FIELD OF THE INVENTION
[0001] The present invention is directed to a system for performing intracardiac transseptal puncture and guide wire access to left heart structures. More specifically, the present invention is directed to achieving transseptal puncture in a highly efficient and safe manner both to gain access to the left atrium by way of a distal needle segment, and mid-looped or coiled left-atrial segment and linear elongated proximal segments. It serves as a platform for structural or other device delivery to the left atrium in the heart. A uniquely configured steerable sheath and dilator may be incorporated with this needle-guide wire. Alternatively, it can be used with most commercially available dilator-sheath transseptal catheter systems.
BACKGROUND
[0002] Transseptal punctures are generally used to access the left atrium (LA) of the heart by way of the right atrium (RA). Access to the LA is commonly required for atrial fibrillation ablation and, more recently, treatment of valvular and other structural heart diseases. The current transseptal device(s) must be able to locate specific locations on the fossa ovalis ("FO") reliably to safely and accurately puncture the FO septum for a given procedure. Inadvertently, puncturing structures such as the aorta, left or right atrial free wall or pulmonary vein can result in cardiac perforation and tamponade. In addition, highly specific sites on the FO must now be traversed to pinpoint specific left heart targets for device positioning.
[0003] Current transseptal procedures have specific challenges, including: (1) difficulty engaging with precision and stability on specific locations of the FO resulting from, for example, severe kyphosis, altered cardiac orientation in relation to external landmarks, abnormal cardiac rotation (secondary to multiple cardiac pathologies) and highly variable FO positions and configurations on the intra-atrial septum; (2) difficulty with needle advancement, often due to thickened or scarred septum; (3) redundant or aneurysmal septum leaving the apex of the tented needle on the FO, adjacent to the LA free wall and thus at risk for perforation and pericardial tamponade; and (4) prior septal occluder placement necessitating alternative puncture locations on the native septum or direct occluder puncture.
[0004] US 2009/112062 discloses an overtube for use with an endoscopic surgical instrument., where the overtube may comprise a hollow tubular member that has an implantable tip detachably affixed to a distal end thereof. The implantable tip may have at least one retention member formed thereon to retain the tip within an organ wall. The implantable tip may further have a lumen extending therethrough to form a passageway through the organ wall. A plug member may be provided to selectively seal off the lumen within the implantable tip.
[0005] WO 2015/019132 discloses medical devices including dilators and wires usable alone or in combination and configured to facilitate tissue access and puncture at various anatomical locations from desired access sites. The medical devices each include one or more sections having sufficient flexibility for accessing the tissue site from the access site while retaining sufficient stiffness to perform one or more additional functions.
ABBREVIATIONS
[0006] Unless otherwise noted, the following abbreviations apply throughout the disclosure: FO: fossa ovalis
202; Fr: French (increments for catheter sizing diameter); GW: guide wire
10; LA: left atrium
208; LAA: left atrial appendage
210; MRI: magnetic resonance imaging; MV: mitral valve
212; RA right atrium
206; TEE: transesophageal echocardiography; TTE: transthoracic echocardiography.
SUMMARY OF THE INVENTION
[0007] The present invention relates to a unique catheter system and more specifically a novel needle-guide wire
10 for use in atrial transseptal puncture with a uniquely configured needle
12 distally in continued proximity with the segmented GW
10 for catheter system device delivery. The general target for puncturing the atrial septum in the heart
200 is the FO
202, a depression on the right side of the intra-atrial septum
204 on the wall between the right atrium
206 and left atrium
208. The FO
202 is the remnant of a thin fibrous membrane that usually covers the foramen ovale during fetal development.
[0008] Specifically, the present invention is directed in part to a transseptal GW 10 incorporated with a transseptal needle
12. The GW
10 segment comprises a stiff proximal segment end
16 and a middle loop segment
14, wherein the distal end
22 comprises the junction of the transseptal needle
12. At least two mid-segment GW loops
24, 26 come to rest in the LA
208. The middle loop segment
14 is formed of a shape memory material to form at least two looped segments, the second more distal, usually outer, broad coil
24 and a first, more proximal, or inner coil
26; wherein the middle segment
14 is in continuity with the elongated linear extra-stiff GW segment
16 at proximal end
25, which eventually rests externally for exchanges.
[0009] The present invention is further directed to a transseptal GW puncture system that traverses the FO
202, comprising a proximal end
16, a distal end
22, a middle coiled segment
14, a transseptal dilator
108, and a sheath
100. The distal end of the GW puncture needle
18 comprises a transseptal needle
12 attached to the looped GW segment
14 at its distal end
22 and in turn is positioned in continuity with the distal end
17 of the linear, extra-stiff GW segment
16. The transseptal needle
12 has shape memory at the point of attachment to the looped GW segment
14 wherein the shape memory is sufficient to have the transseptal needle
12 retain a pre-specified abrupt angle with respect to the looped guide wire segment
14 to maintain atraumatic stability within and central to the loops
24, 26. One or more of the loops
24, 26 are positioned and stabilized in the LA
208 resting adjacent to the inner surface of the LA
208. The middle looped segment
14 is formed of a shape memory material to form the two loops
24, 26; wherein the proximal end
25 of the more proximal coil
24 is in continuity with the proximal elongated extra-stiff segment of the GW
16; and wherein a secondary bend
29 is positioned in the RA
206 transitioning into the elongated, linear proximal most segment of the GW
10.
[0010] The transseptal dilator
108 comprises an elongated catheter
109 which rests within the sheath
100, tapering down to a narrowed dilator distal segment
110, wherein the catheter lumen
111 throughout remains compatible with the GW
10, which may have a full spectrum of diameters ranging from 0.5334 mm and 0.889 mm (0.021 inches to 0.035 inches or more). At some point along the distal segment
106 is a radiopaque marker
122 positioned to be overlapped with the radiopaque tip marker
123 on the sheath
100 when at that point the transseptal dilator
108 and sheath
100 are of equivalent external diameters. The dilator
108 is advanced forward into a precise position of the FO
202 for "tenting" the FO
202 by way of a series of forward movements of the actuator
112 adjacent to the distal end of the handle
104. Steerable maneuvers on the proximal sheath handle
104 permit antigrade and retrograde flexion, and torqueing anterior or posterior of the entire sheath
100 will be carried out to position the distal end
124 of the sheath and the retained dilator tip
110 adjacent to the specific FO site for the specific procedure. Advancement and retraction movements of the dilator distal segment
110 relative to a stabilized sheath
100 with the use of an actuator
112 on the proximal sheath
100 interacts with the proximal end
119 of the dilator
108.
[0011] Once the FO
202 is tented with the dilator
108 which contains the transseptal needle
12, the needle
12 is advanced, puncturing the FO septum
202 and crossing into the LA
208. The transseptal needle
12 folds or bends from shape memory at a discrete angle at the proximal end/hinge point
20 on the coiled GW segment
14 to which it is connected after being advanced across the FO
202. It forms an angle which may range from about 45° to 140°. Further advancement of the transseptal GW
10 will position the looped section
14 coils of the GW
10 stable within the LA chamber
208 aiding also in preserving the needle position atraumatically in the central LA
208 by way of remaining central to the loops. Preferably, the GW coils
24, 26 have a small inner diameter coil
26 and larger outer diameter coil
24 aiding in preserving the needle
12 highly central to the LA
208. The smaller in diameter inner coils prevent excessive needle
12 damage to the tissue in the LA wall. In another embodiment, the coils
24, 26 may be of equal diameters.
[0012] In another embodiment, the coils
24, 26 may be offset, as illustrated in
FIGS. 3 and 4, to further aid in preserving a central location of the needle
12 which can also be folded in a third dimension, an additional feature making it less susceptible to perforating LA
208 structures when the folded distal transseptal needle
12 is advanced and deflected medially further aiding in maintaining a central needle
12 position within the offset but equal spaced loops
14. Coils
24, 26 may be offset by approximately 1.905 - 5.08 cm (0.75 - 2 inches). The coils
24, 26 are intermediate in stiffness allowing for less traumatic interaction with the LA free walls. A secondary bend
29 in the right atrial GW segment aids in preserving a perpendicular trajectory across the FO
202 and co-axially in the IVC
215. The elongated, proximal extra-stiff GW segment
16 will have a preferable length of 260 cm (but may be significantly longer) for purposes of catheter or device exchange.
[0013] Novel features unique to this dilator and deflectable sheath in the system include a longer extendable dilator tip in relation to the sheath. Strategic positioning by overlapping the dilator radiopaque marker
122 and sheath radiopaque marker
123 for alignment at equivalent external diameters permit smooth transitioning of the transseptal dilator
108 and sheath
100 across the membrane of FO
202.
[0014] The forward positioning of the catheter system of the present invention allows for precise positioning of the distal sheath for precise device positioning thereby establishing ideal LA
208 positioning ultimately dictated by the specific left heart target for a given device, i.e., LAA
210, MV
212. The system is intuitive and simple to accurately position on a specific FO
202 target by using iterative dilator advancement under echo or other imagining guidance. After the coils have been advanced across the FO
202 and secured in the LA
208, the dilator
108 is then advanced over the coiled GW
10 into the LA
208 preserving the overlapping radiopaque segments in place until the sheath
100 has crossed into the LA
208. Overlapping radiopaque markers
122, 123 on the distal dilator end
106 and sheath tip
124 are used to confirm that they are at equivalent diameters for smooth simultaneous advancement of the dilator
108 and sheath
100 across the FO
202.
[0015] The deflectable and steerable nature of the sheath
100 will permit the sheath
100 to obtain the directionality, angulation and reach using a single size forward looking catheter system for the variety of RA
206 sizes and FO
202 angles in various patient-specific anatomy.
[0016] The collective system preferably includes a needled GW wire
10 delivered by the "one size fits all" catheter system for iteratively advancing the dilator
108, containing the retracted needle
12, into a precise tenting position on the FO
202. An actuator
112 on the sheath
100 adjacent to the handle
104 permits highly controlled advancement of the distal segment
110 for "tenting" the FO membrane prior to needle puncture. The actuator
112 can be advanced or retracted with the operator's thumb without removing the operator's hand from the rotatable handle
104. The dilator
108 may have a more flexible distal segment to permit smooth tracking over the coiled GW segment in the LA
208. The deflectable sheath tip
124 may have monopolar or bipolar directionality. Preferably the steerable sheath
100 will have a distal fixed 2° bend within the RA
206 which may range from 2° to 20° to more easily establish perpendicularity to the FO
202. Standard, commercially available sheath dilator catheters may also be used in combination with the previously described novel needle GW.
[0017] Advantageously, the device satisfies the following: (1) improved ease of use; (2) intuitive manipulation for precise distal control; (3) improved device and procedural efficacy; (4) increased device safety across a wide range of operator skills; (5) enhanced workflow and decreased procedural times; and (6) decreased procedural costs secondary to a combined needle GW.
[0018] The objects and advantages of the invention will be highlighted in greater detail in the following description of the preferred embodiment of the invention in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019]
FIG. 1 is a side plan view of the first embodiment of the present invention of the combined transseptal needle and GW profiled in the frontal plane.
FIG. 2 is a side plan view of a second embodiment of the combined transseptal needle and GW of the present invention in the frontal plane.
FIG. 3 is a side plan view of a third embodiment of the present invention of the combined transseptal needle and GW with offset loops viewed from a frontal planar perspective.
FIG. 4 is a front plan view of the transseptal needle of FIG. 3 which has been rotated ninety degrees.
FIG. 5 is a side plan view illustrating a representative unipolar deflectable sheath for use with the needle-GW in the present invention.
FIG. 6 is a side plan view illustrating a dilator for use with the deflectable sheath of FIG. 5.
FIG. 7 is a front view schematic representation of the human central venous circulatory system including the heart and venous system with a steerable sheath present in the system.
FIG. 8 is a front view schematic representation of a cross-section of the human heart with the deflectable sheath positioned across the atrial septum and positioned in the LA with the distal needle GW loops in the LA.
DETAILED DESCRIPTION OF THE INVENTION
[0020] With reference to the guide number in the drawings, the transseptal puncture system of the present invention is preferably a "one size fits all" system whereby a single-sized system may be used in a variety of anatomical configurations and atrial sizes. An exception to this new standard is directed to the use of multiple wire diameters on the order of about 0.5334 mm to greater than 0.889 mm (0.021 inches to greater that 0.035 inches). The system includes specialized components, including an exchange GW with a distal transseptal needle and adjacent coils or loops for GW securement in the LA
206. In addition, the catheter components may include a novel dilator which interacts with an actuator on the proximal sheath handle for controlled positioning on the FO aided by the steerable sheath.
[0021] Reference is made to
FIGS. 1 - 4 illustrating a needle-guide wire
10. The transseptal needle-GW
10 should be a single component and avoid the need for a separate transseptal needle, multiple exchanges and multiple lengths and curves for various anatomies. The single wire has at least three defined segments: (1) the distal transseptal needle
12; (2) the middle or looped LA segment
14; and (3) the proximal elongated linear, extra-stiff GW segment
16.
Transseptal Needle 12
[0022] The transseptal needle
12 is positioned in continuity with the distal end
22 of the GW loop segment
14. The transseptal needle
12 is preferably relatively short, with a length between about 0.75 to about 2.0 cm. The needle
12 also should preferably have an ultra-low profile tip
18. The proximal end
20 of the needle
12 in continuity with the adjacent distal loop segment
14 is linear when retained in the central lumen
111 of the dilator tip prior to advancement.
[0023] The transseptal needle
12 has a lubricious coating to minimize resistance and a sharply tapered tip
18 to puncture and easily transition across the FO
202 (illustrated in
FIG. 8) including those that may be densely scarred or aneurysmal. Inadvertent needle lurching across the FO membrane and loss of the preferred puncture site is avoided by the extra-fine point on the needle tip
18, slow iterative delivery of the forward-looking tapered transseptal dilator
108 into the FO
202 for stable positioning and "tenting" of the membrane by the dilator tip
18 which is in turn supported by a steerable transseptal sheath
100. With this forward looking system, unintended anterior or posterior, torqueing forces resulting in sliding across the FO
202 should be greatly minimized.
[0024] The transseptal needle
12 is preferably composed of a metallic material, such as stainless steel or alloy including nitinol with shape memory, and is attached to the GW loop segment
14 for example with a weld or possibly interdigitating slots which interact to form a more stable, yet flexible, union allowing the needle to fold on itself thereby avoiding puncturing the LA free wall, the pulmonary vein, etc. Other means of creating a pre-shaped angle between the needle
12 and loop segment
14 can also be conceived and utilized.
[0025] The transseptal needle
12 sharply angles at the proximal end/hinge point
20 where it connects to the distal end
22 of the looped GW segment
14 having retained a pre-specified angle central to the LA loop segment
14, thus maintaining atraumatic stability within the central LA loop segment
14, thus preventing contact and possible perforation of LA
208 structures including a pulmonary vein, LA free wall and LAA
210.
[0026] Following the wire advancement and transseptal puncture, the needle
12 abruptly flexes centrally preferably at an acute angle with the adjoined looped GW segment
14 as illustrated in
FIGS. 1 - 4. The needle
12 remains linear after entering the LA
208 but flexes inward, preferably at an angle of about 45° to 140° relative to the distal looped GW segment
14. The diameter of the transseptal needle tip
18 can be ground down to an ultra-low profile and tapered back to conjoin the distal loop segment
14, most likely transitioning to a profile in the range of 0,5334 to 0,889 mm (0.021" to 0.035") or greater.
Guide Wire Loop Segment 14
[0027] The looped GW segment
14 is designed to stabilize the GW
10 position atraumatically in the LA
208 and, in addition, assists in protecting the left atrial free wall from unwanted needle puncture. Two or more looped segments
24, 26 may typically range between about 2.5 cm and 4.0 cm in diameter and formed by shape memory as it exits from the transseptal dilator
108 into the LA
208. The distal GW looped segment
14 in one embodiment would be formed by two roughly equal in size circular or possibly non-circular loops potentially in a plurality of shapes which are again formed upon deployment in the LA chamber, as illustrated in
FIGS. 3 -4.
[0028] The coils provide at least four useful functions:
- 1. The coils can confirm the correct LA chamber positioning, by taking on the unconstrained, known shape within the LA 208.
- 2. The coils 14 maintain stable positioning in the LA 208 to avoid inadvertent withdrawal of the GW 10 into the RA 206 or forceful needle tip 12 advancement into the LA free wall or pulmonary vein.
- 3. The outer broad coil 24 provides a longer GW support ramp over which the dilator 108 and sheath 100 can be advanced with less resistance into the LA 208 around the curve to facilitate catheter support.
- 4. The coils form an outer protective shield in which the centrally positioned needle 12 is kept at a safe distance from penetrating LA 208 structures.
[0029] In another embodiment, there are at least two circular coils, the inner coil
26 diameter being smaller than the outer coil
24 diameter, as illustrated in
FIGS. 1 - 4, the inner coil thus central to the outer coil
24. In this embodiment, the larger, outer coil
24 can be compressed by LA
208 structures in the absence of any conformational change of the inner coil
26 thus further protecting deformity of the distal needle
12 and preserving its central location.
[0030] As an example, the inner coil
26 of the GW
10 may have a diameter between about 1.5 cm and 3.0 cm, preferably about 2.5 cm. The outer coil
24 may have a diameter between about 3.0 cm and 4.0 cm, preferably about 3.5 cm.
[0031] In a third embodiment, the two coils
24, 26 are parallel and equal in diameter, but can be offset by about 0.75 cm to about 2.0 cm, which in combination with a second preformed bend at the junction of the distal transseptal needle
12 and the GW loop segment
14 in the third dimension central to the two offset wire coils
24, 26, as illustrated in
FIG. 5. Its purpose is to further aid in preventing needle perforation of the LA
208 by allowing the needle
12 to not only be centered circumferentially in two dimensions upon flexion with this embodiment but the needle
12 is to be directed centrally in a third dimension between the breadth of two offset loops
24, 26. The distance between the coils
24, 26 would preferably be about 1 cm, and may range from about 0.75 cm to about 2.0 cm.
Proximal Guide Wire Segment 16
[0032] The proximal GW segment
16 is in continuity with the adjacent coil segment
14 at the distal end
17 of the segment
16. The proximal GW segment
16 includes a proximal free end 28, which is exteriorized with adequate length to permit catheter or device exchange while preserving distal GW loop segment
14 positioned in the LA. The distal end
17 of this segment transitions linearly across the atrial septum into the LA
208. There is then preferably a shallow fixed second degree bend
29 roughly in the mid-RA
206, retaining a preferable angle of 2° to 20°. The elongated proximal extra-stiff GW segment
16 extends from most distal end of the long proximal segment
17 to the most proximal end
28 having a preferred diameter 0,5334 to 0,889 mm (0,021" to 0,035"). The long proximal extra stiff GW segment
16 may extend from 240 cm to 300 cm, preferably 260 cm in length. This long, extra stiff GW segment
16 will serve as a supportive rail for exchanging an array of catheters and devices for delivery to left heart targets.
Guide Wire Introduction Sheath 100
[0033] Referring to
FIG. 5, the transseptal delivery sheath (or sheath)
100 is preferably a unipolar, but may be a bipolar, deflectable sheath actuated with a rotatable proximal ergonomic handle
104 for superior/inferior flexion, and one-to-one sheath torque control for optimal anterior/posterior positioning, advancement or retracting the transseptal sheath
100 permits superior and inferior positioning for controlled, atraumatic guidance in all planes. The sheath
100 has a proximal end
102 located adjacent the actuator
112 and a distal segment
107. Current transseptal systems designed for commercial use are brought into the FO
202 using a clockwise torque of the sheath/dilator system generally from a femoral vein access sight that may be overly aggressive (excessive in length) which may in turn result in inadvertent "stored up" torque if the over-reaching dilator
108 momentarily "catches" distally on an atrial septum prominent ridge. Further efforts to position the dilator distal segment
110 within the FO
202 may result in perforation of the RA
206 free wall or appendage. Conversely, a dilator
108 of insufficient length or "reach" and inability to engage the membrane across the FO
202 results in an inability to puncture the FO
202.
[0034] Multiple sheath sizes for each system must be available to accommodate variable RA sizes and configurations in these current commercially available systems. The sheath 100 has an ergonomic two-way rotatable handle
104 for superior and inferior distal sheath flexion, illustrated by arrow
125 and reach at the sheath tip
124 of the sheath
100. In addition, 1:1 torque transfer distally in an anterior to posterior position is accomplished through wire braid reinforcement (not illustrated) of the sheath
100 which also improves back up support for enhanced device delivery. The sheath
100 is initially positioned adjacent to but without engagement of the atrial septum using fluoroscopic and TEE guidance and when available, possibly real time MRI and computer tomography.
[0035] As will be illustrated shortly, once the sheath
100 is accurately positioned at the appropriate short distance from the FO
202 (probably about 0.5 to about 2.0 cm) in the RA
206 under imaging guidance, the dilator
108 is advanced while keeping the sheath
100 stationary. The sheath handle
104 and adjacent actuator
112 for the dilator will permit total system (sheath and dilator) manipulation with one hand kept in position without need for use of the operator's contralateral hand. The actuator
112 for the dilator
108 can be manipulated by the operator's thumb or other digit for iterative forward advancement or retraction by interacting with the frictional elements
121 on the dilator
108. The wire-braid, reinforced sheath
100 provides strong backup, kink-resistant support for advancing the dilator distal segment
110 of the dilator
108 and subsequently the dilator
108 into a precisely controlled specific location of the FO 202 for "tenting" of the membrane.
[0036] The sheath
100 preferably includes but will not necessitate a dilatable shaft to accommodate highly variable device profiles; on the other hand, a series of fixed diameter sheaths may be used to accommodate a variety of device profiles. Ideally expandable or dilatable sheaths, ranging from about 8.5 Fr to potentially up to 30 Fr, could eliminate the need for keeping multiple sheath diameters available for different procedures. One embodiment is thus a single sheath size which is conformed to be dilatable across a range of diameters. Transseptal sheaths which may require deflectability at two or more distances from the proximal handle may be preferred for device delivery around complex or multiple curves.
[0037] A plurality of other supportive structures may run linearly within the sheath body to preserve an adequate level of support for subsequent device delivery across more angulated anatomy. A 2° to 20° secondary bend may be positioned proximal to the more distal deflectable bend which would aid in achieving a more perpendicular angle at the FO for strong coaxial backup support. In addition, this would permit distal flexion greater than 180°, which may on occasion be needed to achieve appropriate sheath positioning within the medial aspects of the left heart. A tight hemostatic valve on the sheath hub
114 would minimize back bleeding around the GW
10, including those with diameters down to 0,5334 mm (0,021 inch). Preferably, the sheath
100. will be 90 cm long (70 cm usable length) or longer. Hubs for locking the dilator to the sheath may be incorporated.
Transseptal Dilator 108
[0038] The transseptal dilator
108 (or "dilator") preferably has an ultra-low-profile distal segment
110 with a reverse taper back, illustrated at
106, to a fixed external diameter
118 at the distal end
106 of the dilator
108, compatible with the internal sheath diameter. The dilator
108 can be advanced in a forward motion until "tenting" of the FO membrane is demonstrated in a precise position specific to the position visualized by TEE or other real time imaging detectors specific to the procedure being performed.
[0039] In a preferred embodiment, the dilator
108 will interact with the actuator
112 adjacent to the sheath handle
104 by way of a frictional contact element
121 or use of interlocking gears for precise gentle control of the dilator movements. An actuator
112 that permits advancement or retraction of the dilator will preferably be controlled with the ipsilateral thumb, preserving the ability to maneuver both the dilator
108 and sheath handle
104 with one hand. The dilator
108 has variable flexibility along its length, with a more flexible distal segment
118 to prevent excessive straightening or movement of the catheter system as it is advanced over the GW looped segment
14.
[0040] The maximum length of the dilator distal segment
106 should be able to be advanced beyond the stationary distal sheath
100, preferably up to about 5 cm, although it may be altered to extend beyond the sheath tip from about 3.0 cm up to about 8.0 cm. This allows controlled advancement of the dilator
108 across the FO
202 and into the LA
208 over the distal GW
10. After the septal puncture and advancement of the dilator
108 into the LA
208, while maintaining the sheath
104 fixed in the RA
206, there should be ample space until the radiopaque markers
122, 123 overlap in the RA
206 side of the septum following which the composite system with transseptal dilator
108 and sheath
100, having flush external diameters, are now able to be advanced into the LA
208 as a single unit.
[0041] The dilator distal segment
106 ends in a low profile tip
110 and has a radiopaque marker
122 proximal to the dilator distal segment
106 matching the profile of the radiopaque marker
123 on the sheath tip
124 rendering a point of smooth transition between the two for simultaneous advancement across the FO
202 preventing "hang-up" of the sheath tip edge on the atrial septal crossing point.
Method of Operation
[0042] Referring to
FIGS. 7 and 8, an exemplary method of operation is as follows on a human patient
201. As described below, this technique generally is guided by TEE or TTE supplemented with standard fluoroscopy. It should be understood that the procedure could also be guided by intra-cardiac echo, real-time MRI or image integration with pre-procedural volume rendered computer tomography images. This later imaging method uses standard fluoroscopic images to which the pre-acquired computer tomography images may be oriented and superimposed on for guidance. Reference is made to
U.S. Patent 8,900,214 to Nance et al, disclosed as a general description of human anatomy, including the heart
200, and insertion of a transseptal sheath
100 into the atrial region.
[0043] A J-tipped GW is advanced from the right femoral vein
216 into the superior vena cava
218 using fluoroscopy. The steerable sheath
100 and dilator
108 are advanced as a unit over the J-tipped GW
10 and positioned in the mid RA
206. The J-tipped GW
10 is removed and the dilator
108 is flushed. The distal tip
18 of the GW
10 is then advanced into the 0.032 compatible dilator
108 under fluoroscopy and the distal tip
18 of the GW
10 positioned just proximal to the dilator distal segment
110.
[0044] The ergonometric handle
104 on the sheath
100 is oriented axially to permit the deflectable tip
124 to be ante-flexed toward the FO
202. One to 3 cm of the dilator
108 is advanced distal to the fixed sheath
100 fluoroscopically and echocardiographically prior to maneuvering the sheath
100 toward the FO
202. To accomplish this anterior or posterior orientation, the sheath
100 is torqued anteriorly or posteriorly. The sheath
100 is advanced or withdrawn to gain a more superior or inferior position. Once again, the proximal sheath handle
104 is turned to flex the distal tip
124 to a superior, i.e., retrograde, or inferior, i.e., antigrade, trajectory. A TEE probe is most commonly used for optimal imaging of the FO
202 and adjacent dilator distal tip
110 using orthogonal views: bicaval view for superior-inferior orientation and short axis view at the aortic level to demonstrate anterior-posterior positioning. Using these TEE views, a precise position on the FO
202 for a procedure specific puncture can be obtained. The actuator
112 adjacent to the sheath handle
104 is used to slowly and iteratively advance the dilator tip
110 creating "tenting" within the FO
202 and the correct position confirmed by TEE. If the dilator distal tip
110 is incorrectly positioned, the dilator
108 can be withdrawn with the actuator
112 and redirected after manipulating the sheath
100.
[0045] With correct positioning confirmed using the tenting position, the GW
10 proximal end and the needle tip
18 punctures and crosses the FO
202 membrane. As the GW
10 is further advanced, the needle
12 flexes sharply at the hinge point
20 where it is attached to the loop segment
14 of the GW
10. As the GW
10 is still further advanced, its distal coils
14 are self-positioned in the LA
208 and the needle
12 kept flexed central to the coils
24, 26. Catheters are always aspirated and flushed with exchanges. The patient is therapeutically heparinized as soon as the GW loop segment
14 is advanced into the LA. Correct positioning of the GW
10 is confirmed by verifying its preformed shape. The coiled or looped segment
14 can take on several different embodiments as noted under the device description. The dilator
108 is advanced over the coiled wire maintaining the sheath
100 in a fixed position within the RA
206.
[0046] With the appropriate length of dilator
108 advanced under fluoroscopy, the radiopaque markers
122, 123 on the dilator
108 and sheath tip
124 come to overlap in the RA
206 confirming that the outer diameters of both catheters are equivalent and ready to be advanced into the LA 208 as a single unit. The sheath tip
124 now comes to rest across the FO
202 and in the LA
208. Again, all the dilator
108 and sheath
100 manipulations are carried out as a single-handed procedure. The dilator
108 is removed, keeping the GW wire loops
24, 26 and sheath
100 stationary in the LA
208.
[0047] The elongated proximal segment of the GW
10 is loaded with the primary device that is now advanced to the sheath tip
124 and the GW
10 is removed. The sheath
100 can then be more finely manipulated to deliver the device to the target and subsequently deployed. After deployment, the steerable sheath
100 is drawn back into the RA
206 and subsequently removed from the patient. The heparin is reversed with protamine and the percutaneous vascular entry is closed.
[0048] This transseptal procedure is carried out with a forward-looking catheter system which is iteratively advanced onto a precise position of the FO
202 prior to being punctured. The nature of the catheter system is such that only one device shape will be required to access the LA
208. This is unlike current techniques where catheters are torqued into the FO
202 using a multitude of catheter sizes which may be initially too small and unable to reach the FO
202 or too long placing the patient at risk for slipping off the FO membrane and potentially perforating the RA free wall.
[0049] Any version of any component or method step of the invention may be used with any other component or method step of the invention. The elements described herein can be used in any combination whether or not explicitly described.
[0050] All combinations of method steps as used herein can be performed in any order, unless otherwise specified or clearly implied to the contrary by the context in which the referenced combination is made.
[0051] As used herein, the singular forms "a", "an", and "the" include plural referents unless the content clearly dictates otherwise.
[0052] Numerical ranges as used herein are intended to include every number and subset of numbers contained within that range, whether specifically disclosed or not. Further, these numerical ranges should be construed as providing support for a claim directed to any number or subset of numbers in that range. For example, a disclosure of from 1 to 10 should be construed as supporting a range of from 2 to 8, from 3 to 7, from 5 to 6, from 1 to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth.
[0053] The devices, methods, compounds and compositions of the present disclosure can comprise, consist of, or consist essentially of the essential elements and limitations described herein, as well as any additional or optional steps, ingredients, components, or limitations described herein or otherwise useful in the art.
[0054] While this invention may be embodied in many forms, what is described in detail herein is the specific preferred embodiment of the invention as defined in claim 1. The present disclosure is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated. It is also understood that the terminology used herein is used for the purpose of describing particular embodiments only and is not intended to be limiting since the scope of the present invention will be limited to only the appended claims and equivalents thereof.
[0055] The scope of use for this device can be expanded for other, i.e., nontransseptal procedures, both vascular and nonvascular cavitary organ structures.
1. Transseptaler Führungsdraht (10), der ein proximales Ende (25), ein distales Ende (22) und ein mittleres Segment (14) umfasst,
a. wobei das distale Ende (22) eine transseptale Nadel (12) umfasst, die an dem distalen Führungsdrahtende (22) befestigt und in ununterbrochenem Zusammenhang mit dem distalen Ende (22) des Führungsdrahts (10) angeordnet ist,
b. wobei sich das proximale Ende (25) in ununterbrochenem Zusammenhang mit dem mittleren Segment (14) befindet, und
dadurch gekennzeichnet, dass
c. wobei das mittlere Segment (14) aus einem Formgedächtnismaterial geformt ist, um mindestens ein geschlungenes Segment (24, 26) zu bilden.
2. Transseptaler Führungsdraht nach Anspruch 1, wobei die transseptale Nadel (12) an dem Punkt der Befestigung an dem Führungsdraht (10) ein Formgedächtnis aufweist, wobei das Formgedächtnis ausreichend ist, um die transseptale Nadel (12) einen vorspezifizierten Winkel in Bezug auf den Führungsdraht beibehalten zu lassen, um eine zentrale atraumatische Stabilität aufrechtzuerhalten.
3. Transseptaler Führungsdraht nach Anspruch 2, wobei der vorspezifizierte Winkel zwischen etwa 45 ° und 140 ° in Bezug auf den Führungsdraht (10) beträgt.
4. Transseptaler Führungsdraht nach Anspruch 1, wobei das mittlere Segment (14) aus einem Formgedächtnismaterial geformt ist, um mindestens zwei geschlungene Segmente (24, 26) zu bilden.
5. Transseptaler Führungsdraht nach Anspruch 1, wobei das geschlungene Segment (24, 26) zwischen etwa 2,5 cm und 4,0 cm im Durchmesser beträgt.
6. Transseptaler Führungsdraht nach Anspruch 4, wobei die geschlungenen Segmente (24, 26) zwischen etwa 2,5 cm und 4,0 cm im Durchmesser betragen.
7. Transseptaler Führungsdraht nach Anspruch 4, der eine innere Schlinge (26) und eine äußere Schlinge (24) bildet, wobei die innere Schlinge (26) einen Durchmesser zwischen etwa 1,5 cm und 3,0 cm aufweist und die äußere Schlinge (24) einen Durchmesser zwischen etwa 3,0 cm und 4,0 cm aufweist.
8. Transseptaler Führungsdraht nach Anspruch 4, wobei die innere Schlinge (26) gegenüber der äußeren Schlinge (24) um eine Strecke von etwa 0,75 cm bis etwa 2,0 cm versetzt ist.
9. Transseptaler Führungsdraht nach Anspruch 1, der ferner einen transseptalen Dilatator (108) zum Platzieren der transseptalen Nadel (12) an der Fossa ovalis umfasst.
10. Transseptaler Führungsdraht nach Anspruch 9, wobei der transseptale Dilatator (108) ein Lumen (111) aufweist, das einen Durchmesser zwischen etwa 0,5334 mm und 0,889 mm aufweist.
11. Transseptaler Führungsdraht nach Anspruch 1, der ferner eine Hülle (100) umfasst.
12. Transseptaler Führungsdraht nach Anspruch 11, wobei die Hülle ein einpoliges oder zweipoliges ablenkbares distales Segment (107) und einen proximalen Handgriff (104) zum Steuern und Positionieren des distalen Segments (107) aufweist.
13. Transseptales Führungsdraht-Punktionssystem durch die Fossa ovalis, das ein proximales Ende (16), ein distales Ende (22) und ein mittleres Segment (14) umfasst,
a. wobei das distale Ende (22) eine transseptale Nadel (12) umfasst, die an dem distalen Führungsdrahtende (22) befestigt und in ununterbrochenem Zusammenhang mit dem distalen Ende (22) des Führungsdrahts (10) angeordnet ist, wobei die transseptale Nadel (12) an dem Punkt der Befestigung an dem Führungsdraht ein Formgedächtnis aufweist, wobei das Formgedächtnis ausreichend ist, um die transseptale Nadel (12) einen vorspezifizierten Winkel in Bezug auf den Führungsdraht beibehalten zu lassen, um eine atraumatische zentrale Positionierung aufrechtzuerhalten,
b. wobei sich das proximale Ende (16) in ununterbrochenem Zusammenhang mit dem mittleren Segment (14) befindet,
dadurch gekennzeichnet, dass
das transseptale Führungsdraht-Punktionssystem ferner einen transseptalen Dilatator (108) und eine Hülle (100) umfasst,
c. wobei das mittlere Segment (14) aus einem Formgedächtnismaterial geformt ist, um mindestens zwei geschlungene Segmente (24, 26) zu bilden,
d. wobei der transseptale Dilatator (108) ein proximales Ende (119) und ein distales Ende (106) aufweist, wobei das distale Ende (106) eine Spitze (110) mit niedrigem Profil zum Platzieren an der Fossa ovalis umfasst, und
e. wobei die Hülle (100) eine einpolige ablenkbare Hülle ist, die ein proximales Ende und ein distales Ende aufweist, wobei das proximale Ende einen Handgriff (104) zum proximalen Betätigen der Hülle (100) aufweist.
14. Transseptales Führungsdraht-Punktionssystem nach Anspruch 13, wobei der transseptale Dilatator (108) eine strahlungsundurchlässige Markierung (122) an dem distalen Ende (106) aufweist und die Hülle (100) eine entsprechende strahlungsundurchlässige Markierung (123) an dem distalen Hüllenende (107) aufweist.
15. Transseptales Führungsdraht-Punktionssystem nach Anspruch 13, wobei die Hülle (100) einen Aktuator (112) nahe dem Handgriff (104) umfasst und wobei das distale Dilatatorende Reibungselemente (121) einschließt, wobei der Aktuator (112) mit den Reibungselementen (121) in Wechselwirkung tritt, um eine Bewegung des Dilatators (108) innerhalb der Hülle (100) einzuleiten.