The present disclosure relates to system(s), method(s), and device(s) for accessing the left atrium while preventing inadvertent needle puncture of cardiac structures and other complications.
Transseptal punctures are performed in various cardiac procedures that require access to the left side of the heart. An estimated 300,000 transseptal puncture procedures are performed annually in the United States. Due to its technically demanding nature, transseptal punctures require skilled operators and sound understanding of cardiac anatomy. Even with skilled physicians, transseptal procedures are accompanied by a high incidence of complications.
In some patients, the septum can be extremely compliant when tenting the fossa ovalis. In other patients, fibrotic scarring of the fossa and other abnormalities make transseptal punctures very difficult. In both cases, there is an increased risk of perforation of the heart wall following puncture of the fossa. There are no tools available that can adequately address this safety issue today.
Transseptal punctures (TSPs) are a commonly used procedure as a method of gaining access to the left atrium in a minimally invasive way. This procedure is used to facilitate various cardiovascular procedures, including but not limited to left atrial appendage closures, heart valve repairs, and cardiovascular device implantations. Due to a wide range of associated applications and medical procedures, around 300,000 transseptal punctures are performed per year in the United States.
One limitation of the procedure is that the target site for puncture, the fossa ovalis, accounts for only 20% of the area of the interatrial septum, making it difficult to locate. This difficulty is further exacerbated by the fact that the user must navigate and maneuver the catheter assembly to the interatrial septum without the aid of direct visualization.
A second limitation of the procedure is that controlled puncture of the fossa ovalis with a transseptal needle can be very difficult, especially for patients with an aneurysmal or fibrotic septum. About 40% of patients have an aneurysmal septum, meaning the septum (or the fossa ovalis) is more compliant (i.e. stretchy) and prone to distension during tenting with the dilator. As a result, an aneurysmal septum can allow for the sharp tip of a transseptal needle to come dangerously close to the heart wall of the left atrium before the needle finally punctures through the septum. Conversely, for patients with a fibrotic septum, the septum is less compliant (i.e. tougher) and less prone to distension during tenting with the dilator. As a result, a fibrotic septum can require the application of a significant amount of force to the transseptal needle before the needle is able to puncture through the septum. When puncture finally occurs, it is very difficult for the user to rapidly cease the application of force to the transseptal needle and—similarly to transseptal puncture of an aneurysmal septum—as a result, the user may unintentionally over-advance the transseptal needle and injury the heart wall leading to costly complications and even death.
Another drawback is that current visualization techniques for TSPs are limited in their ability to provide useful information to the user of a transseptal access device. Techniques such as fluoroscopy only allow for 2D projections of 3D space and therefore do not provide sufficient detail into device orientation and positioning in 3D space. Physicians performing TSPs often need several years of experience with the procedure before they are able to draw meaningful information from the visualization or the slight “drops” as the assembly is placed along the fossa ovalis.
Due to the challenges that arise with this procedure, TSPs are associated with 3,000 fatal complications, 51,000 repeat procedures, and 42,000 other issues each year out of the 300,000 performed annually in the United States. Therefore, there exists a need to address these issues and improve patient outcomes. Transseptal access devices are in need of a means to facilitate the process of locating the fossa ovalis. Transseptal access devices are also in need of a method to better control the advancement of transseptal needles through the septum before, during, and after puncture—especially in cases where a patient presents with an aneurysmal or fibrotic septum. Lastly, transseptal access devices are in need of a means to better determine device position and orientation within the body using conventional medical imaging technologies.
Thus, improvements are needed.
To combat potential complications from arising during transseptal puncture procedures, these transseptal access devices often have sleek profiles, soft atraumatic distal tips, specific braid composite designs for ideal torque transmission, and/or hemostatic valves to prevent backflow and air ingress. Despite the sophistication of the market leader's devices, controlling the advancement of transseptal access devices into the left atrium during transseptal puncture remains a challenge, especially for patients with an atrial septum of atypical material properties (i.e. an aneurysmal and/or fibrotic septum). Furthermore, maintaining transseptal access for the introduction of additional devices into the left atrium also remains a challenge due to unintentional migration of transseptal access devices out of the left atrium after achieving access.
Accordingly, there exists a need for a reliable, cost effective system, method, and device for performing transseptal puncture in a safer, more controlled manner as well as a need for maintaining access to the left atrium after transseptal puncture has been achieved.
In the present disclosure, a device may comprise a shaft comprising a hollow body and an anchor disposed adjacent an end of the shaft, wherein the anchor is configured to engage a surface to releasably secure the shaft to the surface.
In the present disclosure, the device may additionally comprise a needle at least partially disposed within the shaft wherein the needle is configured to be advanced toward the surface and outside of the shaft.
In the present disclosure, a device may comprise a catheter comprising a hollow body configured to be disposed to enclose at least a portion of a transseptal sheath, wherein the device comprises a hollow body and an anchor disposed adjacent an end of the catheter, wherein the anchor is configured to engage a surface to releasably secure the catheter to the surface.
In the present disclosure, a device may comprise a catheter comprising a hollow body configured to be disposed to enclose at least a portion of a transseptal dilator, wherein the device comprises a hollow body and an anchor disposed adjacent an end of the catheter, wherein the anchor is configured to engage a surface to releasably secure the catheter to the surface.
In the present disclosure, a device may comprise a catheter comprising a hollow body configured to be disposed to enclose at least a portion of a transseptal needle, wherein the device comprises a hollow body and an anchor disposed adjacent an end of the catheter, wherein the anchor is configured to engage a surface to releasably secure the catheter to the surface.
In the present disclosure, a device may comprise a catheter comprising a hollow body configured to be disposed to enclose at least a portion of a transseptal access catheter assembly, wherein the device comprises a hollow body and an anchor disposed adjacent an end of the catheter, wherein the anchor is configured to engage a surface to releasably secure the catheter to the surface, and wherein the transseptal access catheter assembly comprises at least one of a transseptal sheath, a dilator, a transseptal sheath, and a guidewire.
In the present disclosure, a method may comprise disposing a device adjacent a biological surface, wherein the device comprises at least a shaft having a hollow body and a needle disposed at least partially within the hollow body of the shaft, causing the device to engage the surface to releasably secure at least a portion of the device to the surface, and causing the needle to be advanced toward the surface and outside of the hollow body of the shaft, while the at least a portion of the device is secured to the surface.
The foregoing and other features and advantages of the disclosure will be apparent from the following, more particular description of preferred embodiments of the disclosure, as illustrated in the accompanying drawings.
The present relates to system(s), method(s) and device(s) for securing a biological surface (e.g., tissue) to allow a controlled puncture of the surface. The present disclosure may relate to system(s), method(s) and device(s) where access to the left atrium is needed. The present disclosure comprises a method and device configured for controlled transseptal puncture of the atrial septum. The present disclosure additionally comprises a method and device configured for maintaining access to the left atrium following transseptal puncture. The present disclosure comprises a catheter comprising a hollow body with an anchor disposed at a distal end of the catheter, wherein the anchor is configured to releasably secure the catheter to a biological surface such as the atrial septum or fossa ovalis. The catheter may additionally be configured to at least partially enclose at least one of a transseptal sheath, a dilator, a transseptal needle, and a guidewire.
The catheter of the present disclosure may be configured to at least partially enclose transseptal access catheter assemblies used in conventional transseptal puncture procedures, wherein the catheter is configured for the introduction of a transseptal sheath and wherein the catheter is slidably and rotationally disposed along the outer surface of the shaft of the transseptal sheath.
The catheter of the present disclosure may be configured to at least partially enclose a dilator used in conventional transseptal puncture procedures, wherein the catheter is configured for the introduction of a dilator and wherein the catheter is slidably and rotationally disposed along the outer surface of the shaft of the dilator.
The catheter of the present disclosure may be configured to at least partially enclose a dilator used in conventional transseptal puncture procedures, wherein the catheter is configured for the introduction of a dilator and wherein the catheter is slidably and rotationally disposed along the outer surface of the shaft of the dilator.
The catheter of the present disclosure may be configured to at least partially enclose a transseptal needle used in conventional transseptal puncture procedures, wherein the catheter is configured for the introduction of a transseptal needle and wherein the catheter is slidably and rotationally disposed along the outer surface of the shaft of the transseptal needle.
As an example, conventional transseptal puncture procedures as referenced herein may comprise use of catheter assemblies that may further comprise a transseptal needle that is housed within a dilator sheath. This dilator sheath is then housed within a final outer sheath. These three components may be configured to be slidably disposed relative to each other, and thereby the position of each component along their shared common axis can be adjusted by the user. As an illustrative example, a catheter assembly comprising a transseptal needle, a dilator, and a transseptal sheath may be used in the following manner to access the left atrium from the right atrium:
In an exemplary embodiment, the device of the present disclosure comprises a catheter with a helical coil disposed at the distal end of the catheter, wherein the helical coil of the device is configured to “anchor” the device to the atrial septum to provide structural support to the advancement of a transseptal needle during transseptal puncture. Furthermore, the anchoring action of the helical coil to the septum as described in the present disclosure allows for sustained maintenance of an access pathway into the left atrium for the introduction of other devices through the hollow body of the present disclosure.
The device may comprise an elongated tubular structure with a helical anchoring coil configured to be slidably and rotationally disposed along the shaft of at least one of a transseptal sheath, a dilator, a transseptal needle, and a guidewire. The device may additionally comprise a hollow body with a variable inner diameter that may function to limit the distal advancement of a transseptal needle through the hollow body of the device of the present disclosure. The device may comprise an elongated tube with an axis, a proximal end, a distal end, a hollow lumen extending longitudinally through, and depth position markings. The helical coil anchor of the device of the present disclosure may comprise a sharpened tip configured for the controlled advancement of the helical coil anchor into a target tissue site. The advancement of the helical coil anchor into a target tissue site may comprise rotating the device of the present disclosure in one direction to secure the catheter to the surface of the target tissue site. Conversely, releasing the helical coil anchor from a target tissue site may comprise rotating the device of the present disclosure in the opposite direction to disengage the helical coil anchor of the catheter from the target tissue site. Securing the device of the present disclosure to the atrial septum helps prevent excessive tenting of the atrial septum during transseptal puncture with a transseptal needle. Securing the device of the present disclosure to the atrial septum helps prevent unintentional perforation of the heart wall due to uncontrolled advancement of a transseptal needle through the atrial septum into the left atrium during transseptal puncture with a transseptal needle. Securing the device of the present disclosure to the atrial septum helps maintain access to the left atrium after transseptal puncture by helping prevent unintentional removal of a transseptal sheath from the left atrium.
Although shown and described in what is believed to be the most practical and preferred embodiments, it is apparent that departures from specific designs and methods described and shown will suggest themselves to those skilled in the art and may be used without departing from the spirit and scope of the disclosure. The present disclosure is not restricted to the particular constructions described and illustrated but should be constructed to cohere with all modifications that may fall within the scope of the appended claims.
The present disclosure comprises at least the following aspects:
Commonly performed procedures to allow access to a left atrium for catheter ablation may include transseptal punctures. Historically, the conventional means used for the commonly performed procedures comprise mechanically puncturing the fossa ovalis, which may have serious complications, such as perforation of the heart wall, skiving of cardiovascular tissues, or puncture of the aorta. As an illustrative example,
Additionally, previous studies have evaluated the feasibility and safety of radiofrequency (RF) energy applied to a conventional needle as a technique to access a left atrium, particularly in patients with a repeat procedure, fibrotic septum, or aneurysmal septum. The use of RF energy to aid in transseptal punctures has increased in popularity, despite limited literature to support associated superiority and safety compared to the commonly performed procedures. Barriers to adoption still exist, particularly a limited availability of RF generators in catheterization laboratories.
A novel method and/or device is required to aid in the mechanical puncture of the fossa ovalis for access to the left atrium.
Disclosed herein is a device configured for releasably anchoring to at least a portion of the atrial septum to create a force-neutral mechanism to aid in an advancement of a transseptal needle into a left atrium.
Disclosed herein is a device comprising a high-torque catheter shaft outfitted with a helical anchoring coil at a most distal end. A lumen of said device is configured to enclose at least a portion of at least one of a transseptal sheath, a dilator, and transseptal needle, and a guidewire, and wherein the device is configured to be slidably and rotationally disposed along the shaft of a transseptal needle such that the transseptal needle may be advanced and retracted through the hollow body of the device for the purposes of puncturing through tissue. The needle may or may not comprise a hollow lumen.
A needle puncture into a fossa ovalis of a heart may create a small opening through which at least one of a guidewire, a dilator, and a transseptal sheath may be passed into a left atrium of the heart. A dilator may be advanced along the shaft of the transseptal need and/or along the shaft of a guidewire to widen the small opening created in the septum to allow for advancement of larger diameter devices into the left atrium, such as a transseptal sheath, an ablation catheter, a mapping catheter, a diagnostic catheter, an LVAD, and other devices.
The access sheath 902 may comprise a hollow body. The hollow body may be sized and/or configured to be disposed to enclose at least a portion of another component such as a commercially available sheath or transseptal sheath 904, or other components. The hollow body of the access sheath 902 may be generally tubular. However other shapes and sizes may be used. An anchor 910 may be disposed adjacent an end of the access sheath 902, such as a distal end that is configured to be advanced. The anchor 910 may be configured to engage a surface to releasably secure the access sheath 902 or another component to the surface. The anchor 901 may comprise a coil, for example having a helical, corkscrew shape. The anchor 910 may comprises a coil configured to be advanced toward the surface in a first rotating motion to engage the surface and a second opposite rotating motion to disengage the surface. The anchor 910 may comprises a tip or an edge configured to pierce at least a portion of the surface. The surface may comprise a biological surface. The surface may comprise a septum or a fossa ovalis of a heart. Other surfaces may be used. Other configurations of the anchor 910 may be used.
The transseptal sheath 904 may comprise a commercially available transseptal sheath. The transseptal sheath 904 may be configured to be disposed within the hollow body of the access sheath 902. The transseptal sheath 904 may comprise a hollow body configured to receive one or more components therein and/or there through. One or more of a transseptal needle or a dilator may be at least partially disposed within the transseptal sheath and may be configured to be advanced outside of the transseptal sheath 904. As an example, the catheter 906 may be configured to be disposed within the transseptal sheath 904 and may be used to guide and control advancement of a transseptal needle.
As an illustrative example, the anchor 910 (e.g., anchoring) coil may allow for stabilization of a fossa ovalis of a heart, preventing excessive tenting and simplifying a transseptal puncture. The access sheath 902 may be externally placed over any commercially available transseptal sheath 904. Once the transseptal sheath 904 is properly positioned in a superior vena cava of the heart and the fossa ovalis is tented with a blunt dilator, a locking mechanism (e.g., Tuohy Borst valve) on the access sheath 902 may be disengaged and the catheter 906 may be able to rotate freely about an axis of the transseptal sheath 904. The transseptal sheath 904 may be advanced until the anchor 910 at the tip is in-contact with the fossa ovalis The access sheath 902 may be rotated to advance the anchor 910 into the fossa ovalis, thereby securing the access device 900 in place. A septum of the heart may be punctured with the needle 1000 such as any commercially available transseptal needle. The transseptal sheath 904 and a dilator assembly (not shown) may be advanced into the left atrium for access. The access sheath 902 may be removed by rotating the sheath 902 counterclockwise until the anchor 910 fully disengages with the fossa ovalis.
It is contemplated that the anchor 910 may be disposed in various configuration relative the other components.
An example device may comprise a shaft comprising a hollow body, an anchor disposed adjacent an end of the shaft, wherein the anchor is configured to engage a surface to releasably secure the shaft to the surface, and a needle at least partially disposed within the shaft and is configured to be advanced toward the surface and outside of the shaft. The hollow body of the shaft may be generally tubular. The anchor may comprise a coil. The coil may be disposed to encircle at least a portion of the shaft. The coil may be configured to be advanced toward the surface in a first rotating motion to engage the surface and a second opposite rotating motion to disengage the surface. The anchor may be formed integrally with the end of the shaft or may be coupled to the end of the shaft. The anchor may be disposed along a longitudinal axis of the shaft and at least a portion of the anchor extends beyond the end of the shaft. The shaft may comprise an access sheath and the device further comprises a transseptal sheath at least partially disposed within the hollow body of the access sheath, wherein the needle comprises a transseptal needle at least partially disposed within the transseptal sheath, and wherein the transseptal needle is configured to be advanced outside of the transseptal sheath. Alternatively, the shaft may comprise a catheter and the device further comprises a transseptal sheath at least partially disposed around the hollow body of the shaft, wherein the needle comprises a transseptal needle at least partially disposed within the transseptal sheath, and wherein the transseptal needle is configured to be advanced outside of the transseptal sheath.
An example device 1200 is illustrated in
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The system(s), method(s), and/or device(s) disclosed herein may utilize an anchoring coil at a tip of a high-torque catheter that stabilizes a fossa ovalis of a heart, preventing excessive tenting and simplifying transseptal puncture.
The system(s), method(s), and/or device(s) disclosed herein may comprise an anchoring catheter compatible with commercially available transseptal sheaths, dilators, and transseptal needles.
The system(s), method(s), and/or device(s) disclosed herein may comprise a catheter that facilitates a secure hold to a septum of a heart so that a transseptal needle may be advanced with precise control.
The system(s), method(s), and/or device(s) disclosed herein may comprise a catheter with locking features to stabilize a transseptal sheath and prevent unwanted movement or migration during transseptal needle advancement.
The system(s), method(s), and/or device(s) disclosed herein may comprise a catheter with radiopaque markers to enhance physician visibility during a procedure.
The system(s), method(s), and/or device(s) disclosed herein may comprise a catheter that facilitates transseptal puncture of an aneurysmal septum and/or a fibrotic septum with ease.
The system(s), method(s), and/or device(s) disclosed herein may comprise a low-cost catheter that significantly reduces the difficulty and risk of transseptal punctures.
The system(s), method(s), and/or device(s) disclosed herein may comprise a low-cost catheter that provides left atrial access with minimal changes to existing procedural workflow.
The present disclosure relates to novel methods and devices for improving the positioning and functional operation of an access catheter when interfacing with various anatomical structures and/or biological surfaces. The present disclosure relates to novel methods and devices configured to assist with determining catheter orientation within the body.
The disclosure relates to methods and devices for stabilizing the distal end of a transseptal access catheter when interfacing with highly variable cardiac tissue geometries. Such stabilizing may enhance the determination of catheter position and orientation within the body, and may improve physician confidence in the positioning and operation of the access catheter via improved tactile feedback.
The present disclosure comprises an access catheter attachment device comprising an inner sheath slidably disposed within an outer sheath. In one exemplary embodiment, the inner sheath of the device is configured for the introduction of a transseptal access catheter and comprises a deployable stabilization cone disposed at one end (e.g., distal) thereof. The stabilization cone may be constrained and held in an undeployed, coaxial state by an outer sheath. The outer sheath may be configured to be withdrawn proximally along the shaft of the inner sheath to facilitate the radial deployment of the stabilization cone of the inner sheath.
In one exemplary embodiment, the stabilization cone comprises a flexible material comprising a conical geometry in its unconstrained, relaxed state. By adjusting the position of the outer sheath relative to the inner sheath, the maximum diameter of the stabilization cone at the terminal aspect of the inner sheath may be selectively modified to optimize the robustness of the access catheter attachment device to varying anatomical structures. The cone may comprise metal or nitinol spines impregnated within or disposed adjacent the cone. The inner sheath may comprise a lumen which allows any existing, commercially available transseptal puncture catheter assembly to be fitted, making the overall device compatible with a transseptal puncture (TSP) procedure.
The present disclosure comprises an attachment device that may be assembled with any existing commercially available transseptal puncture catheters. The attachment device adds a new step to a conventional transseptal puncture procedure that increases stability during the puncture step. The attachment device may comprise a cone sheath (e.g., inner sheath) and an outer sheath. The cone sheath may be configured to be disposed over a catheter. The cone sheath may comprise a tubular main body that runs the length of the catheter and terminates at and end with a flexible cone. The cone is held in a collapsed position by the outer sheath, which fits over the cone sheath.
Transseptal puncture devices, apparatuses, and methods are discussed herein. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be evident, however, to one skilled in the art that the present invention may be practiced without these specific details. The present disclosure is to be considered as an exemplification of the invention, and is not intended to limit the invention to the specific embodiments illustrated by the figures or description below.
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In operation, the cone 1500 allows for stabilization at the fossa ovalis, preventing excessive tenting and simplifying transseptal puncture. Once the transseptal sheath is properly positioned at the fossa ovalis, the outer sheath 1700 is drawn back allowing the cone 1500 to expand. Pressure is applied to the cone 1500 where it is in contact with the fossa ovalis tissue, thereby providing more stability than merely tenting with the blunt dilator. This increase in stability is facilitated at least by the fact that the cone 1500 provides 360° of contact with the fossa rather than single point contact provided by the existing assembly. This larger area of contact prevents the needle housed within the assembly from slipping in any particular direction, reducing the amount of time needed in the procedure and reducing tissue morbidity at the fossa ovalis. The fossa ovalis is then punctured with any commercially available transseptal needle and the transseptal sheath and dilator assembly can be advanced into the left atrium for access.
Clinical Impact
There are currently two device-based approaches to access a left atrium of a heart: mechanical transseptal needles, and transseptal needles outfitted with a radiofrequency (RF) electrode (RF-enabled transseptal devices). Mechanical transseptal needles, such as the BRK-1, are the most common type of device used for transseptal puncture and are reimbursable. However, mechanical transseptal needles are associated with serious complications arising from the high, uncontrollable force required to successfully puncture an atrial septum of a heart. RF-enabled transseptal devices, such as the Baylis NRG, use a blunt-tipped electrode to deliver a short and highly focused RF energy pulse to puncture a septum without the need for excessive mechanical force. Although RF-enabled transseptal devices reduce the risk of serious complications, RF-enabled transseptal devices require use of an RF generator and other additional accessories that increase procedural costs.
The sheaths and anchors disclosed herein is a cost-effective solution for simplifying left atrial access and offers significant benefits over existing devices, such as mechanical transseptal needles and RF-enabled transseptal devices, by reducing complications without negatively impacting procedural workflow.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well as the singular forms, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one having ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and the present disclosure and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
In describing the invention, it will be understood that a number of techniques and steps are disclosed. Each of these has individual benefits and each can also be used in conjunction with one or more, or in some cases all, of the other disclosed techniques. Accordingly, for the sake of clarity, this description will refrain from repeating every possible combination of the individual steps in an unnecessary fashion. Nevertheless, the specification and claims should be read with the understanding that such combinations are entirely within the scope of the invention and the claims.
Although the present invention has been illustrated and described herein with reference to preferred embodiments and specific examples thereof, it will be readily apparent to those of ordinary in the art that other embodiments and examples may perform similar function and/or achieve like results. All such equivalent embodiments and examples are within the spirit and scope of the present invention, are contemplated thereby, and are intended to be covered by the aforementioned claims.
This application claims the benefit of U.S. Provisional Patent Application No. 62/886,411 filed Aug. 14, 2019.
Number | Date | Country | |
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62886411 | Aug 2019 | US |