Fixation of a debris protection device in a body cavity

Abstract

A device for anchoring a medical device within a large body lumen includes an elongated support configured to axially support the medical device within the body lumen and resist longitudinal movement along the body lumen, the elongated support being axially inflexible but laterally flexible. An anchoring frame for anchoring within a body lumen, the frame sized and shaped to expand to a diameter corresponding to the aorta. Related devices and methods are also described.

Description

[Technical Field]

[0001] This application is a PCT application claiming benefit of priority to U.S. Provisional Patent Application No. 63 / 400,779, entitled "Anchoring of Debris Protection Device in a Body Cavity," filed August 25, 2022, and is related to U.S. Provisional Patent Application No. 63 / 398,546, entitled "Capturing Debris Flowing Within Blood Vessels and Other Body Cavities," filed August 17, 2022.

[0002] This application is also related to U.S. Provisional Patent Application No. 63 / 400,771, filed August 25, 2022, entitled "Protection of Coronary and Myocardial Vascular Vessels During Medical Procedures," U.S. Provisional Patent Application No. 63 / 400,773, filed August 25, 2022, entitled "Management of Debris Protection Associated with Vascular or Cardiac Medical Procedures," and U.S. Provisional Patent Application No. 63 / 400,866, filed August 25, 2023, entitled "Capturing Debris Flowing Within a Vena Cava."

[0003] The entire contents of the above applications are incorporated herein by reference as if fully set forth herein. [Background technology]

[0004] The present disclosure, in some embodiments thereof, relates to mechanisms and methods for securing and / or anchoring tubular devices in a body lumen, more particularly, but not exclusively, to mechanisms and methods for securing and / or anchoring debris protection devices in a body lumen, and even more particularly, but not exclusively, to mechanisms and methods for securing and / or anchoring debris protection devices in the aorta.

[0005] Additional background art includes the following: International Patent Application Publication No. WO 2019 / 064223 to Brandeis, which describes an aortic protection device comprising a mesh lumen shaped and sized to extend along the aorta from the cardiac side of the brachiocephalic artery's exit from the aorta to distal to the left subclavian artery's exit from the aorta, the mesh lumen being arranged to change the porosity of the mesh pores in response to an external control.

[0006] International Patent Application Publication No. WO2017 / 042808 by Eli describes an embolic protection device including a porous deflection screen that includes a filter and is positioned along the wall of the aortic arch to expand and cover the entrances of arteries branching from the aorta; an embolus collecting portion that includes a cylinder that expands and is positioned along the wall of the descending aorta, and is pressed against the wall of the descending aorta to lock the porous deflection screen; and a connecting portion that connects the porous deflection screen and the embolus collecting portion and is positioned to lock the porous deflection screen against the wall of the aortic arch.

[0007] The disclosures of all documents mentioned above and throughout the specification, and of all documents cited within those documents, are hereby incorporated by reference. Summary of the Invention

[0008] The present disclosure, in some embodiments thereof, relates to mechanisms and methods for anchoring and / or anchoring tubular devices in a body lumen, more particularly, but not exclusively, to mechanisms and methods for anchoring and / or anchoring debris protection devices in a body lumen, and even more particularly, but not exclusively, to mechanisms and methods for anchoring and / or anchoring debris protection devices in the aorta.

[0009] In accordance with an aspect of some embodiments of the present disclosure, there is provided a device for anchoring a medical instrument within a large body cavity, the device comprising an elongate support configured to axially support the medical instrument within the body cavity against longitudinal movement along the body cavity, the elongate support being axially inflexible but laterally flexible.

[0010] According to some embodiments of the present disclosure, the large body cavity is the aorta.

[0011] According to some embodiments of the present disclosure, the device comprises a plurality of supports.

[0012] According to some embodiments of the present disclosure, the support comprises a hollow tube.

[0013] According to some embodiments of the present disclosure, the support comprises a hollow tube, the hollow tube comprising a control wire for controlling the medical device.

[0014] According to some embodiments of the present disclosure, the medical device includes a blood filtering mesh.

[0015] According to some embodiments of the present disclosure, the medical instrument includes a device for capturing debris flowing along the body cavity.

[0016] According to some embodiments of the present disclosure, the medical instrument includes a device for preventing debris from entering a coronary artery.

[0017] According to some embodiments of the present disclosure, the medical instrument includes a device for preventing debris from entering arteries leading to the brain.

[0018] According to some embodiments of the present disclosure, the medical instrument includes a device for capturing debris present in a vein.

[0019] According to some embodiments of the present disclosure, the medical instrument includes a device for capturing debris present in the vena cava.

[0020] According to an aspect of some embodiments of the present disclosure, there is provided a system comprising a filter and an anchor, the anchor comprising a hollow tube that is axially inflexible but laterally flexible.

[0021] According to some embodiments of the present disclosure, the tube is connected to the filter at or near the distal end of the filter.

[0022] According to some embodiments of the present disclosure, the tube is connected to the filter at or near the distal end of the tube.

[0023] According to an aspect of some embodiments of the present disclosure, there is provided a method of anchoring a medical device within a body cavity, the method comprising: pushing a first medical device into the body cavity, the first medical device being supported by a support, the support being longitudinally inflexible and laterally flexible to prevent longitudinal movement of the first medical device along the body cavity.

[0024] According to some embodiments of the present disclosure, the first medical device includes a filter.

[0025] According to some embodiments of the present disclosure, the support is attached to the first medical device.

[0026] According to some embodiments of the present disclosure, the support comprises a hollow tube.

[0027] According to some embodiments of the present disclosure, the hollow tube includes a control wire for controlling the first medical device.

[0028] According to some embodiments of the present disclosure, the hollow tube includes a control wire for controlling a second medical device.

[0029] According to some embodiments of the present disclosure, the medical device includes a blood filtering mesh.

[0030] According to some embodiments of the present disclosure, a medical instrument includes a device for capturing debris flowing along a body cavity.

[0031] According to some embodiments of the present disclosure, the medical instrument includes a device for preventing debris from entering a coronary artery.

[0032] According to some embodiments of the present disclosure, the medical instrument includes a device for preventing debris from entering arteries leading to the brain.

[0033] According to some embodiments of the present disclosure, the medical instrument includes a device for capturing debris present in a vein.

[0034] According to some embodiments of the present disclosure, the medical instrument includes a device for capturing debris present in the vena cava.

[0035] In accordance with an aspect of some embodiments of the present disclosure, there is provided an anchoring frame for anchoring within a body lumen, the frame sized and shaped to expand to a diameter corresponding to the aorta.

[0036] According to some embodiments of the present disclosure, the locking frame is sized and shaped to expand to a diameter corresponding to the aorta of an adult human.

[0037] According to some embodiments of the present disclosure, the anchoring frame is sized and shaped to expand to a diameter corresponding to the ascending aorta between the coronary arteries and the brachiocephalic trunk.

[0038] According to some embodiments of the present disclosure, the locking frame is sized and shaped to expand to a diameter corresponding to the vena cava.

[0039] According to some embodiments of the present disclosure, the locking frame includes two concentric layers.

[0040] According to some embodiments of the present disclosure, a first outer layer is configured to be extruded from the catheter first and a second inner layer is configured to be extruded from the catheter second, pushing the outer layer outward.

[0041] According to some embodiments of the present disclosure, a longitudinally stiff wire is included that is configured to connect to a debris protection device located upstream of said locking frame.

[0042] According to some embodiments of the present disclosure, the locking frame is connected to a debris protection device located upstream of said locking frame.

[0043] According to some embodiments of the present disclosure, a wire configured to connect to a debris protection device located downstream of the locking frame is included.

[0044] According to some embodiments of the present disclosure, the locking frame is connected to a debris protection device located downstream of said locking frame.

[0045] According to some embodiments of the present disclosure, the frame is configured to leave a space for a medical instrument to pass through the center of the frame when expanded.

[0046] According to some embodiments of the present disclosure, the locking frame is configured to expand under radial pressure and exert force against the wall of the body cavity both radially and longitudinally along the body cavity.

[0047] According to some embodiments of the present disclosure, the frame includes a locking mechanism that locks the frame in the expanded state.

[0048] According to some embodiments of the present disclosure, the frame includes a protective film on its outer surface.

[0049] According to some embodiments of the present disclosure, the outer wall of the frame is covered with a material to reduce damage to the vessel wall.

[0050] According to some embodiments of the present disclosure, the outer wall of the frame is coated with a polymer.

[0051] According to some embodiments of the present disclosure, the inner wall of the frame is coated with a polymer.

[0052] According to some embodiments of the present disclosure, the locking frame is configured to be withdrawn from the patient's body without releasing debris from the walls of said body cavity.

[0053] According to some embodiments of the present disclosure, the catheter is configured to be withdrawn from the patient's body without damaging the walls of the body cavity.

[0054] According to some embodiments of the present disclosure, the catheter is configured with a star-shaped cross-section that expands to a tubular cross-section to exert a radially outward force on the wall of the body cavity.

[0055] According to some embodiments of the present disclosure, the frame includes a feature within its outer wall that has a star-shaped cross-section, which expands into a tubular cross-section to exert a radially outward force on the frame.

[0056] According to some embodiments of the present disclosure, an outer wall of the frame includes a mechanism configured to apply a radially outward force to the frame.

[0057] According to some embodiments of the present disclosure, an outer wall of the frame includes a hexagonal mechanism configured to apply a radially outward force to the frame.

[0058] According to some embodiments of the present disclosure, the device further includes a wire attached at one end to the locking frame and at the other end to the blood filtering mesh to prevent the mesh from being washed downstream when the frame is fully expanded.

[0059] According to some embodiments of the present disclosure, the device further includes a wire attached at one end to the locking frame and at the other end to the device for capturing debris in the aorta to prevent the device from being washed downstream when the frame is fully expanded.

[0060] According to some embodiments of the present disclosure, the retention frame is configured, when expanded against the wall of the ascending aorta, to withstand a force of 10 to 30 Newtons pulling the retention frame in a direction parallel to the surface of the wall of the ascending aorta, preventing it from slipping along the wall.

[0061] According to some embodiments of the present disclosure, a control mechanism is included for controlling the radial force applied to the wall of the body cavity from outside the patient's body.

[0062] According to an aspect of some embodiments of the present disclosure, there is provided a method for anchoring a medical device within a body cavity, the method comprising: inserting a first medical device attached to an anchoring frame into a body cavity; positioning the first medical device at a desired location along the body cavity; and expanding the frame to contact a wall of the body cavity and apply an anchoring force to the wall of the body cavity.

[0063] According to some embodiments of the present disclosure, the locking frame is attached to a wire for supporting a first medical instrument upstream of the locking frame, and expanding the locking frame includes expanding the locking frame downstream of the first medical instrument such that the locking frame supports the first medical instrument to prevent it from shifting from a desired position.

[0064] According to some embodiments of the present disclosure, the locking frame is attached to a wire for supporting a first medical instrument downstream of the locking frame, and expanding the locking frame includes expanding the locking frame upstream of the first medical instrument such that the locking frame supports the medical instrument to prevent it from shifting from a desired position.

[0065] According to some embodiments of the present disclosure, further comprising passing a second medical instrument through the center of the frame.

[0066] According to some embodiments of the present disclosure, expanding the locking frame includes actuating a locking mechanism that locks the locking frame in an expanded state.

[0067] According to some embodiments of the present disclosure, further comprising removing the locking frame from the patient's body.

[0068] According to some embodiments of the present disclosure, removing the locking frame from the patient's body includes removing the locking frame without expelling debris from the wall of the body cavity.

[0069] According to some embodiments of the present disclosure, removing the locking frame from the patient's body includes removing it without damaging the wall of the lumen.

[0070] According to some embodiments of the present disclosure, expanding the frame to contact the wall of the body cavity and apply a force to anchor it to the wall of the body cavity includes expanding the frame to withstand a torque in the range of 10 to 30 Newton meters pulling the anchoring frame in a direction parallel to the surface of the wall of the body cavity and applying sufficient force to prevent it from slipping along the wall.

[0071] According to some embodiments of the present disclosure, expanding the frame to apply a force sufficient to withstand a torque in the range of 10 to 30 Newton-meters includes operating a control mechanism to apply the force.

[0072] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this disclosure belongs.Although methods and materials similar or equivalent to those described herein can be used to practice or test the embodiments of this disclosure, exemplary methods and / or materials are described below.In case of conflict, the patent specification, including definitions, shall prevail.In addition, materials, methods, and examples are merely illustrative and are not necessarily intended to be limiting. [Brief explanation of the drawings]

[0073] Several embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings and images. It will be emphasized that the details shown below, with particular reference to the drawings, are for the purpose of illustration and for the purpose of providing a detailed description of embodiments of the present disclosure. Similarly, by reference to the description in conjunction with the drawings, it will become apparent to those skilled in the art how embodiments of the present disclosure may be practiced.

[0074] [Figure 1A] 1 is a simplified line drawing of a debris protection device such as that described in the above-referenced International Patent Application Publication No. WO2019 / 064223 (Brandeis), which could potentially benefit from anchoring according to an exemplary embodiment. [Figure 1B] 1 is a simplified line drawing of a debris protection device described in the above-mentioned co-filed U.S. provisional patent application, "Protection of Coronary and Myocardial Vascular Vessels During Medical Procedures" (Application Docket No. 91186), which potentially benefits from anchoring according to an exemplary embodiment. [Figure 1C] 1 is a simplified line drawing of a debris protection device described in the above-mentioned co-filed U.S. provisional patent application, "Protection of Coronary and Myocardial Vascular Vessels During Medical Procedures" (Application Docket No. 91186), which potentially benefits from anchoring according to an exemplary embodiment. [Figure 1D] 1 is a simplified line drawing of a debris protection device such as that described in the above-referenced US Provisional Patent Application No. 63 / 398,546, which could potentially benefit from anchoring according to an exemplary embodiment. [Figure 1E] FIG. 1 is a diagram of a device that optionally includes aortic protection and debris capture as described in the above-referenced US Provisional Patent Application No. 63 / 398,546, and potentially benefits from anchoring according to an exemplary embodiment. [Figure 1F] 1 is a simplified line drawing of a device having optional debris capture as described in the above-referenced US Provisional Patent Application No. 63 / 398,546, which could potentially benefit from anchoring according to an exemplary embodiment. [Figure 2A] 10A-10C are diagrams of a locking mechanism according to an exemplary embodiment. [Figure 2B] 10A-10C are diagrams of a locking mechanism according to an exemplary embodiment. [Figure 2C] 10A-10C are diagrams of a locking mechanism according to an exemplary embodiment. [Figure 2D] 10A-10C are diagrams of a locking mechanism according to an exemplary embodiment. [Figure 2E] 10A-10C are diagrams of a locking mechanism according to an exemplary embodiment. [Figure 2F] 10A-10C are diagrams of a locking mechanism according to an exemplary embodiment. [Figure 3A] FIG. 1 is a simplified diagram of a support and control wires passing through it, according to an exemplary embodiment. [Figure 3B] FIG. 10 is a simplified diagram of a locking frame and support and / or control wires according to an exemplary embodiment. [Figure 4A] FIG. 10 is a simplified diagram of a locking frame exiting a catheter according to an exemplary embodiment. [Figure 4B] FIG. 1 is a simplified diagram of a locking frame according to an exemplary embodiment. [Figure 4C] FIG. 1 is a simplified diagram of a locking frame according to an exemplary embodiment. [Figure 4D] FIG. 1 is a simplified diagram of a locking frame according to an exemplary embodiment. [Figure 5] 1 is a simplified flowchart of a method for anchoring a medical device within a body cavity according to an exemplary embodiment. [Figure 6A]1 is a diagram of a locking frame according to an exemplary embodiment; [Figure 6B] 1 is a diagram of a locking frame according to an exemplary embodiment; [Figure 6C] 1 is a diagram of a locking frame according to an exemplary embodiment; [Figure 6D] 1 is a diagram of a locking frame according to an exemplary embodiment; [Figure 6E] 1 is a diagram of a locking frame according to an exemplary embodiment; [Figure 6F] 1 is a diagram of a locking frame according to an exemplary embodiment; [Figure 6G] 1 is a diagram of a locking frame according to an exemplary embodiment; [Figure 7A] FIG. 10 is an illustration of an inner layer of a locking frame according to an exemplary embodiment. [Figure 7B] FIG. 10 is an illustration of an inner layer of a locking frame according to an exemplary embodiment. [Figure 7C] FIG. 10 is an illustration of an inner layer of a locking frame according to an exemplary embodiment. [Figure 7D] FIG. 10 is an illustration of an inner layer of a locking frame according to an exemplary embodiment. [Figure 7E] FIG. 10 is an illustration of an inner layer of a locking frame according to an exemplary embodiment. [Figure 7F] FIG. 10 is an illustration of an inner layer of a locking frame according to an exemplary embodiment. [Figure 8] 10 is a simplified flowchart of a fixation method including controlled application of additional radial force, according to an exemplary embodiment. [Figure 9] 10 is a simplified flowchart of a fixation method including controlled self-expansion and application of additional radial force according to an exemplary embodiment. [Figure 10] 1 is a simplified line drawing of a debris protection device, potentially benefiting from anchoring according to an exemplary embodiment; DETAILED DESCRIPTION OF THE INVENTION

[0075] The present disclosure, in some embodiments thereof, relates to mechanisms and methods for anchoring and / or anchoring tubular devices in a body lumen, more particularly, but not exclusively, to mechanisms and methods for anchoring and / or anchoring debris protection devices in a body lumen, and even more particularly, but not exclusively, to mechanisms and methods for anchoring and / or anchoring debris protection devices in the aorta.

[0076] Before describing at least one embodiment of the present disclosure in detail, it is understood that the present disclosure is not necessarily limited in its application to the details of construction and the arrangement of elements and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0077] <Summary> Various medical procedures and devices need to be inserted into and placed in a body cavity. Some such devices are inserted to remain permanently, or at least for a long period of time, such as support stents.

[0078] Some such devices are inserted to remain in place for a limited period of time. Non-limiting examples include debris protection devices, such as the aortic protection device described in the above-referenced International Patent Application Publication No. WO 2019 / 064223 (Brandeis), and / or the debris capture device described in the above-referenced U.S. Provisional Patent Application No. 63 / 398,546, and / or the above-referenced co-filed U.S. Provisional Patent Application entitled "Protection of Coronary Arteries and Myocardial Vascular Vessels During Medical Procedures" (Application Docket No. 91186).

[0079] Various embodiments described herein relate to long-term fixation or anchoring of a medical device in a body cavity, and various embodiments described herein relate to temporary fixation or anchoring of a medical device in a body cavity.

[0080] It is desirable to fixate structural elements involved in medical procedures, i.e., stents, stent grafts, and endovascular repair elements, as permanent or temporary devices, and more particularly, but not exclusively, devices and methods for protecting such devices from migration, migration, or propagation during medical procedures.

[0081] Stents and stent-grafts used to repair aortic vascular injuries and diseases, such as aortic aneurysms, aortic dissections, coarctation of the aorta, dilated aortas, aortic leaks, and aortic ruptures, are known to migrate, shift, and change position in the deployed area. Various solutions for securing stents and stent-grafts in their deployed position are described herein. These solutions take into account the fragility of the aorta (shaggy aorta, porcelain aorta).

[0082] It should be noted that the fixation devices and methods described herein may also be used as an add-on to an existing stent graft, either as a temporary or permanent add-on.

[0083] In some embodiments, the fixation devices and methods described herein are configured to allow other medical instruments, i.e., catheters, guidewires, delivery systems, and drug delivery systems, to pass along or through the fixation portion.

[0084] (device) An aspect of some embodiments relates to devices and methods for anchoring a medical device in a body cavity by expansion of a frame to apply a radially outward force to the wall of the body cavity.

[0085] In some embodiments, the force is optionally spread evenly across the contact area between the device and the cavity wall. As a non-limiting example, taking a cylindrical contact area, the force is optionally distributed evenly across the area of ​​the cylinder, where area is 2πR x length, where R is the radius of the cylinder and length is the length of the cylinder.

[0086] In some embodiments, the shape of the frame is optionally configured to conform to the shape of the interior of the body lumen, for example, to have a non-circular cross section and / or to conform longitudinally to a curved body lumen such as the aortic arch, and in some embodiments, the outer surface of the frame optionally follows the actual topography of the interior surface of the body lumen.

[0087] In some embodiments, the frame is configured to expand to the diameter of a significantly larger body lumen, for example, the aorta, an adult aorta, or a vena cava.

[0088] In some embodiments, the frame is configured to apply pressure to the wall of the body cavity in two steps: the first step applies some radial pressure to help maintain the frame's position within the body cavity, and the second step applies additional radial pressure to provide support to prevent downstream displacement of the frame due to the pressure of the flowing fluid.

[0089] In some embodiments, the frame is anchored within the body cavity to prevent downstream displacement.

[0090] In some embodiments, the frame includes attachments and / or attachment wires for connecting to any medical device and securing the medical device against downstream displacement.

[0091] The two-step deployment of fixation optionally reduces the potential impact on the walls of the body cavity, aorta, and tubular vessels, preventing potential leakage, rupture, scratching, detachment of particles (plaque, calcifications, organized thrombus), and injury to the potentially hard and vulnerable aortic segment.

[0092] One aspect of some embodiments relates to devices and methods for anchoring a medical device within a body cavity, where the device is supported longitudinally by a support configured to not bend longitudinally even if it bends side to side, and passes through various body cavities on its way to a desired location.

[0093] The support is configured to be stiff in the longitudinal direction to prevent the supported device from gradually shifting downstream due to the pressure of a flowing fluid, such as blood, and in some embodiments, the support is configured to be flexible in the lateral direction, allowing it to be manipulated into and move along the tortuosity of a body cavity.

[0094] In some embodiments, the longitudinal support is actually more than one longitudinal support, such as 2, 3, 4, 5, 6, 7, 8, etc., up to 25 supports.

[0095] In some embodiments, one or more of the longitudinal supports may optionally be in the form of a tube through which control wires pass and are used to control the medical device.

[0096] In some embodiments, the tube-shaped longitudinal support provides longitudinal support and is optionally in the form of a coil spring that can bend laterally.

[0097] In some embodiments, the frame optionally resembles a stent-like device.

[0098] The fixation devices described herein contemplate the use of a variety of materials, including polymer struts, polymer poles, extruded poles or struts, pultruded poles or struts, fiber reinforced poles or struts, wire, combinations of metal and polymer fiber or strut poles, the use of biodegradable components for temporary additional fixation, and the use of bioengineered tissue in addition to fixation.

[0099] (Lock / Fixed Position) An example of an anchoring and / or fixation location for anchoring / fixation devices to the ascending aorta includes upstream of the brachiocephalic trunk.

[0100] Examples of anchoring and / or fixation locations when anchoring / fixing the device to the ascending aorta include upstream of the brachiocephalic artery and downstream of the coronary artery.

[0101] (Timing and / or duration of retention / immobilization) As described above, various locking / fixation device embodiments are inserted into a body cavity and remain in place for extended periods of time, such as days, weeks, months, or years, after insertion.

[0102] The timing of insertion of such a locking / securing device may optionally be prior to performing a medical procedure in which it is desired to lock such a debris protection device, and / or after a medical event that is known or expected to generate blood-borne debris.

[0103] As described above, various locking / securing device embodiments are inserted into a body cavity to remain in place temporarily, such as for the duration of a medical procedure known or expected to generate blood-borne debris.

[0104] Reference is now made to Figure 1A, which is a simplified line drawing of a debris protection device such as that described in the above-referenced International Patent Application Publication No. WO2019 / 064223 (Brandeis), which could potentially benefit from anchoring in accordance with an exemplary embodiment.

[0105] FIG. 1A shows an aortic protection device deployed in an aorta 102, which comprises two mesh layers: a first mesh layer 104 and a closely packed second mesh layer 108.

[0106] FIG. 1A also shows an expandable retention frame 106 on the proximal side of the aortic protection device, a first control wire 112 attached to the distal end of the device, a second control wire 110 attached to the proximal end of the device and / or to the expandable retention frame 106, and a tube 114 through which the first control wire 112 and second control wire 110 pass to the outside of the patient's body.

[0107] Reference is now made to Figure 1B, which is a simplified line drawing of a debris protection device such as that described in the above-mentioned co-filed U.S. provisional patent application, "Protection of Coronary and Myocardial Vascular Vessels During Medical Procedures" (Application Docket No. 91186), which could potentially benefit from anchoring according to an exemplary embodiment.

[0108] FIG. 1B shows a simplified schematic block diagram of a coronary protection device 122 deployed in the aorta 102 , the coronary protection device being connected to a control wire 126 .

[0109] In some embodiments, the coronary protection device 122 includes anchoring with an expandable frame as described herein.

[0110] Reference is now made to Figure 1C, which is a simplified line drawing of a debris protection device such as that described in the above-mentioned co-filed U.S. provisional patent application entitled "Protection of Coronary and Myocardial Vascular Vessels During Medical Procedures" (Application Docket No. 91186), which could potentially benefit from anchoring in accordance with an exemplary embodiment.

[0111] FIG. 1C shows a simplified schematic block diagram of a coronary artery 124 protection device 132 deployed in the aorta 102, the coronary artery protection device 124 including a one-way valve 134, and the coronary artery protection device connected to a control wire 136.

[0112] In some embodiments, the coronary protection device 132 includes anchoring with an expandable frame as described herein.

[0113] Reference is now made to Figure 1D, which is a simplified line drawing of a debris protection device such as that described in the above-referenced U.S. Provisional Patent Application No. 63 / 398,546, which could potentially benefit from anchoring according to an exemplary embodiment.

[0114] FIG. 1D shows a simplified schematic block diagram of a debris capture device 754 deployed in the aorta 102.

[0115] In some embodiments, the debris capture device 754 includes anchoring with an expandable frame as described herein.

[0116] In some embodiments, the debris capture device 754 includes a longitudinal support as described herein.

[0117] Reference is now made to Figure IE, which is an illustration of a device with optional aortic protection and debris capture, such as described in the above-referenced U.S. Provisional Patent Application No. 63 / 398,546, that could potentially benefit from anchoring according to an exemplary embodiment.

[0118] FIG. 1E shows a device including a locking or anchoring portion 142, a first debris trap 144, a frame lumen 146, a second debris trap 148, and an optional tapered end 150 of the device.

[0119] In some embodiments, the device optionally includes a mesh (not shown) covering the frame lumen 146. The mesh optionally serves to filter debris from entering the branch arteries, as described, for example, in the above-referenced International Patent Application Publication No. WO 2019 / 064223 (Brandeis).

[0120] For clarity of illustration, FIG. 1E does not show optional control wires that may be used to control one or more of the following:

[0121] Activating and deactivating the locking or fixing action of the locking or fixing portion 142; Activating and deactivating debris trapping of the first debris trapping unit 144; Varying the mesh size of the optional mesh covering the frame lumen 146; Activating and deactivating the debris trapping of the second debris trapping unit 148, and Pushing and pulling the optionally narrowing end 150 of the device to place the device in place and / or remove the device.

[0122] In some embodiments, the optionally narrowing end 150 of the device may be anchored and / or supported by longitudinal support embodiments as described herein.

[0123] Reference is now made to Figure 1F, which is a simplified line drawing of a device with optional debris capture, such as that described in the above-referenced U.S. Provisional Patent Application No. 63 / 398,546, that would potentially benefit from anchoring according to an exemplary embodiment.

[0124] 1F shows a vena cava 162 and a debris capture device 164 residing within the vena cava 162. The vena cava 162 collects blood from the veins into the right atrium of the heart 168. The heart pumps the blood to the lungs. If debris reaches the lungs, it can be very harmful.

[0125] In some embodiments, a debris trapping device 164 is placed in the vena cava 162 to block such debris. In some embodiments, the debris trapping device 164 traps the debris and is eventually removed from the body along with the debris. In some embodiments, the debris trapping device 164 is optionally controlled by a control wire to open and close the debris trap.

[0126] In some embodiments, the control wires provide longitudinal support to the debris capture device 164 .

[0127] In some embodiments, the control wires pass through a longitudinal support (not shown) that provides longitudinal support to the debris capture device 164 .

[0128] Reference is now made to Figures 2A-2D, which are illustrations of locking mechanisms according to exemplary embodiments.

[0129] 2A-2D are intended to illustrate the controlled expansion of the locking frame mechanism and the optional vertical support of the locking frame mechanism.

[0130] 2A-2D show an expandable locking frame 202 attached to two supports 204A, 204B.

[0131] In some embodiments, the supports 204A, 204B are hollow tubes through which the control wires 206A, 206B pass. For example, in Figures 2A-2D, a first control wire 206A passes through the first support 204A and exits at a distal end 208A of the first support 204A, looping the control wire 206A around the distal side of the expandable locking frame 202. A second control wire 206B passes through the second support 204B and exits at a distal end 208B of the second support 204B, looping the control wire 206B around the distal side of the expandable locking frame 202.

[0132] 2B, 2C, and 2D show the same elements as FIG. 2A, but for clarity, the figures do not include reference numbers so that the elements are more clearly visible.

[0133] As first control wire 206A and / or second control wire 206B are retracted into first support 204A and / or second support 204B, respectively, the loop shortens, pulling locking frame 202 closed. This is shown in the series of views in Figures 2A-2D.

[0134] Conversely, when the first control wire 206A and / or the second control wire 206B are released from the first support 204A and / or the second support 204B, respectively, the wires allow the locking frame 202 to expand, as can be seen in the order of Figures 2D, 2C, 2B, and 2A.

[0135] In some embodiments, the locking frame 202 comprises a shape memory material that exerts an expansion force, and the first control wire 206A and / or the second control wire 206B exert a compression force on the locking frame 202 .

[0136] In some embodiments, the first support 204A and / or the second support 204B provide longitudinal support, fixation, or locking to the locking frame 202 and / or any medical device that receives locking from the locking frame 202. The first support 204A and / or the second support 204B are optionally laterally flexible and longitudinally incompressible.

[0137] Reference is now made to Figures 2E and 2F, which are illustrations of a locking mechanism according to an exemplary embodiment.

[0138] 2E and 2F are intended to illustrate the locking frame mechanism and its vertical support, which is an optional feature.

[0139] 2E and 2F show the expandable locking frame 212 attached to four supports 214A-214D.

[0140] In some embodiments, one or more of the supports 214A-214D are hollow tubes through which control wires pass. A non-limiting example includes two control wires 216A and 216B. For example, in FIGS. 2E and 2F, a first control wire 216A passes through the first support 214A and exits the first support 214A to form a looped control wire 206A that surrounds the distal side of the expandable locking frame 212. A second control wire 216B passes through the second support 214B and exits the second support 214B to form a looped control wire 206B that surrounds the distal side of the expandable locking frame 212.

[0141] In some embodiments, one or more of supports 214A-D provide longitudinal support, fixation, or locking to locking frame 212 and / or any medical device that receives locking from locking frame 212. One or more of supports 214A-D are optionally laterally flexible and longitudinally incompressible.

[0142] Reference is now made to Figure 3A, which is a simplified diagram of a support and control wires passing through the support, according to an exemplary embodiment.

[0143] FIG. 3A shows a hollow support 302 and a control wire 304 passing through the hollow support 302 .

[0144] In some embodiments, the control wires 302 serve to control the medical instruments and / or locking devices and / or locking frames to which the control wires 302 are connected.

[0145] In some embodiments, the support 302 is optionally laterally flexible to pass through various torsions of the body cavity and is optionally longitudinally incompressible to prevent longitudinal displacement of a medical device connected to the support 302.

[0146] Reference is now made to Figure 3B, which is a simplified diagram of a locking frame and support and / or control wires according to an exemplary embodiment.

[0147] 3B shows an aorta 312 with an anchoring frame 314 positioned in the ascending aorta. In some embodiments, the anchoring frame 314 is optionally controllable by one or more control wires 316 and / or longitudinal supports 316.

[0148] In some embodiments, the locking frame 314 is optionally provided with longitudinal support by one or more longitudinal supports 316 .

[0149] In some embodiments, anchoring frame 314 may optionally be part of an aortic protection device (not shown), such as, by way of non-limiting example, described in the above-referenced International Patent Application Publication No. WO2019 / 064223. The aortic protection device may optionally extend along the aortic arch from location 318 to location 319, by way of non-limiting example, to protect the entrances of the arteries branching from the aortic arch.

[0150] In some embodiments, activation of the fixation occurs in two stages: in the first stage, the locking frame is positioned / deployed at the desired location, applying a relatively low radial force to the body cavity wall; after the desired deployment position is confirmed, the locking frame is activated, applying an additional radial force.

[0151] In some embodiments, additional force is applied by withdrawing the delivery catheter beyond the initial withdrawal that releases the locking frame, hi some embodiments, the expanded fixation region applies equal radial pressure across the fixation region.

[0152] Reference is now made to Figure 4A, which is a simplified illustration of a locking frame exiting a catheter according to an exemplary embodiment. Figure 4A is intended to show a locking frame comprising two generally concentric layers.

[0153] FIG. 4A shows a body cavity 402, an introducer catheter 404, and a locking frame comprising two layers: an outer layer 406 and an inner layer 408.

[0154] In some embodiments, the outer layer 406 expands and presses against the walls of the body cavity 402. In some embodiments, the outer layer comprises a shape memory material configured to expand and apply pressure to the walls of the body cavity 402.

[0155] In some embodiments, the outer layer 406 is configured to begin expanding only under external control, eg, an external control releases the outer layer 406 to expand.

[0156] In some embodiments, the inner layer 408 expands and pushes against the inner surface of the outer layer 406 , increasing the pressure of the outer layer 406 against the wall of the body cavity 402 .

[0157] In some embodiments, the inner layer 408 comprises a shape memory material configured to expand and apply pressure to the inner surface of the outer layer 406 .

[0158] In some embodiments, the inner layer 408 is configured to begin expanding only under external control, eg, the external control releases the inner layer 408 to expand.

[0159] Reference is now made to Figure 4B, which is a simplified diagram of an exemplary embodiment of a locking frame, showing a cross section in a body cavity of the exemplary embodiment shown in Figure 4A, intended to show a locking frame comprising two layers.

[0160] 4B shows a cross section of a body cavity 402 and a locking frame comprising two layers: an outer layer 406 and an inner layer 408. In some embodiments, the outer layer 406 expands and presses against the wall of the body cavity 402.

[0161] In some embodiments, the inner layer 408 expands and pushes against the inner surface of the outer layer 406 , increasing the pressure of the outer layer 406 against the wall of the body cavity 402 .

[0162] In some embodiments, the cross section of the inner layer 408 is star-shaped and is configured to expand and exert pressure on the outer layer 406 .

[0163] In some embodiments, the outer layer 406 optionally has a lubricious coating, such as a polymer coating, on its outer surface to prevent damage to the walls of the body cavity 402 .

[0164] In some embodiments, outer layer 406 optionally has a lubricious coating, such as a polymer coating, on both its outer and inner surfaces. Figure 4B also shows introducer catheter 404 in cross section.

[0165] In some embodiments, the locking frame is configured to apply a substantially uniform pressure across the entire or majority of the exterior surface of the locking frame. Such a substantially uniform pressure may provide one or all of the following advantages:

[0166] This prevents localized pressure peaks that could damage or injure the walls of the body cavity, and reduces the pressure per area of ​​the body cavity wall required to lock a medical device against specific forces that would displace a medical device neglected by the locking frame.

[0167] Reference is now made to Figure 4C, which is a simplified diagram of a locking frame according to an exemplary embodiment, intended to show a side view of the exemplary embodiment shown in Figure 4A when released for expansion in a body cavity.

[0168] Figure 4C shows a body cavity 402 and a locking frame comprising two layers: an outer layer 406 and an inner layer 408. Figure 4C also shows one or more control wires 404.

[0169] In some embodiments, the control wires 404 are used to control the expansion of the outer layer 406 and / or the inner layer 408 .

[0170] In some embodiments, the control wire 404 is used to control the withdrawal of the outer layer 406 and / or the inner layer 408 into a catheter for removal from the patient's body.

[0171] Reference is now made to Figure 4D, which is a simplified diagram of a locking frame according to an exemplary embodiment, intended to show a side view of the exemplary embodiment locking frame shown in Figure 4A when both layers are expanded.

[0172] 4D shows a body cavity 402 and a locking frame comprising two layers: an outer layer 406 and an inner layer 408. Again, in some embodiments, the locking frame is configured to apply a substantially even pressure across the entire or majority of the outer surface of the locking frame.

[0173] Reference is now made to Figure 5. Figure 5 is a simplified flowchart of a method for anchoring a medical device in a body cavity, according to an exemplary embodiment.

[0174] The method of FIG. 5 includes the following: Inserting a first medical instrument attached to a locking frame into a body cavity (step 502); Positioning a first medical device at a desired location along a body cavity (step 504); Expanding the frame so that it contacts the wall of the body cavity and applies an anchoring force to the wall of the body cavity (step 506).

[0175] Reference is now made to Figures 6A-6G, which are illustrations of a locking frame according to an exemplary embodiment. Figures 6A-6G are intended to show a frame comprising two generally concentric layers: an outer layer that applies pressure against the wall of the body cavity, and an inner layer that applies outward pressure to the outer layer.

[0176] Figures 6A-6G show an expandable frame 602, an outer layer 604, and an inner layer 606. Figures 6A-6D show the frame 602 in an open state, with the inner layer 606 adjacent to the outer layer 604. In this state, the inner layer 606 exerts little or no pressure on the outer layer 604.

[0177] Figures 6A and 6B are side views, Figure 6C is an isometric view, and Figure 6D is a cross-section along frame 602. Figures 6E-6G show frame 602 in an activated or closed state where inner layer 606 is pushing radially outward against outer layer 604. In this state, inner layer 606 exerts more pressure on outer layer 604. Figure 6E is a side view, Figure 6F is an isometric view, and Figure 6G is a cross-section along frame 602.

[0178] Reference is now made to Figures 7A-7F, which are illustrations of the inner layer of a locking frame according to an exemplary embodiment. Figures 7A-7F are intended to show the inner layer of an expandable frame comprising two layers: an outer layer that applies pressure against the wall of the body cavity, and an inner layer that applies outward pressure to the outer layer.

[0179] Figures 7A-7F show the expandable frame 702 and elements of the inner layer 706. Figures 7A-7C show the inner layer 606 in an open position, exerting little or no pressure on the outer layer (not shown). Figure 7A is a side view, Figure 7B is a cross-section along the frame 702, and Figure 7C is an isometric view.

[0180] 7D-7F show frame 702 in an activated or closed state, with elements of inner layer 706 positioned to push radially outward against outer layer (not shown). In this state, the components of inner layer 706 exert more pressure on the outer layer. FIG. 7D is a side view, FIG. 7E is a cross-sectional view along frame 602, and FIG. 7F is an isometric view.

[0181] Reference is now made to Figure 8, which is a simplified flowchart of a fixation method including controlled application of additional radial force, according to an exemplary embodiment.

[0182] The method of FIG. 8 includes the following: Positioning the delivery system (or "guided" system) at the proximal deployment point (where the trigger wire is connected to a handle extending from the patient's body) (step 802); Removing the fixing portion (step 804); The removal process passes the marked point (end of fixation) and a trigger wire is connected to activate an additional radial force from outside the patient's body (step 806); performing a medical procedure (step 808); Releasing the fixation portion via the trigger wire handle after the medical procedure is completed (step 810); Attaching the fixation portion to the delivery catheter at the distal fixation point (step 812).

[0183] Circumferentially retracting and / or collapsing the fixation portion prior to removal from the patient's body may provide some or all of the following advantages: preventing the fixation portion from dragging along the body cavity, which could injure and / or harm the patient; preventing the fixation portion from being dragged along the wall of the body cavity, which could release debris.

[0184] Reference is now made to Figure 9, which is a simplified flowchart of a fixation method including self-expansion and controlled application of additional radial force, according to an exemplary embodiment.

[0185] The method of FIG. 9 includes the following: Positioning a delivery system (or "guided" system) at a proximal deployment point (step 902); Removing the fixing portion (step 904); The "guided" system releases the fixation and further radial force is applied (step 906), or the extraction process passes the marked point (end of fixation) and further radial force is activated (step 908). performing a medical procedure (step 910); At the end of the medical procedure, the fixation device is retrieved (step 912) by either storing the fixation portion in the delivery catheter (step 914) or by retracting the fixation portion in the delivery catheter at the distal fixation point to cancel or shut off any further radial forces (step 916).

[0186] Reference is now made to Figure 10. Figure 10 is a simplified line drawing of a debris protection device according to an exemplary embodiment, which potentially benefits from locking according to an exemplary embodiment.

[0187] Figure 10 shows a heart 1002, coronary arteries 1022, the ascending aorta 1004, an artery leading to the brain 1006, and the descending aorta 1008. Figure 10 also shows a debris protection device 1014 having a distal end 1012 and a proximal end 1016.

[0188] In some embodiments, the debris protection device 1014 has control wires 1018B that pass through a hollow tube 1018A that is optionally axially rigid and laterally flexible and optionally functions as an elongated support that holds the debris protection device 1014.

[0189] In some embodiments, the hollow tube 1018A extends outside the patient's body and can be controlled and manipulated back and forth to move the debris protection device 1014 and / or to support the debris protection device 1014 by holding it in a desired position.

[0190] In some embodiments, the hollow tubes 1018A are connected to a filter at or near the distal end of the tube. In some embodiments, the number of hollow tubes 1018A can range from 1, 2, 3, 4, 5, 6, or even 10, 12, 16, or even 20.

[0191] In some embodiments, the material of the hollow tube 1018A is composed of a metal, such as Nitinol, and / or a polymer, and / or other material approved for use within the body to provide axial support.

[0192] It is expected that many related devices, such as debris protection devices and debris capture devices, that may use the fixation described herein will be developed during the life of any patent granted based on this application, and it is intended that the scope of the terms medical device, debris protection device, and debris capture device that may use fixation proactively encompass all such new technologies.

[0193] As used herein, "about" and "approximately" mean "within ±25%" with respect to an amount or value.

[0194] The terms "comprising," "including," "having," and conjugated forms thereof mean "including but not limited to." The term "consisting of" means "including and limited to."

[0195] The term "consisting essentially of" means that a composition, method, or structure may include additional components, steps, and / or moieties, provided that the additional components, steps, and / or moieties do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0196] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. For example, "a unit" or "at least one unit" includes plural units and can also include combinations thereof.

[0197] The words "example" and "exemplary" are used herein to mean "serving as an example, instance, or illustration." An embodiment described as "example" or "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments and / or does not necessarily exclude features of other embodiments from being incorporated.

[0198] "Optionally" is used herein to mean "provided in some embodiments and not provided in other embodiments." Any particular embodiment of the present disclosure may include multiple "optional" features unless those "optional" features contradict each other.

[0199] Throughout this application, various embodiments of the present disclosure may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and is not an inflexible limitation on the scope of the present disclosure. Thus, the description of a range should be considered to specifically disclose all of the possible subranges and individual numerical values ​​within that range. For example, description of a range such as 1 to 6 specifically discloses subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as individual numerical values ​​within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the magnitude of the range.

[0200] When a range of values ​​is provided herein (e.g., any pair of numbers connected by "10-15," "10 to 15," or other range designations), it is intended to include any number (fractional or integer) within the limits of the range provided, unless the context clearly dictates otherwise. The phrases "range between" a first designated number and a second designated number, and "range," "range to," "range to," or "range including" (or other similar range terminology) "from" a first designated number to a second designated number, are used interchangeably herein and are meant to include the first and second designated numbers and all fractional and integer values ​​therebetween.

[0201] Unless otherwise indicated, numbers used herein, and any numerical ranges based thereon, are approximations within the accuracy of reasonable measurement and rounding errors, as will be understood by one of ordinary skill in the art.

[0202] It should be understood that certain features of the present disclosure, which are for clarity described in the context of separate embodiments, may also be provided in any combination of these features in a single embodiment. Conversely, multiple features of the present disclosure, which are for brevity described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or with respect to other described embodiments as appropriate. Certain features described in the context of various embodiments should not be construed as essential to that embodiment, unless the particular embodiment is inoperable without that element.

[0203] While this disclosure has been described in conjunction with specific embodiments thereof, many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0204] It is the intention of the applicants that all publications, patents, and patent applications mentioned in this specification be incorporated herein by reference in their entirety to the same extent as if each individual publication, patent, and patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. Nor should it necessarily be construed as limiting, to the extent that section headings are used. In addition, the priority document of this application, if any, is incorporated herein by reference in its entirety.

Claims

1. 1. A device for anchoring a medical instrument within a large body cavity, the device comprising: a support configured to axially support the medical instrument within the body cavity against longitudinal movement along the body cavity; The support is axially inflexible; The support is flexible in the lateral direction; The device, wherein the support is configured to connect to a medical device to anchor the medical device within the body cavity.

2. The device of claim 1 , wherein the large body cavity is the aorta.

3. 10. The device of claim 1, wherein the large body lumen is the aorta and the device is shaped and sized to extend across the ascending aorta.

4. The device of claim 1 , wherein the large body cavity is the vena cava.

5. The device of claim 1 , wherein the large body cavity is a vena cava and the device is shaped and sized to extend across the vena cava.

6. The device of claim 1 or 2, wherein the device comprises a plurality of supports.

7. The device of any one of claims 1 to 3, wherein the support comprises a hollow tube.

8. The device of any one of claims 1 to 4, wherein the support comprises a hollow tube, the hollow tube containing a control wire for controlling the medical instrument.

9. The device of any one of claims 1 to 5, wherein the medical appliance comprises a blood filtering mesh.

10. The device of any one of claims 1 to 6, wherein the medical implement comprises a device for capturing debris flowing along the body cavity.

11. The device according to any one of claims 1 to 10, wherein the medical instrument comprises a device for capturing debris present in a vein.

12. The device according to any one of claims 1 to 9, wherein the medical instrument comprises a device for capturing debris present in the vena cava.

13. A system comprising a filter and an anchor, the anchor comprising a hollow tube that is axially inflexible but laterally flexible.

14. The system of claim 11 , wherein the tube is connected to a filter at or near the distal end of the tube.

15. 1. A method of anchoring a medical device within a body cavity, comprising: pushing a first medical device supported by a support into the body cavity; The method, wherein the support is longitudinally inflexible and laterally compliant to prevent longitudinal movement of the first medical device along the body cavity.

16. The method of claim 15 , wherein the first medical device comprises a filter.

17. 17. The method of claim 15 or 16, wherein the support is attached to the first medical device.

18. 18. The method of claim 17, wherein the hollow tube includes a control wire for controlling a second medical device.

19. The method of any one of claims 15 to 18, wherein the medical instrument comprises a device for preventing debris from entering a coronary artery.

20. The method of any one of claims 15 to 19, wherein the medical instrument comprises a device for preventing debris from entering arteries leading to the brain.

21. The method according to any one of claims 15 to 20, wherein the medical instrument comprises a device for capturing debris present in a vein.

22. The method of any one of claims 15 to 21, wherein the medical instrument comprises a device for capturing debris present in the vena cava.

23. An anchoring frame for anchoring within a body lumen, the frame sized and shaped to expand to a diameter corresponding to the aorta.

24. 24. The anchoring frame of claim 23, sized and shaped to expand to a diameter corresponding to the aorta of an adult human.

25. 25. The anchoring frame of claim 23 or 24, sized and shaped to expand to a diameter corresponding to a vena cava.

26. A locking frame according to any one of claims 23 to 25, comprising two concentric layers.

27. 27. The locking frame of claim 26, wherein a first outer layer is configured to be extruded from the catheter first and a second inner layer is configured to be extruded from the catheter second, pushing the outer layers outward.

28. A locking frame according to any one of claims 23 to 27, comprising longitudinally stiff wires configured to connect to a debris protection device arranged upstream of the locking frame.

29. A locking frame according to any one of claims 23 to 28, connected to a debris protection device arranged upstream of the locking frame.

30. A locking frame according to any one of claims 23 to 29, comprising a wire configured to connect to a debris protection device arranged downstream of the locking frame.

31. A locking frame according to any one of claims 23 to 30, connected to a debris protection device arranged downstream of the locking frame.

32. 31. The anchoring frame of any one of claims 23 to 30, configured to expand under radial pressure and exert force against the wall of the body cavity both radially and longitudinally along the body cavity.

33. A locking frame according to any one of claims 23 to 32, wherein the frame includes a locking mechanism for locking the frame in an expanded state.

34. A locking frame according to any one of claims 23 to 33, wherein the frame includes a protective membrane on its outer surface.

35. The anchoring frame of any one of claims 23 to 34, wherein the outer wall of the frame is covered with a material to reduce damage to the vessel wall.

36. A locking frame according to any one of claims 23 to 35, wherein the inner wall of the frame is covered with a polymer.

37. 37. The anchoring frame of any one of claims 23 to 36, configured to be retrieved from a patient's body without releasing debris from the wall of the body cavity.

38. 38. The anchoring frame of any one of claims 23 to 37, configured to have a star-shaped cross-section that expands to a tubular cross-section to apply a radially outward force to a wall of the body cavity.

39. A locking frame according to any one of claims 23 to 38, comprising a mechanism within an outer wall of the frame configured to apply a radially outward force to the frame.

40. A locking frame according to any one of claims 23 to 39, comprising a hexagonal mechanism within an outer wall of the frame, the hexagonal mechanism being configured to apply a radially outward force to the frame.

41. The retention frame of any one of claims 23 to 40, further comprising a wire attached at one end to the retention frame and at the other end to the blood filtering mesh to prevent the blood filtering mesh from being washed downstream when the frame is fully expanded.

42. 42. The anchoring frame of any one of claims 23 to 41, configured, when expanded against a wall of the ascending aorta, to withstand a force of 10 to 30 Newtons pulling the anchoring frame in a direction parallel to the surface of the wall of the ascending aorta, so as to prevent slippage along the wall.

43. 1. A method of anchoring a medical device within a body cavity, comprising: inserting a first medical instrument attached to a locking frame into a body cavity; positioning the first medical device at a desired location along the body cavity; and expanding the frame to contact and apply an anchoring force to the wall of the body cavity.

44. the retention frame is attached to a wire for supporting the first medical device upstream of the retention frame; 44. The method of claim 43, wherein expanding the frame comprises expanding the frame downstream of the first medical device such that the locking frame supports the first medical device from shifting from the desired position.

45. the retention frame is attached to a wire for supporting the first medical device downstream of the retention frame; 44. The method of claim 43, wherein expanding the frame comprises expanding the frame upstream of the first medical device such that the locking frame supports the first medical device from shifting from the desired position.

46. The method of any one of claims 43 to 45, further comprising passing a second medical instrument through the center of the frame.

47. The method of any one of claims 43 to 46, wherein expanding the frame comprises actuating a locking mechanism that locks the frame in an expanded state.

48. The method of any one of claims 43 to 47, further comprising removing the locking frame from the patient's body.

49. 49. The method of claim 48, wherein removing the locking frame from the patient's body comprises removing the locking frame without expelling debris from the wall of the body cavity.

50. 50. The method of any one of claims 43 to 49, wherein expanding the frame to contact the wall of the body cavity and apply a force to anchor it to the wall of the body cavity comprises expanding the frame to withstand a torque in the range of 10 to 30 Newton meters pulling the anchoring frame in a direction parallel to the surface of the wall of the body cavity and applying sufficient force to prevent it from slipping along the wall.

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