Devices, systems, and methods for transseptal puncture

Abstract

Various devices, apparatus, and methods for transseptal puncture and crossing are disclosed herein. The transseptal puncture and crossing devices may include a novel puncture member having a crossing coil fitted to a body portion to allow both crossing of tissue and insertion of a wire or guard through the puncture member. Although not required, the puncture member may have one or more novel features including a tapered coil section, a transition cutter, a gripper coil section, an atraumatic guard, and a shaped cutting wire. The methods for transseptal puncture and crossing include applying rotation, vibration, and / or ultrasound to the transseptal puncture device.

Description

[Technical field]

[0001] SUMMARY OF THE DISCLOSURE Embodiments of the present disclosure relate to devices, apparatus, and methods for transseptal puncture and crossing. [Background technology]

[0002] Transseptal puncture is a procedure performed to gain access to the left atrium by puncturing the fossa ovalis (FO). The interatrial septum, formed by the fusion of the septum primum and septum secundum, divides the left and right atrial cavities and should be clearly distinct from the right atrial septum, which extends both superiorly and inferiorly beyond the left atrial cavity. The interatrial septum is the anatomical target for transseptal puncture and is represented anatomically by the FO and its adjacent muscular margins. The FO has a mean vertical diameter of 18.5 mm, and a mean horizontal diameter of 10 mm, with a mean thickness of 4-1 to 2 mm.

[0003] Transseptal puncture remains a demanding procedural step in accessing the left atrium with inherent risks and safety concerns, including inadvertent cardiac perforation or injury, cardiac tamponade, and other injuries. This procedure has traditionally been performed through a FO from the right femoral vein. Commonly used transseptal puncture techniques include needle puncture and radiofrequency puncture. Summary of the Invention [Means for solving the problem]

[0004] The systems, methods, and devices of the present disclosure each have several innovative aspects, implementations, or aspects, no single one of which is solely responsible for the desirable attributes disclosed herein.

[0005] Disclosed herein are embodiments of transseptal puncture devices and methods of transseptal puncture and crossing.

[0006] Some embodiments of a transseptal puncture device for creating an opening in a patient's septum or other tissue include an elongated body portion, a coiled portion distal to the body portion, and a longitudinally extending lumen extending axially through the entire length of the elongated body portion and the coiled portion. The coiled portion has a distal end and a proximal end, the proximal end being closer to the body portion. The distal end of the coiled portion is sharp. The transseptal puncture device is configured to create an opening in a patient's septum by advancing the distal end of the coiled portion into contact with the septum and rotating the device in a first direction.

[0007] In a variation of the above embodiment, the coiled portion comprises a helical wall having an axial thickness of the transseptal puncture device that increases along the length of the coiled portion from the distal end of the coiled portion to the proximal end of the coiled portion so as to increase the size of the septal opening as the coiled portion of the device advances through the septal opening.

[0008] In a variation of the above embodiment, the thickness of the axial helical wall at the proximal end of the coiled portion is equal to or greater than the outer diameter of the coiled portion at the proximal end of the coiled portion.

[0009] In a variation of the above embodiment, the thickness of the axial helical wall at the proximal end of the coiled portion adjacent the proximal end of the coiled portion is at least twice the thickness of the axial helical wall at the distal end of the coiled portion adjacent the distal end of the coiled portion.

[0010] In a variation of the above embodiment, the coiled portion includes a gap between adjacent coils of the helical wall, the gap having a constant axial width along the length of the coiled portion from the distal end of the coiled portion to the proximal end of the coiled portion.

[0011] In a variation of the above embodiment, the gap is located at a distal portion of the coiled portion and includes a distal gap portion between adjacent coils of the helical wall and a proximal gap portion located proximal to the distal gap portion.

[0012] In a variation of the above embodiment, the proximal gap portion is located at or adjacent to the transition portion of the transseptal puncture device.

[0013] In a variation of the above embodiment, the proximal gap portion extends axially.

[0014] A variation of the above embodiment further includes a transition gap portion between the proximal gap portion and the distal gap portion, the angle of the transition gap portion relative to the axial centerline of the coiled portion being different than the angle of the distal gap portion relative to the axial centerline of the coiled portion.

[0015] In a variation of the above embodiment, at least a body portion of the transseptal puncture device is flexible.

[0016] A variation of the above embodiment further includes a transition portion between the body portion and the coiled portion, the transition portion including a sharp outer edge.

[0017] In a variation of the above embodiment, the lumen extending through the body portion and the coiled portion is configured to receive a guidewire or needle therein.

[0018] A variation of the above embodiment further includes a needle configured to move axially within the lumen through the body portion and the coiled portion.

[0019] A variation of the above embodiment further includes a helical guard comprising a guard body portion and a guard helix portion configured to move axially within the lumen through the body portion and the coiled portion, and a distal end of the guard helix portion configured to be blunt or atraumatic.

[0020] In a variation of the above embodiment, the guard spiral portion is configured such that when the guard spiral portion is advanced through the coiled portion, the guard spiral portion intertwines with the coiled portion.

[0021] A variation of the above embodiment further includes a distal coil guard configured to retractably extend out from the distal end of the coiled portion, the distal end of the distal coil guard being configured to be blunt or atraumatic.

[0022] A variation of the above embodiment further includes a removable cover disposed on the distal end of the coiled portion.

[0023] In a variation of the above embodiment, at least the coiled portion is laser cut from the tube.

[0024] In a variation of the above embodiment, the distal portion of the coiled portion further comprises serrations along one or more edges of the coiled portion.

[0025] In a variation of the above embodiment, the distal portion of the coiled portion further comprises a hook-shaped tip.

[0026] In a variation of the above embodiment, the coiled portion is formed from a wire or ribbon.

[0027] A variation of the above embodiment further includes an electromechanical motion generator coupled to the body portion.

[0028] Another embodiment relates to a method of transseptal puncture, comprising advancing a coiled portion of a transseptal puncture device into contact with a septum within a patient's heart. The method also includes rotating the transseptal puncture device in a first direction to cause the coiled portion of the transseptal puncture device to puncture the septum. The method also includes rotating the transseptal puncture device in a first direction to advance the coiled portion of the transseptal puncture device through the septum, such that the wall of the septum surrounds at least a portion of the coiled portion of the transseptal puncture device. The method includes further rotating the transseptal puncture device to expand the size of the hole in the wall of the septum. The method further includes continuing to advance the transseptal puncture device to transition the wall of the septum from surrounding the coiled portion of the transseptal puncture device to surrounding an outer surface of a body portion of the transseptal puncture device.

[0029] A variation of the above embodiment further includes penetrating the septum by extending a needle through the coiled portion of the transseptal puncture device to create a hole in the wall of the septum prior to puncturing the septum with the coiled portion of the transseptal puncture device.

[0030] A variation of the above embodiment further includes extending a blunt guard through the coiled portion of the transseptal puncture device before advancing the coiled portion of the transseptal puncture device into contact with the septum to prevent the transseptal puncture device from inadvertently puncturing or cutting the septum.

[0031] A variation of the above embodiment further includes applying vibrations to the coiled portion of the transseptal puncture device to expand the size of the hole in the septal wall.

[0032] A variation of the above embodiment further includes actuating the transseptal puncture with an electromechanical motion generator. [Brief description of the drawings]

[0033] [Figure 1]FIG. 1 is a cross-sectional view of the Right Atrium (RA) and Left Atrium (LA) showing a guidewire being advanced towards the FO. [Diagram 2] A cross-sectional view of the LA is shown showing a standard transseptal puncture device extending through the FO. [Figure 3A] 1 shows a cross-sectional view of the heart showing a standard transseptal puncture device extending through the FO. [Figure 3B] FIG. 3B shows an enlarged cross-sectional view of a standard transseptal puncture device from FIG. 3A showing the wire of the standard transseptal puncture device passing through the FO. [Figure 3C] FIG. 3B shows an enlarged cross-sectional view of the standard transseptal puncture device from FIG. 3A showing a wire being advanced through the FO. [Figure 3D] FIG. 3B shows an enlarged cross-sectional view of the standard transseptal puncture device from FIG. 3A showing the wire being advanced towards the LA. [Figure 3E] FIG. 3B shows an enlarged cross-sectional view of a standard transseptal puncture device from FIG. 3A showing the sheath of the standard transseptal puncture device being advanced through the FO. [Figure 4] FIG. 1 shows a side view of a standard transseptal puncture device pressed against a FO. [Diagram 5] FIG. 5 shows a side close-up view of the standard transseptal puncture device from FIG. [Figure 6] 13A shows an enlarged cross-sectional view of an embodiment of a transseptal puncture device with a puncture member, showing a dilator pressed against the FO. [Figure 7] 7 shows an enlarged cross-sectional view of the transseptal puncture device from FIG. 6 with the puncture member being advanced through the FO. [Figure 8] 7 shows an enlarged cross-sectional view of the transseptal puncture device from FIG. 6 with a wire being advanced through the FO. [Figure 9] 7 shows an enlarged cross-sectional view of the transseptal puncture device from FIG. 6 with a dilator being advanced through the FO. [Figure 10] 7 shows an enlarged cross-sectional view of the transseptal puncture device from FIG. 6 with the sheath being advanced through the FO. [Figure 11] FIG. 1 is a perspective view of one embodiment of a transseptal puncture device. [Figure 12] 12 is a perspective view of the transseptal puncture device from FIG. 11 being advanced through a barrier surface, showing the tip of the advancing puncture member. [Figure 13] 12 is a perspective view of the transseptal puncture device from FIG. 11 showing the coiled portion of the puncture member being advanced through a barrier surface. [Figure 14] FIG. 12 is a perspective view of the transseptal puncture device from FIG. 11 continuing to advance through the barrier surface. [Figure 15] FIG. 12 is a perspective view of the transseptal puncture device from FIG. 11 continuing to advance through the barrier surface. [Figure 16] FIG. 12 is a perspective view of the transseptal puncture device from FIG. 11 continuing to advance through the barrier surface. [Figure 17] FIG. 12 is a perspective view of the transseptal puncture device from FIG. 11 continuing to advance through the barrier surface. [Figure 18] FIG. 12 is a perspective view of the transseptal puncture device from FIG. 11 continuing to advance through the barrier surface. [Figure 19] FIG. 12 is a perspective view of the transseptal puncture device from FIG. 11 continuing to advance through the barrier surface. [Figure 20] 15 is a perspective view of the transseptal puncture device from FIG. 11 showing the proximal end of the coiled portion of the puncture member from FIG. 14. [Figure 21] FIG. 13 is a side view of one embodiment of a piercing member. [Figure 22] FIG. 13 is a side view of another embodiment of a piercing member. [Diagram 23] FIG. 13 is a side view of another embodiment of a piercing member. [Figure 24] FIG. 13 is a side view of another embodiment of a piercing member. [Diagram 25] FIG. 13 is a side view of another embodiment of a piercing member. [Figure 26] FIG. 26 is a perspective view of the piercing member from FIG. 25. [Figure 27] FIG. 26 shows a barrier surface and the piercing member of FIG. 25 pressed against the barrier surface from behind. [Figure 28] FIG. 28 illustrates the barrier surface and piercing member from FIG. 27 showing the piercing member advancing through the barrier surface. [Figure 29] FIG. 28 illustrates the barrier surface and piercing member from FIG. 27 showing the piercing member continuing to advance through the barrier surface. [Diagram 30] 13A-13C are perspective views of an embodiment of a piercing member with a sharp transition. [Diagram 31] FIG. 13 is a side view of another embodiment of a piercing member with a sharp transition. [Diagram 32] FIG. 32 is a perspective view of the puncture member of FIG. 31. [Diagram 33] 32 is a cross-sectional view of an embodiment of a transseptal puncture device with the puncture member from FIG. 31 being advanced toward a barrier surface. [Diagram 34] 13A is a cross-sectional view of a transseptal puncture device showing a puncture member gripper advancing through a barrier surface. FIG. [Diagram 35] 1 is a cross-sectional view of a transseptal puncture device showing a needle advancing through a barrier surface. [Diagram 36] FIG. 2 is a perspective view of a penetrating member gripper; [Figure 37] FIG. 37 is a perspective view of the penetrating member gripper from FIG. 36 with a needle extending through the penetrating member gripper. [Figure 38] FIG. 2 shows a barrier surface and a penetrating member gripper pressed against the barrier surface from behind. [Figure 39] FIG. 39 illustrates the barrier surface and piercing member from FIG. 38 showing the piercing member advancing through the barrier surface. [Diagram 40] FIG. 39 illustrates the barrier surface and piercing member from FIG. 38 showing the wire and sheath being advanced through the barrier surface. [Diagram 41] FIG. 13 is a side view of one embodiment of a crossing guidewire with a spiral guard. [Diagram 42] FIG. 42 is a cross-sectional view of the cross guidewire with spiral guard from FIG. 41 taken through the axial centerline. [Diagram 43]FIG. 42 is a side view of the crossing guidewire with spiral guard from FIG. 41 with the spiral guard retracted. [Diagram 44] FIG. 44 is a cross-sectional view of the cross guidewire with spiral guard from FIG. 43 taken through the axial centerline. [Diagram 45] FIG. 42 is a perspective view of the crossing guidewire from FIG. 41 without the spiral guard. [Figure 46] FIG. 42 is a perspective view of the spiral guard from FIG. 41 without the crossing guidewire. [Figure 47] FIG. 13 is a perspective view of one embodiment of a distal coil guard inside a crossing guidewire. [Figure 48] FIG. 13 is a perspective view of another embodiment of a distal coil guard inside a crossing guidewire. [Figure 49] FIG. 13 is a perspective view of another embodiment of a distal coil guard inside a crossing guidewire. [Figure 50] FIG. 13 is a perspective view of another embodiment of a distal coil guard inside a crossing guidewire. [Figure 51] FIG. 2 is a perspective view of an embodiment of a solid core coil. [Figure 52] FIG. 52 is another perspective view of the solid core coil of FIG. 51. [Figure 53] FIG. 13 is a perspective view of one embodiment of a shaped cutting wire with a serrated tip. [Figure 54] FIG. 54 is a side view of the shaped cutting wire from FIG. 53. [Figure 55] FIG. 13 is a side close-up view of another embodiment of a shaped cutting wire with a hook-shaped tip. [Figure 56] FIG. 56 is an enlarged perspective view of the shaped cutting wire from FIG. 55. [Figure 57] FIG. 13 is a perspective view of another embodiment of a shaped cutting wire with a hook-shaped tip. [Figure 58] FIG. 58 is a side view of the shaped cutting wire from FIG. 57. [Figure 59] FIG. 13 is a perspective view of another embodiment of a shaped cutting wire with a coiled tip. [Figure 60]FIG. 13 is a side view of another embodiment of a shaped cutting wire with serrations. [Figure 61] FIG. 61 is a perspective view of the shaped cutting wire of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] Described herein are embodiments of novel devices, systems, and methods for transseptal puncture and crossing. Transseptal puncture has traditionally been performed from the right femoral artery through the fossa ovalis (FO), as shown in Figures 1-5. A standard transseptal puncture device may include a sheath 1, a dilator 2 inserted through the sheath 1, and a needle 3 inserted through the dilator 2. A commonly used standard needle is a Brockenbrough needle, which is inserted through the dilator of an 8-F, 63-cm Mullins sheath. A standard transseptal puncture device may apply forward axial pressure to the FO and puncture through the FO using needle 3, as shown in Figures 3A-3B.

[0035] 1. Coil crossing (general) An embodiment of a transseptal puncture device is illustrated and described below.

[0036] Rather than applying forward axial pressure to the FO with a needle, embodiments of the transseptal puncture device disclosed herein may be configured to apply a force that is tangential or at an acute angle to the surface of the tissue (hereinafter collectively referred to as an angled force), or that has a tangential or acute-angled component of the force. In this configuration, some embodiments of the transseptal puncture device disclosed herein may create an opening through the FO with much less axial or forward pressure than a conventional needle or straight hypotube. The embodiments of the transseptal puncture device are described herein in the context of use to create an opening in the septum. However, any embodiment disclosed herein may be configured to create an opening or passageway in any tissue within the body, and none of the disclosed embodiments are limited in scope to use solely for creating an opening in the septum.

[0037] 6-10 show an embodiment of a transseptal puncture device 100 having a puncture member 13 (which may be tubular, if desired) having a coiled portion 32 instead of a standard needle. In any of the embodiments disclosed herein, the puncture member 13 may have a body portion 36 and a coiled portion 32 at a distal end of the puncture member 13. The coiled portion 32 may be integrally formed with the body member 36. For example, and without limitation, the coiled portion 32 and body portion 36 may be formed by laser cutting a hypotube.

[0038] The coiled portion 32 (also referred to herein as the helical portion) of the puncture member 13 may have a helical shape in some embodiments. For example, the coiled portion 32 may have a shape similar in some respects to the shape of the helical portion of a corkscrew for opening a bottle of wine in some embodiments. The coiled portion 32 may be configured such that once engaged with the septum (e.g., when the distal tip 31 of the coiled portion 32 is in contact with the septum), an opening in the septum may be formed in a very controlled manner by rotating the puncture member 13 of the transseptal puncture device 100 while maintaining pressure against the septum with the distal end of the coiled portion. Continuing to rotate the puncture member 13 of the transseptal puncture device 100 causes the coiled portion 32 to continue to advance through the septum or other tissue as long as a torque is applied to the puncture member 13. The puncture member 13 may either be used to stabilize the traverse position for a conventional needle that may follow through it, or it may perform a full traverse by coiling through the tissue to create a hole or passageway to the LA.

[0039] By limiting the forward pressure required from the needle and instead applying an angled force to the surface of the tissue using the piercing member 13, there is less risk of unexpected migration or "popping" through the tissue and contact with another part of the heart. Unlike transverse Radio Frequency (RF) methods, which require a separate external power source and generator, this mechanical method does not require external power.

[0040] Some embodiments of the transseptal puncture device 100 may include a standard transseptal dilator 2 and guide sheath 1 designed for use with a standard crossing needle. In some embodiments, as shown in FIG. 6, the puncture member 13 may include a body portion 36 and a coiled portion 32, although the portion of the body portion 36 proximal to the coiled portion 32 may be flexible.

[0041] As an initial step in the transseptal puncture procedure, the dilator 2 may be used to apply a slight axial forward pressure to the septum to "tent" it as a means to determine the proper location for transseptal fluoroscopy and echo, as shown in FIG. 6. In some embodiments, the puncture member 13 may be retracted within the dilator until it is advanced for use. The puncture member 13 may then be advanced to the septal tissue (FO) and then rotated, which drives the puncture member 13 to puncture the tissue and transverse the septum, as shown in FIG. 7. Once transverse, a standard guidewire 4 may be advanced through the puncture member 13 and FO, as shown in FIG. 8. The puncture member 13 may then be retracted within the dilator 2, while the distal tip of the dilator 2 may be advanced through the hole 11 formed by the puncture member 13, as shown in FIG. 9. The sheath 1 may then follow and further expand the hole 11 in the FO to create access for a subsequent larger device to traverse the FO.

[0042] In some embodiments, the coiled portion 32 of the puncture member 13 can be a multi-turn coil (e.g., 2 turns, 3 turns, etc.) In other embodiments, the coiled portion 32 can be a single-turn coil (e.g., 1 turn).

[0043] In some embodiments, the piercing member 13 may be hollow so that a guidewire or another device may be passed through the piercing member 13. In other embodiments, the piercing member 13 may also be solid throughout and function as a guidewire. In some embodiments, when the piercing member 13 also functions as a guidewire, the piercing member 13 may have a removable protective covering at the distal end around the coiled portion 32.

[0044] In some embodiments, the puncture member 13 may be laser cut from standard hypotubing. In some embodiments, the puncture member 13 may be machined using conventional machining methods. In some embodiments, the puncture member 13 may be laser ablated using advanced laser machining methods. In some embodiments, the puncture member 13 may be a wire formed from a straight wire or ribbon. In other embodiments, the puncture member 13 may be a wire formed from a tapered wire or ribbon.

[0045] 2. Tapered piercing member 11-29 show another aspect of the transseptal puncture device 200, including various embodiments of a puncture member configured to be tapered. Any of the embodiments of the transseptal puncture device 200 shown or described below may have any of the components, features, or other details of any of the other transseptal puncture device embodiments disclosed herein, including but not limited to any of the transseptal puncture device embodiments described above, in any combination with any of the components, features, or details of the transseptal puncture device 200 described below. Similarly, any of the components, features, or other details of any of the other transseptal puncture devices disclosed herein may have any of the components, features, or other details of any of the transseptal puncture device embodiments disclosed herein, in any combination with any of the components, features, or details of the transseptal puncture device embodiments disclosed herein.

[0046] One major challenge with some embodiments of puncture member 13 having a coiled portion 32 fitted to a body portion 36 relates to the transition where the coiled portion 32 meets the body portion 36 (i.e., the portion without the helical groove). The transition can be a pinch point, which in some embodiments may trap the hole 11 formed by the coiled portion 32 as it abruptly transitions into the body portion 36, which may be circular and larger than the coiled portion 32 (e.g., larger than the width of the coil).

[0047] In some embodiments, the puncture member 13a may include a coiled portion 32a that tapers into the body portion 36, but the thickness T of each helical turn of the coiled portion 32a in the axial direction, parallel to the length of the device, increases as each helical turn approaches the body portion 36, as shown in Figure 11. In some embodiments, the coiled portion 32a may be tapered such that the angle of the grooves at the proximal portion 37a relative to a plane perpendicular to the longitudinally extending centerline axis of the coiled portion 32a (referred to herein as the perpendicular plane) is greater than the angle of the grooves relative to the perpendicular plane at the distal tip 31a.

[0048] 11, the distal groove portion between adjacent helical turns in the distal portion of coiled portion 32a can be at an acute angle relative to the vertical plane (e.g., without limitation, less than or about 10 degrees, less than or about 15 degrees, or less than or about 20 degrees, or between or about 5 degrees and or about 30 degrees). In some embodiments, the proximal groove portion can be parallel or nearly parallel to the axial centerline of the coiled portion (i.e., perpendicular or at a large angle relative to the vertical plane).

[0049] In some embodiments, the grooves between adjacent helical turns at the distal portion of the tapered coiled portion 32a may be non-parallel to the grooves at the proximal portion 37a of the tapered coiled portion 32a. In other embodiments, the grooves between adjacent helical turns at the distal tip 31a of the tapered coiled portion 32a may be perpendicular to the grooves at the proximal portion 37a of the tapered coiled portion 32a. In some embodiments, the gap of the piercing member may have a transition gap portion between the proximal gap portion and the distal gap portion, but the transition gap portion has an angle between the angle of the proximal gap portion and the angle of the distal gap portion. The tapered coiled portion 32a may be made in some embodiments by laser cutting the piercing member 13a from standard hypotube and tapering the coiled portion 32a.

[0050] In some embodiments, at the point where the thickness T of the coiled portion 32a is equal to the diameter D of the hypotube, the hole 11 through the septal FO may transition from only surrounding the coiled portion 32a to covering or surrounding the outer diameter of the entire body portion 36. In some embodiments, in this configuration, a transseptal puncture device (including but not limited to any embodiment of the transseptal puncture device 100, 200) may use the puncture member 13a to slide through the hole 11 with very little axial force, but give the operator significantly greater control over the device in the axial direction to avoid cardiac perforation or other damage. Again, in some embodiments, this may be accomplished by gradually stretching the drilled hole 11 and gradually enlarging the hole 11 as the puncture member 13a is advanced through the hole 11 by rotating the puncture member 13 until the stretched hole 11 around the puncture member 13a has the same diameter as the diameter D of the body portion 36.

[0051] In some embodiments, the groove or cutout in coiled portion 32a can have a proximal portion 37a (see FIG. 11 ) that has an orientation that is generally aligned with an axial centerline of transseptal puncture device 200. In some embodiments, the orientation of proximal portion 37a can be, for example, but not limited to, parallel to the axial centerline of transseptal puncture device 200. This can, in some embodiments, inhibit (e.g., prevent) tissue trapping or snagging points and reduce or prevent the risk of tissue trapping points.

[0052] FIG. 11 illustrates one embodiment of the puncture member 13a of the transseptal puncture device 200. FIGS. 12-20 illustrate the puncture member 13a as it is rotated and advanced through a barrier surface 10 (e.g., septal tissue) and illustrate the motion of the puncture member 13a as the coiled portion 32a of the puncture member 13a is advanced through the septal FO. In any embodiment disclosed herein, the barrier surface 10 may be the atrial septum, and all instances of the term barrier surface disclosed herein may be used to refer to the atrial septum. As shown in FIG. 12, the distal tip 31a of the puncture member 13a may first be advanced through the barrier surface 10. Next, the coiled portion 32a may be rotated and advanced through the barrier surface 10, as shown in FIG. 13. As illustrated in FIGS. 14-16, the barrier surface 10 may be stretched to a larger size by increasing the thickness T of the coiled portion 32a. In some embodiments, the transseptal puncture device 200 may rotate the tissue so that the orientation of the holes 11 is at an angle to the tissue surface. In FIG. 17, the holes 11 on the barrier surface 10 are stretched a sufficient amount (e.g., the diameter of the holes is equal to the diameter D of the puncture member 13a) to cause the barrier surface 10 to surround the outer surface of the puncture member 13a. FIGS. 18-19 show the position of the puncture member when the barrier surface 10 is no longer engaged by the grooves of the puncture member 13a. Rather, the barrier surface 10 surrounds the outer surface of the puncture member 13a. The puncture member 13a or other components of the transseptal puncture device 200 (e.g., a dilator) may be advanced axially through the holes 11 on the barrier surface 10 without the need for a twisting motion. As shown in FIG. 20, when the puncture member 13a is advanced through the hole 11 on the barrier surface 10, other components of the transseptal puncture device 200 or another device may be advanced through the hole 11 and through the lumen 39 of the puncture member 13a.

[0053] 21-26 illustrate various embodiments of puncture members 13a-13e having coiled portions 32a-32e with different pitches, angles, and shapes. For example, puncture member 13b can include a proximal portion 37b of coiled portion 32a that is shorter than proximal portion 37a. In some embodiments, puncture member 13c can include a proximal portion 37c of coiled portion 32a that is curved to potentially reduce the risk of tissue getting caught on proximal portion 37c. In other embodiments, referring to FIG. 24, proximal portion 37d of coiled portion 32d can be short. For example, but not by way of limitation, proximal portion 37d of the groove can have a length that is the same as, approximately the same as, or shorter than the width of the gap.

[0054] In any embodiment, the proximal portion of the gap (i.e., the portion of the gap at the proximal end of the coiled portion) may be straight or generally straight, may be aligned with the axial centerline of the coiled portion, and may have a length that is the same as or about the same as the width of the gap in the proximal portion of the gap, or a length that is less than the width of the gap. In other embodiments, the proximal portion of the gap (i.e., the portion of the gap at the proximal end of the coiled portion) may be straight or generally straight, may be aligned with the axial centerline of the coiled portion, and may have a length that is greater than the width of the gap, including having a length that is 2 times the width of the gap at the proximal portion of the gap, or 2.5 times the width of the gap or more than 2.5 times the width of the gap, or from 2 times or less than 2 times to 5 times or more than 5 times the width of the gap at the proximal portion of the gap. Any of the embodiments disclosed herein may have a cutting edge formed on the gap or at the proximal end of the gap, for example, as shown in FIG. 24.

[0055] 25-26 show an embodiment of a tapered puncture member 13e attached to a flexible proximal body portion 5 (which may be formed from hypotube). In some embodiments, the flexible proximal hypotube may include laser cut cutouts 51 configured to allow the body portion of the puncture member to bend and flex. The various embodiments of the puncture members disclosed herein may be laser cut from standard hypotube and may be made from stainless steel, nitinol, or any other desired material.

[0056] Figures 27-29 show tapered piercing member 13e traversing an exemplary barrier surface 10 held by fingers 8 and 9. Figure 27 shows tapered piercing member 13e being pressed from behind against barrier surface 10. In Figures 28-29, tapered piercing member 13e can be advanced through barrier surface 10, showing coiled portion 32e advancing from behind barrier surface 10.

[0057] 3. Puncture member with transition cutter One major challenge with puncture members is the transition between the coiled portion and the body portion (e.g., hypotube) when they are mated to form the puncture member. In some embodiments, when the coiled portion contacts or joins the body portion, there may be a pinch point that may trap tissue surrounding the small hole created by the puncture member as the coiled portion of the puncture member transitions to the larger rounded body portion. In some embodiments, the transseptal puncture device 300 may include a beveled or sharp edge (e.g., created by grinding an edge on the puncture member) at the transition point between the coiled portion and the body portion of the puncture member. Once the tissue surface reaches the sharp transition, the tissue may be pulled into the sharp transition by the torque and cut. In this way, the puncture member may function as a cutter rather than a hole punch so as not to create any separated tissue that may present other hazards. Some variations of seam rippers used in stitching and sewing use similar features.

[0058] Any embodiment of the transseptal puncture device 300 shown or described below may have any of the components, features, or other details of any other transseptal puncture device embodiment disclosed herein, including but not limited to any of the above transseptal puncture device embodiments, in any combination with any of the components, features, or details of the transseptal puncture device 300 described below. Similarly, any component, feature, or other detail of any other transseptal puncture device disclosed herein may have any of the components, features, or other details of any of the transseptal puncture device embodiments disclosed herein, in any combination with any of the components, features, or details of the transseptal puncture device embodiments disclosed herein.

[0059] FIGURE 30 illustrates an embodiment of a puncture member 13f of a transseptal puncture device 300 having a sharp interface 33 at the transition from the coiled portion 32f to the body portion 36 (which may be solid and / or groove-less). In some embodiments, the sharp interface 33 may include a sharp outer edge configured to cut tissue. Similarly, FIGURES 31-32 illustrate another embodiment of a puncture member 13g having a sharp interface 33 at the transition from the coiled portion 32g to the body portion 36.

[0060] 4. Gripper with needle Additional embodiments of the transseptal puncture device 400 are described below. Any of the embodiments of the transseptal puncture device 400 shown or described below may have any of the components, features, or other details of any of the other transseptal puncture device embodiments disclosed herein, including but not limited to any of the transseptal puncture device embodiments described above, in any combination with any of the components, features, or details of the transseptal puncture device 400 described below. Similarly, any of the components, features, or other details of the other transseptal puncture devices disclosed herein may have any of the components, features, or other details of any of the transseptal puncture device embodiments disclosed herein, in any combination with any of the components, features, or details of the transseptal puncture device embodiments disclosed herein.

[0061] One challenge with conventional mechanical needles is that the forward axial pressure required to puncture a difficult septum can cause excessive "tenting" of tissue, whereby the operator would be concerned about unexpected sudden forward movement of the needle once it pops through the tissue, which could damage other cardiac tissue. Some embodiments of the puncture members disclosed herein may be configured to grasp and hold tissue as a conventional needle would follow from within the puncture member, thus nearly eliminating the risk of any unexpected tenting of tissue and damage to other cardiac tissue.

[0062] During an exemplary transseptal puncture procedure, the dilator 2 of the transseptal puncture device 400 may be used in some embodiments to apply a slight axial forward pressure to the barrier surface 10 to "tent" it as a means to determine the proper position for cross-sectional fluoroscopy and echo, as shown in Figure 33. The transseptal puncture device 400 may include a puncture member 13j that functions as a gripper and is configured to be retracted within the dilator until later advanced for use (see Figure 33).

[0063] The piercing member 13j may be advanced to the barrier surface 10 and then rotated, which may pierce the barrier surface 10 and drive the coil into and across the barrier surface 10. In some embodiments, the coiled portion 32j of the piercing member 13j may hold the barrier surface 10 for piercing by the needle 3, as shown in FIG. 34. The needle 3 may then be advanced through the piercing member 13j, which may pierce and traverse the barrier surface 10 with very little tenting, or significantly less tenting compared to conventional methods, as shown in FIG. 35. A standard traversal procedure may then be followed.

[0064] Any of the embodiments of the transseptal puncture devices disclosed herein (e.g., coil hypotubes, coil hypotube grippers, etc.) may be laser cut from standard hypotubes. As shown in FIGS. 36-37, the transition from the coiled portion 32j to the body portion 36 of the puncture member 13j may be abrupt, as there is little or no coil transition or stretching of the tissue as the transseptal puncture device advances through the tissue. In some embodiments, the coiled portion 32j of this embodiment may be used to hold the tissue as the needle 3 is advanced through the lumen of the puncture member 13j to puncture the septum.

[0065] 38-40 show one embodiment of a transseptal puncture device 400 including a puncture member 13j used to form a puncture through the barrier surface 10 held by fingers 8 and 9. As shown in FIG. 39, the barrier surface 10 may be pressed by the transseptal puncture device from the back side. FIG. 40 shows that the coiled portion 32j of the puncture member 13j may be advanced through the barrier surface 10 and may hold tissue for advancement with the needle 3 as described. Additionally, FIG. 40 shows the needle 3 punctured through the barrier surface 10, and the dilator 2 may also follow and advance through the barrier surface 10.

[0066] 5. Puncture member with spiral guard Additional embodiments of the transseptal puncture device 500 are described below. Any of the embodiments of the transseptal puncture device 500 shown or described below may have any of the components, features, or other details of any of the other transseptal puncture device embodiments disclosed herein, including but not limited to any of the transseptal puncture device embodiments described above, in any combination with any of the components, features, or details of the transseptal puncture device 500 described below. Similarly, any of the components, features, or other details of the other transseptal puncture devices disclosed herein may have any of the components, features, or other details of any of the transseptal puncture device embodiments disclosed herein, in any combination with any of the components, features, or details of the transseptal puncture device embodiments disclosed herein.

[0067] Some embodiments disclosed herein include the use of a standard dilator and sheath in conjunction with a novel atraumatic crossing guidewire that can cross tissue and be atraumatic instead of a standard mechanical needle (which can present some challenges). Figures 41-46 show an exemplary embodiment of a novel crossing guidewire having a helical guard configured to be atraumatic.

[0068] One variation of the transseptal puncture device 500 disclosed herein may include a puncture member 13h having an auger-like corkscrew coiled portion 32h with a sharpened distal tip 31h. The coiled portion 32h may be connected to a body portion 36 (e.g., a flexible hypotube) as shown in FIG. 45. The puncture member 13h may include a helical rounded guard 34 positioned inside the puncture member 13h. In some embodiments, the puncture member 13h may have a diameter of 0.035 inches to fit the guard inside. In some embodiments, the puncture member 13h may be configured to cross the septum when the helical rounded guard 34 is retracted proximally as shown in FIGS. 43 and 44. In some embodiments, the helical rounded guard 34, when advanced distally, can prevent the sharp distal tip 31h from contacting and piercing tissue, as shown in Figures 41 and 42. The helical rounded guard 34 can include a relatively rounded tip 41 (see Figure 47) configured to make atraumatous contact with tissue, allowing the piercing member 13h to atraumatically guide the dilator and sheath with the helical rounded guard 34 advanced.

[0069] 6. Crossing guidewire with guard (general) Additional embodiments of the transseptal puncture device 600 are described below. Any of the embodiments of the transseptal puncture device 600 shown or described below may have any of the components, features, or other details of any of the other transseptal puncture device embodiments disclosed herein, including but not limited to any of the transseptal puncture device embodiments described above, in any combination with any of the components, features, or details of the transseptal puncture device 600 described below. Similarly, any of the components, features, or other details of the other transseptal puncture devices disclosed herein may have any of the components, features, or other details of any of the transseptal puncture device embodiments disclosed herein, in any combination with any of the components, features, or details of the transseptal puncture device embodiments disclosed herein.

[0070] As mentioned above, some aspects of the present disclosure are to use standard dilators and sheaths with novel crossing guidewires that can cross and be atraumatic instead of mechanical needles. Alternative variations of atraumatic crossing guidewires with guards are shown and described below.

[0071] 47 shows an embodiment of a transseptal puncture device 600 including a crossing guidewire 38 with a distal coil guard 35 at its distal end, which is inserted through the puncture member 13h. In some embodiments, the distal coil guard 35a can be a balloon or soft expandable polymer to allow the distal coil guard 35a to be retracted into the puncture member 13h for puncture and advanced out again for protection of the tissue.

[0072] 48 shows an embodiment of a transverse guidewire 38 having a distal coil guard 35b inserted through a piercing member 13h. In some embodiments, the distal coil guard 35b can be a laser cut dilator tube formed into an atraumatic tip. In some embodiments, the distal coil guard 35b can be made from a material such as Nitinol, polymer, or stainless steel and has a cut pattern design that allows the distal coil guard 35b to be retracted into the coil for piercing and advanced back again for protection.

[0073] 49 shows an embodiment of a transverse guidewire 38 having a distal coil guard 35c inserted through a piercing member 13h. In some embodiments, the distal coil guard 35c can be laser cut and shaped or wire formed to form an expandable ball at the distal end of the tip. In some embodiments, the distal coil guard 35c can be made from materials such as Nitinol, polymer, or stainless steel and has a pattern design that allows it to be retracted into the coil for puncture and advanced out again for protection.

[0074] 50 shows an embodiment of a transverse guidewire 38 having a distal coil guard 35d inserted through a piercing member 13h. In some embodiments, the distal coil guard 35d may be formed from a single wire and may create an expandable ball at the distal end of the tip. In some embodiments, the distal coil guard 35d may be made from a material such as Nitinol, polymer, or stainless steel and has a pattern design that allows it to be retracted into the coil for puncture and advanced out again for protection.

[0075] Alternatively, the transseptal puncture device 600 disclosed herein may also include a puncture member 13i in the form of a solid core coil (screw-like) without a guard, as shown in Figures 51 and 52. This embodiment may be used for crossings where the design has control over having low septal tenting. The inner diameter of the puncture member 13i may be increased to gradually increase the size of the hole 11.

[0076] 7. Forming cutting wire (needle) with rotation / vibration Additional embodiments of the transseptal puncture device 700 are described below. Any of the embodiments of the transseptal puncture device 700 shown or described below may have any of the components, features, or other details of any of the other transseptal puncture device embodiments disclosed herein, including but not limited to any of the transseptal puncture device embodiments described above, in any combination with any of the components, features, or details of the transseptal puncture device 700 described below. Similarly, any of the components, features, or other details of the other transseptal puncture devices disclosed herein may have any of the components, features, or other details of any of the transseptal puncture device embodiments disclosed herein, in any combination with any of the components, features, or details of the transseptal puncture device embodiments disclosed herein.

[0077] Rather than applying significant anterior axial pressure to the septum (or FO) with a needle, embodiments of the devices and methods below may apply only slight axial pressure because a rotational or oscillatory motion is added to significantly reduce the axial pressure used to cross the tissue.

[0078] 53 and 54 show an embodiment of a transseptal puncture device 700 that includes a shaped cutting wire 50. The shaped cutting wire 50 includes a sharpened needle tip 55, which may be a hypodermic needle tip. In some embodiments, the shaped cutting wire 50 may include one or more cutouts 52 on the sharpened needle tip 55 to create serrated tips or teeth 54 and 53. When rotation or vibration is applied, the teeth 54 and 53 may easily and quickly cut through tough septal tissue.

[0079] 55-58 show another embodiment of a transseptal puncture device 700 that includes a shaped cutting wire 60. The shaped cutting wire 60 can include a hooked tip 61 with a cut-away portion 62. The hooked tip 61 and cut-away portion 62 of the shaped cutting wire 60 can be used to pull and cut its way through tough septal tissue when rotation or vibration is applied.

[0080] FIG. 59 shows another embodiment of a transseptal puncture device 700 including a shaped cutting wire 70 with a coiled tip 71 that may pull and cut its way through tough septal tissue when rotation or vibration is applied.

[0081] 60 and 61 show another embodiment of a transseptal puncture device 700 that includes a shaped cutting wire 80 that includes a (e.g., sharp) hypodermic syringe 81 at the distal end and small serrations 82 added to the sharp face or edge of the hypodermic syringe 81. The serrations 82 can saw or cut their way through the septal tissue when rotation or vibration is applied.

[0082] 8. Ultrasonic forming and cutting wire (needle) One disadvantage of rotating or oscillating a needle through tissue may be the number of cycles required to pierce difficult tissue. Another aspect of the present disclosure includes an electromechanical motion generator configured to reduce the pressure that needs to be applied by the operator to pierce through tissue and improve the operator's user experience. An ultrasonic mechanical oscillator or other form of electromechanical vibration may be used, similar to, but not limited to, an ultrasonic oscillator as used in sonic toothbrushes. Any embodiment of the transseptal puncture device described herein may be configured to include an ultrasonic oscillator that selectively vibrates at least a distal portion of the transseptal puncture device.

[0083] Although specific embodiments of the present invention have been described, these embodiments are presented for illustrative purposes only and are not intended to limit the scope of the present disclosure. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions, and modifications may be made to the systems and methods described herein without departing from the inventive spirit of the present disclosure. The appended claims and their equivalents are intended to cover such forms or modifications as are within the scope and spirit of the present disclosure. Accordingly, the scope of the present invention is defined solely by reference to the appended claims.

[0084] It should be understood that features, materials, properties, or groups described in connection with a particular aspect, embodiment, or example are applicable to any other aspect, embodiment, or example described in this section or elsewhere in this specification, unless inconsistent. All of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), and / or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. Protection is not limited to the details of any of the foregoing embodiments. Protection extends to any novel, or any novel combination of features disclosed in this specification (including any accompanying claims, abstract, and drawings), or any novel, or any novel combination of steps of any method or process so disclosed.

[0085] Moreover, certain features described in the present disclosure in the context of separate implementations may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented in multiple implementations separately or in any suitable subcombination. Furthermore, although some features may be described above as functioning in a particular combination, one or more features from the claimed combination may in some cases be excluded from the combination, and the combination may be claimed as a subcombination or a variation of the subcombination.

[0086] Furthermore, although operations may be shown in the figures or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order to achieve desirable results, nor need all operations be performed. Other operations not described or illustrated may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Furthermore, in other implementations, operations may be rearranged or reordered. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the illustrated and / or disclosed processes may differ from those shown in the figures. Depending on the embodiment, some of the above steps may be removed and other steps may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which are within the scope of the present disclosure. It should also be understood that the separation of various systems in the above implementations is not to be understood as requiring such separation in all implementations, and that the components and systems described may generally be integrated together in a single product or packaged in multiple products.

[0087] For purposes of this disclosure, certain aspects, advantages, and novel features have been described herein. Not necessarily all such advantages may be realized by any particular embodiment. Thus, for example, one skilled in the art will recognize that the present disclosure may be embodied or carried out in a manner that achieves one advantage or group of advantages as taught herein, without necessarily achieving other advantages as may be taught or suggested herein.

[0088] Conditional language such as "can," "could," "might," or "may," unless otherwise specified or understood otherwise within the context in which it is used, is generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not include certain features, elements, and / or steps. Thus, such conditional language is not generally intended to imply that the features, elements, and / or steps are required in any way for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps are included in or performed in any particular embodiment, with or without user input or prompting.

[0089] Unless otherwise noted, conjunctive language such as the phrase "at least one of X, Y, and Z" is understood in the context as it is commonly used to convey that an item, term, etc. can be either X, Y, or Z. Thus, such conjunctive language is generally not intended to imply that at least one of X, at least one of Y, and at least one of Z must be present in a particular embodiment.

[0090] As used herein, degree language, such as the terms "approximately," "about," "generally," and "substantially," refers to a value, amount, or characteristic that is close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to an amount that is within 10%, 5%, 1%, 0.1%, and 0.01% of the stated amount. As another example, in certain embodiments, the terms "generally parallel" and "substantially parallel" refer to a value, amount, or characteristic that deviates from strict parallelism by no more than 15 degrees (°), 10 degrees (°), 5 degrees (°), 3 degrees (°), 1 degree (°), or 0.1 degrees (°). The ranges disclosed herein also encompass any and all overlaps, subranges, and combinations thereof, as well as any specific values ​​within those ranges. Words such as "up to," "at least," "greater than," "less than," "between," and the like include the recited numbers. Numbers and values ​​used herein preceded by terms such as "about" or "approximately" include the recited numbers. For example, "approximately 7 mm" includes "7 mm," and numbers and ranges preceded by terms such as "about" or "approximately" should be interpreted as disclosing the numbers and ranges with or without such terms before the numbers or values, and thus, the present application supports the claiming of numbers, values, and ranges disclosed in the specification and / or claims with or without terms such as "about" or "approximately" before such numbers, values, or ranges, for example, "approximately two times to approximately five times" also includes the disclosure of the range "two times to five times."The scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere herein, but may be defined by the claims, as presented in this section or elsewhere herein, or as presented in the future. The language of the claims should be interpreted broadly based on the language used in the claims, and not limited to the examples described herein or during prosecution of the application, which examples should be interpreted as non-exclusive.

[0091] [Embodiment] (1) A transseptal puncture device for creating a hole in a patient's septum, comprising: A long and slender body portion, a coiled portion distal to the body portion, the coiled portion having a distal end and a proximal end, the proximal end being closer to the body portion; a longitudinally extending lumen extending axially through an entire length of the elongated body portion and the coiled portion; the distal end of the coiled portion is sharp; The device is configured to create an opening in the septum of the patient by advancing the distal end of the coiled portion into contact with the septum and rotating the device in a first direction. (2) The device of embodiment 1, wherein the coiled portion comprises a helical wall having an axial thickness of the transseptal puncture device that increases along the length of the coiled portion from the distal end of the coiled portion to the proximal end of the coiled portion so as to increase the size of the opening in the septum as the coiled portion of the device advances through the opening in the septum. (3) The device of embodiment 2, wherein the thickness of the axial helical wall at the proximal end of the coiled portion is equal to or greater than the outer diameter of the coiled portion at the proximal end of the coiled portion. (4) The device of embodiment 2, wherein the thickness of the axial helical wall at the proximal end of the coiled portion adjacent the proximal end of the coiled portion is at least twice the thickness of the axial helical wall at the distal end of the coiled portion adjacent the distal end of the coiled portion. (5) The device of any one of claims 1 to 4, wherein the coiled portion includes a gap between adjacent coils of the helical wall, the gap having a constant axial width along the length of the coiled portion from the distal end of the coiled portion to the proximal end of the coiled portion.

[0092] (6) The device of embodiment 5, wherein the gap comprises a distal gap portion located at a distal portion of the coiled portion and between adjacent coils of the helical wall, and a proximal gap portion located proximal to the distal gap portion. (7) The device of embodiment 6, wherein the proximal gap portion is located at or adjacent to a transition portion of the transseptal puncture device, the transition portion being between the main body portion and the coiled portion. (8) The device of embodiment 6, wherein the proximal gap portion extends in an axial direction generally aligned with an axially extending centerline of the coiled portion. (9) The device of claim 6, further comprising a transition gap portion between the proximal gap portion and the distal gap portion, wherein an angle of the transition gap portion relative to an axial centerline of the coiled portion is different from an angle of the distal gap portion relative to the axial centerline of the coiled portion. (10) The device of any one of embodiments 1 to 9, wherein the coiled portion includes a gap between adjacent coils of the helical wall, the gap having a pitch or angle relative to an axial centerline of the coiled portion that decreases along the length of the coiled portion from the distal end of the coiled portion to the proximal end of the coiled portion as the thickness of the helical wall increases along the length of the coiled portion from the distal end of the coiled portion to the proximal end of the coiled portion.

[0093] (11) The device according to any one of embodiments 1 to 10, wherein at least the body portion of the transseptal puncture device is flexible. (12) The device of any one of the preceding claims, further comprising a transition portion between the body portion and the coiled portion, the transition portion having a sharp outer edge. (13) The device of any one of embodiments 1 to 12, wherein the lumen extending through the body portion and the coiled portion is configured to receive a guidewire or needle therein. (14) The device described in any one of embodiments 1 to 13, further comprising a needle configured to move axially through the body portion and the coiled portion within the lumen. (15) The device of any of embodiments 1 to 14, further comprising a spiral guard having a guard body portion and a guard spiral portion, the spiral guard configured to move axially within the lumen through the body portion and the coiled portion, and a distal end of the guard spiral portion configured to be blunt or atraumatic.

[0094] (16) A device as described in any one of the preceding claims, wherein the guard spiral portion is configured such that the coiled portion and the guard spiral portion intertwine when the guard spiral portion is advanced through the coiled portion. (17) The device of any one of embodiments 1 to 16, further comprising a distal coil guard configured to retractably extend out from the distal end of the coiled portion, the distal end of the distal coil guard being configured to be blunt or atraumatic. (18) The device described in any one of embodiments 1 to 17, further comprising a removable cover disposed at the distal end of the coiled portion. (19) The device of any one of claims 1 to 18, wherein at least the coiled portion is laser cut from a tube. (20) The device of any one of the preceding embodiments, wherein the distal portion of the coiled portion further comprises serrations along one or more edges of the coiled portion.

[0095] (21) The device of any one of embodiments 1 to 20, wherein the distal portion of the coiled portion further comprises a hook-shaped tip. (22) The device described in any one of embodiments 1 to 21, wherein the coiled portion is formed from a wire or ribbon. (23) The device described in any one of embodiments 1 to 22, further comprising an electromechanical motion generator coupled to the body portion. (24) A transseptal puncture method, comprising: advancing a coiled portion of the transseptal puncture device into contact with a septum within the patient's heart; rotating the transseptal puncture device in a first direction to cause the coiled portion of the transseptal puncture device to puncture the transseptal puncture device; further rotating the transseptal puncture device in the first direction to advance the coiled portion of the transseptal puncture device through the septum such that a wall of the septum surrounds at least a portion of the coiled portion of the transseptal puncture device; further rotating the transseptal puncture device to increase the size of the hole in the wall of the septum; and continuing to advance the transseptal puncture device to transition the wall of the septum from surrounding the coiled portion of the transseptal puncture device to surrounding an outer surface of a body portion of the transseptal puncture device. (25) The method of embodiment 24, further comprising penetrating the septum by extending a needle through the coiled portion of the transseptal puncture device to create the hole in the wall of the septum prior to puncturing the septum with the coiled portion of the transseptal puncture device.

[0096] (26) The method of embodiment 24 or 25, further comprising extending a blunt guard through the coiled portion of the transseptal puncture device prior to advancing the coiled portion of the transseptal puncture device into contact with the septum to prevent the transseptal puncture device from inadvertently puncturing or cutting the septum. (27) The method of any one of embodiments 24 to 26, further comprising applying vibrations to the coiled portion of the transseptal puncture device to expand the size of the hole in the wall of the septum. (28) The method of any one of embodiments 24 to 27, further comprising actuating the transseptal puncture using an electromechanical motion generator. (29) A method of puncturing a septum substantially as herein described or shown in the accompanying drawings. (30) A device configured to puncture a tissue wall substantially as herein described or shown in the accompanying drawings.

Claims

1. 1. A transseptal puncture device for creating a hole in a patient's septum, comprising: A long and slender body portion, a coiled portion distal to the body portion, the coiled portion having a distal end and a proximal end, the proximal end being closer to the body portion; a longitudinally extending lumen extending axially through an entire length of the elongated body portion and the coiled portion; the distal end of the coiled portion is sharp; The device is configured to create an opening in the septum of the patient by advancing the distal end of the coiled portion into contact with the septum and rotating the device in a first direction.

2. 2. The device of claim 1, wherein the coiled portion comprises a helical wall having an axial thickness of the transseptal puncture device that increases along the length of the coiled portion from the distal end of the coiled portion to the proximal end of the coiled portion so as to increase the size of the opening in the septum as the coiled portion of the device advances through the opening in the septum.

3. The device of claim 2 , wherein the thickness of the helical wall in the axial direction at the proximal end of the coiled portion is equal to or greater than an outer diameter of the coiled portion at the proximal end of the coiled portion.

4. 3. The device of claim 2, wherein the thickness of the axial helical wall at the proximal end of the coiled portion adjacent the proximal end of the coiled portion is at least twice the thickness of the axial helical wall at the distal end of the coiled portion adjacent the distal end of the coiled portion.

5. 5. The device of claim 1, wherein the coiled portion comprises a gap between adjacent coils of the helical wall, the gap having a constant axial width along the length of the coiled portion from the distal end of the coiled portion to the proximal end of the coiled portion.

6. 6. The device of claim 5, wherein the gap comprises a distal gap portion located at a distal portion of the coiled portion and between adjacent coils of the helical wall, and a proximal gap portion located proximal to the distal gap portion.

7. The device of claim 6 , wherein the proximal gap portion is located at or adjacent a transition portion of the transseptal puncture device, the transition portion being between a body portion and the coiled portion.

8. The device of claim 6 , wherein the proximal gap portion extends in an axial direction generally aligned with an axially extending centerline of the coiled portion.

9. 7. The device of claim 6, further comprising a transition gap portion between the proximal gap portion and the distal gap portion, the angle of the transition gap portion relative to an axial centerline of the coiled portion being different than the angle of the distal gap portion relative to the axial centerline of the coiled portion.

10. 2. The device of claim 1, wherein the coiled portion comprises a gap between adjacent coils of the helical wall, the gap having a pitch or angle relative to an axial centerline of the coiled portion that decreases along the length of the coiled portion from the distal end of the coiled portion to the proximal end of the coiled portion as the thickness of the helical wall increases along the length of the coiled portion from the distal end of the coiled portion to the proximal end of the coiled portion.

11. The device of claim 1 , wherein at least the body portion of the transseptal puncture device is flexible.

12. The device of claim 1 , further comprising a transition portion between the body portion and the coiled portion, the transition portion comprising a sharp outer edge.

13. The device of claim 1 , wherein the lumen extending through the body portion and the coiled portion is configured to receive a guidewire or needle therein.

14. The device of claim 1 , further comprising a needle configured to move axially within the lumen through the body portion and the coiled portion.

15. 10. The device of claim 1, further comprising a helical guard comprising a guard body portion and a guard helix portion, the helical guard configured to move axially within the lumen through the body portion and the coiled portion, and a distal end of the guard helix portion configured to be blunt or atraumatic.

16. The device of claim 1 , wherein the guard spiral portion is configured such that the coiled portion and the guard spiral portion intertwine when the guard spiral portion is advanced through the coiled portion.

17. 10. The device of claim 1, further comprising a distal coil guard configured to retractably extend out from the distal end of the coiled portion, the distal end of the distal coil guard configured to be blunt or atraumatic.

18. The device of claim 1 , further comprising a removable cover disposed on the distal end of the coiled portion.

19. The device of claim 1 , wherein at least the coiled portion is laser cut from a tube.

20. The device of claim 1 , wherein the distal portion of the coiled portion further comprises serrations along one or more edges of the coiled portion.

21. The device of claim 1 , wherein the distal portion of the coiled portion further comprises a hook-shaped tip.

22. The device of claim 1 , wherein the coiled portion is formed from a wire or ribbon.

23. The device of claim 1 , further comprising an electromechanical motion generator coupled to the body portion.

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