Embolism protection device

Abstract

To provide an embolic protection device comprising a catheter.SOLUTION: The present invention includes an embolic protection device comprising: a catheter having a self-expanding embolic filter that is disposed around the catheter proximal to a distal portion, where the embolic filter comprises a frame, and the frame defines an opening of the embolic filter that faces the distal end of the catheter; a deployment mechanism that is disposed around at least a portion of the catheter, where the deployment mechanism is longitudinally movable relative to the catheter, the deployment mechanism is configured to contain the embolic filter in a collapsed configuration, and the embolic filter is configured to self-expand upon longitudinal retraction of the deployment mechanism; and a wire coupled to the frame for expanding the size or diameter of the embolic filter opening.SELECTED DRAWING: None

Description

[Technical Field]

[0001] (Cross-reference of related applications) This PCT application claims the benefits of U.S. Provisional Application No. 62 / 639,618, filed on March 7, 2018, and U.S. Provisional Application No. 62 / 812,391, filed on March 1, 2019. These documents are incorporated herein by reference to each other in their entirety.

[0002] This application relates to an embolic protection device including a catheter, and to a method of using such an embolic protection device in a medical procedure (e.g., a closed cardiac surgery procedure). [Background technology]

[0003] Conventional pigtail catheters are used during percutaneous cardiac procedures where the positioning of various instruments and devices within the patient's vascular system is critical. These pigtail catheters feature a curved distal end that can be positioned within the patient's biostructure (e.g., an artery (e.g., the aorta)) and held in place while other instruments and devices are being delivered into the patient's vascular system. Some conventional pigtail catheters include a lumen and a small opening at their distal end through which a contrast agent can be injected into the patient's vascular system to image relevant portions of the patient's biostructure and identify anatomical landmarks.

[0004] However, the use of conventional pigtail catheters in percutaneous cardiac procedures often results in serious and fatal complications for patients. For example, cerebral embolism is a common complication in cardiac procedures such as valve replacement and repair, where conventional pigtail catheters are deployed. During such procedures, plaque, calcium, thrombus, or any combination thereof within blood vessels, valves, and / or cardiac chambers may be dislodged by the catheter or other medical device introduced into the patient's vascular system. The dislodged plaque, calcium, thrombus, or any combination thereof can be transported into the patient's brain via the blood flow from the aorta, where it can cause an obstruction, leading to embolic events such as stroke. Approximately 2.9% to 6.7% of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) experience a stroke within 30 days, and even more (4.5% to 10.6%) experience a stroke within one year, often leading to death. Furthermore, up to 85% of patients undergoing TAVI have evidence of embolic events in the brain based on neuroimaging. Although clinically asymptomatic, such embolic phenomena are associated with cognitive decline (Astraci 2011, Ghanem 2010, Kahlert 2010, Rodes-Caban 2011).

[0005] Currently, a small number of devices designed to protect the brain, abdominal organs, and carotid arteries from embolisms are on the market, but these devices suffer from various significant drawbacks. For example, the Embrella Embolic Deflector(R), available from Edwards Lifesciences (Irvine, California), employs a deflector that directs embolisms from the carotid artery into the descending aorta, but this device fails to capture the embolism, allowing it to freely progress to other areas of the body and cause harmful complications. Similarly, the EMBOL-X(R), also available from Edwards Lifesciences, employs a filtering screen, but this device is designed for use with open-heart cardiac procedures, presenting additional medical risks and increased morbidity. In addition, the use of multiple devices, such as catheters for visualization and separate filter devices, prolongs procedure time and increases the risk of complications for the patient. [Overview of the Initiative] [Means for solving the problem]

[0006] These and other needs are met by the present invention, which presents an embolic protection device comprising a deployable embolic filter positioned around a catheter, having a distal portion that can form an arc-shaped configuration which is at least semicircular, and having a wire that is operable to manipulate the embolic filter into a configuration that fully engages with a body lumen.

[0007] The combination of a catheter and an embolic filter within the same device can provide the benefits of both devices individually, as well as synergistic effects. For example, the integration of a catheter and an embolic filter can reduce the duration of medical procedures and decrease the occurrence of complications (e.g., complications caused by detached emboli). In other embodiments, the expansion of the embolic filter can help anchor the catheter in place and provide more precise catheter positioning than when the catheter position can be affected by blood flow, tissue movement, and equivalents. In valve replacement procedures, catheter anchoring and more precise catheter positioning can help ensure that the prosthetic valve is properly positioned and stabilized. In another embodiment, catheter positioning can help ensure that the filter is properly positioned.

[0008] In some respects, the embolic protection device comprises a catheter, a self-expanding embolic filter coupled to the catheter, a pull wire for reorienting the filter by bending the filter's frame, and an outer sheath movable relative to the embolic filter and catheter. The outer sheath holds the embolic filter in a collapsed configuration when surrounding it and retracts proximally to deploy the embolic filter. The outer sheath can be recaptured from the embolic filter and any residue trapped therein by advancing distally. Both the filter and the outer sheath are movable relative to the catheter, and it may be possible, for example, to move the embolic filter longitudinally without having to move the entire catheter longitudinally. The pull wire is advantageous due to its ability to bend the frame, thereby orienting the filter opening toward the distal end of the device and more fully engaging the embolic filter with the body lumen.

[0009] In some aspects, a catheter has a proximal end and a distal end. A lumen extends from the proximal end to the distal end of the catheter. In some embodiments, the lumen may be configured to house a guidewire.

[0010] In some respects, the catheter is a pigtail catheter. A pigtail catheter is configured to round at its distal end, forming a roughly arched shape that is at least semicircular. The pigtail may have a radiopaque marker visible on X-ray or other medical imaging devices. The radiopaque marker is located on the distal portion of the rounded pigtail in the form of a longitudinal marker, a circumferential band, or equivalent. The pigtail may also have one or more openings for dispensing drugs and / or contrast agents through the lumen.

[0011] In some aspects, the guidewire is inserted through the patient's skin into a body lumen, such as the femoral, radial, or brachial artery, and manipulated near the target site. The guidewire is inserted into the lumen of the embolic protection device, which is pushed or tracked along the guidewire to the target site. When the guidewire is retracted from at least the distal portion of the catheter, the catheter takes on a roughly arched shape. Radiopaque markers on the catheter are used to visualize and position the catheter. Once the catheter is in position, the outer sheath is retracted to deploy the embolic filter, and the pull wire is retracted to bend the filter frame and traverse the vessel to position the distal opening of the filter. The user can then perform procedures such as valve replacement, valve repair, radiofrequency ablation, and equivalents. When the procedure is complete, the pull wire is advanced, and the outer sheath is advanced to recapture the embolic filter and any residue trapped within the embolic filter. The device is then withdrawn from the blood vessel, and the catheter is non-traumatic to the blood vessel during withdrawal.

[0012] Another aspect is a method for capturing embolic residue during a closed cardiac surgical procedure, which includes the step of inserting the distal end of the catheter of an embolic protection device into a body lumen. This method further includes the steps of enabling the embolic filter to form an expanded deployment configuration, and retracting a pull wire and bending the frame of the filter so that the distal opening of the filter straddles the body lumen.

[0013] In some respects, the embolic protection device comprises a catheter, a self-expanding embolic filter coupled to the catheter, a push wire for reorienting the filter by bending the filter frame longitudinally and extending the frame radially, and an outer sheath movable relative to the embolic filter and catheter. The outer sheath holds the embolic filter in a collapsed configuration when surrounding it and retracts proximally to deploy the embolic filter. The outer sheath can be recaptured by advancing distally, thereby recapturing the embolic filter and any residue trapped therein. The push wire is advantageous due to its ability to bend and extend the frame, thereby orienting the filter opening toward the distal end of the device and more fully engaging the embolic filter with the body lumen.

[0014] In some aspects, the catheter has a proximal end and a distal end. The lumen extends along the longitudinal axis of the catheter from the proximal end to the distal end. In some embodiments, the lumen may be configured to house a guidewire.

[0015] In some respects, the catheter is a pigtail catheter. A pigtail catheter is configured to round at its distal end, forming a roughly arched shape that is at least semicircular. The pigtail may have a radiopaque marker visible on X-ray or other medical imaging devices. The radiopaque marker is located on the distal portion of the rounded pigtail in the form of a longitudinal marker, a circumferential band, or equivalent. The pigtail may also have one or more openings for dispensing drugs and / or contrast agents through the lumen.

[0016] In some aspects, the guidewire is inserted through the patient's skin into a body lumen, such as the femoral, radial, or brachial artery, and manipulated near the target site. The guidewire is inserted into the lumen of the embolic protection device, which is pushed or tracked along the guidewire to the target site. When the guidewire is retracted from at least the distal portion of the catheter, the catheter takes on a roughly arched shape. Radiopaque markers on the catheter are used to visualize and position the catheter. Once the catheter is in position, the outer sheath is retracted to deploy the embolic filter, and the pushwire is advanced to bend and extend the frame of the filter and position the distal opening of the embolic filter across the vessel. The user can then perform procedures such as valve replacement, valve repair, radiofrequency ablation, and equivalents. When the procedure is complete, the pushwire is retracted, and the outer sheath is advanced to recapture the embolic filter and any residue trapped within the embolic filter. The device is then withdrawn from the blood vessel, and the catheter is non-traumatic to the blood vessel during withdrawal.

[0017] Another aspect is a method for capturing embolic residue during a closed cardiac surgical procedure, which includes the step of inserting the distal end of the catheter of an embolic protection device into a body lumen. This method further includes the steps of enabling the embolic filter to form an expanded deployment configuration, and advancing a push wire and bending and extending the frame of the filter so that the distal opening of the filter straddles the body lumen. The present invention provides, for example, the following: (Item 1) Embolism protection device, A catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end along the longitudinal axis of the catheter, wherein the lumen is configured to house a guidewire, and the distal portion of the catheter, which is substantially arc-shaped, is at least semicircular when the guidewire is at least partially retracted in the longitudinal direction, A self-expanding embolic filter positioned proximal to the distal portion and surrounding the catheter, wherein the embolic filter comprises a frame, the frame defining the opening of the embolic filter, and A deployment mechanism positioned around at least a portion of the catheter, wherein the deployment mechanism is movable longitudinally relative to the catheter, and is configured to contain the embolic filter in a collapse configuration, and the embolic filter is configured to self-expand in response to the longitudinal retraction of the deployment mechanism, A wire connected to the frame of the embolic filter, wherein the wire is movable in the longitudinal direction and is configured to bend the frame longitudinally toward the proximal end of the catheter and laterally outward from the catheter, such that when the wire is retracted in the longitudinal direction, the opening of the embolic filter generally faces the distal end of the catheter. An embolism protection device equipped with the following features. (Item 2) The embolic protection device according to item 1, wherein the wire is coupled to the frame at the distal connection point. (Item 3) The embolic protection device according to item 1 or 2, wherein the wire is configured to bend the frame such that when it is retracted longitudinally to a proximal position, the opening of the embolic filter defined by the frame is substantially perpendicular to the longitudinal axis of the catheter. (Item 4) The embolic protection device according to any one of items 1-3, wherein the wire is configured to position the frame such that, when advanced longitudinally to a distal position, the opening of the embolic filter defined by the frame is substantially parallel to the longitudinal axis of the catheter, or angled to less than 45 degrees. (Item 5) The embolic protection device according to any one of items 1-4, wherein the embolic protection device has a handle, the handle comprising a mechanism configured to advance or retract the wire. (Item 6) The plug protection device has a handle, and the handle includes a mechanism configured to move the deployment mechanism forward or backward. The plug protection device according to any one of items 1-5. (Item 7) The opening of the plug filter defined by the frame is substantially elliptical in shape. The plug protection device according to any one of items 1-6. (Item 8) The catheter extends through the opening of the plug filter. The plug protection device according to any one of items 1-7. (Item 9) The distal portion of the catheter includes a radiopaque marker. The plug protection device according to any one of items 1-8. (Item 10) The radiopaque marker includes one or more circumferential bands. The plug protection device according to item 9. (Item 11) The frame includes a shape memory material. The plug protection device according to any one of items 1-10. (Item 12) The plug filter includes a filter medium including a semipermeable polyurethane material having a pore size of about 100 microns to about 150 microns. The plug protection device according to any one of items 1-11. (Item 13) The plug protection device includes a longitudinal groove along the outer surface of the plug protection device. The plug protection device according to any one of items 1-12. (Item 14) The plug protection device further includes a self-expanding deflector coupled to the catheter proximal to the distal portion, and the deflector has a longitudinal axis parallel to the longitudinal axis of the catheter. The plug protection device according to any one of items 1-13. (Item 15) The embolic protection device according to any one of items 1-14, wherein the deployment mechanism comprises a sheath circumferentially positioned around at least a portion of the catheter, the sheath deploying the self-expanding embolic filter when the sheath is retracted at least partially longitudinally. (Item 16) The embolic protection device according to any one of items 1-15, wherein the distal portion of the catheter has one or more openings communicating with the lumen of the catheter. (Item 17) A method for capturing embolic residue during a closed cardiac procedure, wherein the method is: The distal end of the embolic protection device is inserted into a body lumen, and the embolic protection device is A catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end along the longitudinal axis of the catheter, wherein the lumen is configured to house a guidewire, and the distal portion of the catheter, which is substantially arc-shaped, is at least semicircular when the guidewire is at least partially retracted in the longitudinal direction, A self-expanding embolic filter positioned proximal to the distal portion and surrounding the catheter, wherein the embolic filter comprises a frame, the frame defining the opening of the embolic filter, and A deployment mechanism positioned around at least a portion of the catheter, wherein the deployment mechanism is movable longitudinally relative to the catheter, and is configured to contain the embolic filter in a collapse configuration, and the embolic filter is configured to self-expand in response to the longitudinal retraction of the deployment mechanism, A wire connected to the frame of the embolic filter, the wire being movable in the longitudinal direction, and bending the frame longitudinally toward the proximal end of the catheter and laterally outward from the catheter, such that when the wire is retracted in the longitudinal direction, the opening of the embolic filter generally faces the distal end of the catheter. To be equipped with, To trace the lumen of the catheter across the guidewire that is inserted percutaneously into the body lumen. Methods that include... (Item 18) The method according to item 17, further comprising retracting the guidewire at least partially longitudinally from the lumen of the catheter such that the distal portion of the catheter forms a substantially arc shape which is at least a semicircle. (Item 19) The method according to item 17 or 18, wherein the distal portion of the catheter is provided with a radiopaque marker, and the method further includes positioning the catheter by visualizing the radiopaque marker using an imaging technique. (Item 20) The method according to any one of items 17-19, further comprising retracting the deployment mechanism at least partially in the longitudinal direction to allow the self-expanding embolic filter to form an expanded deployment configuration. (Item 21) The method according to any one of items 17-20, further comprising retracting the wire longitudinally, thereby bending the frame longitudinally toward the proximal end of the catheter and laterally outward from the catheter, wherein the opening defined by the frame substantially straddles the body lumen. (Item 22) The method according to any one of items 17-20, further comprising retracting the wire longitudinally to a proximal position, thereby bending the frame such that the opening of the embolic filter defined by the frame is substantially perpendicular to the longitudinal axis of the catheter, and the opening defined by the frame substantially straddles the body lumen. (Item 23) The method according to any one of items 17-22, wherein the embolic filter is movably coupled to the catheter and is movable longitudinally relative to the catheter, and the method further includes moving the embolic filter longitudinally relative to the catheter. (Item 24) The method according to any one of items 17-23, wherein the embolic protection device further comprises a self-expanding deflector coupled to the catheter, located proximal to the distal portion, and the method further comprises deploying the self-expanding deflector to direct the embolic residue toward the embolic filter. (Item 25) The method according to any one of items 17-24, wherein the deployment mechanism is a sheath circumferentially positioned around at least a portion of the catheter. (Item 26) The method according to any one of items 17-25, wherein the distal portion of the catheter comprises one or more openings communicating with the lumen of the catheter, and the method further comprises perfusing fluid into the body lumen through the one or more openings. (Item 27) The method according to any one of items 17-26, wherein the embolic protection device is provided with longitudinal grooves along the outer surface of the embolic protection device, and the method further comprises inserting a second catheter device alongside the embolic protection device by tracking the second catheter device along the grooves. (Item 28) The method according to item 27, wherein the second catheter device is advanced over the embolic filter of the embolic protection device while the embolic filter is in a deployed configuration. (Item 29) A method for capturing embolic residue during a closed cardiac procedure, wherein the method is: The distal end of the embolic protection device is inserted into a body lumen, and the embolic protection device is A catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen is configured to house a guidewire, and the distal portion of the catheter has a substantially arc shape that is at least semicircular when the guidewire is at least partially retracted longitudinally. A self-expanding embolic filter positioned proximal to the distal portion and surrounding the catheter, wherein the embolic filter comprises a frame, the frame defining the opening of the embolic filter, and A deployment mechanism positioned around at least a portion of the catheter, wherein the deployment mechanism is movable longitudinally relative to the catheter, and is configured to contain the embolic filter in a collapse configuration, and the embolic filter is configured to self-expand in response to the longitudinal retraction of the deployment mechanism, A wire connected to the frame of the embolic filter, the wire being movable in the longitudinal direction, and bending the frame longitudinally toward the proximal end of the catheter and laterally outward from the catheter, such that when retracted in the longitudinal direction, the opening of the embolic filter generally faces the distal end of the catheter; To be equipped with, Tracking the lumen of the catheter across the guidewire that is percutaneously inserted into the body lumen, As the guidewire is retracted from the distal portion of the catheter, the guidewire is retracted at least partially in the longitudinal direction from the lumen of the catheter such that the distal portion of the catheter forms a substantially arc shape that is at least a semicircle. The deployment mechanism is retracted in the vertical direction to deploy the self-expanding embolic filter, The wire is retracted in the longitudinal direction, and the frame of the embolic filter is bent longitudinally toward the proximal end of the catheter and laterally outward from the catheter. Methods that include... (Item 30) A method for capturing embolic residue during closed cardiac procedures, (i) To provide an embolic protection device, the embolic protection device is A catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen is configured to house a guidewire, and the distal portion of the catheter, which is substantially arc-shaped, is at least semicircular when the guidewire is at least partially retracted longitudinally. A self-expanding embolic filter positioned proximal to the distal portion and surrounding the catheter, wherein the embolic filter comprises a frame, the frame defining the opening of the embolic filter, and A deployment mechanism positioned around at least a portion of the catheter, wherein the deployment mechanism is movable longitudinally relative to the catheter, and is configured to contain the embolic filter in a collapse configuration, and the embolic filter is configured to self-expand in response to the longitudinal retraction of the deployment mechanism, A wire connected to the frame of the embolic filter, wherein the wire is movable in the longitudinal direction and is configured to bend the frame longitudinally toward the proximal end of the catheter and laterally outward from the catheter, such that when the wire is retracted in the longitudinal direction, the opening of the embolic filter generally faces the distal end of the catheter. To be equipped with, (ii) Inserting the distal end of the embolic protection device into the body lumen by tracing the lumen of the catheter along a guidewire that is inserted percutaneously into the body lumen, (iii) Retracting the deployment mechanism in the vertical direction to deploy the self-expanding embolic filter Methods that include... (Item 31) Embolism protection device, A catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end along the longitudinal axis of the catheter, wherein the lumen is configured to house a guidewire, and the distal portion of the catheter, which is substantially arc-shaped, is at least semicircular when the guidewire is at least partially retracted in the longitudinal direction, A self-expanding embolic filter positioned proximal to the distal portion and surrounding the catheter, wherein the embolic filter comprises a frame, the frame defining the opening of the embolic filter, and A deployment mechanism positioned around at least a portion of the catheter, wherein the deployment mechanism is movable longitudinally relative to the catheter, and is configured to contain the embolic filter in a collapse configuration, and the embolic filter is configured to self-expand in response to the longitudinal retraction of the deployment mechanism, A wire coupled to the frame of the embolization filter, wherein the wire is movable in the longitudinal direction relative to the catheter, and Equipped with, As the wire is advanced longitudinally distally to a first position, the wire is configured to bend the frame longitudinally toward the distal end of the catheter and laterally outward from the catheter, such that the opening of the embolic filter generally faces the distal end of the catheter and expands to a first diameter. An embolic protection device wherein, when the wire is advanced longitudinally distally to a second position distal to the first position, the wire is configured to extend the frame radially outward from the catheter such that the opening of the embolic filter expands to a second diameter larger than the first diameter. (Item 32) The embolic protection device according to item 31, wherein the wire is configured to bend the frame such that, when advanced longitudinally to the first position, the opening of the embolic filter defined by the frame is substantially perpendicular to the longitudinal axis of the catheter. (Item 33) The embolic protection device according to item 31 or 32, wherein the wire is configured to position the frame such that, when retracted longitudinally to a proximal position, the opening of the embolic filter defined by the frame is substantially parallel to the longitudinal axis of the catheter or angled to less than 45 degrees. (Item 34) The frame includes two sides, The embolic protection device according to item 31, wherein each side of the frame generally extends in a first lateral direction away from the catheter, then loops backward on the opposite side around the catheter, converges and abuts to form an opening in the embolic filter having a substantially elliptical, oval, or circular shape, and generally extends in the opposite lateral direction. (Item 35) The aforementioned frame is A fixing portion located proximal to the distal portion and connected to the catheter, wherein the fixing portion does not move in the longitudinal direction, A movable portion which is continuous with the fixed portion of the frame, wherein the movable portion is coupled to the wire and pushed by the wire. Includes, As the wire is advanced to the first position, the wire presses the movable portion of the frame longitudinally toward the distal end of the catheter, bending the frame and expanding the opening of the embolic filter to the first diameter. The embolic protection device according to item 31, wherein when the wire is advanced to the second position, the wire pushes the radially movable portion of the frame away from the catheter, extending the frame and expanding the opening of the embolic filter to the second diameter. (Item 36) The catheter further comprises an outer catheter positioned around at least a portion of the catheter and coaxial with the lumen of the catheter, wherein the outer catheter is slidable longitudinally across the catheter. The embolic protection device according to item 35, wherein the wire is coupled to the distal portion of the outer catheter so that the wire is moved by the outer catheter through which the wire slides. (Item 37) An inner catheter disposed between the outer catheter and the catheter, wherein the inner catheter is slidable longitudinally across the catheter, A guide, wherein the guide is attached at one end to the distal portion of the inner catheter so that the guide is moved by the inner catheter sliding across the catheter, and the guide slidably receives a movable portion of the frame and bends outward so that the guide moves away from the catheter, and The embolic protection device described in item 36, further comprising the features described therein. (Item 38) The embolic protection device according to item 37, wherein the guide is an upper guide, and the embolic protection device further comprises a bottom guide attached to the catheter at one end, the bottom guide and the upper guide are arranged on the opposite side of the catheter, and the bottom guide receives a fixed portion of the frame and causes the bottom guide to bend outward away from the catheter. (Item 39) The embolic protection device according to any one of items 31-35, wherein the embolic protection device has a handle, the handle comprising a mechanism configured to advance or retract the wire. (Item 40) A handle is attached to the proximal end of the catheter, An upper pull is coupled to the proximal portion of the outer catheter and is movable longitudinally within the handle, A bottom pull, which is coupled to the proximal portion of the inner catheter and is movable longitudinally within the handle, wherein the bottom pull temporarily engages with the upper pull. Furthermore, When the upper pull and the lower pull are engaged, they move simultaneously by the movement of the slider, which in turn pushes the guide together with the vertically movable portion of the frame, expanding the opening of the embolus filter to the first diameter. The embolic protection device according to item 37, wherein when the upper pull and the lower pull are engaged or disengaged, the upper pull is moved by the movement of the slider without the lower pull, which in turn pushes the radially movable portion of the frame and expands the opening of the embolic filter to the second diameter. (Item 41) The catheter is an embolic protection device according to any one of items 31-40, extending through the opening of the embolic filter. (Item 42) The distal portion of the catheter is an embolic protection device according to any one of items 31-41, comprising a radiopaque marker. (Item 43) The radiopaque marker comprises one or more circumferential bands, as described in item 42, for the embolic protection device. (Item 44) The frame is an embolic protection device according to any one of items 31-43, comprising a shape memory material. (Item 45) The embolic protection device according to any one of items 31-44, comprising a filter medium containing a semipermeable polyurethane material having a pore size of approximately 100 microns to approximately 150 microns. (Item 46) The embolic protection device is the embolic protection device according to any one of items 21-45, wherein the embolic protection device is provided with longitudinal grooves along the outer surface of the embolic protection device. (Item 47) The embolic protection device according to any one of items 31-46, wherein the deployment mechanism comprises a sheath circumferentially positioned around at least a portion of the catheter, the sheath deploying the self-expanding embolic filter when the sheath is retracted at least partially longitudinally. (Item 48) The embolic protection device according to any one of items 31-47, wherein the distal portion of the catheter comprises one or more openings communicating with the lumen of the catheter. (Item 49) A method for capturing embolic residue during a closed cardiac procedure, wherein the method is: The distal end of the embolic protection device is inserted into a body lumen, and the embolic protection device is A catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end along the longitudinal axis of the catheter, wherein the lumen is configured to house a guidewire, and the distal portion of the catheter, which is substantially arc-shaped, is at least semicircular when the guidewire is at least partially retracted in the longitudinal direction, A self-expanding embolic filter positioned proximal to the distal portion and surrounding the catheter, wherein the embolic filter comprises a frame, the frame defining the opening of the embolic filter, and A deployment mechanism positioned around at least a portion of the catheter, wherein the deployment mechanism is movable longitudinally relative to the catheter, and is configured to contain the embolic filter in a collapse configuration, and the embolic filter is configured to self-expand in response to the longitudinal retraction of the deployment mechanism, A wire coupled to the frame of the embolization filter, wherein the wire is movable in the longitudinal direction relative to the catheter, and Equipped with, As the wire is advanced longitudinally distally to a first position, the wire is configured to bend the frame longitudinally toward the distal end of the catheter and laterally outward from the catheter, such that the opening of the embolic filter generally faces the distal end of the catheter and expands to a first diameter. When the wire is advanced longitudinally distally to a second position distal to the first position, the wire is configured to extend its frame radially outward from the catheter such that the opening of the embolic filter expands to a second diameter larger than the first diameter. That thing, To trace the lumen of the catheter across the guidewire that is inserted percutaneously into the body lumen. Methods that include... (Item 50) The method according to item 49, further comprising retracting the guidewire at least partially longitudinally from the lumen of the catheter such that the distal portion of the catheter forms a substantially arc shape which is at least a semicircle. (Item 51) The method according to either item 49 or 50, wherein the distal portion of the catheter is provided with a radiopaque marker, and the method further includes positioning the catheter by visualizing the radiopaque marker using an imaging technique. (Item 52) The method according to any one of items 49-51, further comprising retracting the deployment mechanism at least partially in the longitudinal direction to allow the self-expanding embolic filter to form an expanded deployment configuration. (Item 53) The method according to item 49-52, further comprising advancing the wire longitudinally to the first position, thereby bending the frame longitudinally toward the distal end of the catheter and laterally outward from the catheter, and expanding the opening of the embolic filter substantially straddling the body lumen to a first diameter. (Item 54) The method according to item 53, further comprising advancing the wire longitudinally to a second position distal to the first position, thereby extending the frame radially outward from the catheter and expanding the opening of the embolic filter substantially straddling the body lumen to a second diameter greater than the first diameter. (Item 55) The method according to any one of items 49-52, further comprising advancing the wire longitudinally to the first position, thereby bending the frame such that the opening of the embolic filter defined by the frame is substantially perpendicular to the longitudinal axis of the catheter, and the opening defined by the frame substantially straddles the body lumen. (Item 56) The method according to any one of items 49-55, wherein the deployment mechanism is a sheath positioned circumferentially around at least a portion of the catheter. (Item 57) The method according to any one of items 49-56, wherein the distal portion of the catheter comprises one or more openings communicating with the lumen of the catheter, and the method further comprises perfusing fluid into the body lumen through the one or more openings. (Item 58) The method according to any one of items 49-57, wherein the embolic protection device is provided with longitudinal grooves along the outer surface of the embolic protection device, and the method further includes inserting a second catheter device alongside the embolic protection device by tracking the second catheter device along the grooves. (Item 59) The method according to item 58, wherein the second catheter device is advanced over the embolic filter of the embolic protection device while the embolic filter is in a deployed configuration. (Item 60) A method for capturing embolic residue during a closed cardiac procedure, wherein the method is: The distal end of the embolic protection device is inserted into a body lumen, and the embolic protection device is A catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen is configured to house a guidewire, and the distal portion of the catheter has a substantially arc shape that is at least semicircular when the guidewire is at least partially retracted longitudinally. A self-expanding embolic filter positioned proximal to the distal portion and surrounding the catheter, wherein the embolic filter comprises a frame, the frame defining the opening of the embolic filter, and A deployment mechanism positioned around at least a portion of the catheter, wherein the deployment mechanism is movable longitudinally relative to the catheter, and is configured to contain the embolic filter in a collapse configuration, and the embolic filter is configured to self-expand in response to the longitudinal retraction of the deployment mechanism, A wire coupled to the frame of the embolization filter, wherein the wire is movable in the longitudinal direction relative to the catheter, and To be equipped with, Tracking the lumen of the catheter across the guidewire that is percutaneously inserted into the body lumen, As the guidewire is retracted from the distal portion of the catheter, the guidewire is retracted at least partially in the longitudinal direction from the lumen of the catheter such that the distal portion of the catheter forms a substantially arc shape that is at least a semicircle. The deployment mechanism is retracted in the vertical direction to deploy the self-expanding embolic filter, The wire is advanced longitudinally distally to the first position, thereby bending the frame longitudinally toward the distal end of the catheter and laterally outward from the catheter, and expanding the opening of the embolic filter to the first diameter. Methods that include... (Item 61) The method according to item 60, further comprising advancing the wire longitudinally distally to a second position distal to the first position, thereby extending the frame radially outward from the catheter, and expanding the opening of the embolic filter to a second diameter larger than the first diameter. (Item 62) A method for capturing embolic residue during closed cardiac procedures, (i) To provide an embolic protection device, the embolic protection device is A catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen is configured to house a guidewire, and the distal portion of the catheter, which is substantially arc-shaped, is at least semicircular when the guidewire is at least partially retracted longitudinally. A self-expanding embolic filter positioned proximal to the distal portion and surrounding the catheter, wherein the embolic filter comprises a frame, the frame defining the opening of the embolic filter, and A deployment mechanism positioned around at least a portion of the catheter, wherein the deployment mechanism is movable longitudinally relative to the catheter, and is configured to contain the embolic filter in a collapse configuration, and the embolic filter is configured to self-expand in response to the longitudinal retraction of the deployment mechanism, A wire coupled to the frame of the embolization filter, wherein the wire is movable in the longitudinal direction relative to the catheter, and To be equipped with, (ii) Inserting the distal end of the embolic protection device into the body lumen by tracing the lumen of the catheter along a guidewire that is inserted percutaneously into the body lumen, (iii) Retracting the deployment mechanism in the vertical direction to deploy the self-expanding embolic filter, (iv) Advance the wire longitudinally distally to a first position, thereby bending the frame longitudinally toward the distal end of the catheter and laterally outward from the catheter, and expanding the opening of the embolic filter to a first diameter. Methods that include... (Item 63) The method according to item 62, further comprising advancing the wire longitudinally distally to a second position distal to the first position, thereby extending the frame radially outward from the catheter, and expanding the opening of the embolic filter to a second diameter larger than the first diameter. [Brief explanation of the drawing]

[0018] The following figures are provided as examples and are not intended to limit the scope of the claimed invention.

[0019] [Figure 1A] Figures 1A and 1B illustrate partial side views of embodiments of the embolic protection device of the present invention. In Figure 1A, the embolic filter of the embolic protection device is shown in a collapsed (unexpanded) configuration. In Figure 1B, the embolic filter is shown in an expanded (unexpanded) configuration, in which the pull wire attached to the frame of the embolic filter is advanced to a distal position, so that the frame has a self-expanding and unbent (i.e., unbent) configuration. [Figure 1B] Figures 1A and 1B illustrate partial side views of embodiments of the embolic protection device of the present invention. In Figure 1A, the embolic filter of the embolic protection device is shown in a collapsed (unexpanded) configuration. In Figure 1B, the embolic filter is shown in an expanded (unexpanded) configuration, in which the pull wire attached to the frame of the embolic filter is advanced to a distal position, so that the frame has a self-expanding and unbent (i.e., unbent) configuration.

[0020] [Figure 1C] Figure 1C shows a side perspective view of an embodiment of the embolic filter of the present invention, in which the pull wire attached to the frame of the embolic filter is partially retracted in the longitudinal direction to a proximal position, forming a partially deflected (i.e., partially unbent) configuration.

[0021] [Figure 1D]Figure 1D illustrates a cross-sectional view of an embodiment of the embolic filter of the present invention, in which the pull wire is fully retracted in the longitudinal direction, thereby forming a fully deflected (e.g., fully bent) configuration that deflects the filter.

[0022] [Figure 1E] Figures 1E and 1F illustrate front views of embodiments of the embolic filter frame of the present invention. In Figure 1E, the filter frame is not deployed; the frame is crushed and sealed by the outer sheath. In Figure 1F, the outer sheath is retracted longitudinally, and the filter frame is deployed to its self-expanding configuration. [Figure 1F] Figures 1E and 1F illustrate front views of embodiments of the embolic filter frame of the present invention. In Figure 1E, the filter frame is not deployed; the frame is crushed and sealed by the outer sheath. In Figure 1F, the outer sheath is retracted longitudinally, and the filter frame is deployed to its self-expanding configuration.

[0023] [Figure 2A] Figures 2A-2B illustrate a partial side view of an embodiment of the embolic protection device of the present invention, which includes a shoulder portion. [Figure 2B] Figures 2A-2B illustrate a partial side view of an embodiment of the embolic protection device of the present invention, which includes a shoulder portion.

[0024] [Figure 3A] Figures 3A-3D illustrate a partial side view of an embodiment of the embolic protection device of the present invention, which includes an intermediate tube. [Figure 3B] Figures 3A-3D illustrate a partial side view of an embodiment of the embolic protection device of the present invention, which includes an intermediate tube. [Figure 3C] Figures 3A-3D illustrate a partial side view of an embodiment of the embolic protection device of the present invention, which includes an intermediate tube. [Figure 3D] Figures 3A-3D illustrate a partial side view of an embodiment of the embolic protection device of the present invention, which includes an intermediate tube.

[0025] [Figure 4A] Figures 4A-4C illustrate partial side views of an embodiment of the embolic protection device of the present invention, which includes a deflector. [Figure 4B] Figures 4A-4C illustrate partial side views of an embodiment of the embolic protection device of the present invention, which includes a deflector. [Figure 4C] Figures 4A-4C illustrate partial side views of an embodiment of the embolic protection device of the present invention, which includes a deflector.

[0026] [Figure 5A] Figure 5A illustrates an embodiment of an embolic protection device equipped with a handle. Figure 5B illustrates the distal portion of an embolic protection device equipped with an embolic filter and a pigtail catheter. [Figure 5B] Figure 5A illustrates an embodiment of an embolic protection device equipped with a handle. Figure 5B illustrates the distal portion of an embolic protection device equipped with an embolic filter and a pigtail catheter.

[0027] [Figure 6A] Figure 6A shows a partial side view of an embodiment of the embolic protection device of the present invention, which includes an embolic filter in a collapsed (unexpanded) configuration.

[0028] [Figure 6B] Figures 6B and 6C illustrate a side view and anterior view of the embolic filter in a self-expanding (deploying) configuration, in which the push wire connected to the frame of the embolic filter is retracted to a proximal position so that the frame forms an unbent (i.e., uncurved) configuration. [Figure 6C] Figures 6B and 6C illustrate a side view and anterior view of the embolic filter in a self-expanding (deploying) configuration, in which the push wire connected to the frame of the embolic filter is retracted to a proximal position so that the frame forms an unbent (i.e., uncurved) configuration.

[0029] [Figure 6D]Figures 6D and 6E illustrate a side view and anterior view of the embolic filter in a partially expanded configuration, in which a push wire, coupled to the frame of the embolic filter, is advanced longitudinally to a first distal position, such that the frame forms a deflected (i.e., bent) configuration. [Figure 6E] Figures 6D and 6E illustrate a side view and anterior view of the embolic filter in a partially expanded configuration, in which a push wire, coupled to the frame of the embolic filter, is advanced longitudinally to a first distal position, such that the frame forms a deflected (i.e., bent) configuration.

[0030] [Figure 6F] Figures 6E and 6F illustrate a side view and a front view of the embolic filter in a fully extended configuration, respectively, in which the frame forms an extended configuration and the push wire, which is coupled to the frame of the embolic filter, is advanced longitudinally to a second distal position further than the first distal position shown in Figure 6C. [Figure 6G] Figures 6E and 6F illustrate a side view and a front view of the embolic filter in a fully extended configuration, respectively, in which the frame forms an extended configuration and the push wire, which is coupled to the frame of the embolic filter, is advanced longitudinally to a second distal position further than the first distal position shown in Figure 6C.

[0031] [Figure 7A] Figures 7A-7C illustrate partial side views of an embodiment of the embolic protection device of the present invention, which has an operating mechanism for operating an embolic filter. [Figure 7B] Figures 7A-7C illustrate partial side views of an embodiment of the embolic protection device of the present invention, which has an operating mechanism for operating an embolic filter. [Figure 7C] Figures 7A-7C illustrate partial side views of an embodiment of the embolic protection device of the present invention, which has an operating mechanism for operating an embolic filter.

[0032] [Figure 8A]Figures 8A and 8B illustrate embodiments of the embolic protection device of the present invention, which have a handle for manually operating the embolic filter. [Figure 8B] Figures 8A and 8B illustrate embodiments of the embolic protection device of the present invention, which have a handle for manually operating the embolic filter.

[0033] [Figure 8C] Figures 8C-8F illustrate embodiments of the handle. [Figure 8D] Figures 8C-8F illustrate embodiments of the handle. [Figure 8E] Figures 8C-8F illustrate embodiments of the handle. [Figure 8F] Figures 8C-8F illustrate embodiments of the handle.

[0034] [Figure 9A] Figures 9A-9E illustrate a stepwise method for using the embolic protection device of the present invention. [Figure 9B] Figures 9A-9E illustrate a stepwise method for using the embolic protection device of the present invention. [Figure 9C] Figures 9A-9E illustrate a stepwise method for using the embolic protection device of the present invention. [Figure 9D] Figures 9A-9E illustrate a stepwise method for using the embolic protection device of the present invention. [Figure 9E] Figures 9A-9E illustrate a stepwise method for using the embolic protection device of the present invention.

[0035] [Figure 10] Figure 10 illustrates the deflection and capture of embolic residue by the embolic protection device of the present invention, which is equipped with a deflector.

[0036] [Figure 11] Figure 11 illustrates the deflection and capture of embolic residue by the embolic protection device of the present invention, in which a second catheter device is present.

[0037] [Figure 12A] Figures 12A-12D illustrate a stepwise method of using the embolic protection device of the present invention to operate the embolic filter. [Figure 12B] Figures 12A-12D illustrate a stepwise method of using the embolic protection device of the present invention to operate the embolic filter. [Figure 12C] Figures 12A-12D illustrate a stepwise method of using the embolic protection device of the present invention to operate the embolic filter. [Figure 12D] Figures 12A-12D illustrate a stepwise method of using the embolic protection device of the present invention to operate the embolic filter.

[0038] [Figure 13A] Figures 13A and 13B are photographs of the distal portion of the embolic protection device of the present invention, positioned within the vascular system of a cadaver, according to Example 1. In Figure 13A, the embolic protection device has a longitudinal groove into which a second catheter is inserted alongside the embolic protection device. In Figure 13B, the second catheter is positioned adjacent to the embolic protection device, where the longitudinal groove is absent. [Figure 13B] Figures 13A and 13B are photographs of the distal portion of the embolic protection device of the present invention, positioned within the vascular system of a cadaver, according to Example 1. In Figure 13A, the embolic protection device has a longitudinal groove into which a second catheter is inserted alongside the embolic protection device. In Figure 13B, the second catheter is positioned adjacent to the embolic protection device, where the longitudinal groove is absent.

[0039] [Figure 14] Figure 14 is a bar graph showing the performance data of the embolism protection device (EPD-1 device) of the present invention according to Example 2.

[0040] [Figure 15A] Figures 15A-15J show images generated from diffusion-weighted magnetic resonance imaging (DW-MRI) of a representative object according to Example 2. [Figure 15B]Figures 15A-15J show images generated from diffusion-weighted magnetic resonance imaging (DW-MRI) of a representative object according to Example 2. [Figure 15C] Figures 15A-15J show images generated from diffusion-weighted magnetic resonance imaging (DW-MRI) of a representative object according to Example 2. [Figure 15D] Figures 15A-15J show images generated from diffusion-weighted magnetic resonance imaging (DW-MRI) of a representative object according to Example 2. [Figure 15E] Figures 15A-15J show images generated from diffusion-weighted magnetic resonance imaging (DW-MRI) of a representative object according to Example 2. [Figure 15F] Figures 15A-15J show images generated from diffusion-weighted magnetic resonance imaging (DW-MRI) of a representative object according to Example 2. [Figure 15G] Figures 15A-15J show images generated from diffusion-weighted magnetic resonance imaging (DW-MRI) of a representative object according to Example 2. [Figure 15H] Figures 15A-15J show images generated from diffusion-weighted magnetic resonance imaging (DW-MRI) of a representative object according to Example 2. [Figure 15I] Figures 15A-15J show images generated from diffusion-weighted magnetic resonance imaging (DW-MRI) of a representative object according to Example 2. [Figure 15J] Figures 15A-15J show images generated from diffusion-weighted magnetic resonance imaging (DW-MRI) of a representative object according to Example 2.

[0041] [Figure 16A] Figure 16A is a photograph of a thrombus captured by the embolic protection device (EPD-1 device) of the present invention, according to Example 2.

[0042] [Figure 16B] Figure 16B is a photograph of collagen fragments captured within the filter of the embolic protection device (EPD1 device) according to Example 2.

[0043] Similar reference numbers in various drawings refer to the same elements. [Modes for carrying out the invention]

[0044] The present invention provides an embolism protection device and a method for using the embolism protection device to capture embolic residues during surgical procedures.

[0045] I. Definition

[0046] As used herein, the term “self-expanding” means expanding, spreading, or unfolding from a compressed state in response to removal or the removal of a limiting or restraining force.

[0047] As used herein, the term “closed heart” refers to any surgical procedure involving the heart in which the thoracic cavity is not opened.

[0048] As used herein, the term “woven” refers to any material comprising multiple strands, where strands are woven together to form a net, mesh, or screen. Examples of woven materials, though not limited to them, include nets or meshes comprising polymers, metals, or metal alloys.

[0049] As used herein, the term “nonwoven” refers to any material including a continuous film. Nonwoven materials may be permeable, semi-permeable, or impermeable. For example, a permeable or semi-permeable nonwoven material may optionally contain one or more pores through which a fluid can pass.

[0050] As used herein, the term “alloy” refers to a homogeneous mixture or solid solution produced by combining two or more metallic elements to produce, for example, superior strength or corrosion resistance. For example, alloys include brass, bronze, steel, nitinol, chromium cobalt, MP35N, 35NLT, Elgiloy, and equivalents.

[0051] As used herein, “nitinol” and “nickel-titanium” are used synonymously to refer to alloys of nickel and titanium.

[0052] As used herein, “chromium cobalt” refers to an alloy of chromium and cobalt.

[0053] As used herein, "MP35N" refers to a nickel-cobalt alloy.

[0054] As used herein, “35NLT” refers to a cobalt-based alloy that may also consist of chromium, nickel, molybdenum, carbon, manganese, silicon, phosphorus, sulfur, titanium, iron, and boron.

[0055] As used herein, “Elgiloy” refers to an alloy of cobalt, chromium, nickel, iron, molybdenum, and manganese.

[0056] As used herein, “body lumen” refers to the internal space of tubular structures within the body, such as arteries, intestines, veins, the digestive tract, bronchi, renal tubules, and urinary tracts. In some cases, “body lumen” refers to the aorta.

[0057] II. Embolism Protection Devices

[0058] While certain embodiments and examples are described below, those skilled in the art will recognize that this disclosure extends beyond the specifically disclosed embodiments and / or uses obvious modifications and their equivalents. Therefore, the scope of the disclosure presented herein is not intended to be limited by any particular embodiment described below.

[0059] For the purposes of this disclosure, the terms “upper,” “lower,” “right,” “left,” “rear,” “front,” “vertical,” “horizontal,” and their derivatives relate to the present invention as oriented in Figures 1B and 1F (or in Figures 6B and 6C). However, it should be understood that the present invention may have various alternative orientations unless expressly provided otherwise. Also for the purposes of this disclosure, the term “joined” (in all its forms, i.e., joining, joining, being joined, etc.) generally means the jointing of two components (electrical or mechanical) to each other, directly or indirectly. Such joints may be essentially stationary or essentially movable, and may be achieved such that the two components (electrical or mechanical) and any additional intermediate members are formed integrally with each other or with the two components as a single entity, and may be essentially permanent or essentially removable or detachable.

[0060] Figures 1A and 1B illustrate embodiments of the embolic protection device 100. In these embodiments, the device 100 comprises a catheter 102 (e.g., a pigtail catheter) having a proximal end 114, a distal end 116, and a lumen 118 extending from the proximal end 114 to the distal end 116. The lumen 118 may be configured to house a guidewire 990 (see Figures 9A and 9B) which is movable longitudinally through the lumen to coil or straighten the distal portion 104 of the catheter 102, depending on whether the guidewire is retracted (to coil the distal portion) or extended (to straighten the distal portion). In some embodiments, the catheter 102 includes a distal portion 104 configured to have a substantially arc shape, which is at least a semicircle. The sidewall of the catheter 102 may optionally include one or more openings 108 within the distal portion 104, configured to deliver one or more fluids (e.g., imaging dyes, contrast agents, oxygenated blood, saline solution, any combination thereof, or equivalents) to a body lumen 992 (see Figure 9A). The openings 108 (multiple, but intended to include embodiments in which the distal portion includes one opening 108) are in fluid communication with the lumen 118. In some embodiments, the distal portion 104 of the catheter 102 includes one or more radiopaque markers 106. In some embodiments, the radiopaque markers 106 are wrapped around the circumference of the distal portion of the catheter and may have the same or different widths. In other embodiments, the radiopaque markers are collinear with the lumen and extend to the distal end of the catheter. The device 100 further comprises a self-expanding embolic filter 110 defined by a frame 124 and a filter medium 126, and a deployment mechanism 112 (e.g., a longitudinally retractable outer sheath or a longitudinally retractable ring). The embolic filter 110 is positioned around the catheter 102.

[0061] As shown in Figure 1B, in its deployed configuration, the embolic filter 110 includes a distal opening 140 defined by a frame 124, facing the distal end 116 of the catheter 102, and extending proximal from the distal opening 140 to the closed proximal end 142. The device 100 further includes a pull wire 122 that is coupled to the frame 124 and can be retracted to deflect or bend the frame 124 and change the orientation and shape of the distal opening 140.

[0062] In some embodiments, retracting the pull wire 122 may engage the distal opening 140 of the embolic filter 110 with at least a portion of the wall of the internal body lumen 992 (see Figure 9D). Figure 1B illustrates the pull wire 122 in an advanced, i.e., non-retracted or self-expanding configuration, with a frame that is angled slightly (e.g., less than about 45 degrees) posteriorly in the lateral direction, but generally oriented to extend distally longitudinally. The catheter 102 may be partially surrounded toward its proximal end 114 by a support catheter 150 that terminates at a head 152, proximal to the distal portion 104 of the catheter 102. The support catheter 150 may be made from a thicker, more rigid material to add rigidity and provide a protective or support layer surrounding the catheter 102.

[0063] Figure 1C illustrates an embolic filter 110 deployed (e.g., self-expanding) by the retraction of a deployment mechanism (e.g., outer sheath) 112, with a partially deflected, i.e., partially bent frame 124, by the retraction of a pull wire 122. The pull wire 122 is coupled to the frame 124 at a distal connection 134. The distal opening 140 is mainly defined by a first portion 132 of the frame 124. The first portion 132 of the frame 124 defines the shape of the distal opening 140, which is substantially elliptical (i.e., shaped like an ellipse), or alternatively, substantially egg-shaped or circular. In this embodiment, the portion 132 of the frame 124 may be substantially elliptical and terminate at a V-shaped point at its proximal end, i.e., the portion 132 of the frame 124 may reverse its curvature at one end of its substantially elliptical shape (e.g., at its distal end) to become a point at its proximal end. The distal opening 140 may be substantially defined by the frame 124, but may also straddle the frame 124 adjacent to a point-like segment of the frame 124. The filter material 126 may define a portion of the distal opening 140 by straddling the frame 124, i.e., adjacent to the attachment point of the frame 124 to the catheter 102 or support catheter 150.

[0064] The attachment of the frame 124 to the support catheter 150 (or, alternatively, directly to the catheter 102) is accomplished via a second portion 130 of the frame 124 that surrounds the support catheter 150 (or catheter 102) and is at an angle to the longitudinal axis of the catheter 102. The second portion 130 of the frame 124 may be fixed in place by friction and by the lateral and / or longitudinal tension of the embolic filter 110. In other embodiments, the fixed attachment of the second portion 130 of the frame 124 to the support catheter 150 (or catheter 102) may also be accomplished via adhesive, welding, or equivalent.

[0065] The first portion 132 of the frame 124 may extend in a first lateral direction away from the catheter 102 and away from the second portion 130 of the catheter 102, loop backward across the catheter 102, and extend in the opposite lateral direction. In this embodiment, the first portion 132 of the frame 124 has two sides (132a, 132b) that each generally extends in a first lateral direction away from the catheter 102, then loop backward on the opposite side around the catheter 102, and generally extend in the opposite lateral direction before converging and abutting to form a substantially elliptical shape. As shown in Figure 1F, the embolic filter 110 is symmetrical with respect to the pull wire 122. For the sake of ease of discussion, the embolic filter 110 is referred to as having a left side and a right side. The left side element of the embolic filter 110 is analogous to the right side element of the embolic filter 110.

[0066] When the pull wire 122 is in its advanced position (or partially but not fully retracted), the frame 124 extends distally longitudinally as it extends from its attachment point to the catheter 102 (or support catheter 150). When the pull wire 122 is in its retracted position (i.e., fully retracted) (see Figures 1D and 9E), the frame 124 extends distally longitudinally. It extends distally in the longitudinal direction to the catheter 102 near the attachment point, and then bends to extend approximately perpendicular to the longitudinal axis of the catheter 102.

[0067] Figure 1D shows a cross-sectional view of the distal opening 140 of the embolic filter 110 when it is in an expanded configuration and the pull wire 122 is fully retracted, completely deflecting (or bending) the frame 124. The pull wire 122 deflects or bends the frame 124 proximal longitudinally and laterally outward. In the fully deflected configuration (i.e., when the pull wire 122 is fully retracted), the distal opening 140 of the embolic filter 110 may be approximately perpendicular to the longitudinal axis of the catheter 102 and may laterally straddle the body lumen 992 (see Figures 9D and 9E) approximately perpendicular to the longitudinal axis of the body lumen 992. The fully deflected (or bending) configuration may allow the embolic filter 110 to fully engage with the body lumen 992. In this fully deflected configuration, the distal opening 140 is approximately perpendicular to the longitudinal axis of the catheter 102. In the fully deflected configuration, the width x traversing the distal opening 140 may be increased compared to the corresponding dimension in the undefended configuration. Similarly, in the fully deflected configuration, the length y traversing the distal opening 140 may be decreased compared to the corresponding dimension in the undefended configuration. By increasing the width x, in the bent configuration, the frame 124 defining the distal opening 140 may be fully engaged with the body lumen 992.

[0068] In the embodiments illustrated in Figures 1A-1D, the catheter 102 extends through the distal opening 140 of the embolic filter 110, and the frame 124 extends away from the catheter 102 in a first lateral direction and then curves posteriorly around the catheter 102 in the opposite direction.

[0069] The embolic protection device 100 with the deployed embolic filter 110 (i.e., with the deployment mechanism 112 retracted) may be configured as undefended (Figure 1B), partially deflected (Figure 1C), or fully deflected (Figures 1D and 5E). These configurations are achieved by engaging the pull wire 122 in a fully advanced, partially retracted (or partially advanced) or fully retracted position. In the fully advanced position, the pull wire 122 is in a distal position. In the fully retracted position, the pull wire 122 is in a proximal position. When retracted longitudinally to the proximal position, the pull wire 122 is configured to deflect (or bend) the frame 124 such that the distal opening 140 of the filter 110 is substantially perpendicular to the longitudinal direction of the catheter 102 and the distal opening 140 faces the distal end 116 of the catheter 102. When advanced longitudinally to the distal position, the pull wire 122 is configured to position the frame 124 such that the distal opening 140 of the filter 110, defined by the frame 124, is substantially parallel to the longitudinal direction of the catheter 102, or angled to less than 45 degrees.

[0070] In some embodiments, the distal opening 140 of the embolic filter 110 has a diameter of about 2 cm to about 6 cm (e.g., about 2.5 cm to about 5 cm or about 4.5 cm). The embolic filter 110 may have any preferred size or diameter to accommodate the anatomical variability within the patient's body lumen 992 (see Figure 9C). In some embodiments, the embolic filter 110 is coupled to the catheter 102 at the proximal and / or distal ends of the embolic filter 110, and / or at any other point in between. For example, the embolic filter 110 may be coupled to the catheter 102 via a frame 124, specifically a second portion 130 (distal attachment) of the frame 124, and also via a filter material 126 at an attachment point within the sheath 112.

[0071] Figures 1E and 1F illustrate the frame 124 of the embolic filter 110. In the embodiment shown in Figure 1E, the frame 124 is compressed within the outer sheath 112, i.e., the sheath 112 is advanced across the frame 124. In the embodiment shown in Figure 1F, the frame 124 is unfolded outside the sheath 112, i.e., the sheath 112 is retracted. The pull wire 122 is coupled to the frame 124 at the distal coupling 134. The pull wire 122 may be coupled to the frame 124 at the distal coupling 134 in various ways, including using a hole in the frame 124 through which the pull wire 122 is screwed and crimped to hold it in place. The distal coupling 134 may also include variations in the curvature of the frame 124, i.e., by reversing the curvature of the frame 124 and making it a point. This curvature, along with the curvature of the frame 124 adjacent to the attachment point of the frame 124 to the catheter 102, can assist in crushing the frame 124 to advance the sheath 112 across the embolic filter 110. In some embodiments, the frame 124 includes a shape memory material (e.g., a metal alloy or polymer). Examples of shape memory materials include, but are not limited to, nitinol, chromium cobalt, and / or other metal alloys such as MP35N, 35NLT, Elgiloy, and equivalents. In some embodiments, the frame 124 is laser-cut from a tube or sheet.

[0072] Figures 2A and 2B illustrate embodiments of an alternative deployment mechanism for an embolic protection device 200, comprising a catheter 202, an embolic filter 210, and a movable outer sheath 212. In some embodiments, the outer sheath 212 may include a voluntary lip 260 projecting inward from the distal end of the outer sheath 212. The catheter 202 may include one or more shoulder portions 262 (e.g., a distal shoulder portion 262a and a proximal shoulder portion 262b) projecting outward from the outer wall of the catheter 202. The lip 260 of the outer sheath 212 is configured to engage with one or more shoulder portions 262 of the catheter 202 to prevent or restrict excessive movement of the outer sheath 212 in either the proximal or distal direction. The lip 260 and shoulder portions 262 may be arched, forked, a combination thereof, and equivalents.

[0073] In some embodiments, the outer sheath 212 and / or catheter 202 are provided with a projection and / or a stopper configured to provide the user with information about the longitudinal position of the outer sheath without preventing further movement. In some embodiments, the outer sheath 212 and catheter 202 are provided with a lip 260, a shoulder 262, and a stopper and projection (for example, to prevent excessive longitudinal movement of the outer sheath 212 in any direction and to provide information about the degree of movement of the outer sheath 212 relative to the catheter 202 (e.g., retracted 1 / 2, retracted 1 / 4, etc.)).

[0074] The advantages of the outer sheath 212 deployment mechanism may include its simplicity, ease of operation, and small number of moving parts. The embolic protection device 200 is very suitable for use in conjunction with delicate cardiac procedures that carry serious risks. As the duration of the procedure increases, the risk of complications also typically increases. Therefore, it may be advantageous for the user to be able to deploy and recapture the embolic filter 210 quickly and easily. More complex devices may be more difficult to operate and more likely to malfunction or cause adverse effects. The ability to move the outer sheath 212 relative to the embolic filter 210 may, as an advantage, allow the user to partially recapture the embolic filter 210, for example, to adjust the width of the distal opening 140. In some embodiments, narrowing the distal opening 140 allows the user to introduce a second catheter or instrument into the patient's body lumen 992 (see Figure 9D) and to manipulate the second catheter or instrument around and beyond the catheter 202 and the embolic filter 210, as described herein. In some embodiments, the embolic protection device, as described herein, may have a longitudinally extending groove (not shown) along its surface, for example, along the catheter 102, along the support catheter 150, or along the deployment mechanism (e.g., outer sheath) 112. In such embodiments, the second catheter or instrument may be inserted while engaging with the groove and guiding the second device alongside the embolic protection device.

[0075] Figures 3A-3D illustrate embodiments of an embolic protection device 300 in which an embolic filter 310 is movably coupled to a catheter 302 by a frame 324 and is longitudinally movable relative to the catheter 302. In some embodiments, the embolic filter 310 is coupled to an intermediate tube 330 that at least partially surrounds the catheter 302 circumferentially. The intermediate tube 330 is longitudinally movable relative to the catheter 302. An outer sheath 312 is configured to at least partially surround both the catheter 302 and the intermediate tube 330 circumferentially. The intermediate tube 330 and the outer sheath 312 can be moved simultaneously and independently. The longitudinal position of the embolic filter 310 relative to the catheter 302 can be adjusted while the embolic filter 310 is in a collapsed configuration or in an expanded or partially expanded configuration. In some embodiments, the area around the distal opening of the embolic filter 310 is provided with one or more radiopaque markers to allow the user to visualize the location of the distal opening relative to various anatomical landmarks, for example. For example, if the user is performing a procedure on a patient's aortic valve and wishes to prevent the embolus from entering the cerebral artery, the radiopaque markers can be used to ensure that the distal opening of the embolic filter 310 is located in the ascending aorta upstream from the carotid artery.

[0076] Figure 3A illustrates the embolic filter 310 enclosed in a closed configuration by the outer sheath 312 and the distal end of the intermediate tube 330 in position (a). When the intermediate tube 330 is held stationary in position (a), the outer sheath 312 can be retracted to deploy the embolic filter 310, as shown in Figure 3C. If the intermediate tube 330 and the outer sheath 312 are moved simultaneously instead, the embolic filter 310 remains enclosed by the outer sheath 312, while its longitudinal position is adjusted. For example, Figure 3B illustrates the embolic filter 310 still enclosed by the outer sheath 312, with the intermediate tube 330 retracted so that its distal end is in position (b). When the intermediate tube 330 is then held stationary in position (b), the outer sheath 312 can be retracted to deploy the embolic filter 310, as shown in Figure 3D. The intermediate tube 330 and the outer sheath 312 can be moved to adjust the longitudinal position of the embolic filter 310 in a deployed or partially deployed configuration. For example, the intermediate tube 330 and the outer sheath 312 can be moved simultaneously to retract the intermediate tube 330 from the position shown in Figure 3C to the position shown in Figure 3D (b).

[0077] In addition to those described in detail herein, a wide variety of deployment mechanisms for embolic filters are possible. For example, the deployment system may include a portion of an annular sheath, including an inwardly projecting end portion that is guided along a trajectory parallel to the catheter body. One such embodiment may, advantageously, reduce the external shape of the catheter. In another embodiment, the deployment system may include a threaded sheath that moves longitudinally in response to torsion by the user. In yet another embodiment, the deployment system may include multiple annular bands capable of capturing the embolic filter longitudinally and / or circumferentially. Combinations of the deployment systems described herein and other deployment systems are also possible.

[0078] Figures 4A-4C illustrate another embodiment of the embolic protection device 400, comprising a catheter 402, a deflector 460, an embolic filter 410, and a movable outer sheath 412. In some embodiments, the embolic protection device 400 is similar to the embolic protection device 100, with the addition of a deflector 460.

[0079] Deflectors of various types and designs can be used in conjunction with embolic protection devices such as the embolic protection device 400. Such deflectors may have different shapes and / or sizes, and the location and manner in which they are coupled to the catheter may vary. For example, deflectors may be manufactured in various sizes to adapt to differences in patient biomimetic structures. In some embodiments, deflectors include shape memory materials, such as nitinol, chromium cobalt, and / or alloys such as MP35N, 35NLT, Elgiloy, and equivalents. In some embodiments, deflectors include a porous membrane, such as a semipermeable polyurethane membrane / material, mounted on a self-expanding frame, such as a frame containing shape memory material.

[0080] Embodiments of the deflector 460 shown in Figures 4A-4C have a substantially butterfly or elliptical shape, with two wings or petals 460a and 460b extending to either side of the central axis 464. The wings or petals 460a and 460b may be identical or different in size, shape, material, and equivalents. The deflector 460 is coupled to the side of the catheter 402 via an extension member 462, which is coupled to the central axis 464 of the deflector 460 at one end and to the catheter 402 at the other end (e.g., by bonding, welding, soldering, joining using separate components, combinations thereof, and equivalents). In some embodiments, the extension member 462 includes a shape memory material, including nitinol, chromium cobalt, and / or alloys such as MP35N, 35NLT, Elgiloy, and equivalents, which are configured (e.g., shaped) to bias the deflector away from the catheter 402. The deflector 460 is configured to be released into an open configuration, as shown in Figures 4B and 4C, when it is not confined by the outer sheath 412, for example. In some embodiments, the deflector 460 is configured such that the wings or petals 460a and 460b fold together along the central axis 464 away from the extension member 462, as shown in Figure 4A, so that the deflector 460 can be contained, for example, within the outer sheath 412. As shown in Figure 4A, the deflector 460 can be initially folded and contained within the outer sheath 412 so that the wings or petals 460a and 460b are positioned distal to the central axis 464. In some embodiments, the deflector 460 can be initially folded in the opposite direction so that the wings or petals 460a and 460b are positioned proximal to the central axis 464.

[0081] In some embodiments, the catheter 402 is a pigtail type catheter as shown in Figures 4A and 4B and described herein. The catheter 402 includes a distal portion 404 configured to have a substantially arc shape, which is at least semicircular. In some embodiments, the distal portion 404 of the catheter 402 includes one or more radiopaque markers 406. The sidewall of the catheter 402 may optionally include one or more openings 408 within the distal portion 404, configured to deliver one or more fluids (e.g., imaging dyes, contrast agents, oxygenated blood, saline solution, any combination thereof, or equivalents) into a body lumen.

[0082] The catheter 402 has a proximal end 414 and a distal end 416. As shown in Figure 4B, an embodiment of the catheter 402 is partially surrounded toward its proximal end 414 by a support catheter 450 that terminates at a head 452, located proximal to the distal portion 404 of the catheter 402. The support catheter 450 may be made from a thicker, more rigid material to add rigidity and provide a protective or support layer surrounding the catheter 402.

[0083] As shown in Figure 4B, the embolic filter 410 comprises a frame 424 and a filter medium 426. In its deployed configuration, the embolic filter 410 includes a distal opening 440 defined by the frame 424, facing the distal end 416 of the catheter 402, and extending proximal from the distal opening 440 to the closed proximal end 442. The device 400 further comprises a pull wire 422, connected to the frame 424 in a manner similar to that described above with reference to Figure 1B-1D, which can be retracted to deflect or bend the frame 424 and change the orientation and shape of the distal opening 440.

[0084] In some embodiments, the deflector 460 and the embolic filter 410 are accompanied by another type of catheter, for example, a distal portion configured to form an arc shape. don'tIt can be coupled to a catheter. The embolic filter 410 may be analogous to the embolic filters 110 and 210 shown in Figures 1A-1D, 2A and 2B and described herein. In some embodiments, the embolic filter 410 is coupled to the catheter 402 proximal to the deflector 460, for example, as shown in Figures 4A-4B. In some embodiments, the embolic filter 410 is coupled to the catheter 402 distal to the deflector 460. The embolic filter 410 is coupled so as to be positioned around the catheter 402. This configuration is advantageous as it allows the embolic filter 410 to engage with the wall of the internal body lumen 992 (see Figure 9D) as the position of the catheter 402 within the body lumen 992 (see Figure 9D) may be affected by the deployed deflector 460.

[0085] The combination of the deflector 460 and the embolic filter 410 can, advantageously, provide additional protection against potential complications caused by thrombi in the bloodstream. For example, if the embolic filter 410 (e.g., the distal end of the embolic filter 410) is distal to the deflector 460, the embolic filter 410 can act as a primary means of embolic protection, and the deflector 460 can act as a secondary means of embolic protection. If some blood can flow around the embolic filter 410 rather than through it, the deflector 460 can act as a secondary (or backup) protective device, preventing any residue not captured by the embolic filter 410 from entering the cerebral arteries and progressing to the brain. If the embolic filter 410 is proximal to the deflector 460, the deflector 460 can act as a primary means of embolic protection, and the embolic filter 410 can act as a secondary means of embolic protection. The deflector 460 first deflects the residue away from the carotid artery, and then the embolic filter 410 captures the residue (including, for example, the deflected residue) as the blood flows through the descending aorta.

[0086] In some embodiments, the catheter 402 and the outer sheath 412 may have lips, shoulders, projections, and / or retainers, similar to those shown, for example, in Figures 2A and 2B and described herein. For example, the lips, shoulders, projections, and / or retainers may be positioned on the catheter 402 distal to the deflector 460, between the deflector 460 and the embolic filter 410, and proximal to the embolic filter 410, so as to engage with the corresponding lips, shoulders, projections, and / or retainers on the outer sheath 412. Advantageously, the lips, shoulders, projections, and / or retainers can provide the user with information about their longitudinal position on the outer sheath 412 so as to the user know when either the deflector 460 or the embolic filter 410 is deployed, or when one or both are deployed. In some embodiments, either or both of the deflector 460 and the embolic filter 410 can be movably coupled to the catheter 402 via an intermediate tube similar to those shown in Figures 3A-3D and described herein.

[0087] Embodiments of an embolic protection device 500, similar to the embolic protection device 100 in Figures 1A-1E, are shown in Figures 5A and 5B. The embolic protection device 500 comprises a catheter 502, an embolic filter 510, a movable outer sheath 512, and a handle 570. In some embodiments, the catheter 502 is a pigtail type catheter, as shown in the close-up view of Figure 5B and described herein. The catheter 502 includes a distal portion 504 configured to have a substantially arc shape, which is at least semicircular. In some embodiments, the distal portion 504 of the catheter 502 includes one or more radiopaque markers 506. The sidewall of the catheter 502 may optionally include one or more openings 508 within the distal portion 504, configured to deliver one or more fluids (e.g., imaging dyes, contrast agents, oxygenated blood, saline, any combination thereof, or equivalents) into a body lumen.

[0088] As shown in Figure 5B, the embolic filter 510 comprises a frame 524 and a filter medium 526. In its deployed configuration, the embolic filter 510 opens toward the distal end 516 of the catheter 502. The device 500 further comprises a pull wire 522, connected to the frame 524 in a manner similar to that described above with reference to Figure 1B-1D, which can be retracted to deflect or bend the frame 524 and change the orientation and shape of the embolic filter 510.

[0089] Referring to Figure 5A, the handle 570 has a wire engagement mechanism 574 configured to advance or retract the pull wire 522 by the movement of a first slider 572. The handle 570 also has a sheath engagement mechanism 578 configured to advance or retract the deployment mechanism (e.g., outer sheath) 512 by the movement of a second slider 576.

[0090] Figures 6A-6G illustrate embodiments of the embolic protection device 600. In these embodiments, the embolic protection device 600 comprises a catheter 602 (e.g., a pigtail catheter) having a proximal end 614, a distal end 616, and a lumen 618 extending from the proximal end 614 to the distal end 616 along the longitudinal axis of the catheter 602. The lumen 618 may be configured to house a guidewire 1290 (see Figure 12A) which is movable longitudinally through the lumen to coil or straighten the distal portion 604 of the catheter, depending on whether the guidewire is retracted (to coil the distal portion) or extended (to straighten the distal portion). In some embodiments, the catheter 602 includes a distal portion 604 configured to have a substantially arc shape, which is at least a semicircle. The sidewall of the catheter 602 may optionally include one or more openings 608 within the distal portion 604, configured to deliver one or more fluids (e.g., imaging dyes, contrast agents, oxygenated blood, saline solution, any combination thereof, or equivalents) to a body lumen 1292 (see Figure 12A). The openings 608 (multiple, in embodiments where the distal portion 604 includes one opening 608) are in fluid communication with the lumen 618. In some embodiments, the distal portion 604 of the catheter 602 includes one or more radiopaque markers 606. In some embodiments, the radiopaque markers 606 are wrapped around the circumference of the distal portion 604 of the catheter 602 and may have the same or different widths. The embolic protection device 600 further comprises a self-expanding embolic filter 610 defined by a frame 624 and a filter medium 626, and a deployment mechanism 612 (e.g., a longitudinally retractable outer sheath or a longitudinally retractable ring). The embolic filter 610 is positioned around the catheter 602.

[0091] Figure 6B illustrates the embolic filter 610 deployed in a self-expanding configuration by the retraction of the deployment mechanism (e.g., outer sheath) 612. The embolic filter 610 includes a distal opening 640 defined by a frame 624, facing the distal end 616 of the catheter 602, and extending proximal from the distal opening 640 to the closed proximal end 642. The embolic protection device 600 further comprises a push wire 622 coupled to the frame 624. The push wire 622 can be advanced distally to deflect (or bend) and extend the frame 624, thereby changing the configuration of the embolic filter 610 between self-expanding, partial expansion, and full expansion. In some embodiments, advancing the push wire 622 may cause the distal opening 640 of the embolic filter 610 to change orientation, shape, and / or size, and engage with at least a portion of the wall of the internal body lumen 1292 (see Figure 12D). Figure 6B illustrates the push wire 622 in a retracted, or non-advancing, state, with a frame 624 extending distally longitudinally, angled slightly (e.g., less than about 45 degrees) posteriorly laterally toward the proximal end 614. The catheter 602 may be partially surrounded toward its proximal end 614 by a support catheter 650 terminating at a head 652 located proximal to the distal portion 604 of the catheter 602. The support catheter 650 may be made from a thicker, more rigid material to add rigidity and provide a protective or supportive layer surrounding the catheter 602.

[0092] Figures 6C, 6E, and 6G show front view views of the embolic filter 610 as viewed from the distal opening 640 in self-expanding, partially-expanding, and fully-expanding configurations, respectively. The catheter 602 has been removed from these figures for clarity. The frame 624 has two sides (624a, 624b) that extend generally in the opposite lateral direction before generally extending in the first lateral direction away from the catheter 602 / support catheter 650, then looping posteriorly on the opposite side around the catheter 602 / support catheter 650, converging and abutting to form a roughly elliptical (i.e., shaped like an ellipse), or alternatively, a roughly oval (i.e., shaped like an oval) or circular shape. As shown, the embolic filter 610 is symmetrical about a plane (identified in the figure as a dotted line labeled "P"). For ease of discussion, the embolic filter 610 is referred to as having a left and a right side. The left element of the embolic filter 610 is similar to the right element of the embolic filter 610.

[0093] Figures 6D and 6E illustrate the embolic filter 610 in a partially expanded configuration, with a frame 624 deflected (i.e., bent) by the distal advancement of a push wire 622. The frame 624 comprises a movable portion 630 and a fixed portion 632. The movable portion 630 of the frame 624 can move longitudinally relative to the catheter 602 / support catheter 650. The movable portion 630 can move longitudinally relative to the catheter 602 / support catheter 650, while the fixed portion 632 cannot move. The frame 624 is coupled to the push wire 622 at the movable portion 630. In a convenient embodiment, the push wire 622 and the movable portion 630 are joined by crimping. In other embodiments, the push wire 622 and the movable portion 630 are joined by welding, adhesive, or threading. The frame 624 is attached to the support catheter 650 (or, alternatively, directly to the catheter 602) by the fixing portion 632. The fixing portion 632 of the frame 624 may be attached to the catheter 602 / support catheter 650 by welding, adhesive, or equivalent.

[0094] Starting from the fixed portion 632, the frame 624 extends distally longitudinally and then bends at an angle with respect to the longitudinal axis of the catheter 602 / support catheter 650. When the push wire 622 is in its retracted position, the frame 624 bends at an acute angle and extends proximal longitudinally, so that the frame 624 folds over itself (see Figure 6B). Advantageously, in this configuration, the embolic filter 610 can more effectively retain embolic residue captured during the procedure. The curvature of the frame 624 adjacent to the movable portion 630 can assist in crushing the frame 624 to advance the outer sheath 612 across the embolic filter 610.

[0095] Figure 6E shows a front view of the embolic filter 610 as seen from the distal opening 640 when the push wire 622 is advanced and the embolic filter 610 is in a partially expanded configuration. The advancing push wire 622 pushes the movable portion 630 forward relative to the catheter 602 / support catheter 650. (Shown as an arrow pointing away from the support catheter 650 in Figure 6D.) This, in turn, deflects or bends the frame 624 longitudinally distally and laterally outward. In the deflected configuration (i.e., when the push wire 622 is advanced), the distal opening 640 of the embolic filter 610 may be approximately perpendicular to the longitudinal axis of the catheter 602 / support catheter 650 and may laterally straddle the body lumen 1292 (see Figure 12D) approximately perpendicular to the longitudinal axis of the body lumen 1292. In the deflected configuration, the width X traversing the distal opening 640 bent This is increased compared to the corresponding dimension in the unbiased configuration. Width X in the bent configuration bent By increasing the angle, the frame 624 defining the distal opening 640 engages with the body lumen 1292.

[0096] Figures 6F and 6G illustrate the embolic filter 610 in a fully extended configuration, with a frame 624 extended by further distal advancement of the push wire 622. Further distal advancement of the push wire 622 pushes the movable portion 630 laterally relative to the catheter 602 / support catheter 650. This, in turn, extends the frame 624 radially outward, away from the catheter 602 / support catheter 650. (Shown in Figure 6G as left and right arrows pointing away from the support catheter 650.) In some embodiments, in addition to radially extending the frame 624, the advancing push wire 622 moves the movable portion 630 forward relative to the catheter 602 / support catheter 650, which in turn bends the frame 624 further longitudinally. In one embodiment, the movable portion 630 is formed with a curve or bend to assist in radially extending the frame 624.

[0097] In the extended configuration, the width X spans the distal opening 640. extended This refers to the corresponding dimensions (X) in the partially extended configuration of the embolic filter 610. bent Compared to, it is increased. Width X in the extended configuration extended By increasing the size, the frame 624 defining the distal opening 640 engages with the body lumen 1292. Partial expansion configuration of the embolic filter 610 (X bent ) and fully expandable configuration (X extended The increase in width across the distal opening 640 between (and the intermediate configuration between them) may represent a range of filter size or diameter, e.g., 25 mm to 40 mm. The range of filter size adapts to variations in the patient's vascular system. Advantageously, instead of a uniform device or multiple devices of different sizes, one embodiment of the embolic protection device 600 provides a single device that can be tailored to a particular patient and / or a particular surgical procedure. For example, a surgeon can expand the embolic filter 610 to a first size and then adjust the embolic filter 610 to a second size to achieve a better fit within the patient's vascular system.

[0098] In some embodiments, the distal opening 640 of the embolic filter 610 has a diameter of approximately 2 centimeters (cm) to approximately 6 cm (e.g., approximately 2.5 cm to approximately 4 cm or approximately 4.5 cm). The embolic filter 610 may have any preferred size or diameter to accommodate the anatomical variability of the patient's body lumen 1292 (see Figure 12A).

[0099] Figures 7A–7C illustrate another embodiment of the embolic protection device 700, comprising a catheter 702, an embolic filter 710, a movable outer sheath 712, and an actuation mechanism for operating the embolic filter 710. A portion of the catheter 702 is slidably received and supported by a fixed inner catheter 750 terminating at a head 752. The fixed inner catheter 750 may be made from a thicker, more rigid material to add rigidity and provide a protective or supportive layer surrounding the catheter 702. The embolic filter 710 is positioned around the fixed inner catheter 750 and is configured to self-expand into a radially expanding configuration as shown in Figure 7A when not confined or restrained by the outer sheath 712.

[0100] The embolic filter 710 includes a frame 724 and a filter medium 726. The frame 724 defines the distal opening 740 of the embolic filter 710 and includes a movable portion 730 for controlling the size or diameter of the distal opening 740. The embolic filter 710 extends proximal from the distal opening 740 to a closed proximal end 742. The frame 724 further includes a fixing portion 732 for attaching the frame 724 to the fixed internal catheter 750 at a location adjacent to the closed proximal end 742 of the embolic filter 710. In some embodiments, the embolic protection device 700 is similar to the embolic protection device 600 shown in Figures 6A-6G, with the addition of an operating mechanism.

[0101] The operating mechanism comprises an inner catheter 756 and an outer catheter 758. The inner catheter 756 slides over a fixed inner catheter 750. The outer catheter 758 slides over the inner catheter 756. The movement of the inner catheter 756 and the outer catheter 758 relative to the fixed inner catheter 750 controls the size or diameter of the embolic filter 710, as will be described in more detail below.

[0102] The embolic protection device 700 further includes a push wire 722 coupled to the distal portion 764 of the outer catheter 758. The push wire 722 is longitudinally movable by the outer catheter 758 between a fully retracted state, a partially advanced (or partially retracted) state, and a fully advanced state. The push wire 722 is further coupled to a movable portion 730 of the frame 724. Moving the outer catheter 758 relative to the fixed inner catheter 750 is translated into moving the push wire 722 between the fully retracted, partially advanced, and fully advanced states. This, in turn, pushes the movable portion 730 and deflects (or bends) or extends the frame 724.

[0103] In various embodiments of the embolic protection device 700, the aforementioned device components may be joined to each other by any number of means and techniques as described above. For example, in a convenient embodiment, a sleeve made of polyether block amide (PEBAX(R)) or other similar biocompatible material attaches the push wire 722 to the distal portion 764 of the outer catheter 758, the upper guide 760 to the distal portion 766 of the inner catheter 756, and the bottom guide 762 to the fixed inner catheter 750. In addition, or alternatively, the device components may be joined together with a biocompatible adhesive.

[0104] The operating mechanism further includes an upper guide 760 and a bottom guide 762 to direct the deflection and extension of the frame 724 so that the distal opening 740 of the embolic filter 710 faces toward the distal end (or working end) of the device 220 as it expands. In some embodiments, the upper guide 760 and the bottom guide 762 keep the movable portion 730 and the fixed portion 732 of the frame 724 in a straight line, respectively. The upper guide 760 and the bottom guide 762 are arranged at opposite points around the fixed inner catheter 750, with portions positioned along the fixed inner catheter 750. The upper guide 760 is coupled at one end to the distal portion 766 of the inner catheter 756. A portion of the upper guide 760 distal to the distal portion 766 is slidably engaged with the fixed inner catheter 750 at the closed proximal end 742 of the embolic filter 710, or otherwise adjacent thereto. For example, a portion of the upper guide 760 slides along the fixed inner catheter 750 beneath the filter medium 726 and passes through the closure proximal end 742 of the embolic filter 710. The bottom guide 762 is fixedly attached to the fixed inner catheter 750 at the closure proximal end 742 of the embolic filter 710, or otherwise adjacent thereto.

[0105] At the distal opening 740 of the embolic filter 710, the upper guide 760 and the bottom guide 762 are movable away from the fixed inner catheter 750. The upper guide 760 slidably receives the movable portion 730 of the frame 724, and the bottom guide 762 receives the fixed portion 732. The arrangement causes the upper guide 760 and the bottom guide 762 to spread outward or bend away from the fixed inner catheter 750 (as one moves from the closed proximal end 742 of the embolic filter 710 to the distal opening 740), thereby giving the embolic filter 710 a substantially funnel-shaped appearance. The upper guide 760 and the bottom guide 762 may also support the filter material 726 longitudinally and laterally between the distal opening 740 and the closed proximal end 742 of the embolic filter 710. In a convenient embodiment, the upper guide 760 and the bottom guide 762 are hypotubes made from stainless steel, polyetheretherketone (PEEK), or other biocompatible materials.

[0106] Figure 7A further illustrates the outer sheath 712 fully retracted over the embolic filter 710, and the exposed embolic filter 710. The inner catheter 756 and outer catheter 758 are in their initial positions (labeled "A" in the figure) relative to the fixed inner catheter 750. When the embolic filter 710 is unshielded, the movable portion 730 and fixed portion 732 of the frame 724, along with the upper guide 760 and bottom guide 762, bend outward away from the fixed inner catheter 750. This positions the distal opening 740 of the embolic filter 710 at a certain angle to the fixed inner catheter 750. For example, the frame 724 and the fixed inner catheter 750 are at an angle of 45 degrees or less. At this stage of deployment, the embolic filter 710 is in a self-expanding configuration with the unbent frame 724.

[0107] Figure 7B illustrates the distal opening 740 partially expanded to a first size or diameter. The inner catheter 756 and outer catheter 758 are simultaneously advanced distally across the fixed inner catheter 750. The inner catheter 756 and outer catheter 758 are moved from their initial position (labeled "A" in the figure) to their intermediate position (labeled "B" in the figure) relative to the fixed inner catheter 750. The simultaneous movement of the inner catheter 756 and outer catheter 758 advances both the push wire 722 and the upper guide 760, thereby pushing the movable portion 730 of the frame 724 longitudinally distally (forward). This rotates the distal opening 740 of the embolic filter 710 to an orientation approximately perpendicular to the longitudinal axis of the fixed inner catheter 750, expanding the distal opening 740 to a first size (e.g., a diameter of approximately 25 mm).

[0108] Figure 7C illustrates the distal opening 740 fully expanded to a second size, which is larger than the first size. In Figure 7E, the outer catheter 758 is advanced distally across the inner catheter 756 and the fixed inner catheter 750. Without the inner catheter 756 moving, the outer catheter 758 moves from its intermediate position (labeled "B" in the figure) to its final position (labeled "C" in the figure) relative to the fixed inner catheter 750. The continued distal movement of the outer catheter 758 moves the push wire 722 without moving the upper guide 760. The length of the movable portion 730 of the frame 724 is extended radially outward from the upper guide 760 (i.e., outward from the plane of the page), extending the frame 724 and further expanding the distal opening 740 of the embolic filter 710 to a second size (e.g., a diameter of approximately 40 mm).

[0109] Figures 8A-8F illustrate an embodiment of an embolic protection device 800, comprising a catheter 802, an embolic filter 810, a movable outer sheath 812, and a handle 870 for manually operating the embolic filter 810. In Figure 8B, the embolic protection device 800 further comprises a push wire 822, a filter frame 824, a filter medium 826, a movable portion 830, a fixed portion 832, a fixed inner catheter 850, an inner catheter 856, an outer catheter 858, an upper guide 860, and a bottom guide 862, arranged in a configuration similar to that described above with reference to Figures 7A-7C. For example, the push wire 822 is coupled to the distal portion 864 of the outer catheter 858, and the upper guide 860 is coupled to the distal portion 866 of the inner catheter 856 at one end. In some embodiments, the embolic protection device 800 is similar to the embolic protection device 700 in Figures 7A-7C, with the addition of a handle 870.

[0110] Figure 8A illustrates a handle 870 having a first slider 872 that is operable to manually retract the outer sheath 812 over the catheter 802 and embolic filter 810, and to deploy the embolic filter 810 in a self-expanding configuration. The first slider 872 is further used to manually advance the outer sheath 812 over the catheter 802 and embolic filter 810, and to crush / return the embolic filter 810 to its original position. The handle 870 further includes a second slider 874 that is operable to manually increase or decrease the size or diameter of the distal opening 840 of the embolic filter 810. (The embolic filter 810 extends proximal from the distal opening 840 to the closed proximal end 842.)

[0111] In some embodiments, the catheter 802 is a pigtail type catheter as shown in Figure 8B and described herein. The catheter 802 includes a distal portion 804 configured to have a substantially arc shape, which is at least semicircular. In some embodiments, the distal portion 804 of the catheter 802 includes one or more radiopaque markers 806. The sidewall of the catheter 802 may optionally include one or more openings 808 within the distal portion 804, configured to deliver one or more fluids (e.g., imaging dyes, contrast agents, oxygenated blood, saline, any combination thereof, or equivalents) into a body lumen.

[0112] The catheter 802 has a proximal end, a distal end 816, and a lumen 818 extending between the proximal and distal ends 816. The lumen 818 may be configured to house a guidewire 1290 (see Figures 12A and 12B) which is movable longitudinally through the lumen to coil or straighten the distal portion 804 of the catheter 802, depending on whether the guidewire is retracted (to coil the distal portion) or extended (to straighten the distal portion). The opening 808 and the lumen 818 may be in fluid communication with each other to deliver one or more fluids to a body lumen as described above.

[0113] As shown in Figure 8B, an embodiment of catheter 802 is partially surrounded toward its proximal end by a fixed inner catheter 850 located proximal to the distal portion 804 of catheter 802, terminating at head 852. The fixed inner catheter 850 may be made from a thicker, more rigid material to add rigidity and provide a protective or supportive layer surrounding catheter 802.

[0114] Figure 8C illustrates an embodiment of a handle 870 (with the handle cover removed for clarity) that includes a sheath engagement mechanism 876 configured to advance or retract the outer sheath 812 by the movement of a first slider 872. The outer sheath 812 is joined to the sheath engagement mechanism 876. Any number of preferred means (e.g., fasteners and / or adhesives) or techniques (e.g., ultrasonic welding, solvent welding, and overmolding) can be used to join the outer sheath 812 and the sheath engagement mechanism 876.

[0115] The sheath engagement mechanism 876 is movable within the handle 870 between a distal initial position (shown in Figure 8C) and a proximal final position (shown in Figure 8D). The initial position of the sheath engagement mechanism 876 corresponds to the outer sheath 812, which is circumferentially positioned around at least a portion of the embolic filter 810, and the embolic filter 810, which is housed in a collapse configuration. The final position of the sheath engagement mechanism 876 corresponds to the outer sheath 812, which is retracted longitudinally across the embolic filter 810, and the embolic filter 810, which is deployed in a self-expanding configuration.

[0116] The sheath engagement mechanism 876 is selectively operable by the first slider 872. For example, the operator presses the first slider 872 with their thumb to release the sheath engagement mechanism 876 from the handle 870 in order to move the sheath engagement mechanism 876 from its initial position (shown in Figure 8C) to its final position (shown in Figure 8D). The operator uses their thumb to move the first slider 872 proximal, retracting the outer sheath 812 and exposing the embolic filter 810. To crush / return the embolic filter 810, the operator moves the first slider 872 distally, advancing the outer sheath 812 over the embolic filter 810.

[0117] An embodiment of the handle 870 shown in Figure 8C further includes an engagement mechanism 878 configured to change the size or diameter of the distal opening 840 of the embolic filter 810 by moving a second slider 874. The engagement mechanism 878 comprises an upper pull 880 and a bottom pull 882. The upper pull 880 is coupled to the proximal portion of the outer catheter 858, and the bottom pull 882 is coupled to the proximal portion of the inner catheter 856 (shown in Figure 8F).

[0118] The engagement mechanism 878 is movable within the handle 870 between an initial (proximal) position (shown in Figures 8C and 8D), an intermediate position (shown in Figure 8E), and a final (distal) position (shown in Figure 8F). The initial position of the engagement mechanism 878 corresponds to the embolic filter 810 in a self-expanding configuration with an unbent (unbent) filter frame 824. The intermediate position of the engagement mechanism 878 corresponds to the embolic filter 810 in a partially expanding configuration with a longitudinally deflected (or bent) filter frame 824. The final position of the engagement mechanism 878 corresponds to the embolic filter 810 in a fully expanding configuration with a radially extended filter frame 824.

[0119] The engagement mechanism 878 is selectively operable by the second slider 874. For example, with the engagement mechanism 878 in its initial position (shown in Figure 8D), the user presses down on the second slider 874. The applied force moves a projection (not shown) extending from the second slider 874 downward through a hole (not shown) in the upper pull 880 into a recess (not shown) in the bottom pull 882.

[0120] In Figure 8E, when viewed in conjunction with Figure 8B, the second slider 874 is pressed and engages with both the upper pull 880 and the bottom pull 882. The operator then uses their thumb to move the second slider 874 distally, advancing both the outer catheter 858 and the inner catheter (hidden from the figure). The simultaneous movement of the outer catheter 858 and the inner catheter moves the push wire 822 and the upper guide 860 together (i.e., they are moved simultaneously). This, in turn, advances the longitudinally movable portion 830 distally (forward), expanding the distal opening 840 of the embolic filter 810.

[0121] The distal opening 840 continues to expand as the second slider 874 moves distally until the engagement mechanism 878 reaches the intermediate position shown in Figure 8E. At the intermediate position, the distal opening 840 is of a first size (e.g., a diameter of approximately 25 mm), and the second slider 874 is partially disengaged from the engagement mechanism 878. For example, a spring and ball plunger (not shown) located within the handle 870 lifts a projection outward from a recess in the bottom pull 882. The second slider 874 is disengaged from the bottom pull 882 but remains engaged with the upper pull 880. It may be convenient to refer to the engagement between the upper pull 880 and the bottom pull 882 as temporary.

[0122] In Figure 8F, referring to Figure 8B in combination, the operator moves the second slider 874 distally, continuing to advance the outer catheter 858 further distally. Once the bottom pull 882 is engaged and disengaged, the inner catheter 856 and upper guide 860 are fixed in place, while the push wire 822 advances further distally. As a result, the length of the movable portion 830 expands radially outward from the upper guide 860 (i.e., outward from the plane of the page), further expanding the distal opening 840 of the embolic filter 810 to the next size (e.g., a diameter of approximately 30 mm). The distal opening 840 expands to its maximum size (e.g., a diameter of approximately 40 mm) when the engagement mechanism 878 is in the final position as shown in Figure 8F. To return the embolic filter 810 to its original state, the process described above is reversed with reference to Figures 8C-8F.

[0123] In some embodiments, the wires of the embolic protection device as described herein, for example, the pull wire 122 of the embolic protection device 100 in Figure 1B or the push wire 622 of the embolic protection device 600 in Figure 6B, include a metallic material, such as stainless steel. Alternatively, the wires may include a plastic material or other suitable material. In some embodiments, the wires are stainless steel coated with polytetrafluoroethylene (PTFE). In the case of a wire that is a pull wire, similar to the pull wire 122 in Figure 1B, the pull wire may be flexible but have sufficient rigidity to deflect (or bend) the frame of the embolic filter proximal when the pull wire is retracted, in a manner similar to those described above with reference to Figures 1C and 1D. In the case of a push wire, similar to the push wire 622 in Figure 6B, the push wire is flexible, but may have sufficient rigidity to extend the frame radially as the pull wire is further advanced, so as the pull wire is advanced, to deflect / bend the frame of the embolic filter distally as the pull wire is advanced, in a manner similar to that described above with reference to Figures 6D-6F.

[0124] In some embodiments, the filter medium (e.g., filter medium 126 in Figure 1A or filter medium 626 in Figure 6B) comprises a braided mesh, for example, a braided nitinol mesh. In some embodiments, the filter medium comprises a porous membrane, for example, a semipermeable polyurethane membrane. In other embodiments, the filter medium has a pore size of about 100 microns to about 150 microns (e.g., about 125 microns).

[0125] In some embodiments, the embolic filter (e.g., the embolic filter 110 in Figure 1B or the embolic filter 610 in Figure 6B) is advantageously equipped with an antithrombotic coating (e.g., a heparin coating or other coatings containing thrombin or an antiplatelet agent) to reduce thrombus formation.

[0126] The embolic filter is configured to self-expand into a radially expanding configuration, for example, as illustrated in Figures 1B and 1C, and Figures 6B and 6C, when it is not confined or restrained by a deployment device such as the outer sheath 112 in Figure 1A or the outer sheath 612 in Figure 6A.

[0127] In some embodiments, where the deployment mechanism comprises an outer sheath (e.g., a movable outer sheath 112 in Figure 1A or a movable outer sheath 612 in Figure 6A), the outer sheath is configured to be circumferentially positioned around at least a portion of the catheter and embolic filter (e.g., catheter 102 and embolic filter 110 in Figure 1A, or catheter 602 and embolic filter 610 in Figure 6A). The outer sheath is configured to contain or house the embolic filter in a collapse configuration. The outer sheath is longitudinally movable relative to the catheter and can be retracted longitudinally (i.e., moved longitudinally proximal) to deploy the embolic filter and advanced longitudinally (i.e., moved longitudinally distally) to recapture the embolic filter and any embolic material collected by the embolic filter. The embolic filter is configured to self-expand in response to the longitudinal retraction of the outer sheath.

[0128] In some embodiments, the embolic filters of the embolic protection device described herein (e.g., embolic filter 110 in Figure 1A and embolic filter 610 in Figure 6A) are configured to be at least partially crushed in accordance with the longitudinal extension of the outer sheath (e.g., outer sheath 112 in Figure 1A and outer sheath 612 in Figure 6A). In these embodiments, the distal openings of the embolic filters (e.g., distal opening 140 in Figure 1B and distal opening 640 in Figure 6B) form a substantially closed configuration, thereby isolating or substantially isolating the filtered material.

[0129] In some embodiments, the catheters of the embolic protection devices described herein (e.g., catheter 102 in Figure 1A and catheter 602 in Figure 6A) may contain a flexible material so as to be maneuverable within a body lumen (e.g., body lumen 992 in Figure 9A and body lumen 1292 in Figure 12A), as further described herein. For example, in some embodiments, the catheter contains a metal or metal alloy. In other embodiments, the catheter contains a polymer (e.g., polyurethane, silicone, latex, polytetrafluoroethylene (PTFE), plastic materials, any combination thereof, or equivalents). In some embodiments, the catheter contains a metal-reinforced plastic (e.g., nitinol, stainless steel, and equivalents). Other materials are also possible. In some embodiments, the catheter is substantially free of latex (natural or rubber), which may cause allergic reactions in some patients. In some embodiments, the catheter is advantageously equipped with braided reinforcement tubes to increase the strength of the catheter. In some embodiments, the catheter comprises a braided catheter shaft including a layer of braided wire between two layers of the catheter tubule, which can increase the strength of the catheter. In some embodiments, the catheter does not include a braided layer, which can increase the flexibility of the catheter. In some embodiments, the catheter comprises a lubricating coating, e.g., a coating with a low coefficient of friction, which is advantageous in allowing smoother navigation through tortuous vascular systems. In some embodiments, the catheter coating is advantageous in having antithrombotic properties to prevent thrombus formation. In some embodiments, the catheter has a size (i.e., outer diameter) of 3 French to about 5 French (about 2 mm to about 3 mm). Other sizes are also possible, for example, depending on the size of the target body lumen of a particular patient. In some embodiments, the catheter has a length of about 65 centimeters (cm) to about 135 cm. Other lengths are also possible, for example, to allow insertion of the catheter into the femoral, radial, humeral, or subclavian artery. The catheter can be manufactured, for example, by extrusion, injection molding, or another preferred process.

[0130] In some embodiments, the embolic protection device described herein may include one or more radiopaque marker bands located on the distal portion of the catheter. For example, the embolic protection device 100 in Figures 1A and 1B with radiopaque marker 106 is located on the distal portion 104 of the catheter 102. In another embodiment, the embolic protection device 600 in Figures 6A and 6B with radiopaque marker 606 is located on the distal portion 604 of the catheter 602. When the distal portion has a substantially arc shape, the circumferential radiopaque marker band may be visualized to confirm that the distal portion is substantially arc-shaped. In some embodiments, the radiopaque marker band is positioned such that, when its distal portion has a substantially arc-shaped configuration, the marker band is at the most distal point of the catheter, i.e., actually extends beyond the distal end of the catheter (for example, beyond the distal end 116 of catheter 102 shown in Figures 1A and 1B, or beyond the distal end 616 of catheter 602 shown in Figures 6A and 6B).

[0131] Radiopaque markers include radiopaque materials such as platinum, tantalum, tungsten, palladium, and / or iridium. Other radiopaque materials are also possible. In some embodiments, the material may have, for example, an average atomic number greater than 24, or a density of about 9.9 g / cm³. 3 If the value exceeds a certain threshold, it may be considered radiopaque. In some embodiments, the distal portion of the catheter (e.g., distal portion 104 of catheter 102 in Figures 1A and 1B, and distal portion 604 of catheter 602 in Figures 6A and 6B) may be injected with radiopaque material so that the entire distal portion is visible using imaging techniques.

[0132] In some embodiments, the outer sheath of an embolic protection device, as described herein, comprises a hollow tube configured to circumferentially surround at least a portion of the catheter. For example, the outer sheath 112 of the embolic protection device 100 in Figures 1A-1F, or the outer sheath 612 of the embolic protection device 600 in Figures 6A-6G. The outer sheath is longitudinally movable relative to the catheter and is configured to at least partially contain or house the embolic filter in a collapsed configuration when surrounding the embolic filter circumferentially, as shown in Figures 1A and 6A. The outer sheath is longitudinally retractable proximal to release the embolic filter into an expanded open configuration when not contained by the outer sheath.

[0133] In some embodiments, the outer sheath extends proximal to the proximal end of the catheter (e.g., the proximal end 114 of catheter 102 shown in Figure 1A or the proximal end 614 of catheter 602 shown in Figure 6A) so that the user can directly grasp and manipulate the outer sheath. In some embodiments, the outer sheath extends proximal only over a portion of the catheter, and a secondary device (e.g., a push rod, as found in stent deployment systems) is coupled to the outer sheath (e.g., to the proximal end of the outer sheath) to allow indirect manipulation of the outer sheath. Manipulation of the outer sheath can be mechanical, electronic, manual, a combination thereof, and equivalent.

[0134] In some embodiments, an embolic protection device as described herein may have a groove (not shown) extending longitudinally along its outer surface. For example, the embolic protection device 100 in Figure 1B includes a groove extending longitudinally along the catheter 102, along the support catheter 150, or along the deployment mechanism (e.g., outer sheath) 112. In another embodiment, the embolic protection device 600 in Figure 6B includes a groove extending longitudinally along the catheter 602, along the support catheter 650, or along the deployment mechanism / outer sheath 612. In some embodiments, the groove may extend substantially from the proximal end to the distal end of the embolic protection device. The groove may be useful for guiding another catheter device alongside the embolic protection device. For example, the groove may be useful for guiding a valve delivery device alongside and beyond the distal end of the embolic protection device. Advantageously, the second device may be tracked along the groove and pass beyond the embolic protection device while the embolic filter is being deployed, for example, as shown in Figure 13A.

[0135] The devices disclosed herein may comprise some or all of the features of embolic protection devices 100, 200, 300, 400, 500, 600, 700, and 800, as shown in Figures 1A-1F, 2A and 2B, 3A-3D, 4A-4C, 5A and 5B, 6A-6G, 7A-7C, and 8A-8F, in various combinations as described herein.

[0136] III. Methods for capturing embolic residue

[0137] Another aspect of the present invention provides a method 900 for capturing embolic debris during a closed cardiac medical procedure (e.g., an aortic valve replacement procedure) using an embolic protection device of the present invention (e.g., embolic protection devices 100, 200, 300, 400, or 500 as described herein), as illustrated in a stepwise manner in Figures 9A–9E.

[0138] Referring to Figure 9A, in one embodiment, the guidewire 990 is percutaneously inserted into a patient's body lumen 992, for example, the femur, radius, humerus, or subclavian artery, and navigated to a desired anatomical location, for example, the ascending aorta. The guidewire 990 may be a J-shaped tip wire having a diameter of about 0.035 inches (about 0.089 cm). Other types and dimensions of guidewires 990 useful for this method are also possible.

[0139] In some embodiments, the proximal end of the guidewire 990 is inserted into the opening at the distal end 116 of the catheter 102. When the guidewire 990 is in the lumen 118 of the catheter 102 at the distal portion 104 of the catheter 102, the distal portion 104 of the catheter is straightened or forms the curvature of the guidewire 990. The distal end 116 of the catheter 102 is inserted into the body lumen 992 by tracing the lumen 118 of the catheter 102 along the guidewire 990, as shown in Figure 9A. The outer diameter of the guidewire 990 is smaller than the inner diameter of the embolic protection device 100 so that the embolic protection device 100 can be traced along the guidewire 990. The inner surface of the lumen 118 and / or the outer surface of the guidewire 990 may include a lubricating coating to reduce friction during tracing. The guidewire 990 keeps the distal portion 104 of the catheter 102 in a nearly straight position (for example, from a nearly arched shape) as the catheter 102 is inserted into the patient's body and navigated within it.

[0140] The radiopaque marker 106 is used to visualize and position the distal portion 104 of the catheter 102 during tracking. The guidewire 990 is moved backward, i.e., longitudinally proximal, by a distance sufficient to allow the distal portion 104 of the catheter 102 to form a substantially arched shape, as shown in Figure 9B. The distal portion 104 of the catheter 102 is positioned at a desired anatomical landmark, for example, the inferior boundary of the non-coronary cusp of the aortic valve. The radiopaque marker 106 is located on the most distal segment of the distal portion 104 when the distal portion 104 forms its substantially arched shape. In some embodiments, the distal portion 104 of the catheter 102 may be injected with radiopaque material so that the entire distal portion 104 is visible using imaging techniques.

[0141] In some embodiments of the method, the proximal end 114 of the catheter 102 is connected to a contrast agent injector, and a contrast agent is injected into the lumen 118 of the catheter 102 so that, for example, the biostructure around the device 100 is visualized. The contrast agent exits the lumen 118 of the catheter 102 through an opening at the distal end 116 of the catheter 102 and / or through one or more openings 108 in the side wall of the catheter 102. Injecting the contrast agent can help visualize and position the catheter 102.

[0142] In some embodiments, a second guidewire is percutaneously inserted into a second body lumen, for example, another femoral artery, and a second catheter is tracked along the second guidewire. The second catheter can carry a medical device or instrument, such as a replacement valve, valve repair system, or radiofrequency ablation system. Once the second catheter and associated device or instrument are properly positioned, the outer sheath 112 of the catheter 102 is retracted longitudinally proximal, allowing the embolic filter 110 to form an expanded deployment configuration, as shown in Figure 9C.

[0143] Next, the pull wire 122 can be retracted to bend the frame 124 of the embolic filter 110. The pull wire 122 bends the frame 124 proximal longitudinally and laterally outward. In a fully bent configuration (i.e., with a fully retracted pull wire) as shown in Figures 9D and 9E, the distal opening 140 of the embolic filter 110 may be substantially perpendicular to the catheter 102 and may laterally straddle the body lumen 992, traversing the body lumen 992 substantially perpendicular to the longitudinal axis of the body lumen 992. The fully bent configuration may engage with the body lumen 992 and thereby capture the embolic residue 994 within the embolic filter 110 without allowing the embolic residue to advance around the outside of the embolic filter 110. A second guidewire and / or a second catheter may also be positioned after the embolic filter 110 has been deployed. The distal opening 140 of the embolic filter 110 is located within the ascending aorta so that blood flows through the filter before flowing into the carotid artery or descending aorta. In some embodiments, when the embolic filter 110 is deployed, the catheter 102 is placed against the inner lumen wall, thereby stabilizing the catheter 102. The procedure can then be performed, and any embolic residue released during the procedure or otherwise present in the bloodstream is captured by the embolic filter 110.

[0144] Following this procedure, the pull wire 122 is advanced, and the outer sheath 112 is advanced longitudinally distally to recapture the embolic filter 110, return the frame to an unbent configuration, return the embolic filter 110 to a collapsed configuration, and capture any embolic residue 994 (see Figure 9E) contained within the embolic filter 110. The second catheter and catheter 102 can then be withdrawn from the patient's body. The catheter 102 can be retracted over the guidewire 990, or without straightening the distal portion 104 of the catheter 102, as the arched shape of the distal portion 104 is non-traumatic to the blood vessel.

[0145] In some embodiments, the procedure performed is a heart valve replacement procedure, such as an aortic valve replacement procedure. The embolic protection device 100 is introduced into the patient and navigated to the aortic valve, as described herein and shown in Figures 9A–9E. A radiopaque marker 106 helps contour the inferior boundary of the non-coronary cusp and assists in the proper positioning of the percutaneously implanted replacement aortic valve. Once the catheter 102 is positioned, a second guidewire can be percutaneously inserted into a second body lumen and navigated to the level of the ascending aorta or left ventricle. A balloon can be tracked along the second guidewire to the aortic valve. The outer sheath 112 is then retracted to deploy the embolic filter 110, and the pull wire 122 is retracted to bend the frame 124 into a bent configuration. The valve balloon can then be inflated, and the embolic filter 110 captures any embolic residue 994 that is released during the procedure or otherwise present in the bloodstream. After pre-inflation of the balloon, the pull wire 122 is advanced, and the outer sheath 112 is advanced to recapture the embolic filter 110 and any embolic residue 994 contained within the embolic filter 110. The balloon is removed, and a second catheter carrying the prosthetic valve is advanced to the level of the ascending aorta by tracking the catheter across a second guidewire. The outer sheath 112 is retracted again to redeploy the embolic filter 110, and the pull wire 122 is retracted again. A radiopaque marker 106 allows the user to properly position the prosthetic valve, for example, about 4 mm to 6 mm below the lower boundary of the non-coronary cusp. After the procedure is completed, the pull wire 122 is advanced, the outer sheath 112 is advanced to recapture the embolic filter 110 and any captured embolic residue 994, and the catheter is removed from the body. In some embodiments, a second catheter may be removed prior to recapturing the embolic filter 110 and embolic residue 994.

[0146] In some embodiments, the procedure is a cardiac valve repair procedure. The method described herein can also be adapted for mitral valve repair or replacement procedures. In some embodiments, the procedure is, for example, a radiofrequency ablation procedure for treating atrial fibrillation. In some embodiments, the procedure is a catheter insertion procedure or a structural cardiac procedure.

[0147] In some embodiments, the method of capturing embolic residue as described herein may include the step of inserting a second catheter device through the same vessel as the embolic protection device. The second catheter device may be inserted after the embolic protection device and may be tracked along a longitudinal groove on the outer surface of the embolic protection device. For example, a valve delivery catheter device may be guided alongside the embolic protection device and beyond its distal end by tracking the valve delivery device along the groove. Advantageously, the second device may be tracked along the groove and pass beyond the embolic protection device while the embolic filter is being deployed, for example, as shown in Figure 13A.

[0148] Figure 10 illustrates another embodiment of method 1000 of deflecting and capturing embolic residue during a medical procedure using an embolic protection device 1001. The embolic protection device 1001 is similar to the embolic protection device 300 described in Figures 3A-3D in that it has an intermediate tube 1030. The embolic protection device 1001 further comprises an embolic filter 1010 which is movably coupled to the catheter 1002 by a frame 1024 and is longitudinally movable relative to the catheter 1002. As shown in the figure, the catheter 1002 is at least partially surrounded by a support catheter 1050 which terminates at a head 1052 proximal to the distal portion 1004 of the catheter 1002. The embolic filter 1010 is coupled to an intermediate tube 1030 which at least partially surrounds the support catheter 1050 circumferentially. The intermediate tube 1030 is longitudinally movable relative to the catheter 1002.

[0149] The embolic protection device 1001 further comprises an outer sheath (not shown) configured to at least partially surround both the catheter 1002 / support catheter 1050 and the intermediate tube 1030 in the circumferential direction. The intermediate tube 1030 and the outer sheath can be moved simultaneously and independently. The longitudinal position of the embolic filter 1010 relative to the catheter 1002 can be adjusted while the embolic filter 1010 is in a collapsed configuration or in an expanded or partially expanded configuration.

[0150] Method 1000 includes the step of capturing the embolus using an embolus protection device 1001 in a manner similar to Method 900 described above with reference to Figures 9A-9E. For example, the distal end 1016 of a catheter 1002 is inserted into the patient's body lumen 1080 by tracking the lumen 1018 of the catheter 1002 via a guidewire that has been previously inserted percutaneously into the body lumen 1080. The guidewire keeps the distal portion 1004 of the catheter 1002 substantially straight (from, for example, a substantially arc-shaped state) as the catheter 1002 is inserted into the patient's body and navigated within the body. A radiopaque marker 1006 is used to visualize and position the distal portion 1004 of the catheter 1002 during tracking. Visualization may also be performed by perfusing an imaging dye or contrast agent through an opening 1008 in the distal portion 1004 of the catheter 1002. Once positioned at the desired anatomical landmark (e.g., the inferior boundary of the non-coronary cusp of the aortic valve), the guidewire is retracted by a sufficient distance for the distal portion 1004 of the catheter 1002 to form a roughly arched shape, as shown in Figure 10.

[0151] The longitudinal position of the embolic filter 1010 within the body lumen 1080 can be adjusted by simultaneously moving the intermediate tube 1030 and the outer sheath. When the embolic filter 1010 is in the desired longitudinal position within the body lumen 1080, the intermediate tube 1030 is held stationary while the outer sheath is retracted to deploy the embolic filter 1010. The pull wire 1022 is then retracted to bend the frame 1024, opening the embolic filter 1010 and capturing the embolus.

[0152] Method 1000 further includes a step of deflecting the embolus. The embolus protection device 1001 also comprises a deflector 1060 similar to that shown in Figures 4A-C. Once the embolus protection device 1001 is in position (as described above), the deflector 1060 is deployed from the outer sheath to cover the brachiocephalic and left common carotid arteries. In some patients, the deflector 1060 may also cover the left subclavian artery. During the subsequent medical procedure, the deflector 1060 can prevent the embolus from entering the carotid artery, and the embolus filter 1010 can capture the embolus deflected by the deflector 1060 before it can advance to other parts of the patient's body. Method 1000 can also be performed, for example, with various other embolus protection devices, such as those described herein, and deflector devices, the configuration and the way they are inserted into the body and navigated to the aortic arch may vary.

[0153] Figure 11 illustrates another embodiment of the method 1100 for deflecting and capturing embolic residue. The embolic protection device 1101 comprises a catheter 1102 (e.g., a pigtail catheter) with a radiopaque marker 1106, and an embolic filter 1110 positioned around the catheter 1102, similar to the embolic filter 110 shown in Figures 1A-1F and described herein. As shown in the figure, the catheter 1102 is partially surrounded by a support catheter 1150 terminating at a head 1152, proximal to the distal portion 1104 of the catheter 1102.

[0154] Method 1100 includes the step of capturing the embolus using an embolus protection device 1101 in a manner similar to Method 900 described above with reference to Figures 9A-9E. For example, the distal end 1116 of a catheter 1102 is inserted into the patient's body lumen 1180 by tracking the lumen 1118 of the catheter 1102 via a guidewire that has been previously inserted percutaneously into the body lumen 1180. The guidewire keeps the distal portion 1104 of the catheter 1102 substantially straight (from, for example, a substantially arc-shaped state) as the catheter 1102 is inserted into the patient's body and navigated within the body. A radiopaque marker 1106 is used to visualize and position the distal portion 1104 of the catheter 1102 during tracking. Visualization may also be performed by perfusing an imaging dye or contrast agent through an opening 1108 in the distal portion 1104 of the catheter 1102.

[0155] Once positioned at the desired anatomical landmark (e.g., the inferior boundary of the non-coronary cusp of the aortic valve), the guidewire is retracted by a sufficient distance for the distal portion 1104 of the catheter 1102 to form a roughly arched shape, as shown in Figure 11. The outer sheath of the catheter 1102 (not shown) is retracted longitudinally proximal, allowing the embolic filter 1110 to form an expanded deployment configuration, as shown in Figure 11. Next, the pull wire 1122 is retracted to bend the frame 1124 and open the embolic filter 1110 to capture the embolus.

[0156] Method 1100 further includes the step of deflecting the embolization using a deflector 1160. As shown, the deflector 1160 is mounted on a shaft 1162 and contained within an introducer 1168 during insertion. The introducer 1168 is introduced into the patient's body through an artery (e.g., the right radial artery) and navigated to the aortic arch via the brachiocephalic artery. Once in position, the deflector 1160 is deployed from the introducer 1168 and pulled backward to cover the brachiocephalic and left common carotid arteries. In some patients, the deflector 1160 may also cover the left subclavian artery. In some embodiments, the deflector 1160 can be introduced and deployed before the catheter 1102 is navigated to the aortic arch. During subsequent medical procedures, the deflector 1160 can prevent the embolus from entering the carotid artery, and the embolus filter 1110 can capture the embolus deflected by the deflector 1160 before it can progress to other parts of the patient's body. Method 1100 can also be performed with deflector devices, for example, with various other embolus protection devices as described herein, and the configuration and the way in which they are introduced into the body and navigated to the aortic arch can vary.

[0157] Another aspect of the present invention includes the step of inserting the distal end of an embolic protection device into a body lumen, wherein the embolic protection device is a catheter having a proximal end, a distal end, and a lumen extending from the proximal end of the catheter to the distal end of the catheter, the lumen being configured to house a guidewire, and the distal portion of the catheter having a substantially arc shape being at least semicircular when the guidewire is at least partially retracted longitudinally, and a self-expanding embolic filter positioned around the catheter proximal to the distal portion, the embolic filter comprising a frame, the frame defining the opening of the embolic filter, and the catheter A method is provided for capturing embolic residue during a closed cardiac procedure, comprising: a deployment mechanism positioned around a portion of the catheter, the deployment mechanism being movable longitudinally relative to the catheter, the deployment mechanism being configured to contain an embolic filter in a collapse configuration, the embolic filter being configured to self-expand in response to the longitudinal retraction of the deployment mechanism; and a pull wire coupled to the frame of the embolic filter, the wire being movable longitudinally, and bending the frame longitudinally toward the proximal end of the catheter and laterally outward from the catheter, such that when longitudinally retracted, the opening of the embolic filter generally faces the distal end of the catheter. The method further includes the step of tracking the lumen of the catheter over a guidewire inserted percutaneously into a body lumen.

[0158] Some embodiments further include the step of retracting the guidewire at least partially longitudinally from the lumen of the catheter so that the distal portion of the catheter forms a substantially arc shape which is at least semicircular.

[0159] In some embodiments, the distal portion of the catheter is equipped with a radiopaque marker, and the method further includes the step of positioning the catheter by visualizing the radiopaque marker using an imaging technique.

[0160] Some embodiments include the step of retracting the deployment mechanism at least partially in the longitudinal direction, allowing the self-expanding embolic filter to form an expanded deployment configuration.

[0161] Some embodiments include a step of retracting the wire longitudinally, thereby bending the frame longitudinally toward the proximal end of the catheter and laterally outward from the catheter, so that the opening defined by the frame substantially straddles a body lumen.

[0162] Some embodiments include the step of retracting the wire longitudinally to a proximal position, thereby bending the frame so that the opening of the filter defined by the frame is substantially perpendicular to the longitudinal direction of the catheter, and the opening defined by the frame substantially straddles the body lumen.

[0163] In some embodiments, the embolic filter is movably coupled to a catheter and is movable longitudinally relative to the catheter, and the method includes the step of moving the embolic filter longitudinally relative to the catheter.

[0164] In some embodiments, the embolic protection device comprises a self-expanding deflector coupled to a catheter, located proximal to the distal portion, and the method includes the step of deploying the self-expanding deflector to direct the embolic residue toward the embolic filter.

[0165] In some embodiments, the deployment mechanism is a sheath positioned circumferentially around at least a portion of the catheter.

[0166] In some embodiments, the distal portion of the catheter has one or more openings that communicate with the lumen of the catheter, and the method further includes the step of perfusing a fluid into a body lumen through one or more openings.

[0167] In some embodiments, the embolic protection device has longitudinal grooves along the outer surface of the embolic protection device, and the method further includes the step of inserting a second catheter device alongside the embolic protection device by tracking the second catheter device along the grooves.

[0168] In some embodiments, a second catheter device is advanced over the embolic filter of an embolic protection device while the embolic filter is in a deployed configuration.

[0169] Another aspect of the present invention provides a method for capturing embolic residue during a closed cardiac procedure, the method comprising the step of inserting the distal end of an embolic protection device into a body lumen, the embolic protection device being a catheter having a proximal end, a distal end, and a lumen extending from the proximal end of the catheter to the distal end of the catheter, the lumen being configured to house a guidewire, the distal portion of the catheter having a substantially arc shape which is at least semicircular when the guidewire is at least partially retracted longitudinally, and a self-expanding embolic filter positioned around the catheter proximal to the distal portion, the embolic filter comprising a frame, the frame being the opening of the embolic filter The device comprises a self-expanding embolic filter defining a portion, a deployment mechanism positioned around at least a portion of the catheter, the deployment mechanism being movable longitudinally relative to the catheter, the deployment mechanism being configured to contain the embolic filter in a collapse configuration, and the embolic filter being configured to self-expand in response to the longitudinal retraction of the deployment mechanism, and a wire coupled to the frame of the self-expanding filter, the wire being movable longitudinally and bending the frame longitudinally toward the proximal end of the catheter and laterally outward from the catheter, such that when longitudinally retracted, the opening of the embolic filter generally faces the distal end of the catheter.

[0170] The method further includes the steps of tracing the lumen of the catheter over a guidewire inserted percutaneously into a body lumen, and at least partially retracting the guidewire longitudinally from the lumen of the catheter so that the distal portion of the catheter forms a substantially arc shape that is at least semicircular, in response to retracting the guidewire from the distal portion of the catheter. The method further includes the steps of retracting the deployment mechanism longitudinally to deploy a self-expanding embolic filter. The method further includes the steps of retracting the wire longitudinally to bend the frame of the embolic filter longitudinally toward the proximal end of the catheter and laterally outward from the catheter.

[0171] A further aspect of the present invention provides a method 1200 for capturing embolic debris during a closed cardiac medical procedure (e.g., an aortic valve replacement procedure) using an embolic protection device of the present invention (e.g., an embolic protection device 600, 700, or 800 as described herein), as illustrated in a stepwise manner in Figures 12A–12D.

[0172] Referring to Figure 12A, in one embodiment, the guidewire 1290 is percutaneously inserted into a patient's body lumen 1292, for example, the femur, radius, humerus, or subclavian artery, and navigated to a desired anatomical location, for example, the ascending aorta. The guidewire 1290 may be a J-shaped tip wire having a diameter of about 0.035 inches (about 0.089 cm). Other types and dimensions of guidewires useful for this method are also possible.

[0173] In other embodiments, the proximal end of the guidewire 1290 is inserted into the opening at the distal end 616 of the catheter 602. When the guidewire 1290 is in the lumen 618 of the catheter 602 at the distal portion 604 of the catheter 602, the distal portion 604 of the catheter is straightened or forms the curvature of the guidewire 1290. The distal end 616 of the catheter 602 is inserted into the body lumen 1292 by tracing the lumen 618 of the catheter 602 along the guidewire 1290, as shown in Figure 12A. The outer diameter of the guidewire 1290 is smaller than the inner diameter of the embolic protection device 600 so that the embolic protection device 600 can be traced along the guidewire 1290. The inner surface of the lumen 618 and / or the outer surface of the guidewire 1290 may include a lubricating coating to reduce friction during tracing. The guidewire 1290 keeps the distal portion 604 of the catheter 602 (for example, from a roughly curved shape) nearly straight as the catheter 602 is inserted into the patient's body and navigated within the body.

[0174] The radiopaque marker 606 is used to visualize and position the distal portion 604 of the catheter 602 during tracking. The guidewire 1290 is moved backward, i.e., longitudinally proximal, by a distance sufficient to allow the distal portion 604 of the catheter 602 to form a substantially arched shape, as shown in Figure 12B. The distal portion 604 of the catheter 602 is positioned at a desired anatomical landmark, for example, the inferior boundary of the non-coronary cusp of the aortic valve. The radiopaque marker 606 is located on the most distal segment of the distal portion 604 when the distal portion 604 forms its substantially arched shape. In some embodiments, the distal portion 604 of the catheter 602 may be injected with radiopaque material so that the entire distal portion 604 is visible using imaging techniques.

[0175] In another embodiment of the method, the proximal end 614 of the catheter 602 is connected to a contrast agent injector, and a contrast agent is injected into the lumen 618 of the catheter 602 to visualize, for example, the biostructure around the embolic protection device 600. The contrast agent exits the lumen 618 through an opening at the distal end 616 of the catheter 602 and / or through one or more openings 608 in the side wall of the catheter 602. Injecting the contrast agent can help visualize and position the catheter 602.

[0176] In other embodiments, a second guidewire is percutaneously inserted into a second body lumen, for example, another femoral artery, and a second catheter is tracked along the second guidewire. The second catheter can carry a medical device or instrument, such as a replacement valve, valve repair system, or radiofrequency ablation system. Once the second catheter and associated device or instrument are properly positioned, the outer sheath 612 is retracted longitudinally proximal, allowing the embolic filter 610 to form a self-expanding deployment configuration, as shown in Figure 12C.

[0177] Next, the push wire 622 can be advanced to bend the filter frame of the embolic filter 610. The push wire and filter frame are not shown in Figures 12A–12D, but can be considered as the push wire 622 and frame 624 in Figures 6B–6F, respectively. The push wire bends the filter frame distally longitudinally and laterally outward. In a bend configuration as shown in Figure 12D (i.e., with a pull wire advanced distally), the distal opening 640 of the embolic filter 610 may be approximately perpendicular to the catheter 602 and may laterally straddle the body lumen 1292, traversing the body lumen 1292 approximately perpendicular to its longitudinal axis. To accommodate the size of the body lumen 1292, the push wire can be further advanced to extend the frame radially and further expand the embolic filter 610.

[0178] The bent configuration may engage with the body lumen 1292, thereby trapping the embolic residue 1294 within the embolic filter 610 without allowing the embolic residue to advance around the outside of the embolic filter 610. A second guidewire and / or second catheter may also be positioned after the embolic filter 610 has been deployed. The distal opening 640 of the embolic filter 610 is positioned in the ascending aorta so that blood flows through the embolic filter 610 before flowing into the carotid artery or descending aorta. In some embodiments, when the embolic filter 610 is deployed, the catheter 602 is placed against the inner lumen wall, thereby stabilizing the catheter 602. The procedure can then be performed, and any embolic residue 1294 released during the procedure or otherwise in the bloodstream is trapped by the embolic filter 610.

[0179] Following this procedure, the push wire 622 is retracted, and the outer sheath 612 is advanced longitudinally and distally to recapture the embolic filter 610, return the filter frame to an unbent configuration, and return the embolic filter 610 to a collapsed configuration. This then captures any embolic residue 1294 (see Figure 12D) contained within the embolic filter 610. The second catheter and catheter 602 can then be withdrawn from the patient's body. Catheter 602 can be retracted over the guide wire 1290, or without straightening the distal portion 604 of catheter 602, as the arched shape of the distal portion 604 is non-traumatic to the blood vessel.

[0180] In other embodiments, the procedure performed is a heart valve replacement procedure, such as an aortic valve replacement procedure. The embolic protection device 600 is introduced into the patient and navigated to the aortic valve, as described herein and shown in Figures 12A–12D. A radiopaque marker 606 helps contour the inferior boundary of the non-coronary cusp and assists in the proper positioning of the percutaneously implanted replacement aortic valve. Once the catheter 602 is positioned, a second guidewire can be percutaneously inserted into a second body lumen and navigated to the level of the ascending aorta or left ventricle. A balloon can be tracked along the second guidewire to the aortic valve. The outer sheath 612 is then retracted to deploy the embolic filter 610, and the push wire 622 is advanced to bend the frame 624 into a bent configuration. If engagement with the internal body lumen 1292 is required, the push wire 622 may be advanced further to extend the frame 624 into the extended configuration. The valve balloon inflation may then be performed, and the embolic filter 610 captures any embolic residue 1294 that is released during the procedure or otherwise in the bloodstream. After pre-inflation of the balloon, the push wire 622 is retracted, and the outer sheath 612 is advanced to recapture the embolic filter 610 and any embolic residue 1294 contained within the embolic filter 610. The balloon is removed, and a second catheter carrying the prosthetic valve is advanced to the level of the ascending aorta by tracking the catheter across a second guidewire. The outer sheath 612 is again retracted to redeploy the embolic filter 610, and the push wire 622 is advanced again. The radiopaque marker 606 allows the user to properly position the prosthetic valve, for example, approximately 4 mm to 6 mm below the lower boundary of the non-coronary cusp. After the procedure is completed, the push wire 622 is retracted, the outer sheath 612 is advanced to recapture the embolic filter 610 and any captured embolic residue 1294, and the catheter is removed from the body. In some embodiments, a second catheter may be removed prior to recapturing the embolic filter 610 and embolic residue 1294.

[0181] In other embodiments, the procedure is a heart valve repair procedure. The methods described herein can also be adapted for mitral valve repair or replacement procedures. In some embodiments, the procedure is, for example, a radiofrequency ablation procedure for treating atrial fibrillation. In some embodiments, the procedure is a catheter insertion procedure or a structural heart procedure.

[0182] In other embodiments, a method of capturing embolic debris as described herein may include inserting a second catheter device through the same blood vessel as the embolic protection device. The second catheter device may be inserted after the embolic protection device and may be tracked along a longitudinal groove within the outer surface of the embolic protection device. For example, a valve delivery catheter device may be guided alongside and beyond the distal end of the embolic protection device by tracking the valve delivery device along the groove. Advantageously, the second device may be tracked along the groove and passed beyond the embolic protection device, for example, as shown in FIG. 13A, while the embolic filter is deployed.

[0183] Another aspect of the present invention provides a method for capturing embolic debris during a closed-heart procedure, comprising inserting a distal end of an embolic protection device into a body lumen where the embolic protection device is a catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end of the catheter, the lumen being configured to house a guide wire, the distal portion of the catheter being configured to assume a generally arcuate shape that is approximately semi-circular when the guide wire is at least partially retracted longitudinally, a self-expanding embolic filter disposed around the catheter proximal to the distal portion, the embolic filter comprising a frame that defines an opening of the embolic filter, a deployment mechanism disposed around at least a portion of the catheter, the deployment mechanism being longitudinally movable relative to the catheter and configured to contain the embolic filter in a crimped configuration, the embolic filter being configured to self-expand in response to longitudinal retraction of the deployment mechanism, a wire coupled to the frame of the embolic filter, the wire being longitudinally movable relative to the catheter and configured such that when the wire is longitudinally advanced distally to a first position, the wire bends the frame longitudinally toward and laterally outwardly from the catheter such that the opening of the embolic filter generally faces the distal end of the catheter and expands to a first diameter, and when the wire is longitudinally advanced distally to a second position that is further distal than the first position, the wire extends the frame radially outwardly from the catheter such that the opening of the embolic filter expands to a second diameter that is larger than the first diameter. The method further comprises tracking the lumen of the catheter over a guide wire that is percutaneously inserted into the body lumen.

[0184] Other embodiments further comprise at least partially retracting the guide wire longitudinally from the lumen of the catheter such that the distal portion of the catheter assumes a generally arcuate shape that is approximately semi-circular.

[0185] In other embodiments, the distal portion of the catheter is provided with a radiopaque marker, and the method further includes the step of positioning the catheter by visualizing the radiopaque marker using an imaging technique.

[0186] Other embodiments include the step of retracting the deployment mechanism at least partially in the longitudinal direction, allowing the self-expanding embolic filter to form an expanded deployment configuration.

[0187] Other embodiments include the step of advancing a wire longitudinally, thereby bending the frame longitudinally toward the proximal end of the catheter and laterally outward from the catheter, so that the opening defined by the frame substantially straddles a body lumen.

[0188] Other embodiments include advancing the wire longitudinally to a first position, thereby bending the frame longitudinally toward the distal end of the catheter and laterally outward from the catheter, and expanding the opening of the embolic filter that substantially straddles the body lumen to a first diameter.

[0189] Other embodiments include advancing the wire longitudinally to a second position distal to the first position, thereby extending the frame radially outward from the catheter and expanding the opening of the embolic filter, which substantially straddles the body lumen, to a second diameter greater than the first diameter.

[0190] In other embodiments, the deployment mechanism is a sheath positioned circumferentially around at least a portion of the catheter.

[0191] In other embodiments, the distal portion of the catheter comprises one or more openings communicating with the lumen of the catheter, and the method further includes the step of perfusing a fluid into a body lumen through one or more openings.

[0192] In other embodiments, the embolic protection device has longitudinal grooves along the outer surface of the embolic protection device, and the method further includes the step of inserting a second catheter device alongside the embolic protection device by tracking the second catheter device along the grooves.

[0193] In other embodiments, the second catheter device is advanced over the embolic filter of the embolic protection device while the embolic filter is in a deployed configuration.

[0194] Another aspect of the present invention provides a method for capturing embolic residue during a closed cardiac procedure, the method comprising the step of inserting the distal end of an embolic protection device into a body lumen, the embolic protection device being a catheter having a proximal end, a distal end, and a lumen extending from the proximal end of the catheter to the distal end of the catheter, the lumen being configured to house a guidewire, the distal portion of the catheter having a substantially arc shape which is at least semicircular when the guidewire is at least partially retracted longitudinally, and the proximal end of the distal portion being positioned around the catheter A self-expanding embolic filter comprising: a self-expanding embolic filter comprising a frame, the frame defining an opening for the embolic filter; a deployment mechanism positioned around at least a portion of a catheter, the deployment mechanism being longitudinally movable relative to the catheter, the deployment mechanism being configured to contain the embolic filter in a collapse configuration, and the embolic filter being configured to self-expand in response to the longitudinal retraction of the deployment mechanism; and a wire coupled to the frame of the embolic filter, the wire being longitudinally movable.

[0195] The method further includes the steps of tracing the lumen of the catheter over a guidewire inserted percutaneously into a body lumen, and retracting the guidewire at least partially longitudinally from the lumen of the catheter so that the distal portion of the catheter forms a substantially arc shape that is at least semicircular, in response to retracting the guidewire from the distal portion of the catheter. The method further includes the step of retracting the deployment mechanism longitudinally to deploy a self-expanding embolic filter. The method further includes the step of advancing the wire longitudinally distally to a first position, thereby bending the frame longitudinally toward the distal end of the catheter and laterally outward from the catheter, and expanding the opening of the embolic filter to a first diameter. [Examples]

[0196] IV. Examples

[0197] Example 1: Corpse Model

[0198] Referring to Figures 13A and 13B, the embolic protection device (EPD-1) of the present invention was tested in a human cadaver model to visually assess the device's ability to cover all cerebral vessels with an embolic filter while the intravascular device passes through the aorta alongside the EPD-1. In the photographs of Figures 13A and 13B, the EPD-1 is deployed and covering the openings of the cerebral vessels in the cadaver, while the TAVR delivery system passes above the filter at the same time. In Figure 13A, the TAVR delivery system is tracked along the longitudinal groove on the outer surface of the EPD-1 catheter. In Figure 13B, the TAVR delivery system is tracked outside the groove of the EPD-1 catheter.

[0199] Example 2: Clinical Trial

[0200] Referring to FIGS. 14 and 15A - 15J, the safety and performance of an embolic protection device (“EPD - 1”) according to the present invention was evaluated during a trans - catheter aortic valve replacement (TAVR) procedure in human subjects. The primary objective was to assess the performance and therapeutic effect of the use of EPD - 1 during TAVR on procedure - related cerebral embolic burden as determined by diffusion - weighted magnetic resonance imaging (DW - MRI). The secondary objective was to analyze the safety profile and types of captured residues from the EPD - 1 filter after TAVR.

[0201] This study was designed as a multi - center non - randomized trial including up to five clinical sites to evaluate the performance and therapeutic effect of the use of EPD - 1 during TAVR on procedure - related asymptomatic ischemic disorders and cerebral embolic burden as determined by DW - MRI examinations performed before and after the procedure. The secondary objective was to analyze the safety profile and types of captured residues from the EPD - 1 filter after TAVR. The potential risks of neurological injury and stroke were evaluated based on neurological assessments before and after the procedure. The study population consisted of up to 30 subjects with severe native aortic valve stenosis who met the commercially approved criteria for TAVR and adhered to the inclusion / exclusion criteria.

[0202] Primary evaluation items: 1) Device performance: Defined as successful insertion, placement, and removal of EPD - 1. Device performance was evaluated during and after the TAVR index procedure. 2) Reduction of acute cerebral embolic burden after TAVR, defined as the number and volume of cerebral lesions detected using DW - MRI on days 2 - 5 after the TAVR procedure compared to a reference.

[0203] Secondary evaluation items: 1) The rate of major adverse cardiac and cerebrovascular events on day 30 after the TAVR index procedure compared to historical data. Major adverse cardiac and cerebrovascular events (MACCE) were defined as all - cause mortality, all strokes (severe, mild, TIA), and acute kidney injury (class 3). 2) Clinical assessment of the neurological status of the subjects before and after the index procedure using the NIH Stroke Scale.

[0204] Eleven subjects were enrolled in a multicenter non-randomized prospective pilot study. The performance characteristics of EPD-1 were evaluated after the procedure and scored on a 5-point scale (1 (unacceptable) to 5 (excellent)). The mean performance across all patients for all characteristics of EPD-1 was 4.8 at clinical site 1 and 3.4 at clinical site 2. The mean performance scores for each of the characterized EPD-1 performances (at each of the clinical sites) are illustrated in the bar graph of FIG. 14. The characteristics scored were vascular access, tracking, use of sheath and deployment button, positioning, re-occlusion, removal, visualization during aortic angiography, deployment, positioning, repositioning, retrieval, stability, visibility in place, ease of deployment, and ease of occlusion.

[0205] The pre- to post-procedure aortic gradient measurements were on average 86.4% reduced across all 11 subjects, confirming the success of TAVR treatment.

[0206] All subjects underwent DW-MRI before and after the procedure, and the image evaluation was consistent with the identification of several ischemic lesions. MRI was performed at baseline and pre-discharge (days 2 - 5) visits in 11 subjects who underwent transcatheter aortic valve replacement (TAVR) procedures at each of two clinical sites. The MRI protocol consisted of the following sequences: axial DWI, axial FLAIR, and 3D T1-weighted IR-GRE. DWI contrast agents are sensitive to water molecules and help localize and quantify fresh lesions. Total lesions were counted, lesion location, size, and volume were scored, and total lesion volume was analyzed. FIGS. 15A - 15J show DW-MRI images of the brains of three representative human subjects (001 - 05, 001 - 06, and 002 - 01).

[0207] Six central lesion counts and 193.9 mm 3 of central lesion volume were observed among the 11 subjects. The breakdown of lesions by location is detailed in Table 1. These results show fewer lesion counts and volumes compared to both historical controls and clinical trials using approved and investigational embolic protection devices.

[0208] [Table 1]

[0209] Table 2 provides a detailed comparison of the number and volume of lesions between the clinical trial of this embodiment 2 and clinical trials of equivalent devices. These results demonstrate that protection using EPD-1 can reduce the number or volume of ischemic lesions and thus support the usefulness of the procedure.

[0210] [Table 2]

[0211] The timing of MRI acquisition differed among these studies. DW-MRI was performed within 48 hours post-procedure for all patients in Example 2, while imaging was performed at a later time for the other referenced studies. Since it is known that the appearance of high intensity during DW-MRI acquisition evolves over time, these other referenced studies would likely have observed higher lesion volumes if DW-MRI had been performed within 48 hours post-procedure. Nevertheless, EPD-1 was superior to referenced equivalent devices in terms of reducing the burden of acute cerebral embolism. Three patients had elevated lesion volumes, however, they were considered abnormal as the filter was recaptured and the TAVR device was retrogradely expanded. During these abnormal procedural events, the operator was concerned about the interaction of the balloon catheter with the filter frame due to small biostructures in the aorta. This typically results in the release of residue.

[0212] EPD-1 captured thrombi in all procedures. Two examples of captured thrombi are shown in photographs in Figures 16A and 16B. Photograph in Figure 16A shows a thrombus captured by EPD-1 in Example 2. Photograph in Figure 16B shows the actual pathological findings of a 4.6 mm collagen fragment captured within the EPD-1 filter during a TAVR procedure. Neurological assessments using NIHSS at discharge and 30 days post-procedure showed that scores for all patients remained at the normal level, with the exception of one patient who developed limb ataxia. No adverse events were recorded. The residue captured by the EPD-1 embolic filter contained collagen, fibrin, thrombi, and calcium.

[0213] Table 3 outlines the evaluation criteria.

[0214] [Table 3]

[0215] Other Embodiments Although the present invention has been described in conjunction with its detailed description, it should be understood that the foregoing description is intended to illustrate, not limit, the scope of the invention as defined by the appended claims. Other aspects, advantages, and modifications also fall within the scope of the subsequent claims.

[0216] Those skilled in the art will understand that the specific devices and processes illustrated in the accompanying drawings and described herein are merely exemplary embodiments of the concept of the invention as defined in the accompanying claims. Therefore, the specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered limiting unless otherwise expressly stated in the claims. It should also be understood that the structure of the invention and other components described is not limited to any specific material. Other exemplary embodiments of the invention disclosed herein may be formed from a wide variety of materials unless otherwise described herein.

[0217] Modifications and alterations to the embodiments described in detail may be implemented without departing from the principles of the present invention, and are intended to be limited only to the scope of the appended claims, as they would be interpreted in accordance with the principles of patent law, including the doctrine of equivalents.

Claims

1. Embolism protection device, wherein the embolic protection device is A catheter having a proximal end and a distal end, A self-expanding embolic filter located proximal to the distal end of the catheter, wherein the self-expanding embolic filter comprises a frame, the frame defining the opening of the self-expanding embolic filter, and the frame A fixing portion located proximal to the distal end and connected to the catheter, wherein the fixing portion does not move in the longitudinal direction, The fixed portion and the movable portion of the frame Includes a self-expanding embolic filter, A wire coupled to the frame of the self-expanding embolic filter, wherein the wire is movable longitudinally relative to the catheter, and Equipped with, The wire is configured to position the frame such that when it is advanced longitudinally to a distal position, the opening of the self-expanding embolic filter is angled at less than 45 degrees with respect to the longitudinal axis of the catheter. An embolic protection device wherein the wire is configured to pull the movable portion of the frame longitudinally and bend the frame longitudinally toward the proximal end of the catheter and laterally outward from the catheter, such that when the wire is retracted longitudinally away from the distal position, the opening of the self-expanding embolic filter is angled with respect to the longitudinal axis of the catheter at a greater angle than when the wire is at the distal position.

2. The embolic protection device according to claim 1, wherein the wire is connected to the frame at the distal connection point.

3. The embolic protection device according to claim 1, wherein the wire is configured to bend the frame such that when it is retracted longitudinally to a proximal position, the opening of the self-expanding embolic filter is perpendicular to the longitudinal axis of the catheter.

4. The embolic protection device according to claim 1, wherein the wire is configured to position the frame such that when it is advanced longitudinally to the distal position, the opening of the self-expanding embolic filter is parallel to the longitudinal axis of the catheter.

5. The embolic protection device according to claim 1, further comprising a handle, the handle comprising a mechanism configured to advance or retract the wire.

6. The embolic protection device according to claim 1, wherein the wire is coupled to the movable portion of the frame.

7. The embolic protection device according to claim 1, wherein the catheter extends through the opening of the self-expanding embolic filter.

8. The aforementioned catheter is A lumen extending along the longitudinal axis of the catheter from the proximal end to the distal end, and extending from the distal end of the catheter, the lumen being configured to house a guidewire configured to engage with the catheter, One or more openings of the catheter that communicate with the lumen The embolic protection device according to claim 1, comprising:

9. The embolic protection device according to claim 1, wherein the opening of the self-expanding embolic filter defined by the frame is elliptical in shape.

Images