Medical dilator

Abstract

A medical dilator is provided. The medical dilator includes an elongated member having a distal end and a proximal end with a lumen therebetween, and a reinforcing member that is shapeable and configured to provide rigidity and support for an atrioventricular septal puncture system.

Description

[0001] This application is a divisional application of patent application no. 201780081271.6, filed on October 31, 2017, entitled "Methods and devices for puncturing tissue", having the same assignee as the present application. TECHNICAL FIELD

[0002] The present disclosure relates to systems and methods for creating a puncture in tissue. More particularly, the present disclosure relates to systems and methods for creating a puncture using an assembly comprising a puncture device and a support member. BACKGROUND

[0003] In order to perform an atrioventricular septal procedure, it is necessary to obtain access to the heart. This access (particularly to the right atrium of the heart) can be obtained from an upper approach (obtaining access to the heart from an access point above the heart, such as from the jugular vein through the superior vena cava), or, alternatively, the access can be obtained from a femoral or lower approach (obtaining access to the heart from an access point below the heart, such as from the femoral vein through the inferior vena cava). Once access to the right atrium is obtained, a puncture device is utilized to puncture tissue, such as through the septum of the heart, to obtain access from the right atrium to the left atrium of the heart.

[0004] Some conventional atrioventricular septal procedures, such as those that use a lower approach to obtain access to the heart, use a needle to perform the atrioventricular septal puncture. Certain limitations can be associated with performing an atrioventricular septal puncture procedure using a needle or other rigid device.

[0005] These limitations can include one or more of the following: (1) a separate exchange wire is required to obtain access to the SVC, resulting in multiple device exchanges on the right side; (2) the use of a needle can require multiple device exchanges in order to complete the procedure; (3) if the target positioning on the fossa is missed, it can be difficult to correct the placement of the puncture device after insertion within the right atrium; (4) there can be a lack of repeatability for certain aspects of the procedure to complete the puncture in an efficient and timely manner; (5) the puncture device can not provide sufficient atraumaticity and can cause excessive force to be applied to the punctured tissue, resulting in tissue damage; (6) there can be a risk of trauma to structures within the left atrium upon puncture due to the force of the advancement; (7) there can be a lack of proper anchoring to maintain the access after puncture; (8) an additional exchange on the left side is required, requiring removal of the puncture device and advancement of other wires (such as a pigtail wire) to facilitate anchoring; and / or (9) the ability to loop a wire to allow for additional devices to be advanced over the wire once on the left side.

[0006] The inventors of the present invention have discovered systems and methods that attempt to overcome the limitations associated with prior art systems. SUMMARY

[0007] The present invention provides a medical dilator comprising:

[0008] an elongated member having a distal end and a proximal end with a lumen therebetween; and

[0009] a reinforcing member that is shapeable and configured to provide rigidity and support for a transseptal puncture system. BRIEF DESCRIPTION OF DRAWINGS

[0010] In order that the invention can be readily understood, embodiments of the invention are illustrated by way of example in the accompanying drawings, in which:

[0011] FIG. 1A and FIG. 1B is an illustration of a transseptal assembly according to an embodiment of the invention;

[0012] FIG. 1C and FIG. 1D is an illustration of a dilator including a reinforcing member according to an embodiment of the invention;

[0013] FIG. 1E is an illustration of a locking mechanism for enabling coupling of a sheath and a dilator during use according to an embodiment of the invention;

[0014] FIG. 1F is an illustration of a dilator hub having a key for enabling locking of the dilator hub to a sheath hub according to an embodiment of the invention;

[0015] FIG. 2A is an illustration of a flow chart showing a method of performing a transseptal procedure according to an embodiment of the invention;

[0016] FIG. 2B-FIG. 2G illustrates steps of a method of performing a transseptal procedure according to an embodiment of the invention;

[0017] FIG. 3A is an illustration of a transseptal assembly according to an alternative embodiment of the invention;

[0018] FIG. 3B is an illustration of an assembly including a dilator, a stylet defining a reinforcing member and an RF wire in a pull-down position according to an embodiment of the invention;

[0019] FIG. 3C is an illustration of an assembly including a dilator, a stylet defining a reinforcing member and an RF wire in an arcing position according to an embodiment of the invention;

[0020] FIG. 4Ais an illustration of a flow chart showing a method of performing an atrioventricular septal procedure according to an alternative embodiment of the present application;

[0021] FIG. 4B-FIG. 4G illustrates steps of a method of performing an atrioventricular septal procedure according to an alternative embodiment of the present application;

[0022] FIG. 5A is an illustration of an atrioventricular septal assembly according to a further embodiment of the present application;

[0023] FIG. 5B shows a locking mechanism for coupling a stylet and RF wire during use according to an embodiment of the present application;

[0024] FIG. 5C shows steps of a method according to an embodiment of the present application with the stylet and RF wire in a locked position;

[0025] FIG. 5D shows steps of a method according to the present application with the stylet and RF wire in a pulled down position within the dilator;

[0026] FIG. 5E shows steps of a method according to an embodiment of the present application with the stylet and RF wire in a pierced position within the dilator;

[0027] FIG. 5F shows a stylet and RF wire according to an alternative embodiment of the present application;

[0028] FIG. 6A is an illustration of a flow chart showing a method of performing an atrioventricular septal procedure according to yet another embodiment of the present application;

[0029] FIG. 6B-FIG. 6H illustrates steps of a method of performing an atrioventricular septal procedure according to an alternative embodiment of the present application; and

[0030] FIG. 7A-FIG. 7C illustrates a dilator according to a further alternative embodiment of the present application. DETAILED DESCRIPTION

[0031] In order to perform an atrioventricular septal procedure, it is necessary to obtain access to the heart. This access (in particular to the right atrium of the heart) can be obtained from an upper approach (by obtaining access to the heart from an entry point above the heart, for example from the jugular vein through the superior vena cava), or, alternatively, the access can be obtained from a femoral or lower approach (by obtaining access to the heart from an entry point below the heart, for example from the femoral vein through the inferior vena cava). Once access to the right atrium is obtained, a puncture device is used to puncture tissue, for example through the septum of the heart, to obtain access from the right atrium to the left atrium of the heart.

[0032] Some conventional atrioventricular septal procedures, such as those using an inferior approach to gain access to the heart, use needles to perform atrioventricular septal puncture. Certain limitations can be associated with performing atrioventricular septal puncture procedures using needles or other rigid devices.

[0033] These limitations can include one or more of the following: (1) a separate exchange wire is needed to gain access to the SVC, resulting in multiple device exchanges on the right side; (2) the use of needles can require multiple device exchanges in order to complete the procedure; (3) if the target location on the fossa is missed, it can be difficult to correct the placement of the puncture device after insertion into the right atrium; (4) there can be a lack of reproducibility for certain aspects of the procedure to be completed in an efficient and timely manner; (5) the puncture device can not provide sufficient atraumaticity and can cause excessive force to be applied to the punctured tissue, resulting in tissue damage; (6) there can be a risk of trauma to structures within the left atrium due to the force of the advancement after puncture; (7) there can be a lack of adequate anchoring to maintain access after puncture; (8) an additional exchange on the left side is required, requiring removal of the puncture device and advancement of other wires (such as a pigtail wire) to facilitate anchoring; and / or (9) the ability to loop a wire to allow for additional devices to be looped over the wire once on the left side.

[0034] The inventors of the present invention have discovered systems and methods that attempt to overcome the limitations associated with prior art systems.

[0035] In some such instances, where a sharp mechanical needle is used, the device can not be sufficiently atraumatic to minimize the risk of damaging tissue, and the mechanical needle can not provide adequate anchoring after puncture.

[0036] In other instances of the'1 1 1, where an energy-based needle (such as an RF needle) is used, the RF needle can require multiple device exchanges and can lack reproducibility for one or more steps in the procedure, resulting in increased procedure time and / or inefficiency. Furthermore, the RF needle can not provide adequate anchoring after puncture.

[0037] In a broad aspect, the inventors have discovered systems and methods that provide an RF wire and a device for supporting the RF wire in order to facilitate atrioventricular septal puncture, such as using an inferior approach. The systems and methods of the present invention attempt to overcome the limitations associated with conventional atrioventricular septal systems that utilize needles to complete atrioventricular septal puncture procedures. Some such conventional atrioventricular septal procedures that require the use of needles use an inferior approach to gain access to the heart in order to perform atrioventricular septal puncture.

[0038] Current rigid mechanical needles are provided with sharp tips to puncture tissue. Such mechanical needles can have several limitations, which can include one or more of the following: (1) sharp mechanical needles can not provide sufficient atraumaticity and can cause excessive force to be applied to the punctured tissue, resulting in tissue damage; (2) there can be a risk of trauma to structures within the left atrium due to the force of the advancement after puncture (3) the need for additional exchanges on the left side, requiring removal of the needle and advancement of other wires (such as pigtail wires) to facilitate anchoring, and / or loopability to allow additional devices to loop over the wire once on the left side.

[0039] Furthermore, current rigid energy-based devices for puncturing tissue can also have one or more of the several limitations described above.

[0040] The inventors of the present invention have developed various embodiments of a novel system and method that involve providing, in one broad aspect, a puncture device having two components: (1) a separate puncture component or member and (2) a substantially rigid and / or stiff support member that is removable or independent of the puncture component or member, allowing the support member to be selectively used with the puncture device.

[0041] In some examples, (1) the separate puncture component or member includes a substantially flexible tissue puncture component or member. In some such examples, the separate substantially flexible tissue puncture component or member can be substantially atraumatic. Furthermore, in some examples, the separate substantially flexible tissue puncture component or member can have a relatively sharp component, such as a relatively sharp distal tip component.

[0042] In some embodiments, the inventors of the present invention have developed a novel system that involves providing a rigid energy-based puncture device having two components: (1) a flexible [atraumatic] energy-based puncture device or member, such as a radiofrequency (RF) wire, and (2) a rigid support member, such as a stiffening member, that is removable or independent of the flexible energy-based puncture device.

[0043] In another broad aspect, a novel assembly is provided that includes a separate needle assembly, which includes: (1) a substantially flexible tissue puncture member or component for puncturing tissue (which can additionally be substantially atraumatic), and (2) a substantially rigid needle shaft for supporting the puncture member that can be selectively used therewith. In some such embodiments, the needle shaft is substantially rigid to provide force transmission capabilities but lacks tissue puncture capabilities (in other words, the needle shaft is still sufficiently atraumatic to avoid puncturing tissue).

[0044] Accordingly, some embodiments of the present application include the separation of components of a puncture device into two independently operable components, which form an assembly, and thereby provide two separate and independent functions, (i) the function of puncturing tissue using a substantially flexible and / or atraumatic component (such as a flexible energy delivery device, but not limited thereto) and (ii) the function of supporting the substantially atraumatic puncture component using a substantially rigid or stiff needle shaft. These embodiments provide one or more advantages not previously realized or achievable using existing systems.

[0045] Advantages can include one or more of the following: (i) providing a substantially flexible and / or atraumatic puncture device (such as an energy delivery puncture device), while (ii) providing a substantially stiff support member, such as a stiff needle shaft, for supporting the substantially atraumatic puncture device:

[0046] — enabling the substantially flexible puncture device to be used separately from the substantially stiff support member, to enable the substantially flexible puncture device to function as an exchange wire;

[0047] — enabling the substantially flexible puncture device to be used in conjunction with the substantially stiff support member, for example by allowing the substantially stiff support member to cap (cap over / cover) advancement over the substantially flexible puncture device to allow sufficient force and / or moment transfer to the distal tip of the assembly (for example, to facilitate a pull-down procedure to determine the location of a fossa as described below) and to provide sufficient support to facilitate puncture (using the substantially flexible puncture device and to facilitate passage using the substantially flexible puncture device);

[0048] — enabling the use of the substantially flexible puncture device separately from the substantially stiff support member, to enable the substantially flexible puncture device to additionally function as a puncture device to puncture tissue, while minimizing the risk of damaging tissue (such as, for example, non-punctured tissue) during puncture and to facilitate passage using the substantially flexible puncture device;

[0049] — enabling the use of the substantially flexible puncture device separately from the substantially stiff support member, to minimize the risk of tissue damage, for example once access to the left side of the heart is obtained, for example in an atrioventricular septum puncture, by providing an atraumatic tip and reducing the force required to puncture tissue, for example, by using energy delivery;

[0050] — enabling the substantially rigid support member, such as a needle shaft, to be removed or retracted to reposition the assembly against a target tissue site, by allowing a substantially flexible (may additionally be atraumatic) energy delivery puncture device to be used independently of the substantially rigid support member to be re-circuit to the desired vasculature to enable the substantially rigid support member to be sheathed over the substantially flexible energy delivery device to be re-advanced, for example, to reposition the assembly against the fossa in a pull-down procedure in an inter-atrial septum puncture;

[0051] — enabling the substantially rigid support member, such as a needle shaft, to be removed after puncture, thereby allowing a substantially atraumatic energy delivery device to be used independently of the substantially rigid support member to provide anchoring after puncture, by using the puncture device to maintain its positioning on the left side of the heart to maintain access to the left side of the heart, and additionally allowing for the ability of additional devices to be circuit over the puncture device to guide into the left side of the heart.

[0052] The system of the present invention provides several advantages corresponding to the problems described above, wherein the combination of a substantially flexible atraumatic puncture device, such as an RF wire, with a separate or independent support member, such as a substantially rigid needle shaft or reinforcing member (e.g. which forms a substantially rigid needle shaft), which is selectively usable with the substantially flexible atraumatic puncture device, provides the following advantages:

[0053] a) the system enables the reinforcing member to be advanced over the RF wire, thereby allowing the RF wire to function as an exchange wire, which can facilitate simplifying the workflow and reducing the number of device exchanges on the right side of the heart to help reduce the procedure time and complexity;

[0054] b) the system enables repeatability of the pull-down procedure by enabling partial removal or partial retraction or withdrawal of the reinforcing member to enable repositioning and / or re-advancement of the RF puncture device, such as an RF wire, within the SVC without the need for additional exchanges;

[0055] c) the system also enables the reinforcing member to be removed after puncture: (i) to maintain the RF wire positioned within the left atrium to help avoid the risk of trauma; and / or (ii) to enable anchoring within the left side without the need for additional exchanges, for example to improve the safety or efficiency of the procedure; and / or (iii) to maintain the RF wire within the left atrium for circuiting, or in other words, to facilitate subsequent device delivery or devices subsequently circuiting over the RF wire. In addition to reducing time / steps, the benefit of minimising exchanges is minimising the risk of infection. This is particularly important on the left side of the heart, where any unnecessary exchanges can lead to an increased risk of embolism, stroke, etc.

[0056] As noted 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 instances, selectively used means that the substantially flexible energy-based piercing device can be detachably used or selectively inserted within or detachably coupled to the support member for use with the support member during a portion of a procedure and removable, detachable, or retractable from the support member, or can be used independently of the support member during other portions of the procedure.

[0057] In one broad aspect, embodiments of the present application include a needle assembly for piercing tissue and improving the efficiency of a procedure by facilitating exchange and positioning, the needle assembly comprising: a piercing device for piercing tissue; and a support member for supporting the piercing device; wherein the piercing device is insertable within the support member and selectively usable with the support member during a portion of a procedure to pierce tissue, and wherein the piercing device is usable independently of the support member during other portions of the procedure.

[0058] In another broad aspect, embodiments of the present application include an assembly for piercing tissue, the assembly comprising: a substantially flexible piercing device for piercing tissue; and a support member for supporting the substantially flexible piercing device; wherein the substantially flexible piercing device is selectively insertable within the support member for selective use with the support member during a portion of a procedure to pierce tissue, and wherein the substantially flexible piercing device is usable independently of the support member during other portions of the procedure to facilitate exchange and positioning while piercing tissue.

[0059] In another broad aspect, embodiments of the present application include an assembly for piercing tissue, the assembly comprising: a substantially flexible energy-delivering piercing device for piercing tissue by energy delivery; and a support member for supporting the substantially flexible energy-delivering piercing device; wherein the substantially flexible energy-delivering piercing device is selectively insertable within the support member for selective use with the support member during a portion of a procedure to pierce tissue, and wherein the substantially flexible energy-delivering piercing device is usable independently of the support member during other portions of the procedure to facilitate exchange and positioning while providing substantially atraumatic tissue piercing.

[0060] In another broad aspect, embodiments of the present application include a needle assembly for piercing tissue, the needle assembly comprising: a flexible piercing device for piercing tissue; and a rigid member for supporting the piercing device; wherein the piercing device is selectively usable with the rigid member during a portion of a procedure, and wherein the piercing device is usable independently of the reinforcing member during other portions of the procedure to pierce tissue and improve the efficiency of a procedure by facilitating exchange and positioning.

[0061] In another broad aspect, embodiments of the present application include a method for puncturing tissue, the method comprising the steps of: (i) accessing a tissue region in a patient's body by advancing a device into the tissue region; and (ii) positioning the device at a target tissue site in the tissue region by a support member that follows a path on the device to support the device advancing the device toward the target tissue site, so as to position the device at the target tissue site for puncturing; wherein the accessing and positioning steps are performed using the same device, wherein the device is usable without the support member during the accessing step, and wherein the device is usable with the support member during the positioning step.

[0062] In yet another broad aspect, embodiments of the present application include a method for puncturing tissue, the method comprising the steps of: (i) accessing a tissue region in a patient's body using an accessing device; and (ii) positioning the device at a target tissue site in the tissue region by a support member that follows a path defined by the accessing device to support the device advancing the device toward the target tissue site, so as to position the device at the target tissue site for puncturing; wherein the accessing and positioning steps are performed using separate devices, wherein the accessing step is performed without the support member, and wherein the device is usable with the support member during the positioning step.

[0063] In one broad aspect, embodiments of the present application include a method for puncturing tissue, the method comprising the steps of: advancing a flexible puncture device into a tissue region; advancing a sheath and a support member over the flexible puncture device into the tissue region; withdrawing the flexible puncture device into the support member; positioning the flexible puncture device, the sheath and the support member as an assembly at a target tissue site in the tissue region; tenting with the support member; advancing the flexible puncture device to a puncture location; puncturing and advancing the flexible puncture device; and passing the sheath and a dilator over the flexible puncture device.

[0064] In another broad aspect, embodiments of the present application include a method for performing an atrioventricular septum puncture, comprising the steps of: advancing an RF guide wire into the superior vena cava; advancing a sheath and a dilator over the RF guide wire into the superior vena cava; withdrawing the RF guide wire into the dilator; pulling down from the superior vena cava into the heart to find the fossa; tenting with the dilator; advancing the RF guide wire to a puncture location; puncturing and advancing the RF guide wire using the RF guide wire; and passing the sheath and the dilator over the RF guide wire.

[0065] In yet another broad aspect, embodiments of the present application include a method of performing an atrial septostomy, the method comprising the steps of: advancing an RF guidewire into the superior vena cava; advancing a sheath and dilator over the RF guidewire into the superior vena cava; inserting a stylet into the dilator until it reaches a stop; withdrawing the RF guidewire into the stylet; pulling down from the superior vena cava into the heart to find the fossa; tenting with the dilator; advancing the RF guidewire to the puncture site; puncturing and advancing the RF wire; passing the sheath and dilator over the RF wire; and removing the stylet.

[0066] In yet another broad aspect, embodiments of the present application include a method for performing an atrial septostomy, the method comprising: advancing a J-shaped wire into the superior vena cava; advancing a sheath and dilator over the wire into the superior vena cava; removing the J-shaped wire; inserting a needle assembly comprising a stylet and an RF guidewire into a two-finger position within the dilator; pulling down from the superior vena cava into the heart to find the fossa; tenting with the dilator; advancing the needle assembly to the puncture site; puncturing and advancing the needle assembly until a stop within the dilator; holding position and unlocking the RF guidewire; advancing the RF guidewire to the anchor; passing the sheath and dilator over the RF guidewire; and removing the stylet.

[0067] In some embodiments of the method of puncturing tissue, the device comprises a flexible energy-based puncturing device, wherein substantially all of the steps are performed using the flexible energy-based puncturing device.

[0068] In some embodiments of the method of puncturing tissue, the device comprises a flexible RF guidewire, and wherein substantially all of the steps are performed using the flexible RF guidewire.

[0069] In some embodiments of the method of puncturing tissue, the device comprises a flexible mechanical guidewire having a relatively sharp distal tip, wherein substantially all of the steps are performed using the flexible mechanical guidewire.

[0070] With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of certain embodiments of the present application. In this regard, no aspect is intended to limit the application to the particular constructions shown and described. Alternatively, the described embodiments of the application are susceptible to modifications, and alternative constructions can be used without departing from the application. Accordingly, although specific references can be made to the examples with or without specific reference to any particular examples or directions thereof, it is understood that this is provided for illustration purpose only. The application is not limited to the specific details provided herein.

[0071] As an overview of embodiments of the present application, some embodiments of the system provide a two-part assembly that includes a flexible RF component and a rigid support member to enhance the utility of the system. The rigid member, such as a stiffening member, is provided separately from and removable from the flexible RF component, such as an RF wire, and thus can be introduced independently of the flexible RF wire. This provides flexibility in that the combination of the two components (RF wire and stiffening member) can be used. The RF wire can be used independently of the stiffening member, with the initial advancement of the flexible RF wire without the stiffening member eliminating the need for a separate exchange wire for passage for initial access (superior vena cava) SVC. The stiffening member can then be selectively used - the stiffening member can be advanced into the SVC to provide sufficient force transmission to facilitate the pull-down procedure to locate the fossa. If the initial pass to locate the fossa is unsuccessful, the two-part assembly enables the rigid support member to be partially removed or withdrawn to enable the RF wire to be repositioned. The rigid support member can then be re-advanced or repositioned to provide sufficient rigidity and force transmission to repeat the pull-down procedure to locate the fossa and provide sufficient support to facilitate puncture using the RF wire and facilitate passage of the RF wire therethrough. Thus, the rigid support member facilitates atrioventricular septal puncture using the RF wire and additionally facilitates passage into the left side after puncture is completed. The stiffening member can be removed and the flexible RF left in the left side of the heart. Thus, the flexible RF wire can be used independently of the stiffening member to facilitate anchoring, facilitate circuiting, to minimize left side exchange to minimize the risk of embolization, and to minimize the risk of trauma. Thus, the stiffening member can be selectively introduced for the portion of the procedure that requires rigidity, and can be (partially or completely) removed thereafter to facilitate the remainder of the procedure. Moreover, because the enhancement component is provided separately from the flexible RF wire, the enhancement component can be re-advanced or re-inserted as needed to complete aspects of the procedure.

[0072] According to some embodiments of the present application, details of the RF wire are disclosed in Application No. PCT / IB2013 / 060287 and Publication No. WO2015019132, which are incorporated by reference in their entirety. Details provided below include several embodiments of support members that can be used with a puncture device such as the RF guidewire disclosed in the cited applications.

[0073] In some embodiments of the present invention, an assembly for puncturing tissue is provided, where the assembly includes a substantially flexible puncturing device (which is substantially atraumatic, such as an energy-based puncturing device) for puncturing tissue through energy delivery. The assembly further includes a support member for supporting the substantially flexible puncturing device, such as a rigid needle shaft. In some such examples, the support member includes a stiffening member (which can form the needle shaft). The support member is operable to be selectively used with the substantially flexible puncturing device, and can be detached or removed therefrom. Additionally, the substantially flexible puncturing device is operable independent of the support member to puncture tissue. In some such examples, the substantially flexible puncturing device is an energy-based device for delivering energy to puncture tissue.

[0074] In some such embodiments of the present invention, the substantially flexible energy-based puncturing device is selectively used in cooperation with the substantially rigid support member during a portion of a procedure. Additionally, the substantially flexible energy-based puncturing device is used independent of the support member during other portions of the procedure.

[0075] In some such examples, the support member is removable from the substantially flexible energy-based puncturing device during a portion of a procedure to enable the substantially flexible energy-based puncturing device to be used separately therefrom.

[0076] The assembly enables the substantially flexible energy-based puncturing device to be used independent of the support member during a portion of a procedure, and can be used in cooperation with the support member during a portion of a procedure. This facilitates exchange, by allowing the flexible energy-based puncturing device to be used to puncture tissue and as an exchange wire, facilitating exchange and additionally providing the advantage of providing an atraumatic tip for puncturing tissue, as the substantially flexible energy-based puncturing is substantially atraumatic. If the flexible energy-based puncturing device is not positioned at a desired target location, the separation of the energy delivery portion of the assembly from the support member additionally enables the support member to be removed, enabling the substantially flexible energy-based puncturing device to be repositioned to enable the support member to be re-advanced over the substantially flexible energy-based puncturing device to facilitate positioning of the energy delivery portion of the flexible puncturing device against a desired target tissue location, and can additionally reduce procedure complexity and improve procedure efficiency.

[0077] Example 1

[0078] Assembly including a puncturing device and a support member

[0079] In some embodiments, as FIG. 1A and FIG. 1BAs shown in FIG. 1, the present application provides an assembly 100 for puncturing tissue, such as creating an atrioventricular septal puncture through a heart septum, where the assembly provides a tissue puncture or puncture device 110, and a separate support member 130 that can be selectively used with the tissue puncture device 110 to support the puncture device 110. The puncture device 110 can be selectively used with the support member 130 during one or more portions or steps of a procedure, and the puncture device 110 can be used independent of the support member during other one or more portions or steps of the procedure in order to puncture tissue. In some such embodiments, the separate puncture device 110 and support member 130 for selective use with the puncture device additionally increase procedural efficiency by facilitating exchange and positioning.

[0080] Referring again to FIG. 1A and FIG. 1B In some embodiments, an assembly 100 for puncturing tissue is provided that includes a substantially flexible puncture device 112 for puncturing tissue as discussed further below, and a support member 130 for supporting the substantially flexible puncture device. Similar to the embodiments described above, the substantially flexible puncture device 112 can be selectively inserted within the support member 130 for selective use with the support member during a portion of a procedure, and where the substantially flexible puncture device 112 can be used independent of the support member during other portions of the procedure in order to puncture tissue and facilitate exchange and positioning. In some such examples, the substantially flexible puncture device 112 includes an energy delivery device operable to deliver energy to puncture tissue. In some such examples, the support member 130 includes a reinforcing member 34 as described in further detail below.

[0081] In one such example, the assembly 100 includes a needle assembly for puncturing tissue, where the needle assembly includes a puncture device 110 and a support member 130. In some such embodiments of the needle assembly, the puncture device includes a substantially flexible puncture device 112 as shown in FIG. 1A and 1B

[0082] In a particular example of the needle assembly, the puncture device 110 includes a substantially atraumatic distal tip 112d as shown in FIG. 1A where the puncture device 110 is substantially atraumatic. Referring again to FIG. 1A ​In some embodiments, the puncture device 110 includes an energy-based puncture device 114, such as a substantially flexible energy-based puncture device 114 having an energy delivery portion or component 114d at its distal tip for delivering energy to puncture tissue. In a particular example of this, the puncture device 110 includes a flexible (radio frequency) RF guide wire 10 having a distal electrode tip 10d for delivering radio frequency energy to puncture tissue.

[0083] In some cases, the RF guide wire 10 is a flexible wire that is generally electrically insulated except for a selected distal region, such as the distal electrode tip 10d.

[0084] In a particular example of a needle assembly, as shown in FIG. 1A the puncture device includes a mechanical puncture device 118. In some such embodiments of a needle assembly, the mechanical puncture device 118 includes a relatively sharp distal tip 118d for puncturing tissue.

[0085] In some such embodiments of an assembly 100, such as a needle assembly, as shown in FIG. 1A and FIG. 1B the support member includes a reinforcing member. In some such embodiments, as shown, the support member 130 includes a needle shaft 132 that includes a reinforcing member 34 for supporting the puncture device 110. In some such embodiments, the needle shaft 132 can provide or have the characteristics of a mechanical needle. In one particular example, the reinforcing member [such as a metal hypo-tube] is constructed with one or more polymer layers to form the needle shaft 132.

[0086] In some embodiments as described below, the assembly 100, such as a needle assembly, includes an RF wire and a separate reinforcing member. Accordingly, some embodiments of the invention provided below are described with respect to an RF guide wire, but some such embodiments described herein can also be with respect to other puncture devices, such as mechanical puncture devices, such as mechanical guide wires. However, the RF guide wire can provide advantages not available in other puncture devices, such as mechanical guide wires.

[0087] Device Embodiment 1

[0088] The support member includes a needle shaft / reinforcing dilator

[0089] In one broad aspect, embodiments of the present application provide an assembly 100 for puncturing tissue, the assembly 100 including a substantially flexible energy-based (or energy delivery) puncture device 114 for puncturing tissue by energy delivery and a support member 130 for supporting the substantially flexible energy delivery puncture device 114. The substantially flexible energy delivery puncture device 114 is selectively insertable within the support member 130 for selective use in cooperation with the support member during a portion of a procedure, and wherein the substantially flexible energy delivery puncture device 114 can be used independent of the support member during other portions of the procedure in order to facilitate exchange and positioning while providing substantially atraumatic tissue puncture. In the illustrated example, the support member 130 includes a reinforcing member 34.

[0090] In one such example, referring now to the embodiments illustrated in FIG. 1A the assembly 100 includes a substantially flexible energy delivery puncture device or component 114 that is provided separately from and operable independent of the support member 130. In one such example, the flexible energy delivery puncture device or component 114 (also referred to as a flexible energy-based delivery device or a flexible energy delivery puncture device) includes a radio frequency (RF) guide wire 10, and the separate support member 130 includes a needle shaft 132 including a reinforcing member 34 and one or more polymer layers 38 forming a polymer shaft 39 of a dilator 30A, wherein the reinforcing member 34 is substantially surrounded by the one or more polymer layers.

[0091] Modified electrode tip

[0092] In the illustrated example, the RF guide wire 10 includes an electrode for delivering radio frequency energy. In one specific example, as illustrated, the RF guide wire 10 has a distal electrode tip lOd for delivering radio frequency energy to puncture tissue. In some such embodiments, the distal electrode tip lOd is substantially atraumatic to reduce 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 atraumatic to reduce pressure exerted on the tissue.

[0093] In some such examples, referring to FIG. 1AIn some such examples, the RF guidewire 10 can include a cylindrical body with a hemispherical electrode tip 10d as shown by reference numeral 10c, which in some examples can be formed as a cap formed distally and adjacent to the cylindrical body 10c. In other words, the electrode tip 10d can be defined by a dome on the top of the cylindrical body 10c, such as a substantially complete circular dome. In some such examples, the outer diameter of the dome can substantially match the outer diameter of the cylindrical body 10c. This can help to provide a substantially atraumatic distal junction to the tissue to minimize the risk of trauma and / or damage at the desired target tissue site. In some such implementations, the domed distal electrode tip 10d of the RF guidewire 10 can reduce the amount of pressure exerted on the tissue by the distal tip to make the tip more atraumatic, thus the force exerted by the distal tip is spread over a larger area. In some such examples, the RF guidewire 10 is provided as a 0.035” wire.

[0094] More specifically, with reference to FIG. 1A and FIG. 1C the assembly further includes a sheath 10 and a support member, the support member including a reinforced dilator that can be used with the flexible RF wire, such as dilator 30A, wherein the dilator 30A includes a reinforcing member 34 and one or more polymer layers 38 defining a polymer shaft 39 of the dilator 30A, wherein the reinforcing member 34 is substantially surrounded by the one or more polymer layers 38.

[0095] In some such implementations of the present application, an assembly 100 for puncturing tissue is provided, wherein the support member 130 includes a needle shaft 132, wherein the needle shaft 132 includes a reinforcing member 34 and one or more polymer layers 38, wherein the reinforcing member 34 is substantially surrounded by the one or more polymer layers 38. In some such implementations, the needle shaft 132 is disposed within the dilator 30A. Thus, in some implementations, the support member includes a needle shaft 132 that is disposed as part of or defined by the dilator 30A, wherein the needle shaft 132 is embedded in or surrounded by the one or more polymer layers 38 of the dilator 130.

[0096] Details of the reinforcing member 34 are shown in FIG. 1C More specifically, FIG. 1CA support member 130 is illustrated that includes a reinforcing dilator 30A having a needle shaft 132, where the support member 130 is provided separately from a substantially flexible tissue puncturing device or member 112, such as an energy-based tissue puncturing device 114, such as an RF guide wire 10. In one example, the needle shaft 132 is provided as part of or in other words 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-puncturing component for supporting the tissue puncturing device or member. In some such examples, the dilator 30A including the needle shaft 132 includes a proximal portion 31 that terminates at a distal tip 41. In some such implementations, the reinforcing member 34 provides sufficient rigidity that is substantially similar to the rigidity of a rigid needle.

[0097] In some such examples, the dilator shaft 32 extends along the proximal portion 31 and includes the reinforcing member 34. In the particular example shown, the reinforcing member 34 is substantially surrounded by one or more polymer layers 38. In some such examples, the reinforcing member 34 is embedded within the 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 the inner tubular member 35 and the outer tubular member 37 of the dilator shaft 32. In some such examples, substantially surrounded can be considered to mean that the reinforcing member 34 is substantially surrounded on its outside or exterior by the one or more polymer layers 38 forming a polymer shaft 39 (forming the dilator shaft 32) around the reinforcing member 34. In some implementations, the dilator 30A can further include a radiopaque marker 42 at the distal tip 41. In one example, the reinforcing member 34 includes a hypotube, such as a metallic hypotube. In one such example, the reinforcing member 34 includes a stainless steel hypotube, and the inner and outer tubular members 35, 37 include HDPE.

[0098] Hypotube defines lumen of support member

[0099] In one such example, the reinforcing member 34, such as a stainless steel hypotube, extends longitudinally within the one or more polymer layers, e.g., within the inner and outer tubular members 35, 37, as shown. Thus, the reinforcing member 34 [e.g., hypotube] defines a lumen of the support member 130. FIG. 1C Hypotube positioned between one or more polymer layers

[0100] In one example, the support member 130, again with reference to

[0101] FIG. 1C ​, the one or more polymer layers 38 include an inner polymer layer and an outer polymer layer, which in some examples can include the inner tubular member 35 and the outer tubular member 37. In certain instances, as noted above, the reinforcing member 34 is substantially surrounded along its exterior by the one or more polymer layers 38. In other examples, the reinforcing member 34 is substantially surrounded by the one or more polymer layers 38 such that the reinforcing member 34 is positioned between the inner polymer layer and the inner polymer layer, for example, as defined by the inner tubular member 35 and the outer tubular member 37, as shown in FIG. 1D some examples, the hypotube is positioned or sandwiched between two layers of polymer. In other words, the reinforcing member 34 is substantially surrounded by and embedded within both the inner polymer layer and the outer polymer layer. In other words, the reinforcing member 34 is sandwiched or positioned between the inner polymer layer and the outer polymer layer 38 and the polymer shaft 39 forming the dilator shaft 32. In some such examples, the inner tubular member 35 and the outer tubular member 37 include high density polyethylene (HDPE).

[0102] In some embodiments of the atrioventricular septum assembly 100, the sheath 10 includes a standard atrioventricular septum sheath, the needle shaft 132 (disposed as part of or defined by the dilator 30A) includes a reinforcing member 34 as described above and the RF guide wire or RF wire is provided as a 0.035" wire. In some such examples, the RF wire includes a J-tip wire, or in alternative examples, the RF wire includes a pigtail wire.

[0103] Hypotube secured within the lumen of a dilator

[0104] In some such embodiments of the present application, the reinforcing member 34 includes a distal end 34D and a proximal end 34P, wherein the reinforcing member 34 extends within the lumen of the dilator 30A, as shown in FIG. 1C In some such embodiments, the assembly 100 provides a substantially gapless joint 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 secured within the one or more polymer layers 38 forming the polymer shaft 39 of the dilator 30A. In one such example, reference is now made to FIG. 7A-FIG. 7CThe reinforcing member 34 is substantially fixed at its distal end and proximal end (in other words, the reinforcing member distal end and the reinforcing member proximal end) to the one or more polymer layers 38 of the dilator 30A to provide a substantially gapless joint at the junction between the reinforcing member 34 at the distal end and proximal end and the one or more polymer layers 38 of the dilator 30A. The figure shows the joint at the distal end of the reinforcing member 34. A similar joint is provided at the proximal end of the reinforcing member 34. In some such embodiments of the application, the reinforcing member 34 is substantially sealed at its distal end and proximal end (in other words, at the reinforcing member distal end and the reinforcing member proximal end) to the one or more polymer layers 38 of the dilator 30A. In some such embodiments, this can prevent blood or other fluids from entering between the reinforcing member 34 and the polymer shaft 39 of the dilator 30A by substantially eliminating the gap between the reinforcing member 34 and the polymer shaft 39 of the dilator 30A.

[0105] Force transmission and / or moment transmission

[0106] Support member provides force transmission / moment

[0107] In some such embodiments of the application, the support member 130 provides sufficient rigidity to the puncturing device (such as the RF wire) to enable sufficient force transmission to enable force to be transmitted to the distal end of the assembly 100.

[0108] In some such embodiments, the support member 130 provides sufficient rigidity to the puncturing device to enable moment transmission to the distal end of the assembly.

[0109] Reinforcing member provides force transmission / moment

[0110] In some such instances, the reinforcing member 34 provides sufficient rigidity to the support member 130 to enable sufficient force transmission to enable force to be transmitted to the distal end of the assembly 100. More particularly, the reinforcing member 34 provides sufficient rigidity to the assembly 100 such that the substantially flexible puncturing device 112 (such as the substantially flexible energy-based puncturing device 114, such as the RF wire 10) together with the support member 130 is able to enable sufficient force transmission to enable force to be transmitted to the distal end of the assembly 100 (and thus to the distal end of the substantially flexible puncturing device 112).

[0111] Thus, the reinforcing member 34 is able to impart force transmission capability to the substantially flexible RF wire 10, which when used together with the support member 130 is able to transmit force to enable force to be transmitted to the distal end of the assembly 100, for example for engaging tissue at a target tissue site. Thus, the reinforcing member 34 functions as a force transmission portion of the assembly 100.

[0112] In some such examples, the assembly 100 further includes a sheath 20, as shown in FIG. 1A which can be used with the support member 130 to provide rigidity to the assembly 100 to facilitate the transmission of force to the distal end of the assembly 100.

[0113] In some such embodiments of the present application, the stiffening member 34 provides sufficient rigidity to enable the transmission of torque to the distal end of the assembly 100. Thus, the stiffening member 34 provides sufficient rigidity to the assembly, where the substantially flexible puncture device 112 (such as the substantially flexible energy-based puncture device 114) provides sufficient rigidity to the assembly 100, along with the support member 130, to enable the transmission of torque to the distal end of the assembly 100 (and thus the transmission of torque to the distal end of the substantially flexible puncture device 112).

[0114] Some such embodiments of the present application facilitate atrioventricular septum puncture, where the stiffening member 34 provides sufficient rigidity to the assembly 100 to enable sufficient force transmission to engage a desired tissue site (such as a septum of a heart). In some such examples, the support member 130 provides force transmission capability to the substantially flexible puncture device 112, where the substantially flexible puncture device 112 is capable of transmitting force when used with the support member 130.

[0115] In some such embodiments, the assembly 100 further includes a sheath 20, as shown in FIG. 1A which can be used with the support member 130 to provide rigidity to the assembly 100 to enable the transmission of torque to the distal end of the assembly 100.

[0116] In some such examples, the sheath 20 can be coupled to the dilator 30A, which can use one or more components [i.e., the sheath 20 or the dilator 30A] for force and / or torque transmission. In other words, the user can not have to manipulate both the sheath 20 and the dilator 30A (the user can only manipulate the sheath 20 or the dilator 30A) and the RF guide wire 10 follows the guidance and / or direction of the sheath 20 or the dilator 30A. In some such examples, the sheath 20 has some contribution to the total torque. In some such embodiments, twisting the sheath 20 and / or the dilator 30A enables the stiffening member 34 to twist therewith.

[0117] Rigidity of the Stiffening Member

[0118] In some embodiments of the present application, the force transmission portion of the assembly 100 has at least about 0.0085 Nm 2 such as about 0.0115 Nm 2stiffness. In some embodiments of the invention, the force transmission portion of the assembly is the support member 130, which has a stiffness or rigidity with a bending stiffness value of at least about 0.0115 Nm 2 , such that sufficient force transmission is enabled for the 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 0.0085 Nm 2 to about 0.0145 Nm 2 . In one such example, the support member 130 is the reinforced dilator 30A, which has a bending stiffness of at least about 0.0085 Nm 2 , such as about 0.0115 Nm 2 . In a specific example, the reinforced dilator 30A has a bending stiffness of about 0.0085 Nm 2 to about 0.0145 Nm 2 . In one such example, the reinforced dilator 30A is the reinforced dilator 30A as provided in Example 1, such as that provided in relation to FIG. 2A-FIG. 2G .

[0119] In some such examples, the support member 130 is used to impart rigidity or stiffness to the assembly 100 comprising a puncturing device, such as a substantially flexible puncturing device, to provide force transmission capability to the assembly comprising a puncturing device, such as a substantially flexible puncturing device.

[0120] In some examples, the bending stiffness value provided for the support member 130 can also be used in relation to Example 2 and Example 3 provided herein. FIG. 4A-FIG. 4G and FIG. 6A-FIG. 6H .

[0121] Example 2 and Example 3

[0122] In some embodiments of the invention, the force transmission portion of the assembly is the support member 130, which is a reinforced member comprising a stylet. The stylet has a stiffness or rigidity with a bending stiffness value of at least about 0.008 Nm 2 , such as about 0.015 Nm 2 , such that sufficient force transmission is enabled for the 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 .

[0123] Stiffness of the puncturing device

[0124] In some embodiments of the present application, the distal portion of the puncturing device, such as the substantially flexible puncturing device, has a bending stiffness of the distal portion or distal region. In some such examples, a substantially flexible RF guide wire 10 is provided, wherein the substantially flexible RF guide wire 10 has a distal portion [including along the distal electrode tip 10d] wherein the RF guide wire 10 has a distal portion stiffness defined by a bending stiffness of at least about 3.57 x 10 -6 Nm 2 , for example, about 4.76 x 10 -6 Nm 2 . In some embodiments of the present application, the RF guide wire 10 has a distal portion stiffness or rigidity, the bending stiffness being between about 3.57 x 10 - 6 Nm 2 and about 5.95 x 10 -6 Nm 2 .

[0125] In some such examples, the distal region of the RF guide wire 10 tapers down from the proximal region of the RF guide wire 10 by about 12 cm - 15 cm. In other words, the distal portion of the RF guide wire 10 has a length of between about 12 cm and about 15 cm. In some such examples, the distal portion of the RF guide wire 10 is the thinnest point of the RF guide wire 10.

[0126] In some such embodiments, the substantially flexible RF guide wire 10 has a proximal portion, the proximal portion having a bending stiffness of less than about 0.00179 Nm 2 , for example, about 0.00143 Nm 2 . In some embodiments of the present application, the RF guide wire 10 has a proximal portion stiffness or rigidity, the bending stiffness being between about 0.00107 Nm 2 and about 0.00179 Nm 2 .

[0127] In some embodiments of the present application, wherein the substantially flexible puncturing device comprises an RF guide wire 10, the RF guide wire 10 has a bending stiffness of between about 2.0 x 10 -6 and about 1.4 x 10 -3 Nm 2 . In some such examples, the RF guide wire 10 has a wire diameter of between about 0.127 mm and about 0.635 mm.

[0128] Shaping ability of support member / stiffening member

[0129] More specifically, the reinforcing member 34 is shapeable to enable the support member 130 (e.g., including a needle shaft 132 disposed as part of or defined by the reinforcing dilator 30A) to be removed from the substantially flexible energy delivery puncture device 110 (such as the RF wire 10) so that the curvature of the support member 130 can be reshaped for reinsertion therein in order to optimize the positioning of the assembly 100 against a target tissue site (such as an atrial septum pocket).

[0130] In some embodiments of the present application, the support member 130 is shapeable to enable it to be removed from a puncture device (such as the substantially flexible puncture device 114, such as the RF guide wire 10) to reshape the curvature of the support member 130 for reinsertion therein in order to optimize the positioning of the assembly 100 against a target tissue site. In some such examples, the reinforcing member 34 additionally provides shapeability, and enables the reinforcing member 34 and thus the support member 130 to be shapeable. In some such embodiments, in which the reinforcing member 34 is shapeable to enable the support member 130 (which includes the reinforcing member 34) to be removed from a substantially flexible puncture device (such as an RF guide wire) to enable the curvature of the support member to be reshaped for reinsertion therein in order to optimize the positioning of the assembly 100 against a target tissue site (such as an atrial septum of a heart).

[0131] In some such embodiments, the support member 130 includes the reinforcing member 34 disposed within the reinforcing dilator 30A (such as within the needle shaft 132 of the reinforcing dilator 30A), and thus imparts shapeability to the dilator 30A. In other examples, the support member 130 includes the stylet 60 disposed separately from the dilator 30A (as described in the embodiments further described below), and imparts shapeability to the assembly 100. In other words, the role of the stylet 60 is to impart the desired curvature and stiffness to the assembly 100 when used with the assembly 100. The stylet 60 can be removed from the assembly, and can be reshaped and reinserted into the assembly 100 to provide the desired curvature to the assembly 100.

[0132] Coupling between dilator and sheath

[0133] Locking feature of embodiment 1

[0134] In some embodiments of the present application, reference is now made to FIG. 1C , and as FIG. 1AThe assembly 100 shown includes a sheath 20 for use with a reinforcing dilator 30a during a portion of a surgical procedure. In some such instances, the assembly 100 includes a locking mechanism to allow axial and rotational coupling of the dilator 30A to the sheath 20 for use during a portion of the procedure. In some embodiments of the invention, the locking mechanism allows for mate engagement between the sheath 20 and the dilator 30A to provide rotational and axial coupling. This can help minimize the risk of rotational misalignment between the sheath 20 and the dilator 30A, and thus reduce the risk of confusion caused by misalignment.

[0135] Now for reference FIG. 1E The support member 130, including (as part of or defined by the expander 30A) the needle shaft 132, includes an expander hub 51 operable to couple to a sheath hub 21 during a portion of the procedure. In one example, such as FIG. 1F As illustrated, a locking mechanism is provided, wherein the expander hub 51 includes one or more keys 52 for engaging with corresponding features (such as key receiving features) on the sheath hub 21, enabling axial and rotational locking with the sheath 20. Thus, in some embodiments of the invention, a locking mechanism is provided to allow axial and rotational coupling of the expander to the sheath during a portion of the procedure. In some instances, a maneuverable sheath is provided, wherein the maneuverable sheath 20 may be an 8Fr maneuverable sheath. Alternatively, an 8.5Fr maneuverable sheath 20 may be provided. In some such instances, the maneuverable sheath 20 may be provided with different curvatures. In specific instances, the maneuverable sheath 20 may be provided with different curvatures, specifically angles of 37 degrees, 45 degrees, 55 degrees, 90 degrees, or 135 degrees. In a specific case of this example, the sheath includes an inner PTFE liner, a braided fabric, and a Pebax outer sheath. In some such embodiments, a support member 130 is provided that includes (e.g., as part of or defined by an 8Fr expander 30A) a needle shaft 132, compatible with an 8Fr sheath. Alternatively, a support member 130 may be provided that includes a needle shaft 132, which may be part of or defined by an 8.5Fr expander 30A, compatible with an 8Fr operable sheath 20. The support member 130 that includes (e.g., as part of or defined by an expander 30A) the needle shaft 132 may have a curvature of 50 degrees or 86 degrees. In some instances, the material may include HDPE and a metal thiouret forming the reinforcing member 34. In some such instances, the RF wire includes a 0.035” OD wire and may be a J-tip wire or a pigtail wire. In a specific case of this example, the wire may include a stainless steel core with a PTFE coating.

[0136] Non-transmissive markers

[0137] In some embodiments, as shown in FIG. 1C and FIG. 1D The support member 130 includes one or more radiopaque markers, such as a support member radiopaque marker 42. In some such examples as described above, the assembly 100 provides a support member 130 (e.g., including a needle shaft 132 provided as part of or defined by the reinforcing dilator 30A) including a radiopaque marker 42, such as at a distal tip of the support member 130. In some such examples, the support member 130 includes a radiopaque marker 42 embedded within a polymer of a distal tip thereof, as shown.

[0138] In particular examples, as shown in FIG. 7A , FIG. 7B and FIG. 7C The radiopaque marker 42 includes a radiopaque coil 142 embedded within a polymer of the support member 130 (e.g., including a needle shaft 132 provided as part of or defined by the reinforcing dilator 30A), such as within one or more polymer layers 38 (forming a polymer shaft 39, which in turn forms a dilator shaft 32), e.g., at a distal tip thereof. In more particular examples, the radiopaque coil 142 is embedded within one or more polymer layers such that the one or more polymer layers extend distally beyond the radiopaque coil 42.

[0139] Using the radiopaque marker to align

[0140] In some embodiments of the present application, a substantially flexible energy-based puncturing device 114 (such as an RF guidewire) is provided including one or more device-side radiopaque markers located at a distal end thereof (or in other words, one or more device radiopaque markers), e.g., as shown in FIG. 3B and FIG. 3C In some such embodiments, as described above, the support member 130 also includes a support member radiopaque marker located at a distal end of the support member 130 (as shown in FIG. 1C and FIG. 1D In some such embodiments, similar to the embodiments shown in FIG. 3B and FIG. 3C The one or more device radiopaque markers 12 are configured to cooperate with the support member radiopaque marker 42 to indicate a relative position of the substantially flexible energy-based puncturing device 114 (such as the RF guidewire 10). FIG. 3B and FIG. 3CThe embodiment shown in FIG. 1 illustrates a dilator 30B that is provided separately from the stylet 64. However, in the presently described alternative embodiment, the stylet 64 can be a reinforcing member 34 that is provided within the dilator 30A.

[0141] In some such embodiments, the assembly 100 includes an initial configuration 100A in which the substantially flexible energy-based puncturing device 114 (such as the RF guidewire 10) is positionable within the support member 130 such that the one or more device radiopaque markers 12 are not aligned with the support member 130 radiopaque markers 42, as shown in FIG. 1. In some such examples, under imaging, the plurality of radiopaque markers can be visible, including the one or more device radiopaque markers 12 and the support member radiopaque markers 42. FIG. 3A In some such examples, under imaging, the plurality of radiopaque markers can be visible, including the one or more device radiopaque markers 12 and the support member radiopaque markers 42.

[0142] In some such embodiments, the assembly 100 includes a first configuration 100B, as shown in FIG. 2, in which the substantially flexible energy-based puncturing device 114 (such as the RF guidewire 10) is positionable within the support member 130 such that the one or more device radiopaque markers 12 are aligned with the support member 130 radiopaque markers 42, as shown in FIG. 2. In some such examples, under imaging, the single radiopaque marker can be visible [including the one or more device radiopaque markers 12 and the support member radiopaque markers 42, which can be arranged in close proximity to one another]. FIG. 3B In some such examples, under imaging, the plurality of radiopaque markers can be visible, including the one or more device radiopaque markers 12 and the support member radiopaque markers 42. FIG. 3B In some such examples, under imaging, the plurality of radiopaque markers can be visible, including the one or more device radiopaque markers 12 and the support member radiopaque markers 42, where the one or more device radiopaque markers 12 are distal to the support member radiopaque markers 42, indicating that the distal electrode tip 10d is positioned against the target tissue site (such as the septum of the heart) for puncturing tissue.

[0143] The assembly 100 additionally has a second configuration 100B in which the substantially flexible energy-based puncturing device 114 (such as the RF guidewire 10) is positionable / advanceable within the support member 130 such that the one or more device radiopaque markers 12 are substantially not aligned or misaligned with the support member radiopaque markers 42. In some such examples, the misalignment of the one or more device radiopaque markers 12 with the support member radiopaque markers 42 indicates that the energy delivery portion 114d of the flexible energy-based puncturing device 114 (such as the RF electrode tip 10d of the RF guidewire 10) is beyond the support member (e.g., distal to the distal tip or end of the support member 130) for positioning against a target tissue site for puncturing tissue. In some such examples, under imaging, the plurality of radiopaque markers can be visible [including the one or more device radiopaque markers 12 and the support member radiopaque markers 42, where the one or more device radiopaque markers 12 are distal to the support member radiopaque markers 42, indicating that the distal electrode tip 10d is positioned against the target tissue site (such as the septum of the heart) for puncturing tissue. FIG. 3A In some such examples, under imaging, the plurality of radiopaque markers can be visible, including the one or more device radiopaque markers 12 and the support member radiopaque markers 42, where the one or more device radiopaque markers 12 are distal to the support member radiopaque markers 42, indicating that the distal electrode tip 10d is positioned against the target tissue site (such as the septum of the heart) for puncturing tissue.

[0144] In some such instances, the sheath 20 and the dilator 30A and the reinforcing member 34 are radiopaque and have radiopaque characteristics to enable them to be visible under imaging. In some such instances, one or more of the sheath 20, the dilator 30A and the reinforcing member 34, such as a metal hypotube, include a radiopaque material in addition to the radiopaque marker

[42] . The reinforcing member 34, such as a metal shaft or hypotube, is also radiopaque. In some such embodiments, the polymer forming the sheath 20 and / or the dilator 30A can contain a polymer radiopaque filler, such as 20% barium sulfate, thus providing contrast with the one or more markers [12, 42] at the distal tip. In other words, this can provide visibility under imaging and can additionally provide contrast with the one or more markers [42, 12], which can allow the user to see the dilator 30A under imaging as compared to the RF guide wire 10 to see if the RF guide wire 10 is positioned inside or outside of the dilator 30A [i.e., if the distal segment of the RF guide wire 10 is distal to the dilator 30A.

[0145] Blunt dilator tip [Embodiment 1]

[0146] In some embodiments of the present invention, the support member 130 includes a substantially blunt distal tip or edge 143, as shown in FIG. 1A FIG. 1, to provide a substantially atraumatic distal tip 143 while providing the advantages of a substantially rigid or stiff support member 130 therein, such as by providing a reinforcing member 34. In some such embodiments, as noted above, the reinforcing dilator 30A is provided, again referring to FIG. 1A In some instances, the dilator 30A includes a substantially blunt distal tip or edge 144 to provide a substantially atraumatic distal tip 144. In some such embodiments, the reinforcing dilator 30A includes a substantially thick distal wall along the distal tip 144, wherein the distal tip 144 is defined by a substantially circular distal tip edge. In some such embodiments, the dilator 30A provides the advantages of providing a substantially atraumatic distal tip as well as a tapered profile at the distal tip to provide ease of routing and passage, in addition to providing the advantages associated with providing a substantially rigid body by being able to provide a rigid component therein, such as the reinforcing member 34, in addition to being able to use the RF guide wire 10 for one or more of positioning, routing, puncturing and anchoring.

[0147] In one such embodiment, a general method / workflow is provided that illustrates a method of performing an atrioseptal puncture procedure using assembly 100, as described above. The method disclosed herein provides one or more advantages associated with the assembly, which includes an energy delivery component that is disposed independently of a rigidity component. Details of the method are provided below.

[0148] Method

[0149] Method [Example 1]

[0150] Initial loop / entry and positioning using same device

[0151] In some embodiments of the present invention, and referring now to FIG. 2A-FIG. 2G , a method for puncturing tissue is disclosed. The method includes the following steps: [1] entering a tissue region in a patient, by advancing a device (such as puncture device 110, such as RF guidewire 10) into the tissue region, as shown in FIG. 2B In some such examples, the method of puncturing a tissue region includes a method of performing an atrioseptal puncture, wherein the step of entering a tissue region includes advancing a device (such as puncture device 110) into the superior vena cava (SVC) 501 adjacent to the heart 500 of the patient.

[0152] In some embodiments of the present invention, the method for puncturing tissue further includes the following step: [3] positioning the device at a target tissue site in the tissue region, as shown in FIG. 2D for example: [2] first looping a support member 130 (such as stiffening dilator 30A) on the puncture device 110 to support the device (such as puncture device 110), as shown in FIG. 2C [3] advancing the device (such as puncture device 110) toward the target tissue site so as to position the device at the target tissue site for puncturing, as shown in FIG. 2D

[0153] In some such examples, the step of positioning the puncture device 110 at the target tissue site includes performing [3] pulling down from the superior vena cava (SVC) into the heart 500 of the patient to determine the location of the fossa ovalis (or in other words, the fossa) 504 along the septum 502 of the heart 500, first for example (2) looping or advancing a support member 130 (such as dilator 30A) on the device (such as puncture device 110) into the SVC to (3) facilitate the pulling down of the puncture device 110 at the fossa 504.

[0154] In some such examples, as shown in FIG. 2B-FIG. 2D the entering step [1] as shown in FIG. 2B and the positioning step [3] as shown in FIG. 2D ​The illustrated positioning step [3] is performed using the same device, such as the puncture device 110, where the puncture device 110 can be used without the support member 130 during the accessing step [1], and where the device can be used with the support member 130 during the positioning step [3].

[0155] Using the puncture device for initial access and positioning

[0156] In some such embodiments of the application, as illustrated in FIG. 1 1 1, the accessing and positioning steps are performed using the puncture device 1 10. FIG. 2B-FIG. 2D

[0157] Using the same device for initial access, positioning, and puncturing

[0158] In some such embodiments of the application, as illustrated in FIG. 1 1 1, the accessing and positioning steps are performed using the puncture device 1 10. FIG. 2E FIG. 2D In some such embodiments of the application, as illustrated in FIG. 1 1 1, the accessing and positioning steps are performed using the puncture device 1 10.

[0159] In some embodiments of the application, the step of puncturing through the target tissue site [4] includes a step of puncturing through the fossa 504 to gain access to the left side of the heart 500. This allows one or more devices of the assembly 100, such as the support member 130 of the assembly 100 (such as the dilator 30A) and the sheath 20, to be routed over the RF guidewire 10 to the left side of the heart.

[0160] Using the puncture device for initial access, positioning, and puncturing

[0161] In some such embodiments of the application, as illustrated in FIG. 1 1 1, the accessing and positioning steps are performed using the puncture device 1 10. FIG. 2B-FIG. 2E

[0162] Using the same device for initial access, positioning, and puncturing, and anchoring

[0163] According to embodiments of the application, the method further includes an anchoring step, as illustrated in FIG. 1 1 1, where the anchoring step is performed using a device (such as the puncture device 1 10) after the step of puncturing through the target tissue site [4] to maintain access through the target tissue site to the other side of the target tissue site to allow one or more other devices [such as the sheath 20 and the support member 130 including the dilator 30A] to be routed over the device (such as the puncture device 1 10) to the other side of the target tissue site. FIG. 2E FIG. 2F ​​​​as shown in FIG. 1 1 1, where the steps of entering, positioning, puncturing, and anchoring are performed using the same device. The puncturing device 1 10, such as the RF guidewire 10, can be left in place to maintain access to the left side of the heart, as shown in FIG. 1 12. FIG. 2G The support member 130, for example, including the dilator 30A, can be removed or retracted to allow anchoring using the RF guidewire 10. 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 to guide one or more devices to the left side of the heart while being substantially atraumatic to minimize damage to tissue.

[0164] In some such embodiments of the invention, the step of anchoring to maintain access through the target tissue site includes advancing a device, such as the puncturing device 1 10, through the fossa to the left side of the heart to maintain access to the left side of the heart. This step further includes the step of removing the support member 130 [such as the dilator 30A] and leaving the puncturing device 1 10 [such as the RF guidewire 10] to maintain access to the tissue region, such as the left side of the heart.

[0165] Thus, in some examples, the step of anchoring includes removing the support member 130 including the dilator 30A to enable anchoring by allowing the RF guidewire 10 to remain positioned to maintain access to the left side of the heart. Additionally, the sheath 20 can also be removed.

[0166] Using a puncturing device for initial entry, positioning, and puncturing

[0167] In some such embodiments of the invention, the steps of entering, positioning, puncturing, and anchoring are performed using a puncturing device.

[0168] Alternatives to the device used for initial entry, positioning, and / or puncturing - dependent claims based on independent claims on which these dependent claims rely

[0169] In some such embodiments of the invention, the device includes a flexible puncturing device 1 12, where one or more of the steps of entering, positioning, puncturing, and anchoring are performed using the flexible puncturing device 1 12. In some such examples, each of the steps of entering, positioning, puncturing, and anchoring are substantially performed using the flexible puncturing device 1 12.

[0170] In some such embodiments of the application, the device includes a substantially flexible guidewire (such as mechanical guidewire 118 or RF guidewire 10), wherein one or more of the accessing, positioning, puncturing, and anchoring steps are performed using the substantially flexible guidewire (such as mechanical guidewire 118 or RF guidewire 10). In some such examples, each of the accessing, positioning, puncturing, and anchoring steps are substantially performed using the substantially flexible guidewire (such as mechanical guidewire 118 or RF guidewire 10).

[0171] In some such embodiments of the application, the device includes a flexible energy-based puncturing device 114, wherein one or more of the accessing, positioning, puncturing, and anchoring steps are performed using the flexible energy-based puncturing device 114. In some such examples, each of the accessing, positioning, puncturing, and anchoring steps are substantially performed using the substantially flexible energy-based puncturing device 114.

[0172] In some such embodiments of the application, the device includes a flexible RF guidewire 10, and wherein one or more of the accessing, positioning, puncturing, and anchoring steps are performed using the flexible RF guidewire 10. In some such examples, each of the accessing, positioning, puncturing, and anchoring steps are substantially performed using the flexible flexible RF guidewire 10.

[0173] In some such embodiments of the application, wherein the device includes a flexible mechanical guidewire 118 having a relatively sharp distal tip 118d, wherein one or more of the accessing, positioning, puncturing, and anchoring steps are performed using the flexible mechanical guidewire 118. In some such examples, each of the accessing, positioning, puncturing, and anchoring steps are substantially performed using the flexible mechanical guidewire 118.

[0174] Repeating the accessing and positioning steps

[0175] In some such embodiments of the application, the method further includes repeating the accessing step [1] as shown in FIG. 2B and the positioning step [3] as shown in FIG. 2D until the device (such as puncturing device 110) is positioned at the desired target tissue site prior to the puncturing step [4] as shown in FIG. 2E

[0176] Reshaping the support member

[0177] In some such examples, repeating the positioning step [3] as shown in FIG. 2D further includes reshaping the curvature of the support member 130 after the support member 130 is removed, and repeating the positioning step [3] as shown in FIG. 2D ​The illustrated positioning step is preceded by re-routing the support member 130 over the device [2], as FIG. 2C illustrated in the middle (such as the puncture device 110 having been repositioned [1] within the SVC, as FIG. 2B illustrated in the middle), which in the illustrated example includes a pull-down procedure for finding the fossa 504. In a particular example, the support member 130 includes a reinforcing member 34, wherein the positioning step is performed using the reinforcing member 34.

[0178] In some such embodiments of the present application, the method includes reshaping the support member 130 (such as the reinforcing dilator 30A). In some such examples, the method includes pulling out and reshaping the dilator element or dilator 30A. In other examples, both the dilator element 30A and the sheath 20 are pulled out and reshaped.

[0179] The support member includes a reinforcing dilator

[0180] In some such examples, the reshaping is performed using the support member 130 including the reinforcing dilator 30A, wherein the reinforcing dilator 30A includes a reinforcing member 34, wherein the positioning step is performed using the reinforcing dilator 30A which can be reshaped.

[0181] The support member includes a stylet

[0182] In some embodiments, alternatively, as discussed further below, with reference to FIG. 4A-FIG. 4E illustrated in the middle, the reshaping step can be performed using the support member 130 including the stylet 60, wherein the stylet 60 is a reinforcing member 34, and the positioning step is performed using the stylet 60.

[0183] In some such examples, the stylet element 60 can be taken out and reshaped. In other examples, the stylet element 60 along with the sheath 20 and / or dilator 30B can be pulled out and reshaped to see what the effective (last) shape can be, and then can be reinserted therein.

[0184] The methods outlined herein above can also be used for the embodiments with a removable stylet 60 discussed further below, as FIG. 4A-FIG. 4E and FIG. 6A-FIG. 6H illustrated in the middle.

[0185] The mapping system is used to visualize the initial access route and positioning

[0186] In some such embodiments with reference to FIG. 2A-FIG. 2G , and additionally with reference to FIG. 4A-FIG. 4E and FIG. 6A-FIG. 6HIn some such instances, the positioning and puncturing steps are performed using the flexible RF guidewire 10. Still additionally, in some such instances, the positioning, puncturing, and anchoring steps are performed using the flexible RF guidewire 10. In some such instances, the positioning and anchoring steps can be visualized using a mapping system set up as follows. In some such instances, as FIG. 2A-2G and FIG. 4A-FIG. 4E As shown in the method of FIG. 1, the mapping system can be used to visualize the flexible RF guidewire 10 during the puncturing step. In some such instances, the mapping system can be used to visualize the flexible RF guidewire 10 during the puncturing step using a mapping system set up as follows. In some such instances, the method further comprises the step of visualizing the flexible RF guidewire 10 during the puncturing step using the mapping system.

[0187] Accordingly, these embodiments of the present invention provide a mapping system that can be used to visualize the RF guidewire 10 during the method of puncturing tissue during one or more of the steps of the accessing, positioning, and anchoring steps.

[0188] In some cases, the mapping device comprises an electroanatomical mapping system, which can be magnetic or impedance based to create a virtual volume. In some instances, the electroanatomical mapping system can be used with other echocardiography imaging modalities, which can be ultrasound. The echocardiography imaging modalities can be used as overlays in the map, in other words, they can be used to provide additional information to the mapping system. The echocardiography imaging modalities can include intracardiac echocardiography or TEE echocardiography.

[0189] In some instances, the method involves switching between a mapping mode for each of the accessing, positioning, and anchoring steps and a puncturing mode for the puncturing step.

[0190] In some such instances, the method of mapping the RF guidewire 10 for visualization using an imaging modality can be used with a flexible wire having an electrode, which can or can not deliver energy that can be used for recording purposes. In some cases, it can be a passive electrode for recording purposes. Alternatively, as described above, if the RF guidewire 10 is used, the mapping system can be used with an active electrode such as the distal electrode tip 10d of the RF guidewire 10. Accordingly, the recording and mapping properties of the mapping system can be used with a guidewire having a passive electrode or an active electrode. In a specific instance, when the wire is provided with a passive electrode for mapping, the wire can comprise a puncturing device or a device for puncturing tissue. In one case, the wire can comprise a mechanical guidewire 118, which can have a sharp distal tip 118d for puncturing tissue.

[0191] In some such embodiments, the reinforcing member is a stylet 60, which can be used independently of the substantially flexible energy-based puncture device 114, such as the RF wire 10.

[0192] As a general overview, in one broad embodiment, again referring to FIG. 2A-FIG. 2G , there is provided a method for performing an atrioventricular septum puncture, 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 into the superior vena cava, as shown in FIG. 2C , (iii) withdrawing the RF wire into the dilator, as shown in FIG. 2D , (iv) pulling down from the SVC into the heart to find the fossa, as further shown in FIG. 2D , (v) dilating with the dilator, (vi) advancing the RF wire to the puncture location, also referring to FIG. 2D , (vii) puncturing and advancing the RF wire, as shown in FIG. 2E , and (viii) passing the sheath and dilator over the RF wire, as shown in FIG. 2F .

[0193] More specifically, in a specific embodiment of the inventive method, again referring to FIG. 2A , there is provided a method for performing an atrioventricular septum puncture procedure using an assembly 100 comprising a flexible RF wire 10, a sheath 20, and a dilator 30A, the method comprising the steps of: at step 202, [1] advancing the RF wire into the superior vena cava (SVC) to gain access, as further exemplified in FIG. 2B . In some such embodiments, providing the energy delivery component (flexible RF wire) independent of the reinforcing member enables the energy delivery component to be used as an access wire. More specifically, the dilator 30A can be later advanced, allowing the flexible RF wire to provide access to the SVC without the need to use another access wire. This can help reduce the number of steps and simplify the procedure, and thus can reduce the procedure time and complexity.

[0194] The method further comprises the step of: at step 204, [2] advancing the sheath 20 and dilator 30A combination over the flexible RF wire into the SVC. Thus, the flexible RF wire 10 functions as an access wire and enables the sheath 20 and dilator 30A (e.g., as an assembly) to follow over the flexible RF wire 10 into the SVC, as shown in FIG. 2C .

[0195] The method further provides: at step 206, withdrawing the RF wire into the dilator 30A, and step 208, [3] performing a pull down from the SVC into the heart to determine the location of the fossa, as shown in FIG. 2DAs shown, to perform the steps of positioning assembly 100. In one such example, having a stiffening member 34 (within dilator 30A) separate from and operable independently of the flexible RF wire provides an additional advantage: allowing a repeat of the pull-down if the ostium was missed on the first pass. More specifically, it eliminates the need for re-wiring, in other words, re-inserting the access wire, removing the access wire, and then re-advancing a stiff puncture device such as a needle into the SVC in order to repeat the pull-down. More specifically, in embodiments of the present application, dilator 30A (and thus stiffening member 34) can be partially removed or retracted with sheath 20, and flexible RF wire 10 can be re-advanced into the SVC. Sheath 20 and dilator 30 can then be re-advanced over flexible RF wire 10, as shown in FIG. 2C and the pull-down can be repeated to engage the RF wire 10 with the ostium. This can help reduce procedure time and improve safety, as an additional exchange is not needed. Adding an additional exchange can add more time and increase unnecessary risk. Thus, with the current embodiments of energy delivery component and stiff component separation, procedure time and risk can be reduced.

[0196] Stiffening member 34 [within dilator 30A] provides an additional advantage: providing sufficient rigidity to assembly 100 to facilitate the pull-down of step 208. Thus, stiffening member 34 is able to achieve sufficient force transmission and moment to allow assembly 100 to engage the septum, as illustrated in FIG. 2D The method further includes, at step 212, tensioning with dilator 30A, with reference to FIG. 2D Stiffening member 34 provides sufficient rigidity to assembly 100 to enable force to be applied to the distal end of assembly 100, enabling tensioning with dilator 30A. In some examples, having stiffening member 34 within dilator 30A such that it is removed and reshaped to allow for optimized positioning against the ostium. In some such embodiments, prior to the tensioning step, at step 210, the physician can assess whether the angle of dilator 30A and / or assembly 100 is sufficient. If the angle is not deemed sufficient, at step 211, the physician can pull out dilator 30A and reshape the curve. Dilator can then be re-inserted as shown in step 213. The process can then be repeated starting at step 210, and the pull-down can be performed again using assembly 100. Once the location of the ostium is determined, the physician can proceed to the step of tensioning with the dilator at step 212.

[0197] The method further includes the steps of, at step 214, advancing RF wire 10 to the puncture location, and at step 216 [4] puncturing and advancing RF wire 10, as shown in FIG. 2EThe RF wire 10 is advanced into the left side of the heart 500 so that the RF wire 10 can be anchored to the left side of the heart to maintain access into the left side of the heart. The flexible RF wire 10 can provide the additional advantage of allowing the operator to hard push without damage because the flexible RF wire is more flexible. The method further includes, at step 218, passing the sheath and dilator over the RF wire 10 as shown in FIG. 2F The flexible RF wire 10 can additionally protect the open end of the sheath 20 / dilator 30A from being hard pushed into tissue. At step 218, the sheath 20 and dilator 30A [including the stiffening member 34] can then be removed.

[0198] As outlined herein, the energy delivery member is provided as a flexible RF wire 10 that is separate from a rigid member such as the stiffening member 34 [provided within the dilator 30A], where the stiffening member 34 [with the dilator 30A] can be separated or removed from the flexible RF wire 10. This provides the additional advantage that the stiffening member 34 [within the dilator 30A] can be removed after the atrioventricular septum puncture and access, thereby providing a step [6] that allows the flexible RF wire 10 to remain positioned within the left atrium, which allows the flexible RF wire to immediately anchor within the left atrium as shown in FIG. 2G In one such example, the RF wire can be positioned within the left superior pulmonary vein for anchoring. This can enable the RF wire to maintain access into the left atrium, allowing the stiffening member 34 [with the dilator 30A] to be removed to facilitate device exchange into the left atrium using the flexible RF wire. This can additionally reduce left side exchanges because it can eliminate the need for the physician to advance another wire after puncture to maintain access to the left side for other devices to be looped into the left side. In addition to reducing procedure time and the number of steps required, the other benefit of minimizing left side exchanges is minimizing the risk of infection, embolization, and stroke. In another example, the RF wire 10 can have a pigtail bend at the distal end. This can enable the RF wire 10 to anchor in the left atrium rather than in the pulmonary vein. Alternatively, the RF wire 10 can be used to anchor in the pulmonary vein. In some such examples, the former approach of anchoring in the left atrium can provide other advantages not found in the latter approach.

[0199] Example 1 [Stiffening Dilator]

[0200] In summary, in some embodiments of the present application, a method for puncturing tissue is disclosed, the method comprising the steps of: advancing a flexible puncture device 112 into a tissue region; advancing a sheath 20 and support member 130 over the flexible puncture device 112 into the tissue region; withdrawing the flexible puncture device into the support member 130; positioning the assembly 100 at a target tissue site in the tissue region; tensioning with the support member 130; advancing the flexible puncture device 112 to a puncture location; puncturing and advancing the flexible puncture device 112; and passing the sheath 20 and dilator 30A over the flexible puncture device.

[0201] In some such examples, as described above, the method for puncturing tissue comprises a method for performing an atrioventricular septal puncture, wherein the tissue region comprises the superior vena cava. In some examples, the flexible puncture device comprises an RF guide wire 10, and the support member comprises a reinforcing dilator 30A.

[0202] Some such embodiments of the present application comprise a method for performing an atrioventricular septal puncture, comprising the steps of: advancing an RF guide wire into the superior vena cava; advancing a sheath and dilator over the RF guide wire into the superior vena cava; withdrawing the RF guide wire into the dilator; pulling down from the superior vena cava into the heart to find the fossa; tensioning with the dilator; advancing the RF guide wire to a puncture location; puncturing and advancing the RF guide wire using the RF guide wire; and passing the sheath and dilator over the RF wire.

[0203] Example 2

[0204] In another example, an embodiment of the present application provides an assembly 300 as shown in FIG. 3A for puncturing tissue, such as creating an atrioventricular septal puncture through a septum of a heart. Similar to the embodiments described above, the assembly 300 provides a puncture device, such as a substantially flexible energy delivery puncture device 114, for puncturing tissue by energy delivery, such as a flexible RF guide wire 10 and a support member for supporting the substantially flexible energy delivery puncture device, such as a separate reinforcing member 34. In some such examples, the support member comprises a 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 within the support member 130 for selective use therewith during a portion of a procedure, and wherein the substantially flexible energy delivery puncture device 114, such as an RF guide wire 10, is usable independently thereof during other portions of the procedure, in order to facilitate exchange and positioning while providing substantially atraumatic tissue puncture.

[0205] Device

[0206] In one such example, as FIG. 3AAs illustrated in FIG. 30, assembly 300 includes a flexible energy delivery component 114 that can be provided separately from and operable independent of a support member. In one such example, the flexible energy delivery component includes RF wire 10 and the separate support member 130 includes stylet 60 defining stiffening member 34. In other words, as provided below, support member 130 is a stiffening member 34 provided as stylet 60 that can be used independent of puncture device 110, such as flexible puncture device 112. In yet other words, support member 130 is defined by stiffening member 34, where in one example, stiffening member 34 includes stylet 60. Assembly 300 also includes sheath 20 and dilator 30B, which can be used with flexible RF wire 10. In the particular example shown, stiffening member 64 is also provided separately from and removable from dilator 30B, which in this embodiment is provided as a flexible dilator.

[0207] Some such embodiments include dilator 30B that can be used with support member 130 to form support member assembly 134 for selective use during a portion of a procedure, as shown in FIG. 31. FIG. 3B As described above, in some such embodiments, support member 130 includes stylet 60 defining stiffening member 34. In some examples, dilator 30B is provided for selective use with stylet 60 to form stylet assembly 164, as shown in FIG. 32. FIG. 3C

[0208] In some such embodiments, puncture device 110 includes a substantially flexible energy-based puncture device 114. In the particular case of this example, substantially flexible energy-based puncture device 114 includes flexible RF guidewire or wire 10. In some embodiments, RF guidewire 10 can be selectively used in cooperation with stylet 60 (e.g., by being selectively coupled to the stylet) during a portion of a procedure, and RF guidewire 10 can be used independent of stylet 60 during other portions of a procedure. In the selective use of RF guidewire 10 in conjunction with and without stylet 60, tissue puncture is facilitated.

[0209] Shaping capability of support member / stiffening member

[0210] ​In some such embodiments of the application in which the support member 130 is provided separately from the dilator 30B, the assembly 300 provides a support member 130 that is shapeable to enable it to be removed from the puncture device 110 (such as a flexible tissue puncture device 112, e.g., a substantially flexible energy-based tissue puncture device 114) to enable reshaping of the curvature of the support member 130 for reinsertion thereof. For example, the reshaped support member 130 can be reinserted and / or used with the substantially flexible energy-based tissue puncture device 114 and / or one or more other components of the assembly 300, such as the dilator 30B and / or the sheath 20, in order to optimize positioning of the assembly 300 against the target tissue site to facilitate puncture (such as a fossa ovalis to facilitate atrioventricular septum puncture).

[0211] In particular examples, the stylet 60 is shapeable to enable the stylet 60 to be removed from the substantially flexible puncture device to enable reshaping of the curvature of the stylet 60 for reinsertion thereof in order to optimize positioning of the assembly against the target tissue site. In some such examples, the stylet 60 can be removed from one or more components or members of the assembly 300 to be reshaped for reinsertion thereof to position the assembly 300 at the target tissue site.

[0212] Details of the stylet 60 defining the stiffening member 34 when used with the dilator 30B and the flexible RF wire 10 are illustrated in FIG. 3B and FIG. 3C More particularly, FIG. 3B and FIG. 3C A dilator 30B is illustrated, which in some examples is a flexible dilator, such as a standard atrioventricular septum dilator, in which no stiffening member is embedded or in other words which is provided separately from the dilator 30B, the dilator 30B comprising a proximal portion 31 terminating at a distal tip 41. In some embodiments, the dilator 30B can also comprise a radiopaque marker 42 at the distal tip 41. Similar to the embodiments disclosed above, the dilator 30B comprises a dilator shaft 32 extending along the proximal portion 31. However, unlike the embodiments discussed above, the assembly 300 provides a stiffening member or component 34 defined by the stylet 60, which is provided separately from the dilator 30B and functions as a removable stiffening member that can be removed from the dilator 30B. Thus, the stiffening member 34 is provided separately from the flexible RF wire 10 and the dilator 30B and is removable from the flexible RF wire and the dilator. FIG. 3B The assembly 300 is shown in a pulled down position, while FIG. 3C The assembly 300 is shown in a position for use in breaking through to effect atrioventricular septum puncture.

[0213] atraumatic stylet

[0214] In some embodiments, the stylet 60 is configured as a substantially atraumatic stylet 68, such as shown in FIG. 5F In some such examples, the atraumatic stylet 68 includes a tapered distal tip 69 for preventing and / or helping to minimize scraping and to provide a smoother feel for the user during insertion of the dilator.

[0215] In some embodiments, in addition to or instead of configuring the tapered distal tip 69, the stylet 60 is configured as a substantially atraumatic stylet by configuring a lubricious coating 67 on the stylet 60 in order to prevent and / or help to minimize scraping and to provide a smoother feel for the user during insertion of the dilator.

[0216] In some such examples, the lubricious coating 67 includes a PTFE coating. The PTFE coating can be sprayed on the stylet 60 or can be configured as a heat shield.

[0217] Alignment using radiopaque markers

[0218] In some embodiments of the present application, similar to the embodiments previously discussed with respect to assembly 100, the assembly 300 includes a substantially flexible energy-based puncturing device 114 (such as RF guidewire 10) including one or more device radiopaque markers 12 located at a distal end thereof. Additionally, the support member assembly includes one or more support assembly radiopaque markers 42 located at a distal end of the support member assembly 134 (e.g., including a separate reinforcing member 34 such as a stylet 60 and a puncturing device 110 such as a substantially flexible energy-based puncturing device 114). In one such example, the support assembly radiopaque markers 42 are configured on the dilator 30B of the support member assembly 134. In some such examples, the one or more device radiopaque markers 12 are configured to cooperate with the support assembly radiopaque markers 42 to indicate a relative position of the substantially flexible energy-based puncturing device 114.

[0219] In some such embodiments, the assembly 300 includes an initial configuration 100A in which the substantially flexible energy-based puncturing device 114 (such as RF guidewire 10) can be positioned within the support member assembly 134 such that the one or more device radiopaque markers 12 are not aligned with the support assembly radiopaque markers 42, as shown in FIG. 3A In some such examples, the plurality of radiopaque markers are visible under imaging, including the one or more device radiopaque markers 12 and the support member radiopaque markers 42.

[0220] Component 300 also has a first configuration 100B in which a substantially flexible energy-based puncture device 114 can be positioned within the support member assembly 134 such that one or more device-transparent markers 12 are aligned with support member-transparent markers 42. In some such instances, individual transmissive markers may be visible under imaging [including one or more device-transmissive markers 12 and support member-transmissive markers 42, which may be arranged very close to each other].

[0221] Component 300 also has a second configuration 100B in which a substantially flexible energy-based puncture device 114 (such as RF guidewire 10) can be positioned / advanced within the support member assembly 134 such that one or more transmissive markers 12 of the device are misaligned / not aligned with transmissive markers 42 of the support assembly. In some such instances, the misalignment of one or more transmissive markers 12 of the device with transmissive markers 42 of the support assembly indicates that the energy delivery portion 114 of the flexible energy-based puncture device 114 (such as the distal electrode tip 10d, or also referred to as the distal electrode tip 10d) is positioned beyond the support member assembly 134 (e.g., as far as the distal tip or end of the support member 130) against the target tissue site for puncture.

[0222] Now for reference FIG. 3A Similar to FIG. 3A In the embodiments shown and previously discussed, multiple radiopaque markers may be visible under imaging, including one or more device radiopaque markers 12 and support member radiopaque markers 42, wherein one or more device radiopaque markers 12 are positioned distal to support member radiopaque markers 42, indicating that the distal electrode tip 10d is positioned against the target tissue site (such as the diaphragm of the heart) for tissue puncture.

[0223] In some embodiments of the present application, one or more members or components in assembly 300 can be radiopaque to facilitate visualization of assembly 300. In one such example, sheath 20 and / or dilator 30B comprise a radiopaque polymer and stylet 60 (e.g., comprising a metal shaft) is radiopaque. Thus, in some examples, stylet 60, sheath 20 and / or dilator 30B are all radiopaque and thus have radiopaque properties. In a specific example, the polymer forming sheath 20 and / or dilator 30B comprises a radiopaque filler, such as 20% barium sulfate, to provide contrast with one or more markers 12, 42 at the distal tip so as to allow the user to see sheath 20 and / or dilator 30B as compared to RF guidewire 10. Thus, the present configuration can enhance visualization and can allow the user to determine when RF guidewire 10 (more specifically the electrode distal tip 10d of the RF guidewire) is positioned inside or whether it extends beyond or past the distal tip of dilator 30B.

[0224] In some embodiments of the atrioventricular septum assembly 300, sheath 20 comprises a standard atrioventricular septum sheath, dilator 30B comprises a standard flexible dilator, and flexible RF wire 10 is provided as a 0.035" wire. In some such examples, flexible RF wire 10 can be a J-tip wire or a pigtail wire. In one specific example, dilator 30 comprises HDPE. Dilator 30 defines an inner diameter sufficient to accommodate stylet 60. In one example, stylet 60, which defines stiffening member 34, comprises a hypotube, such as a metal hypotube. In a specific example, stylet 60 comprises a metal hypotube, which comprises a stainless steel hypotube. In one such example, the stainless steel hypotube has an ID greater than about 0.035".

[0225] In some examples, the steerable sheath 20 can be an 8 French (Fr) steerable sheath. Alternatively, an 8.5 Fr steerable sheath 20 can be provided. In some such examples, the steerable sheath 20 can be provided with different curvatures. In particular examples, the steerable sheath 20 can be provided with different curvatures, specifically at angles of 37 degrees, 45 degrees, 55 degrees, 90 degrees, or 135 degrees. In particular cases of this example, the sheath tube includes an inner PTFE liner, a braid, and a Pebax outer jacket. In some such implementations, an 8 French (Fr) dilator 30B is provided, which is compatible with the 8 French (Fr) sheath. Alternatively, an 8.5 (Fr) dilator 30B can be provided, which is compatible with the 8 French (Fr) steerable sheath 20. Some such dilators can be provided with a 64 degree curvature and an HDPE shaft. The stylet 60 can be provided as a metal hypotube. In one such example, the stylet 60 can have an ID greater than about 0.038" and an OD less than about 0.060". The dilator 30A can be provided with a 50 degree or 86 degree curvature. In some examples, the material can include HDPE and a metal hypotube forming the stiffening member 34. In some such examples, the RF wire 10 includes a 0.035" OD wire and can be a J-tip wire or a pigtail wire. In particular cases of this example, the RF wire 10 can include a stainless steel core with a PTFE coating.

[0226] Method

[0227] Method [Example 2 - removable stylet]

[0228] Same device used for initial loop / entry and positioning

[0229] In some implementations of the present application, and referring now to FIG. 4A-FIG. 4G , a method for puncturing tissue is disclosed. The method includes the following steps: [1] entering a tissue region in a patient by advancing a device (such as the puncture device 110, such as the RF guide wire 10) into the tissue region, as shown in FIG. 4B . In some such examples, the method of puncturing a tissue region includes a method of performing an interatrial septum puncture, wherein the step of entering a tissue region includes advancing a device (such as the puncture device 110) into the superior vena cava (SVC) 501 adjacent to the heart 500 of the patient, as shown in FIG. 4B .

[0230] In some implementations of the present application, the method for puncturing tissue further includes the following step: [4] positioning the device at a target tissue site in the tissue region, as shown in FIG. 4D , by, for example: [3] first looping the support member 130 on the puncture device 110 to support the device (such as the puncture device 110), as shown in FIG. 4CAs shown in [4], the device (such as puncture device 110) is advanced toward the target tissue site to position the device at the target tissue site for puncture, as FIG. 4D As shown in the image.

[0231] In some such instances, the step of positioning the puncture device 110 at the target tissue site includes performing [4] a pull-down from the superior vena cava (SVC) into the patient's heart 500 to locate the fossa ovalis (or fossa) 504 along the diaphragm 502 of the heart 500, firstly by means of a support member 130 (such as a pedicle needle) that first, for example (3), travels or advances along the device (such as the puncture device 110) into the SVC to facilitate [4] the positioning of the fossa ovalis (or fossa) 504. FIG. 4D The pull-down process shown is used to position the puncture device 110 in the fossa. For example, this involves pulling the component 300 down from the superior vena cava into the heart to locate the fossa.

[0232] In some instances, the positioning step [4] is first performed, for example, by advancing a sheath 20 capped on a device (such as RF guidewire 10) and a dilator 30B into the superior vena cava, which may include inserting a pedicle needle 60 into the dilator 30B [e.g., until it reaches the stop] before tracing and advancing the support member 130, as FIG. 4C As shown in the figure. In some such instances, the positioning step [4] is performed after the step of withdrawing the RF guidewire into the core 60.

[0233] In some such instances, such as FIG. 4B-FIG. 4D As shown, FIG. 4B The entry steps shown [1] and as follows FIG. 4D The positioning step [4] shown is performed using the same device, such as the puncture device 110, which can be used without the support member 130 [including the mandrel 60] during the entry step [1], and which can be used with the support member 130 [including the mandrel 60] during the positioning step [4].

[0234] A puncture device is used for initial entry and positioning.

[0235] In some such embodiments of the invention, such as FIG. 4B-FIG. 4D As shown, the entry and positioning steps are performed using a puncture device 110 [such as RF guidewire 10].

[0236] The same device was used for initial entry, positioning, and puncture.

[0237] In some such embodiments of the invention, such as FIG. 4E As shown, the method further includes: in such FIG. 4DThe positioning step [4] shown is followed by a puncture step [5] using a device (such as puncture device 110) through the target tissue site. A support member 130 [including a core 60] supports the device (such as puncture device 110) during puncture [5], wherein the entry [1], positioning [4] and puncture [5] steps are performed using the same device.

[0238] In some embodiments of the invention, the puncture step through the target tissue site [5] includes a puncture step through the fossa 504 to obtain a passage to the left side of the heart 500 [5]. This allows one or more devices of the assembly 100, such as the support member 130 of the assembly 100 (such as the dilator 30A) and the sheath 20, to be guided along the RF guidewire 10 into the left side of the heart.

[0239] In some such embodiments, the puncture step [5] is performed by first advancing a device (such as RF guidewire 10) and then stretching it with the aid of a dilator 30B, such as FIG. 4D As shown, the RF guidewire 10 is advanced to the puncture position to puncture the septum 502 at the fossa 504.

[0240] Use a puncture device for initial entry, positioning, and puncture.

[0241] In some such instances, such as FIG. 2B-FIG. 2E As shown, the entry, positioning, and puncture steps are performed using the puncture device 110.

[0242] The same device was used for initial entry, positioning and penetration, as well as anchoring.

[0243] According to an embodiment of the present invention, the method further includes an anchoring step [6], such as FIG. 4E As shown, following the puncture step [5] through the target tissue site, an anchoring step is performed using a device (such as puncture device 110) to maintain access to the other side of the target tissue site through the target tissue site, allowing one or more other devices [such as sheath 20 and dilator 30B] to advance or follow along on the device (such as puncture device 110, e.g., RF guidewire 10) to allow sheath 20 and dilator 30B to pass through the other side of the target tissue site, e.g., into the left side of the heart, as shown. FIG. 4F As shown, the steps of entry [1], positioning [4], puncture, and anchoring [5] are performed using the same device. The RF guidewire 10 can be left in place to maintain access to the left side of the heart, as... FIG. 4G As shown. The RF guidewire 10 functions as a guide rail to guide one or more devices to the left side of the heart. In some such instances, the RF guidewire 10 is configured with a substantially rigid guide rail to guide one or more devices to the left side of the heart while being substantially non-invasive to minimize damage to tissues.

[0244] In some such embodiments of the invention, the step of anchoring to maintain the passage 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 the passage into the left side of the heart.

[0245] In some such instances, the step of anchoring further includes removing the stylet 60 while the RF guidewire 10 is left in place to maintain the passage into the left side of the heart. The sheath 20 and / or the dilator 30B can also be removed in addition.

[0246] In some such embodiments, the steps of accessing, positioning, puncturing, and anchoring are substantially performed using a wire, such as the RF guidewire and the removable stylet 60.

[0247] Use of a puncture device for initial access, positioning, and puncturing

[0248] In some such embodiments of the invention, the steps of accessing, positioning, puncturing, and anchoring are performed using a puncture device, such as a wire including the RF guidewire 10, and a removable stylet 60.

[0249] Alternatives to the device used for initial access, positioning, and / or puncturing - dependent claims based on independent claims on which these depend

[0250] In some such embodiments of the invention, the device includes a flexible puncture device 112, wherein one or more of the steps of accessing, positioning, puncturing, and anchoring are performed using the flexible puncture device 112. In some such instances, each of the steps of accessing, positioning, puncturing, and anchoring are substantially performed using the flexible puncture device 112.

[0251] In some such embodiments of the invention, the device includes a substantially flexible guidewire, such as the mechanical guidewire 118 or the RF guidewire 10, wherein one or more of the steps of accessing, positioning, puncturing, and anchoring are performed using the substantially flexible guidewire, such as the mechanical guidewire 118 or the RF guidewire 10. In some such instances, each of the steps of accessing, positioning, puncturing, and anchoring are substantially performed using the substantially flexible guidewire, such as the mechanical guidewire 118 or the RF guidewire 10.

[0252] In some such embodiments of the invention, the device includes a flexible energy-based puncture device 114, wherein one or more of the steps of accessing, positioning, puncturing, and anchoring are performed using the flexible energy-based puncture device 114. In some such instances, each of the steps of accessing, positioning, puncturing, and anchoring are substantially performed using the flexible energy-based puncture device 114 substantially.

[0253] In some such embodiments of the invention, the device includes a flexible RF guidewire 10, and wherein one or more of the accessing, positioning, puncturing, and anchoring steps are performed using the flexible RF guidewire 10. In some such examples, each of the accessing, positioning, puncturing, and anchoring steps are substantially performed using the flexible RF guidewire 10.

[0254] In some such embodiments of the invention, wherein the device includes a flexible mechanical guidewire 118 having a relatively sharp distal tip 118d, wherein one or more of the accessing, positioning, puncturing, and anchoring steps are performed using the flexible mechanical guidewire 118. In some such examples, each of the accessing, positioning, puncturing, and anchoring steps are substantially performed using the flexible mechanical guidewire 118.

[0255] Repeating the accessing step and the positioning step

[0256] In some such embodiments of the invention, the method further includes repeating the accessing step [1] as shown in FIG. 4B and the positioning step [4] as shown in FIG. 4D until the device (such as the puncture device 110) is positioned at the desired target tissue site prior to the puncturing step [5] as shown in FIG. 4E .

[0257] Reshaping the support member

[0258] In some such examples, repeating the positioning step [4] as shown in FIG. 4D also includes reshaping the curvature of the support member 130 [stylet 60] after removing the support member 130 [stylet 60], and re-routing the support member 130 [stylet 60] over the device [3] as shown in FIG. 4C (such as the puncture device 110 that has been repositioned [1] within the SVC as shown in FIG. 4B prior to repeating the positioning step as shown in FIG. 4D which in the example shown includes a pull-down procedure for finding the niche 504. In a particular example, the support member 130 includes a stylet 60, wherein the positioning step is performed using the stylet 60.

[0259] In some such embodiments of the invention, the method includes reshaping the support member 130 (by pulling the stylet 60 out and allowing it to reshape).

[0260] The support member includes a stylet

[0261] In some embodiments, as with FIG. 4A-FIG. 4EAs discussed, the reshaping step can be performed using a support member 130 that includes a stylet 60, where the stylet 60 is the reinforcing member 34, and the positioning step is performed using the stylet 60.

[0262] In some such instances, the stylet element 60 can be taken out and reshaped. In other instances, the stylet element 60 along with the sheath 20 and / or dilator 30B can be pulled out and reshaped to see what the effective shape can be, and then can be reinserted therein.

[0263] The methods outlined herein above can also be used in the embodiments discussed further below, which have a removable stylet 60, as shown in FIG. 6A-FIG. 6H .

[0264] Similar to the embodiments described above, an overall method / workflow is provided that illustrates a method of performing an atrioventricular septal puncture using assembly 300, as described above. The methods disclosed herein provide one or more advantages associated with the assembly, which includes an energy delivery component that is disposed separately from a rigidity component. Details of the method are provided below.

[0265] As a general overview, in one broad embodiment, as shown in FIG. 4A-FIG. 4G , a method for performing an atrioventricular septal 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 until it reaches a stop; (iv) withdrawing the RF guide wire into the stylet; (v) pulling down from the SVC into the heart to find the fossa; (vi) tenting with the dilator; (vii) advancing the RF wire to the puncture location; (viii) puncturing and advancing the RF wire; and (ix) passing a sheath and dilator over the RF wire; and (x) removing the stylet.

[0266] More specifically, referring again to FIG. 4A , a method of performing an atrioventricular septal puncture procedure using assembly 100, which includes a flexible RF wire 10 or RF guide wire 10, a sheath 20, a standard atrioventricular septal dilator 30B, and a stylet 60, is provided, the method comprising the following steps: at step 402, [1] advancing the RF wire into the superior vena cava (SVC) to get an entry channel, as shown in FIG. 4BAs previously noted, in some such embodiments, the energy delivery component (flexible RF wire 10) is provided separately from the stiffening member 34 such that the energy delivery component functions as an access wire or launch wire. More specifically, the stylet 60 defining the stiffening member 34 can be advanced later, such that the flexible RF wire 10 provides a pathway into the SVC without the need for an additional access wire. This can help reduce the number of steps and simplify the procedure, and thus can reduce the procedure time and complexity.

[0267] The method further includes the step of: [2] at step 404, the sheath 20 and the flexible dilator 30B are advanced together over the flexible RF wire into the SVC. Thus, in this embodiment, the flexible RF wire 10 also functions as an access wire, and enables the sheath 20 and dilator 30B (e.g., as an assembly) to be routed over the flexible RF wire 10 into the SVC, as shown in FIG. 4C Additionally, in one such example, a standard interatrial septum dilator 30B can be provided without an embedded stiffening member. This can help allow the initial routing of the sheath 20 and dilator 30B to provide the physician with a similar feel to a standard interatrial septum.

[0268] The method further provides the additional steps of: at step 406, [3] the stylet 60 is inserted until a stop within the dilator 30B is reached. At step 408, the RF wire is withdrawn into the dilator 30B, and at step 410, the steps of positioning the assembly 300 are provided by [4] performing a pull-down from the SVC into the heart to determine the location of the fossa, as shown in FIG. 4D to position the assembly 300 along the septum 502 of the heart 500 at a target tissue site, such as the fossa 504. The stiffening member 34 [defined by the stylet 60] provides sufficient rigidity to the assembly 100 to facilitate the pull-down. Thus, the stiffening member 34 enables sufficient force transmission and moment to allow the assembly 100 to engage the septum 502, as illustrated in FIG. 4D

[0269] In one such example, the stiffening member 34 (defined by the stylet 60), which is separate from and can be operated independently of the flexible RF wire 10, can additionally assist with repeatability if it is necessary to repeat one or more steps in the procedure. If the initial placement of the flexible RF wire 10 against the septum 502 is inadequate after the pull-down, the sheath 20 and dilator 30B together with the stylet 60 [and thus the stiffening member 34] can be partially removed or partially withdrawn and the flexible RF wire 10 can be repositioned within the superior vena cava (SVC). The sheath 20, dilator 30B, and stylet 60 [and thus the stiffening member 34] can be advanced over the RF wire 10 to provide sufficient force transmission and moment to reposition the RF wire 10 against the septum in a pull-down, as illustrated in​FIG. 4D As shown, the fovea 504 is positioned prior to RF delivery, for example, during the step of positioning component 300 at a target tissue site such as fovea 504. Therefore, reinforcing component 34 and RF wire 10 by reducing the need for reinsertion of the exchange wire can help minimize device exchange. This can help reduce surgical time and enhance safety by eliminating exchange. Thus, the current implementation, utilizing the separation of the energy delivery component and the rigid component, can reduce surgical time and risk.

[0270] Furthermore, in the embodiments described herein, a removable reinforcing member is provided, wherein the needle 60 and therefore the reinforcing member 34 can be removed and detached from the dilator 30B. The removable rigid element provided by the removable needle 60 allows the needle to be given different curvatures. A variable system is provided, wherein the position of the needle 60 within the dilator 30B can be adjusted to utilize a more preferred position for positioning against the dilator 30B abutment socket 504. Additionally, the needle 60 can be reshaped, allowing and being pulled out and manually reshaped. In some such embodiments, after the pull-down is performed in step 410, the physician can assess whether the angle of the needle 60 and / or component 300 is sufficient in step 412 before dilation. If the angle is not considered sufficient, the physician can pull out the needle 60 and reshape the curvature in step 422. This process can then be repeated from step 406 to step 412.

[0271] If the angle is deemed sufficient, in step 412, the method further includes: in step 414, stretching using expander 30B, referencing FIG. 4D The reinforcing member 34 provides sufficient stiffness to the assembly 100 so that forces can be applied to the distal end of the assembly 100, thereby enabling tension by means of the expander 30B. The method further includes the following steps: in step 416, advancing the RF wire 10 to the puncture position, and in step 416[5] puncturing and advancing the RF wire 10, as FIG. 4E As shown, the step of anchoring with the RF wire 10 is set up so that the RF wire 10 is punctured through the septum 502 at the fossa 504 to enter the left side of the heart. In some such instances, the RF wire 10 acts as an anchor to maintain the channel into the left side of the heart after puncture. A flexible RF wire 10 can provide an additional advantage: it allows the operator to push hard without damage because the flexible RF wire 10 is more flexible. The method also includes: in step 420, [6] in which the sheath 10 capped over the RF wire 10 and the dilator 30B with the endocardial needle 60 are passed through, as FIG. 4FThe flexible RF wire 10 can otherwise protect the open end of the sheath 20 / dilator 30B from being pushed hard into the tissue. At step 422, the sheath 20 and dilator 30 can then be removed [as well as the strengthening member 34 defined thereby by the removal of the stylet 60].

[0272] As outlined herein, the energy delivery component is provided as a flexible RF wire 10 that is separate from a rigid component such as the strengthening member 34 [as provided by the stylet 60], wherein the stylet 60 can be separated from and removed from the flexible RF wire 10. This provides an additional advantage in that the strengthening member 34 [defined by the stylet 60] can be removed after the atrioventricular septal puncture and access is provided, setting a step [7] in which the flexible RF wire 10 remains positioned within the left atrium, which allows the flexible RF wire 10 to immediately anchor within the left atrium, for example as FIG. 4G In one such example, the RF wire 10 can be positioned within the left superior pulmonary vein for anchoring. This can enable the RF wire 10 to maintain access to the left atrium, allowing the stylet 60 [and thus the strengthening member 34] to be removed to facilitate the exchange of a device into the left atrium using the flexible RF wire 10. This can additionally reduce the left side exchange as it can eliminate the need for the physician to advance another wire to maintain access to the left side to loop other devices into the left side after puncture. As noted above, in addition to reducing the procedure time and the number of steps required, the present embodiment also provides the additional benefit of minimizing the risk of infection, embolism, and stroke by minimizing the left side exchange.

[0273] Summary of Embodiment 2

[0274] Stylet and separate RF wire

[0275] Thus, in summary, in embodiments of the present invention, there is provided a method for performing an atrioventricular septal puncture, the method comprising: advancing an RF guide wire into the superior vena cava; advancing a sheath and dilator over the RF guide wire into the superior vena cava; inserting a stylet into the dilator until it reaches a stop; withdrawing the RF guide wire into the stylet; pulling down from the superior vena cava into the heart to find the fossa; dilating with the dilator; advancing the RF wire to the puncture location; puncturing and advancing the RF wire; passing the sheath and dilator over the RF wire; and removing the stylet.

[0276] Embodiment 3

[0277] In another example, embodiments of the present invention provide an assembly 302 for creating an atrioventricular septal puncture through a septum of a heart. Similar to the embodiments described above, the assembly 302 provides a flexible RF wire and a separate strengthening member.

[0278] Device

[0279] In one such example, as exemplified in FIG. 5A Assembly 302 is similar to assembly 300 previously described and includes a flexible energy delivery component that is disposed separately from and operable independently of the support member. In some embodiments, assembly 302 is provided as an example of assembly 300. Assembly 302 includes RF wire 10, stylet 60 defining stiffening member 34, sheath 10, and standard atrioseptal dilator 30B, the details of which are described above. In the particular example shown, stiffening member 34 is also disposed separately from and removable from dilator 30B as well as flexible RF wire 10.

[0280] In some embodiments of the present application, and with reference now to FIG. 5A and FIG. 5B Assembly 302 also includes a locking feature 75 to allow a flexible energy-based puncture device 114, such as RF guide wire 10, to be coupled to a stiffening member 34, such as stylet 60, to form a needle assembly 136 so that the flexible energy-based puncture device 114, such as RF guide wire 10, can be selectively used with the stiffening member 34 to provide the feel of a needle while being able to use the RF guide wire.

[0281] In a particular example, locking feature 75 of assembly 302 enables RF guide wire 10 to be coupled to stylet 60 so that RF guide wire 10 is selectively used with stylet 60 to provide the feel of a needle while being able to use RF guide wire 10.

[0282] In some such examples, locking feature 75 can enable the wire, such as RF guide wire 10, and stylet 60 to be axially locked so that the wire and stylet 60 can be moved back and forth together. In further embodiments, locking feature 75 can additionally provide rotational locking.

[0283] The embodiments presented herein provide a means of locking a flexible RF wire 10 and a stiffening member 34 that enables the combination to provide the feel of a stiff RF needle while being able to use RF wire 10. The combination provides the advantages of the separate energy delivery system provided above in which a flexible energy delivery component, such as RF wire 10, is disposed separately from a support member 130, such as stiffening member 34. More particularly, in one example, as exemplified in FIG. 5BAs shown in the middle, the stylet 60 includes a locking handle 71 that is operable to couple to the flexible RF wire 10 along its proximal portion for a portion of the procedure. The locking handle 71 includes a locking arm 73 that can be spring biased to allow the locking arm to engage the RF wire 10 and lock it into place to the stylet 60 defining a locking feature 75. In some examples, the stylet 60 and / or the RF wire 10 further include a marker band 62 to facilitate the relative positioning of the stylet 60 / RF wire 10 prior to locking. Thus, the stylet handle 71 is locked onto the flexible RF wire 10 for alignment.

[0284] FIG. 5C 、 FIG. 5D and FIG. 5E Details of the assembly 302 used according to various steps of the procedure are illustrated. More specifically, FIG. 5C A flexible RF wire 10 positioned within a stylet 60 is illustrated, which in one example is configured to be assembled and locked outside the patient. In another example, the stylet 60 and RF wire 10 can be locked once positioned within the patient. FIG. 5D The coupled RF wire 10 and stylet 60 assembly is illustrated in a pulled down position, referred to as the two-finger position, positioned within a dilator 30B. FIG. 5E The stylet 20, RF wire 10 assembly is illustrated positioned within a dilator 30B in a punch through position.

[0285] In some examples, as described above, the steerable sheath 20 can be an 8 Fr steerable sheath. Alternatively, an 8.5 Fr steerable sheath 20 can be provided. In some such examples, the steerable sheath 20 can be provided with different curvatures. In particular examples, the steerable sheath 20 can be provided with different curvatures, specifically at angles of 37 degrees, 45 degrees, 55 degrees, 90 degrees, or 135 degrees. In particular cases of this example, the sheath tube includes an inner PTFE liner, braid, and Pebax outer jacket. In some such implementations, an 8 Fr dilator 30B is provided that is compatible with the 8 Fr sheath. Alternatively, an 8.5 Fr dilator 30B can be provided that is compatible with the 8 Fr steerable sheath 20. Some such dilators can be provided with a 64 degree curvature and an HDPE shaft. The stylet 60 can be provided as a metal hypotube. In one such sub-example, the stylet 60 can have an ID greater than about 0.038” and an OD less than about 0.060”. The dilator 30B can be provided with a 50 degree or 86 degree curvature. In some examples, the materials can include HDPE and a metal hypotube forming the reinforcing member 34. In some such examples, the RF wire 10 includes a 0.035” OD wire and can be a J-tip wire or a pigtail wire. In particular cases of this example, the RF wire 10 wire can include a stainless steel core with a PTFE coating.

[0286] Method

[0287] Example 3 [Lockable stylet and RF guidewire]

[0288] The same device is used for initial loop or access and positioning

[0289] In some embodiments of the invention, referring now to FIG. 6A-FIG. 6H , a method for puncturing tissue is disclosed. The method includes the following steps: [1] accessing a tissue region in a patient, by advancing a device (such as J-wire 101) into the tissue region, as shown in FIG. 6B In some such examples, the method of puncturing a tissue region includes a method of performing an interatrial septum puncture, wherein the step of accessing a tissue region includes advancing a device (such as J-wire 101) into the superior vena cava (SVC) 501 adjacent to the heart 500 of a patient, as shown in FIG. 6B

[0290] In some embodiments of the invention, the method for puncturing tissue further includes the following step: [5] positioning a device at a target tissue site in the tissue region, as shown in FIG. 6D by, for example, first: [2] advancing a sheath 20 and dilator 30B over the wire (such as J-wire 101) into the superior vena cava, and [3] removing the J-wire; and [4] advancing or looping a support member 130 [including a stylet 60] within the dilator. More specifically, the step of advancing or looping the support member [4] includes the step of inserting a needle assembly into the dilator 30B (e.g. at a two-finger position) within the dilator 30B. The needle assembly includes a stylet 60 and a puncturing device 110 such as an RF guidewire 10. In some such examples, the needle assembly includes a locking feature to lock the RF guidewire 10 to the stylet 60.

[0291] The stylet 60 is used to support a device (such as a puncturing device 110), as shown in FIG. 6C to [5] advance the device (such as a puncturing device 110) toward the target tissue site so as to position the device at the target tissue site for puncturing, as shown in FIG. 6D

[0292] In some such examples, the step of positioning the puncturing device 110 at the target tissue site includes performing [5] a pull-down from the superior vena cava (SVC) into the heart 500 of a patient to locate the fossa ovalis (or fossa) 504 along the septum 502 of the heart 500. For example, this involves pulling down the assembly 300 from the superior vena cava into the heart to find the fossa.

[0293] ​​In some instances, the step of withdrawing the RF guidewire into the stylet 60 can not be required, as the RF guidewire 10 sits within the dilator 30B when the RF guidewire 10 and the stylet 60 are inserted within the dilator 30B in their locked position.

[0294] Using different or separate devices for accessing and positioning [Embodiment 3]

[0295] Thus, in some such embodiments, a J-shaped wire is provided and used for the step of accessing a tissue region within a patient; an RF wire 10 is provided and used for the step of positioning the device at a target tissue site in the tissue region (which is provided, for example, as a needle assembly having the RF wire 10 coupled to the stylet 60) by routing the support member (provided, for example, as the stylet 60) along with the device (provided as the RF wire 10) to support the device (such as the RF wire 10) to advance the device (such as the RF wire 10) toward the target tissue site to facilitate positioning the device at the target tissue site for puncturing. Thus, in some instances, the accessing and positioning steps are performed using different or separate devices (e.g., a J-shaped wire and an RF wire 10, respectively, where the accessing step is performed without a support member (such as the stylet 60), and where the device (such as the RF wire 10) can be used with a support member (such as the stylet 60) during the positioning step.

[0296] Using the same device for initial positioning and puncturing

[0297] In some such embodiments of the present application, as shown in FIG. 6E the method further comprises the step of puncturing through the target tissue site using the device (such as the puncturing device 110) after the positioning step [5], as shown in FIG. 6D the method further comprises the step of puncturing through the target tissue site using the device (such as the puncturing device 110) after the positioning step [5], as shown in

[0298] In some embodiments of the present application, the step of puncturing through the target tissue site [5] comprises the step of puncturing through the fossa 504 to gain access to the left side of the heart 500. In some such embodiments, the puncturing step [5] is performed by first expanding the dilator 30B, advancing the needle assembly to the puncturing position, and puncturing and advancing the needle assembly until a stop within the dilator 30B, as shown in FIG. 6E the RF guidewire 10 is advanced to the puncturing position to puncture the septum 502 at the fossa 504.

[0299] Using a puncturing device for positioning and puncturing

[0300] In some such instances, as shown in FIG. 6B-FIG. 6H the positioning and puncturing steps are performed using the puncturing device 110.

[0301] The same device is used for positioning and puncturing and anchoring

[0302] According to embodiments of the application, the method further comprises an anchoring step [6] as shown in FIG. 6F , wherein after the puncturing step [5] through the target tissue site, the anchoring step is performed using a device (such as the puncture device 110) to maintain a passageway through the target tissue site into the other side of the target tissue site to allow one or more other devices [such as the sheath 20 and dilator 30B] to be advanced or routed over the device (such as the puncture device 110, e.g., the RF guidewire 10) to facilitate allowing the sheath 20 and dilator 30B to pass through the other side of the target tissue site, e.g., into the left side of the heart, as shown in FIG. 6G , wherein the positioning, puncturing, and anchoring steps are performed using the same device.

[0303] In some such examples, the anchoring step as shown in FIG. 6F is performed by first maintaining the position of the assembly comprising the needle assembly and unlocking the RF guidewire from the stylet 60 and advancing the RF guidewire to anchor. The method further comprises passing the sheath 20 and dilator 30B over the RF guidewire 10 and removing the stylet 60, as shown in FIG. 6G .

[0304] In some such embodiments of the application, the step of anchoring to maintain a passageway of access through the target tissue site comprises advancing a device (such as the puncture device 110) through the fossa to the left side of the heart to maintain a passageway of access to the left side of the heart.

[0305] In some such examples, the anchoring step further comprises removing the stylet 60 to enable anchoring by allowing the RF guidewire 10 to remain positioned to maintain a passageway of access to the left side of the heart. The sheath 20 and / or dilator 30B can also be additionally removed. In some such embodiments, the accessing, positioning, puncturing, and anchoring steps are performed substantially using a wire, such as the RF guidewire, and a removable stylet 60. The puncture device 110 can be left to maintain a passageway of 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 to guide one or more devices to the left side of the heart while being substantially atraumatic to minimize damage to tissue.

[0306] The same device is used for positioning, puncturing, and anchoring

[0307] In some such embodiments of the application, the positioning, puncturing, and anchoring steps are performed using a puncture device of the needle assembly (such as a wire comprising the RF guidewire 10) and a removable stylet 60.

[0308] Alternatives for devices for positioning and / or puncturing and anchoring

[0309] In some such embodiments of the present invention, the device includes a flexible puncture device 112, wherein one or more of the positioning, puncturing, and anchoring steps are performed using the flexible puncture device 112. In some such examples, each of the positioning, puncturing, and anchoring steps is substantially performed using the flexible puncture device 112.

[0310] In some such embodiments of the present invention, the device includes a substantially flexible guidewire (such as the mechanical guidewire 118 or the RF guidewire 10), wherein one or more of the positioning, puncturing, and anchoring steps are performed using the substantially flexible guidewire (such as the mechanical guidewire 118 or the RF guidewire 10). In some such examples, each of the positioning, puncturing, and anchoring steps is substantially performed using the substantially flexible guidewire (such as the mechanical guidewire 118 or the RF guidewire 10).

[0311] In some such embodiments of the present invention, the device includes a flexible energy-based puncture device 114, wherein one or more of the positioning, puncturing, and anchoring steps are performed using the flexible energy-based puncture device 114. In some such examples, each of the positioning, puncturing, and anchoring steps is substantially performed using the substantially flexible energy-based puncture device 114.

[0312] In some such embodiments of the present invention, the device includes a flexible RF guidewire 10, and wherein one or more of the positioning, puncturing, and anchoring steps are performed using the flexible RF guidewire 10. In some such examples, each of the positioning, puncturing, and anchoring steps is substantially performed using the substantially flexible flexible RF guidewire 10.

[0313] In some such embodiments of the present invention, wherein the device includes a flexible mechanical guidewire 118 having a relatively sharp distal tip 118d, wherein one or more of the positioning, puncturing, and anchoring steps are performed using the flexible mechanical guidewire 118. In some such examples, each of the positioning, puncturing, and anchoring steps is substantially performed using the substantially flexible mechanical guidewire 118.

[0314] Repeating the accessing and positioning steps

[0315] In some such embodiments of the present invention, the method further includes repeating the accessing step [1] as shown in FIG. 6B and the positioning step [2] as shown in FIG. 6DThe positioning step [5] shown continues until the device (such as the puncture device 110) is positioned at the desired target tissue site prior to the puncture step [5], such as... FIG. 6E shown.

[0316] Remodeling support components

[0317] In some such instances, repeating as FIG. 6D The positioning step shown [4] also includes reshaping the curvature of the mandrel 60 and retracing its path on the device [4] as part of the needle assembly [the mandrel 60 is coupled to the puncture device], such as FIG. 6C As shown (such as, e.g.) FIG. 6B As shown, the puncture device 110, which has been repositioned within the SVC [1], is repeatedly subjected to... FIG. 4D Prior to the positioning step shown, in the illustrated example, it includes a pull-down process for locating the socket 504. In a particular example, the support member 130 includes a mandrel 60, wherein the positioning step is performed using the mandrel 60.

[0318] In some such embodiments of the invention, the method includes reshaping the support member 130 (by pulling out and reshaping the core needle 60), and, for example, by unlocking it from the needle assembly.

[0319] Support components include core pins

[0320] In some implementations, such as regarding FIG. 6A-FIG. 6E The discussed reshaping step can be performed, the mandrel 60 is the reinforcing member 34, and the positioning step is performed using the mandrel 60.

[0321] In some of these instances, the mandrel element 60 can be removed and reshaped. In other instances, the mandrel element 60, together with the sheath 20 and / or the expander 30B, can be pulled out and reshaped to see what the effective shape might be, and then reinserted.

[0322] Similar to the implementation method described above, FIG. 6A An overall method / workflow for performing an atrioventricular septal puncture using component 302 is illustrated as described above. The method disclosed herein provides one or more advantages associated with the component, which includes an energy delivery component provided separately from the rigid component. Details of the method are provided below.

[0323] General Overview

[0324] As a general overview, in a broad implementation, such as FIG. 6A-6HAs shown, a method for performing an atrioventricular septal puncture is provided, the method comprising: (i) advancing a J-wire into the superior vena cava, (ii) advancing a sheath and dilator over the wire into the superior vena cava; (iii) removing the J-wire; (iv) inserting a stylet / wire assembly into a two-finger position within the dilator; (v) pulling down from the SVC into the heart to find the fossa; (vi) dilating with the dilator; (vii) advancing the stylet / RF wire assembly to the puncture location; (viii) puncturing and advancing the stylet / RF wire assembly until a stop within the dilator; (ix) keeping the position and unlocking the RF wire; (x) advancing the wire to anchor; (xi) passing a sheath and dilator over the RF wire; and (xii) removing the stylet.

[0325] More specifically, referring again to FIG. 6A , a method for performing an atrioventricular septal puncture procedure using assembly 302, which includes flexible RF wire 10, sheath 20, standard atrioventricular septal dilator 30B, and stylet 60, is provided, the method comprising the following steps: at step 602, assembling and locking together stylet and RF wire 10 outside the patient; at step 604, [1] advancing a J-wire into the superior vena cava (SVC) to get access, as further illustrated in FIG. 6B . The method further comprises the following steps: at step 606, [2] advancing a sheath 20 and flexible dilator 30B combination over the J-wire into the SVC, as illustrated in FIG. 6C ; and at step 607, [3] removing the J-wire. Since a standard atrioventricular septal dilator 30B is provided without an embedded reinforcing member, the initial course of sheath 20 and dilator 30B can provide the physician with a similar feel to a standard atrioventricular septal procedure. The method further provides the following step: at step 608, [4] inserting stylet 60 / RF wire 10 assembly 302 into a two-finger position, as further illustrated in FIG. 6C . The method further comprises: at step 610, [5] performing a pull-down from the SVC into the heart 500 to locate the fossa, as illustrated in FIG. 6D . Stylet 60 defines reinforcing member 34 and provides sufficient rigidity to assembly 302 to facilitate the pull-down.

[0326] In some embodiments of the present disclosure, dilator 30B is provided as a standard atrioventricular septal dilator 30B. In other embodiments, dilator 30B can be softer or more flexible (or, in other words, less stiff) than a standard atrioventricular septal dilator 30B.

[0327] More specifically, reinforcing member 34 is capable of achieving sufficient force transmission and moment to engage septum with assembly 100, as further illustrated in FIG. 6D .

[0328] In one such example, similar to the previously discussed embodiments, having the stiffening member 34 (as defined by the stylet 60) separate from and independently operable from the flexible RF wire 10 can additionally contribute to the repeatability of aspects of the procedure if one or more steps in the procedure need to be repeated. If the initial placement of the flexible RF wire 10 against the septum after the pull-down is inadequate, the sheath 20 and dilator 30B and stylet 60 [after being separated from the RF wire] can be partially removed or partially retracted and the flexible RF wire 10 can be repositioned within the superior vena cava (SVC) and the pull-down procedure can be repeated after the sheath 20 / dilator 30B is re-advanced and the stylet 60 can be re-advanced over the RF wire 10 as described above.

[0329] Further, in the embodiments described herein, a removable stiffening member is provided, wherein the stylet 60 and thus the stiffening member 34 is removable and separable from the dilator 30B. Providing a removable rigid element by means of the removable stylet 60 can allow the stylet to impart different curvatures. A variable system is provided, wherein the position of the stylet 60 within the dilator 30B can be adjusted to utilize a more optimal position to be positioned against the fossa against the dilator 30B. As previously described, the stylet 60 can be remodelable, allowing and can be pulled out and manually remodeled. In some such embodiments, after the pull-down has been performed at step 610, the physician can evaluate at step 612 whether the angle of the stylet 60 and / or the assembly 300 is sufficient prior to tensioning. If the angle is not deemed sufficient, the physician can pull out the stylet 60 and remodel the curvature at step 613. The process can then be repeated from step 608 through step 612.

[0330] If the angle is deemed sufficient at step 612, the method further comprises tensioning by means of the dilator 30B at step 614. The stiffening member 34 provides sufficient rigidity to the assembly 100 to enable a force to be applied to the distal end of the assembly 100 to enable tensioning by means of the dilator 30B. The method further comprises the steps of advancing the RF wire 10 / stylet 60 assembly to the puncture location at step 616 and [6] puncturing and advancing the RF wire 10 / stylet 60 assembly until the stop within the dilator 30B as shown in FIG. 6E The flexible RF wire 10 can provide an additional advantage of allowing the operator to push hard without injury, as the flexible RF wire 10 is more flexible.

[0331] The method further comprises retaining the position and unlocking the RF wire 10 from the RF wire 10 / stylet 60 assembly and advancing the RF wire 10 to anchor at step 620 as shown in FIG. 6F Similar to embodiment 2, as described above, with respect to FIG. 4A-FIG. 4GIn Example 3, as outlined with respect to FIG. 6A-FIG. 6H The removable stiffener, the stylet 60, can facilitate simplifying the procedure. The energy delivery component is provided as a flexible RF wire 10, where the stylet 60 can be decoupled from and removable from the flexible RF wire 10. This provides additional advantages in that the RF wire 10 can be advanced independent of the rigid component, to the left side. The steps of positioning the RF wire 10 [7] and advancing to the left side can provide similar advantages as outlined above with respect to Example 2, including anchoring, enhanced safety, minimizing exchange to the left side, and facilitating routability of other devices. The method further includes the steps of: [8] passing the sheath 20 / dilator 30B [and stylet 60] through the left side 624 and removing or retracting the stylet at step 626. In some instances, the stylet 60 can be passed to the left side with the sheath 20 and dilator 30B. Alternatively, the stylet 60 can be left on the right side of the heart while facilitating passage of the sheath 20 / dilator 30B to the left side of the heart. This can provide additional advantages such as providing atraumatic passage during passage while maintaining access to the left side, which is not found in methods where the stylet 60 can be passed to the left side.

[0332] Thus, in some embodiments, the removable stiffener can be used in conjunction with but separate from the sheath 20 / dilator 30B assembly that forms a stiffened support member that can be used in conjunction with the RF wire 10 to facilitate force transmission and moment to ensure engagement with the septum and to facilitate positioning the fossa during the pull-down procedure. The removable stiffener [such as the stylet 60] can be unlocked from the RF wire 10 removed from the sheath / dilator assembly, then exit the RF wire 10, and in some instances, the sheath and / or dilator remain positioned within the left atrium to facilitate exchange of other devices.

[0333] Needle assembly with rigid member and flexible puncture device

[0334] Rigid member

[0335] As described above, some embodiments of the present application provide a needle assembly for puncturing tissue, the needle assembly comprising a puncture device 110 flexible puncture device 112 (such as an RF guidewire 10 or a mechanical guidewire 118) for puncturing tissue and a rigid member (such as a support member 130 such as a dilator 30A or a stiffening member 34 such as a stylet 60) for supporting the puncture device, with reference to FIG. 1A , FIG. 1B and FIG. 3B-FIG. 3C The puncture device can be selectively used in cooperation with the rigid member during a portion of the procedure, and wherein the puncture device can be used independent of the stiffening member during other portions of the procedure, to puncture tissue and improve procedural efficiency by facilitating exchange and positioning.

[0336] In some such embodiments, as shown in FIGS. 1-3, the needle assembly includes a substantially flexible puncture device 112, which includes a mechanical puncture device 118. In some such embodiments, as shown in FIGS. 1-3, the substantially flexible puncture device 112 includes an energy-based puncture device 114. In some embodiments, as shown in FIGS. 1-3, the needle assembly provides a substantially flexible puncture device 112, which includes a substantially atraumatic tip (such as an RF guidewire 10). In some embodiments, as shown in FIGS. 1-3, the substantially flexible puncture device includes a relatively sharp (distal) tip 118d. In some embodiments, as shown in FIGS. 1-3, the rigid member includes a stiffening member 34. FIG. 1B FIG. 1A FIG. 1A FIG. 1B FIG. 1A FIG. 1B FIG. 3A-FIG. 3B

[0337] In one broad aspect, embodiments of the present application provide an interatrial septum system to facilitate interatrial septum puncture procedures with an underlying path. The system involves converting a rigid energy-based puncture device into (i) a flexible energy delivery component for delivering RF energy, such as an RF wire for use with RF puncture, and (ii) a separate support member, such as a stiffening member, for imparting structural and mechanical support to the assembly and providing sufficient moment transfer to enable the RF wire to engage the septum and facilitate advancement through the puncture site. Thus, in some embodiments, the system of the present application provides an RF wire and a stiffening member that are separate from and removable from each other to overcome limitations associated with needle-based systems of the prior art. In some such embodiments, the system of the present application provides a workflow that can reduce the number of device exchanges, facilitate repeatability, provide proper anchoring, and enhance safety. Thus, in some embodiments, the system of the present application provides a separate system that functionally separates the energy delivery component and provides a flexible energy delivery component while providing structural support through a separate stiffening component.

[0338] As an advantage, after positioning of the RF wire, the stiffening member can be advanced over the RF wire, allowing the RF wire to function as an exchange wire to help eliminate the need for a separate exchange wire for gaining access to the heart. Thus, the system is able to reduce the number of device exchanges on the right side by using a flexible energy delivery component, such as an RF wire that provides exchange capability.

[0339] ​​​​​​​As a further advantage, the system is able to remove the stiffening member after puncture so that the energy delivery member, the RF wire, is able to remain in the left atrium to facilitate anchoring within the left atrium, navigability and safety while advancing into the left side.

[0340] As a further advantage, the system is able to remove the stiffening member after puncture so that the energy delivery member, the RF wire, is able to remain in the left atrium to facilitate anchoring within the left atrium, navigability and safety while advancing into the left side.

[0341] Example 3 [Lockable stylet and RF guidewire]

[0342] Accordingly, some embodiments of the present application provide a method for performing an atrioventricular septal puncture, the method comprising: advancing a J-shaped wire into the superior vena cava; advancing a sheath and dilator over the wire into the superior vena cava; removing the J-shaped wire; inserting a needle assembly comprising a stylet and RF guidewire into a two-finger position within the dilator; pulling down from the superior vena cava into the heart to find the fossa; dilating with the dilator; advancing the needle assembly to a puncture location; puncturing and advancing the needle assembly until a stop within the dilator; maintaining position and unlocking the RF guidewire; advancing the RF guidewire to anchor; passing a sheath and dilator over the RF guidewire; and removing the stylet.

[0343] Accordingly, in some embodiments, the system of the present application provides a workflow that can reduce the number of device exchanges, facilitate repeatability, provide proper anchoring and enhance safety.

[0344] The embodiments of the application described above are intended to be exemplary only. Accordingly, the scope of the present application is intended to be limited only to the scope of the appended claims.

[0345] It should be understood that certain of the application's features can also be provided in combinations other than the combinations explicitly described herein without departing from the scope of the application. With respect to the methods, some embodiments of the application can include a substantially similar combination of steps to the combinations of steps explicitly described herein but in different order.

[0346] While the application has been described in connection with specific embodiments thereof, it will be understood that many modifications, substitutions and alterations, apparent to those skilled in the art, can be made without departing from the spirit and scope of this application. Accordingly, it is intended to embrace all alternatives, modifications and variations thereof that fall within the scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated by reference in their entirety as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present application.

Claims

1. A medical dilator for an atrial septostomy procedure, comprising: an elongated member having a distal end and a proximal end with a lumen therebetween; and A reinforcing member comprising a hypotube surrounded by an inner polymeric layer and an outer polymeric layer and is shapeable to allow a physician to remove and reshape during a procedure and is configured to provide rigidity and support for an atrioventricular septal puncture system, wherein the medical dilator has a bending stiffness of 0.0085 Nm 2 to 0.0145 Nm 2 ​ wherein the hypotube has a distal end with a joint between the hypotube and the inner polymeric layer defining a joint with no gap.

2. The medical dilator of claim 1, wherein, The elongated member includes a polymeric layer and an outer surface of the reinforcing member is surrounded by the polymeric layer.

3. The medical dilator of claim 1, wherein, The medical dilator includes at least one radiopaque marker at the distal end of the elongated member.

4. The medical dilator of claim 1, wherein, The reinforcing member is composed of a radiopaque material.

5. The medical dilator of claim 1, wherein, The medical dilator includes an atraumatic distal tip and a tapered distal end profile.

6. The medical dilator of claim 1, wherein, The reinforcing member terminates at a distal portion of the elongated member.

7. The medical dilator of claim 1, wherein, The reinforcing member is positioned within the lumen. The medical dilator includes a polymeric layer and an outer surface of the reinforcing member is surrounded by the polymeric layer. The medical dilator includes at least one radiopaque marker at the distal end of the elongated member. The reinforcing member is composed of a radiopaque material. The medical dilator includes an atraumatic distal tip and a tapered distal end profile. The reinforcing member terminates at a distal portion of the elongated member. The reinforcing member is positioned within the lumen.

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