Internal medical procedures are typically either performed surgically or trans-catheterally (percutaneously), with the latter being relatively new due to the significant innovation that has occurred in this field over past few decades. This innovation has been driven by the significant advantages presented by percutaneous procedures—decreased risk of infection, significantly decreased scarring, significantly decreased patient trauma, reduced amounts and durations of anesthesia, reduced occurrence of complications during and after the procedure, significantly faster recovery times, reduction in the need for post-procedural pain medications, just to name a few.
The disadvantages, however, arise during more complicated procedures and involve the physician's inability to directly see and manually manipulate the targeted area. Additionally, as mentioned above, percutaneous procedures involve highly specialized tools that must be able to navigate to the targeted area and manipulate tissue in order to perform the desired procedure.
With regard to visualization, some procedures, especially those performed on the inside of lumens, are performed using imaging technology such as fluoroscopy. Other procedures that are performed on the outsides of organs or bodily passageways use endoscopes to provide a live visual image. These procedures often involve inflating a body cavity with a gas to provide viewing and illumination space to allow the camera to focus.
Procedures that involve the shunting of one lumen to another lumen are often performed surgically due to the unique challenges presented to performing them percutaneously. A percutaneous approach would necessarily involve a first catheter being navigated through a first lumen and a second catheter being navigated through a second lumen. The two catheters would then need to be brought into close proximity and the shunt would have to be created or installed without allowing the fluids carried in either lumen from being spilled into the bodily cavity between the two lumens.
There is thus a need for a device and method that may be used to perform procedures involving the implantation of shunts between multiple lumens.
The present invention is directed toward devices and methods that use magnets to assist in navigation and connection or communication between two or more percutaneous devices and/or implants.
In one aspect, magnets may be used for temporary guidance and placement use or may be permanently implanted.
In another aspect, the magnets are circular or have other geometric shapes including, but not limited to, a torus. The magnets are placed in both chambers and lumens that are desired to be placed in apposition.
Another aspect of the invention provides catheters with magnets mounted thereon and used to provide points of shunt contact or placement.
In at least one embodiment, the magnetic attraction will pull tissues and catheters together in a fixed, reliable geometric manner.
In at least one embodiment, a perforating needle, wire, or other tool centered or proximate the magnets can then be reliably made to transfer opposing anatomical structures in ideal locations. The magnet will thus serve as a guidance method using “hole” or other patterns on which to guide the placement of the shunt.
In at least one embodiment, the magnets may be released and removed from the body at the procedure's end. In other embodiments, the magnets may be left in place, for example, if a chronic implant is required. If left in place, the magnets may cover with tissue and become embedded in a tissue covering, or experience ingrowth. Texturing the magnet surface or adding a textured coating or a chemical surface coating may facilitate ingrowth.
One aspect of the invention provides magnets having flat mating surfaces that spread the pressure of the connection in order to prevent adverse tissue shear and tearing, especially compared to typical point connections such as sutures and other conventional connection methods.
One aspect of the invention provides shunt devices that have lips or flanges that contain magnets or may be magnetized. A magnetic shunt may provide attraction forces that hold the tissues together chronically in a desired configuration.
Another aspect of the invention provides a mechanical backbone or structure of the device that prevents physiologic expansion of the shunt, which could result in two halves of the shunt growing at unnatural or adverse diameters.
One aspect of the invention provides a system for establishing a connection across tissue walls of adjacent anatomical spaces comprising a first catheter having a first lumen and carrying a tool in said lumen; a second catheter having a second lumen; a first magnetic feature on a distal end of said first catheter; a second magnetic feature on a distal end of said second catheter; wherein said first magnetic feature includes a polar arrangement configured to attract said second magnetic feature; a first aperture on said first catheter and a second aperture on said second catheter; wherein said first and second apertures align to form a passageway when said first and second magnetic features are connected across said tissue walls; wherein said tool is positioned to puncture said tissue walls when advanced through said first lumen; a tool receiver associated with said second catheter for engaging the tool after it crosses through said tissue walls in order to establish a connection across the tissue walls.
Another aspect of the invention is a method of forming a connection across tissue walls of adjacent anatomical spaces comprising: navigating a first catheter to a first target location in a first anatomical space; navigating a second catheter to a second target location in second anatomical space adjacent said first anatomical space; using magnetic force to create a connection between said first and second catheter across tissue walls of said first and second anatomical spaces; passing a tool through the tissue walls from said first catheter to said second catheter thereby establishing a mechanical connection; removing said first and second catheters.
Yet another aspect of the invention is a system for establishing a connection across tissue walls of adjacent anatomical spaces comprising: a first navigable device having a first magnetic feature on a distal end thereof; a second navigable device having a second magnetic feature on a distal end thereof; wherein said first and second magnetic features are attracted to each other across tissue walls such that said distal ends of said first and second navigable devices become temporarily fixed to each other when brought into magnetic proximity of each other; a tool passable through tissue from one of said first and second navigable devices to the other, thereby establishing a mechanical connection across the tissue walls.
These and other aspects, features and advantages of which embodiments of the invention are capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which
Specific embodiments of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements.
Referring now to the figures and first to
In the example of
Once the guidewires are in place, the first and second catheters 20 and 30 may be advanced over the guidewires to the target location. Fluoroscopy or other imaging methods may be used to ensure proper locations have been reached. Once established, the magnetic features 22 and 32 may be “activated” or brought into attractive proximity so that they connect across the vascular tissues. Mechanical connection may then be established as described in more detail below.
The tool 50 may be a needle, wire, probe, RF wire, blade, or other puncture or cutting device. Further more, any or all of the tools herein may include a magnetic tip that would be attracted to the magnet of the receiving side to prevent the tool from hitting the vessel walls The tool 50 is used to puncture tissue and create a passage from the first lumen to the second lumen, and to establish a connection between the two lumens. In the embodiment of
The magnetic feature 60 of the first catheter 42 includes at least one, preferably two or more magnets 62. In the embodiment of
The magnetic feature 60 of the first catheter 42 may further include a moveable magnetic shield 64. The magnetic shield 64 is advanceable and retractable within a shield lumen 54 of the first catheter 42. The magnetic shield 64 may be a ferromagnetic material or other material that interrupts or blocks the magnetic field of the magnets 62. Thus, advancing the shield to a distal position between the magnetic features of the first and second catheters allows the catheters to be separated without risking tissue damage. In one example, the magnetic shield is a magnet that has its poles arranged to repel the magnetic features or one or both catheters. The magnetic shield 64 may be a set of magnets of similar size, shape and strength magnets 62, or may be slightly weaker while still allowing atraumatic separation. Alternatively, the shield 64 may be formed as an inner or outer sheath that blocks the magnetic field sufficiently to effect atraumatic separation. The magnetic shield and all other magnetic disengagement systems described herein may be operated by a device that provides the operator with a mechanical advantage such as a knob or lever.
The tool receiver 76 is used to allow the tool 50 of the first catheter 42 to enter the second catheter 70. In at least one embodiment, the tool receiver may be a lumen forgivably sized to receive the tool 50.
The tool retaining mechanism 78 functions to grab the tool once received by the tool receiver 76. The tool retaining mechanism 78 is shown in
The magnetic feature 90 of the second catheter 70 includes at least one, preferably two or more magnets 92. The number of magnets 92 on the second catheter 70 is dictated by the number of magnets 62 on the first catheter 42. In the embodiment of
The magnetic feature 90 of the second catheter 70 may optionally include a moveable magnetic shield (not shown) but this would likely unnecessary as the function of interrupting the field would preferably be accomplished by shield 64 of the first catheter 42. Alternatively, the shield feature could be supplied on the second catheter 70 instead of the first catheter 42.
Referring to
The needle 51 of the tool 50 has advanced and emerged from the tool aperture 49 and has punctured the walls W1 and W2, as directed by the shape of the tool lumen 48. The needle 51 is aligned with, and has begun to enter, the tool receiver 76 of the second catheter 70.
Next, as shown in
In
In
Next, the magnetic shield 64 is advanced until located between the magnets 62 of the first catheter 42 and the magnets 92 of the second catheter 70. Having severed the magnetic relationship between the two sets of magnets 62 and 92, the second catheter is retracted, pulling the wire 53 with it, as seen in
Referring now to
The second catheter 150 is similar to the first catheter 110 and includes a body 152 and a second magnetic feature 160 that is constructed and arranged to be attracted to the first magnetic feature 130 in an axial configuration as shown. A tool 140, such as a wire (
The magnetic features 130 and 160 may be identical with the exception of polar orientation. The halves of each magnetic feature have opposite poles such that they are attracted to each other and remain together as a complete circle or cylinder until forcibly separated. Similarly, the upper (for sake of explanation only) half 132A of the first magnetic feature 130, is a polar opposite of the corresponding upper half 162A of the second magnetic feature 160. Thus, if magnet 132A has a N designation, for example, 132B would be S, 162A would be S and 162B would be N. Additionally. as shown in
The first and second catheter bodies 112 and 152 have distal ends 114 and 154 that can be seen without the magnetic feature 130 and 160 in
The design and orientation of the magnetic features 130 and 160 accommodate the placement of a balloon-expanded shunt in the form of a rivet, stent, or other anastomotic—forming implant (not shown). In use, each of the first and second catheters 110 and 150 are navigated to target locations in adjacent bodily spaces, such as a lumen or cavity, that are desired to be joined. The catheters 110 and 150 are either rotated up to 90 degrees toward each other, either via a steering mechanism or a preformed bend that may be released from a straightened configuration, such that the two distal ends 114 and 154 face each other in an axial alignment. This configuration aligns the two central lumens of the catheters and magnetic features, allowing a tool, such as a needle, RF wire, or sharpened guidewire, to be advanced through the first catheter, second catheter, or both, to puncture the tissue walls trapped between the magnetic features 130 and 160. The magnetic features 130 and 160 are strong enough to hold the tissue walls together to form a seal, preventing any of the fluids traveling through the bodily spaced from escaping.
Once the tissue walls are punctured by the tool, an expandable implant can be advanced and centered within the magnets. In at least one embodiment, an interaction between the magnets and the implant sends an electronic or visual signal indicating proper placement of the implant.
Having verified the proper placement of the implant, a balloon may be advanced to the center of the implant, or the balloon may have been advanced with the implant and expanded. Expanding the balloon expands the implant and causes the implant to form a connection between the two body spaces, as well as causing the magnetic features 130 and 160 to spread apart and disengage each other. The permanent connection between the magnetic components 132 and 162 of the magnetic features 130 and 160 and the distal halves 118 and 150 of the distal ends 114 and 154 prevent the magnetic components 132 and 162 from separating from the catheters 110 and 150.
One embodiment 190, shown in
The specific target location may give rise to different embodiments. For example, some adjoining tissue walls are already externally adhered to each other. Take for example, the pulmonary artery (PA) and the superior vena cava (SVC). Because these are externally adhered, the strength of the magnets may be reduced, as they do not have to form a seal, and the risk of injury to the therapy site is reduced during separation. In this case the purpose of the magnetic features is simply to locate where the vessels cross, and to protect the receiving vessel during puncture. Thus, the cylindrical magnets on each catheter may be a complete cylinder, without sections, and the procedure may be to puncture across the tissue with a wire, remove the magnet catheters, track a balloon catheter over the wire, and expand the balloon and implant. Similarly, it the target locations involve tissues that self-fuse when magnetic compression is applied, the need for covered implants and laser cut breakaway designs may be obviated.
Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.
This application claims priority to Provisional Patent Application Ser. No. 62/881,239, filed Jul. 31, 2019, entitled Coronary Artery-LAA Shunt; and, Provisional Patent Application Ser. No. 62/906,001, filed Sep. 25, 2019, entitled LAA Flow Augmentation, all of which are hereby incorporated herein by reference in their entireties.
Filing Document | Filing Date | Country | Kind |
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PCT/US20/44347 | 7/30/2020 | WO |
Number | Date | Country | |
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62881239 | Jul 2019 | US | |
62906001 | Sep 2019 | US |