WO2019035993A1

WO2019035993A1 - Steerable endoluminal punch with cutting stylet

Info

Publication number: WO2019035993A1
Application number: PCT/US2018/000274
Authority: WO
Inventors: Jay A. Lenker; James A. Carroll; Eugene M. BREZNOCK
Original assignee: Indian Wells Medical, Inc.
Priority date: 2017-08-16
Filing date: 2018-08-16
Publication date: 2019-02-21

Abstract

An endoluminal punch with distal end configured to articulate laterally away from the longitudinal axis of the endoluminal punch. The transseptal needle is configured for use with an introducer which can also include side windows.

Description

STEERABLE ENDOLUMINAL PUNCH WITH CUTTING STYLET

Field of the Inventions

[ 0001 ] The invention relates to devices and methods for performing endo vascular access to the cardiovascular system or other body vessels or body lumens, especially procedures performed in the fields of cardiology, radiology, electrophysiology, and surgery.

Background

[ 0002 ] The currently accepted procedure for left atrial access involves routing a needle called a Brockenbrough needle into the right atrium with the Brockenbrough needle pre-placed within a guiding catheter. The guiding catheter specifically preferred for use with a Brockenbrough needle is called a Mullins catheter or transseptal introducer. The

Brockenbrough needle is a long, small diameter punch, generally formed from a stainless steel wire stylet that is surrounded by a stainless steel tube.

Summary

[ 0003 ] The devices and methods described below provide for improved left atrial access with an endoluminal punches with a distal tip that can be inserted through the vasculature in a first, blunt configuration and transitioned to a sharp configured after being located proximate the left atrium. Additional devices and methods described below provide for improved left atrial access with an endoluminal punch which includes a sharp central stylet with an expandable structures (expandable upon distal translation from the punch proper) to increase its effective diameter where it projects out the distal end of the endoluminal punch. The central stylet may be rotatable, so that it may be operated to enlarge an initial perforation of the interatrial septum, thereby easing passage of the punch and/or a dilator. Additional devices and methods provide for lateral support of a steered endoluminal punch within the vena cava, so that longitudinal translation of the punch within an accompanying guide catheter/sheath better results in lateral movement of the tip of the punch to the interatrial septum. Brief Description of the Drawings

[ 0004 ] Figure 1 illustrates a side view of a trans-septal punch assembled so that the inner tube is bent in a direction 180 degrees opposite that of the outer tube, resulting in a substantially straight punch configuration, according to an embodiment of the invention;

[ 0005 ] Figure 2 illustrates a side view of the disassembled trans-septal punch showing the central core wire or stylet, the inner tube bent in one direction and the outer tube bent in another direction, according to an embodiment of the invention;

[ 0006 ] Figure 3 illustrates a side view of the trans-septal punch assembled so that the inner tube bend is aligned in the same direction as the outer tube bend, resulting in a curved distal end on the punch assembly, according to an embodiment of the invention;

[ 0007 ] Figure 4 illustrates a side view of a trans-septal punch comprising a flexible region proximal to the distal end and pull-wires disposed between the distal end and the proximal end of the punch, according to an embodiment of the invention;

[ 0008 ] Figure 5 illustrates a side view of the trans-septal punch of Figure 4 wherein one of the pull-wires is placed in tension causing the distal flexible region of the punch to deflect into an arc away from the longitudinal axis of the punch, according to an embodiment of the invention;

[ 0009 ] Figure 6 illustrates an adjustable, spacer, which sets and maintains the distance between the distal end of the punch hub and the proximal end of a guide catheter hub, according to an embodiment of the invention;

[ 0010 ] Figure 7 A illustrates a side, partial breakaway, view of an outer tube of an articulating trans-septal punch comprising a plurality of slots near the distal end to generate a region of increased flexibility, according to an embodiment of the invention;

[ 0011 ] Figure 7B illustrates a side, partial breakaway, view of an intermediate, or inner, tube of an articulating trans-septal punch comprising a longitudinal slot dividing the tube into two axially oriented parts which are connected at the distal end of the inner tube, according to an embodiment of the invention; [ 0012 ] Figure 8 illustrates a cross-sectional view of the proximal end of the articulating trans-septal punch comprising a stopcock and a bend adjusting mechanism, according to an embodiment of the invention;

[ 0013 ] Figure 9 illustrates a partial breakaway view of the distal end of the

articulating trans-septal punch comprising the outer tube and the inner tube arranged concentrically and oriented circumferentially, according to an embodiment of the invention;

[ 0014 ] Figure 10 illustrates an oblique view of the proximal end of the articulating trans-septal punch, according to an embodiment of the invention;

[ 0015 ] Figure 11 illustrates a side view of the distal end of the articulating trans- septal punch incorporating a control rod and a control rod retainer, separated from each other, and the outer T-slotted tube with the inner tube being pulled proximally relative to the outer tube causing the outer tube to deform into a curve having very stiff, or rigid, mechanical properties, according to an embodiment of the invention;

[0016 ] Figure 12A illustrates a side, partial cutaway view of an introducer sheath comprising a window in its side wall proximate the distal end and further comprising a window in the side wall of the dilator in the same region as the window in the side wall of the introducer, according to an embodiment of the Invention;

[ 0017 ] Figure 12B illustrates a side view of the punch system wherein an articulating endoluminal punch, in its straightened configuration, has been advanced such its distal end and articulating portion are aligned with the side windows of the sheath and dilator, according to an embodiment of the invention;

[0018] Figure 12C illustrates a view of the punch system of Figure 12B wherein the punch has been articulated sideways through the side window, further wherein the support structure provides backup support for the punch to allow lateral force to be applied to tissue being incised, according to an embodiment of the invention;

[ 0019 ] Figure 13 A illustrates a steerable endoluminal punch having a distal end that can be reconfigured from a first, more blunted or atraumatic shape (as illustrated) into a second shape, which is configured to be sharper and more capable of cutting tissue, according to an embodiment of the invention; [ 0020 ] Figure 13B illustrates the reconfigurable distal end of the steerable endoluminal punch with its distal end having been reconfigured into a sharper shape, according to an embodiment of the invention;

[ 0021 ] Figure 13C illustrates the punch of Figure 13B wherein the stylet control rod has been advanced distally;

[ 0022 ] Figure 14A illustrates the distal end of a steerable endoluminal punch comprising a conic section; according to an embodiment of the invention;

[ 0023 ] Figure 14B illustrates the distal end of a steerable endoluminal punch which includes the conic section of Figure 14A combined with a bevel to create a sharp edge that is displaced radially inward from the outer diameter of the steerable endoluminal punch, according to an embodiment of the invention;

[ 0024 ] Figure 15 illustrates the distal end of a steerable endoluminal punch comprising a blunted stylet that protects the walls of a catheter from the sharp edge of the endoluminal punch, according to an embodiment of the invention;

[ 0025 ] Figure 16 illustrates a steerable endoluminal punch being used to access the fossa ovalis of the heart by way of a superior approach through the superior vena cava and an access point cranial to the superior vena cava, according to an embodiment of the invention;

[ 0026 ] Figure 17A illustrates a steerable endoluminal punch having a 4-pointed crown-shaped sharp distal end configured to penetrate tissue with and without the use of a central punch, according to an embodiment of the invention; and

[ 0027 ] Figure 17B illustrates a steerable endoluminal punch having a two-point crown-shaped sharp distal end configured to penetrate tissue with and without the use of a central punch, according to an embodiment of the invention.

[ 0028 ] Figures 18A and 18B illustrates the distal end of a steerable endoluminal punch system comprising a cutting stylet with laterally biased wires or blades.

[ 0029 ] Figures 19A and 19B illustrate a cutting introducer. Detailed Description

[ 0100 ] Figure 1 illustrates a side view of a punch, needle, or catheter assembly 100, with an integral articulating or bending mechanism. The punch assembly 100 comprises a stylet or obturator wire 102, an inner tube 104, an outer tube 106, an obturator grasping tab 108, a stopcock 1 10, an inner tube pointer 1 12, an outer tube pointer 1 14, an inner tube hub 1 16, and an outer tube hub 118.

[ 0101 ] Referring to Figure 1, the obturator wire 102 is affixed to the obturator grasping tab 108. The stylet or obturator wire 102 is inserted through the central lumen of the inner tube 104 and is slidably disposed therein. The stopcock 1 10 is affixed to the inner tube hub 1 16 and the through lumen of the stopcock 1 10 is operably connected to the central lumen of the inner tube 104. The inner tube pointer 112 is affixed to the inner tube hub so that it is visible to the user. The outer tube pointer 114 is affixed to the outer tube hub 118 so that it is visible to the user. The inner tube hub 1 16 and the inner tube 104 are able to rotate about the longitudinal axis within the outer tube hub 1 18 and the outer tube 106. In an embodiment, the inner tube 104 is restrained from longitudinal motion relative to the outer tube 106. In this embodiment and other embodiments in which the inner tube is fixed to the outer tube, the inner tube may be longitudinally fixed to the outer tube at a point distal to the "flexible region" of the outer tube, but not longitudinally fixed to the outer tube at any point proximal to the "flexible region" so that the inner tube and outer tube can be tensioned relative to each other to affect bending of the "flexible region." The distal end of the inner tube 104 can be sharpened and serve as a punch. The distal end of the inner tube 104 is sheathed inside the outer tube 106 to protect the tissue from the sharp distal edge of the inner tube 104 until the inner tube 104 is advanced distally outside the distal end of the outer tube 106. Figure 2 illustrates a side view of a stylet or obturator 140 further comprising the obturator wire 102 and the obturator-grasping tab 108. The obturator wire 102 is blunted at its distal end to render it as atraumatic as possible. In another embodiment, the obturator wire 102 can be tapered in diameter to render it very flexible and therefore atraumatic at its distal end. The obturator wire 102, in another embodiment, can be sharpened and serve as a needle or primary punching mechanism. Figure 2 also illustrates an intermediate punch assembly 120 further comprising the inner tube 104, the stopcock 110, the inner tube pointer 112, the inner tube hub 1 16, an inner tube seal 124, an inner tube pointer ball 126, a through lumen port 128, a beveled distal tip 132, and a pre-set curve 136. Figure 2 further illustrates an outer tube assembly 122 further comprising the outer tube 106, the outer tube hub 118, the outer tube pointer 114, an outer tube distal curve 130, and an outer tube pointer ball 134.

[ 0102 ] The inner tube hub 1 16 further comprises a circumferential groove with an "O" ring 124 affixed thereto. The "O" ring 124 serves to form a fluid (e.g. air, blood, water) tight seal with the inner diameter of the outer sheath hub 118 central lumen and allows for circumferential rotation of the inner tube hub 116 within the outer tube hub 1 18. The "O" ring 124 can be fabricated from rubber, silicone elastomer, thermoplastic elastomer, polyurethane, or the like and may be lubricated with silicone oil or similar materials. The stopcock 1 10 can be a single way or a three-way stopcock without or with a sideport, respectively.

[ 0103 ] Figure 3 illustrates a side view of the punch assembly 100 fully assembled and aligned so that both the inner tube distal curve 136 (Refer to Figure 2) and the outer tube distal curve 130 are aligned in the same direction resulting in a natural bend out of the axis of the punch 100. The punch assembly 100 comprises the obturator wire 102, the inner tube 104, the outer tube 106, the obturator grasping tab 108, the stopcock 1 10, the inner tube pointer 112, the outer tube pointer 1 14, the inner tube hub 1 16, the inner tube pointer ball 126, and the outer tube pointer ball 134.

[0104 ] Referring to Figure 3, the outer tube pointer 1 14 and inner tube pointer 1 12 are aligned together and in this configuration, the tubing assembly possesses its maximum curvature, which is oriented in the same directions as the pointers 112 and 1 14. The pointer balls 126 and 134 are aligned together to provide additional tactile and visual indices of curvature direction. In an embodiment, the curvature of the tube assembly 104 and 106 is unbiased with no net force exerted therebetween and an angle of approximately 45 degrees is subtended by the device in the illustrated configuration. Further curvature can also occur out of the plane of the page so that the curvature takes on a 3 -dimensional shape, somewhat similar to a corkscrew. In another embodiment, the curvature of the aligned inner tube 104 and the outer tube 106 subtends an angle of 90-degrees or greater. Again, the inner tube 104 and the outer tube 106 have stiffness sufficient that the assembly is capable of guiding any catheter through which the punch 100 is passed.

[0105 ] Figure 4 illustrates a side view of another embodiment of a needle or punch assembly 400 comprising an obturator wire 102, an obturator wire grasping tab 108, a stopcock 110, an inner tube 404, an outer tube 406, a plurality of deflecting wires 412, an outer tube hub 414, a deflecting lever 416, a weld 420, an axis cylinder 424, a plurality of deflecting wire channels 426, and a flexible region 430. The distal end of the region just proximal to the flexible region 430 is shown in breakaway view. Furthermore, the distal end of the region just proximal to the flexible region 430 as well as the flexible region 430 has been expanded in scale so that certain details are more clearly visible.

[0106 ] Figure 5 illustrates a side view of the punch assembly 400 wherein the deflecting lever 416 has been withdrawn proximally causing increased tension in one of the deflecting wires 412, causing the flexible region 430 to bend 422 out of the longitudinal axis. The punch assembly 400 further comprises the obturator wire 102, the obturator wire grasping tab 108, the stopcock 1 10, the deflecting lever 416, an axis cylinder 424, the hub 414, the outer tube 406, the inner tube 404, and the bend 422.

[0107 ] Figure 6 illustrates a side view of an adjustable spacer 600 interconnecting a guide catheter 620 and a punch assembly 100. The spacer 600 further comprises a proximal connector 602, a rotating nut 604, an inner telescoping tube 608, a threaded region 606, a distal locking connector 610, and an outer telescoping tube 614. The guide catheter further comprises a tube 622, a hub 624, and a proximal connector 626. The punch assembly 100 further comprises the stopcock 110, the distal rotating locking connector 612, the inner tube pointer 1 12, the outer tube pointer 1 14, and the inner tube hub 1 16. The spacer 600 can comprise an optional slot 630.

[ 0108 ] Figure 7A illustrates a side view, in partial breakaway, of the distal end of an axially elongate outer tube 710, comprising a lumen 714, a proximal, uncut portion 712, a plurality of lateral partial cuts 716, and a plurality of longitudinal "T" cuts 718, according to an embodiment.

[0109 ] Figure 7B illustrates an embodiment of a side view, in partial breakaway, of the distal end of an axially elongate inner tube 720, comprising a lumen 724, a proximal, uncut portion 722, a longitudinal slot 726 further comprising an angled lead in 728, a free side 734, a pusher or connected side 732, and a distal tip 730.

[0110] Figure 8 illustrates a side, cross-sectional view of an embodiment of a hub end 800 of an articulating septal punch. The hub end 800 comprises the outer tube 710, the inner tube 720, a hub body 802, a stopcock petcock 804 further comprising a petcock handle 808 and a petcock through bore 806, a Luer lock fitting 812, an arrow pointer 810, a keyed lumen 834, a setscrew or pin 820, a jackscrew body 816 further comprising a plurality of threads 828 and a central lumen 832, a control knob 814 further comprising a plurality of threads 818, a central lumen 830, the protrusion 838, and a circumferential recess 822, an outer tube weld 824, an orientation mark 840, and an inner tube weld 826. The hub body 802 can further comprise a plurality of recesses or complementary structures 836.

[0111] Figure 10 illustrates an oblique external view of an embodiment of the proximal end 800 of the steerable trans-septal needle comprising the outer tube 710, the knob 814, the hub body 802, the arrow pointer 810 further comprising the pointed end 1004, a stopcock body 1006, the petcock 804, the petcock handle 808, and the Luer fitting 812 further comprising a locking flange 1002.

[0112] Figure 11 illustrates an embodiment of the distal end 900 of the articulating trans- septal needle in a curved configuration. The distal end 900 comprises the outer tube 710, the inner tube 720, the outer tube lumen 714, the distal end of the proximal region of outer tube 712, the distal end 730 of the inner tube 720 further comprising the sharpened distal tip 1 102, the plurality of outer tube longitudinal cuts or slots 718, and the plurality of outer tube partial lateral cuts 716.

[0113] Figure 12A illustrates a side view of a Side Window Introducer system 4900, configured to deliver a steerable endoluminal punch or needle, in partial cutaway section. The Side Window Introducer system 4900 comprises a sheath 4902 with a sheath side window 4906 and optionally, a dilator 4904 with a dilator side window 4908.

[ 0114 ] The sheath 4902 comprises the side window 4906. The dilator 4904 also comprises the side window 4908. Both windows 4906 and 4908 can be aligned so that the endoluminal punch 4910 can bend out of the longitudinal axis, as shown in Figure 12C.

[ 0115 ] Figure 12B illustrates a side view of the introducer system 4900 in partial breakaway view, wherein a steerable endoluminal punch or needle 4910 has been inserted and resides with its distal end within the area of the windows 4906 and 4908. The

endoluminal punch 4910 tip can be aligned such that the entire bendable region of the endoluminal punch 4910 or a portion thereof is disposed within the windows 4906 and 4908 and thus permitted to articulate to at least some degree. [0116] Figure 12C illustrates the steerable endoluminal punch or needle 4910 being articulated out through the side windows 4906 and 4908. With the sheath 4902 and dilator 4904 positioned within a body vessel, the sheath can provide a backstop to permit the needle 4910 to be pushed laterally against tissue to effect a perforation. Having both the region distal to, and proximal to, the bendable region of the needle 4910 provides for more backstop than if just the region proximal to or distal to the needle 4910 are secured against a wall of a body vessel or lumen.

[ 0117 ] In use, the sheath 4902 and the dilator 4904 can be inserted into the body lumen and the dilator 4904 can be removed from the lumen of the sheath 4902 before inserting the needle 4910. In this method, the needle 4910 bendable region need be aligned within the sheath window 4906 without worry about alignment of the dilator window 4908. Such alignment can be controlled, of course, at the hub end of the sheath 4902 and dilator 4904 with alignment keys or rotational positioning devices as well as longitudinal stops or keys.

[ 0118 ] Figure 13A illustrates a steerable endoluminal punch or needle 5000 comprising an outer tube 5004, a composite inner tube and pull rod 5002, which further comprises a lumen 5006, an end cap comprising a sharp tip 5008, a hinge region 5012, and a gap 5010.

[ 0119 ] The hinge 5012 connects the inner tube 5002 to the end cap 5008 and permits rotational motion about the axis of the hinge while retaining the end cap 5008 firmly affixed to the inner tube 5002 distal end.

[0120] Figure 13B illustrates the punch 5000 of Figure 13A wherein a stylet 5014 or other control rod has been inserted into the lumen 5006 (See Figure 13 A) such that the stylet distal end resides adjacent the sharp, hinged end cap 5008.

[ 0121 ] Figure 13C illustrates the punch 5000 of Figure 13B wherein the stylet control rod 5014 has been advanced distally bending the hinge 5012, widening the gap 5010, and causing the sharp tip of 5008 to be more distally forward oriented such that the sharp tip of 5008 is now in a configuration to cut tissue upon application of distal axial movement than in its non- bent condition of Figures 13A and 13B. The hinge 5012 can be a flexible strip of metal, polymer, etc. or it can comprise a pin and interlocking receivers for each side. The hinge 5012 can be spring biased, magnetically biased, or the like. The end cap, or any of the other structures, can further comprise radiopaque markers (not shown) such as, but not limited to, tantalum, platinum, platinum iridium, gold, barium sulfate, and the like. [ 0122 ] Figure 14A illustrates a first step in generating a sharp distal end on a tissue punch 5100 comprising an outer tube 5104, an inner tube 5102, and a truncated conical region 5106 at its distal end 5108.

[ 0123 ] The conical region traverses from the OD of the tube to the ID of the tube and provides increasing sharpness by minimizing the remaining wall thickness at the distal end. This reduced wall thickness also reduces any shoulders that might be forced against tissue to be perforated and might therefore resist said tissue perforation. Ideally, the distal remaining wall thickness is approximately 0.001 or less.

[ 0124 ] Figure 14B illustrates a second step in generating a sharp distal end on a tissue punch 5100 comprising the outer tube 5104, the inner tube 5102, a bevel 51 10, the truncated conical region 5106, and a rounded, dulled heel region 51 12.

[ 0125 ] The angle of the bevel 51 10 can range between about 50 degrees and about 10 degrees with a preferred angle range of about 40 and 25 degrees.

[ 0126 ] Figure 15 illustrates the distal end of a steerable endoluminal punch 5100 comprising the outer tube 5104, the inner tube 5102, the heel 51 12, the conic section 5106, the sharp tip 5108, and a blunt protective stylet 5202 further comprising a blunt, rounded end 5204, and a hub (not shown). The blunt protective stylet 5202 need not project too far out the front of the distal end of the punch 5100 because it could cause procedural problems, if too long. The blunt protective stylet 5202 can project between about 1mm and about 10mm with a preferred range of about 2mm to about 6mm. Larger diameter stylets 5202 present a reduced gap between the stylet and the point of the needle and are thus, more protective than smaller diameter stylets 5202.

[0127 ] Figure 16 illustrates a section of a human heart 5300 comprising a left atrium 5308, a superior vena cava 5304, a right atrium 5302, an inferior vena cava 5306, and an interatrial septum 5301. Also illustrated are the introducer sheath system 4900 and the steerable endoluminal punch 4910 of Figure 12C.

[ 0128 ] Access can be gained through a subclavian vein or a jugular vein. The introducer sheath system 4900 can be routed over a guidewire, which is then replaced with the endoluminal punch 4910. After the endoluminal punch passes into the left atrium of the heart through the interatrial septum 5310, a guidewire (not shown) can be passed through the central lumen of the inner tube of the punch 4910 and be routed into the left atrium 5308 to establish a pathway into the left atrium.

[ 0129 ] Superior access, through the superior vena cava, to the left side of the heart entails use of a shorter catheter than access from the inferior direction (through a femoral vein and the inferior vena cava). However, the geometries are such that the device needs to be angled quite more than in the inferior approach. Thus a puncture device that is able to articulate to about 90 degrees or more is beneficial. Furthermore the puncture device needs to be able to generate lateral forces on the atrial septal wall after turning this sharp angle, and this using generally axial movement imparted on the proximal portion of the punch, provided by the physician operator. The Side Window Introducer 4900 provides a backbone against which a puncture device, such as the Steerable Endo luminal Punch 4910, can push. Additional stiffness can be added to the Side Window Introducer 4900 such as, but not limited to, support bars, metal components in the sheath 4902 or dilator 4904, or radially enlargeable components such as balloons, expandable metal or plastic, or the like. This additional stiffness can be added after placement of the Side Window Introducer to permit flexibility in access to a treatment site, in this case the interatrial septum 5310. The Side Window

Introducer can further comprise ultrasound capability to provide for imaging at the point of treatment. Such ultrasound capability can include 2-D or real time 3-D imaging.

[ 0130 ] Figure 17A illustrates the distal end of a steerable endoluminal punch comprising an outer tube 5400 further comprising a plurality of radially oriented slots 5410, optionally comprising strain reliefs on each slot. The punch 5400 further comprises an inner tube 5402, a 4 pointed crown distal end 5406, and sharpened edges of the crown 5408.

[ 0131 ] Figure 17B illustrates the distal end of a steerable endoluminal punch comprising an outer tube 5420 further comprising the plurality of radially oriented slots 5410, optionally comprising strain reliefs on each slot. The punch 5420 further comprises an inner tube 5422, a 2 pointed crown distal end 5426, and sharpened edges of the crown 5428. Note that in Figure 17B, the T-slot is oriented 90 degrees toward the viewer relative to its orientation in Figure 17A. The steerable endoluminal punch 5420 articulates within the plane of the paper in Figure 17A, whereas the steerable endoluminal punch 5420 articulates up out of the plane of the paper in Figure 17B. The illustrated orientations are preferred embodiments. [ 0132 ] The distal end of the steerable endoluminal punch can comprise any number of points between 1 and about 10 but more preferably between about 1 and about 4. Another embodiment comprises a distal end having a three-pointed crown (not shown). The blunt stylet 5202 (see Figure 15) can be used to shield the sharp crown points from the walls of a catheter or dilator through which it might be passed.

[ 0133 ] Figure 18 A and 18B illustrate the distal end of a steerable endoluminal punch system 5500 comprising the endoluminal punch and a cutting stylet 5502 disposed within a lumen of the endoluminal punch. The stylet is slidably disposed within the lumen

(longitudinally translatable within the lumen) and may be rotatable (rotationally translatable) within the lumen or rotationally fixed within the lumen. The stylet further comprises a sharp distal tip 5504, a single laterally biased wire or blade 5506 (Figure 18A) or two laterally biased wires or blades 5506 (Figure 18B) which may optionally include sharp edges 5508. The endoluminal punch includes the inner tube 5402, the outer tube 5404 further comprising a plurality of radially oriented slots 5410, a hub (not shown) at the proximal end, and a distal end 5408 optionally comprising one or more sharp edges 5406. In the illustrated

embodiment, the one or two laterally biased wires or blades 5506 are able to be compressed to a first, small diameter configuration for insertion into the lumen of the endoluminal punch (preferably, the inner tube 5402 of the punch illustrated) by the user. The laterally biased blades(s) 5506 are resiliently biased toward an outwardly bowed configuration so that when advanced beyond the end of the inner tube distal end 5408, they can resiliently spring outward to a second, large diameter configuration (the blades may be forced outward with a control rod if they are provided in a non-resilient material) to, preferably, extend beyond the diameter of the punch inner rube or outer tube. Once deployed from the distal end of the inner tube and reconfigured to the second large configuration, the stylet may be rotated (by operation at the proximal end of the device) to push and force an initial perforation into a larger hole which better allows the inner tube to pass through the interatrial septum. If the blades have sharpened edges (depicted as item 5508), the expanded blades may be rotated to cut a larger incision in tissue than would be possible with the unexpanded diameter of the cutting stylet 5502. This embodiment is especially useful for making a sufficiently large incision through which to pass the inner tube 5402, the outer tube 5404, and any sheaths and dilators disposed over the punch, especially in very elastic tissue, scar tissue, or thickened tissue. [ 0134 ] A primary issue with an endoluminal punch, or needle, is that it generally creates an incision or hole in tissue through which a catheter, dilator, or other axially elongate instrumentation is to be advanced. Creation of an incision that is large enough for the endoluminal punch to pass, does not guarantee that larger diameter devices riding over or on the endoluminal punch will be able to pass through this small incision or hole. Thus, it can be beneficial, or even mandatory, to create an incision that is larger than that needed for a sharp stylet and larger than that needed for the endoluminal punch to pass through the hole so that a catheter, dilator, or combination thereof, may pass through the hole. The expanding stylet can accomplish this. Application of electrical energy, such as radiofrequency energy, at the tip of the endoluminal punch can perform this hole enlargement by weakening the tissue in a tissue penumbra around the needle tip. This is especially important when the tissue is scarred, thickened, or extremely elastic. Punching a hole in such tissue and then dilating that hole up to a larger diameter by tapered dilators can stretch the tissue and locally increase its resistance to further penetration. An introducer comprising a small cutting element at its distal end, near or on the dilator taper region, can provide for additional tissue incision and permit the larger diameter catheter and dilator to pass through an enlarged incision. The cutting element on the introducer or its dilator can be operated from the proximal end through use of a control rod or wire or by selective use of the blunt stylet, a cutting stylet, or both, such that the cutting element stays retracted and is only activated when desired, by user control.

[ 0135 ] Figure 19A illustrates a cutting introducer 5600 comprising a sheath 5602, a tapered dilator 5604 further comprising a secondary lumen 5606, through which is slidably inserted a cutting instrument 5608. The tapered dilator 5604 further comprises a central lumen through which is slidably and removably inserted an endoluminal punch 5610. The endoluminal punch 5610 further comprises a small diameter distal tubing projection 5612 tipped with a sharp end 5614. Also illustrated is a piercing stylet 5616 further comprising a sharp trocar distal tip 5616, which is slidably inserted through a central lumen of the endoluminal punch 5610. The cutting instrument 5608 is configured to be selectively advanced, when needed, to assist with cutting an incision bigger than that which can be cut by the sharp end 5614 and the piercing stylet 5616.

[ 0136 ] Figure 19B illustrates a cutting introducer 5630 further comprising the introducer sheath 5602, a dilator 5624 further comprising a cutting element lumen 5622 and a cutting element 5620. An endoluminal punch 5610 is inserted into a central lumen of the dilator 5624. The optional piercing stylet 5616 is inserted through a central lumen of the

endoluminal punch 5610. Distal end of the larger diameter portion of the endoluminal punch 5610 is configured to engage the proximal end of the cutting element 5620 and force it distally thus exposing its distal sharp end to assist with tissue incision. The cutting element 5620 is trapped within the cutting element lumen 5622 and cannot be removed from the system. The distal component of the cutting element 5620 is preferably biased in its retracted position by a spring (not shown) or other biasing element.

[ 0137 ] The steerable needle can comprise monitoring systems to measure, display, announce, record, or evaluate operating parameters of the steerable transseptal needle. In an embodiment, the steerable transseptal needle can comprise strain gauges to measure the force being applied by the user to bend the needle. A torque gauge can also be comprised by the system to measure torque being applied to the control knob or the torque being applied by the distal curvature movement. The strain gauge or torque gauge can be affixed within the hub or elsewhere within the steerable transseptal needle to measure compression or tension forces. This information can be displayed in the form of a readout device, such as a digital display of the force or torque. The number of turns can be counted and displayed by, for example, a Hall-Effect sensor, mechanical counter, or the like. In an embodiment, the force or torque can be correlated to the angle of deflection at the distal end, the number of turns applied to the control knob, or both. The readout can be digital or analog and can be affixed to the hub or can be wirelessly received and displayed on external equipment such as a smart phone, computer, tablet computer, panel display, or the like. The wireless technology can, for example, comprise Wi-Fi, Bluetooth®, or other standardized protocols. The human interface can comprise audible feedback such as a simple beep or tone, or it can be more sophisticated and provide information using language callouts such as force, turns, torque, or the like.

[ 0138 ] In operation, the system operates similarly to the standard steerable transseptal needle with a few exceptions. The procedure is to advance a steerable transseptal needle, with a tissue piercing stylet affixed in place, through a transseptal introducer that has already been placed. The steerable transseptal needle is articulated to generate the proper curve, as determined under fluoroscopic or ultrasound guidance. The steerable transseptal needle transseptal introducer assembly is withdrawn caudally out of the superior vena cava and into the right atrium of the heart. Proper location, orientation, tenting, and other features are confirmed. Radiopaque dye can be injected through the steerable transseptal needle to facilitate marking of the fossa ovalis or blood flow around the distal end of the steerable transseptal needle. Pressure measurements can also be taken through the lumen of the steerable transseptal needle to confirm tracings consistent with the right or left atrium of the heart. Once proper positioning has been confirmed, a safety is removed from the stylet hub and a button on the stylet hub is depressed or actuated to cause the sharpened stylet tip to advance out beyond the distal end of the steerable transseptal needle. This sharpened stylet punches through the fossa ovalis and the septal tissue pulls over the stylet, over the inner tube, and over the obturator or dilator of the transseptal introducer. At this point, the sharp stylet is released and retracts proximally within the steerable transseptal needle. The transseptal introducer is now within the left atrium of the heart and the steerable transseptal introducer can be withdrawn from the lumen of the obturator.

[ 0139 ] Thus, as described above, one of the inventive systems is a device for punching a hole in the interatrial septum of the heart of a patient which comprises an (1) endoluminal punch having a proximal end and a distal end, with the distal end adapted for insertion into the vasculature of the patient and navigation into the vena cava of the patient, and a lumen extending from said distal end to said proximal end (the punch may be, but need not be, steerable as described in relation to Figures 1 through 1 1) and (2) a stylet having a distal end and a proximal end, said stylet slidably disposed within the lumen of the endoluminal punch such that the distal end of the stylet is longitudinally translatable beyond the distal end of the endoluminal punch, said stylet having a sharp distal tip, where the stylet further comprises a distal portion, proximal to the sharp distal tip, having one or more laterally outwardly biased wires or blades. These wire(s) or blade(s) have a first, small diameter configuration permitting insertion into the lumen of the endoluminal punch (in particular, the lumen at the distal end of the punch), and a second, larger diameter configuration assumable by the wires or blades when the distal end of the stylet is translated out of the distal end of the lumen of the endoluminal punch. This device may be used by navigating the punch distal tip to a point proximate the interatrial septum, and the translating the stylet distally such that the distal end the stylet protrudes from the distal end of the endoluminal punch, piercing the interatrial septum with the sharp distal tip of the stylet to create a perforation, and then, with the

I expanded wire(s) or blade(s) disposed within the perforation, rotating the stylet to enlarge the perforation, and thereafter pushing the endoluminal punch through the enlarged perforation. The wires or blades of this device can be resiliently biased to assume an outwardly bowed configuration in the second, larger diameter configuration. The wires or blades of this device can have sharp edges along the length of said wires of blades. The stylet may be rotatable within the lumen of the endoluminal punch, so that it may be rotated to enlarge the perforation with rotating the entire punch, or it may be rotationally fixed with the punch, and rotation of the wires or blades may be accomplished by rotating the entire device. In addition to the sharp distal tip of the stylet, that endoluminal punch may be provide with a shard distal tip. The endoluminal punch may have a deflectable region proximate the distal end of the endoluminal punch.

[ 0140 ] Also as describe above, one of the inventive systems comprises device for punching a hole in the interatrial septum of the heart of a patient which includes an introducer sheath having a distal end and a proximal end, and a lumen extending therethrough, with a side window in the introducer sheath proximate said distal end. The introducer sheath is configured for insertion into the vasculature of the patient, with the window located along the length of the introducer sheath such that, with the distal end of the introducer sheath disposed in one of the superior or inferior vena cava of the patient, and a portion of the introducer sheath proximal to the distal end disposed in a the other of the superior or inferior vena cava, the window is located proximate the right atrium of the patient. The system further includes the endoluminal punch which is longitudinally slidably disposed within the introducer sheath. The endoluminal punch has a deflectable or steerable distal end, and means for deflecting or steering the distal end laterally out of the window to place a distal tip of the endoluminal punch against the interatrial septum of the heart. This system may include a dilator having a distal end and a proximal end, and a lumen extending therethrough, with the dilator slidably disposed within the lumen of the introducer sheath, wherein the endoluminal punch is disposed with the lumen of the dilator. The dilator preferably has a dilating tip which is extendable from the distal end of the introducer sheath, and the dilator further comprises a dilator window located along the length of the dilator such that, with the distal end of the dilator disposed extending from the distal end of the introducer sheath, the dilator window is disposed along the length of the introduce sheath aligned with the window of the introducer. The dilator may be rotatable within the introducer sheath, so that the dilator window can be radially aligned with the window of the introducer sheath.

Claims

We claim:

1. A device for punching a hole in the interatrial septum of the heart of a patient, said device comprising: an endoluminal punch having a proximal end and a distal end, said distal end adapted for insertion into the vasculature of the patient and navigation into the vena cava of the patient, and a lumen extending from said distal end to said proximal end; a stylet having a distal end and a proximal end, said stylet slidably disposed within the lumen of the endoluminal punch such that the distal end of the stylet is longitudinally translatable beyond the distal end of the endoluminal punch, said stylet having a sharp distal tip, said stylet further comprising a distal portion, proximal to the sharp distal tip, having one or more laterally outwardly biased wires or blades, said wires or blades having a first, small diameter configuration permitting insertion in the lumen of the endoluminal punch, said wires or blades having a second, larger diameter configuration assumable by the wires or blades when the distal end of the stylet is translated out of the distal end of the lumen of the endoluminal punch.

2. The device of claim 1 wherein the wires or blades are resiliently biased to assume an outwardly bowed configuration in the second, larger diameter configuration.

3. The device of any of the preceding claims, wherein the wires or blades have sharp edges along the length of said wires of blades.

4. The device of any of the preceding claims, wherein the stylet is rotatable within the lumen of the endoluminal punch.

5. The device of any of the preceding claims, wherein the endoluminal punch has a sharp distal tip.

6. The device of any of the preceding claims, wherein the endoluminal punch has a deflectable region proximate the distal end of the endoluminal punch.

7. A device for punching a hole in the interatrial septum of the heart of a patient, said device comprising an introducer sheath having a distal end and a proximal end, and a lumen extending therethrough, said sheath having a side window proximate said distal end, said introducer sheath configured for insertion into the vasculature of the patient, with the window located along the length of the introducer sheath such that, with the distal end of the introducer sheath disposed in one of the superior or inferior vena cava of the patient, and a portion of the introducer sheath proximal to the distal end disposed in a the other of the superior or inferior vena cava, the window is located proximate the right atrium of the patient; an endoluminal punch longitudinally slidably disposed within the introducer sheath, said endoluminal punch having a deflectable or steerable distal end, and means for deflecting or steering the distal end laterally out of the window to place a distal tip of the endoluminal punch against the interatrial septum of the heart.

8. The device of claim 7, further comprising: a dilator having a distal end and a proximal end, and a lumen extending therethrough, said dilator slidably disposed within the lumen of the introducer sheath, wherein the endoluminal punch is disposed with the lumen of the dilator, and said dilator has a dilating tip which is extendable from the distal end of the introducer sheath, said dilator further comprising a dilator window located along the length of the dilator such that, with the distal end of the dilator disposed extending from the distal end of the introducer sheath, the dilator window is disposed along the length of the introduce sheath aligned with the window of the introducer.

9. The device of claim 8, wherein: the dilator is rotatable within the introducer sheath, so that the dilator window can be radially aligned with the window of the introducer sheath.

10. A method of accessing a body cavity or lumen comprising the steps of:

Introducing a catheter into a mammalian body from a superior approach through an access channel; Wherein the catheter comprises at least one side window;

Advancing a steerable endoluminal punch such that a bendable region is aligned with the side window in the catheter;

Bending the bendable region of the steerable endoluminal punch such that the tip is forced radially outward away from the axis of the catheter;

Producing axial force on the endoluminal punch;

Generating off-axis forces at the tip of the endoluminal punch by forcing the catheter into the wall of an access channel;

Puncturing a target region in the mammalian body with the steerable endoluminal punch distal end.

11. The method of Claim 10 further comprising the step of inserting a dilator into the central lumen of the catheter prior to advancing the steerable endoluminal punch into the catheter.

12. The method of Claim 10 further comprising the step of inserting a dilator into the central lumen of the catheter wherein the dilator comprises a side window that can be aligned with the side window of the catheter.