Transseptal wire piercing system

Abstract

The transatrial septal catheter system for delivering a maneuverable sheath into the left atrium comprises three components. The first component is a three-segment needle guidewire (10) consisting of a distal needle (12) designed to abruptly flex relative to an attached loop guidewire segment (14) after fossa ovalis puncture and needle advancement. The distal guidewire loop is advanced into the left atrium, thereby maintaining the angled needle in a centered position relative to the loop for a non-invasive position while stabilizing the loop in the left atrium. A slender, proximal, ultra-rigid guidewire segment (16) is connected to the loop segment, which passes through the fossa ovalis and extends proximally for externalization to the femoral vein. This segment is ultra-rigid and significantly elongated to allow for catheter and device replacement. The guidewire serves as a support track on which the dilator (108) and sheath (100) can be advanced into the left atrium. This septal penetration system is uniquely forward-thinking and allows for the careful and iterative delivery of the dilator into the fossa ovalis, “tent-shaped” by a proximal sheath actuator that interacts with the dilator. The GW, now externalized at the proximal end, is then advanced to allow fossa ovalis puncture. After precise fossa ovalis puncture, the needle and coiled guidewire loop are further advanced into the left atrium. Using the proximal actuator (112), the dilator is advanced through the fossa ovalis into the left atrium via single-handed manipulation for individual dilator advancement and by rotating or actuating the sheath handle.

Description

Technical Field

[0001] This invention relates to a system for performing transseptal puncture and guiding a guidewire into the left cardiac structures. More specifically, the invention aims to achieve transseptal puncture in an efficient and safe manner, allowing access to the left atrium via a distal needle segment, an intermediate loop or coil-shaped left atrial segment, and a linear, elongated proximal segment. It serves as a platform for delivering structures or other devices into the left atrium of the heart. A specially constructed, maneuverable sheath and dilator can be combined with this needle guidewire. Alternatively, it can be used with most commercially available dilator-shelter transseptal catheter systems. Background Technology

[0002] Septal puncture is typically used to access the left atrium (LA) of the heart through the right atrium (RA). Atrial fibrillation ablation often requires access to the LA, and more recently, treatment of valvular and other structural heart diseases also requires access to the LA. Existing septal puncture devices must be able to reliably locate specific sites on the fossa ovalis (“FO”) to safely and accurately puncture the FO septum for a given procedure. Inadvertent puncture of structures such as the aorta, the free wall of the left or right atrium, or the pulmonary veins can lead to cardiac perforation and tamponade. Furthermore, highly specific locations on the FO must now be traversed to clearly identify specific left cardiac targets for device localization.

[0003] Existing septal puncture procedures present specific challenges, including: (1) difficulty in precisely and stably engaging the specific location of the FO due to factors such as severe kyphosis, altered cardiac orientation relative to external landmarks, abnormal cardiac rotation (secondary to multiple heart diseases), and the highly variable FO position and structure on the intraatrial septum; (2) difficulty in advancing the needle due to septal thickening or scarring; (3) redundant or aneurysmal septa leaving a tented apex of the needle on the FO, adjacent to the free wall of the LA, thus posing a risk of perforation and cardiac tamponade; and (4) prior placement of a septal occluder, which requires an alternative puncture site on the natural septum; or direct occluder puncture.

[0004] abbreviation

[0005] Unless otherwise stated, the following abbreviations apply throughout the public disclosure:

[0006] ·FO: Oval fossa 202

[0007] • Fr: French (increment of catheter diameter)

[0008] ·GW: Guide wire 10

[0009] ·LA: left atrium 208

[0010] • LAA: Left atrial appendage 210

[0011] MRI: Magnetic Resonance Imaging

[0012] ·MV: Mitral 212

[0013] •RA: Right atrium 206

[0014] • TEE: Transesophageal echocardiography

[0015] • TTE: Transthoracic echocardiography Summary of the Invention

[0016] This invention relates to a unique catheter system, and more specifically to a novel needle guidewire 10 for atrial septal puncture, the needle guidewire 10 having a uniquely constructed needle 12 that is distally connected to a segmented GW 10 for delivery of the catheter system device. The general target for puncturing the atrial septum in the heart 200 is FO 202, the depression to the right of the intraatrial septum 204 located in the wall between the right atrium 206 and the left atrium 208. FO 202 is a remnant of the thin fibrous membrane that normally covers the fossa ovalis during fetal development.

[0017] Specifically, the present invention relates in part to a septum GW 10 coupled with a septum needle 12. The GW 10 segment comprises a rigid proximal segment 16 and an intermediate annular segment 14, wherein the distal end 22 includes a node of the septum needle 12. At least two intermediate segment GW rings 24, 26 are resting in LA 208. The intermediate annular segment 14 is formed of shape memory material to form at least two annular segments: a second, more distal, generally outer, wide coil 24 and a first, more proximal or inner coil 26; wherein the intermediate segment 14 is connected at its proximal end 25 to an elongated, linear, ultra-rigid GW segment 16 that is ultimately located externally for replacement.

[0018] The present invention further relates to a transseptal GW puncture system traversing FO 202, the transseptal GW puncture system comprising a proximal end portion 16, a distal end portion 22, an intermediate coiled segment 14, a transseptal dilator 108, and a sheath 100. The distal end of the GW puncture needle 18 includes a transseptal needle 12, which is attached at its distal end portion 22 to the annular GW segment 14 and subsequently positioned to engage with the distal end portion 17 of the linear ultra-rigid GW segment 16. The transseptal needle 12 has shape memory at its attachment point with the annular GW segment 14, wherein the shape memory is sufficient to maintain a predetermined abrupt angle of change relative to the annular guidewire segment 14 to maintain non-invasive stability within and centrally to the rings 24, 26. One or more of the rings 24, 26 are positioned and stabilized within LA 208 by resting adjacent to the inner surface of LA 208. The middle annular segment 14 is formed of shape memory material to form two rings 24, 26; wherein the proximal end 25 of the more proximal coil 24 is connected to the elongated ultra-rigid segment of the proximal end of GW 16; and wherein the second bend 29 is positioned in RA 206, which transitions to the elongated linear proximal end segment of GW 10.

[0019] The transseptal dilator 108 includes an elongated conduit 109 resting within a sheath 100, tapering to a narrow distal segment 110 of the dilator, wherein the lumen 111 of the conduit remains in contact with a GW 10, which may have a variety of diameters ranging from 0.021 inches to 0.035 inches or greater. At a point along the distal segment 106, a radiopaque marker 122 is positioned to overlap with a radiopaque tip marker 123 on the sheath 100, at which point the transseptal dilator 108 and the sheath 100 have equal outer diameters. The dilator 108 is advanced forward into a precise position in the FO 202 to "tent-shaped" the FO 202 by a series of forward movements of an actuator 112 at the distal end adjacent to the handle 104. Manipulation on the proximal sheath handle 104 allows for anterograde and retrograde flexion, as well as the execution of twisting of the entire sheath 100 at the front or rear to position the distal end 124 of the sheath and the held expander tip 110 adjacent to a specific FO site for a particular surgical procedure. The distal segment 110 of the expander is advanced and retracted relative to the stabilized sheath 100 by the interaction of the actuator 112 on the proximal sheath 100 with the proximal end 119 of the expander 108.

[0020] Once the dilator 108, including the septal needle 12, tents the FO 202, the needle 12 is advanced, piercing the FO septum 202 and penetrating the LA 208. After its advancement through the FO 202, the septal needle 12 folds or bends at discrete angles based on shape memory at the proximal end / hinge point 20 on the coiled GW segment 14 to which it is connected. The angles formed can range from approximately 45° to 140°. Further advancement of the septal GW 10 will stably position the coil of the annular segment 14 of GW 10 within the LA 208 cavity, which also helps to non-invasively maintain the needle position in the center of the LA 208 by keeping it centered in the annulus. Preferably, the GW coils 24, 26 have a smaller inner diameter coil 26 and a larger outer diameter coil 24, thereby helping to keep the needle 12 at the height center of the LA 208. The smaller diameter inner coil prevents excessive needle 12 from damaging tissue in the LA wall. In another embodiment, the coils 24, 26 may have equal diameters.

[0021] In another embodiment, coils 24 and 26 can be offset, such as... Figure 3 and 4 As shown, to further aid in maintaining the centered position of needle 12, needle 12 can also be three-dimensionally folded. This additional feature makes it less likely for needle 12 to perforate the LA 208 structure when it is advanced through the distal end of the fold and deflected medially, thus further aiding in maintaining the centered position of needle 12 within the offset but equidistant ring 14. Coils 24, 26 can be offset by approximately 0.75 to 2 inches. Coils 24, 26 have moderate rigidity, thus allowing for less invasive interaction with the free wall of the LA. The second bend 29 in the right atrial GW segment helps to maintain a vertical trajectory coaxially in FO 202 and in IVC 215. The length of the elongated proximal ultra-rigid GW segment 16 will preferably be 260 cm (but can also be significantly longer) for catheter or device replacement.

[0022] The novel functional component unique to this system, which includes an expandable expander tip that is longer than that of the sheath, is present in this expander and deflectable sheath. Strategic positioning, which involves overlapping the transmissive marker 122 of the expander and the transmissive marker 123 of the sheath to align them at equal outer diameters, allows for a smooth transition of the trans-septum expander 108 and the sheath 100 across the membrane of FO202.

[0023] The anterior positioning of the catheter system of the present invention allows for precise positioning of the distal sheath for accurate device positioning, thereby establishing an ideal LA 208 positioning, which is ultimately determined by a specific left cardiac target (i.e., LAA 210, MV 212) for a given device. The system intuitively, simply, and accurately positions a specific FO 202 target using repeated dilator advances under echo or other imaging guidance. After advancing the coil through FO 202 and securing it in LA 208, the dilator 108 is then advanced into LA 208 on the coiled GW 10, thereby holding overlapping radiopaque segments in place until the sheath 100 is inserted into LA 208. Overlapping radiopaque markers 122, 123 on the distal dilator 106 and the sheath tip 124 confirm that they are at equal diameters, allowing for smooth and simultaneous advance of the dilator 108 and sheath 100 through FO 202.

[0024] The deflectable and maneuverable nature of the sheath 100 will allow for a single-size, forward-looking catheter system to achieve directionality, angularity, and reach of the sheath 100 for various RA 206 sizes and FO 202 angles in a variety of patient-specific anatomy.

[0025] The overall system preferably includes a needle guidewire 10, delivered by a one-size-fits-all catheter system to repeatedly advance a dilator 108 containing a retracted needle 12 into a tent-shaped, precise position on the FO 202. An actuator 112, adjacent to the handle 104 on the sheath 100, allows for highly controlled advance of the distal segment 110 to tent the FO membrane prior to needle puncture. The actuator 112 can be advanced or retracted using the operator's thumb without removing the operator's hand from the rotatable handle 104. The dilator 108 may have a more flexible distal segment to allow for smooth tracking on the coiled GW segment in the LA 208. The deflectable sheath tip 124 may have unipolar or bipolar directionality. Preferably, the maneuverable sheath 100 will have a distally fixed 2° bend within RA 206, which can be in the range of 2° to 20°, to more easily establish perpendicularity with FO202. Standard commercially available sheath dilator catheters can also be used in combination with the aforementioned novel needle guidewire.

[0026] Advantageously, the device satisfies the following conditions: (1) improved ease of use; (2) intuitive operation for precise remote control; (3) improved device and surgical outcomes; (4) enhanced device safety across a wide range of operator skills; (5) enhanced workflow and reduced surgical time; and (6) reduced surgical costs associated with combined needle guidewires.

[0027] The objects and advantages of the invention will be emphasized in more detail in the following description of preferred embodiments of the invention, taken in conjunction with the accompanying drawings. Attached Figure Description

[0028] Figure 1 This is a side plan view of a first embodiment of the combined through-hole septum needle and GW of the present invention, depicted from the front.

[0029] Figure 2 This is a side plan view of a second embodiment of the combined through-hole septum needle and GW of the present invention, depicted from the front.

[0030] Figure 3 This is a side plan view of the third embodiment of the combined through-hole needle and GW of the present invention, which, when viewed from the front, has an offset ring.

[0031] Figure 4 It has been rotated 90 degrees. Figure 3 A front view of the septum needle.

[0032] Figure 5 This is a side plan view showing a representative monopolar deflectable sheath used with the needle guidewire of the present invention.

[0033] Figure 6 It is shown that... Figure 5 Side view of the expander used in conjunction with the deflectable sheath.

[0034] Figure 7 This is a frontal schematic diagram of the human central venous circulation system, which includes the heart and venous system (with a maneuverable sheath within the system).

[0035] Figure 8 It is a frontal view of a cross-section of the human heart, in which a deflectable sheath is positioned to pass through the septum and be located in the LA, with the distal needle guidewire loop in the LA. Invention Details

[0037] Referring to the reference numerals in the accompanying drawings, the septal puncture system of the present invention is preferably a "one-size-fits-all" system, whereby a single-size system can be used in a variety of anatomical configurations and atrial sizes. One exception to this new standard involves the use of multiple wire diameters from about 0.021 inches to greater than 0.035 inches. The system includes a dedicated component containing a GW replacement with a distal septal puncture needle and an adjacent coil or loop for securing the GW in the LA 206. Furthermore, the catheter assembly may include a novel dilator that interacts with an actuator on the proximal sheath handle to be controllably positioned on the FO via a maneuverable sheath.

[0038] Needle guide wire

[0039] Reference shows the needle guide wire 10 Figures 1 to 4 The septal needle guidewire 10 should be a single component, eliminating the need for separate septal needles for various anatomical structures, multiple replacement parts, and multiple lengths and curves. The single wire has at least three defined segments: (1) the distal septal needle 12; (2) the intermediate or annular LA segment 14; and (3) the proximal slender linear ultra-rigid GW segment 16.

[0040] Insert 12 septum needles

[0041] The septum needle 12 is positioned to engage with the distal end 22 of the GW annular segment 14. The septum needle 12 is preferably relatively short, with a length between about 0.75 and about 2.0 cm. The needle 12 should also preferably have an ultra-low profile tip 18. When held in the central cavity 111 of the expander tip before advancement, the proximal end 20 of the needle 12 engaging with the adjacent distal annular segment 14 is linear.

[0042] The septal needle 12 has a lubricating coating to minimize resistance, and a sharply tapered tip 18 for puncture and easy transition into the FO 202, which may contain dense scars or aneurysms. Figure 8 (As shown in the diagram). The ultrafine dot on the needle tip 18, the slow, repeated delivery of the forward-tapering septal dilator 108 to the FO 202 for stable positioning, and the "tent-like" shape of the membrane by the dilator tip 18, which is then supported by the tamperable septal sheath 100, all prevent the needle from suddenly and unintentionally piercing the FO membrane and missing the preferred puncture site. With this forward-looking system, unexpected anterior or posterior torques that could cause slippage on the FO 202 should be minimized.

[0043] The septal needle 12 is preferably made of a shape-memory metallic material such as stainless steel or an alloy containing nickel-titanium, and is attached to the GW annular segment 14, for example by welding or possibly by intersecting seams that interact to form a more stable and flexible bond, thereby allowing the needle to fold itself and thus avoiding puncture of the LA free wall, pulmonary vein, etc. Other means of forming a pre-shaped angle between the needle 12 and the annular segment 14 are also conceivable and can be utilized.

[0044] The septal needle 12 is abruptly angled at its proximal end / hinge point 20 where it connects to the distal end 22 of the annular GW segment 14, which has maintained a predetermined angle with the center of the LA annular segment 14, thereby maintaining non-invasive stability at the central LA annular segment 14 and thus avoiding contact and possible perforation of the LA 208 structure containing the pulmonary vein, LA free wall and LAA 210.

[0045] After guidewire advancement and septal puncture, needle 12 suddenly bends at the center, preferably forming an acute angle with the adjacent annular GW segment 14, such as... Figures 1 to 4 As shown. The needle 12 remains linear after entering LA 208, but preferably bends inward at an angle of about 45° to 140° relative to the distal annular GW segment 14. The diameter of the septum needle tip 18 can be ground to an ultra-low profile and tapered back to connect to the distal annular segment 14, most likely transitioning to a profile ranging from 0.021 inches to 0.035 inches or larger.

[0046] Guide wire annular segment 14

[0047] The annular GW segment 14 is designed to non-invasively stabilize the GW 10 within the LA 208, and further helps protect the free wall of the left atrium from unnecessary needle puncture. Two or more annular segments 24, 26 can typically have diameters ranging from approximately 2.5 cm to 4.0 cm, and are formed through shape memory as they enter the LA 208 from the transseptal dilator 108. In one embodiment, the distal GW annular segment 14 is formed by two circular or possibly non-circular rings of approximately the same size, which can potentially have various shapes that are re-formed upon unfolding within the LA chamber, such as... Figures 3 to 4 As shown.

[0048] The coil provides at least four useful functions:

[0049] 1. The coil can confirm the correct LA chamber positioning by presenting the known, unconstrained shape within LA 208.

[0050] 2. Coil 14 is kept stably positioned in LA 208 to prevent GW 10 from being unintentionally withdrawn into RA 206 or to prevent the needle tip 12 from being forcefully advanced into the free wall of LA or the pulmonary vein.

[0051] 3. The outer wide coil 24 provides a longer GW support ramp on which the expander 108 and sheath 100 can be advanced into the LA 208 with less resistance around the curve to facilitate catheter support.

[0052] 4. The coil forms an outer protective cover, wherein the centrally positioned needle 12 maintains a safe distance from the penetrating LA 208 structure.

[0053] In another embodiment, there are at least two circular coils, with the diameter of the inner coil 26 being smaller than the diameter of the outer coil 24, such as... Figures 1 to 4As shown, the inner coil is therefore located at the center of the outer coil 24. In this embodiment, the larger outer coil 24 can be compressed by the LA 208 structure without any construction changes to the inner coil 26, thus further protecting the distal pin 12 from deformation and maintaining its central position.

[0054] As an example, the inner coil 26 of GW 10 may have a diameter between about 1.5 cm and 3.0 cm, preferably about 2.5 cm. The outer coil 24 may have a diameter between about 3.0 cm and 4.0 cm, preferably about 3.5 cm.

[0055] In the third embodiment, the two coils 24, 26 are parallel and have the same diameter, but can be offset by approximately 0.75 cm to approximately 2.0 cm. This is combined with a second pre-formed bend at the junction of the distal end of the septum needle 12 and the GW annular segment 14, which is three-dimensionally centered on the two offset coils 24, 26. Figure 5 As shown. The purpose is to further help prevent needle perforation of LA 208 by allowing the needle 12 to be circumferentially centered not only in two dimensions when bent, but also oriented centrally in a third dimension between the widths of the two offset loops 24, 26. The distance between the loops 24, 26 will preferably be about 1 cm, and can be in the range of about 0.75 cm to about 2.0 cm.

[0056] Proximal guidewire segment 16

[0057] The proximal GW segment 16 is joined to the adjacent coil segment 14 at its distal end 17. The proximal GW segment 16 includes a proximal free end 28, which is externally positioned and of sufficient length to allow catheter or device replacement while maintaining the distal GW annular segment 14 in the LA. The distal end 17 of this segment linearly transitions through the atrial septum into the LA 208. A fixed, slightly curved portion 29, preferably at the midpoint of the RA 206, is then present, maintaining a preferred angle of 2° to 20°. An elongated, ultra-rigid proximal GW segment 16 extends from the distal end of the long proximal segment 17 to the proximal end 28, preferably with a diameter of 0.021 to 0.035 inches. The length of the long ultra-rigid proximal GW segment 16 can extend from 240 cm to 300 cm, preferably 260 cm. This long ultra-rigid GW segment 16 will serve as a support rail for replacing a series of catheters and devices delivered to the left cardiac target.

[0058] Guide wire introduction sheath 100

[0059] refer to Figure 5The septal delivery sheath (or sheath) 100 is preferably a monopolar deflectable sheath, but can also be a bipolar deflectable sheath. It is actuated by a rotatable proximal ergonomic handle 104 for superior / inferior flexion and one-to-one sheath torque control for optimal anterior / posterior positioning. Advancing or retracting the septal delivery sheath 100 allows for superior / inferior positioning for controlled, non-invasive guidance in all planes. The sheath 100 has a proximal end 102 adjacent to the actuator 112 and a distal segment 107. Existing septal penetration systems designed for commercial use typically use a clockwise torque from the sheath / diverter system at the femoral vein access sight to enter FO 202. This clockwise torque can be excessive (too long) if the over-reaching diverter 108 momentarily "gets stuck" distally on the atrial septal protrusion ridge, potentially resulting in unintentionally "stored" torque. Further effort to position the distal segment 110 of the diverter within FO 202 may lead to perforation of the free wall of RA 206 or the atrial appendage. Conversely, insufficient length or "extension" of the diverter 108, and its inability to penetrate FO 202 through the conjunctival membrane, results in failure to puncture FO 202.

[0060] Each system must have multiple available sheath sizes to accommodate the variable RA sizes and constructions in these existing commercially available systems. Sheath 100 features an ergonomic, bidirectional, rotatable handle 104 for distal sheath bending, as indicated by arrow 125, and a sheath tip 124 extending to sheath 100. Furthermore, a 1:1 torque transfer distally in the anterior-to-rear position is achieved via a wire braided reinforcement (not shown) of sheath 100, which also improves backup support for enhanced device delivery. Sheath 100 is initially positioned adjacent to, but not conjoined with, the atrial septum using fluoroscopic examination and TEE guidance, and, where possible, real-time MRI and computed tomography.

[0061] As will be explained shortly, once the sheath 100 is precisely positioned under imaging guidance at a suitable short distance (likely about 0.5 to about 2.0 cm) from the FO 202 in the RA 206, the expander 108 is advanced while keeping the sheath 100 fixed. The sheath handle 104 for the expander and the adjacent actuator 112 will allow the operator to keep one hand in place without using the other hand to operate the entire system (sheath and expander). The actuator 112 for the expander 108 can be operated by the operator's thumb or other fingers to repeatedly advance or retract by interacting with the friction element 121 on the expander 108. The wire-braided reinforced sheath 100 provides a robust, kink-resistant support to advance the distal expander segment 110 of the expander 108, subsequently advancing the expander 108 into a precisely controlled, specific position in the FO 202 to make the membrane “tent-like”.

[0062] The sheath 100 preferably includes, but does not necessarily have, an expandable axis to accommodate device profiles of varying heights; on the other hand, a range of sheaths with fixed diameters can be used to accommodate various device profiles. Ideally, stretchable or expandable sheaths ranging from about 8.5 Fr to potentially up to 30 Fr can eliminate the need to reserve multiple available sheath diameters for different procedures. Therefore, one embodiment is suitable for a single sheath size that is expandable within a certain diameter range. For device delivery around complex or multiple curves, a septal sheath that may require deflection at two or more distances from the proximal handle may be preferred.

[0063] Multiple additional support structures may extend linearly within the sheath body to maintain adequate horizontal support for subsequent device delivery over anatomical structures at greater angles. A second bend of 2° to 20° may be positioned proximal to the more distal deflectable bend, which will help achieve a greater vertical angle at FO for robust coaxial backup support. Additionally, this will allow distal flexion greater than 180°, which may sometimes be necessary for proper sheath positioning on the medial aspect of the left heart. A tight hemostatic valve on the sheath hub 114 will minimize back bleeding around GW 10 (including those with diameters as low as 0.021 inches). Preferably, the sheath 100 will be 90 cm long (70 cm usable length) or longer. A hub may be included for locking the dilator to the sheath.

[0064] 108 septal expanders

[0065] The transseptal dilator 108 (or “dilator”) preferably has an ultra-low profile distal segment 110 with an inverted cone shape (as shown in 106), which connects at the distal end 106 of the dilator 108 to a fixed outer diameter 118 to match the inner diameter of the sheath. The dilator 108 can be advanced in a forward motion until a “tent-shaped” FO membrane appears in a precise position visible via a TEE or other real-time imaging detector for the procedure being performed.

[0066] In a preferred embodiment, the dilator 108 interacts with an actuator 112 adjacent to the sheath handle 104 via a friction contact element 121 or by using interlocking gears to provide precise and gentle control over the movement of the dilator. The actuator 112, which allows the dilator to advance or retract, is preferably controlled with the thumb on the same side, thus maintaining the ability to operate both the dilator 108 and the sheath handle 104 with one hand. The dilator 108 has variable flexibility along its length, with a more flexible distal segment 118 to prevent over-straightening or movement of the catheter system during advancement over the GW annular segment 14.

[0067] The maximum length of the distal segment 106 of the expander should be capable of advancing beyond the fixed distal sheath 100, preferably up to about 5 cm, although it can be varied to extend beyond the tip of the sheath by about 3.0 cm to about 8.0 cm. This allows for controlled advancement of the expander 108 through FO 202 and into LA 208 on the distal GW 10. After the expander 108 has punctured the septum and advanced into LA 208 while keeping the sheath 104 fixed in RA 206, there should be sufficient space until the radiopaque markers 122, 123 overlap on the RA 206 side of the septum, after which the composite system with flush outer diameters, including the septum expander 108 and the sheath 100, can now be advanced into LA 208 as a single unit.

[0068] The distal segment 106 of the dilator terminates at a low-profile tip 110 and has a radiopaque marker 122 at its proximal end that matches the profile of a radiopaque marker 123 on the sheath tip 124, thereby providing a smooth transition point between the two to advance through FO 202 simultaneously, thus preventing the edge of the sheath tip from “hanging” at the atrial septum crossing point. Detailed Implementation

[0069] refer to Figure 7 and 8An exemplary procedure for human patient 201 is as follows. As described below, this technique is typically guided by a TEE or TTE supplemented with standard fluorescence imaging. It should be understood that the procedure can also be guided by intracardiac echocardiography, real-time MRI, or image integration with preoperative volume-rendered computed tomography images. The latter imaging method uses standard fluorescence imaging, allowing pre-acquired computed tomography images to be oriented and superimposed on the fluorescence image for guidance. See U.S. Patent 8,900,214 to Nance et al., which is incorporated herein by reference for a general description of human anatomy, including the heart 200, and the insertion of the septal sheath 100 into the atrial region.

[0070] Using fluorescence inspection, a GW with a 0.032 J-tip is advanced from the right femoral vein 216 into the superior vena cava 218. A maneuverable sheath 100 and dilator 108 are advanced as a single unit onto the J-tip GW 10 and positioned in the middle of the RA 206. The J-tip GW 10 is removed and the dilator 108 is flushed. Then, under fluorescence inspection, the distal tip 18 of the GW 10 is advanced into the 0.032 mating dilator 108, and the distal tip 18 of the GW 10 is positioned just proximal to the distal segment 110 of the dilator.

[0071] The ergonomic handle 104 on the sheath 100 is axially oriented to allow the deflectable tip 124 to flex forward toward FO 202. Before manipulating the sheath 100 toward FO 202, the dilator 108, 1 to 3 cm long, is advanced toward the distal end of the fixed sheath 100 by fluoroscopy and echocardiography. To achieve this anterior or posterior orientation, the sheath 100 is twisted anteriorly or posteriorly. The sheath 100 is advanced or withdrawn to obtain a higher or lower position. Again, the proximal sheath handle 104 is rotated to flex the distal end 124 to an upward (i.e., retrograde) or downward (i.e., antegrade) trajectory. The TEE probe is most commonly used for optimal imaging of FO 202 and the adjacent distal tip 110 of the dilator using orthogonal views: a dual-lumen view for the up-down orientation, and a short-axis view to show the aortic level for anterior-posterior positioning. Using these TEE views, precise positioning on FO 202 can be obtained for targeted surgical puncture. An actuator 112 adjacent to the sheath handle 104 is used to slowly and repeatedly advance the expander tip 110 to create a “tent-like” shape within the FO 202 and confirm the correct position via the TEE. If the distal end 110 of the expander is not positioned correctly, the expander 108 can be retracted using the actuator 112 and reoriented after manipulating the sheath 100.

[0072] After confirming correct positioning using a tent-like arrangement, the proximal end of GW 10 and needle tip 18 puncture and pass through the FO 202 membrane. As GW 10 advances further, needle 12 abruptly flexes at hinge point 20, where it attaches to the annular segment 14 of GW 10. As GW 10 continues to advance, its distal coil 14 automatically positions itself within LA 208, and needle 12 remains flexed at the center of coils 24, 26. The catheter is constantly aspirated and flushed by replacement. The patient receives heparin treatment as soon as the annular segment 14 of GW enters LA. Correct positioning of GW 10 is confirmed by verifying its pre-formed shape. As noted in the device description, the coil or annular segment 14 can be implemented in several different ways. The dilator 108 is advanced over the coiled filament, thereby maintaining the sheath 100 in a fixed position within RA 206.

[0073] During fluorescence inspection, as the dilator 108 of appropriate length is advanced, the radiopaque markers 122 and 123 on the dilator 108 and the sheath tip 124 overlap in RA 206, confirming that the outer diameters of the two catheters are equal and ready to be advanced into LA 208 as a whole unit. The sheath tip 124 is now resting on FO 202 and in LA 208. Again, all manipulation of the dilator 108 and sheath 100 is performed as a single-handed operation. The dilator 108 is removed, thereby retaining the guidewire rings 24 and 26 and the sheath 100 in LA 208.

[0074] The elongated proximal segment of GW 10 is loaded with the main device, which is now advanced into the sheath tip 124, and GW 10 is removed. Sheath 100 can then be manipulated more precisely to deliver the device to the target and subsequently deploy it. After deployment, the maneuverable sheath 100 is pulled back into RA 206 and subsequently removed from the patient. Heparin is reversed with protamine and the percutaneous vascular inlet is closed.

[0075] This septal transluminal procedure is performed using a forward-looking catheter system that is repeatedly advanced to the precise location of FO 202 prior to puncture. This nature of the catheter system allows for access to LA208 with only one device shape. This differs from existing techniques that use multiple catheter sizes twisted into FO202, which may initially be too small to reach FO 202 or too long, thus risking FO membrane slippage and potential perforation of the RA free wall.

[0076] Any component or method step of the present invention may be used in conjunction with any other component or method step of the present invention. Whether explicitly described or not, the elements described herein may be used in any combination.

[0077] Unless otherwise stated or clearly implied to the contrary in the context of the referenced combination, all combinations of method steps used herein may be performed in any order.

[0078] As used herein, unless the content explicitly states otherwise, the singular forms “a,” “an,” and “the” contain plural indicators.

[0079] Whether specifically disclosed or not, the numerical ranges used herein are intended to include every number and subset of numbers contained within that range. Furthermore, these numerical ranges should be construed as supporting claims that involve any number or subset of numbers within that range. For example, disclosures from 1 to 10 should be construed as supporting ranges from 2 to 8, from 3 to 7, from 5 to 6, from 1 to 9, from 3.6 to 4.6, from 3.5 to 9.9, etc.

[0080] All patents, patent publications, and peer-reviewed publications cited herein (i.e., the “References”) are expressly incorporated herein by reference in their entirety, as if each individual reference were specifically and individually indicated as incorporated by reference. In the event of any conflict between this disclosure and the incorporated references, this disclosure shall prevail.

[0081] The apparatus, methods, compounds, and compositions of the present invention may include, or consist of, or substantially consist of, the essential elements and limitations described herein, and any additional or optional steps, ingredients, components, or limitations described herein or otherwise useful.

[0082] Although the invention can be embodied in many forms, the details described herein are of specific preferred embodiments. This disclosure is an example of the principles of the invention and is not intended to limit the invention to the specific embodiments shown. It should be understood that the invention is not limited to the specific examples, processes, and materials disclosed herein, as such processes and materials may be quite limited in some respects. It should also be understood that the terminology used herein is for the purpose of describing specific embodiments only and is not intended to be limiting, as the scope of the invention will be limited to the appended claims and their equivalents.

[0083] The use of this device can be extended to other surgeries on vascular and non-vascular cavity organ structures (i.e., non-septal) procedures.

Claims

1. A septal penetration guidewire, the septal penetration guidewire comprising a proximal end, a distal end, and an intermediate segment, a. wherein the distal end includes a linear septal needle configured to bend to an acute angle relative to the distal end of the guidewire after puncturing the tissue and to be positioned to engage with the distal end of the guidewire; b. wherein the intermediate segment is formed of shape memory material to include at least two annular segments, including an inner coil and an outer coil, the inner coil being centered on the outer coil in the preformed structure; wherein the inner coil and the outer coil are offset; wherein, Once the intermediate segment returns to the preformed structure, the septum piercing needle is positioned in a third dimension between the offset inner and outer coils, in addition to being circumferentially within the inner and outer coils in two dimensions, to maintain the non-traumatic stability of the septum piercing needle within and at the center of the inner and outer coils, preventing the septum piercing needle from perforating the tissue; and c. wherein the proximal end is connected to the intermediate segment via a proximal guidewire segment.

2. The septal guidewire as claimed in claim 1, wherein the septal needle has shape memory at the attachment point with the guidewire, wherein the shape memory is sufficient to maintain the septal needle at a predetermined angle relative to the guidewire to maintain the non-invasive stability of the septal needle inside and at the center of the inner coil and the outer coil.

3. The septal guidewire as claimed in claim 2, wherein the predetermined angle is between 45° and 140° relative to the guidewire.

4. The septal guide wire as claimed in claim 1, wherein the diameter of the annular segment is between 2.5 cm and 4.0 cm.

5. The through-hole guide wire as claimed in claim 1, wherein the inner coil is offset from the outer coil by a distance of 0.75 cm to 2.0 cm.

6. A septal perforation guidewire system for penetrating the fossa ovalis, the septal perforation guidewire system comprising a proximal segment, a distal segment, an intermediate segment, a septal dilator, and a sheath. a. The distal end includes a linear septal needle configured to bend to an acute angle relative to the distal end of the guidewire after puncturing the tissue and to be positioned to engage with the distal end of the guidewire, wherein the septal needle has shape memory at the point of attachment to the guidewire, wherein the shape memory is sufficient to maintain the septal needle at a predetermined angle relative to the guidewire to maintain non-invasive central positioning; b. wherein the intermediate segment is formed of shape memory material to include at least two annular segments, including an inner coil and an outer coil, the inner coil being centered on the outer coil in the preformed structure; wherein the inner coil and the outer coil are offset; wherein, Once the intermediate segment returns to the preformed structure, the septum needle is positioned in a third dimension between the offset inner and outer coils, in addition to being circumferentially inside the inner and outer coils in two dimensions, to maintain the non-traumatic stability of the septum needle inside and at the center of the inner and outer coils, so as to prevent the septum needle from perforating the tissue. c. wherein the proximal end is connected to the intermediate segment via a proximal guidewire segment; d. The septal dilator has a proximal end and a distal end, wherein the distal end includes a low-profile tip for placement on the fossa ovalis; and e. The sheath is a single-pole deflectable sheath having a proximal end and a distal end, wherein the proximal end includes a handle for actuating the sheath towards the proximal end.

7. The septal guidewire puncture system of claim 6, wherein the predetermined angle is between 45° and 140° relative to the guidewire.

8. The septal guidewire puncture system of claim 6, wherein the septal dilator has a radiopaque marker at the distal end, and the sheath has a corresponding radiopaque marker at the distal end of the sheath.

9. The septal guidewire puncture system of claim 6, wherein the sheath includes an actuator adjacent to the handle, and wherein the distal end of the dilator includes a friction element, wherein the actuator interacts with the friction element to initiate movement of the dilator within the sheath.

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