MAGNETIC ASSISTED IN-SITU TUBULAR STENTGRAFT FENESTRATION
20170325934 · 2017-11-16
Assignee
Inventors
Cpc classification
A61F2220/0025
HUMAN NECESSITIES
International classification
Abstract
A magnet assisted surgical device, system, and method employs magnetic sections, catheters, and guidewires to modify tubular stentgrafts in-situ. One example application provides a more reliable way for surgeons to modify stentgrafts insitu to allow blood flow to continue to branching blood vessels that would otherwise be blocked by the stentgraft itself. One such method includes placing a tip section of the device in the desired location, deploying a stentgraft, placing a magnetic device inside the stentgraft, connecting the magnetic device to the tip section, and excising the portion of the stentgraft held between the magnet and the tip section.
Claims
1. An apparatus, comprising: a tip section having a proximal end and a distal end; a first guidewire extending coaxially through the tip section from the distal end to the proximal end; and a second guidewire attached to the tip section; wherein at least a portion of the tip section is magnetic.
2. The apparatus of claim 1, wherein the tip section is ogive-shaped.
3. The apparatus in claim 1, wherein the tip section comprises at least one rare earth magnet.
4. The apparatus in claim 1, wherein the tip section comprises material selected from a group consisting of neodymium, cobalt, iron, samarium, copper, zirconium, aluminum, nickel, and some combination thereof.
5. The apparatus of claim 1, wherein the first guidewire has a diameter of between 0.021 inches and 0.038 inches.
6. The apparatus of claim 1, wherein the second guidewire has a diameter of between 0.014 inches and 0.021 inches.
7. The apparatus of claim 1, wherein the second guidewire is attached to the side of the tip section.
8. The apparatus of claim 1, wherein the apparatus additionally comprises a first catheter and a second catheter, wherein the first catheter surrounds the first guidewire and the second catheter surrounds the second guidewire.
9. An apparatus, comprising: a tip section having a proximal end and a distal end; a docking section having a proximal end and a distal end; and a guidewire attached to the tip section; wherein the distal end of the tip section and the proximal end of the docking section are magnetic such that the tip section and the docking section can be magnetically docked.
10. The apparatus of claim 9, wherein the apparatus additionally comprises at least one catheter that is detachably connected to the distal end of the docking section.
11. The apparatus of claim 9, wherein the guidewire has a diameter of between 0.014 inches and 0.038 inches.
12. The apparatus of claim 9, wherein the apparatus additionally comprises a second guidewire and wherein the tip section and the docking section are configured to allow the second guidewire to coaxially run through them.
13. A system for in-situ fenestration of tubular grafts, comprising: a tip section having a proximal end and a distal end, wherein the distal end is magnetic; a docking section having a proximal end and a distal end, wherein the proximal end is magnetic; a first guidewire; a second guidewire; a third guidewire; a first catheter; and a second catheter; and wherein the tip section is configured to: slidably receive the first guidewire, allowing the first guidewire to run coaxially through the tip section; attach to the second guidewire; detachably connect to the first catheter; magnetically dock with the proximal end of the docking section which connects to the second catheter; and slidably receive the third guidewire, allowing the third guidewire to run coaxially though both the tip section and the docking section.
14. The system of claim 13, wherein the system additionally comprises an electric hot-wire loop wherein the electric hot-wire loop is configured to: surround the second catheter; travel along the second catheter up to the docking section; and excise a substantially round section from the material held between the tip section and the docking section.
15. The apparatus of claim 13, wherein the tip section is ogive-shaped.
16. The apparatus in claim 13, wherein tip section and the docking section comprises material selected from a group consisting of neodymium, cobalt, iron, samarium, copper, zirconium, aluminum, nickel, and some combination thereof.
17. The apparatus of claim 13, wherein the first guidewire has a diameter of between 0.021 inches and 0.038 inches.
18. The apparatus of claim 13, wherein the second guidewire has a diameter of between 0.014 inches and 0.021 inches.
19. The apparatus of claim 13, wherein the second guidewire is attached to the side of the tip section.
20. The apparatus of claim 13, wherein the third guidewire has a diameter of between 0.021 inches and 0.038 inches.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] For a more complete understanding of the disclosed system, apparatus, and methods, reference is now made to the following descriptions taken in conjunction with the accompanying drawings.
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DETAILED DESCRIPTION
[0031]
[0032] The in-situ fenestration device may include additional elements such as catheters to aid in the insertion of guidewires into a patient.
[0033] The tip section 120, in order to be positioned in the desired location, may be detachable from the catheter(s) themselves. For example,
[0034] Further, the tip section 120 and any accompanying catheters may allow for guidewires to pass coaxially through them. For example,
[0035] The present invention may include features that provided flexibility and options to physicians when practicing the disclosed fenestration device. For example,
[0036] Each element of the apparatus may be independent from each other element, while simultaneously allowing for them to interact, connect to, or be guided by other elements. For example,
[0037] In reference to the guidewires, in one embodiment of the disclosure, the first guidewire 102 may have a diameter of 0.035 inches (0.89 mm), but in other embodiments the first guidewire 102 may have a diameter of 0.014 inches (0.36 mm), 0.018 inches (0.46 mm), 0.021 inches (0.53 mm), 0.025 inches (0.64 mm), 0.032 inches (0.81 mm), or 0.038 inches (0.97 mm). Further, in one embodiment of the disclosure, the second guidewire 106 may have a diameter of 0.014 inches (0.36 mm), but in other embodiments the second guidewire 106 may have a diameter of 0.018 inches (0.46 mm), 0.021 inches (0.53 mm), 0.025 inches (0.64 mm), 0.032 inches (0.81 mm), 0.035 inches (0.89 mm), or 0.038 inches (0.97 mm). Because all guidewire sizes are viable, all suitable guidewires are contemplated and the choice of which to use depends on the specific patient being treated and the specifics of that patient's condition.
[0038] With regards to the tip section 120, the first guidewire 102 runs coaxially through the tubular lumen 402 of the tip section 120. In this embodiment, the first guidewire 102 is not connected to the tip section 120, thus allowing the tip section to slide freely along the guidewire 102. Also according to this embodiment, the second guidewire 106 is permanently affixed to the side of the tip section 120. The second guidewire 106 may be attached at such an angle to easily allow for the second guidewire to extend distally along the same path as the first guidewire 102, large catheter 202, and small catheter 404. In one embodiment, the second guidewire 106 is attached to the tip section via vibration welding. However, all suitable methods of attachment are contemplated. For example, in one embodiment of the disclosure, the second guidewire 106 is attached by inserting the guidewire 106 into a channel on the tip section and kinking the guidewire 106 such that the guidewire 106 cannot be removed from the tip section 120 when force is applied to either. In yet another embodiment, the guidewire 106 may be glued to the tip section 120.
[0039] The distal end 108 may be magnetic. The tip section 120 might not be a homogeneous material, but instead may have the distal end 108 alone made of a magnetic material. Alternatively, the tip section 120 as a whole may be magnetic and thus may be made of a single material. In one embodiment, the magnetic portion of the tip section 120 is comprised of one or more rare earth metals. One skilled in the art would understand rare earth metals to identify a type of strong permanent magnets made from combinations or alloys of rare earth elements. Such rare earth elements include, but are not limited to Scandium (Sc), Yttrium (Y), Lanthanum (La), Cerium (Ce), Praseodymium (Pr), Neodymium (Nd), Promethium (Pm), Samarium (Sm), Europium (Eu), Gadolinium (Gd), Terbium (Tb), Dysprosium (Dy), Holmium (Ho), Erbium (Er), Thulium (Tm), Ytterbium (Yb), and Lutetium (Lu). Additionally, one skilled in the art would understand that in addition to these rare earth elements, rare earth magnets may comprise additional elements including, but not limited to, Iron (Fe), Nickel (Ni), Cobalt (Co), Aluminum (Al), Copper (Cu), Titanium (Ti), and Boron (B). These magnetic characteristics may allow the tip section 120 to further interact and magnetically dock with other portions.
[0040] The tip section may be ogive-shaped. A person having ordinary skill in the art would understand the description “ogive” to refer to an object having a roundly tapered end. For example, the tip section 120 of the device is in the shape of a bullet. This shape allows the bullet to more easily pass within vessels by reducing the risk of the vessels being damaged. Additionally, the tip section 120 may include a tubular lumen 402 running coaxially from its proximal end 104 to its distal end 108. The tubular lumen 402 may have a diameter of 0.035 inches, but may alternatively have a diameter of 0.014 inches (0.36 mm), 0.018 inches (0.46 mm), 0.021 inches (0.53 mm), 0.025 inches (0.64 mm), 0.032 inches (0.81 mm), or 0.038 inches (0.97 mm) to fit the various guidewire sizes that may be used in conjunction with the tip section 120.
[0041] In reference to the catheters, the small catheter 404 may run coaxially with the larger catheter 202. Both the small catheter 404 and the larger catheter 202 may be detachably connected from the tip section 120. The size of the larger catheter 202 (and larger catheter 708 shown below) may be dependent upon the diameter of the magnets that are selected and based on a diameter of the vessel being cannulated. In one embodiment, the small catheter 404 is French gauge 4 catheter, but in other embodiments the small catheter 404 may be French gauge 3, 5, 6, or 7. Because all catheter sizes are viable, all suitable catheters are contemplated and the choice of which to use depends on the size guidewires being used, the specific patient being treated, and the specifics of that patient's condition.
[0042] In addition to the tip section 120, the apparatus may include a complementary docking section that magnetically interacts with the tip section. These two sections, when acting together, may be used to isolate a portion of the stentgraft such that the portion may be excised.
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[0044] As with the tip section 120, the docking section 704 may be magnetic. In one embodiment, the docking section 704 is comprised of one or a combination of rare earth metals. One skilled in the art would understand rare earth metals to identify a type of strong permanent magnets made from combinations or alloys of rare earth elements. Such rare earth elements include, but are not limited to Scandium (Sc), Yttrium (Y), Lanthanum (La), Cerium (Ce), Praseodymium (Pr), Neodymium (Nd), Promethium (Pm), Samarium (Sm), Europium (Eu), Gadolinium (Gd), Terbium (Tb), Dysprosium (Dy), Holmium (Ho), Erbium (Er), Thulium (Tm), Ytterbium (Yb), and Lutetium (Lu). Additionally, one skilled in the art would understand that in addition to these rare earth elements, rare earth magnets may comprise additional elements including, but not limited to, Iron (Fe), Nickel (Ni), Cobalt (Co), Aluminum (Al), Copper (Cu), Titanium (Ti), and Boron (B). These magnetic characteristics allow the docking section to further magnetically interact with a tip section 120.
[0045] The docking section 704 may have a cylindrical shape and connect with catheters 706, 708 on one of the two flat cylinder faces. The docking section 704 may additionally have a tubular lumen 702 that runs from one cylinder face to the opposite face in order to allow guidewires to be passed through it. In one embodiment, the tubular lumen 702 has a diameter of 0.035 inches, but may alternatively have a diameter of 0.014 inches (0.36 mm), 0.018 inches (0.46 mm), 0.021 inches (0.53 mm), 0.025 inches (0.64 mm), 0.032 inches (0.81 mm), or 0.038 inches (0.97 mm) to fit the various guidewire sizes that may be used in conjunction with the docking section 704.
[0046] In reference to the catheters that could be used in connection with a docking section 704, in one embodiment, the small catheter 706 runs coaxially with the larger catheter 708. Both the small catheter 706 and the larger catheter 708 may be permanently attached to the docking section 704. In one embodiment, the small catheter 706 is French gauge 4 catheter, but in other embodiments the small catheter 706 may be French gauge 3, 5, 6, 7, or 8. Because all catheter sizes are viable, all suitable catheters are contemplated and the choice of which to use depends on the size guidewires being used, the specific patient being treated, and the specifics of that patient's condition.
[0047] The apparatus may additionally include an element that has the capability of excising a portion of the surgical stentgrafts used by the physician to treat an aneurysm.
[0048] The electric hot-wire loop and the docking section may be configured to interact with one another.
[0049] Bringing many of the described components together,
[0050] Further illustrating the interaction between certain components,
[0051] A method of magnet assisted in-situ fenestration of a stentgraft may be described with respect to the flow chart of
[0052] Further explaining initial steps of the method in certain embodiments,
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[0054] According to one embodiment of the disclosure, the main vessel 1302 is the patient's aorta. The branching vessel 1304 may be a renal artery, but in other embodiments the branching vessel 1304 may include the gonadal arteries, lumbar arteries, inferior or superior mesenteric arteries, median sacral artery, or the celiac trunk. In one embodiment, the entry vessel 1308 refers to one of the common iliac arteries.
[0055] Although the present disclosure and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the disclosure as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the present invention, disclosure, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present disclosure. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.