[0102] In some such embodiments of the present invention, as shown in FIGS. 2B - 2D, the steps of access and positioning are performed using the puncture device 110. Using the Same Device for Initial Access, Positioning, and Puncture

[0103] In some such embodiments of the present invention, as shown in FIG. 2E, the method further includes, as shown in FIG. 2D, a step [4] of puncturing the target tissue site using a device (such as puncture device 110) after the step of positioning [3]. The support member 130 supports the device (such as puncture device 110) during puncture [4] where the steps of access [1], positioning [3], and puncture [4] are performed using the same device.

[0104] In some embodiments of the present invention, the step [4] of puncturing the target tissue site includes the step [4] of puncturing the fossa 504 to gain access to the left side of the heart 500. This enables 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, to be tracked on the RF guide wire 10 to the left side of the heart. Use of a puncture device for initial access, positioning and puncture

[0105] 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

[0106] According to one embodiment of the present invention, the method further includes a step of fixing, 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 through the target tissue site after the step [4] of puncturing through the target tissue site. As shown in FIG. 2F, one or more additional devices [such as the support member 130 including the sheath 20 and the dilator 30A] can be tracked to the other side of the target tissue site over the device (such as the puncture device 110). Here, 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, can 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 can be removed or retracted to enable fixation 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 examples, the RF guide wire 10 provides a substantially rigid rail that guides one or more devices to the left side of the heart while being substantially non-invasive to minimize damage to tissue.

[0107] In some such embodiments of the present invention, the step of fixing to maintain 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) to maintain access to an area of tissue such as the left side of the heart.

[0108] Thus, in some examples, the step of fixing includes enabling fixation by removing the support member 130 comprising the dilator 30A such that the RF guide wire 10 remains positioned to maintain access to the left side of the heart. The sheath 20 may additionally be removed. Use of a puncture device for initial access, positioning and puncture

[0109] In some such embodiments of the present invention, the steps of accessing, positioning, puncturing and fixing are performed using a puncture device. Alternatives to the devices used for initial access, positioning and / or puncturing are based on the basic claims upon which these dependencies depend.

[0110] In some such embodiments of the present invention, the device comprises a flexible puncture device 112, where one or more of the steps of accessing, positioning, puncturing, and fixing are performed using the flexible puncture device 112. In some such examples, each of the steps of accessing, positioning, puncturing, and fixing is performed substantially using the flexible puncture device 112.

[0111] 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), and 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 performed substantially using the substantially flexible guide wire (such as mechanical guide wire 118 or RF guide wire 10).

[0112] In some such embodiments of the present invention, the device includes a flexible energy-based puncture device 114, and one or more of the steps of accessing, positioning, puncturing, and fixing are performed using the flexible energy-based puncture device 114. In some such examples, each of the steps of accessing, positioning, puncturing, and fixing is performed substantially using the flexible energy-based puncture device 114.

[0113] 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 performed substantially using the flexible RF guide wire 10.

[0114] 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 performed substantially using the flexible mechanical guide wire 118. Repeating the steps of access and positioning

[0115] In some such embodiments of the present invention, the method further includes repeating the step of accessing [1] shown in FIG. 2B and the step of positioning [3] shown in FIG. 2D until the device (such as the puncturing device 110) is positioned at a desired target tissue site, before the step of puncturing [4] shown in FIG. 2E. Remolding of the support member

[0116] In some such examples, repeating the positioning step [3] as shown in FIG. 2D includes reshaping the curvature of the support member 130 after removing the support member 130 and re-tracking the support member 130 over a device (such as the puncture device 110 repositioned [1] within the SVC as shown in FIG. 2C and as shown in FIG. 2B), and then repeating the positioning step as shown in FIG. 2D. Repeating the positioning step as shown in FIG. 2D, in the illustrated example, in a specific example, the support member 130 includes a reinforcing member 34, and the positioning step is performed using this reinforcing member 34.

[0117] In some such embodiments of the present invention, the method includes reshaping the support member 130 (such as the reinforced dilator 30A). In some such examples, the method includes pulling out the dilator element or dilator 30A and reshaping it. In other examples, it includes pulling out both the dilator element 30A and the sheath 20a and reshaping them. The support member includes a reinforced dilator.

[0118] In some such examples, the reshaping is performed using the support member 130 comprising the reinforced dilator 30A, the reinforced dilator 30A comprises a reinforcing member 34, and the positioning step is performed using the reinforced dilator 30A that can be reshaped. The support member comprises a stylet.

[0119] In some embodiments, alternatively, as further discussed below with respect to FIGS. 4A - 4E, the stylet 60 can perform the reshaping step using the support member 130 comprising the stylet 60 which is the reinforcing member 34, and the positioning step is performed using the stylet 60.

[0120] In some such examples, the stylet element 60 can be removed and reshaped. In other examples, the stylet element 60 may be withdrawn with the sheath 20 and / or the dilator 30B, reshaped to see what the net shape is, and then reinserted therein.

[0121] The methods outlined above can also be used in the embodiments further discussed below having a removable stylet 60, as shown in FIGS. 4A-4E and FIGS. 6A-6H. Mapping system for visualizing initial access tracking and positioning

[0122] In some such embodiments with respect to FIGS. 2A-2G, reference is further made to the embodiments shown in FIGS. 4A-4E and FIGS. 6A-6H. The positioning step is performed using the flexible RF guidewire 10. In some such examples, the positioning and puncturing steps are performed using the flexible RF guidewire 10. Furthermore, in some such examples, the positioning, puncturing, and fixation steps are performed using the flexible RF guidewire 10. In some such examples, the mapping system as provided below can be used to visualize the positioning and fixation steps. In some such examples, as shown in FIGS. 2A-2G and FIGS. 4A-4E, the accessing step may be further performed using the RF guidewire 10. Thus, in some such examples, the mapping system as provided below can be used to visualize the flexible RF guidewire 10 during the accessing, positioning, and fixation steps using the mapping system. In some such examples, the method further includes the step of visualizing the flexible RF guidewire 10 using the mapping system during the accessing and positioning steps.

[0123] Accordingly, 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 steps of accessing, positioning, and fixing.

[0124] In some examples, the mapping device includes an electro-anatomical mapping system, which can be magnetic or impedance-based to generate a virtual volume. In some embodiments, the electro-anatomical mapping system can be used with other cardiac echo imaging modalities, such as ultrasound. The cardiac echo imaging modality may be used as an overlay in the map, or in other words, may be used to provide additional information to the mapping system. The cardiac echo imaging modality can include intracardiac echocardiography or TEE echocardiography.

[0125] In some examples, the method involves switching between a mapping mode used for each of the accessing, positioning, and fixing steps and a puncturing mode used for the puncturing step.

[0126] In some such examples, the method of mapping the RF guide wire 10 to visualize using an imaging modality can be used with a flexible wire having electrodes that can or cannot deliver energy that can be used to record the objective. In some cases, it may be a passive electrode for recording purposes. Alternatively, as described above, when the RF guide wire 10 is used, the mapping system can be used with an active electrode such as the distal electrode tip lOd of the RF guide wire 10. Thus, the recording and mapping characteristics of the mapping system can be used with a guide wire having a passive or active electrode. In certain examples where the wire comprises a passive electrode for mapping, the wire may comprise a piercing means or means for piercing tissue. In one example, the wire can include a mechanical guide wire 118 that can have a sharp distal tip 118d for piercing tissue.

[0127] 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 an RF wire 10.

[0128] As a general overview, again with respect to FIGS. 2A-2G, in one broad embodiment, 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 over the wire within the superior vena cava as shown in FIG. 2C; (iii) retracting the RF wire into the dilator as shown in FIG. 2D; (iv) additionally dropping down into the heart to find the fossa from the SVC as shown in FIG. 2D; (v) exploring using the dilator; (vi) advancing the RF wire to the puncture location as also shown in FIG. 2D; (vii) puncturing and advancing the RF wire as shown in FIG. 2E; and (viii) crossing the sheath and dilator over the RF wire as shown in FIG. 2F.

[0129] 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 comprising a flexible RF wire 10, a sheath 20, and a dilator 30A is provided. The method, as further shown in FIG. 2B, includes, in step 202, advancing the [1] RF wire into the superior vena cava (SVC) to obtain access. In some such embodiments, by providing an energy delivery component (flexible RF wire) separate from the reinforcement member, the energy delivery component can be used as an access wire. More specifically, the dilator 30A can be advanced later, and the flexible RF wire enables 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 time and complexity of the procedure.

[0130] This method further includes, at step 204, advancing the combination of [2] the sheath 20 and the dilator 30A into the SVC over a flexible RF wire. Accordingly, the flexible RF wire 10 functions as an access wire and enables the sheath 20 and the dilator 30A (e.g., as an assembly) to be tracked into the SVC over the flexible RF wire 10 as shown in FIG. 2C.

[0131] This method further provides, at step 206, pulling the RF wire into the dilator 30A and, at step 208, performing a drop-down from the SVC into the heart to locate the fossa in order to perform the step of [3] positioning the assembly 100 as shown in FIG. 2D. In one such example, having the reinforcement member 34 (within the dilator 30A) separate from and independently operable from the flexible RF wire provides the additional advantage of allowing the drop-down to be repeated if the fossa is missed on the first pass. More specifically, it eliminates the need for rewiring, i.e., the need to reinsert the access wire, remove the access wire, and then re-advance a rigid puncture device such as a needle into the SVC to repeat the drop-down. More specifically, in one embodiment of the present application, the dilator 30A (and thus the reinforcement member 34) may be partially removed or retracted together with the sheath 20, and the flexible RF wire 10 may be re-advanced into the SVC. Next, the sheath 20 and the dilator 30 can be advanced again over the flexible RF wire 10, as shown in FIG. 2C, and the dropdown can be repeated to allow the RF wire 10 to engage the fossa. This can help shorten the procedure time and increase safety since no additional exchanges are required. Adding additional exchanges can add more time and unnecessary risks. Thus, in this embodiment where the energy delivery component and the rigid component are separated, the treatment time and risks can be reduced.

[0132] The reinforcement member 34 (within the dilator 30A) provides the additional advantage of providing the assembly 100 with sufficient rigidity to facilitate the dropdown in step 208. Thus, the reinforcement member 34 allows for sufficient force and torque transmission to enable the assembly 100 to engage the septum, as shown in FIG. 2D. This method further includes, in step 212, exploring with the dilator 30A, with reference to FIG. 2D. The reinforcement member 34 gives the assembly 100 sufficient rigidity to apply force to the distal end of the assembly 100 and thus enables exploration with the dilator 30A. In some embodiments, having the reinforcement member 34 within the dilator 30A allows the dilator 30A to be removed, reshaped, and optimized for position relative to the fossa. In some such embodiments, prior to the exploration step, in step 210, the physician can evaluate whether the angles of the dilator 30A and / or the assembly 100 are sufficient. If the angles are not considered sufficient, in step 211, the physician can withdraw the dilator 30A and reshape the curve. Next, as shown in step 213, the dilator can be reinserted. This procedure is repeated starting from step 210, and the dropdown is performed again using the assembly 100. Once the fossa is located, the physician can proceed to the step of exploring with the dilator in step 212.

[0133] As shown in FIG. 2E, this method further includes, in step 214, advancing the RF wire 10 to the puncture position, and in step 216, [4] puncturing and advancing the RF wire 10. Advancing the RF wire 10 to the left side of the heart 500 enables fixation of the RF wire 10 to the left side of the heart to maintain access to the left side of the heart. The flexible RF wire 10 can provide the additional advantage of allowing the operator to push firmly without injury such that the flexible RF wire is more flexible. As further shown in FIG. 2F, this method further includes, in step 218, [5] crossing the sheath and the dilator over the RF wire 10. The flexible RF wire 10 can further protect the open end of the sheath 20 / dilator 30A and prevent it from being strongly pushed into the tissue. Then, in step 218, the sheath 20 and the dilator 30A (including the reinforcing component 34) can be removed.

[0134] As outlined herein, the energy delivery component is provided as a flexible RF wire 10 that is separated from a rigid component such as the reinforcing member 34 (provided within the dilator 30A), and the reinforcing member 34 (having the dilator 30A) is separable and removable from the flexible RF wire 10. This provides the step of allowing the reinforcing member 34 (within the dilator 30A) to be removable after transseptal puncture and access, and (6) enabling the flexible RF wire 10 to remain positioned within the left atrium, providing the further advantage of allowing immediate fixation of the flexible RF wire within the left atrium, as shown in FIG. 2G. In one such example, the RF wire may be placed within the left superior vena cava for fixation. This allows the RF wire to maintain access to the left atrium and enables removal of the reinforcement member 34 along with the dilator 30A to facilitate replacement of the device into the left atrium using a flexible RF wire. This can eliminate the need for the physician to advance another wire after the puncture to maintain access to the left side for tracking additional devices on the left side, and can further reduce additional exchanges on the left side. A further advantage of minimizing exchanges on the left side is that, in addition to reducing the treatment time and the number of steps required, it minimizes the risks of toxicity, embolism, and stroke. In another example, the RF wire 10 can have a pigtail curve at its distal end. This enables the RF wire 10 to be fixed to the left atrium instead of the respiratory vein. Alternatively, the RF wire 10 may be used to fix within the nerve vein. In some such examples, the former method of fixing to the left atrium can provide additional advantages not seen in the latter method. Example 1 [Reinforced Dilator]

[0135] In some embodiments of the present invention, briefly, a method of puncturing tissue is disclosed, the method comprising advancing a flexible puncture device 112 into a region of the tissue, advancing a sheath over the flexible puncture device 112 into the region of the tissue, retracting the flexible puncture device 112 into a support member 130, positioning the assembly 100 at a target tissue site within the region of the tissue, probing with the support member 130, advancing the flexible puncture device 112 to the puncture position, puncturing and advancing the flexible puncture device 112, and crossing the sheath 20 and the dilator 30A over the flexible puncture device 112.

[0136] In some such examples, as described above, the method of piercing tissue includes the method of performing a transseptal puncture, and the tissue region includes the superior vena cava. In some examples, the flexible puncture device comprises an RF guide wire 10 and the support member comprises a reinforced dilator 30A.

[0137] Some such embodiments of the present invention include a method of performing a transseptal puncture, comprising the steps of advancing an RF guide wire into the superior vena cava, advancing a sheath and a dilator into the superior vena cava over the RF guide wire, retracting the RF guide wire into the dilator, dropping down from the superior vena cava into the heart to find a fossa, exploring with the dilator, advancing the RF guide wire to a puncture position, using the RF guide wire to puncture and advancing the RF guide wire, and crossing the sheath and the dilator over the RF wire. Example 2

[0138] In another example, an embodiment of the present invention provides an assembly 300 for piercing tissue (e.g., generating a transseptal puncture through a septum of the heart), as shown in FIG. 3A. Similar to the above-described embodiments, the assembly 300 provides a substantially flexible energy delivery puncture device 114 (such as a flexible RF guide wire 10) for piercing tissue via energy delivery, and a support member for supporting the substantially flexible energy delivery puncture device, such as a separate reinforcing member 34. In some such embodiments, the substantially flexible energy delivery puncture device 114 (such as an RF guide wire 10) is selectively insertable into the support member 130 so as to be selectively usable in cooperation therewith during a part of the procedure to facilitate exchange and positioning while providing a substantially non-invasive puncture of the tissue, and is usable independently therefrom during another part of the procedure. Device

[0139] In one such example, as shown in FIG. 3A, the assembly 300 includes a flexible energy delivery component 114 that is 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 a separate support member 130 includes a stylet 60 that defines a reinforcing member 34. In other words, below the support member 130, a reinforcing member 34 is provided as a stylet 60 that can be used independently of a puncture device 110 such as the flexible puncture 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 the particular example shown, the reinforcing member 64 is also provided separately from and removable from the dilator 30B, which in this embodiment is provided as a flexible dilator.

[0140] Some such embodiments include a dilator 30B that can be used with the support member 130 to form a support member assembly 134 that is selectively used there during a portion of the procedure, as shown in FIG. 3B. In some such embodiments, as described above, the support member 130 includes a stylet 60 that defines a reinforcing member 34. In some examples, as shown in FIG. 3C, a dilator 30B is provided that can be used with the stylet 60 for selective use there to form a stylet assembly 164.

[0141] In some such embodiments, the puncture device 110 includes a substantially flexible energy-based puncture device 114. In this particular example, the substantially flexible energy-based puncture device 114 includes a flexible RF guide wire or wire 10. In some embodiments, the RF guidewire 10 can be selectively used in cooperation with (e.g., by being selectively coupled to) the stylet 60 during a portion of the procedure, and the RF guidewire 10 can be used independently of the stylet 60 during another portion of the procedure. Combining the RF guidewire 10 with the stylet and selectively using it without the stylet 60 facilitates tissue puncture. Shape capabilities of the support member / reinforcement member

[0142] 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 the curved portion of the support member 130 to be reinserted therewith and to be removed from the puncture device 110 (e.g., a flexible tissue puncture device 112 for a substantially flexible energy-based tissue puncture device 114, etc.). For example, the reformed support member 130 can be reinserted together with and / or used with one or more other components of the assembly 300, such as a substantially flexible energy-based tissue puncture device 114 and / or a dilator 30B and / or a sheath 20, and optimizes the position of the assembly 300 relative to the target tissue site to facilitate puncture (facilitating transseptal puncture, such as in the cardiac fossa).

[0143] In a particular example, the stylet 60 is moldable to allow the stylet 60 to be removed from a substantially flexible puncture device to allow the curved portion of the stylet 60 to be reinserted to optimize the position of the assembly relative to the target tissue site. In some such examples, the stylet 60 is removable from one or more components or members of the assembly 300 and is reformed to be reinserted therewith to position the assembly 300 relative to the target tissue site. The 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 examples, a flexible expander 30B, such as a standard transseptal expander, in which the reinforcement member is not embedded, or in other words, is not embedded separately from the expander 30B. The expander 30B has a proximal portion 31 that terminates at a distal tip 41. In some embodiments, the expander 30B can further include a radiopaque marker 42 at the distal tip 41. Similar to the embodiments disclosed above, the expander 30B includes an expander shaft 32 that extends along the proximal portion 31. However, unlike the above-described embodiments, the assembly 300 provides a reinforcement member or component 34 defined by a stylet 60 that is provided separately from the expander 30B and functions as a removable reinforcement member from the expander 30B. Thus, the reinforcement member 34 is provided separately from and removable from both the flexible RF wire 10 and the expander 30B. FIG. 3B shows the assembly 300 in a dropdown position, while FIG. 3C shows the assembly 300 in an arc discharge position that enables transseptal puncture. Atraumatic stylet

[0144] 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 being inserted. In some such examples, the stylet 68 has a tapered distal tip 69 to help prevent and / or minimize skiving and to provide a smooth feel to the user when inserted into the expander during use.

[0145] In some embodiments, as an alternative to, or in addition to, providing a tapered distal tip 69, the stylet 60 is made substantially non-traumatic by providing a lubricious coating 67 on the stylet 60 to help prevent and / or minimize skiving and to provide a smooth feel to the user when inserted into the dilator during use.

[0146] In some such examples, the lubricious coating 67 includes a PTFE coating. The PTFE coating may be spray-coated onto the stylet 60 or provided as a heat shield. Alignment Using Radiopaque Markers

[0147] In some embodiments of the present invention, similar to the embodiments discussed above with respect to assembly 100, assembly 300 includes a substantially flexible energy-based puncture device 114 (such as RF guide wire 10) having one or more device radiopaque markers 12 at its distal end. Further, the support member assembly includes one or more support assembly radiopaque markers 42 at the distal end of a support member assembly 134 (such as a separate reinforcement member 34 like stylet 60 and a puncture device 110 such as a substantially flexible energy-based puncture device 114). In one such example, the support assembly radiopaque marker 42 is provided on the dilator 30B of the support member assembly 134. In some such examples, one or more device radiopaque markers 12 are configured to cooperate with the support assembly radiopaque markers 42 to indicate the relative position of the substantially flexible energy-based puncture device 114.

[0148] In some such embodiments, the assembly 300 includes an initial configuration 100A, and a substantially flexible energy-based piercing device 114 (such as the RF guide wire 10) can be disposed within the support member assembly 134 such that one or more device radiopaque markers 12 are misaligned with the support assembly radiopaque marker 42, as shown in FIG. 3A. In some such examples, a plurality of radiopaque markers, including one or more device radiopaque markers 12 and support member radiopaque markers 42, may be visible during imaging.

[0149] The assembly 300 further has a first configuration I00B, and a substantially flexible energy-based piercing device 114 can be positioned within the support member assembly 134 such that one or more device radiopaque markers 12 are aligned with the support assembly radiopaque marker 42. In some such examples, a single radiopaque marker may be visible during imaging [including one or more device radiopaque markers 12 and support member radiopaque markers 42 that may be disposed in proximity to each other].

[0150] The assembly 300 further has a second configuration 100B, and a substantially flexible energy-based piercing device 114 (such as the RF guide wire 10) can be positioned / advanced within the support member assembly 134 such that one or more device radiopaque markers 12 are substantially misaligned / misaligned with the support assembly radiopaque marker 42. In some such examples, the misalignment between one or more device radiopaque markers 12 and the support assembly radiopaque marker 42 indicates the positioning of the energy delivery portion 114 (referred to as the electrode distal tip 10d or the electrode distal tip 10d) of the flexible energy-based piercing device 114 (such as the RF guide wire 10) beyond the support member assembly 134 (e.g., distal to the distal tip or end of the support member 130) for positioning relative to the target tissue site for tissue piercing.

[0151] Referring now to FIG. 3A, similar to the embodiment shown in FIG. 3A, a plurality of radiopaque markers can be seen under imaging, including one or more device radiopaque markers 12 and support member radiopaque markers 42. One or more device radiopaque markers 12 are disposed distally relative to the support member radiopaque markers 42, indicating that the distal electrode tip 10d is disposed relative to a target tissue site (such as the septum of the heart) for piercing the tissue.

[0152] 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 one such 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 examples, the stylet 60, the sheath 20, and / or the dilator 30B are all radiopaque and thus have radiopaque properties. In a particular example, the polymer forming the sheath 20 and / or the dilator 30B includes a radiopaque filler such as 20% barium sulfate to provide contrast with one or more markers 12, 42 at the distal tip to enable the user to view the sheath 20 and / or the dilator 30B compared to the RF guide wire 10. Thus, this configuration can enhance visibility and enable the user to confirm whether the RF guide wire 10 (more specifically, the electrode distal tip 10d of the RF guide wire 10) is disposed inside, extends outside the distal tip of the dilator 30B, or extends beyond it.

[0153] In some embodiments of the transseptal assembly 300, the sheath 20 includes a reference transseptal sheath, the dilator 30B includes a reference flexible dilator, and the flexible RF wire 10 is provided as a 0.035 - inch wire. In some such examples, the flexible RF wire 10 may be a J-chip wire or a pigtail wire. In one particular example, the dilator 30 includes HDPE. The dilator 30 defines an inner diameter sufficient to accommodate the stylet 60. In one example, the stylet 60 that defines the reinforcing member 34 includes a hypo tube such as a metal hypo tube. In a particular example, the stylet 60 includes a metal hypo tube that includes a stainless steel hypo tube. In one such example, the stainless steel hypo tube has an ID greater than about 0.035 inches.

[0154] In some examples, the variable sheath 20 may be an 8 French (Fr) variable sheath. Alternatively, an 8.5 Fr variable sheath 20 may be provided. In some such examples, the variable sheath 20 can have different curvatures. In a particular example, the variable sheath 20 may be provided with different curvatures, specifically at angles of 37 degrees, 45 degrees, 55 degrees, 90 degrees, or 135 degrees. In this particular example, the sheath tubing includes an inner PTFE liner, blades, and a Pebax outer jacket. In some such embodiments, an 8 French (Fr) dilator 30B compatible with an 8 French (Fr) sheath is provided. Alternatively, an 8.5 (Fr) dilator 30B that fits an 8 French (Fr) variable sheath 20 may be provided. Some such dilators can have a curvature of 64 degrees and an HDPE shaft. The stylet 60 may be provided as a metal hypo tube. In one such example, the stylet 60 can have an ID greater than about 0.038 inches and an OD less than about 0.060 inches. The dilator 30A may have a curvature of 50 degrees or 86 degrees. In some examples, the material can include HDPE and a metal hypo tube that forms the reinforcing member 34. In some such examples, the RF wire 10 includes a 0.035 inch OD wire and may be a J-chip wire or a pigtail wire. In this particular example, the RF wire 10 can include a stainless steel core with a PTFE coating. Method Method [Example 2 - Detachable stylet] Using the same device for initial tracking / access and positioning

[0155] In some embodiments of the present invention, referring to FIGS. 4A - 4G, a method of puncturing tissue is disclosed. This method includes accessing a region of tissue within a patient's body by advancing a device (such as a puncturing device 110 like the RF guide wire 10) into the region of tissue, as shown in FIG. 4B. In some such examples, the method of puncturing a tissue region includes a transseptal puncture method in which the step of accessing the tissue region includes advancing a device (such as a puncturing device 110) into the superior vena cava (SVC) 501 adjacent to the patient's heart 500, as shown in FIG. 4B.

[0156] In some embodiments of the present invention, the method of puncturing tissue further includes, as shown in FIG. 4D, positioning the device at a target tissue site within the region of tissue, for example, first, as shown in FIG. 4C, tracking a support member 130 on the puncturing device 110 to support the device (such as the puncturing device 110) and enabling the device (such as the puncturing device 110) to be advanced towards the target tissue site.

[0157] In some such examples, the step of positioning the puncture device 110 at the target tissue site first involves, for example, (3) tracking or advancing a support member 130 (e.g., a stylet) within the superior vena cava (SVC) over the device (e.g., the puncture device 110) to facilitate a drop-down procedure as shown in FIG. 4D, and [4] performing a drop-down from the patient's superior vena cava (SVC) into the heart 500 by positioning around the puncture device 110 and positioning a fossa (or fossae) 504 along the septum 502 of the heart 500. For example, this involves dropping the assembly 300 from the superior vena cava into the heart to find the fossa.

[0158] In some embodiments, the positioning step [4] may include, prior to tracking and advancing a support member 130 that may include inserting a stylet 60 into an expander 30B as shown in FIG. 4C [e.g., until reaching a stop], for example, first further including the step [2] of advancing a sheath 20 and an expander 30B over a device (such as an RF guidewire 10) into the superior vena cava. In some such examples, the positioning step [4] is performed after the step of pulling an RF guidewire into the stylet 60.

[0159] In some such examples, as shown in FIGS. 4B - 4D, the accessing step [1] shown in FIG. 4B and the positioning step [4] shown in FIG. 4D are performed using the same device such as the puncture device 110, which can be used without a support member 130 [comprising a stylet 60] during the accessing step [1], and the device can be used with a support member 130 [comprising a stylet 60] during the positioning step [4]. Use of a Puncture Device for Initial Access and Positioning

[0160] In some such embodiments of the present invention, as shown in FIGS. 4B - 4D, the accessing and positioning steps are performed using a puncture device 110 (such as an RF guidewire 10). Using the same device for initial access, positioning, and puncture

[0161] In some such embodiments of the present invention, as shown in FIG. 4D, after the step of positioning [4], the method further includes, as shown in FIG. 4E, a step [5] of puncturing a target tissue site using a device (such as the puncture device 110). The support member 130 [including the stylet 60] supports the device (such as the puncture device 110) during puncture [5], and the steps of accessing [1], positioning [4], and puncturing [5] are performed using the same device.

[0162] In some embodiments of the present invention, the step [5] of puncturing a target tissue site includes a step [5] of puncturing the fossa 504 to obtain access to the left side of the heart 500. This enables one or more devices of the assembly 100, such as the support member 130 (such as the dilator 30A) of the assembly 100 and the sheath 20, to be tracked on the RF guide wire 10 to the left side of the heart.

[0163] In some such embodiments, the step [5] of puncturing is performed by first advancing a device (such as the RF guide wire 10), exploring with the dilator 30B, and advancing the RF guide wire 10 to the puncture position, as shown in FIG. 4D, to enable puncturing of the septum 502 at the fossa 504. Use of a puncture device for initial access, positioning, and puncture

[0164] 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

[0165] According to one embodiment of the present invention, the method further includes a step of fixing [6] as shown in FIG. 4E. The fixing step is performed using a device (such as the puncture device 110) after the step of puncturing through the target tissue site [5] to maintain access to the other side of the target tissue site through the target tissue site. One or more additional devices [such as the sheath 20 and the dilator 30B] are advanced or tracked on the device (such as the puncture device 110, for example, the RF guide wire 10) to enable the sheath 20 and the dilator 30B to cross to the other side of the target tissue site, for example, to the left side of the heart as shown in FIG. 4F. The steps of accessing [1], positioning [4], puncturing, and fixing [5] are performed using the same device. As shown in FIG. 4G, the RF guide wire 10 can be left to maintain access to the left side of the heart. 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 examples, the RF guide wire 10 provides a substantially rigid rail for guiding one or more devices to the left side of the heart while being substantially non-invasive to minimize damage to the tissue.

[0166] 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 fossa to the left side of the heart to maintain access to the left side of the heart.

[0167] 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 be further removed.

[0168] In some such embodiments, the steps of accessing, positioning, puncturing, and securing are performed using a wire such as a substantially RF guidewire and a removable stylet 60. Use of a puncture device for initial access, positioning, and puncture

[0169] In some such embodiments of the present invention, the steps of accessing, positioning, puncturing, and securing are performed using a puncture device (such as a wire comprising an RF guidewire 10) and a removable stylet 60. Alternatives to the devices used for initial access, positioning, and / or puncture are based on the basic claims upon which these dependencies depend.

[0170] In some such embodiments of the present invention, the device comprises a flexible puncture device 112 in which one or more of the steps of accessing, positioning, puncturing, and securing are performed using the flexible puncture device 112. In some such examples, each of the steps of accessing, positioning, puncturing, and securing is performed substantially using the flexible puncture device 112.

[0171] In some such embodiments of the present invention, the device includes a substantially flexible guidewire (such as a mechanical guidewire 118 or an RF guidewire 10), and one or more of the steps of accessing, positioning, puncturing, and securing are performed substantially using the substantially flexible guidewire (such as a mechanical guidewire 118 or an RF guidewire 10). In some such examples, each of the steps of accessing, positioning, puncturing, and securing is performed substantially using the substantially flexible guidewire (such as a mechanical guidewire 118 or an RF guidewire 10).

[0172] 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 fixing are performed using the flexible energy-based piercing device 114. In some such examples, each of the steps of accessing, positioning, piercing, and fixing is performed substantially using the flexible energy-based piercing device 114.

[0173] 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, piercing, and fixing are performed using the flexible RF guide wire 10. In some such examples, each of the steps of accessing, positioning, piercing, and fixing is performed substantially using the flexible RF guide wire 10.

[0174] 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 access, positioning, piercing, and fixing are performed using the flexible mechanical guide wire 118. In some such examples, each of the steps of accessing, positioning, piercing, and fixing is performed substantially using the flexible mechanical guide wire 118. Repeated steps of access and positioning

[0175] In some such embodiments of the present invention, the method further includes repeating the accessing step [1] shown in FIG. 4B and the positioning step [4] shown in FIG. 4D until the device (such as the puncture device 110) is positioned at the desired target tissue site, as shown in FIG. 4E, before the puncturing step [5]. Reforming of the support member

[0176] In some such examples, as shown in FIG. 4D, repeating the positioning step [4] further includes reforming the curvature of the support member 130 [stylet 60] after removing the support member 130 [stylet 60] and retracking the support member 130 [stylet 60] on the device [3] (such as the puncture device 110 repositioned within the SVC as shown in FIG. 4B) before repeating the positioning step in an embodiment that includes a dropdown procedure to find the fossa 504, as shown in FIG. 4D. In certain examples, the support member 130 includes the stylet 60 and the positioning step is performed using the stylet 60.

[0177] In some such embodiments of the present invention, the method includes reforming the support member 130 (by pulling out and reforming the stylet 60). The support member comprises a stylet.

[0178] In some embodiments, as discussed with respect to FIGS. 4A - 4E, the reforming step can be performed using the support member 130 that includes the stylet 60. The stylet 60 is the reinforcing member 34 and the positioning step is performed using the stylet 60.

[0179] In some such examples, the stylet element 60 can be removed and reformed. In other examples, the stylet element 60 can be pulled out with the sheath 20 and / or the dilator 30B and reformed to see what the net shape is and then reinserted therein.

[0180] The method outlined above can also be used in the embodiments further discussed below, which have a removable stylet 60, as shown in FIGS. 6A-6H.

[0181] Similar to the above-described embodiments, an overall method / workflow is provided for performing a transseptal puncture procedure using the assembly 300. The methods disclosed herein provide one or more advantages associated with an assembly that includes an energy delivery component provided separately from the rigid component. The details of this method are shown below.

[0182] As a general overview, as shown in FIGS. 4A-4G, in one broad embodiment, a method of performing a transseptal puncture is provided, the method comprising: (i) advancing an RF wire into the superior vena cava; (ii) advancing a sheath and dilator over the wire into the superior vena cava; (iii) inserting a stylet into the dilator to reach a stop; (iv) retracting the RF wire into the stylet; (v) dropping down from the SVC into the heart to find a fossa; (vi) exploring using the dilator; (vii) advancing the RF wire to a puncture location; (viii) puncturing and advancing the RF wire; (ix) crossing the sheath and dilator over the RF wire; and (x) removing the stylet.

[0183] More specifically, referring again to FIG. 4A, a method of 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 including, as further shown in FIG. 4B, at step 402, 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 time and complexity of the procedure.

[0184] This method further includes, in step 404, advancing the combination of the sheath 20 and the flexible dilator 30B within the SVC over the flexible RF wire. Thus, also in this embodiment, the flexible RF wire 10 functions as an access wire, enabling the sheath 20 and the dilator 30B (e.g., as an assembly) to be tracked within the SVC over the flexible RF wire 10 as shown in FIG. 4C. Furthermore, in such an example, a standard transseptal dilator 30B can be provided without an embedded reinforcement member. This can enable the initial tracking of the sheath 20 and the dilator 30B and can help provide the physician with a feel similar to that of a standard transseptal.

[0185] This method provides an additional step of inserting the stylet 60 in step 406 until reaching a stop within the dilator 30B. In step 408, the RF wire is drawn into the dilator 30B, and in step 410, to position the assembly 300 at a target tissue site such as the fossa 504 along the septum 502 of the heart 500 as shown in FIG. 4D, a step of positioning the assembly 300 is provided by performing a drop-down from the SVC into the heart to position the fossa. The reinforcing member 34 (defined by the stylet 60) imparts sufficient rigidity to the assembly 100 to facilitate the drop-down. Thus, the reinforcing member 34 enables the transmission of sufficient force and torque such that the assembly 100 can engage the septum 502, as shown in FIG. 4D.

[0186] In one such example, having a reinforcing member 34 (such as that defined by the stylet 60) that is separable from the flexible RF wire 10 and operable independently can further assist in reproducibility if one or more steps in the procedure need to be repeated. If the initial placement of the flexible RF wire 10 relative to the septum 502 is inappropriate after the drop-down, the sheath 20 and the dilator 30B can be partially removed or partially withdrawn, along with the stylet 60 [and thus the reinforcing member 34], and the flexible RF wire 10 can be repositioned within the superior vena cava (SVC). The sheath 20, the dilator 30B, and the stylet 60 [and thus the reinforcing member 34] can be advanced forward over the RF wire 10 to provide appropriate force and torque transmission to position the RF wire 10 relative to the septum for a drop-down and repositioning, as shown in FIG. 4D, for example, during the step of positioning the assembly 300 at the target tissue site, such as the fossa 504, prior to RF delivery. Thus, the reinforcing member 34 and the RF wire 10 can help minimize device exchanges by reducing the need to reinsert exchange wires. This can help shorten the procedure time and increase safety by eliminating exchanges. Thus, in this embodiment where the energy delivery component and the rigidity component are separated, the treatment time and risk can be reduced.

[0187] 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 and separable from the dilator 30B. By providing a removable reinforcing element by the removable stylet 60, the stylet can impart different curvatures. A variable system is provided for adjusting the position of the stylet 60 within the dilator 30B to utilize a preferred position for positioning the dilator 30B relative to the fossa 504. Additionally, the stylet 60 may be reshaped or may be withdrawn and manually reshaped. In some such embodiments, after the dropdown is executed at step 410, the physician can evaluate, at step 412, whether the angle of the stylet 60 and / or the assembly 300 is sufficient prior to exploration. If the angle is not considered sufficient, the physician can, at step 422, withdraw the stylet 60 and reshape the curve. Next, the procedure can repeat from step 406 to step 412.

[0188] If the angle is considered sufficient, at step 412, the method further includes, with reference to FIG. 4D, exploring with the dilator 30B at step 414. The reinforcing member 34 imparts sufficient rigidity to the assembly 100 to enable applying a force to the distal end of the assembly 100 and thus enable exploration with the dilator 30B. The method includes advancing the RF wire 10 to the puncture position at step 416 and, at step 416, puncturing and advancing the RF wire 10 as shown in FIG. 4E such that the RF wire 10 punctures the septum 502 at the fossa 504 to enable access to the left side of the heart, thereby further including the step of providing a step of securing using the RF wire 10. In some such examples, the RF wire 10 so positioned functions as an anchor to maintain access to the left side of the heart after puncture. The flexible RF wire 10 can provide the additional advantage that the operator can push strongly without injury since the flexible RF wire 10 is more flexible. This method further includes, as further shown in FIG. 4F, step [6] of crossing the sheath 10 and the dilator 30B with the stylet 60 on the RF wire 10 at step 420. The flexible RF wire 10 can further protect the open end of the sheath 20 / dilator 30B, such that it is not forced rigidly 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) can be removed.

[0189] As outlined herein, the energy delivery component is provided as a flexible RF wire 10 separated from a rigid component such as the reinforcing member 34 (such as provided by the stylet 60), and the stylet 60 is separable and removable from the flexible RF wire 10. This provides the further advantage of providing step [7] which allows the reinforcing member 34 (defined by the stylet 60) to be removable after transverse puncture and access, and for example, as shown in FIG. 4G, allows the flexible RF wire 10 to be immediately secured within the left atrium and allows the flexible RF wire 10 to remain positioned within the left atrium. In one such example, 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 may allow removal of the stylet 60 [and thus the reinforcing member 34] to facilitate exchange of the device into the left atrium using the flexible RF wire 10. This can further reduce additional exchanges on the left side as it can eliminate the need for the physician to advance another wire after the puncture to maintain access to the left side for tracking additional devices on the left side. As outlined above, this embodiment also provides the additional advantage of minimizing the risk of contamination, embolism and stroke, in addition to reducing the treatment time and the number of steps required by minimizing exchanges on the left side. Example 2 General Overview Stylet and separate RF wire

[0190] Thus, in summary, in an embodiment of the present invention, a method of performing a transseptal puncture is provided, the method comprising advancing an RF guide wire into the superior vena cava, advancing a sheath and a dilator into the superior vena cava, inserting a stylet into the dilator and pulling the RF guide wire into the stylet until it reaches a stop, dropping down from the superior vena cava into the heart to find a fossa, exploring with the dilator, advancing the RF wire to the puncture position, puncturing and advancing the RF wire, crossing the sheath and the dilator over the RF wire, and removing the stylet. Example 3

[0191] In another example, an embodiment of the present invention provides an assembly 302 for forming a transseptal through-hole through a septum of the heart. Similar to the above-described embodiment, the assembly 302 provides a flexible RF wire and a separate reinforcing member. Device

[0192] In such an example, as shown in FIG. 5A, the assembly 302 is similar to the aforementioned assembly 300 and comprises a flexible energy delivery component provided separately from and operable independently of the support member. In some embodiments, the assembly 302 is provided as an example of the assembly 300. The assembly 302 comprises an RF wire 10, a stylet 60 defining a reinforcing member 34, a sheath 10, and a standard transseptal dilator 30B, the details of which are described above in this specification. In the particular example shown, the reinforcing member 34 is also provided separately from and removable from the dilator 30B as well as the flexible RF wire 10.

[0193] Referring now to FIGS. 5A and 5B, in some embodiments of the present invention, the assembly 302 further comprises a locking mechanism 75 that enables a flexible energy-based piercing 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 136 that enables the use of an RF guide wire while providing a needle feel.

[0194] In a particular example, the locking mechanism 75 of the assembly 302 enables the RF guide wire 10 to be coupled to the stylet 60, enables the RF guide wire 10 to be selectively used with the stylet 60, and provides a needle feel while enabling the use of the RF guide wire 10.

[0195] In some such examples, the locking mechanism 75 may enable the wire (such as the RF guide wire 10) and the stylet 60 to be axially locked such that the wire and the stylet 60 can be moved back and forth together. In additional embodiments, the locking mechanism 75 can additionally provide a rotational lock.

[0196] The embodiments presented herein provide a means for locking the flexible RF wire 10 and the reinforcement member 34 that enables the use of the RF wire while enabling this combination to provide the feel of a rigid RF needle. This combination provides the advantages provided above for a separate energy delivery system in which a flexible energy delivery component such as the RF wire 10 is provided separate from a support member 130 such as the reinforcement member 34. More specifically, in one example, as shown in FIG. 5B, the stylet 60 comprises a locking handle 71 operable to be coupled to the flexible RF wire 10 along its proximal portion for part of the procedure. The lock handle 71 includes a lock arm 73 that can be spring-biased to enable the lock arm to engage with the RF wire 10 and lock the stylet 60 in a predetermined position, thus defining a locking mechanism 75. In some examples, the stylet 60 and / or the RF wire 10 further comprises a marker band 62 to facilitate the relative positioning of the stylet 60 / RF wire 10 before locking. Thus, the stylet handle 71 locks onto the flexible RF wire 10 for alignment.

[0197] Figures 5C, 5D and 5E show details of the assembly 302 used according to various steps of the procedure. More specifically, Figure 5C shows the flexible RF wire 10 disposed within the stylet 60, which in one example is configured to be assembled and locked outside the patient. In another example, the stylet 60 and the RF wire 10 may be locked when disposed within the patient's body. Figure 5D shows the coupled RF wire 10 and stylet 60 assembly disposed within the expander 30B for the drop-down position, referred to as the two-finger position. Figure 5E shows the stylet 20, RF wire 10 assembly disposed within the expander 30B in the arc position.

[0198] In some examples, as described above, the variable sheath 20 may be an 8Fr variable sheath. Alternatively, an 8.5Fr variable sheath 20 may be provided. In some such examples, the variable sheath 20 can have different curvatures. In a particular example, the variable sheath 20 may be provided with different curvatures, specifically at angles of 37 degrees, 45 degrees, 55 degrees, 90 degrees or 135 degrees. In this particular example, the sheath tubing includes an inner PTFE liner, a blade and a Pebax outer jacket. In some such embodiments, an 8Fr expander 30B adapted to an 8Fr sheath is provided. Alternatively, an 8.5Fr dilator 30B compatible with the 8Fr variable sheath 20 may be provided. Some such dilators can have a curvature of 64 degrees and an HDPE shaft. The stylet 60 may be provided as a metal hypo tube. In one such example, the stylet 60 can have an ID greater than about 0.038 inches and an OD less than about 0.060 inches. The dilator 30B may have a curvature of 50 degrees or 86 degrees. In some examples, the material can include HDPE and a metal hypo tube forming the reinforcing member 34. In some such examples, the RF wire 10 can include a 0.035 inch OD wire and can be a J-tip wire or a pigtail wire. In this particular example, the RF wire 10 can include a stainless steel core with a PTFE coating. Method Example 3 [Lockable Stylet and RF Guide Wire] Using the same device for initial tracking or access and positioning

[0199] In some embodiments of the present invention, referring to FIGS. 6A - 6H, a method of puncturing tissue is disclosed. This method includes, as shown in FIG. 6B, [1] accessing a region of tissue within a patient's body by advancing a device (such as a J-wire 101) into the region of tissue. In some such examples, the method of puncturing a tissue region includes a transseptal puncture method in which the step of accessing the tissue region includes advancing a device (such as a J-wire 101) into the superior vena cava (SVC) 501 adjacent to the patient's heart 500, as shown in FIG. 6B.

[0200] In some embodiments of the present invention, the method of piercing tissue further includes, for example, first advancing [2] the sheath 20 and the dilator 30B over a wire (such as the J-wire 101) into the superior vena cava, [3] removing the J-wire, and [4] inserting the needle assembly into the dilator 30B within the dilator (e.g., at the position of two fingers). [4] The step of advancing or tracking the support member 130 [comprising the stylet 60] within the dilator, and thereby, as shown in FIG. 6D, [5] positioning the device at the target tissue site within the tissue region. More specifically, the step of [4] advancing or tracking the support member includes the step of [4] inserting the needle assembly into the dilator 30B within the dilator (e.g., at the position of two fingers). The needle assembly includes the stylet 60 and a piercing device 110 such as the RF guide wire 10. In some such examples, the needle assembly includes a locking mechanism for locking the RF guide wire 10 to the stylet 60.

[0201] As shown in FIG. 6C, the stylet 60 functions to support the device (such as the piercing device 110), and as shown in FIG. 6D, it enables the advancement of the device (such as the piercing device 110) towards the target tissue site for [5] positioning the device at the target tissue site for piercing.

[0202] In some such examples, the step of positioning the piercing device 110 at the target tissue site includes [5] performing a drop-down from the superior vena cava (SVC) to the patient's heart 500 to identify the oval fossa (or fossa) 504 along the septum 502 of the heart 500. For example, this includes dropping down the assembly 300 from the superior vena cava into the heart to find the fossa.

[0203] In some examples, when the RF guide wire 10 and the stylet 60 are inserted into the dilator 30B in their locked positions, the step of retracting the RF guide wire into the stylet 60 when the RF guide wire seats within the dilator 30B may not be required. [Example 3] Using different or separate devices for access and positioning.

[0204] In some such embodiments, a J-wire is provided and used in the step of accessing a region of tissue within a patient's body, and an RF-wire 10 is provided and used (e.g., provided as a needle assembly having an RF-wire 10 coupled to a stylet 60), and by tracking a support member (e.g., provided as a stylet 60) together with a device (e.g., provided as an RF-wire 10) that supports the device (e.g., provided as an RF-wire 10), the device is placed at a target tissue site within the region of tissue, and is used in the step of advancing the device (e.g., RF-wire 10) towards the target tissue site to place the device at the target tissue site for puncture. Thus, in some examples, the steps of accessing and positioning are performed using different or separate devices (e.g., a J-wire and an RF-wire 10 respectively), the step of accessing is performed without a support member (such as a stylet 60), and the device (such as an RF-wire 10) can be used together with a support member (such as a stylet 60) during the step of positioning. Use of the same device for initial positioning and puncture

[0205] In some such embodiments of the present invention, as shown in FIG. 6E, the method further includes, as shown in FIG. 6D, a step of puncturing the target tissue site [5] using a device (such as a puncture device 110) after the step of positioning [5].

[0206] In some embodiments of the present invention, the step of puncturing the target tissue site [5] includes the step of puncturing the fossa 504 [5] to gain access to the left side of the heart 500. In some such embodiments, the piercing step [5] is first performed by probing with the dilator 30B, advancing the needle assembly to the piercing position, piercing up to the stop within the dilator 30B and advancing the needle assembly as shown in FIG. 6E, advancing the RF guide wire 10 to the piercing position, and piercing the septum 502 at the position in the fossa 504. Use, positioning and piercing of a piercing device

[0207] In some such examples, as shown in FIGS. 6B-6H, the positioning step and the piercing step are performed using the piercing device 110. Use of the same device for positioning, piercing and fixing

[0208] According to one embodiment of the present invention, this method further includes a fixing step [6] as shown in FIG. 6F. The fixing step is performed using a device (such as the piercing device 110) after the piercing step [5] through the target tissue site to maintain access to the other side of the target tissue site through the target tissue site. One or more additional devices [such as the sheath 20 and the dilator 30B] are enabled to advance or track on the device (such as the piercing device 110, for example, the RF guide wire 10) to allow the sheath 20 and the dilator 30B to cross to the other side of the target tissue site, for example, to the left side of the heart as shown in FIG. 6G. The steps of positioning, piercing and fixing are performed using the same device.

[0209] In some such examples, as shown in FIG. 6F, the fixing step is performed by first holding the position of the assembly including the needle assembly, unlocking the RF guide wire from the stylet 60, and advancing the RF guide wire to the anchor. This method further includes a step of crossing the sheath 20 and the dilator 30B on the RF guide wire 10 and a step of removing the stylet 60 as shown in FIG. 6G.

[0210] In some such embodiments of the present invention, the step of securing to maintain access through the target tissue site includes advancing a device (such as the puncture device 110) through a fossa on the left side of the heart to maintain access to the left side of the heart.

[0211] In some such examples, the securing step further includes removing the stylet 60 to enable securing by allowing the RF guidewire 10 to remain positioned to maintain access to the left side of the heart. The sheath 20 and / or the dilator 30B may further be removed. In some such embodiments, the steps of accessing, positioning, puncturing, and securing are performed using wires such as the RF guidewire and the removable stylet 60. The puncture device 110 may be left in place to maintain access to the left side of the heart, as shown in FIG. 6H. The RF guidewire 10 functions as a rail to guide one or more devices to the left side of the heart. In some such examples, the RF guidewire 10 provides a substantially rigid rail that guides one or more devices to the left side of the heart while being substantially non-invasive to minimize damage to the tissue. Use of a Puncture Device for Positioning, Puncturing, and Securing

[0212] In some such embodiments of the present invention, the steps of positioning, puncturing, and securing are performed using a puncture device of a needle assembly (such as a wire comprising the RF guidewire 10) and a removable stylet 60. Alternatives to Devices Used for Positioning and / or Puncturing and Securing

[0213] In some such embodiments of the present invention, the device includes a flexible puncture device 112, and one or more of the steps of positioning, puncturing, and fixing are performed using the flexible puncture device 112. In some such examples, each of the steps of positioning, puncturing, and fixing is performed substantially using the flexible puncture device 112.

[0214] 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), and one or more of the steps of 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 positioning, puncturing, and fixing is performed substantially using the substantially flexible guide wire (such as mechanical guide wire 118 or RF guide wire 10).

[0215] In some such embodiments of the present invention, the device includes a flexible energy-based puncture device 114, and one or more of the steps of positioning, puncturing, and fixing are performed using the flexible energy-based puncture device 114. In some such examples, each of the steps of positioning, puncturing, and fixing is performed substantially using the flexible energy-based puncture device 114.

[0216] 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 positioning, puncturing, and fixing are performed using the flexible RF guide wire 10. In some such examples, each of the steps of positioning, puncturing, and fixing is performed substantially using the flexible RF guide wire 10.

[0217] 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 positioning, puncturing, and fixing steps are performed using the flexible mechanical guidewire 118. In some such examples, each of the positioning, puncturing, and fixing steps is performed using the substantially flexible mechanical guidewire 118. Repeating the access and positioning steps

[0218] In some such embodiments of the present invention, the method further includes repeating the accessing step [1] shown in FIG. 6B and the positioning step [5] shown in FIG. 8D until the device (such as the puncturing device 110) is positioned at the desired target tissue site before the puncturing step [5] as shown in FIG. 6E. Reforming the support member

[0219] In some such examples, as shown in FIG. 6D, repeating the positioning step [4] includes reforming the curvature of the stylet 60 as shown in FIG. 6C (such as the puncturing device 110 repositioned within the SVC as shown in FIG. 6B) and re-tracking the stylet 60 as part of the needle assembly [stylet 60] on the device before repeating the positioning step including the dropdown procedure to find the fossa 504 as shown in FIG. 4D. In a particular example, the support member 130 includes the stylet 60, and the positioning step is performed using the stylet 60.

[0220] In some such embodiments of the present invention, the method includes reforming the support member 130 (by pulling out the stylet 60 and reforming it) and unlocking it from, for example, the needle assembly to reform it. The support member comprises a stylet.

[0221] In some embodiments, as discussed with respect to FIGS. 6A-6E, when the stylet 60 is the reinforcement member 34, the step of reshaping can be performed, and the positioning step can be performed using the stylet 60.

[0222] In some such examples, the stylet element 60 can be removed and reshaped. In other examples, the stylet element 60 can be withdrawn with the sheath 20 and / or the dilator 30B, reshaped to see what the net shape is, and then reinserted therein.

[0223] Similar to the above-described embodiments, FIG. 6A shows the overall method / workflow of a method of performing a transseptal puncture procedure using the assembly 302. The methods disclosed herein provide one or more advantages associated with an assembly that includes an energy delivery component provided separately from the rigid component. The details of this method are shown below. Summary

[0224] As a general overview, as shown in FIGS. 6A-6H, in one broad embodiment, a method of performing a transseptal puncture is provided, the method comprising: (i) advancing a J-wire into the superior vena cava; (ii) advancing a sheath and a dilator over the wire into the superior vena cava; (iii) removing the J-wire; (iv) inserting a stylet / wire assembly into the dilator for the position of two fingers; (v) dropping down from the SVC into the heart to find the fossa; (vi) exploring using the dilator; (vii) advancing the stylet / RF wire assembly to the puncture position; (viii) puncturing and advancing the stylet / RF wire assembly to the stop in the dilator; (ix) unlocking the RF wire while holding the position; (x) advancing the wire for fixation; (xi) crossing the sheath and the dilator over the RF wire; and (xii) removing the stylet.

[0225] More specifically, referring again to FIG. 6A, a method for performing a transseptal puncture procedure using an assembly 302 comprising a flexible RF wire 10, a sheath 20, a standard transseptal dilator 30B, and a stylet 60 is provided, the method comprising the following steps. In step 602, the stylet and RF wire 10 are assembled outside the patient and locked together. In step 604, as further shown in FIG. 6B, [1] the J-wire is advanced into the superior vena cava (SVC) to obtain access. The method further comprises, in step 606, as shown in FIG. 6C, [2] advancing the combination of the sheath 20 and the flexible dilator 30B into the SVC over the J-wire, and, in step 607, [3] removing the J-wire. Since the standard transseptal dilator 30B is provided without an embedded reinforcing member, the initial tracking of the sheath 20 and dilator 30B can provide the physician with a similar feel to a standard transseptal procedure. The method further provides, as further shown in FIG. 6C, an additional step in step 608 of [4] inserting the stylet 60 / RF wire 10 assembly 302 into the position of two fingers. The method further comprises, as shown in FIG. 6D, in step 610 of [5] performing a drop-down from the SVC to the heart 500 to locate the fossa. The stylet 60 defines a reinforcing member 34 and provides sufficient rigidity to the assembly 302 to facilitate the drop-down.

[0226] In some embodiments of the present disclosure, the dilator 30B is provided as a standard transseptal dilator 30B. In other embodiments, the dilator 30B may be softer or more flexible than (or, put another way, less stiff than) a standard transseptal dilator 30B.

[0227] More specifically, as shown in FIG. 6D, the reinforcement member 34 enables sufficient force and torque transmission to allow the assembly 100 to engage with the septum.

[0228] In one such example, having a reinforcement member 34 (such as defined by stylet 60) that is separate from and operable independently of the flexible RF wire 10, as in the embodiments discussed above, can further assist in the reproducibility of the treatment modality when one or more steps of the treatment need to be repeated. If the initial placement of the flexible RF wire 10 relative to the septum after the dropdown is not appropriate, the sheath 20 and dilator 30B may be partially removed or partially retracted (after separation from the RF wire) together with the stylet 60, the flexible RF wire 10 may be repositioned within the superior vena cava (SVC), the dropdown procedure may be repeated after re-advancing the sheath 20 / dilator 30B, and the stylet 60 may be re-advanced over the RF wire 10 as outlined above.

[0229] Furthermore, in the embodiments described herein, a removable reinforcement member is provided in that the stylet 60, and thus the reinforcement member 34, is removable and separable from the dilator 30B. By providing a removable reinforcement element by the removable stylet 60, it can be made possible for the stylet to impart different curvatures. A variable system is provided for adjusting the position of the stylet 60 within the dilator 30B to utilize a preferred position for positioning the dilator 30B relative to the fossa. As described above, the stylet 60 may be reconfigurable and may be withdrawn and manually reconfigured. In some such embodiments, after the dropdown is executed at step 610, the physician can evaluate, prior to the exploration, at step 612, whether the angles of the stylet 60 and / or the assembly 300 are sufficient. If the angles are not considered sufficient, the physician can, at step 613, withdraw the stylet 60 and reshape the curve. Next, the procedure can repeat from step 608 to step 612.

[0230] At step 612, if the angles are considered sufficient, the method further includes, at step 614, exploring using the dilator 30B. The reinforcement 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 exploration by the dilator 30B. This method further includes, at step 616, advancing the RF wire 10 / stylet 60 assembly to the puncture position and, at step 618, puncturing and advancing the RF wire 100 / stylet 60 assembly to the stop within the dilator 30B as shown in FIG. 6E. The flexible RF wire 10 can provide the additional advantage that the operator can strongly push without injury since the flexible RF wire 10 is more flexible.

[0231] This method further includes, at step 620, holding the RF wire 10 in place from the RF wire 10 / stylet 60 assembly and unlocking, and advancing the RF wire 10 to the anchor as shown in FIG. 6F. Similar to Example 2, as outlined above with respect to FIGS. 4A - 4G, in Example 3, a stylet 60 which is a removable reinforcement member is provided as outlined with respect to FIGS. 6A - 6H, which can facilitate the rationalization of the procedure. The energy delivery component is provided as a flexible RF wire 10, and the stylet 60 is separable from and removable from the flexible RF wire 10. This provides an additional advantage in that the RF wire 10 can be advanced leftward independently of the reinforcement component. [7] The steps of positioning and advancing the RF wire 10 leftward can provide advantages similar to those outlined above in Example 2, including facilitating fixation, improving safety, minimizing exchanges on the left side, and enabling traceability of additional devices. This method further includes [8] a step of crossing the sheath 20 / expander 30B [and stylet 60] at the left side 624, and a step of removing or retracting the stylet at step 626. In some examples, the stylet 60 may cross leftward together with the sheath 20 and expander 30B. Alternatively, the stylet 60 may remain on the right side of the heart while facilitating the sheath 20 / expander 30B to cross the left side of the heart. This can provide additional advantages (such as providing atraumaticity during crossing and maintaining access to the left side) not seen in ways where the stylet 60 can cross to the left side.

[0232] Thus, in some embodiments, the removable reinforcement, in conjunction with but separate from the sheath 20 / expander 30B assembly that forms a reinforced support member usable in conjunction with the RF wire 10, can facilitate the transmission of force and torque, ensure engagement with the septum, and facilitate the positioning of the fossa during a drop-down procedure. The removable reinforcement (such as the stylet 60) may be unlocked from the RF wire 10 removed from the sheath / expander assembly, and then, leaving the RF wire 10, in some examples, the sheath and / or expander remain positioned within the left atrium to facilitate further device exchanges. Needle assembly with a reinforcement member and a flexible puncture device Reinforcement member

[0233] As described above, some embodiments of the present invention provide a needle assembly for piercing tissue, the needle assembly comprising, with reference to FIGS. 1A, 1B, and 3B-3C, a piercing device 110 for piercing tissue, a flexible piercing device 112 (such as an RF guide wire 10 or a mechanical guide wire 118), and a reinforcing member for supporting the piercing device (such as a support member 130 like a dilator 30A or a reinforcing member 34 like a stylet 60). The piercing device can be selectively used in cooperation with the reinforcing member during part of the procedure and independently of it during another part of the procedure to increase treatment efficiency by piercing tissue and facilitating exchange and positioning.

[0234] In some such embodiments, as shown in FIG. 1B, the needle assembly comprises a flexible piercing device 112 comprising a mechanical piercing device 118. In some such embodiments, as shown in FIG. 1A, the substantially flexible piercing device 112 comprises an energy-based piercing device 114. In some embodiments, as shown in FIG. 1A, the needle assembly provides a substantially flexible piercing device 112 having a substantially non-invasive tip (such as an RF guide wire 10). In some embodiments, as shown in FIG. 1B, the substantially flexible piercing device has a relatively sharp (distal) tip 118d. In some embodiments, as shown in FIGS. 1A, 1B, and 3A-3B, the reinforcing member comprises a reinforcing member 34.

[0235] In one broad aspect, embodiments of the present invention provide a transseptal system that facilitates a transseptal puncture procedure utilizing a subcostal approach. This system involves converting a rigid energy-based piercing device into (i) a flexible energy delivery component for delivering RF energy, such as an RF wire, for piercing using RF, and (ii) a separate support member, such as a reinforcing member, that provides structural and mechanical support to the assembly, enables the RF wire to engage the septum, and provides sufficient torque transmission to facilitate advancement across the puncture site. Thus, in some embodiments, the system of the present invention provides RF wires and reinforcement members that are separated from each other and removable from each other to overcome the limitations associated with prior art needle-based systems. In some such embodiments, the system of the present invention provides a workflow that can reduce the number of device exchanges, facilitate reproducibility, provide proper fixation, and enhance safety. Thus, in some embodiments, the system of the present invention provides a decoupled system that functionally decouples the energy delivery component while providing structural support through a separate reinforcement member and provides a flexible energy delivery component.

[0236] As an advantage, the reinforcement member can advance over the RF wire after the RF wire is positioned, enabling the RF wire to function as an exchange wire and helping to eliminate the need for a separate exchange wire to gain access to the heart. In this way, the present system enables a reduction in the number of right-sided device exchanges by using a flexible energy delivery component such as an RF wire that provides an exchange capability.

[0237] As a further advantage, the reinforcement member can be selectively advanced to complete aspects of the procedure of imparting structural and mechanical support to the assembly, and to enable the RF wire to engage the septum to create a puncture and facilitate forward movement / crossing to the left side after the puncture, by providing sufficient torque transmission to place the fossa. The reinforcement member is separated from the RF wire and further provides the advantage of enabling repositioning of the RF wire within the SVC to facilitate repeated drop-down procedures, if needed. More specifically, the reinforcement member can be partially removed or partially withdrawn while maintaining the RF wire within the right side of the heart. This eliminates the need to reinsert an exchange wire, thereby eliminating the exchange and reducing the time and complexity of the procedure. The RF wire can be repositioned within the SVC, and the reinforcement member can be advanced again on the RF wire to repeat the drop-down procedure and facilitate the post-puncture crossing.

[0238] As a further advantage, the system enables removal of the reinforcement member after puncture, enables the energy delivery member, the RF wire to remain within the left atrium, facilitates fixation within the left atrium, is trackable, and provides safety while advancing to the left side. Example 3 [Lockable stylet and RF guide wire]

[0239] Thus, some embodiments of the present invention provide a method of performing a transseptal puncture, the method comprising the steps of advancing a J-wire into the superior vena cava, advancing a sheath and dilator into the superior vena cava, removing the J-wire, inserting a needle assembly comprising a stylet and an RF guide wire into the dilator at the position of two fingers, dropping down from the superior vena cava into the heart to find the fossa, exploring using the dilator, advancing the needle assembly to the puncture position, puncturing and advancing the needle assembly to a stop within the dilator, holding the position and unlocking the RF guide wire, advancing the RF guide wire to the anchor, crossing the sheath and dilator over the RF guide wire, and removing the stylet.

[0240] 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 enhance safety.

[0241] The above-described embodiments of the present invention are intended to be merely exemplary. Accordingly, the scope of the present invention is intended to be limited only by the appended claims.

[0242] For clarity, it is understood that certain features of the invention described in the context of separate embodiments may be provided in combination in a single embodiment. Conversely, for brevity, various features of the invention described in the context of a single embodiment may be provided separately or in any suitable sub-combination.

[0243] Although the invention has been described in connection with its specific embodiments, it will be apparent to those skilled in the art that many alternatives, modifications, and variations are possible. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the broad scope of the appended claims. All publications, patents, and patent applications mentioned in this specification are hereby incorporated by reference in their entirety as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated by reference herein. Further, the citation or identification of any document in this application shall not be construed as an admission that such citation is available as prior art to the present invention.

Claims

1. An assembly for puncturing the septum of the heart, comprising: A flexible puncture device including an energy delivery device operable to deliver energy for puncturing the septum of the heart, 0.00107 Nm ２ to 0.00179 Nm ２ A proximal portion of the puncture device having a proximal stiffness of, 3.57×10 －６ Nm ２ to 5.95×10 －６ Nm ２ A distal portion of the puncture device having a distal stiffness of, and the puncture device that facilitates exchange and positioning during the procedure a support member including a proximal portion and a distal portion for supporting the puncturing device. The support member is defined by a reinforcing member and has a lumen configured to receive the puncturing device. The reinforcing member includes a hypo tube surrounded by an inner polymer layer and an outer polymer layer. The reinforcing member extends from the proximal portion to the distal portion of the support member and is moldable to optimize the position of the distal portion of the support member relative to the septum of the heart and has a rigidity that enables transmission of force to the distal portion.

2. The assembly according to claim 1, wherein the support member has a distal tip, and the reinforcing member extends from the proximal portion and terminates proximal to the distal tip.

3. The assembly according to claim 2, wherein the distal tip of the support member is tapered, and the reinforcing member terminates proximal to the tapered distal tip.

4. The assembly according to any one of claims 1 to 3, wherein the support member has a bending stiffness of 0.0085 Nm2 to 0.0145 Nm2.

5. The assembly according to any one of claims 1 to 4, wherein the hypo tube includes stainless steel.

6. The assembly according to any one of claims 1 to 5, wherein the puncturing device includes a puncturing device radiopaque marker at a distal end, and the support member includes a support member radiopaque marker.

7. The assembly according to claim 6, wherein the support member radiopaque marker includes a radiopaque coil embedded in the support member.

8. The assembly according to claim 6 or 7, wherein the puncturing device radiopaque marker is configured to cooperate with the support member radiopaque marker to indicate the relative position of the puncturing device.

9. The assembly according to any one of claims 1 to 8, wherein the inner polymer layer and the outer polymer layer include high density polyethylene.

10. The assembly according to any one of claims 1 to 9, wherein an interface without a gap at a joint between the reinforcing member and the inner polymer layer and the outer polymer layer seals the reinforcing member.

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