Accessory devices for neuroprotection during interventional procedures

Abstract

Improved devices and methods for filtering embolic particles are provided. [Solution] Devices, systems, and methods for filtering embolic particles that may arise from medical procedures, including protection of major branch vessels from the aorta, capture and filter emboli that may arise during a TAVR procedure. The filter devices disclosed herein form an improved seal against the vessel wall that is activated by blood flow. The devices described herein also allow both ends of the filter device to close after capture of emboli, providing additional security against accidental loss of emboli after capture.

Description

[Technical field]

[0001] The present disclosure relates to devices, systems and methods for filtering embolic particles that may arise from medical procedures involving the protection of major branch vessels from the aorta. More particularly, the present disclosure relates to devices, systems and methods for capturing and filtering emboli that may arise during a TAVR procedure. The filter device disclosed herein forms an improved seal against the vessel wall that is activated by blood flow. The devices described herein also allow both ends of the filter device to close after capturing an emboli, providing additional safety against accidental loss of emboli after capture. The TAVR procedure is only one application in which improved benefits can be obtained by using the devices, systems and methods. However, the devices, systems and methods of the present invention can be used in any part of the body. [Background technology]

[0002] Percutaneous coronary valve intervention, which includes both valve replacement and valve repair, is a rapidly growing field of catheter-based medical interventions. Catheter-based interventions have recently been a growing field 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, referred to as transcatheter aortic valve replacement (TAVR). Although TAVR procedures are increasing in frequency and have been highly successful, the procedure carries the risk of displacing blood clots and thrombi within the blood vessels, in the form of thrombi and stenotic fragments. If these clots migrate to the brain, lungs, or peripheral blood vessels, they can cause ischemic stroke.

[0003] Medical devices have been developed to prevent dislodged blood clots from traveling to the brain in an effort to reduce the risk of stroke, and although these devices have met with some success, there remains a need for further refinements and improvements.

[0004] The devices generally fall into two categories: deflection devices and capture devices. Deflectors act to "deflect" thrombi away from vital blood vessels leading to the brain and typically involve the deployment of a Nitinol mesh material (or similar) to prevent the passage of thrombus / stenotic fragments into vital blood vessels leading to the brain. By temporarily deploying the mesh material over the origin of the blood vessels leading to the brain, blood continues to flow but the material causing the thrombus cannot pass through the pores of the mesh (usually pore sizes on the order of 100 micrometers). Since the thrombus material is not captured, it travels elsewhere in the body, typically down the ascending aorta into the peripheral vasculature. For example, in FIG. 1A, the aortic arch 2, left subclavian artery 4, left common carotid artery 6, and brachiocephalic (innominate) artery 8 are illustrated. The left common carotid artery 6 and brachiocephalic artery 8 supply blood to the head and neck. Thus, any migration of emboli 30 poses a risk if emboli 30 travel through these arteries and into the brain.

[0005] 1A-1C show examples of conventional vascular protection devices. For example, FIG. 1A shows a capture device called Sentinel® from Claret Medical. As shown, the capture device is placed in the left common carotid artery 6 and the brachiocephalic artery 8 to prevent emboli 30 from migrating. However, medical literature has shown that these filters do not fit properly anatomically in at least 10% of cases, creating a risk of emboli passing through. FIG. 1B and FIG. 1C show examples of deflection devices 24, 26. As shown, the deflection devices 24, 26 prevent emboli from entering the branching vessels. Furthermore, if any of the conventional devices do not form a proper seal against the vessel wall, blood clots may pass through the device (i.e., between the device and the vessel wall) and into the brain, causing a cerebral ischemic stroke.

[0006] Deflecting devices have additional limitations. First, with most devices, thrombus material is not captured or removed from the body. While it would be advantageous to prevent thrombus material from traveling to the brain and causing an ischemic stroke, the devices deflect thrombus to peripheral blood vessels. Although less hazardous, thrombus can still lead to blockages, such as blood vessels in the legs or kidneys. In addition, deflecting devices also do not form an effective seal in the vasculature, meaning that even if they can prevent some or most of the thrombus from entering the blood vessels leading to the brain, the thrombus may still pass through the device and cause a risk of stroke.

[0007] Apart from the above, conventional capture devices have many additional limitations. Some capture devices do not protect all of the blood vessels leading to the brain (there are three major blood vessels that branch off from the aorta and lead to the brain: the brachial artery, the left common carotid artery, and the left subclavian artery, which feed the right subclavian and right common carotid arteries). The Sentinel® device, manufactured by Claret Medical, Inc. (Santa Rosa, California), protects only two of the three branching blood vessels. Other capture devices, such as the Emboliner® device, manufactured by Emboline, Inc. (Santa Cruz, California), use a Nitinol® mesh cylinder to attempt to cross and cover all three branching blood vessels, but can fail if the seal between the mesh cylinder and the aortic wall is not optimal, allowing blood clots to pass between the mesh cylinder and the blood vessels, which can flow to the brain and cause a stroke.

[0008] In fact, poor contact between the deflector / capture device and the vessel wall is a challenge for all current cerebral protection devices. An incomplete seal can allow the passage of small blood clots to the brain creating the risk of stroke. Current medical literature indicates that these filters do not "fit" properly anatomically in at least 10% of cases.

[0009] Another limitation of current capture devices is the risk that once captured, the clot can potentially dislodge and migrate back into the bloodstream. Both the Sentinel® and Emboliner® devices capture the clot, but leave the distal end of the device open. When the device is removed from the body at the end of the procedure, the clot can migrate from the distal end. This can occur if the device is crushed or geometrically distorted during removal, if the device rubs against plaque and becomes distorted during removal, or if the pulsation of blood flow (very close to the heart) creates flow distortions that dislodge the clot from the filter. Summary of the Invention [Problem to be solved by the invention]

[0010] Improved devices and methods are needed to address the problems discussed above. Although the discussion herein focuses on the application to protecting the cerebral vasculature, the improved devices and methods described below have application to protecting any portion of the vasculature. [Means for solving the problem]

[0011] The embodiments described herein illustrate protection devices, systems, and methods suitable for protecting the vasculature, or other fluid-filled passageways, from debris caused during a procedure performed upstream of the site where the protection device is delivered, or during application of the protection system and / or method. The term emboli can include particles generated by thrombus, plaque, cholesterol, platelet emboli, calcification, naturally occurring foreign bodies (i.e., body parts that are lodged in a lumen), and non-naturally occurring foreign bodies (i.e., parts of medical devices or other non-naturally occurring materials that are lodged in a lumen). However, the devices are not limited to such applications and may be applied to any number of medical applications where protection of a vessel or passageway is required.

[0012] Variations of the invention described herein include a protection system for reducing migration of emboli within the bloodstream of a blood vessel. For example, such a system can include a filter body having a distal portion and a proximal portion, the filter body configured for positioning within a blood vessel such that blood flow enters the distal portion, the walls of the filter body being porous to allow blood flow to pass while trapping emboli within the bloodstream, a sealing membrane circumferentially disposed on the distal portion, the sealing membrane deflecting from the filter body as a result of blood flow against the sealing membrane, the deflection of the sealing member enabling a seal to be formed against the wall of the blood vessel, and a catheter body configured for guidance through the blood vessel, the filter body configured around the exterior of the catheter body.

[0013] In another variation, the invention described herein includes a protection system for reducing migration of emboli within the bloodstream of a blood vessel. For example, such a system can include a filter body having a distal portion and a proximal portion, the filter body configured for positioning within a blood vessel such that blood flow enters the distal portion, the walls of the filter body being porous to allow blood flow to pass while trapping emboli within the bloodstream, a sealing membrane circumferentially disposed on the distal portion, the sealing membrane deflecting from the filter body as a result of blood flow against the sealing membrane such that a seal can be formed against the walls of the blood vessel due to the deflection of the sealing member, and a catheter body configured for guidance through the blood vessel, the filter body configured to re-enter the catheter body upon removal from the patient such that the filter body and emboli disposed within the filter body are protected within the sheath body.

[0014] The sealing membrane can optionally be constructed of a fluid impermeable material. In some variations, the sealing membrane can have one or more openings to control the build-up of pressure at the sealing membrane. Variations of the sealing member can include an expandable portion such that blood flow against the sealing membrane causes the expandable portion to expand. In further variations, the sealing membrane is made of a thin film polymer or elastomer.

[0015] The sealing membrane can be disposed within the filter body. Alternatively or in combination, the sealing membrane can be disposed on an exterior portion of the filter body. In yet another embodiment, the sealing membrane is disposed on the inner diameter of the filter body and the second sealing membrane is disposed on the outer diameter of the filter body, and blood flow deflects the sealing membrane to increase the effective sealing area of ​​the filter device. In a further variation, the sealing membrane is comprised of a first layer and a second layer, the first layer being adjacent to the outer surface of the filter device and the second layer being adjacent to the interior passage of the filter device. In one variation, the first layer is connected to the second layer such that blood flow to the area of ​​the sealing membrane bounded by the first layer and the second layer increases the pressure to further increase 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 outside the filter device.

[0016] A variation of the filter device includes a series of petals at the distal end of the filter body, with the sealing membrane coupled to the series of petals. The series of petals can include at least one deflected petal, and the sealing membrane includes a first layer coupled to the at least one deflected petal and a second layer coupled to the series of petals, such that blood flow to an area between the first and second layers increases pressure in the area.

[0017] The filter body may be constructed of a mesh-like braid or multiple layers of mesh-like braid. The mesh braid may include superelastic Nitinol. Alternatively or in combination, the filter body is constructed of a thin film polymer or elastomer.

[0018] The filter body may include one having a pore size between 40 micrometers and 200 micrometers.

[0019] In a further variation, the seal member further expands in response to blood flow.

[0020] Variations of the devices described herein include a proximal seal membrane within the filter body, which may be positioned adjacent to a proximal portion of the device. Alternatively, or in combination, the filter body is comprised of a sheet of controlled porosity material. In a further variation, the filter body is comprised of strips of material that are overlapped to form a continuous surface.

[0021] The devices described herein can include at least one pull wire coupled to the distal end to bias the distal end to a closed position upon application of a pulling force to the pull wire. In a further variation, the device can further include at least one resilient ring disposed at the distal end of the filter body to bias the distal end to an open position in the absence of a pulling force.

[0022] Any of the systems and / or devices described herein can include a synchronizing member configured to synchronize portions of the filter bodies.

[0023] The present invention also includes a method of filtering a blood vessel for dislodged emboli during a procedure performed within a patient's blood vessel, for example, such a method may include the steps of placing a filter device within the blood vessel at a deployment site, the deployment site being downstream of a procedure site, a distal portion of the filter device including a sealing member, deploying the filter device such that blood flow toward the filter device causes the sealing member to form a seal against a wall of the blood vessel, the body of the filter device permitting passage of blood flow while restricting the flow of emboli, thereby retaining emboli within the bloodstream within the filter device, securing the filter device and emboli disposed within the filter device within a catheter body following the procedure, and removing the catheter body, filter device, and emboli from the blood vessel.

[0024] The methods described herein can 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 embolism from between the second catheter and the proximal opening.

[0025] In a further variation, the method may further include completing the procedure and withdrawing the second catheter from the filter device while contracting a proximal portion of the filter device around the second catheter, and further contracting the filter device to prevent escape of emboli through the proximal opening when removing the second catheter from the filter device.

[0026] In one variation of the method, securing the filter device and the embolus disposed thereon includes withdrawing the filter device within the catheter body.

[0027] The method may further include restricting a distal opening of the filter device prior to withdrawing the filter device within the catheter body.

[0028] In a further variation of the method, the filter device comprises a proximal seal member, where blood flow causes the proximal seal member to form a proximal seal against the second catheter. In a further variation of the method, the filter device is affixed to the distal end of the catheter body.

[0029] The method also includes the step of inverting the filter device within the catheter body prior to deploying the filter device, the step of deploying the filter device including securing a 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 is everted into position within the blood vessel.

[0030] In another variation of the method, prior to deploying the filter device, the filter device is inverted within the catheter body, and the step of deploying the filter device includes the step of advancing a proximal end of the filter device out of the catheter body such that the filter device is everted into position within the blood vessel.

[0031] One variation of the method can also include advancing a second catheter through the catheter body and the filter device to perform the procedure. In a further variation, the method can further include restricting a distal end of the filter body to prevent emboli from passing through the distal end. In another aspect, the method can further include withdrawing a distal end of the filter body into the catheter body such that the filter body everts within the catheter body.

[0032] In a further variation of the method, after the filter device is deployed, a balloon catheter or bristle brush device is used to loosen the emboli from the treatment site to ensure that the emboli are captured within the filter body.

[0033] The method includes positioning the filter device in the aorta. The method may include advancing the filter device and a catheter body through a radial vessel or advancing the filter device and a catheter body through a femoral vessel.

[0034] 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.

[0035] Another variation of the method described herein includes advancing a filter device to a deployment site within a blood vessel, a distal portion of the filter device including a seal member; deploying the filter device proximate to a treatment site, the filter device allowing blood to pass therethrough; forming a first seal between a wall of the blood vessel at the deployment site using the seal member to cause blood to flow into the filter device; advancing a medical device through the filter device to the treatment site; performing a procedure within the blood vessel distal to the filter device using the medical device, the procedure causing an embolism in the blood stream; withdrawing the medical device from the deployment site and further restricting a proximal portion of the filter device such that the embolism remains within the filter device; placing the filter device and the embolism located within the filter device within a catheter to prevent the embolism from passing into the blood stream; and removing the catheter, filter device, and embolism from the patient.

[0036] Variations of the methods 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]

[0037] [Figure 1A] FIG. 1A shows an example of a conventional vascular protection device. [Figure 1B] FIG. 1B shows an example of a conventional vascular protection device. [Figure 1C] FIG. 1C shows an example of a conventional vascular protection device. [Figure 2A] FIG. 2A illustrates an example of a flow-assisted seal of the present disclosure. [Figure 2B]FIG. 2B illustrates an example of a flow-assisted seal of the present disclosure. [Figure 2C] FIG. 2C illustrates an example of a flow-assisted seal of the present disclosure. [Figure 2D] FIG. 2D illustrates an example of a flow-assisted seal of the present disclosure. [Figure 2E] FIG. 2E illustrates an example of a flow-assisted seal of the present disclosure. [Figure 2F] FIG. 2F illustrates an example of a flow-assisted seal of the present disclosure. [Figure 2G] FIG. 2G illustrates an example of a flow-assisted seal of the present disclosure. [Figure 2H] FIG. 2H illustrates an example of a flow-assisted seal of the present disclosure. [Figure 2I] FIG. 2I illustrates one example of a flow-assisted seal of the present disclosure. [Diagram 3] FIG. 3 illustrates a variation of a filter device 100 that includes a collar that comprises a lasso-type mechanism that allows the diameter of a portion of the filter device 100 to be adjusted. [Figure 4A] FIG. 4A shows an example of a flow activated seal. [Figure 4B] FIG. 4B shows an example of a flow activated seal. [Figure 4C] FIG. 4C shows an example of a flow activated seal. [Figure 4D] FIG. 4D shows an example of a flow activated seal. [Figure 4E] FIG. 4E shows an example of a flow activated seal. [Figure 4F] FIG. 4F shows an example of a flow activated seal. [Figure 4G] FIG. 4G shows an example of a flow activated seal. [Figure 4H] FIG. 4H shows an example of a flow activated seal. [Figure 4I] FIG. 4I shows an example of a flow activated seal. [Figure 5A] FIG. 5A illustrates a conventional capture device expanded against the wall of a blood vessel. [Figure 5B] FIG. 5B illustrates an improved filter device with a flow-activated seal that expands against the wall of the blood vessel. [Figure 6A] FIG. 6A illustrates one variation of a device having a proximal flow activated seal located in the proximal region of the filter device. [Figure 6B] FIG. 6B illustrates a variation of the device having a proximal flow activated seal located in the proximal region of the filter device. [Figure 7A] FIG. 7A illustrates a further variation of a filter device integrated into the system for delivery via the femoral artery through the aortic arch. [Figure 7B] FIG. 7B illustrates a further variation of a filter device integrated into the system for delivery via the femoral artery through the aortic arch. [Figure 7C] FIG. 7C illustrates a further variation of a filter device integrated into the system that is delivered via the femoral artery through the aortic arch. [Figure 7D] FIG. 7D illustrates a further variation of a filter device integrated into the system that is delivered via the femoral artery through the aortic arch. [Figure 7E] FIG. 7E illustrates a further variation of a filter device integrated into the system that is delivered via the femoral artery through the aortic arch. [Figure 7F] FIG. 7F illustrates a further variation of a filter device integrated into the system that is delivered via the femoral artery through the aortic arch. [Figure 7G] FIG. 7G illustrates a further variation of a filter device integrated into the system that is delivered via the femoral artery through the aortic arch. [Figure 8A] FIG. 8A shows another variation of a filter device that is integrated directly into the processing device. [Figure 8B] FIG. 8B shows another variation of a filter device that is integrated directly into the processing device. [Figure 8C] FIG. 8C illustrates another variation of a filter device that is integrated directly into the processor. [Figure 8D]FIG. 8D shows another variation of a filter device that is integrated directly into the processor. [Figure 8E] FIG. 8E illustrates another variation of a filter device that is integrated directly into the processor. [Figure 9A] FIG. 9A illustrates additional structure for constraining one or both ends of the filter device. [Figure 9B] FIG. 9B illustrates additional structure for constraining one or both ends of the filter device. [Figure 9C] FIG. 9C illustrates additional structure for constraining one or both ends of the filter device. [Figure 10A] FIG. 10A illustrates the use of one or more balloons to control the opening of the filter device. [Figure 10B] FIG. 10B illustrates the use of one or more balloons to control the opening of the filter device. [Figure 10C] FIG. 10C illustrates the use of one or more balloons to control the opening of the filter device. [Figure 11A] FIG. 11A illustrates an additional variation of a filter device that utilizes a lasso effect to close the ends of the filter. [Figure 11B] FIG. 11B illustrates an additional variation of a filter device that utilizes a lasso effect to close the ends of the filter. [Figure 11C] FIG. 11C illustrates an additional variation of a filter device that utilizes a lasso effect to close the ends of the filter. [Figure 12A] FIG. 12A illustrates another variation of a filter device that is integral with a guide catheter and constrained within an outer sheath. [Figure 12B] FIG. 12B illustrates another variation of a filter device that is integral with a guide catheter and constrained within an outer sheath. [Figure 12C]FIG. 12C illustrates another variation of a filter device that is integral with a guide catheter and constrained within an outer sheath. [Figure 13A] FIG. 13A illustrates a variation of a filter body for use in combination with the devices described herein. [Figure 13B] FIG. 13B illustrates an alternative filter body for use in conjunction with the devices described herein. [Figure 13C] FIG. 13C illustrates an alternative filter body for use in combination with the devices described herein. [Figure 14A] FIG. 14A illustrates another variation of a filter device having a multi-layer seal. [Figure 14B] FIG. 14B illustrates another variation of a filter device having a multi-layer seal. [Figure 14C] FIG. 14C illustrates another variation of a filter device having a multi-layer seal. [Figure 14D] FIG. 14D illustrates another variation of a filter device having a multi-layer seal. [Figure 14E] FIG. 14E illustrates another variation of a filter device having a multi-layer seal. [Figure 15] FIG. 15 illustrates a variation of a filter device configured on the exterior of a guide catheter or sheath. [Figure 16A] FIG. 16A illustrates a further variation of a device for use in the procedures described herein. [Figure 16B] FIG. 16B illustrates a further variation of a device for use in the procedures described herein. [Figure 16C] FIG. 16C illustrates a further variation of a device for use in the procedures described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0038] The following figures illustrate embodiments of the present invention. Variations of the present invention from the illustrated embodiments are contemplated. It is understood that the following examples discuss use in the aortic arch to protect the cerebral vasculature (i.e., arteries). However, unless otherwise noted, variations of the device and method are not limited to use in the cerebral vasculature. Alternatively, the present invention may be applicable to various parts of the body. Additionally, the present invention may be used in a variety of procedures where the benefits of the method and / or device are desired.

[0039] 2A-2I show one example of a flow-assisted seal of the present disclosure. In this variation, a guidewire 110 is advanced through the left subclavian artery 4 to allow for positioning of a filter system (not shown in FIG. 2A) using a radial artery approach. Such an approach allows the filter system to be delivered from the femoral artery without reducing the available space in the vessel. As many TAVR systems are large in diameter, typically 12-18 French, variations of the filter system that are similarly delivered from the femoral artery may compete for space in this vessel. Delivering the filter system from the radial artery allows the space in the femoral artery to accommodate the TAVR system and other necessary devices.

[0040] The seal, filter device and / or guide catheter can have any number of coatings to minimize the possibility of thrombus formation, to minimize platelet activity, or to provide other drug elution benefits as desired. Alternatively, or in combination, the seal, filter device and / or guide catheter can include a hydrophilic coating.

[0041] As shown in FIG. 2A, a guidewire 110 can be introduced from the radial artery through the left subclavian artery 4 into the aortic arch 2 and into the aortic valve 10. A guide catheter or guide sheath 112 is introduced over the guidewire 110 and advanced to a site for deployment of a filter device, which can be located downstream of the treatment site (as shown in FIG. 2B). In this example, the treatment site is at the valve 10. As described, the guide catheter 112 can be introduced over the guidewire 110 while including a collapsed filter system (not yet shown). Alternatively, the filter system can be advanced through the guide catheter 112 when the guide catheter 112 is properly positioned. Exemplary variations of the guide catheter 112 can range from 4F to 8F in diameter, although any size can be used as needed. Additionally, the distal region(s) of the guide catheter can be pre-curved and angled to facilitate guidance at the desired region of tissue. For example, the guide catheter 112 may have a curve proximate its distal end to permit entry into the aortic arch 2 and to enable the distal end to be advanced towards the valve 10.

[0042] 2C illustrates the initial deployment of filter device 100 at a deployment site within the path of blood flow 12 from a treatment site (e.g., valve 10). Filter device 100 may be deployed by applying a force to device 100 to urge device 100 out of delivery catheter 112. Alternatively, guide catheter 112 may be pulled relative to filter device 100 to expose filter device 100 at the desired deployment site. A variation of filter device 100 is constructed from a superelastic Nitinol mesh that is heat set to expand to the arterial surface (typically 2.5 cm to 3.5 cm in the aortic arch 2).

[0043] In one variation of the filter device 100, the Nitinol mesh is a single layer of woven Nitinol wire. Additional variations of the device 100 may include multiple overlapping layers of Nitinol mesh. The Nitinol wire may be circular, square, rectangular, triangular, semicircular, or any combination thereof in cross section. Such irregular shapes may be preferred to limit thrombotic responses, as the shape of the wire may alter blood patterns and flow characteristics.

[0044] Additionally, some of the wires may be constructed of Drawn Filled Tubes (DFTs), where the Nitinol wire contains a core of gold, platinum, or tantalum (or the like) for radiopacity. Alternatively, the individual wires of the mesh may be constructed of solid or hollow platinum, gold, and / or tantalum for radiopacity. Also, rings of gold, platinum, and / or tantalum may be used for radiopacity.

[0045] In one version of filter device 100, the Nitinol mesh has a pore size of about 100 microns, although a range of about 40 to 200 microns or more may be suitable.

[0046] FIG. 2C further illustrates the filter device 100 having a flow seal 102 disposed at a distal end 122 of the filter device 100. The flow seal 102 is activated by blood flow 12 into the device. A variation of the flow seal consists of a section of impermeable soft polymer membrane that expands as blood flows through the membrane. The blood flow 12 expands the flow seal against the arterial wall to form an airtight seal and prevent emboli located within the blood flow 12 from passing through. As discussed above, conventional protection devices can fail to form an airtight seal between the filter device 100 and the vessel wall, thereby allowing emboli to escape the protection device. As discussed above, the walls of the aorta are typically calcified and contain plaque deposits that create geometrically irregular surfaces that make it difficult to form a proper seal using conventional devices. 2C avoids the problems associated with conventional devices by utilizing the naturally occurring blood flow 12 to inflate the membrane of the flow seal 102 to form an airtight seal, thereby requiring emboli to pass through an opening in the filter device 100. Additional variations of the flow seal are described below.

[0047] FIG. 2D shows a variation of the filter device 100 having an adjustable collar 104 at the proximal end of the device 100. The collar 104 can adjust the diameter of the proximal end 120 and position the device by applying force to a connecting wire 106 that extends through the guide catheter 112 and through the left subclavian artery 4 and radial artery. The restrictive collar 104 can be used to securely clamp to a catheter or device (e.g., a TAVR guide catheter, described below) that is inserted into the proximal opening 120 of the device 100. Variations of the device 100 can include a polymer liner on the inner diameter of the mesh at or near the collar 104 to ensure an airtight seal against the catheter or device extending therethrough. In one variation, the collar 104 can comprise a push-pull ribbon that controls the diameter of the filter device 100. Alternatively, as described below, the collar can include or be replaced by any number of ring structures that control the diameter of the filter device 100.

[0048] FIG. 2E shows the deployed filter device 100 positioned to receive a second catheter 130 that will be used to complete the procedure in the vessel. In the illustrated example, the TAVR system is introduced through the femoral artery with the TAVR guidewire 138 advanced into the proximal opening 120 of the device 100 and through the distal opening 122 to the procedure site (again, the valve 10). Again, as described above, the filter device 100 maintains a circumferential seal with the flow seal 102 remaining activated by the flow of blood in the vessel. Next, as shown in FIG. 2E, the TAVR guide catheter 130 and the TAVR valve 132 with balloon 134 are advanced along or over the TAVR guidewire 138. In alternative variations, additional devices (not shown), such as pigtail catheters, infusion catheters, or pressure monitoring catheters or guidewires, can be delivered or advanced through the filter device 100, which can accommodate multiple devices.

[0049] FIG. 2F illustrates the TAVR guide catheter 130 being passed through the filter device 100 and the TAVR valve 132 being positioned within the aortic valve 10. Once the TAVR (or other device for the appropriate procedure) is positioned, the medical practitioner can restrict the collar 104 to form a seal against the TAVR guide catheter 130. The seal may be airtight or may be sufficient to keep the TAVR catheter 130 slidable therethrough. In some variations, an airtight seal is essential to ensure that emboli 30 captured by the filter device 100 remain contained within the filter mesh. As discussed above, the seal can be further improved by providing a structure, such as a polymer ring, on the inner diameter of the filter at the location of the collar. It should also be noted that the collar 104, while allowing relative sliding movement of the TAVR guide 130 relative to the collar 104, is substantially restricted as soon as the TAVR guide 130 enters the filter 100, and can then be further restricted to form an airtight seal once the TAVR guide 130 and TAVR valve 132 are in place.

[0050] 2F shows the TAVR valve 132 deployed against the aortic valve and the TAVR delivery catheter 130 withdrawn from the procedure site. As shown, this procedure can cause embolic particles 30 to migrate within the blood vessel. However, the flow seal 102 directs any embolic particles 30 flowing in the blood toward the distal opening 122 of the filter device 100. Thus, the filter device 100 captures and contains many of the embolic particles 30 that would otherwise migrate to other parts of the body, such as the brain, where they could cause an ischemic stroke.

[0051] FIG 2G shows a post-procedure condition in which the TAVR implant 132 has been positioned in the valve 10 and the TAVR balloon and TAVR wire have been removed from the filter device 100, leaving only the TAVR guide 130 through the filter device 100 (Note: the guidewire may or may not be removed prior to TAVR guide catheter removal). FIG 2H shows the filter device 100 after the TAVR guide has been removed, but the collar 104 has further retracted the proximal portion of the filter device 100 to effectively completely close off the proximal end of the filter device 100. This ensures that trapped embolic material 30 cannot escape through the proximal opening 120 of the filter device 100.

[0052] It should also be noted that, as shown in Figure 2H, the physician may choose to leave the filter device 100 in place for several hours or even days after the procedure as a preventative measure to collect any delayed plaque from the aortic valve, thus providing further protection against stroke.

[0053] 2I illustrates a condition in which filter device 100 can be removed. Filter device 100 can be retracted into guide catheter 112. Alternatively, guide catheter 112 can be advanced over filter device 100, thereby collapsing filter device 100 as it is constrained within guide catheter 112. Because filter device 100 is constrained within guide catheter 112, embolic particles 30 can be prevented from escaping. Once secured, guide catheter 112 and filter device 100 can be removed.

[0054] FIG. 3 illustrates a variation of the filter device 100 having a collar consisting of a lasso-type mechanism that allows the diameter of a portion of the filter device 100 to be adjusted. As illustrated, 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 guide sheath 112. In the illustrated variation, each lasso member 152, 154 is shown to include two pull wires. However, variations of the filter device 100 can include one pull wire for each lasso member 152, 154, or two or more pull wires for each lasso member 152, 154. The advantage 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.

[0055] 4A-4C show several embodiments of the flow-activated seal 102. In one variation, the flow-activated seal 102 is made of a soft polymer membrane that can expand in response to pressure caused by blood flowing against the membrane. The pressure causes the membrane to deflect and / or expand. In some variations, the flow-activated seal 102 only partially deflects and / or expands.

[0056] FIG. 4A shows a variation of the device 100 having a polymer layer that forms a flow-activated seal 102. As shown in FIG. 4B, the flow of blood 12 causes the membrane 102 to expand and / or deflect, increasing surface contact with the inner wall of the blood vessel (not shown). The flow-activated seal variation can simply be deployed from the body of the filter device. Alternatively or in combination, the flow-activated seal (e.g., the central portion not attached to the filter body) can stretch or expand upon receiving blood flow. In a further variation, the flow-activated seal is flow-impermeable such that flow against the seal increases the pressure at the seal. In addition, the flow-activated seal is typically constructed of a softer and more conformable material compared to the mesh of the filter device. This difference allows the flow-activated seal to conform to any irregularities in the vessel wall. This allows the filter device to form an improved seal against the vessel wall. The filter device 100 variation can include a flow-activated seal 102 that increases friction when expanded / deflected against the vessel wall. For example, the membrane 102 may include a roughened surface texture or particles that increase resistance to movement of the filter device in response to blood flow. These expandable sealing members may be distensible or non-distensible.

[0057] FIG. 4C shows another variation of flow activated seal 102 in a filter device 100 in which blood flow causes seal 102 to expand outwardly from the mesh that forms device 100 .

[0058] The membrane variations of the flow activated seal 102 can be made from thin film polymers or elastomers, or similar materials. Thermoplastic urethanes may be very suitable, as well as other thermoplastic elastomers. Device variations include membranes that are about 0.001 inches (about 25.4 micrometers) thick. Alternatively, membrane variations can include thicknesses of 0.0003 inches to 0.003 inches (about 7.62 micrometers to about 76.2 micrometers). To further enhance the ease of opening and size of the membrane, it can be engineered with "redundancy," such as folds or extra slack.

[0059] Figures 4D-4G illustrate further configurations of flow activated seal 102. In Figure 4D, the flow activated seal is comprised of an elastic polymer disposed within the braided structure that forms filter device 100. As shown in Figure 4E, when blood flow 12 enters filter device 100, blood flow 12 deflects / displaces the polymer material along with a portion of mesh 108 that forms filter device 100. Thus, blood flow 12 forces the polymer and mesh 108 to expand and form a seal against the vessel wall.

[0060] FIG. 4F shows another variation in which a polymer layer or membrane is placed within the filter device 100. As shown, a soft, highly compatible polymer (such as urethane or another thermoplastic elastomer TPE) forms a shape within the filter device 100 that captures the blood flow 12 using a bilayer structure including an upper sealing surface 166 and a lower sealing surface 168. The seal 102 shown in FIG. 4F includes, for example, a larger upper sealing surface 166 adjacent the outer surface of the filter device 100 and a smaller lower sealing surface 168 adjacent the inner passageway of the filter device 100. As blood flows into the space between the upper sealing surface 166 and the lower sealing surface 168, the internal (i.e., between the two surfaces) pressure increases due to fluid pressure, which helps the seal 102 advance outward against the blood vessel, as shown in FIG. 4G. In one variation, the lower sealing surface 168 is intentionally smaller than the upper sealing surface 168 to ensure that the upper sealing surface 166 expands more than the lower sealing surface 168. However, alternative variations may be permissible by design selection such that upper sealing surface 166 is less expandable than lower sealing surface 168. As shown in FIG 4G, blood flow 12 enters membrane 102, causing it to deflect and displace such that filter device 100 seals against the arterial wall.

[0061] 4H and 4I show a variation of the filter device 100 having a first flow-activated seal 102 with a second seal 114. In this variation, the flow-activated seal 102 is disposed within the filter device 100 and the second seal 114 is disposed on the exterior of the filter device 100. As each layer 102, 114 is affixed to the two layers of the mesh filter 108 as blood 12 flows through it (as shown in FIG. 4I), the blood flow 12 increases the pressure on the surface of the inner membrane 102, deflecting and pushing against the outer membrane 114. The two membranes 102, 114 form a seal in the overlapping area. This configuration consists of two individual seals 102, 114 acting as a single seal or monolayer.

[0062] Although the flow-activated seal variations described herein are shown in connection with the distal portion of the filter device, further variations of the filter device include flow-activated seals on the proximal region of the filter device as well. Such proximal flow-activated seals can further assist in sealing the filter device against a guide catheter or other device advanced therealong. In such cases, the proximal flow-activated seal configuration would be activated by blood flowing into the distal portion, through the filter device, and toward the proximal portion.

[0063] Flow-activated seals provide significant benefits when used in protective devices by reducing the likelihood of embolic particles bypassing the device. Figures 5A and 5B show differences from conventional devices (e.g., devices such as those shown in Figures 1A-1C) and the improved filter device 100 described herein. Figure 5A shows a cross-sectional view of a blood vessel 2 (the drawing scale has been adjusted to better illustrate the conformity of the device 22 to the vessel wall 14). As shown, the periphery of the device 22 is intended to form a seal against the vessel wall. However, the irregular shape 16 of the blood vessel 2 (e.g., plaque, calcification, vessel shape, or other naturally occurring formations, etc.) results in an irregular shape 18 that cannot be sealed with the protective device. Figure 5B illustrates elements of a flow-activated seal 102 of the present disclosure, which often has greater flexibility or conformability than the mesh structure forming the device 100. This feature allows the flow activated seal 102 to expand or deform into any irregular shapes 18 within the blood vessel 2 to a greater extent than the mesh or filter device 100. This results in an improved seal being formed between the wall 14 of the blood vessel 2 and the filter device 100, which in turn improves filtering of emboli within the bloodstream.

[0064] 6A and 6B show a variation of the device having a proximal flow activated seal 116 disposed in the proximal region of the filter device 100, as well as a distal seal. Note that a collar is shown adjacent the seal 116. However, variations of the filter device 100 can include a proximal seal 116 disposed in any portion of the proximal portion. Any of the seal structures disclosed herein for the distal seal can also be used in the proximal portion, or some combination thereof, as long as they seal against flow from the distal portion of the device.

[0065] 6A and 6B also show a variation in which the proximal seal 116 includes an attachment 118 that connects the seal back to the braid. This connection prevents the seal 116 from everting. In the illustrated variation, the drawings, the seal 116 is permanently secured (i.e., adhesively bonded, thermo-mechanically encapsulated, etc.) to the braid at the location shown. To ensure that the opposite end of the seal does not evert, from the blood flow 12 or from withdrawing the guide catheter, the seal can be additionally anchored 118 in another area of ​​the braid. Anchoring can be achieved using a tack melt, additional encapsulation / heat seal, or additional fiber, polymer or metal filament.

[0066] Another variation of the system can include an enhanced TAVR guide catheter 130 to enhance the sealing properties of the filter. A geometric "bump" or protrusion 138 can be on the outer diameter of the guide 130 in the sealing area. In the variation shown in FIG. 6A, the protrusion 138 is shown on the outside of the filter device 100 for illustrative purposes. The protrusion 138 can be manufactured into the catheter 130. Alternatively or in combination, the protrusion can be added to the TAVR guide catheter 108 in a sterile environment (such as a small sterile sleeve). In addition, a swellable coating, such as a thick hydrophilic coating, can also have a similar effect of increasing the proximal seal.

[0067] 7A-7G show additional variations of filter device 100 integrated into a system for delivery from the aorta through the aortic arch 2 to the valve 10. In this variation, filter device 100 is integrally and permanently secured to a guide catheter 140. FIG. 7A shows an example of a variation of a system having filter device 100 integrated into a guide catheter or sheath 140 that is advanced to a deployment site within a blood vessel 2. In this variation, filter device 100 is everted within guide sheath 140, and a proximal end of device 120 is affixed to distal end 142 of guide catheter 140. As shown in FIG. 7B, a stabilizing device 170 (e.g., a dilator device or support catheter) is advanced to distal end 122 of filter device 100. FIG. 7C shows guide sheath 140 being retracted while stabilizing device 170 stabilizes filter device 100, thereby allowing filter device 100 to evert into place as guide sheath 140 is retracted. Additionally, a stabilization device 170 may be used to ensure that the filter is fully returned to the open or deployed configuration by extending it through the filter device 100. Figure 7C shows a distal portion 122 of the device 100 having a flow activated seal and a proximal portion 120 of the device 100 coupled to the distal end 142 of a guide catheter 140.

[0068] The stabilizer / dilator 170 can be used to "push" the filter 100, forcing the filter 100 distally. Alternatively, the stabilizer / dilator 170 can be advanced to the inverted filter at its proximal end to stabilize the filter, and then the outer sheath restraining sheath can be retracted proximally to remove the sheath from the filter.

[0069] Next, as shown in Figure 7D, the TAVR implant 132 and system 130 are advanced through a guide catheter or sheath 140 along with the integrated filter device 100. The distal end 122 of the filter 100 includes a flow-activated seal 102. Figure 7E illustrates the TAVR implant 132 deployed at a deployment site with an embolus 30 in the blood stream, which is oriented within the filter device 100 due to the flow-activated seal 102. Because the proximal end is integral with the distal end 142 of the guide catheter 140, there is no risk of emboli escaping through the proximal end 120 of the device 100.

[0070] FIG. 7F illustrates the use of one or more pull wires 124 to close the distal end 122 of the filter device 100. As shown, the embolic particles 30 are secured within the closed filter device 100, which is integral / secured to the guide catheter 140. FIG. 7G illustrates an optional element of the system that allows the filter device 100 to invert back into the guide catheter 140. As shown, the pull wires 124 are tensioned to pull the distal portion 122 of the closed filter device 100 back into the catheter body 140, thereby inverting the filter device 100 into the guide body 140. Again, since the filter is closed, there is no risk of losing the captured emboli. Such a step ensures that the filter and emboli are protected during removal from the body.

[0071] It is also noted that additional design options include constructing the filter on a femoral introducer sheath (i.e., an elongated sheath with the filter positioned adjacent to the aortic valve) or using an elongated sheath to constrain the filter if it is not pre-inverted within the guide catheter.

[0072] 8A-8E show another variation of a filter device that is integrated directly into the processing device. For example, the filter device can be built directly into the TAVR guide catheter, eliminating the need for an additional guide catheter just for the filter. FIG. 8A illustrates a TAVR guide catheter 130 that is used to advance a TAVR implant 132 to the site of the valve 10 in the aorta 2. In FIG. 8A, the filter is not shown, but is loaded into the TAVR guide catheter 130.

[0073] FIG. 8B shows the filter device 100 being delivered from the TAVR guide catheter 130. This deployment can be accomplished in any of the ways disclosed herein (inverted within the guide catheter and delivered by "pushing" with another integral or similar tube; or simply compressed within the TAVR guide catheter and sheath removed). FIG. 8C shows the TAVR balloon and guidewire removed from the site. Because the filter device 100 is mechanically integrated with the catheter body 130, there is no concern of emboli escaping through the proximal region of the filter device 100. FIG. 8D illustrates one or more guidewires 124 used to close the distal end 122 of the filter device 100. The proximal end of the filter device 100 is placed within the distal end 128 of the TAVR guide catheter 130. FIG. 8E shows a variation in which the filter device 100 is slidably coupled within the TAVR guide catheter 130, allowing the closed filter to be placed back into the guide lumen during removal.

[0074] The variations shown in Figures 7A-7G and 8A-8E are systems that can be built into the delivery guide catheter of a TAVR system or into a separate delivery catheter.

[0075] 9A-9C illustrate additional configurations for constraining the filter device 100. In the example shown in FIG. 9A, the filter device 100 is comprised of a double mesh layer having an inner mesh 108 and an outer mesh 109. In one embodiment, the mesh layers 108, 109 are comprised of Nitinol braid. An additional ring structure 160 is provided at the end of the filter device 100. In the illustrated example, the ring structure 160 comprises a coil shape. However, alternative shapes (e.g., straight wire, sinusoidal, helical, etc.) can be used as long as the shape provides a radially outward force to keep the end of the filter 100 open. One or more pull wires 156 are coupled to the ring 160 such that application of force to the pull wires 156 closes the ring 160 and the end of the filter device 100. In the illustrated example, the pull wires 156 are shown extending through a tube (e.g., a polyimide tube). 9B shows a ring structure 160 coupled to the pull wire 156 without the mesh of the filter device. As discussed above, the coiled ring 160 provides a radially outward force that opens the ends of the filter device when unconstrained. Applying a force 52 to the wire 156 away from the ring 160 results in closure 54 of the ring 160 and the filter device.

[0076] 9C shows another variation of a self-expanding ring 164. In this variation, the ring has an undulating shape with a pull wire 158 passing through the ring 164. As described above, the ring 164 is self-expanding (or heat activated) to provide an outwardly expanding force to the filter device 100. The pull wire 158 acts to close the ring 164 and the filter device 100 in response to the application of a closing force. The pull wire 158 can optionally pass through the tube 162 or can be incorporated into the mesh of the filter.

[0077] It is noted that any of the ring structures described herein may be used interchangeably for the distal and / or proximal regions of the filter, or any combination thereof. In addition, ring structures may be incorporated into any portion of the interior of the filter as desired.

[0078] 10A-10C illustrate the use of one or more balloons to control the opening of the filter device 100. For example, FIG. 10A illustrates a variation of the filter device 100 having an elastomeric balloon 180 at the end of the filter device 100. In this variation, the balloon is in a closed position (as shown) when not pressurized. Upon application of fluid via line 184, balloon 180 inflates balloon 188 to open the filter device 100. FIG. 10B illustrates another variation of the filter device 100 having balloon 182 in a normally open position. Application of fluid via line 184 causes balloon 182 to fold inward, as shown in FIG. 10C.

[0079] 11A-11C illustrate additional variations of filter devices that utilize a lasso effect to close the ends of the filter. Again, all of the closure mechanisms described herein can be applied to the proximal, distal, and / or inner portions of the filter device. FIG. 11A shows a pull wire 156 used to create an opening at the end of the filter device 100 that can be restricted / occluded by pulling the wire 156. Pulling the wire 156 reduces the diameter of the filter device 100, effectively closing off the attached portion of the filter device 100. In this variation, the wire 156 is located at the distal end of a guide catheter 140 that is integral with the filter device. However, this occlusion structure can be used with any filter device. Additionally, these concepts are equally applicable to the proximal end of the filter.

[0080] As mentioned above, some device applications require a closure mechanism to completely close the open end of the filter to prevent the spread of emboli. In such applications, the wires 156 can be constructed of superelastic Nitinol wire with an oxide coating of about 0.001 inches to about 0.002 inches (about 25.4 micrometers to about 50.8 micrometers), but in device variations, can be up to 0.010 inches (about 254 micrometers). The wires can also be ribbon wires, rectangular wires, or other shapes. Other options include fibers, polymers, and threads. FIG. 11B shows two sets of pull wires 156 coupled to the distal end of the filter device 100. FIG. 11C shows multiple sets of pull wires 156 closing the ends of the filter device.

[0081] 12A-12C show another variation of the filter device 100 that is integral with the guide catheter 140 and constrained within an outer sheath 190. FIG. 12A shows the filter device 100 and guide catheter 140 constrained within the outer sheath 190 so that the system can be advanced to the deployment site as described herein. This variation is typically delivered from the femoral artery where the TAVR system is delivered. FIG. 12B shows the outer constraining sheath 190 being withdrawn 192 while the guide catheter 140 is held stationary. Withdrawal of the constraining sheath 190 expands the filter device 100. As described above, the flow-activated seal will ensure and adequately filter the vessel. This is a two catheter design, a coaxial system, where one catheter 140 is integral with the filter device 100 and one catheter / sheath 190 acts to constrain the filter 100 for delivery. Variations of the system include replacing the outer sheath 190 with another mechanism, such as a coil or short collar, to restrain the filter. In a further variation, the outer sheath 190 may be very thin-walled, such as a coil-reinforced polyimide tube, if it is only intended to restrain the filter and does not need to guide itself. FIG. 12C shows activation of the pull wire 156 after completion of the procedure. Activation of the pull wire closes the end of the filter device 100, securing any embolic particles within the filter 100.

[0082] 13A-13C show variations of filter bodies for use in the devices described herein. FIG. 13A shows a dual-layer filter device 100 with an outer layer of a thin porous material, such as a mesh 108 or a polymer film with holes or pores (e.g., laser drilled, chemically formed, mechanically formed), and an inner layer of a coil or braid 148 configured to provide a radial force such that the filter body 100 expands with a radial force into contact with the vessel wall. FIGs. 13B and 13C respectively illustrate non-expanding and expanding filter devices 100 comprised of an inner expansion member 150 with a mesh or braid 108. The coiled expansion member 150 expands upon expansion to open the braid. It is also noted that the filter device 100 can be formed from components other than a wire braid or mesh. For example, the filter device 100 can be constructed of a porous polymer film, such as polyurethane. The porosity of the film can be achieved by chemical processing such as laser processing, chemical etching, or micro-abrasion processing, or other means known to those skilled in the art. In another embodiment, the filter device is constructed from a thin film process. Thin films such as thin film metal can be formed with any selected porosity. The filter shown in Figures 13A-13C is provided with multiple layers, with the inner layer (e.g., coil, braid, stent-like structure) applying a radially outward force to open the filter, and the outer layer (e.g., braid, polymer, porous film, porous metal film) filtering for blood.

[0083] 14A-14C show another variation of a filter device with a multi-layer seal. In this variation, as shown in FIG. 14A, the mesh 108 of the filter device 100 terminates in a series of petals 105, 107. The structure of the petals 105, 107 can include one or more individual wires from the inner / outer mesh that return to form the inner / outer mesh. The petals can be non-invasive or can include elements that increase friction against the vessel wall (or the wall of the body cavity). FIG. 14B illustrates that the alternating petals 107 are shaped with an offset 126, for example, the alternating petals 107 have an upwardly extending shape 126, and then the next petal 105 can be either horizontal (as shown) or extend slightly downward (into the inner diameter of the device 100), as shown in FIG. 14C. This angular separation of the petals provides space for the attachment of the flow-activated seal 102. As shown, the seal 102 can have both an upper surface 164 and a lower surface 165. In one variation, the seal 102 can be formed from a single piece of polymer film, or it can be two separate pieces that intersect and overlap at an apex. Optional small "holes" 163 in the seal 102 are beneficial to control the pressure within the seal 102 and ensure that blood flow does not overly compress the seal 102 and dislocate the filter device 100. It is also noted that this same design concept can be achieved with a "standard" braid (i.e., no petals). In this case, the individual braid wires are formed to extend outward or flat / extend inward, and then the ends of the wires terminate within the seal polymer. FIG. 14E shows a partial side view of the upper and lower seals 164 and 165 with space between them to increase pressure in response to blood flow. As described herein, the upper seal 164 may be configured (eg, by sizing or material selection) to preferentially bias against the wall of the vessel.

[0084] FIG. 15 shows another variation of the filter device 100. In the variations described above, the filter device 100 was shown attached at or near the distal end of a guide catheter. Here, the filter 100 is attached to the outside of the guide 174. The filter 100 can be self-expanding (or mechanically assisted as described above) and then released by conventional methods (releasing pull wires, activating coils or inflation lumens, or removing an outer sheath or cover). Once thrombus collection is complete, the filter 100 can be closed to the outer diameter of the guide / sheath 174 to capture emboli between the filter and the guide surface. Note that the guide 174 can be a procedure guide, a TAVR guide, or a sheath. Sheath options include an elongated introducer sheath, a procedure sheath, and / or an expandable sheath (i.e., an e-sheath).

[0085] 16A-16C are diagrams illustrating further variations of devices for use in the procedures described herein. FIG. 16A illustrates the distal end of a TAVR guide catheter 144 flaring outward at multiple points 144 to maintain contact with the proximal end of the balloon and possibly contact the compressed TAVR valve. A guide 130 with an inverted (or non-inverted, but simply compressed) filter can still have this flared distal end as shown. The mesh of the filter device 100 can be folded into the guide catheter 130.

[0086] FIG. 16B illustrates a further variation during or after use with the filter device described herein. In this example, after the filter is deployed in place (whether radial or femoral approach), a custom catheter or guidewire having a "brush-like" attachment 176 is advanced to the treatment site (e.g., valve or other treatment site) to loosen plaque or other debris from the treatment site. The custom catheter 176 can be delivered to the treatment site (e.g., aortic valve 10) prior to TAVR installation. The brush attachment is one variation of a device that can loosen debris. For example, the brush device can have bristles or bristle-like protrusions, such as polymer fibers, disposed around the distal end. The protrusions "knock free" loose plaque from the aortic valve prior to placing a new filter. This can be done simply to obtain a better fit of the new valve against the wall of the aorta, or to minimize the possibility of plaque breaking free post-operatively, especially after the filter is removed.

[0087] Another option is to deploy the filter (either via a femoral or radial approach) and pre-dilatate the aortic valve with a balloon catheter as shown in Figure 16B. Balloon dilation may be done simply to allow a better fit of the new valve against the aortic wall or to minimize the chance of plaque breaking free after surgery.

[0088] FIG. 16C shows the change in blood return out of the radial artery through the catheter 112 extending from the left subclavian artery 4. Once outside the patient's body, the blood can flow through a simple filter 196 with similar pore size. Filters can be paper, fabric, polymer, thin film composite, etc. The stenosis ring or collar 104 can still be used in the proximal region to allow the TAVR system to pass through. Alternatively, this design can also be used in post-op patients to collect any late break-off emboli. In this case, the stenosis ring is completely closed, forcing all blood to pass through the catheter and filter. By making parts of the filter impermeable, the amount of blood entering the catheter / filter loop and the amount entering other blood vessels can be controlled. The filtered blood can be returned to the body, for example, through the femoral access point 198.

[0089] Other details of the invention, materials and manufacturing techniques can be adopted within the level of ordinary skill in the art. The same can be said for additional acts generally or logically adopted for method-based aspects of the invention. In addition, the invention has been described with reference to several embodiments incorporating various optional elements, but the invention is not limited to what has been described or shown as contemplated for each variation of the invention.

[0090] Various modifications may be made to the invention described, and equivalents (whether described herein or not, included for brevity) may be substituted without departing from the true spirit and scope of the invention. Also, any element of the variations of the invention may be described and claimed independently or in combination with any one or more of the elements described herein. Thus, the invention contemplates combinations of various aspects of the embodiments, or combinations of the embodiments themselves, where possible. Reference to a singular item includes the possibility of a plurality of the same items. More specifically, as used in this specification and the appended claims, the singular forms "a," "an," "said," and "the" include plural references unless the context clearly dictates otherwise.

[0091] It is important to note that, where possible, aspects of the various described embodiments, or the embodiments themselves, can be combined, and such combinations are intended to be within the scope of the present disclosure.

Claims

1. 1. A protection system for reducing emboli migration within a bloodstream of a blood vessel, comprising: a filter body having a distal portion and a proximal portion, the filter body configured for positioning within the blood vessel such that the blood flow enters the distal portion, the walls of the filter body being porous to allow the blood flow to pass through while trapping emboli within the blood flow; a sealing membrane disposed at the distal portion, the sealing membrane including an expandable portion whereby the blood flow against the sealing membrane expands the expandable portion, the sealing membrane being made of a material that has increased compliance with the walls of the filter body, enabling it to form an improved seal when expanded against the blood vessel, the improved seal providing increased friction when expanded against the blood vessel; A protection system comprising: a device body configured to be guided through the blood vessel, the filter body being configured to be retracted into the device body.

2. The protective system of claim 1 , wherein the sealing membrane is made of a fluid impermeable material.

3. The protective system of claim 1 , wherein the sealing membrane is made of a thin film polymer or elastomer.

4. The protective system of claim 1 , wherein the sealing membrane is disposed within the filter body.

5. 2. The protective system of claim 1, wherein the sealing membrane is a first sealing membrane located inside the filter body and further includes a second sealing membrane located outside the filter body, and blood flow causes the first sealing membrane and the second sealing membrane to deflect, increasing an effective sealing area of ​​the sealing membrane.

6. 2. The protective system of claim 1, wherein the sealing membrane comprises a first layer and a second layer, the first layer adjacent an exterior surface of the filter body and the second layer adjacent an interior passageway of the filter body.

7. 7. The protection system of claim 6, wherein the first layer is connected to the second layer such that blood flow to an area of ​​the sealing membrane bounded by the first layer and the second layer increases pressure to further expand the sealing membrane.

8. 7. The protective system of claim 6, wherein the first layer is configured to expand more than the second layer such that a sealing membrane extends outside the filter body.

9. 10. The protective system of claim 1, further comprising a series of petals disposed at a distal end of the filter body, the sealing membrane being coupled to the series of petals.

10. 10. The protective system of claim 9, wherein the series of petals includes at least one deflected petal, and the sealing membrane comprises a first layer coupled to the at least one deflected petal and a second layer coupled to a non-deflected petal in the series of petals such that blood flow into a region between the first and second layers increases pressure in the region.

11. 10. The protective system of claim 1, wherein the filter body comprises a mesh braid.

12. 12. The protective system of claim 11, wherein the mesh braid is made of superelastic Nitinol.

13. The protective system of claim 1 , wherein the filter body is made of a thin film polymer or elastomer.

14. 10. The protective system of claim 1, wherein the filter body has a pore size between 40 micrometers and 200 micrometers.

15. The protective system of claim 1 , further comprising a proximal sealing membrane within the filter body, the proximal sealing membrane being disposed adjacent the proximal portion of the filter body.

16. 10. The protective system of claim 1, wherein the filter body comprises a sheet of controlled porosity material.

17. The protection system of claim 1, further comprising at least one pull wire coupled to the distal portion, the distal portion being biased into a closed position by applying a tensile force to the at least one pull wire.

18. 20. The protective system of claim 17, further comprising at least one resilient ring disposed at a distal end of the filter body, biasing the distal end to an open position in the absence of the tension force.

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