Auxiliary instrument for providing neuroprotection during interventional therapy surgery

Abstract

Devices, systems, and methods for filtering embolic particles that may be produced by medical procedures include protecting major branch vessels derived from the aorta, and capturing and filtering embolic particles that may be produced during TAVR procedures. The filter devices disclosed herein create an improved seal of the vessel wall that is activated by flowing blood. The instruments described herein also allow the end of the filter instrument to be closed after capturing the emboli, providing further assurance to prevent accidental loss of the captured emboli.

Description

[0001] Cross - Reference to Related Applications

[0002] This application is a non - provisional application of U.S. Provisional Application No. 63 / 368,624, filed on Jul. 15, 2022, the entire content of which is incorporated herein by reference. Field of the Invention

[0003] Devices, systems, and methods are disclosed for filtering embolic particles that may be generated by a medical procedure, including protecting major branch vessels originating from the aorta and capturing and filtering emboli generated during a TAVR procedure. The filter devices disclosed herein form an improved seal against the vessel wall that is activated by flowing blood. The devices described herein also allow for closing the ends of the filter device after an embolus has been captured, thereby providing further assurance against accidental loss of the captured embolus. The TAVR procedure is just one application where the use of the devices, systems, and methods provides improved benefits. However, these devices, systems, and methods can be used in any part of the body. Background of the Invention

[0005] Percutaneous coronary valve interventions, including both valve replacement and valve repair, are a rapidly growing segment of catheter - based medical interventions. Catheter - based interventions have recently become an increasing part of cardiac interventions and currently include mitral valve repair and aortic valve repair and replacement. One segment of this growing market is aortic valve replacement, known as Transcatheter Aortic Valve Replacement (“TAVR”). Although the frequency of TAVR procedures is increasing and has had great success, the procedure has a risk of clots or thrombi in the form of thrombus and / or stenotic debris breaking off and entering the vasculature. If these clots travel to the brain, lungs, or to the peripheral vessels, these clots can potentially cause an ischemic stroke.

[0006] Efforts have been made to reduce the risk of stroke by developing medical devices that are designed to prevent the detached clots from traveling to the brain. Although these devices have had some success, there is still a significant need for further refinement and improvement.

[0007] Previous devices were typically divided into two categories: deflector devices and capture devices. Deflectors are used to "deflect" blood clots away from critical blood vessels leading to the brain, and often require the deployment of a nitinol mesh material (or similar material) to prevent clot / stent debris from entering the critical blood vessels leading to the brain. The doctor would temporarily deploy the mesh material at the origin of the blood vessels leading to the brain so that blood could continue to flow, but clot material could not pass through the mesh pores (which often have an aperture of about 100 microns). Since the clot material is not captured, it travels elsewhere in the body, often down the ascending aorta and into the peripheral vasculature. For example, Figure 1A FIG. shows the aortic arch 2, left subclavian artery 4, left common carotid artery 6, and brachiocephalic trunk (innominate artery) 8. The left common carotid artery 6 and brachiocephalic trunk 8 supply blood to the head and neck. Thus, if an embolus 30 travels through these arteries and into the brain, any migration of the embolus 30 poses a risk.

[0008] Figures 1A to 1C An example of a conventional vascular protection device is shown. For example, Figure 1A A capture device called Sentinel(TM) from Claret Medical is shown. As illustrated, the capture device is positioned within the left common carotid artery 6 and brachiocephalic trunk 8 to prevent the migration of embolus 30. However, it has been published in the medical literature that in at least 10% of cases, these filters do not fit well enough into the anatomy, creating a risk of embolus passage. Figure 1B and Figure 1C Examples of deflector devices 24, 26 are shown. As shown, the deflector devices 24, 26 prevent emboli from entering the branch vessels. Additionally, if any conventional device does not form a sufficient seal against the vessel wall, a blood clot may pass through the device (i.e., pass between the device and the vessel wall) and flow towards the brain, resulting in an ischemic stroke.

[0009] Deflector devices have additional limitations. First, in most devices, the clot material is not captured or removed from the body. While it is beneficial to prevent the clot material from traveling to the brain and causing an ischemic stroke, the device deflects the clot into the peripheral vessels. Although less dangerous, the clot can still cause blockages in the legs, renal vessels, etc. Additionally, deflector devices also cannot form an effective seal in the vasculature, meaning that while some or even most of the clot may be prevented from entering the blood vessels leading to the brain, the clot can still pass through the device, creating a risk of stroke.

[0010] In addition to those described above, conventional capture devices have additional limitations. Some capture devices do not protect all of the blood vessels leading to the brain (there are three main vessels that branch from the aorta and lead to the brain: the brachiocephalic artery (which then supplies the right subclavian artery and the right common carotid artery), the left common carotid artery, and the left subclavian artery). The Sentinel device, made by Claret Medical, Inc. (Santa Rosa, CA), only protects two of the three branch vessels. Other capture devices, such as the Emboliner device (manufactured by Emboline (Santa Cruz, CA)), which uses a nitinol mesh cylinder, attempt to provide coverage of all three branch vessels, but may fail if the seal between the mesh cylinder and the aortic wall is poor, allowing clots to pass between the mesh cylinder and the vessel, thus permitting the clots to flow to the brain and cause a stroke.

[0011] In fact, inadequate contact between the deflector / capture device and the vessel wall is the Achilles' heel of all current brain protection devices. Imperfect seals allow small clots to enter the brain, creating a risk of stroke. Current medical literature states that in at least 10% of cases, these filters do not fit the anatomy adequately.

[0012] Another limitation of current capture devices is that once a clot is captured, there is a risk that the clot may potentially dislodge and travel back into the bloodstream. Both the Sentinel device and the Emboline device capture clots, but the distal end of the device remains open. At the end of the procedure when the device is removed from the body, the clot migrates from the distal end. This can occur if the device collapses or geometrically deforms during removal, if the device scratches and deforms plaque during removal, or if the blood flow is pulsatile (so close to the heart) creating flow distortions that dislodge the clot from the filter.

[0013] There is still a need for improved devices and methods to address the problems discussed above. While the discussion has focused on applications for protecting the cerebral blood vessels, the improved devices and methods described below have applications for protecting any part of the vasculature.

[0014] BRIEF SUMMARY OF THE INVENTION

[0015] The examples discussed herein illustrate variations of protective devices, systems, and methods that are adapted to protect the vasculature or other fluid-filled channels from debris generated during the performance of a procedure upstream of the site where the protective device is being delivered, or where the protective system and / or method is being applied. The term embolus can include particles generated by blood clots, plaque, cholesterol, thrombi, calcifications, naturally occurring foreign bodies (i.e., body parts present in the lumen), and non-naturally occurring foreign bodies (i.e., a portion of a medical device or other non-naturally occurring material present in the lumen). However, the devices are not limited to such applications and can be applied to any number of medical applications where protection of a blood vessel or channel is desired.

[0016] Variations of the invention described herein include protective systems for reducing embolus migration within the blood flow in a blood vessel. Additional variations of the invention include methods and devices for forming an improved seal against the blood vessel wall using the blood flow within the blood vessel. For example, one such medical device can include: a device body configured to traverse through a blood vessel; a tubular member circumferentially positioned around the device body, the tubular member having a distal portion that can be opened away from the device body and a proximal portion coupled to the device body; a filter body positioned external to the device body and coupled to the tubular member, wherein the filter body includes a distal portion, a proximal portion, and a fluid-permeable wall extending between the distal portion and the proximal portion, wherein the distal portion is coupled to the distal portion and the proximal portion is coupled to the device body such that when the device body is positioned in the blood vessel, the distal portion and the distal portion open, allowing blood flow to enter the filter body and pass through the fluid-permeable wall while retaining emboli within the filter body; an external sail-like member circumferentially positioned around the exterior of the distal portion of the tubular member, wherein the blood flow entering the tubular member enters the interior of the external sail-like member such that the external sail-like member moves radially outward from the tubular member such that the exterior of the external sail-like member forms a conformable seal against the blood vessel wall; and a deflecting surface positioned within the tubular member and radially adjacent to the external sail-like member, the deflecting surface configured to provide resistance to the blood flow, wherein the second end of the deflecting surface is coupled to the tubular member and the first end of the deflecting surface extends inwardly from the tubular member away from the external sail-like member to direct the blood flow toward the external sail-like member.

[0017] Another variant of a medical device that uses fluid flow within a blood vessel to form an improved seal against the vessel wall of the blood vessel includes: a tubular member having a distal portion, a proximal portion, and a wall extending between the distal and proximal portions; an external sail member circumferentially positioned around the outer circumference of the distal portion of the tubular member, wherein fluid flow into the tubular member enters the interior of the external sail member, causing the external sail member to move radially outward from the tubular member such that the exterior of the external sail member forms a conformable seal against the vessel wall; and a deflector surface located within the tubular member and radially adjacent to the external sail member, the deflector surface having a first end, a second end, and an intermediate portion extending between the first and second ends, wherein the first end extends inwardly away from the external sail member such that the intermediate portion directs the fluid flow toward the external sail member.

[0018] The present disclosure includes a method of filtering a body passage for emboli shed during a surgical procedure within a body passage of a patient, the method comprising: positioning a filter device at a deployment site within the body passage, wherein the deployment site is downstream of the surgical site; deploying the filter device such that blood flow toward the filter device causes an external sail member circumferentially positioned around the outer perimeter of the filter device to move away from the filter device and form a seal against the wall of the body passage, wherein a deflector surface within the filter device redirects a portion of the blood flow toward the interior of the external sail member, and wherein the body of the filter device allows blood flow through while restricting the flow of emboli such that emboli within the blood flow are retained within the filter device; securing the filter device and the emboli within the filter device after the surgical procedure; and removing the filter device and the emboli from the body passage.

[0019] In another variant, such a system may include a filter body having a distal portion and a proximal portion, wherein the filter body is configured to be positioned within a blood vessel such that blood flow enters the distal portion, wherein the wall of the filter body is porous to allow blood flow therethrough while capturing emboli within the blood flow; a sealing membrane circumferentially located on the distal portion, wherein the sealing membrane deflects from the filter body due to blood flow against the sealing membrane, wherein the deflection of the sealing member allows a seal to be formed against the wall of the blood vessel; and a catheter body configured to pass through the blood vessel, wherein the filter body is configured to be located around the exterior of the catheter body.

[0020] In another variant, a variant of the invention described herein includes a protection system for reducing embolus migration within the blood flow in a blood vessel. For example, such a system can include a filter body having a distal portion and a proximal portion, wherein the filter body is configured to be positioned within the blood vessel such that blood flow enters the distal portion, wherein the wall of the filter body is porous to allow blood flow to pass therethrough while capturing emboli within the blood flow; a sealing membrane circumferentially located on the distal portion, wherein the sealing membrane deflects from the filter body due to blood flow against the sealing membrane, wherein the deflection of the sealing member allows for the formation of a seal against the wall of the blood vessel; and a catheter body configured to pass through the blood vessel, wherein the filter body is configured to re-enter the catheter body such that the filter body and emboli located within the filter body are protected within the sheath body when removed from the patient's body.

[0021] The sealing membrane can optionally include a fluid impermeable material. In some variants, the sealing membrane can have one or more openings to control pressure build-up at the sealing membrane. Variants of the sealing membrane can include an expandable portion such that blood flow against the sealing membrane causes the expandable portion to expand. In additional variants, the sealing membrane includes a thin film polymer or elastomer.

[0022] The sealing membrane can be located within the filter body. Alternatively, or in combination, the sealing membrane can be located on an outer portion of the filter body. In yet another variant, the sealing membrane is located on the inner diameter of the filter body and a second sealing membrane is located outside the filter body, wherein blood flow causes the sealing membrane to deflect to increase the effective sealing area of the filter device. In additional variants, the sealing membrane includes a first layer and a second layer, wherein the first layer is adjacent to the outer surface of the filter device and the second layer is adjacent to the internal passage of the filter device. In one variant, the first layer is connected to the second layer such that blood flow pressure entering the area of the sealing membrane defined by the first layer and the second layer increases to further strengthen the opening of the sealing membrane. Additionally, or in combination, the first layer is configured to expand more than the second layer such that the sealing membrane expands outwardly from the filter device.

[0023] Variants of the filter device include a series of lobes located at the distal end of the filter body, wherein the sealing membrane is coupled to the series of lobes. The series of lobes can include at least one deflected lobe, and wherein the sealing membrane includes a first layer coupled to at least one deflected lobe and a second layer coupled to the series of lobes such that blood flow entering the area between the first layer and the second layer increases the pressure in that area.

[0024] The filter body may include a mesh braid or a multi-layer mesh braid. The mesh braid may include superelastic nitinol. Alternatively, or in combination, the filter body includes a thin film polymer or an elastomer.

[0025] The filter body may include an aperture size of 40 microns to 200 microns.

[0026] In a further variant, the sealing member further opens in response to blood flow.

[0027] Variants of the devices described herein may include a proximal sealing membrane that is positioned within the filter body and adjacent to the proximal portion of the device. Alternatively, or in combination, the filter body includes a sheet of material having a controlled porosity. In a further variant, the filter body includes strips of material that overlap to form a continuous surface.

[0028] The devices described herein may include at least one pull wire coupled to the distal end such that a tension force applied to the pull wire advances the distal end to a closed position. In a further variant, the device may also include at least one resilient ring located at the distal end of the filter body to bias the distal end in an open position in the absence of a tension force.

[0029] Any of the systems and / or devices described herein may include a synching member that is configured to synchronize a portion of the filter body.

[0030] The invention also includes a method for filtering emboli from a blood vessel, the emboli being shed during a surgical procedure performed within a patient's blood vessel. For example, such a method may include positioning a filter device at a deployment site within the blood vessel, wherein the deployment site is downstream of the surgical site, and the distal portion of the filter device includes a sealing member; deploying the filter device such that blood flow to the filter device causes the sealing member to form a seal against the wall of the blood vessel, and wherein the body of the filter device allows blood flow through while restricting the flow of emboli such that emboli within the blood flow are retained within the filter device; securing the filter device and the emboli located within the filter device within a catheter body after the surgical procedure; and removing the catheter body, the filter device, and the emboli from the blood vessel.

[0031] The methods described herein may include advancing a second catheter through a proximal opening of the filter device and constricting a proximal portion of the filter device around the second catheter to prevent emboli from appearing between the second catheter and the proximal opening.

[0032] In another variant, the method may further include completing the procedure and withdrawing the second catheter from the filter device while contracting the proximal portion of the filter device around the second catheter, and further contracting the filter device when removing the second catheter from the filter device to prevent emboli from escaping through the proximal opening.

[0033] In one variant of the method, securing the filter device and an embolus located within the filter device includes withdrawing the filter device into the catheter body.

[0034] The method may further include restricting the distal opening of the filter device before withdrawing the filter device into the catheter body.

[0035] In another variant of the method, the filter device includes a proximal sealing member, wherein blood flow causes the proximal sealing member to form a proximal seal against the second catheter. In another variant of the method, the filter device extends from the distal end of the catheter body.

[0036] The method may also include, before deploying the filter device, inverting the filter device within the catheter body, and wherein deploying the filter device includes securing the proximal end of the filter device within the catheter body while withdrawing the catheter body relative to the filter device such that the filter device flips into place within the blood vessel.

[0037] In another variant of the method, before deploying the filter device, the filter device is inverted within the catheter body, wherein deploying the filter device includes pushing the proximal end of the filter device out of the catheter body such that the filter device flips into place within the blood vessel.

[0038] Variants of the method may also include advancing a second catheter through the catheter body and the filter device to perform the procedure. In another variant, the method may further include restricting the distal end of the filter body to prevent emboli from passing through the distal end. In another variant, the method may further include withdrawing the distal end of the filter body into the catheter body such that the filter body flips within the catheter body.

[0039] In another variant of the method, after deploying the filter device, a balloon catheter or a bristle-brush device is used to loosen emboli from the surgical site to ensure that the emboli are captured within the filter body.

[0040] The method includes positioning the filter device in the aorta. The method may include advancing the filter device and the catheter body through the radial vessel, or advancing the filter device and the catheter body through the femoral vessel.

[0041] In another variation, the method may further include passing a portion of the blood flow outside the patient's body through an external filter and returning the blood flow to the patient's artery.

[0042] Another variation of the method described herein includes advancing a filter device to a deployment site in a blood vessel, wherein a distal portion of the filter device includes a sealing member; deploying the filter device near a surgical site, wherein the filter device allows blood to pass therethrough; forming a first seal between the walls of the blood vessel at the deployment site using the sealing member, thereby causing blood to flow into the filter device; advancing a medical device through the filter device to the surgical site; performing a procedure in the blood vessel distal to the filter device using the medical device, wherein the procedure causes emboli to enter the blood flow; withdrawing the medical device from the deployment site and further constricting a proximal portion of the filter device such that the emboli are retained within the filter device; positioning the filter device and the emboli located therein within a catheter to prevent the emboli from entering the blood flow; and removing the catheter, the filter device, and the emboli from the patient's body.

[0043] A variation of the method described herein may further include, after advancing the medical device through the filter device, constricting a proximal portion of the filter device around the medical device to form a second seal around the medical device. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Each of the following figures schematically illustrates aspects of the present invention. Variations of the aspects of the present invention shown in the figures are contemplated.

[0045] Figures 1A to 1C An example of a conventional vascular protection device is shown.

[0046] Figures 2A to 2I An example of a flow-assisted seal of the present disclosure is illustrated.

[0047] Figure 3 A variation of the filter device 100 with a collar is shown, the collar including a lasso-type mechanism that can adjust the diameter of a portion of the device.

[0048] Figures 4A to 4I An example of a flow-activated seal is illustrated.

[0049] Figure 5A A conventional capture device opened against a blood vessel wall is illustrated.

[0050] Figure 5B An improved filter device with a flow-activated seal opened against a blood vessel wall is illustrated.

[0051] Figure 6A and Figure 6BIllustrates a variant of an instrument having a proximal flow-activatable seal located in the proximal region of a filter instrument.

[0052] Figures 7A to 7G Illustrates an additional variant of a filter instrument integrated with a system that delivers from the femoral artery through the aortic arch.

[0053] Figures 8A to 8E Shows another variant of a filter instrument directly incorporated into a surgical instrument.

[0054] Figures 9A to 9C Illustrates additional configurations for restricting one or both ends of a filter instrument.

[0055] Figures 10A to 10C Illustrates using one or more balloons to control the opening of a filter instrument.

[0056] Figures 11A to 11C Illustrates an additional variant of a filter instrument that utilizes a noose effect to close the ends of the filter.

[0057] Figures 12A to 12C Illustrates another variant of a filter instrument integrated with a guiding catheter and constrained within an outer sheath.

[0058] Figures 13A to 13C Illustrates variants of a filter body for use with the instruments described herein.

[0059] Figures 14A to 14E Shows another variant of a filter instrument having a multi-layer seal.

[0060] Figures 15A to 15E Illustrates variants of a filter instrument configured for use external to a guiding catheter, sheath, guide wire, and / or other instruments.

[0061] Figures 16A to 16C Illustrates additional variants of instruments for use with the surgeries described herein.

[0062] Figure 17A and Figure 17B Shows another variant of a filter instrument that performs a sealing function.

[0063] Figure 18A and Figure 18B Illustrates Figure 17A and Figure 17B variants of the filter instrument shown in

[0064] Figure 18C and Figure 18D Shows additional variants of a medical device where flow-directing sails are used for non-filter type instruments.

[0065] Detailed Description

[0066] It should be understood that the following examples discuss the use in the aortic arch for protecting the cerebral vasculature (i.e., arteries). However, unless specifically stated, variations of the devices and methods are not limited to use in the cerebral vasculature. Instead, the present invention can have applicability in various parts of the body. In addition, the present invention can be used in various procedures where the benefits of the method and / or device are desired.

[0067] Figures 2A to 2I An example of the flow-assisted seal of the present disclosure is illustrated. In this variation, the guide wire 110 is advanced through the left subclavian artery 4 to allow positioning of the filter system using the radial artery approach ( Figure 2A (not shown in the figure). Such a method allows delivery of the TAVR system from the femoral artery without the filter system reducing the available space within the blood vessel. Many TAVR systems are large, typically with a diameter of 12 French - 18 French, so variations of the filter system also delivered from the femoral artery may compete for space within that blood vessel. Delivering the filter system from the radial artery allows the space within the femoral artery to accommodate the TAVR system and other necessary devices.

[0068] The seal, filter device, and / or guide catheter can have any number of coatings to minimize thrombogenicity, minimize platelet activity, or provide other drug-eluting benefits as needed. Alternatively, or in combination, the seal, filter device, and / or guide catheter can include a hydrophilic coating.

[0069] As Figure 2A shown, the guide wire 110 can be introduced from the radial artery through the left subclavian artery 4 into the aortic arch 2 and reach the aortic valve 10. The guide catheter or guide sheath 112 can be introduced over the guide wire 110 and advanced to the site for deploying the filter device, which can be downstream of the surgical site (as Figure 2B shown). In this example, the surgical site is the location of the valve 10. As described above, the guide catheter 112 can be introduced over the guide wire 110 while containing the collapsed filter system (not yet shown). Alternatively, when the guide catheter 112 is properly positioned, the filter system can be advanced through the guide catheter 112. The diameter of an exemplary variation of the guide catheter 112 can range from 4F to 8F. However, any size can be used as needed. In addition, the distal region of the guide catheter can be preformed to have a bend and an angle to facilitate passage through the desired region of the anatomy. For example, the guide catheter 112 can have a bend near the distal end to accommodate entry into the aortic arch 2 and allow advancement of the distal end towards the valve 10.

[0070] Figure 2CIllustrated is the initial deployment of the filter device 100 at the deployment site in the path of the blood flow 12 starting from the surgical site (e.g., the valve 10). The filter device 100 can be deployed by applying a force on the device 100 to push it out of the delivery catheter 112. Alternatively, the guide catheter 112 is pulled relative to the filter device 100 to expose the filter device 100 at the desired deployment site. A variant of the filter device 100 is composed of a superelastic nitinol mesh that is heat-set to open to the arterial surface (in the aortic arch 2, typically 2.5 cm to 3.5 cm).

[0071] In one variant of the filter device 100, the nitinol mesh is a single-layer woven nitinol wire. Additional variants of the device 100 can include multiple layers of nitinol mesh that overlap each other. The cross-section of the nitinol wire can be circular, square, or rectangular, or it can be triangular, semi-circular, or any combination thereof. Such irregular shapes may be preferred for limiting the thrombogenic response because the blood pattern and flow properties may be altered due to the shape of the wire.

[0072] In addition, some portions of the wire can include DFT (Drawn Filled Tube), where for radiopacity, the nitinol wire contains a core of gold, platinum, or tantalum (or similar materials). Alternatively, for radiopacity, individual wires in the mesh can be composed of solid or hollow platinum, gold, and / or tantalum. Gold, platinum, and / or tantalum rings can also be used to achieve radiopacity.

[0073] In one variant of the filter device 100, the nitinol mesh has an aperture size of approximately 100 microns, although a range of approximately 40 microns to 200 microns or even larger may also be suitable.

[0074] Figure 2C Also illustrated is the filter device 100 that has a flow seal 102 located at the distal end 122 of the filter device 100. The flow seal 102 is activated by the blood flow 12 entering the device. Variants of the flow seal include a section of impermeable soft polymer membrane that opens as blood flows into the membrane. The blood flow 12 causes the flow seal to open against the arterial wall to form a tight seal, which prevents emboli located within the blood flow 12 from passing through. As described above, conventional protection devices cannot form a tight seal between the filter device 100 and the vessel wall, which allows emboli to bypass the protection device. As described above, the walls of the aorta are typically calcified and contain plaque deposits, which create a geometrically irregular surface that makes it difficult to form a proper seal using conventional devices. Figure 2CThe flow seal shown avoids the problems associated with conventional devices by using the naturally occurring blood flow 12 to open the membrane of the flow seal 102 and create a tight seal, which requires an embolus to enter the opening of the filter device 100. Additional variations of the flow seal are discussed below.

[0075] Figure 2D A variation of the filter device 100 is illustrated that has an adjustable collar 104 at the proximal end of the device 100. The collar 104 can position the device and adjust the diameter of the proximal end 120 by applying a force on the connecting wire 106, which extends through the guide catheter 112 and through the left subclavian artery 4 and the radial artery. A restraining collar 104 can be used to tightly compress a catheter or device (such as a TAVR guide catheter discussed below) inserted into the proximal opening 120 of the device 100. A variation of the device 100 can include a polymer lining on the ID of the mesh at or near the collar 104 to ensure a tight seal around the catheter or device extending therethrough. In one variation, the collar 104 can include a push-pull ribbon for controlling the diameter of the filter device 100. Alternatively, as discussed below, the collar can include or be replaced by any number of loop structures for controlling the diameter of the filter device 100.

[0076] Figure 2E The deployed filter device 100 is shown in place to receive a second catheter 130, which will be used to complete an endovascular procedure. In the illustrated example, the TAVR system is introduced through the femoral artery, where the TAVR guide wire 138 is advanced into the proximal opening 120 of the device 100 and through the distal opening 122 to the surgical site (also the valve 10). Again, as discussed above, the filter device 100 maintains a circumferential seal with the flow seal 102, which is kept activated by the flow of blood within the blood vessel. Next, as Figure 2E shown, the TAVR guide catheter 130 and the TAVR valve 132 with the balloon 134 are advanced along or on the TAVR guide wire 138. In an alternative variation, additional devices (not shown), such as a pigtail catheter, an infusion catheter, or a pressure monitoring catheter or guide wire, can be delivered or advanced through the filter device 100, which can accommodate multiple devices.

[0077] Figure 2FIllustrated is a state where the TAVR guiding catheter 130 passes through the filter device 100 and the TAVR valve 132 is positioned within the aortic valve 10. Once the TAVR (or other device for the appropriate procedure) is positioned, the physician can restrict the collar 104 to form a seal against the TAVR guiding catheter 130. The seal can be tight or can be sufficient to allow the TAVR catheter 130 to continue to slide therein. In some variations, a tight seal is crucial to ensure that the emboli 30 intercepted by the filter device 100 remain contained within the filter mesh. As previously stated, a polymer ring or other structure at the location of the collar, on the ID of the filter, can be used to further enhance the seal. It should also be noted that once the TAVR guide 130 enters the filter 100, the collar 104 can be substantially restricted while allowing the TAVR guide 130 to slide relative to the collar 104, and then once the TAVR guide 130 and the TAVR valve 132 are in place, the collar 104 is further restricted to form a tight seal.

[0078] Figure 2F Illustrated is a situation where the TAVR valve 132 is deployed against the aortic valve and the TAVR delivery catheter 130 is withdrawn from the surgical site. As shown, the procedure can cause emboli particles 30 to begin to migrate within the blood vessel. However, the flow seal 102 will direct any emboli particles 30 flowing in the blood to the distal opening 122 of the filter device 100. Thus, the filter device 100 intercepts and contains many emboli particles 30 that would otherwise travel to other parts of the body, such as the brain, where the emboli particles could cause an ischemic stroke.

[0079] Figure 2G Illustrated is the state after the procedure, where the TAVR implant 132 is positioned at the valve 10 and where the TAVR balloon and the TAVR wire are removed from the filter device 100. This leaves only the TAVR guide 130 passing through the filter device 100. (Note: The guide wire can be removed or not removed before removing the TAVR guiding catheter). Figure 2H Illustrated is the filter device 100 after the TAVR catheter has been removed, but where the collar 104 further constricts the proximal portion of the filter device 100 to effectively fully close the proximal end of the filter 100. This ensures that the intercepted embolic material 30 cannot escape through the proximal opening 120 of the filter device 100.

[0080] It should also be noted that the physician can choose to leave the filter device 100 in place as shown Figure 2H for several hours or even days after the procedure, as a preventive measure for collecting any newly ruptured plaque from the aortic valve. This will further provide protection against stroke.

[0081] Figure 2I Illustrates the situation where the filter device 100 is ready for removal. The filter device 100 can be withdrawn into the guiding catheter 112. Alternatively, the guiding catheter 112 can be advanced over the filter device 100, causing the filter device 100 to collapse due to being constrained inside the guiding catheter 112. Since the filter device 100 is constrained inside the guiding catheter 112, embolic particles 30 are thus prevented from escaping at present. Once fixed, the guiding catheter 112 and the filter device 100 are removed.

[0082] Figure 3 Shows a variant of the filter device 100 with a collar that includes a lasso-type mechanism that can adjust the diameter of a portion of the device 100. As shown, the filter device 100 can include a proximal lasso 152 and / or a distal lasso 154. Each lasso can be independently adjusted using one or more wires 156, 158 that extend through the guiding sheath 112. In the illustrated variant, each lasso member 152, 154 is shown as including two traction wires. However, variants of the filter device 100 include a single traction wire for each lasso, or more than two traction wires for each lasso member 152, 154. The benefit of having separate control wires for each lasso member 152, 154 is that the proximal and distal ends of the filter device 100 can be independently controlled.

[0083] Figures 4A to 4C Illustrates some examples of the flow-activated seal 102. In one variant, the flow-activated seal 102 includes a soft polymer membrane that can open in response to pressure caused by blood flowing against the membrane. The pressure causes deflection and / or opening of the membrane. In some variants, the flow-activated seal 102 only partially deflects and / or opens.

[0084] Figure 4A Shows a variant of the device 100 having a polymer layer that forms the flow-activated seal 102. As Figure 4BAs shown, the flow of blood 12 causes the membrane 102 to open and / or deflect, which results in an increased surface area in contact with the inner wall of the blood vessel (not shown). Variations of the flow-activated seal can be deployed simply from the body of the filter device. Alternatively, or in combination, the flow-activated seal (e.g., not attached to the central portion of the filter body) can stretch or open when receiving flowing blood. In additional variations, the flow-activated seal is fluid-impermeable such that the flow against the seal increases the pressure at the seal. Further, compared to the mesh of the filter device, the flow-activated seal typically includes a softer, more compliant material. This difference allows the flow-activated seal to conform to any irregularities on the blood vessel wall. This allows the filter device to form an improved seal against the blood vessel wall. Variations of the filter device 100 can include a flow-activated seal 102 that provides increased friction when opened / deflected against the blood vessel wall. For example, the membrane 102 can include a rough surface texture or particles that increase the resistance to movement of the filter device in response to blood flow. These openable seal members can be inflatable or non-inflatable.

[0085] Figure 4C Another variation of the flow-activated seal 102 in the filter device 100 is illustrated, where blood flow causes the seal 102 to balloon or open outward from the mesh forming the device 100.

[0086] Variations of the flow-activated seal 102 membrane can be made of thin film polymers or elastomers or similar materials. Thermoplastic urethanes may be very suitable, as can other thermoplastic elastomers. Variations of the device include a membrane with a thickness of approximately 0.001”. Alternatively, variations of the membrane can include a thickness from 0.0003” to 0.003”. The membrane can be processed to have “redundancy” (such as folds or extra slack) to further enhance the ease of opening and sizing of the membrane.

[0087] Figures 4D to 4G Another configuration of the flow-activated seal 102 is illustrated. In Figure 4D , the flow-activated seal includes an elastic polymer positioned on the inside of the braided structure forming the filter device 100. As Figure 4E shown, when blood flow 12 enters the filter device 100, the blood flow 12 deflects / shifts the polymeric material as well as a portion of the mesh 108 forming the filter device 100. Thus, the blood flow 12 forces the polymer and the mesh 108 to open and form a seal against the blood vessel wall.

[0088] Figure 4FIllustrates another variant in which a polymer layer or film is located within the filter device 100. As shown, a soft, super-compliant polymer (such as urethane or another thermoplastic elastomer TPE) forms a shape within the filter device 100 that utilizes a bilayer configuration including an upper sealing surface 166 and a lower sealing surface 168 to capture the blood flow 12, with the lower sealing surface 168 acting as a fluid diversion surface. For example, Figure 4F the seal 102 shown in includes a larger upper sealing surface 166 adjacent to the outer surface of the filter device 100 and a smaller lower sealing surface 168 adjacent to the internal channel of the filter device 100. As blood flows into the space between the upper sealing surface 166 and the lower sealing surface 168, the pressure inside (i.e., between the two surfaces) increases the fluid pressure, which helps the seal 102 to push outwards against the blood vessel, as Figure 4G shown in. In one variant, the lower sealing surface 168 is intentionally smaller than the upper sealing surface to ensure that the upper surface 166 opens more than the lower surface 168. However, alternative variants permit design choices to allow the upper surface 166 to open less than the lower surface 168. As Figure 4G shown in, the blood flow 12 enters the membrane 102 to cause deflection and displacement such that the filter device 100 seals against the arterial wall.

[0089] Figure 4H and Figure 4I illustrates a variant of the filter device 100 having a first flow-actuated seal 102 with a second seal 114. In this variant, the flow-actuated seal 102 is located within the filter device 100 while the second seal 114 is located outside the device 100. When blood is flowing 12 (as Figure 4I shown in), since layer 102 and layer 114 are attached to two layers of the mesh filter 108, the flow 12 increases the pressure on the surface of the inner membrane 102 to deflect and push the outer membrane 114. The two membranes 102, 114 form a seal at the region where they overlap. This configuration includes two separate seals 102 and 114 that act as a single seal or a single layer.

[0090] Although the variants of the flow-actuated seals discussed herein are shown with respect to the distal portion of the filter device, additional variants of the filter device also include flow-actuated seals located on the proximal region of the filter device. Such proximal flow-actuated seals can further help to form a seal of the filter device against a guide catheter or other device advanced through the filter device. In such cases, the design of the proximal flow-actuated seal will be activated by the blood flowing into the distal portion, through the filter device, and towards the proximal portion.

[0091] When used in a protection device, the flow-activated seal provides significant advantages by reducing the likelihood that embolic particles will bypass the device. Figure 5A and Figure 5B illustrate the difference between a conventional device (such as the device shown in Figures 1A to 1C ) and the improved filter device 100 discussed herein. Figure 5A illustrates a cross-sectional view of blood vessel 2 (the scale of the figure is adjusted to better illustrate the fit of device 22 against the wall 14 of the blood vessel). As shown, the perimeter of device 22 is designed to form a seal against the blood vessel wall. However, irregularities 16 in blood vessel 2 (such as plaque, calcification, the shape of the blood vessel, or other naturally occurring shapes) result in an irregular geometry 18 that cannot be sealed by the protection device. Figure 5B illustrates the features of the flow-activated seal 102 of the present disclosure, where the seal often has greater softness or flexibility than the mesh structure forming device 100. This feature allows the flow-activated seal 102 to open or deform into any irregularity 18 in blood vessel 2 to a greater extent than the mesh or filter device 100. This forms an improved seal between the wall 14 of blood vessel 2 and filter device 100, thereby improving the filtration of emboli in the blood flow with enhanced sealing.

[0092] Figure 6A and Figure 6B illustrate a variant of the device having a proximal flow-activated seal 116 that is located in the proximal region of filter device 100 and is very similar to the distal seal. Note that a collar is shown adjacent to seal 116. However, variants of filter device 100 may include a proximal seal 116 in any part of the proximal portion. Any of the seal designs for the distal seal disclosed herein may also be used in the proximal position, or some combination thereof, as long as they seal the flow from the distal part of the device.

[0093] Figure 6A and Figure 6B also illustrate a variant in which proximal seal 116 includes an attachment 118 that connects the seal back to the braid. This connection prevents inversion of seal 116. In the illustrated variant, as shown, seal 116 is permanently secured to the braid (i.e., adhesively bonded, thermomechanically encapsulated, etc.). To ensure that the opposite ends of the seal do not invert due to blood flow 12 or due to withdrawal of the guide catheter, the seal may be additionally tethered 118 to another area of the braid. Tethering can be achieved by tack melt, additional encapsulation / heat fusion, or using additional fibers or polymers or metal filaments.

[0094] Another variant of the system may include an enhanced TAVR guiding catheter 130 to enhance the sealing properties of the filter in this way. Geometric "bumps" or protrusions 138 may be in the sealing area, on the OD of the guide 130. In Figure 6A the variant shown, for illustrative purposes, the protrusion 138 is shown outside the filter device 100. The protrusion 138 may be manufactured into the catheter 130. Alternatively, or in combination, the protrusion may be added to the TAVR guiding catheter 108 in a sterile environment (such as a small sterile sleeve). Additionally, a swellable coating, such as a thick hydrophilic coating, may also achieve a similar effect of enhancing the proximal seal.

[0095] Figures 7A - Figures 7G Another variant of the filter device 100 is illustrated, which is integrated with a system for delivery from the femoral artery, through the aortic arch 2 to the valve 10. In this variant, the filter device 100 is integrated and permanently fixed to the guiding catheter 140. Figure 7A An example of a variant of a system with a filter device 100 is shown, which is integrated with a guiding catheter or sheath 140 advanced to a deployment site within the blood vessel 2. In this variant, the filter device 100 is inverted within the guiding sheath 140, and the proximal end 120 of the device is attached to the distal end 142 of the guiding catheter 140. As Figure 7B shown, a stabilizing device 170 (such as a dilator device or a support catheter) is advanced to the distal end 122 of the filter device 100. Figure 7C The situation is shown where the guide 140 is withdrawn while the stabilizing device 170 stabilizes the filter device 100 such that the filter device 100 flips into place when the guiding sheath 140 is withdrawn. The stabilizing device 170 can also be used to ensure that the filter fully returns to its open or deployed shape by extending it through the filter device 100. Figure 7C The distal portion 122 of the device 100 with a flow-activated seal and the proximal portion 120 of the device 100 attached to the distal end 142 of the guiding catheter 140 are shown.

[0096] The use of the stabilizing device 170 allows the filter to be "extruded" by pushing the filter 100 distally using the stabilizer / dilator 170. Alternatively, the stabilizer / dilator 170 can be advanced proximally to stabilize the inverted filter, and then the outer sheath of the sheath can be withdrawn proximally to release the filter.

[0097] Next, as Figure 7D shown, the TAVR implant 132 and the system 130 are advanced through the guiding catheter or sheath 140 with the integrated filter device 100. The distal end 122 of the filter 100 includes a flow-activated seal 102. Figure 7EIllustrated is a TAVR implant 132 deployed at a deployment site, where an embolus 30 is in flowing blood but is directed into a filter device 100 due to flow activation of a seal 102. Since the proximal end is integrated with the distal end 142 of a guiding catheter 140, there is no risk of an embolus escaping through the proximal end 120 of the device 100.

[0098] Figure 7F Illustrated is closing of the distal end 122 of the filter device 100 using one or more pull wires 124. As illustrated, embolus particles 30 are secured within the closed filter device 100, which is integrated / fixed to the guiding catheter 140. Figure 7G Illustrated is an optional feature of the system, where the filter device 100 can be flipped back into the guiding catheter 140. As shown, the pull wires 124 are tightened to bring the distal portion 122 of the closed filter device 100 back into the catheter body 140, which causes the filter device 100 to flip into the guiding body 140. Also, since the filter is closed, there is no risk of losing the captured emboli. Such a step can ensure protection of the filter and emboli during removal from the body.

[0099] It should also be noted that additional design options include building the filter into a femoral introducer sheath (i.e., a long sheath where the filter is near the aortic valve), or using a long sheath to constrain the filter (if the filter is not pre-inverted within the guiding catheter).

[0100] Figures 8A to 8E Illustrated is another variant of a filter device directly incorporated into a surgical instrument. For example, the filter device can be directly built into a TAVR guiding catheter, thus eliminating the need for an additional guiding catheter dedicated to the filter. Figure 8A Illustrated is a TAVR guiding catheter 130 for advancing a TAVR implant 132 to the site of a valve 10 within the aorta 2. Figure 8A No filter is shown, but the filter is loaded inside the TAVR guiding catheter 130.

[0101] Figure 8B Illustrated is a filter device 100 being delivered from a TAVR guiding catheter 130. Such a deployment can be accomplished in any of the ways disclosed herein (inverted inside the guiding catheter and delivered by "pushing" with another integrated tube or the like; or simply squeezed within the TAVR guiding catheter and unsheathed). Figure 8C Illustrated is a TAVR balloon and guide wire removed from the site. Since the filter device 100 is mechanically integrated into the catheter body 130, there is no need to worry about emboli escaping through the proximal region of the filter device 100. Figure 8DIllustrated is one or more guide wires 124 for closing the distal end 122 of the filter device 100. The proximal end of the filter device 100 is positioned within the distal end 128 of the TAVR guiding catheter 130. Figure 8E A variant is shown in which the filter device 100 is coupled to be slidable within the TAVR guiding catheter 130, which allows the closed filter to be brought back into the guide lumen while being removed.

[0102] Figures 7A - Figures 7G and Figures 8A - Figures 8E The variant shown in is a system that can be configured as a delivery guiding catheter of a TAVR system or as a separate delivery catheter.

[0103] Figures 9A to 9C Illustrated is an additional configuration for restricting the filter device 100 in Figure 9A In the example shown in, the filter device 100 includes a double-layer mesh layer having an inner mesh 108 and an outer mesh 109. In one example, the mesh layers 108, 109 include nitinol braids. An additional loop structure 160 is provided at the end of the filter device 100. In the illustrated example, the loop structure 160 includes a coil shape. However, alternative shapes (e.g., straight wire, sine, helix, etc.) can be used as long as the shape provides an outward radial force to hold the end of the filter 100 in an open configuration. One or more traction wires 156 are coupled to the loop 160 such that a force applied on the traction wires 156 closes the loop 160 and the end of the filter device 100. The illustrated example shows the traction wires 156 extending through a tube (e.g., a polyimide tube). Figure 9B Shown is the loop structure 160 coupled to the traction wires 156 without the mesh of the filter device. As described above, the coil-shaped loop 160 provides an outward radial force that opens the end of the filter device when unconstrained. Applying a force 52 on the wire 156 away from the loop 160 results in the closing 54 of the loop 160 and the filter device.

[0104] Figure 9C Another variant of a self-expanding ring 164 is shown. In this variant, the ring has a wavy shape, where the traction wire 158 passes through the ring 164. As described above, the ring 164 is self-expanding (or heat-activated) to provide an outward expanding force on the filter device 100. The traction wire 158 is used to close the ring 164 and the filter device 100 when a closing force is applied. The traction wire 158 can optionally pass through the tube 162 or can be incorporated into the mesh of the filter.

[0105] Note that any loop design discussed herein can be used interchangeably in the distal region and / or proximal region of the filter, or any combination thereof. Additionally, if desired, the loop design can be incorporated at any intermediate portion of the filter.

[0106] Figures 10A to 10C Illustrated is the use of one or more balloons to control the opening of the filter device 100. For example, Figure 10A Illustrated is a variant of the filter device 100 having an elastomeric balloon 180 at the end of the filter device 100. In this variant, the balloon is in the closed position when not pressurized (as shown). Applying fluid through line 184 causes the balloon 180 to expand 188 to open the filter device 100. Figure 10B Illustrated is another variant of the filter device 100 having a balloon 182 in the normally open position. Applying fluid through line 184 causes the balloon 182 to collapse inwardly, as Figure 10C shown therein.

[0107] Figures 11A to 11C Illustrated is an additional variant of the filter device that utilizes a snare effect to close the end of the filter. Again, all of the closing mechanisms discussed herein can be applied to the proximal portion, distal portion, and / or intermediate portion of the filter device. Figure 11A Shown is a pull wire 156 that is used to form a hole or opening at the end of the filter device 100, which can be restricted / closed by pulling on the wire 156. Pulling on the wire 156 reduces the diameter of the filter device 100 and effectively closes the attachment portion of the filter 100. In this variant, the wire 156 is located at the distal end of a guide catheter 140 with an integrated filter device. However, this closing structure can be used on any filter device. Additionally, these concepts can equally apply to the proximal end of the filter.

[0108] As described above, in order to prevent embolus spread, some applications of the device require the closing mechanism to fully and adequately close the open end of the filter. In such applications, the wire 156 can be constructed of superelastic nitinol wire with an oxide coating (approximately 0.001” to 0.002”), but the device deformation allows for an oxide coating thickness up to 0.010”. The wire can also be ribbon wire, rectangular, or other shapes. Fibers or polymers or threads are also options. Figure 11B Shown are two sets of pull wires 156 attached to the distal end of the filter device 100. Figure 11C Shown are multiple sets of pull wires 156 for closing the end of the filter device.

[0109] Figures 12A to 12C Illustrated is another variant of the filter device 100 integrated with the guide catheter 140 and constrained within an outer sheath 190.Figure 12A Shown is a filter device 100 and a guide catheter 140 constrained within an outer sheath 190 such that the system can be advanced to a deployment site as discussed herein. This variant is typically delivered from the femoral artery, where the TAVR system is delivered. Figure 12B Shown is the external constraint sheath 190 being withdrawn 192 while the guide catheter 140 remains stationary. Withdrawing the constraint sheath 190 causes the filter device 100 to open. As described above, the flow-activated seal will ensure proper filtration of the blood vessel. This is a dual catheter design or coaxial system, where one catheter 140 is integrated with the filter device 100, and one catheter / sheath 190 is used to constrain the filter 100 for delivery. Variants of this system include replacing the outer sheath 190 with another mechanism (such as a coil or a short collar) to constrain the filter. In another variant, the outer sheath 190 can be very thin, such as a polyimide tube reinforced with a coil, in which case it is only intended to constrain the filter and does not need to traverse by itself. Figure 12C Shown is the activation of the pull wire 156 after the procedure is completed. Activation of the pull wire closes the end of the filter device 100 to secure any embolic particles within the filter 100.

[0110] Figures 13A to 13C Illustrated is a variant of the filter body for use with the devices described herein. Figure 13A Shown is a double-layer filter device 100, where the outer layer includes a mesh 108 or a thin-film porous material, such as a polymer membrane having pores or apertures (e.g., laser-drilled, chemically formed, mechanically formed), and the inner layer includes a coil or braid 148 that is designed to provide a radial force such that the filter body 100 opens using the radial force to contact the wall of the blood vessel. Figure 13B and Figure 13C Illustrated are, respectively, a non-open and an open filter device 100 that includes an internal expansion member 150 with a mesh or braid 108. The coil-type expansion member 150 opens and expands the braid when expanded. It should also be noted that the filter device 100 can be made of components other than wire braids or meshes. For example, the filter device 100 can include a porous polymer membrane, such as polyurethane or a similar material. The porosity of the membrane can be achieved by laser machining, chemical etching, or other chemical processes, or by microabrasion processes, or by other means known to those skilled in the art. In another variant, the filter device is constructed by a thin-film process. A thin film, such as a thin-film metal, can be made to have a custom-selected porosity. Figures 13A to 13CThe filter shown provides multiple layers, where the inner layer (e.g., coil, braid, stent-like structure) provides an outward radial force to open the filter, and the outer layer (e.g., braid, polymer, porous membrane, porous metal membrane) provides filtration of the blood.

[0111] Figures 14A to 14E Another variant of a filter device having multiple layer seals is shown. In this variant, as Figure 14A shown, the mesh 108 of the filter device 100 terminates in a series of lobes 105, 107. The construction of the lobes 105, 107 can include individual filaments or filaments from the inner / outer mesh (which return to form the outer / inner mesh). The lobes can be atraumatic or can include features that increase friction with the blood vessel wall (or wall of the body cavity). Figure 14B Illustrated is an alternating lobe 107 that is shaped to have an offset 126, e.g., the alternating lobe 107 is shaped to extend upward 126, and then the next lobe 105 can be horizontal (as shown), or even extend slightly downward (into the ID of the device 100), as Figure 14C shown. This angling and separation of the lobes creates space for attaching the flow-activated seal 102. As shown, the seal 102 can have both an upper surface 164 and a lower surface 165. In one variant, the seal 102 can be formed from a single piece of polymer film, or can be two separate pieces that meet and overlap at the apex. It is also possible that selective small "holes" 163 in the seal 102 can be beneficial for controlling the pressure inside the seal 102 and ensuring that blood flow does not overpressure the seal 102 and dislodge the position of the filter device 100. It should also be noted that this same design concept can be achieved with a "standard" braid (i.e., without lobes). In this case, the individual braid filaments would be formed to extend outward or flare / inward, and then the ends of the filaments would terminate within the sealing polymer. Figure 14E A partial side view of the upper seal 164 and the lower seal 165 is illustrated, with space therebetween for increasing pressure in response to blood flow. As described herein, the upper seal 164 can be configured to preferentially deflect into the wall of the blood vessel (e.g., by sizing or material selection).

[0112] Figure 15A and Figure 15DShows an additional variant of the filter device 100 in a pre-deployment configuration. Previous variants have been shown with the filter device 100 attached at or near the distal end of a guiding catheter. Here, the filter 100 is attached to the exterior of a guide 174, which can be a guide wire, sheath, catheter, or other medical device. The filter 100 can be self-expanding (or mechanically assisted, as previously described) and then opened by conventional methods (releasing a pull wire, activating a coil or inflating a lumen, or removing an outer sheath or covering). Once expanded, the device 100 assumes Figure 15B and Figure 15D the configuration shown in. Figure 15A and Figure 15B show the filter device 100 extending from the guiding device 174, while Figure 15D and Figure 15E show the filter device 100 extending beyond the distal end of the guiding device 174. Figure 15C Illustrates a variant similar to Figure 15B but with a portion of the mesh 109 extending into or embedded within the guiding device 174. Once thrombus collection is complete, the filter 100 can be closed onto the OD of the guide / sheath 174, thereby trapping the embolus between the surfaces of the filter and the guide. It should be noted that the guide 174 can be a surgical guide, a TAVR guide, and / or a sheath. Sheath options include long introducer sheaths, surgical sheaths, and / or expandable sheaths (i.e., e-sheaths).

[0113] Figures 16A to 16C Illustrates an additional variant of the device for use with the procedures described herein. Figure 16A Illustrates the distal end of a TAVR guiding catheter 144, where the distal end is expanded outwardly at multiple points 144, presumably to maintain contact on the proximal edge of the balloon and perhaps even contact on the compressed TAVR valve. As shown, a guide 130 with an inverted (or non-inverted, but simply compressed) filter can still have this expanded distal end. The mesh of the filter device 100 can be folded into the guiding catheter 130.

[0114] Figure 16BAdditional variations are shown during or after use with the filter devices described herein. In this example, after the filter is deployed in place (regardless of the radial or femoral approach), a custom catheter or guidewire with a "brush-like" 176 attachment is advanced to the surgical site to loosen any plaque or other debris from the surgical site (e.g., the valve or any other surgical site). The custom catheter 176 can be delivered to the surgical site (e.g., the aortic valve 10) prior to TAVR introduction. The brush attachment is one variation of an instrument that can loosen debris. For example, the brush instrument can have bristles or bristle-like protrusions, such as polymeric fibers, disposed around the distal end. The protrusions "knock free" any loosened plaque from the aortic valve prior to placement of the new filter. This can be done simply to achieve a better fit of the new valve relative to the aortic wall, or it can be done to minimize the likelihood of plaque rupture and release after the procedure is performed, particularly likely after removal of the filter.

[0115] Another option is to deploy the filter (femoral or radial approach) as shown in Figure 16B and pre-dilate the aortic valve with a balloon catheter. The opening of the balloon can simply allow for a better fit of the new valve relative to the aortic wall, or it can be performed to minimize the likelihood of plaque rupture and release after the procedure is performed.

[0116] Figure 16C A variation is shown in which blood is returned through a catheter 112 extending from the left subclavian artery 4 and exiting the radial artery. Once outside the patient, the blood can flow through a simple filter 196 with a similar pore size. The filter is readily obtained in paper, woven textile, polymer, and thin film composites. The constriction ring or collar 104 can still be used in the proximal region to allow passage of the TAVR system. Alternatively, this design configuration can also be used in the patient after the procedure is performed to collect any newly ruptured emboli. In this case, the constriction ring would be fully closed, forcing all of the blood through the catheter and filter. A portion of the filter can be made impermeable to control how much blood flows into the catheter / filter circuit and how much blood flows into the other blood vessels. The filtered blood can return to the body via, for example, the femoral entry point 198.

[0117] Figure 17A and Figure 17B Additional variations of the filter device 200 attached to a medical device body 202 are shown, including but not limited to catheters, guidewires, or other structures that require a sealing function, as discussed herein. Figure 17AIllustrated is a filter device 200 in a collapsed or delivery configuration, where the filter device 200 includes a filter body 210 having an outer seal formed by an outer sail member 218 circumferentially positioned about the device 202 and a tubular member 204, which in some variations acts as a reinforcing structure. The filter device 200 may also include a deflecting surface (not shown in Figure 17A or Figure 17B ) positioned within the filter body 210 that redirects blood flow into the outer sail member 218. As shown, variations of the device 200 may include a filter body 210 coupled to the tubular member 204 (such as a braid, stent, or similar structure). The filter body 210 may cover the reinforcing member 204 along all or a portion of the tubular member 204 or may be integrated with the tubular member 204 along all or a portion of the tubular member 204 (e.g., embedded, coated onto the tubular member 204). As described below, the filter body 210 will be attached to the tubular member 204 at the proximal 210 and distal 214 of the filter body 210 to allow blood to flow through a permeable section 216 that filters emboli from the blood. The filter device 200 may be constrained in a collapsed or delivery configuration using a constraining device such as an outer sheath, wire, cord, or other structure.

[0118] Figure 17B Illustrated is the filter device 200 in an open or deployed configuration, where the tubular member 204 and the filter body 210 are opened away from the device 202, and where the outer sail member 218 moves radially outwardly away from the filter body 210. The outer sail member may be elastic or inelastic, but will deflect due to fluid / blood flowing into the interior of the sail 218.

[0119] Figure 18A and Figure 18B Illustrated is Figure 17A and Figure 17B a variation of the filter device 200 shown in Figure 4F and Figure 4GAs discussed, the flow turning surface 220 can include a part of the sealing structure (in this case, the outer sail-like member 218), or the flow turning surface 220 can include a separate material. In some variations, the flow turning surface 220 is inside the filter body 210. However, portions of the flow turning surface 220 can extend out of or be outside the filter body 210. The outer sail-like member 218 and the flow turning surface 220 are displaced in opposite directions by the blood flow 12. The outer sail-like member 218 is made of a non-porous or low-porosity material such that the blood flow 12 moves the sail-like member 218 in a radially outward direction against the wall of the blood vessel 14 to form a seal. Figure 18A and Figure 18B The flow turning surface 220 shown in Figure 18B is shown for illustrative purposes only and can include stiffeners to prevent the flow turning surface 220 from inverting within the filter body 210. The inner sail-like member 220 can be semi-porous or low-porosity as long as it redirects some fluid flow into the outer sail-like member 218. As shown, the flow turning surface 220 redirects some of the blood flow 26 towards the outer sail-like member 218. The free end of the flow turning surface 220 extends inwardly towards the device 202, while the opposite end is typically connected to the outer sail-like member 218 via a tubular member 204. In some variations of the device 200, the flow turning surface is connected in such a way as to form a fluid-tight joint with the outer sail-like member 218. As Figure 18B shown, emboli 30 or other particles in the blood flow 12 enter the filter body 210, which includes a fluid-permeable section 216 that allows the blood flow to exit the filter body 210 while retaining the emboli 30 therein.

[0120] As described above, the outer sail-like member 218 is constructed to be flexible or conformable, allowing the flow-activated seal to open or deform to any irregularities in the blood vessel to a greater extent than conventional mesh or filter devices 100. This forms an improved seal between the wall 14 of the blood vessel 2 and the filter device 200, thereby improving the filtration of emboli in the blood flow with an enhanced seal.

[0121] As for other details of the present invention, materials and manufacturing techniques can be adopted at the level of those skilled in the relevant art. In terms of additional actions that are commonly or logically adopted, this can equally apply to the method-based aspects of the present invention. Additionally, although the present invention has been described with reference to several examples, optionally combined with various features, the present invention is not limited to what is described or indicated as contemplated for each variation of the present invention.

[0122] Various changes may be made to the described invention and equivalents may be substituted for elements thereof (whether recited herein or not recited for brevity) without departing from the true spirit and scope of the invention. In addition, any optional features of the inventive variations may be set forth and claimed independently or in combination with any one or more of the features described herein. Thus, where possible, the invention contemplates combinations of aspects of embodiments or combinations of embodiments themselves. Reference to a single item includes the possibility that there are a plurality of the same items. More specifically, as used herein and in the appended claims, the singular forms "a", "and", "said", and "the" include plural references unless the context clearly dictates otherwise.

[0123] It is important to note that, where possible, aspects of the various described embodiments or the embodiments themselves may be combined. All such combinations are intended to fall within the scope of the present disclosure.

Claims

1. A medical device for using blood flow within a blood vessel to form an improved seal against the blood vessel wall, the medical device comprising: an instrument body configured to traverse through the blood vessel; a tubular member circumferentially positioned around the instrument body, the tubular member having a distal portion that can open away from the instrument body and a proximal portion coupled to the instrument body; a filter body positioned external to the instrument body and coupled to the tubular member, wherein the filter body includes a distal portion, a proximal portion, and a fluid-permeable wall extending between the distal portion and the proximal portion, wherein the distal portion is coupled to the distal portion and the proximal portion is coupled to the instrument body such that when the instrument body is positioned within the blood vessel, the distal portion and the distal portion open, allowing blood flow to enter the filter body and pass through the fluid-permeable wall while retaining emboli within the filter body; an external sail member circumferentially positioned around the exterior of the distal portion of the tubular member, wherein blood flow entering the tubular member enters the interior of the external sail member such that the external sail member moves radially outward from the tubular member, such that the exterior of the external sail member forms a conformable seal against the blood vessel wall; and a deflecting surface positioned within the tubular member and radially adjacent to the external sail member, the deflecting surface configured to provide resistance to blood flow, wherein a second end of the deflecting surface is coupled to the tubular member, and a first end of the deflecting surface extends inwardly from the tubular member away from the external sail member to direct blood flow towards the external sail member.

2. The medical device according to claim 1, wherein, the deflecting surface is continuous with the external sail member.

3. The medical device according to claim 1, wherein, the deflecting surface is coupled to the external sail member.

4. The medical device according to claim 1, wherein, the deflecting surface is non-porous or semi-porous.

5. The medical device according to claim 4, wherein, the first end forms a cone.

6. The medical device according to claim 1, wherein, the external sail member comprises a fluid-impermeable material.

7. The medical device according to claim 1, wherein, the external sail member comprises a low-porosity material.

8. The medical device according to claim 1, wherein, the exterior of the external sail member comprises an elastically expandable material such that blood flow entering the interior of the external sail member causes the external sail member to expand.

9. The medical device according to claim 1, wherein, the tubular member comprises a reticulated braid.

10. The medical device according to claim 9, wherein, the reticulated braid comprises superelastic nitinol.

11. The medical device according to claim 1, wherein, the tubular member comprises a thin film polymer or an elastomer.

12. The medical device according to claim 1, wherein, The tubular member has a pore size of 40 microns to 200 microns.

13. The medical device according to claim 1, wherein, the filter body includes a sheet of material having a controlled porosity.

14. The medical device according to claim 1, further comprising at least one traction wire coupled to a distal portion of the filter body such that tension applied to the at least one traction wire advances the distal portion to a closed position around the device body.

15. The medical device according to claim 1, wherein, the device body includes a structure selected from a guide wire, a sheath, and a catheter.

16. A method of filtering a body passage for emboli shed during a procedure within a body passage of a patient, the method comprising: positioning a filter device at a deployment site within the body passage, wherein the deployment site is downstream of the surgical site; deploying the filter device such that blood flow toward the filter device causes an outer sail-like member positioned circumferentially about an outer perimeter of the filter device to move away from the filter device and form a seal against a wall of the body passage, wherein a deflecting surface within the filter device redirects a portion of the blood flow toward an interior of the outer sail, and wherein a body of the filter device permits blood flow therethrough while restricting flow of emboli such that emboli within the blood flow are retained within the filter device; fixing the filter device and emboli located within the filter device after the procedure; and removing the filter device and emboli from the body passage.

17. A medical device for forming an improved seal against a vessel wall of a blood vessel using fluid flow within the blood vessel, the medical device comprising: a tubular member having a distal portion, a proximal portion, and a wall extending between the distal portion and the proximal portion; an outer sail-like member circumferentially positioned about an outer circumference of the distal portion of the tubular member, wherein fluid flow entering the tubular member enters an interior of the outer sail-like member, causing the outer sail-like member to move radially outward from the tubular member such that an exterior of the outer sail-like member forms a conformable seal against the vessel wall; and a deflecting surface located within the tubular member and radially adjacent to the outer sail-like member, the deflecting surface having a first end, a second end, and an intermediate portion extending between the first end and the second end, wherein the first end extends inwardly away from the outer sail-like member such that the intermediate portion directs the fluid flow toward the outer sail-like member.

18. The medical device according to claim 17, wherein, the tubular member includes a structure selected from the group consisting of a stent graft, a stent, a shunt, and a flow deflector.

19. The medical device according to claim 17, wherein, the tubular member includes a guide wire.

20. The medical device according to claim 17, wherein, the tubular member includes a catheter body configured to traverse through the blood vessel.

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