Auxiliary device for protecting nerves during an intervention procedure

Abstract

To provide a device, system, and method for filtering embolic particles that may occur during medical treatment. **Solution**: Devices, systems, and methods for filtering embolic particles that may occur during medical treatment include protecting major branch vessels from the aorta and capturing and filtering emboli that may occur during a TAVR procedure. The filter devices disclosed herein form an improved seal against the vessel wall that is actuated by blood flow. The devices described herein can also close both ends of the filter device after embolus capture, enhancing safety against the unexpected disappearance of captured emboli.

Description

Technical Field

[0001] (Cross - Reference to Related Applications)

[0001] This application is a non - provisional application of U.S. Provisional Application No. 63 / 368,624, filed on July 15, 2022, the entire content of which is incorporated herein by reference.

[0002]

[0002] Devices, systems, and methods for filtering embolic particles that may occur during medical procedures are disclosed. These include protecting major branch vessels from the aorta and capturing and filtering emboli that occur during a TAVR procedure. The filter devices disclosed herein form an improved seal against the vessel wall and are actuated by blood flow. The devices described herein can also close both ends of the filter device after embolus capture, enhancing safety against the unexpected disappearance of captured emboli. The TAVR procedure is just one example of an application that is improved by the use of this device, system, and method. However, this device, system, and method can be used in any part of the body.

Background Art

[0003]

[0003] Percutaneous coronary valve interventions such as valve replacement and valve repair are rapidly growing fields among catheter - based medical interventions. Catheter - based interventions are a growing field in cardiac interventions and currently include mitral valve repair, aortic valve repair, replacement, etc. One of the growing markets is aortic valve replacement called transcatheter aortic valve replacement ( "TAVR"). The number of TAVR procedures is increasing and the success rate is high, but this procedure has a risk of debris and thrombi detaching within the vascular system in the form of thrombi and / or stenotic fragments. If these thrombi migrate to the brain, lungs, or peripheral vessels, they can cause ischemic stroke.

[0004]

[0004] Efforts have been made to reduce the risk of stroke through the development of medical devices designed to prevent detached blood clots from migrating to the brain. While these devices have achieved some success, further improvements and enhancements are still sorely needed.

[0005]

[0005] Previous devices are typically classified into two types: deflector devices and capture devices. Deflectors work to “deflect” blood clots away from the major blood vessels leading to the brain, usually by deploying a nitinol mesh material (or similar) to prevent thrombi / stent fragments from entering the major blood vessels leading to the brain. The physician temporarily deploys this mesh material at the origin of the blood vessels leading to the brain. This maintains blood flow while preventing the causative material of the blood clot from passing through the mesh pores (usually about 100 microns in diameter). Since the blood clot material is not captured, it moves to another location in the body, usually to the peripheral vascular system through the ascending aorta. For example, FIG. 1A shows the aortic arch 2, left subclavian artery 4, left common carotid artery 6, and brachiocephalic artery (innominate artery) 8. The left common carotid artery 6 and brachiocephalic artery 8 supply blood to the head and neck. Thus, if an embolus 30 migrates through these arteries to the brain, there is a risk of embolism 30 movement.

[0006]

[0006] FIGS. 1A through 1C illustrate examples of conventional vascular protection devices. For example, FIG. 1A shows a capture device called Sentinel (trademark) by Claret Medical. As shown, the capture device is placed within the left common carotid artery 6 and brachiocephalic artery 8 to prevent the movement of embolus 30. However, it has been reported in the medical literature that these filters do not fit properly to the anatomical structure in at least 10% of cases, thereby creating a risk of emboli passing through. FIGS. 1B and 1C illustrate examples of deflector devices 24, 26. As shown, deflector devices 24, 26 prevent emboli from entering the branch vessels. Again, if the conventional device does not form a proper seal against the vessel wall, the blood clot may pass through the device (i.e., between the device and the vessel wall) and flow into the brain, potentially causing a cerebral ischemic attack.

[0007]

[0007] The deflector device has another limitation. First, in most devices, the clot material is not captured and not removed from the body. This device is advantageous in preventing the clot material from moving to the brain and causing an ischemic attack, but it deflects the clot to the peripheral blood vessels. Although the risk is low, the clot can still cause blockages in blood vessels such as those in the lower extremities and kidneys. Furthermore, the deflector device does not form an effective seal within the vascular system. This may prevent some or most of the clot from entering the blood vessels leading to the brain, but the clot can still pass through the device, meaning there is a risk of stroke.

[0008]

[0008] In addition to the above, conventional capture devices have yet another limitation. Some capture devices do not protect all of the blood vessels leading to the brain (there are three main blood vessels branching from the aorta and leading to the brain, namely, the brachiocephalic artery connecting to the right subclavian artery and the right common carotid artery, the left common carotid artery, and the left subclavian artery). The Sentinel device manufactured by Claret Medical (Santa Rosa, California) protects only two of the three branched blood vessels. Another capture device, for example, the Emboliner device manufactured by Emboline (Santa Cruz, California), attempts to cover all three branched blood vessels using a nitinol mesh cylinder, but if the seal between the mesh cylinder and the aortic wall is not optimal, it cannot be covered, and the clot can pass between the mesh cylinder and the blood vessel, causing the clot to flow into the brain and trigger a stroke.

[0009]

[0009] In fact, insufficient contact between the deflection / capture device and the blood vessel wall is a problem for all current brain protection devices. If the seal is incomplete, small clots can flow into the brain, resulting in a risk of stroke. Current medical literature reports that these filters do not "fit" properly to the anatomical structure in at least 10% of cases.

[0010]

[0010] Another limitation of current capture devices is the risk that once a blood clot is captured, it may dislodge and return to the bloodstream. Both the Sentinel device and the Emboline device capture blood clots, but the distal end of the device remains open. When removing the device from the body at the end of the procedure, the blood clot may move from the distal end. This can occur when the device is crushed or geometrically distorted during removal, when the device rubs against plaque and becomes distorted during removal, or when flow disturbances occur due to blood flow pulsations (very close to the heart) and the blood clot is dislodged from the filter.

[0011]

[0011] To address the above problems, improved devices and methods are still needed. Although focused on applications for cerebrovascular protection, the improved devices and methods described below also have applications for protecting any part of the vascular system.

Summary of the Invention

[0012]

[0012] The examples described herein illustrate variations of protective devices, systems, and methods. These are suitable for protecting a vascular system or another fluid-filled flow path from debris generated during a procedure that occurs upstream of the site where the protective device is delivered or to which the protective system and / or method is applied. The term embolus can include particles resulting from blood clots, plaque, cholesterol, thrombi, calcifications, naturally occurring foreign bodies (i.e., parts of the body remaining within the lumen), and non-naturally occurring foreign bodies (i.e., parts of a medical device or another non-naturally occurring substance remaining within the lumen). However, these devices are not limited to such applications and are applicable to any medical application where protection of blood vessels or flow paths is required.

[0013]

[0013] Variations of the invention described herein include a protection system for reducing the movement of emboli within the blood flow of blood vessels. Another variation of the invention includes methods and devices for forming an improved seal against the walls of blood vessels using the blood flow within the blood vessels. For example, one such medical device includes a device body configured to advance within a blood vessel, a tubular member disposed circumferentially about the device body, the tubular member having a distal portion expandable away from the device body and a proximal portion coupled to the device body, a filter body disposed external to the device body and coupled to the tubular member, the filter body including a distal portion, a proximal portion, and a fluid-permeable wall extending therebetween, the distal portion being coupled to the distal portion and the proximal portion being coupled to the device body such that when the device body is disposed within the blood vessel, the distal portion and the distal portion expand and blood flow enters the filter body and passes through the fluid-permeable wall while emboli are retained within the filter body, a filter body, and an outer sail member circumferentially positioned external to the distal portion of the tubular member, wherein blood flow to the tubular member enters the interior of the outer sail member such that the outer sail member moves radially outward from the tubular member and the exterior of the outer sail member forms a seal conforming to the wall of the blood vessel, an outer sail member, and a tortuous surface positioned within the tubular member and radially adjacent to the outer sail member, the tortuous surface being configured to resist blood flow, a second end of the tortuous surface being joined to the tubular member, and a first end of the tortuous surface extending inwardly from the tubular member away from the outer sail member to direct blood flow toward the outer sail member, a tortuous surface.

[0014] Another variant of a medical device that forms an improved seal against the vessel wall of a blood vessel using fluid flow within the blood vessel includes a tubular member having a distal portion, a proximal portion, and a wall extending therebetween, and an outer sail member circumferentially positioned outside the distal portion of the tubular member, wherein fluid flow into the tubular member enters the interior of the outer sail member, causing the outer sail member to move radially outward from the tubular member and the exterior of the outer sail member to form a seal conforming to the blood vessel wall, an outer sail member, a tortuous surface positioned within the tubular member and radially adjacent to the outer sail member, the tortuous surface having a first end, a second end, and an intermediate portion extending therebetween, the first end extending inwardly away from the outer sail member so that the intermediate portion directs fluid flow toward the outer sail member, and a tortuous surface.

[0015]

[0015] The present disclosure includes a method for filtering an embolism detached during a procedure performed within a patient's body passage from the body passage. The method includes placing a filter device at a deployment site within the body passage, the deployment site being downstream of the treatment site, and deploying the filter device such that blood flow toward the filter device causes an outer sail surrounding the filter device to move away from the filter device and form a seal against the wall of the body passage, wherein a tortuous surface located within the filter device redirects a portion of the blood flow toward the interior of the outer sail, and the body of the filter device allows blood flow to pass through but restricts the flow of the embolism such that the embolism within the blood flow is retained within the filter device, fixing the filter device and the embolism located therein after the procedure, and removing the filter device and the embolism from the body passage.

[0016]

[0016] In another variant, the system may include a filter body having a distal portion and a proximal portion, the filter body being configured to be disposed within a blood vessel such that blood flow enters the distal portion, the wall of the filter body being porous such that it allows blood flow through but captures emboli within the blood flow, a filter body, a sealing membrane positioned circumferentially about the distal portion, the sealing membrane being deflected from the filter body as a result of blood flow against the sealing membrane, and a seal being formed against the blood vessel wall by the deflection of the sealing member, a sealing membrane, and a catheter body configured to advance within the blood vessel, the filter body being configured outside the catheter body.

[0017]

[0017] In another variant, the invention described herein includes a protection system for reducing the movement of emboli within the blood flow of a blood vessel. For example, such a system may include a filter body having a distal portion and a proximal portion, the filter body being configured to be disposed within a blood vessel such that blood flow enters the distal portion, the wall of the filter body being porous such that it allows blood flow through but captures emboli within the blood flow, a filter body, a sealing membrane positioned circumferentially about the distal portion, the sealing membrane being deflected from the filter body as a result of blood flow against the sealing membrane, and a seal being formed against the blood vessel wall by the deflection of the sealing member, a sealing membrane, and a catheter body configured to advance within the blood vessel, the filter body being configured to re-enter the catheter body so that the filter body and the emboli located therein are protected within the sheath body when removed from the patient, a catheter body.

[0018]

[0018] The sealing membrane may optionally include a fluid-impermeable material. In some variants, the sealing membrane may have one or more openings for controlling the pressure rise in the sealing membrane. A variant of the sealing member may include an expandable portion such that blood flow against the sealing membrane expands the expandable portion. In another variant, the sealing membrane includes a thin film polymer or an elastomer.

[0019]

[0019] The sealing membrane can be located within the filter body. Alternatively, or in combination, the sealing membrane can be located on an external portion of the filter body. In yet another variation, the sealing membrane is located on the inner diameter of the filter body, a second sealing membrane is located on the exterior of the filter body, and the sealing membrane is deflected by the blood flow to increase the effective sealing area of the filter device. In another variation, the sealing membrane includes a first layer and a second layer, 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 variation, since the first layer is connected to the second layer, blood flows into the region of the sealing membrane that contacts the boundary of the first layer, and the pressure of the second layer increases to further expand the opening of the sealing membrane. Further, or in combination, since the first layer is configured to expand more than the second layer, the sealing membrane expands outward from the filter device.

[0020]

[0020] A variation of the filter device includes a series of petals at the distal end of the filter body, and the sealing membrane is connected to the series of petals. The series of petals may include at least one deflecting petal, and since the sealing membrane includes a first layer connected to at least one deflecting petal and a second layer connected to the series of petals, blood flow into the region between the first layer and the second layer increases the pressure in that region.

[0021]

[0021] 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.

[0022]

[0022] The filter body may have a pore size of 40 microns to 200 microns.

[0023]

[0023] In another variation, the sealing member further expands in response to blood flow.

[0024]

[0024] A variant of the device described herein may include a proximal seal membrane within a filter body positioned adjacent to the proximal portion of the device. Alternatively, or in combination, the filter body may include a sheet of material having a controlled porosity. In another variant, the filter body consists of strips of material that overlap to form a continuous surface.

[0025]

[0025] The device described herein may include at least one pull wire connected to the distal end. When tension is applied to this pull wire, the distal end is urged to the closed position. In another variant, the device may further include at least one elastic ring positioned at the distal end of the filter body such that the distal end is biased to the open position in a tension-free state.

[0026]

[0026] Any system and / or device described herein may include a synchronization member configured to synchronize with a part of the filter body.

[0027]

[0027] The present invention also includes a method for filtering embolisms detached from the blood vessels during a procedure performed within a patient's blood vessel. For example, such a method includes placing a filter device at a deployment site within the blood vessel, which is downstream of the treatment site, the filter device having a distal portion that includes a sealing member; deploying the filter device such that the sealing member forms a seal against the wall of the blood vessel by the blood flow directed towards the filter device, the body of the filter device allowing the blood flow to pass through but restricting the flow of embolisms such that embolisms within the blood flow are retained within the filter device; fixing the filter device and the embolisms located therein within the catheter body after the procedure; and removing the catheter body, the filter device, and the embolisms from the blood vessel.

[0028]

[0028] The method described herein may include advancing a second catheter through the proximal opening of the filter device and compressing the proximal portion of the filter device around the second catheter to prevent a plug from between the second catheter and the proximal opening.

[0029]

[0029] In another variation, the method may further include completing the procedure and withdrawing the second catheter from the filter device while compressing the proximal portion of the filter device around the second catheter, and further compressing the filter device to prevent a plug from leaking out of the proximal opening when removing the second catheter from the filter device.

[0030]

[0030] In one variation of this method, securing the filter device and the plug located therein includes withdrawing the filter device within the catheter body.

[0031]

[0031] The method may also further include restricting the distal opening of the filter device prior to withdrawing the filter device within the catheter body.

[0032]

[0032] In another variation of this method, the filter device includes a proximal seal member, and the blood flow causes the proximal seal member to form a proximal seal against the second catheter. In another variation of this method, the filter device extends from the distal end of the catheter body.

[0033]

[0033] The method may also include inverting the filter device within the catheter body prior to deploying the filter device. Deploying the filter device includes securing the proximal end of the filter device within the catheter body, but withdrawing the catheter body relative to the filter device to evert the filter device to an appropriate position within the blood vessel.

[0034]

[0034] In another variation of this method, the filter device is inverted within the catheter body before deploying the filter device. Deploying the filter device includes advancing the proximal end of the filter device from the catheter body and everting the filter device into an appropriate position within the blood vessel.

[0035]

[0035] Variations of this method may also include advancing a second catheter through the catheter body and the filter device to perform the procedure. In another variation, the method may further include restricting the distal end of the filter body so that the embolus does not pass through the distal end. In another variation, the method may further include retracting the distal end of the filter body into the catheter body so that the filter body is inverted within the catheter body.

[0036]

[0036] In another variation of this method, after deploying the filter device, a balloon catheter or a wire brush device is used to loosen the embolus from the treatment site in order to securely capture the embolus within the filter body.

[0037]

[0037] This method includes placing the filter device within the aorta. This method may include advancing the filter device and the catheter body through the radial blood vessel or advancing the filter device and the catheter body through the femoral blood vessel.

[0038]

[0038] In another variation, this method may further include allowing a portion of the blood flow to flow out of the patient's body through an external filter and returning that blood flow to the patient's artery.

[0039]

[0039] Another variation of the method described herein is to advance a filter device to a deployment site within a blood vessel, the distal portion of which includes a seal member, to deploy the filter device near the treatment site, the filter device being deployable to allow blood to pass through, to form a first seal between the walls of the blood vessel at the deployment site using a seal member that creates blood flow to the filter device, to advance a medical device through the filter device to the treatment site, to perform a treatment within the blood vessel distal to the filter device using the medical device, the treatment causing an embolism to occur in the blood flow, to withdraw the medical device from the deployment site and further restrict the proximal portion of the filter device so that the embolism remains within the filter device, to place the filter device and the embolism located therein within a catheter so that the embolism does not flow into the blood flow, and to remove the catheter, the filter device, and the embolism from the patient.

[0040]

[0040] A variation of the method described herein may further include compressing the proximal portion of the filter device around the medical device so that a second seal is formed around the medical device after the medical device has been advanced through the filter device.

Brief Description of the Drawings

[0041]

[0041] The following drawings each illustrate an aspect of the present invention. Variations of the present invention from the aspects shown in the drawings are contemplated.

[0042]

Fig. 1A-C

[0042] An example of a conventional vascular protection device is shown.

Fig. 2A-I

[0043] An example of the flow assistance seal of the present disclosure is shown.

Fig. 3

[0044] A variation of the filter device 100 with a collar including a throw-rope type mechanism with an adjustable diameter of a part of the device is shown.

Fig. 4A-I

[0045] An example of a flow-actuated seal is shown.

Fig. 5A

[0046] A conventional capture device expanded against a blood vessel wall is shown.

Fig. 5B

[0047] An improved filter device comprising a flow-actuated seal that expands against a blood vessel wall is shown.

Fig. 6A-B

[0048] A variant of a device having a proximal flow-actuated seal located in the proximal region of the filter device is shown.

Fig. 7A-G

[0049] Another variant of a filter device integrated with a system delivered from the femoral artery through the aortic arch is shown.

Fig. 8A-E

[0050] Another variant of a filter device directly incorporated into a treatment device is shown.

Fig. 9A-C

[0051] Another configuration for restricting one or both ends of the filter device is shown.

Fig. 10A-C

[0052] The use of one or more balloons for controlling the aperture of the filter device is shown.

Fig. 11A-C

[0053] Another variant of a filter device that utilizes a lasso effect to close one end of the filter is shown.

Fig. 12A-C

[0054] Another variant of a filter device integrated with a guide catheter and constrained within an outer sheath is shown.

Fig. 13A-C

[0055] Variants of the filter body for use with the devices described herein are shown.

Fig. 14A-E

[0056] Another variant of a filter device having a multi-layer seal is shown.

Fig. 15A-E

[0057] Variants of a filter device configured for use outside a guide catheter, sheath, guide wire, and / or another device are shown.

Fig. 16A-C

[0058] Another variant of the device for use in the procedures described herein is shown.

Fig. 17A-B

[0059] Another variant of a filter device having a sealing function is shown.

Fig. 18A-B

[0060] The variant of the filter device shown in FIGS. 17A and 17B in the deployed configuration is shown.

Fig. 18C-D

[0061] Another variant of a medical device in which a flow-induced sail is used in a non-filter type device is shown.

DETAILED DESCRIPTION OF THE INVENTION

[0043]

[0062] In the following examples, it is assumed that the use within the aortic arch for protecting the cerebrovascular system (i.e., arteries) will be described. However, unless otherwise specified, the variants of the device and method are not limited to use within the cerebrovascular system. Rather, the present invention has applicability in various parts of the body. Further, the present invention may be used in various procedures where the advantages of this method and / or device are desired.

[0044]

[0063] FIGS. 2A through 2I show an example of the flow assist seal of the present disclosure. In this variant, the guide wire 110 utilizes a radial artery approach, advances through the left subclavian artery 4, and disposes a filter system (not shown in FIG. 2A). By such an approach, the TAVR system can be delivered from the femoral artery without reducing the available space within the blood vessel by the filter system. Since many TAVR systems are large and typically have a diameter of 12 to 18 French, a variant of the filter system delivered from the femoral artery may compete for this space within the blood vessel. By delivering the filter system from the radial artery, the TAVR system and other necessary devices can be accommodated in the space within the femoral artery.

[0045]

[0064] The seal, filter device, and / or guide catheter may have any number of coatings, as necessary, to minimize thrombogenicity, minimize platelet activation, or provide other drug elution benefits. Alternatively, or in combination, the seal, filter device, and / or guide catheter may include a hydrophilic coating.

[0046]

[0065] As shown in FIG. 2A, the guide wire 110 can enter the aortic arch 2 through the left subclavian artery 4 from the radial artery and be introduced to the aortic valve 10. The guide catheter or guide sheath 112 can be introduced over the guide wire 110 and advanced to the deployment site of the filter device, which can be downstream of the treatment site (as shown in FIG. 2B). In this example, the treatment site is the location of the valve 10. As described, the guide catheter 112 can be introduced over the guide wire 110 with 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 a typical guide catheter 112 can range from 4F to 8F. However, any size can be used as necessary. Further, the distal region of the guide catheter can be pre-formed with bends or angles to facilitate advancement in the anatomically desired region. For example, the guide catheter 112 can have a bend proximate to the distal end to accommodate entry into the aortic arch 2 and advance the distal end towards the valve 10.

[0047]

[0066] Figure 2C shows the initial deployment of the filter device 100 at the deployment site in the path of the blood flow 12 from the treatment site (e.g., valve 10). The device 100 can be deployed by applying a force to the filter device 100 to extrude it from the delivery catheter 112. Alternatively, the guide catheter 112 can be 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 heat-set superelastic nitinol mesh that expands to the arterial surface (usually 2.5 cm to 3.5 cm in the aortic arch 2). In one variant of the filter device 100, the nitinol mesh is a single layer of nitinol wire fabric. Another variant of the device 100 may include a plurality of nitinol mesh layers that overlap each other. The cross-section of the nitinol wire may be circular, square, or rectangular, or may be triangular, semi-circular, or a combination thereof. Such irregular shapes may be preferred for restricting the thrombus formation reaction since the blood pattern and flow characteristics may vary depending on the wire shape.

[0048]

[0067] Further, a part of the wire may be composed of DFT (Drawn Filled Tube), and the nitinol wire may include a core of gold, platinum, or tantalum (or the like) for radiopacity. Alternatively, each wire of the mesh may be composed of solid or hollow platinum, gold, and / or tantalum for radiopacity. Rings of gold, platinum, and / or tantalum may also be used for radiopacity.

[0049]

[0068] In one variant of the filter device 100, the pore size of the nitinol mesh is about 100 microns, but a range of about 40 - 200 microns or more would also be suitable.

[0050]

[0069] Figure 2C also shows a filter device 100 having a flow seal 102 located at the distal end 122 of the filter device 100. This flow seal 102 is actuated by the blood flow 12 to the device. A variant of the flow seal includes a portion of an impermeable soft polymer membrane that expands upon the inflow of blood to the membrane. Due to the blood flow 12, the flow seal expands against the arterial wall, forming a hermetic seal. This prevents emboli located within the blood flow 12 from passing through. As described above, conventional protection devices cannot form a hermetic seal between the filter device 100 and the blood vessel wall, allowing emboli to leak out of the protection device. As described above, the aorta wall is typically calcified and contains plaque deposits, creating a geometrically irregular surface. This makes it difficult to form an adequate seal using conventional devices. The flow seal shown in Figure 2C utilizes the naturally occurring blood flow 12 to expand the membrane of the flow seal 102 and form a hermetic seal, avoiding the problems associated with conventional devices. This causes emboli to have to pass through the openings of the filter device 100. Another variant of the flow seal will be described below.

[0051]

[0070] Figure 2D shows a variant of the filter device 100 having an adjustable color 104 at the proximal end of the device 100. The color 104 passes through the guide catheter 112 and applies a force to the connection wire 106 extending through the left subclavian artery 4 and the radial artery, thereby positioning the device and adjusting the diameter of the proximal end 120. The restrictive color 104 can be firmly fixed on a catheter or device (such as the TAVR guide catheter described below) inserted into the proximal opening 120 of the device 100. A variant of the device 100 can include a polymer liner on the position of the color 104 or the inner diameter of the mesh in the vicinity thereof, thereby reliably forming a sealed seal against a catheter or device extending therethrough. In one variant, the color 104 can include a push-pull ribbon that controls the diameter of the filter device 100. Alternatively, as described below, the color can include any number of ring structures that control the diameter of the filter device 100 or be replaced with such ring structures.

[0052]

[0071] Figure 2E shows the deployed filter device 100 arranged to receive a second catheter 130 used to complete a procedure within a blood vessel. In the example shown, the TAVR system is introduced through the femoral artery, the TAVR guide wire 138 enters the proximal opening 120 of the device 100 and advances through the distal opening 122 to the treatment site (here also the valve 10). Here too, as described above, the filter device 100 maintains the surrounding seal by the flow seal 102 in an activated state by the blood flow within the blood vessel. Next, as shown in Figure 2E, the TAVR guide catheter 130 and the TAVR valve 132 having a balloon 134 are advanced along or over the TAVR guide wire 138. In another variant, another device (not shown), such as a pigtail catheter, an injection catheter, or a pressure measurement catheter, or a guide wire can be delivered or advanced through the filter device 100 capable of accommodating a plurality of devices.

[0053]

[0072] Figure 2F shows the state where the TAVR guide catheter 130 passes through the filter device 100 and the TAVR valve 132 is disposed within the aortic valve 10. When a TAVR (or another device for an appropriate procedure) is disposed, the physician can restrict the collar 104 to form a seal against the TAVR guide catheter 130. The seal may be tight or may be sufficient for the TAVR catheter 130 to continue sliding therethrough. In some variations, a tight seal is essential to securely contain the embolus 30 captured by the filter device 100 inside the filter mesh. As described above, the seal can be further strengthened using a polymer ring or another structure on the filter inner diameter at the position of the collar. The collar 104 is substantially restricted as soon as the TAVR guide 130 enters the filter 100, but the TAVR guide 130 can slide relative to the collar 104 and is further restricted to form a tight seal when the TAVR guide 130 and the TAVR valve 132 are disposed at a predetermined position.

[0054]

[0073] Figure 2F shows the situation where the TAVR valve 132 is deployed against the aortic valve and the TAVR delivery catheter 130 is withdrawn from the treatment site. As shown, embolic particles 30 may begin to move within the blood vessel due to the procedure. However, the flow seal 102 guides the embolic particles 30 flowing in the blood to the distal opening 122 of the filter device 100. Thus, the filter device 100 captures and contains many of the embolic particles 30 that may move to another part of the body, such as the brain, where the embolic particles may cause an ischemic attack.

[0055]

[0074] Figure 2G shows the state after the TAVR implant 132 is placed in the valve 10 and the TAVR balloon and TAVR wire are removed from the filter device 100. As a result, only the TAVR guide 130 passing through the filter device 100 remains (Note: The guide wire may or may not be removed before removing the TAVR guide catheter). Figure 2H shows the filter device 100 after the TAVR guide is removed. Here, the collar 104 further compresses the proximal portion of the filter device 100 to effectively completely close the proximal end of the filter 100. As a result, the captured embolic material 30 cannot leak through the proximal opening 120 of the filter device 100.

[0056]

[0075] It should also be noted that the physician has the option to leave the filter device 100 in place for several hours or days after the procedure, as shown in Figure 2H, as a preventive measure to recover newly generated plaque from the aortic valve. This can provide additional protection against stroke.

[0057]

[0076] Figure 2I shows the state in which the filter device 100 can be removed. The filter device 100 can be retracted into the guide catheter 112. Alternatively, the guide catheter 112 can be advanced over the filter device 100, and as a result, the filter device 100 is constrained and crushed within the guide catheter 112. Since the filter device 100 is constrained within the guide catheter 112, the embolic particles 30 no longer leak. Once fixed, the guide catheter 112 and the filter device 100 are removed.

[0058]

[0077] Figure 3 shows a variant of the filter device 100 with a collar having a throw-rope type mechanism for adjusting a part of the diameter of the device 100. As shown, the filter device 100 may include a proximal throw rope 152 and / or a distal throw rope 154. One or more wires 156, 158 extending through the guide sheath 112 are utilized to adjust each throw rope independently. In the illustrated variant, each throw rope member 152, 154 is shown including two pull wires. However, another variant of the filter device 100 includes one pull wire for each throw rope, or more than two pull wires for each throw rope member 152, 154. The advantage of having separate control wires for each throw rope member 152, 154 is that the proximal and distal ends of the filter device 100 can be controlled independently.

[0059]

[0078] FIGS. 4A through 4C show some examples of the fluid-operable seal 102. In one variant, the fluid-operable seal 102 includes a soft polymer membrane that is expandable in response to the pressure generated by the blood flow against the membrane. By the pressure, the membrane deflects and / or expands. In some variants, the fluid-operable seal 102 only partially deflects and / or expands.

[0060]

[0079] Figure 4A shows a variant of device 100 having a polymer layer that forms a flow-actuated seal 102. As shown in Figure 4B, the flow of blood 12 causes the membrane 102 to expand and / or deflect, increasing the surface that contacts the inner wall of the blood vessel (not shown). Variants of the flow-actuated seal can simply extend from the body of the filter device. Alternatively, or in combination, the flow-actuated seal (e.g., a central portion not attached to the filter body) can be stretched or expanded in response to the flow of blood. In another variant, the flow-actuated seal is impermeable to the flow such that the flow against the seal increases the pressure at the seal. Further, the flow-actuated seal typically includes a more flexible and compliant material compared to the mesh of the filter device. This difference allows the flow-actuated seal to conform to any irregularities on the blood vessel wall. Thereby, the filter device can form an improved seal against the blood vessel wall. A variant of the filter device 100 can include a flow-actuated seal 102 that increases friction when expanded / 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 expandable seal members can be expandable or non-expandable.

[0061]

[0080] Figure 4C shows another variant of the flow-actuated seal 102 in the filter device 100. Here, due to the blood flow, the seal 102 bulges or expands outward from the mesh forming the device 100.

[0062]

[0081] Variants of the flow-actuated seal 102 membrane can be manufactured from thin film polymers, elastomers, or similar materials. Thermoplastic urethane, like another thermoplastic elastomer, may be highly suitable. A variant of the device includes a membrane having a thickness of about 0.001 inches. Alternatively, the thickness of the membrane variant can be between 0.0003 inches and 0.003 inches. The membrane can be processed with "surplus" such as folds or extra slack to further improve the clearance and size of the membrane openings.

[0063]

[0082] Figures 4D through 4G show another configuration of the fluid actuated seal 102. In Figure 4D, the fluid actuated seal includes an elastic polymer disposed inside the blade structure forming the filter device 100. As shown in Figure 4E, when blood flow 12 enters the filter device 100, the blood flow 12 deflects / displaces the polymer material along with a portion of the mesh 108 forming the filter device 100. Thus, the blood flow 12 expands the polymer and the mesh 108 to form a seal against the vessel wall.

[0064]

[0083] Figure 4F shows another variant where a polymer layer or membrane is located within the filter device 100. As shown, a flexible and supercompliant polymer (such as urethane or another thermoplastic elastomer TPE) forms the shape within the filter device 100 that captures the blood flow 12 using a bilayer configuration that includes an upper seal surface 166 and a lower seal surface 168 that functions as a fluid diversion surface. The seal 102 shown in Figure 4F includes, for example, a large upper seal surface 166 adjacent to the outer surface of the filter device 100 and a small lower seal surface 168 adjacent to the inner passage of the filter device 100. When blood flow enters the space between the upper seal surface 166 and the lower seal surface 168, the internal (i.e., between the two surfaces) pressure rises due to the fluid pressure and, as shown in Figure 4G, helps the seal 102 to advance outward against the blood vessel. In one variant, the lower seal surface 168 is intentionally made smaller than the upper one so that the upper surface 166 expands more reliably than the lower surface 168. However, in another variant, a design choice is possible such that the expansion of the upper surface 166 is smaller than that of the lower surface 168. As shown in Figure 4G, since the blood flow 12 enters the membrane 102 and causes deflection and displacement, the filter device 100 forms a seal against the arterial wall.

[0065]

[0084] Figures 4H and 4I show a variant of the filter device 100 having the first fluid-actuated seal 102 together with the secondary seal 114. In this variant, the fluid-actuated seal 102 is located within the filter device 100, while the secondary seal 114 is located outside the device 100. Since the layers 102 and 114 are attached to two layers of the mesh filter 108, when blood flows 12 (as shown in Figure 4I), that flow 12 raises the pressure on the surface of the inner membrane 102 and deflects and presses against the outer membrane 114. The two membranes 102, 114 form a seal in the area where they overlap. This configuration includes two separate seals 102, 114 that function as a single seal or a single layer.

[0066]

[0085] While variants of the fluid-actuated seals described herein are shown with respect to the distal portion of the filter device, another variant of the filter device includes a fluid-actuated seal on the proximal region of the filter device. Such a proximal fluid-actuated seal can further assist in sealing the filter device against a guide catheter or another device advancing therethrough. In such a case, the design of the proximal fluid-actuated seal is initiated by the blood flow to the distal portion towards the proximal portion through the filter device.

[0067]

[0086] Flow actuated seals have the important advantage of reducing the likelihood that embolic particles will bypass this device when used in a protection device. FIGS. 5A and 5B illustrate the differences between a conventional device (such as the devices shown in FIGS. 1A - 1C) and the improved filter device 100 described herein. FIG. 5A shows a cross - sectional view of blood vessel 2 (the scale of the drawing is adjusted to better show the fit of device 22 to the wall 14 of the blood vessel). As shown, the perimeter of device 22 is intended to form a seal against the blood vessel wall. However, irregularities 16 (such as plaques, calcifications, the shape of the blood vessel, or other naturally occurring forms) within blood vessel 2 result in an irregular shape 18 where a seal cannot be formed with the protection device. FIG. 5B shows the features of the flow actuated seal 102 of the present disclosure. This seal often has greater flexibility or conformability than the mesh structure forming device 100. Due to this feature, the flow actuated seal 102 can expand or deform to a greater extent than the mesh or filter device 100 to any irregularities 18 within blood vessel 2. This improves the seal between the wall 14 of blood vessel 2 and filter device 100, and the improved seal results in improved filtration of emboli in the blood flow.

[0068]

[0087] FIGS. 6A and 6B illustrate a variant of the device having a proximal flow actuated seal 116 located in the proximal region of filter device 100, which is similar to the distal seal. Note that the color is shown adjacent to seal 116. However, variants of filter device 100 can include proximal seal 116 in any portion of the proximal part. Any one of the seal designs for the distal seal disclosed herein can be used at the proximal location, or combinations thereof can be used as long as they seal the flow from the distal portion of the device.

[0069]

[0088] Figures 6A and 6B also show a variant in which the proximal seal 116 includes an attachment portion 118 that reversely connects the seal to the blade. This connection prevents the reversal of the seal 116. In the variant drawing shown, the seal 116 is permanently fixed to the blade at the shown position (i.e., adhesive bonding, thermomechanical sealing, etc.). The seal can be further moored 118 to another area of the blade so that the opposite end of the seal does not reverse due to the withdrawal of the blood flow 12 or the guide catheter. The mooring can be performed using a tack melt, another seal / thermal fuse, another fiber or polymer, or a metal filament.

[0070]

[0089] Another variant of this system may include an improved TAVR guide catheter 130 in a way that improves the sealing characteristics of the filter. Geometric "bumps" or protrusions 138 may be disposed on the outer diameter of the guide 130 in the seal area. In the variant shown in FIG. 6A, for illustrative purposes, the protrusion 138 is shown outside the filter device 100. The protrusion 138 can be manufactured within 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). Additionally, a swelling coating such as a thick hydrophilic coating can also have a similar effect of increasing the proximal seal.

[0071]

[0090] FIGS. 7A through 7G show another variant of the filter device 100 integrated with a system delivered from the femoral artery through the aortic arch 2 to the valve 10. In this variant, the filter device 100 is integrated with the guide catheter 140 and is permanently fixed. FIG. 7A shows an example of a variant of a system comprising a filter device 100 integrated with a guide catheter or sheath 140 advanced to the deployment site within the blood vessel 2. In this variant, the filter device 100 is inverted within the guide sheath 140, but the proximal end of the device 120 is fixed to the distal end 142 of the guide catheter 140. As shown in FIG. 7B, a stabilization device 170 (e.g., an expansion device or a support catheter) advances to the distal end 122 of the filter device 100. FIG. 7C shows a state in which the guide 140 is being withdrawn while the stabilization device 170 stabilizes the filter device 100 such that the filter device flips out at the position where the guide sheath 140 is withdrawn. The stabilization device 170 can also be used to fully return the filter to its open or deployed shape by extending it through the filter device 100. FIG. 7C shows the distal portion 122 of the device 100 with a fluid-operated seal and the proximal portion 120 of the device 100 connected to the distal end 142 of the guide catheter 140.

[0072]

[0091] Using the stabilization device 170, it is possible to "push out" the filter using the stabilizer / expander 170 and push the filter 100 distally. Alternatively, the stabilizer / expander 170 can be advanced to the inverted filter at the proximal end to stabilize the filter, and then the outer sheath restraint sheath can be pulled proximally to expose the filter.

[0073]

[0092] Next, as shown in FIG. 7D, the TAVR implant 132 and the system 130 advance through the guide catheter or sheath 140 and the integral filter device 100. The distal end 122 of the filter 100 includes a fluid-operated seal 102. FIG. 7E shows the TAVR implant 132 deployed at the deployment site where emboli 30 are present in the blood stream, but due to the fluid-operated seal 102, the blood is directed into the filter device 100. There is no risk of emboli leaking through the proximal end 120 of the device 100 because the proximal end is integrated with the distal end 142 of the guide catheter 140.

[0074]

[0093] FIG. 7F shows the closure of the distal end 122 of the filter device 100 using one or more pull wires 124. As shown, the embolic particles 30 are secured within the sealed filter device 100 integrated / fixed to the guide catheter 140. FIG. 7G shows an optional feature of the system for inverting and returning the filter device 100 back into the guide catheter 140. As shown, the filter device 100 is inverted within the guide body 140 by applying tension to the pull wire 124 to return the distal portion 122 of the sealed filter device 100 back into the catheter body 140. Again, since the filter is sealed, there is no risk of losing the captured emboli. Such steps ensure that the filter and emboli are protected during removal from the body.

[0075]

[0094] It should also be noted that another design option includes constructing the filter within the femoral introducer sheath (i.e., a long sheath with a filter located near the aortic valve), or using a long sheath that constrains the filter if it is not pre-inverted within the guide catheter.

[0076]

[0095] FIGS. 8A-8E illustrate another variant of a filter device directly incorporated within a treatment device. For example, the filter device can be directly constructed within a TAVR guide catheter, thereby eliminating the need for a separate guide catheter for the filter only. FIG. 8A shows a TAVR guide catheter 130 used to advance a TAVR implant 132 to the site of valve 10 within the aorta 2. Although FIG. 8A does not show the filter, it is loaded within the interior of the TAVR guide catheter 130.

[0077]

[0096] FIG. 8B shows a filter device 100 delivered from the TAVR guide catheter 130. This deployment can be performed by any method disclosed herein (delivery by inversion within the guide catheter and "pushing" with another integral tube or the like, or simply compression and exposure within the TAVR guide catheter). FIG. 8C shows the TAVR balloon and guide wire removed from the site. Since the filter device 100 is mechanically integrated within the catheter body 130, there is no risk of emboli leaking through the proximal region of the filter device 100. FIG. 8D shows one or more guide wires 124 used to close the distal end 122 of the filter device 100. The proximal end of the filter device 100 is disposed within the distal end 128 of the TAVR guide catheter 130. FIG. 8E shows a variant in which the filter device 100 is slidably coupled within the TAVR guide catheter 130. This allows it to be returned into the guide lumen while removing the sealed filter.

[0078]

[0097] The variants shown in FIGS. 7A-7G and FIGS. 8A-8E are systems that can be configured within the delivery guide catheter of a TAVR system or another delivery catheter.

[0079]

[0098] Figures 9A through 9C show another configuration for restricting the filter device 100. In the example shown in Figure 9A, the filter device 100 includes a double mesh layer comprising an inner mesh 108 and an outer mesh 109. In one example, the mesh layers 108, 109 include nitinol blades. Another ring structure 160 is provided at the end of the filter device 100. In the example shown, the ring structure 160 includes a coil shape. However, alternative shapes (e.g., straight wire, sine curve, helix, etc.) can be used as long as the shape provides an outward radial force to keep the end of the filter 100 open. One or more pull wires 156 are connected to the ring 160, and when a force is applied to the pull wire 156, the ring 160 and the end of the filter device 100 are closed. The example shown depicts a pull wire 156 extending through a tube (e.g., a polyimide tube). Figure 9B shows the ring structure 160 connected to the pull wire 156, but the mesh of the filter device is not shown. As described above, the coiled ring 160 provides an outward radial force that opens the end of the filter device when unrestrained. Applying a force 52 to the wire 156 away from the ring 160 causes the ring 160 and the closure 54 of the filter device to occur.

[0080]

[0099] Figure 9C shows another variation of the self-expanding ring 164. In this variation, the ring has a wavy shape and a pull wire 158 passes through the ring 164. As described above, the ring 164 is self-expanding (or thermally actuated) and provides an outward expansion force to the filter device 100. When a closing force is applied, the pull wire 158 acts to close the ring 164 and the filter device 100. The pull wire 158 may pass through a tube 162 as needed, or may be incorporated into the mesh of the filter.

[0081]

[0100] Note that any ring design described herein can be used interchangeably for the distal region and / or proximal region of the filter or any combination thereof. Further, if desired, the ring design can be incorporated into any intermediate portion of the filter.

[0082]

[0101] Figures 10A through 10C illustrate the use of one or more balloons to control the aperture of filter device 100. For example, FIG. 10A shows a variant of filter device 100 having an elastomeric balloon 180 at the end of filter device 100. In this variant, the balloon is in a closed position (as shown) when not pressurized. When fluid flows through line 184, balloon 180 expands 188 to open filter device 100. FIG. 10B shows another variant of filter device 100 having a balloon 182 in a normally open position. When fluid flows through line 184, balloon 182 is crushed inwardly as shown in FIG. 10C.

[0083]

[0102] Figures 11A through 11C illustrate another variant of a filter device that utilizes a drawstring effect to close the ends of the filter. Again, all of the closure mechanisms described herein are applicable to the proximal, distal, and / or intermediate portions of the filter device. FIG. 11A shows a pull wire 156 used to create an aperture or opening at the end of filter device 100. By pulling on this wire 156, the aperture or opening can be restricted / closed. Pulling on wire 156 reduces the diameter of filter device 100, effectively closing the attachment portion of filter 100. In this variant, wire 156 is located at the distal end of a guide catheter 140 that includes an integral filter device. However, this closure structure can be used on any filter device. Further, these concepts can be similarly applied to the proximal end of the filter.

[0084]

[0103] As described above, in order to prevent embolism diffusion, in some applications of the device, a closure mechanism is required to completely and sufficiently close the open end of the filter. In such applications, the wire 156 can be composed of superelastic nitinol wire having an oxide coating of about 0.001 inches to 0.002 inches, although in a variant of the device up to 0.010 inches is tolerated. The wire may be a ribbon wire, rectangular, or other shape. Fibers, polymers, or threads can also be selected. FIG. 11B shows two sets of pull wires 156 connected to the distal end of the filter device 100. FIG. 11C shows multiple sets of pull wires 156 that close the end of the filter device.

[0085]

[0104] FIGS. 12A through 12C show another variant of the filter device 100 integrated with the guide catheter 140 and constrained within the outer sheath 190. FIG. 12A shows the filter device 100 and the guide catheter 140 constrained within the outer sheath 190 as described herein, and this system is advanceable to the deployment site. This variant is typically delivered from the femoral artery where the TAVR system is delivered. FIG. 12B shows the outer restraining sheath 190 being withdrawn while holding the guide catheter 140 in a stationary state. When the restraining sheath 190 is withdrawn, the filter device 100 expands. As described above, the fluid-operated seal ensures proper filtration of the blood vessel. This is a two-catheter design, or a coaxial system, where one catheter 140 is integrated with the filter device 100 and one catheter / sheath 190 serves to restrain the filter 100 for delivery. Variants of the system include replacing the outer sheath 190 with another mechanism such as a coil or a short collar for restraining the filter. In another variant, when the filter only needs to be restrained and does not need to advance itself, the outer sheath 190 can be extremely thin, such as a coil-reinforced polyimide tube. FIG. 12C shows the operation of the pull wire 156 after the procedure is completed. When the pull wire is actuated, the end of the filter device 100 is closed and embolic particles are secured within the filter 100.

[0086]

[0105] Figures 13A through 13C illustrate exemplary modifications of a filter body for use with the devices described herein. FIG. 13A shows a bilayer filter device 100 including an outer layer including a thin film porous material such as a mesh 108 or a polymeric film having holes or pores (e.g., laser drilled, chemically formed, mechanically formed), and an inner layer including a coil or blade 148 designed to provide a radial force such that the filter body 100 expands by the radial force and contacts the wall of a blood vessel. FIGS. 13B and 13C show non-expanded and expanded filter devices 100, respectively, including an inner expansion member 150 with a mesh or blade 108. The coiled expansion member 150 expands and opens the blade upon expansion. It should also be noted that the filter device 100 can be formed from components other than wire blades or meshes. For example, the filter device 100 can include a porous polymeric film such as polyurethane or a similar material. The porosity of the film can be achieved by laser machining, chemical etching or another chemical treatment, a micro-polishing process, or another means known to those skilled in the art. In another exemplary modification, the filter device is constituted by a thin film treatment. Thin films such as thin film metals can be manufactured to have a specifically selected porosity. The filters shown in FIGS. 13A through 13C are multilayered, and the inner layer (e.g., coil, blade, stent-like structure) provides an outward radial force to open the filter, and the outer layer (e.g., blade, polymer, porous membrane, porous metal membrane) filters blood.

[0087]

[0106] Figures 14A through 14E show another variant of a filter device having a multilayer seal. In this variant, as shown in Figure 14A, the mesh 108 of the filter device 100 terminates in a series of petals 105, 107. The configuration of the petals 105, 107 can include separate wires or the wires of the inner mesh / outer mesh that are folded back to form the outer mesh / inner mesh. The petals may be non-damaging or may have features that increase friction against the blood vessel wall (or the wall of the body cavity). Figure 14B shows the alternating petals 107 formed with the offset 126. For example, as shown in Figure 14C, the alternating petals 107 are formed to extend upward 126, and the adjacent petals 105 can extend horizontally (as shown) or slightly downward (towards the inner diameter of the device 100). This angling and separation of the petals forms a space for attaching the fluid-operated 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 may be formed from a single part of a polymer film or may be two separate pieces that meet and overlap at the apex. Optionally small "holes" 163 may be opened in the seal 102, which would be beneficial to control the pressure inside the seal 102 and prevent the blood flow from applying excessive pressure to the seal 102 and displacing the position of the filter device 100. It should also be noted that this same design concept can be achieved with "standard" blades (i.e., without petals). In this case, the individual blade wires are formed to extend outward or flat / inward, and the ends of the wires will terminate within the seal polymer. Figure 14E shows a partial side view of the upper seal 164 and the lower seal 165 sandwiching a space for increasing pressure in response to blood flow. As described herein, the upper seal 164 can be configured to preferentially deflect towards the blood vessel wall (e.g., by sizing or material selection).

[0088]

[0107] Figures 15A and 15D show another variant of the filter device 100 in the pre-deployment configuration. In the previous variant, the filter device 100 attached to the distal end or in the vicinity thereof of the guide catheter was shown. Here, the filter 100 is attached outside the guide 174, and the guide can be a guide wire, a sheath, a catheter, or another medical device. The filter 100 may be self-expanding (or mechanically assisted as described above) and can be opened by a conventional method (release of a pull wire, activation of a coil or inflation of a lumen, or removal of an outer sheath or cover). When expanded, the device 100 assumes the configuration shown in FIGS. 15B and 15D. FIGS. 15A and 15B show the filter device 100 extending from the guide device 174, and FIGS. 15D and 15E show the filter device 100 extending beyond the distal end of the guide device 174. FIG. 15C shows a variant similar to FIG. 15B, but a part of the mesh 109 extends into or is embedded in the guide device 174. When the thrombus retrieval is completed, the filter 100 can be closed to the outer diameter of the guide / sheath 174, and the embolus can be captured between the filter and the guide surface. It should be noted that the guide 174 can be a treatment guide, a TAVR guide, and / or a sheath. The sheath options include a long introducer sheath, a treatment sheath, and / or an expandable sheath (i.e., an e-sheath).

[0089]

[0108] FIGS. 16A through 16C show another variant of the device for use in the procedures described herein. FIG. 16A shows the distal end of the TAVR guide catheter 144. The distal end flares outwardly at a plurality of points 144 and probably remains in contact with the proximal edge of the balloon and, in some cases, contacts the compressed TAVR valve. A guide 130 with an inverted (or simply compressed without being inverted) filter may also have this flared distal end as shown. The mesh of the filter device 100 can be folded into the guide catheter 130.

[0090]

[0109] Figure 16B shows another variant during or after the use of the filter device described herein. In this example, after the filter is deployed in place (regardless of whether it is a radial approach or a femoral approach), a special catheter or guide wire with a "brush-like" attachment 176 is advanced to the treatment site to loosen plaque or other debris from the treatment site (e.g., a valve or another treatment site). Prior to the introduction of TAVR, the special catheter 176 can be delivered to the treatment site (e.g., the aortic valve 10). The brush attachment is a variant of a device capable of loosening debris. For example, this brush device may have bristles or bristle-like protrusions such as polymer fibers around the distal end. Before the placement of the new filter, the protrusions "beat off" the loosened plaque from the aortic valve. This may be done only to better fit the new valve against the aortic wall or to minimize the possibility of plaque peeling off after the procedure, especially after filter removal.

[0091]

[0110] Another option is to deploy the filter (either by a femoral approach or a radial approach) as shown in Figure 16B and pre-dilate the aortic valve with a balloon catheter. When the balloon is inflated, the new valve can simply be better fitted against the aortic wall or the possibility of plaque peeling off after the procedure can be minimized.

[0092]

[0111] FIG. 16C shows a variant of returning blood through a catheter 112 extending from the left subclavian artery 4 to outside the radial artery. The blood that has exited the patient's body can flow through a simple filter 196 having a similar pore size. The filter is readily available in paper, woven fabric, polymers, and thin film composite materials. A compression ring or collar 104 can also be used in the proximal region to allow the TAVR system to pass through. Alternatively, this design configuration can be used in a patient after the procedure to retrieve newly generated emboli. In this case, the compression ring is fully closed to allow all blood to pass through the catheter and the filter. A portion of the filter can be made impermeable to control the amount of blood flowing into the catheter / filter loop and the amount of blood flowing into another blood vessel. The filtered blood can be returned to the body, for example, via the femoral access point 198.

[0093]

[0112] Figures 17A and 17B show another variant of the filter device 200 fixed to the medical device body 202. The medical device body includes, but is not limited to, a catheter, a guide wire, or another structure that requires a sealing function as described herein. Figure 17A shows the filter device 200 in a collapsed configuration or a delivery configuration. This filter device 200 includes a filter body 210 having an external seal formed by an outer sail member 218 circumferentially positioned around the device 202, and a tubular member 204 that functions as a reinforcing structure in some variants. The filter device 200 may also include a tortuous surface (not shown in Figures 17A or 17B) disposed within the filter body 210 that redirects blood flow to the outer sail member 218. As shown, a variant of the device 200 may include a filter body 210 coupled to a tubular member 204 (such as a blade, a stent, or a similar structure). The filter body 210 can be superimposed on the reinforcing member 204 or integrated (e.g., embedded, coated on the tubular member 204) with the tubular member 204 along all or part of the tubular member 204. As described below, when the filter body 210 is fixed to the tubular member 204 at the proximal 210 and distal 214 ends of the filter body 210, blood flow can pass through the permeable portion 216 and emboli can be filtered from the blood. The filter device 200 can be constrained in a collapsed configuration or a delivery configuration using a restraint such as an outer sheath, a wire, a string, or another structure.

[0094]

[0113] Figure 17B shows the filter device 200 in an expanded or deployed configuration. The tubular member 204 and the filter body 210 expand away from the device 202, and the outer sail 218 moves radially outward away from the filter body 210. The outer sail may be elastic or inelastic, but deflects as fluid / blood flow enters the interior of the sail 218.

[0095]

[0114] Figures 18A and 18B show a variant of the filter device 200 shown in Figures 17A and 17B in a deployed configuration. Blood flow 12 enters the filter body 210 and flows against the outer sail 218 that forms a seal as described herein. The blood also flows against the tortuous surface 220. As previously explained with respect to Figures 4F and 4G, the tortuous surface 220 can include part of a seal structure (in this case, the outer sail 218), or the tortuous surface 220 can include another material. In some variants, the tortuous surface 220 is inside the filter body 210. However, the tortuous surface 220 can extend partially outside the filter body 210, or can be outside the filter body. The outer sail 218 and the flow tortuous surface 220 are moved in opposite directions by the blood flow 12. Since the outer sail member 218 is made of a non-porous or low-porosity material, the blood flow 12 causes the sail member 218 to move radially outward against the wall of the blood vessel 14 to form a seal. The tortuous surface 220 shown in Figures 18A and 18B is shown for illustrative purposes only and can include a reinforcing material such that the tortuous surface 220 does not invert within the filter body 210. The inner sail 220 can be semi-porous or low-porous as long as it redirects some of the fluid flow to the outer sail 218. As shown, the tortuous surface 220 redirects some of the blood flow 26 towards the outer sail member 218. The free end of the tortuous surface 220 extends inwardly towards the device 202, while the opposite end is typically joined to the outer sail member 218 through the tubular member 204. In some variants of this device 200, the tortuous surface is joined to form a fluid-tight joint with the outer sail 218. As shown in Figure 18B, emboli 30 or other particulates in the blood flow 12 enter the filter body 210. The filter body includes a liquid-permeable portion 216 that allows the blood flow to pass outside the filter body 210 while retaining the emboli 30 inside.

[0096]

[0115] As described above, since the configuration of the outer sail member 218 has flexibility or adaptability, the fluid-operable seal can expand or deform to a greater degree than a conventional mesh or filter device 100 to any unevenness within a blood vessel. Thereby, the seal between the wall 14 of the blood vessel and the filter device 200 is improved, and the filtration of emboli in the blood flow is improved by the improved seal.

[0097]

[0116] Regarding another detail of the present invention, materials and manufacturing techniques can be adopted at a level equivalent to those performed by those skilled in the art. Similarly, from the perspective of another generally or logically adopted act, the same may apply to aspects based on the method of the present invention. Furthermore, although the present invention has been described with reference to a plurality of examples while incorporating various features as necessary, the present invention is not limited to what has been described or shown as intended for each modification of the present invention.

[0098]

[0117] Various changes may be made to the present invention described, and equivalents (whether described in this specification or not included for the sake of brevity) may be substituted without departing from the true spirit and scope of the present invention. Also, any feature of a modification of the invention may be described and claimed independently or in combination with one or more of the features described in this specification. Accordingly, the present invention is intended, where possible, to cover combinations of various aspects of the embodiments or combinations of the embodiments themselves. References to a single item include the possibility that the same item may exist in plurality. More specifically, as used in this specification and the appended claims, the singular forms "a", "an", "said", and "the" include references to the plural unless the context clearly indicates otherwise.

[0099]

[0118] It is important to note that, where possible, aspects of the various described embodiments, or the embodiments themselves, can be combined. Such combinations are considered to be within the scope of this disclosure.

Claims

**Claim 1** A medical device for forming an improved seal against the wall of a blood vessel by utilizing blood flow within the blood vessel, comprising: a device body configured to advance within the blood vessel; a tubular member disposed circumferentially about the device body, the tubular member having a distal portion expandable away from the device body and a proximal portion connected to the device body; a filter body disposed external to the device body and connected to the tubular member, the filter body including a distal portion, a proximal portion, and a fluid-permeable wall extending therebetween, the distal portion being connected to the distal portion and the proximal portion being connected to the device body such that when the device body is disposed within the blood vessel, the distal portion and the distal portion expand and blood flow enters the filter body and passes through the fluid-permeable wall while emboli are retained within the filter body; an outer sail member circumferentially located external to the distal portion of the tubular member, wherein when blood flow to the tubular member enters the interior of the outer sail member, the outer sail member moves radially outward from the tubular member such that the exterior of the outer sail member forms a seal conforming to the wall of the blood vessel; a tortuous surface located within the tubular member and radially adjacent to the outer sail member, the tortuous surface being configured to resist blood flow, a second end of the tortuous surface being joined to the tubular member, and a first end of the tortuous surface extending inwardly from the tubular member away from the outer sail member to direct blood flow toward the outer sail member. **Claim 2** The medical device of claim 1, wherein the tortuous surface is continuous with the outer sail member. **Claim 3** The medical device of claim 1, wherein the tortuous surface is joined to the outer sail member. **Claim 4** The medical device of claim 1, wherein the tortuous surface is non-porous or semi-porous. **Claim 5** The medical device of claim 4, wherein the first end forms a cone. **Claim 6** The medical device of claim 1, wherein the outer sail member comprises a liquid-impermeable material. **Claim 7** The medical device of claim 1, wherein the outer sail member comprises a low-porosity material. **Claim 8** The medical device according to claim 1, wherein an outer portion of the outer sail member contains a material that is elastically expandable so that blood flow into the interior of the outer sail member expands the outer sail member.

9. The medical device according to claim 1, wherein the tubular member includes a mesh blade.

10. The medical device according to claim 9, wherein the mesh blade includes superelastic nitinol.

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

12. The medical device according to claim 1, wherein a pore diameter of the tubular member is from 40 microns to 200 microns.

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

14. The medical device according to claim 1, further comprising at least one pull wire connected to a distal portion of the filter body, wherein when tension is applied to the at least one pull wire, the distal portion is urged 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 for filtering an embolism detached during a procedure within a body passage of a patient from the body passage, comprising: placing a filter device at a deployment site within the body passage, the deployment site being downstream of a treatment site; deploying the filter device such that blood flow toward the filter device causes an outer sail located around the filter device to move away from the filter device and form a seal against a wall of the body passage, wherein a tortuous surface located within the filter device redirects a portion of the blood flow toward the interior of the outer sail, and the body of the filter device allows the blood flow to pass therethrough but restricts the flow of emboli so that emboli within the blood flow are retained within the filter device; fixing the filter device and an embolism located therein after the procedure; and removing the filter device and the embolism from the body passage.

17. A medical device for forming an improved seal against a blood vessel wall using fluid flow within the blood vessel, comprising: A tubular member having a distal portion, a proximal portion, and a wall extending therebetween; An outer sail member circumferentially positioned outside the distal portion of the tubular member, wherein when fluid flow into the tubular member enters the interior of the outer sail member, the outer sail member moves radially outward from the tubular member and the exterior of the outer sail member forms a seal adapted to the vessel wall; an outer sail member; A tortuous surface positioned within the tubular member and radially adjacent to the outer sail member, the tortuous surface having a first end, a second end, and an intermediate portion extending therebetween, the first end extending inwardly away from the outer sail member such that the intermediate portion directs the fluid flow toward the outer sail member; a tortuous surface; a medical device comprising the same. **Claim 18** The medical device according to claim 17, wherein the tubular member comprises a structure selected from the group including a stent graft, a stent, a shunt, and a flow diverter. **Claim 19** The medical device according to claim 17, wherein the tubular member comprises a guide wire. **Claim 20** The medical device according to claim 17, wherein the tubular member comprises a catheter body configured to advance within the blood vessel.

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