Improved embolic protection device and method
阅读说明:本技术 改进的防栓塞保护装置及方法 (Improved embolic protection device and method ) 是由 埃里克·夸比克勒 于 2015-05-21 设计创作,主要内容包括:本发明公开了一种导管装置,包括:长形鞘管(503),具有内腔和用于定位在心脏瓣膜(6)处的远端;防栓塞保护装置(200),用于临时定位在主动脉弓中,以便将栓塞碎片从升主动脉偏转到降主动脉,所述防栓塞保护装置可连接到从连接点(131)向近端延伸的经腔递送单元(130),并且具有:具有外周的框架,位于所述外周内的血液可渗透单元,用于防止栓塞颗粒随主动脉瓣下游的血流从其通过进入所述主动脉弓的侧支管而到达患者的脑部;以及至少一个组织并置维持单元(300、350),其从所述导管延伸到所述主动脉弓中,并且在维持点(502)处附接到所述防栓塞保护装置,用于在所述防栓塞保护装置处,例如在所述外周处,向所述连接点偏置施加稳定力,并且用于当所述导管装置定位在所述主动脉弓内时,朝所述主动脉弓的内壁、远离所述心脏、并且沿垂直于所述外周的纵向延伸的方向上提供所述稳定力,使得所述外周到所述主动脉弓的内壁的组织并置由所述力支撑,以改进稳定性和外周密封。此外,公开了相关方法。(The invention discloses a catheter device, comprising: an elongate sheath (503) having a lumen and a distal end for positioning at a heart valve (6); an embolic protection device (200) for temporary positioning in the aortic arch for deflecting embolic debris from the ascending aorta to the descending aorta, the embolic protection device being connectable to a transluminal delivery unit (130) extending proximally from a connection point (131) and having: a frame having a periphery, a blood permeable unit located within the periphery for preventing embolic particles from passing therethrough into side branch vessels of the aortic arch with blood flow downstream of the aortic valve to the brain of the patient; and at least one tissue apposition maintaining unit (300, 350) extending from the catheter into the aortic arch and attached to the embolic protection device at a maintenance point (502) for biasingly applying a stabilizing force to the connection point at the embolic protection device, e.g. at the periphery, and for providing the stabilizing force towards an inner wall of the aortic arch, away from the heart, and in a direction extending perpendicular to a longitudinal direction of the periphery when the catheter device is positioned within the aortic arch, such that tissue apposition of the periphery to the inner wall of the aortic arch is supported by the force for improved stability and peripheral sealing. Further, related methods are disclosed.)
1. A collapsible, transluminal delivery embolic protection device for temporary positioning in an aortic arch to cover the ostia of side vessels, including at least the carotid artery, to deflect embolic debris from the ascending aorta to the descending aorta, the embolic protection device comprising:
a frame having a periphery and a blood permeable unit located within the periphery;
at least one tether arranged to apply a traction force to urge the embolic protection device in a coronal direction.
2. The embolic protection device of claim 1, wherein said tether is a pushing unit disposed below the frame and configured to exert a pushing force on said periphery and/or said blood permeable unit.
3. An embolic protection device as in claim 1 or 2, wherein the blood permeable unit is a mesh having a surface shaped to bulge from the periphery towards the orifice when arranged in the aortic arch.
4. The embolic protection device of any of claims 1 to 3, wherein said embolic protection device is placed across the apex of the aorta to prevent emboli from flowing into the carotid artery.
5. An embolic protection device as in any of claims 1-4, wherein a connection point is enclosed by or integral with the periphery for connection to a delivery unit.
6. The embolic protection device of claim 5, wherein the delivery unit is pre-shaped to have a bend.
7. An embolic protection device as in any of claims 1-6, comprising a plurality of tethers.
8. An embolic protection device as in any of claims 1-7, comprising at least one eyelet, wherein one or more of the tethers pass through at least one eyelet.
9. The embolic protection device of any of preceding claims 1-8, wherein said tether is attached to said blood permeable unit such that upon application of said traction force, said blood permeable unit is lifted from the plane of said blood permeable unit.
10. An embolic protection device as in any of claims 1-9, wherein the blood permeable unit is volcano-shaped.
11. An embolic protection device as in any of claims 1-10, comprising a catheter having a first channel for the device and a second channel for the tether.
12. A embolic protection device as in any of claims 1-11, further comprising at least one radiopaque fiducial marker.
13. The embolic protection device of any of claims 1-12, wherein said tether is movably arranged with respect to said translumenal delivery unit.
Technical Field
The present invention relates generally to the field of embolic protection devices and catheters for use in cardiac surgery. More particularly, the present invention relates generally to devices, systems and methods for brain protection by deflecting embolic debris during endovascular surgery, and introducers for such procedures, particularly cardiac procedures (e.g., TAVI procedures or electrophysiology procedures or ablation procedures).
Background
Disclosure of Invention
Accordingly, embodiments of the present invention preferably seek to mitigate, alleviate or eliminate one or more of the above-identified deficiencies, disadvantages or issues in the art, such as the above-identified deficiencies in the art, disadvantages or issues, singly or in any combination by providing a device or method according to the appended patent claims, for providing temporary embolic protection of a patient's aortic arch blood vessels during medical procedures, such as cardiac and interventional cardiology and electrophysiology. Embolic particles in the aortic blood flow may be prevented from entering the aortic arch side branch vessels including the carotid arteries leading to the brain.
Systems and methods for embolic deflection, including systems for deployment and removal, are disclosed herein.
According to one aspect of the present disclosure, a catheter device is disclosed, comprising: an elongate sheath (503) having a lumen and a distal end for positioning at a heart valve (6); an embolic protection device (200) for temporary positioning in the aortic arch to deflect embolic debris from the ascending aorta to the descending aorta, the embolic protection device being connectable to a transluminal delivery unit (130), the transluminal delivery unit (130) extending proximally from a connection point (131) with the embolic protection device, and the embolic protection device having: a frame having an outer periphery; a blood permeable unit located within the periphery for preventing embolic particles from passing therethrough into side branch vessels of the aortic arch with blood flow downstream of the aortic valve to the brain of the patient; and at least one tissue apposition maintaining unit (300, 350) extending from a catheter into the aortic arch and attached to the embolic protection device at a maintaining point (502) for applying a stabilizing force at the embolic protection device, e.g. at the periphery, away from the connection point and for providing the stabilizing force towards an inner wall of the aortic arch, away from the heart, and in a direction perpendicular to a longitudinal extension of the periphery when the catheter device is positioned within the aortic arch, such that the periphery is supported by the stabilizing force in apposition with tissue of the inner wall of the aortic arch for improved stability and peripheral sealing. Related methods are also disclosed.
The frame may be elongate as shown. Thus, the
The
In still other examples, the
In some embodiments, the device may be rotated clockwise or counterclockwise, respectively.
The device also includes at least one tissue apposition sustaining unit that is not a delivery shaft or lead of the device. The tissue apposition maintaining unit is configured to apply a force to the device away from the connection point. This force may be referred to as a stabilizing force because it facilitates safe positioning of the embolic protection device in the aortic arch. The offset to the connection point may be, for example, at the periphery. It may also be adjacent the periphery. It may also be in the center of the blood permeable unit within the periphery. When the device is positioned in the aortic arch, the force is applied or directed towards the inner wall of the aortic arch. In this manner, tissue apposition from the periphery to the inner wall of the aortic arch is supported by the force. For example, the traction force so applied may pull the outer periphery of the device toward the inner wall. This traction force may be exerted on the delivery catheter or the like and lifts the anti-embolic protection device towards the aortic wall in a direction away from the heart, preferably in a coronal direction ("up"/towards the neck or head of the patient). This (stabilizing) force support locks the device in place when implanted.
The embolic protection device can thus be reliably placed across the apex of the aorta to prevent emboli from flowing into the carotid artery. The solution of the invention is not iatrogenic because it prevents debris from being generated from e.g. side branch ostia. Iatrogenic refers to an adverse condition of the patient caused by the treatment of a doctor or surgeon. For example, extending into the side branch, arms of secondary embolic protection devices that risk scraping plaque from the inner tube wall or orifice, anchors, delivery shafts, arches, etc. are not required and are only avoided due to the present disclosure.
Embolic particles are effectively prevented from bypassing the device at the periphery of the device into the carotid artery due to the improved seal at the periphery. Avoiding "navigation" of the device in the high pressure blood stream expelled from the heart. Providing stable positioning of the deflection device in the aortic arch.
Preferably, the embolic protection device may be a deflector for deflecting embolic particles. Alternatively or additionally, it may be a filter for capturing embolic particles.
The device may be delivered via a side-channel catheter (e.g., through the femoral artery) in an example. Such side-channel catheters are described in PCT/EP2012/0058384, which PCT/EP2012/0058384 was disclosed in WO2012152761 after the priority date of the present application, the entire content of which is incorporated herein by reference for all purposes. The catheter may also be modified by a plurality of side channels, one for the embolic protection device. The tether may travel in the same channel or other channels of the catheter. Pigtail conduits may be provided in such secondary side channels. The pigtail catheter may be used to further stabilize the catheter against the annulus of the aortic valve and/or the inner wall of the aortic arch, as described in WO2012/094195a1, which is incorporated herein by reference in its entirety for all purposes, see in particular fig. 10A and 10B of WO2012/094195a1 and the related description section in WO2012/094195a 1.
In an example, the device may be delivered via a side branch vessel, for example as described in WO2010/026240a 1.
In AN example, the device may be delivered through the aorta (e.g. in the direct aorta route), FOR example as described in the co-pending US application OF the same applicant, entitled "METHOD FOR delivering AN anti-embolic protection UNIT METHOD" (and which is a priority application with application number US61/726,540, filed 11, 14/2012). Both applications are incorporated herein by reference in their entirety for all purposes.
The above-mentioned forces, also referred to as stabilizing forces, may comprise or be tractive forces. The apposition sustaining/supporting unit may then be an active traction unit, for example, having at least one
The tethers, or more precisely, the drawstrings, are arranged to control the degree of sealing of the periphery. The tether provides for a apposition direction towards the aortic tissue/cerebral artery. The tether may provide positive traction by pulling on a tether that is communicated to a distal connected embolic protection device. The traction force may be different from the pulling force of the delivery device of the embolic protection device, thus advantageously avoiding the suction effect, since the force may be chosen such that the periphery of the device follows the aortic arch movement to a greater extent than the delivery device to which it is attached.
The tether is movable relative to the
In any of the devices of the present invention, the
The tether may be a multi-filament tether, which provides a particularly flexible solution for facilitating narrow lumen navigation.
The tether may extend straight through the blood permeable unit to the front end of the device. Thus, the intermediate wire can be pulled up and the outer circumference pulled tight against the inner wall. The tether provides a lifting force to the front end. When the tether is guided at the mid-line, it may provide a progressive lifting force distributed along the device, which allows to obtain a particularly effective sealing and/or stabilization at the periphery.
The at least one tether may be longitudinally elastic, i.e. it may be longitudinally tensioned and elastically returned to an untensioned longitudinal extension. The tether may be elastic along its entire length. The tether may include one or more elastic portions or elastic elements. The elastic portion may be a helically wound portion of a tether that acts as a spring. The elastic portion may be a tubular braid of double helically wound strands. The resilient portion may be made of a resilient material, preferably a biocompatible material such as rubber. In this way, the traction force is variable. This may be advantageous to prevent breakage of the tether line, as the operator may "feel" the non-linear extension. Such variable traction may also be advantageous if the tether is tensioned, applying the desired traction to improve the sealing of the embolic protection device. The tether may be locked in this position at its proximal end, such as an aperture extending out of the introducer end. Elasticity may be provided to compensate for physiologic motion of the aortic arch relative to the proximal end of the device and/or tether while maintaining tissue apposition. Avoiding the problems associated with the induced draft effect described above. The force is applied within a range suitable to maintain an improved peripheral seal when the aortic arch moves due to the heartbeat and blood pulse waves. The applied force is provided within a range suitable for maintaining an improved peripheral seal as the aortic arch moves due to the beating heart and pulse waves.
The blood permeable unit may have at least one guiding unit, such as perforations, tubular bending elements, rollers or the like. The guiding unit may receive the tether near its distal end where it is attached to the device (e.g. at the blood permeable unit, flange or periphery). The guiding unit (e.g. eyelet, etc.) provides for the juxtaposition at the locally controllable device. The tractive force may be distributed to different areas of the device.
The device may have an attachment point where the distal end of the tether is connected to the device and through which traction may be transferred peripherally to the device. Optionally, one or more radiopaque fiducial markers may be provided at the device. A fiducial marker may be provided at the attachment point. Fiducial markers provide advantageous X-ray visibility and navigation, position feedback and control of the device.
In some examples, the tether extends proximally through the ostium into a selected side branch vessel such that the traction forces center the device relative to the ostium. When the tether is pulled, the tether pulls the device at the periphery of the device toward the inner wall of the aorta to lock the device in place. In this manner, the device will self-align relative to the selected ostium of the side branch vessel due to the tether. When one of skill in the art reads this disclosure to achieve this function, a suitable guide unit may be provided for the tether.
The device may include a plurality of tethers attached along a peripheral distal end. Alternatively or additionally, a single proximal tether may be split distally into multiple (sub-) tethers. For example, the tether may branch in a Y-shape. A single tether to be operated proximally may then distribute traction distally to the embolic protection device through its two distal points. An example with multiple endpoints is shown in fig. 8. Multiple tethers may be used or combined with a tether having multiple distal ends. The plurality of tethers may be collected proximally at the device (e.g., at its base 330). In this way, the device provides a gradual force that is evenly distributed along the periphery of the device. The device may in this way advantageously adapt to the inner shape of the aortic arch. This adaptability may even be enhanced by providing a longitudinal elastic portion at the tether. For example, the branch (sub) tether may be provided by an elastic material, while the main line is substantially inelastic, but flexible.
In some examples, the device may have at least one rib extending between different (preferably opposing) engagement points of the periphery where the tether distal end is attached. The tether may thus apply traction to the ribs, thereby transferring the force to the outer periphery of the device towards the aortic inner wall tissue. The rib may be a beam or a yoke. It may be disposed longitudinally or transversely with respect to the longitudinal axis of the expanded device. There may be a plurality of such ribs in the device. A device having a plurality of lobes or wings may have one or more ribs on one or more lobes or wings to achieve advantageous force distribution. The ribs may be capable of providing structural support to the device. The term "providing structural support" refers to the property of contributing to the shape and rigidity of the device. The stiffness of the
For example, the valve or wings of the device may be disposed upstream with respect to aortic blood flow. Alternatively or additionally, the device may have a valve or wing of the device, which may be arranged downstream with respect to the aortic blood flow. One or more or each of the petals or wings can have a tissue apposition maintaining unit, such as a tether, pusher, spring as described herein. It may be sufficient to provide a tissue apposition maintenance unit for a valve or flap arranged upstream with respect to the aortic blood flow. The downstream arranged valve or flap may be sufficiently pushed towards the aortic inner wall tissue by the pulsatile blood flow in the aorta proceeding along the blood permeable unit of the device. However, having a tissue apposition sustaining unit at a valve or flap disposed downstream from the point of attachment may advantageously be supported by such tissue apposition sustaining unit during pressure changes of the aorta. Aortic pressure is lower during the diastolic phase and may tend to leak to a greater extent than during the systolic phase. The tissue apposition sustaining unit may be sized for adequate support during diastole and thus be more advantageous (smaller, lighter mass) for insertion into the body than sized for systolic support.
The tissue apposition maintaining unit may restrict movement of the blood permeable unit caused by pulsatile blood flow. The above-mentioned "navigation" of the device is thus limited or avoided by the tissue apposition unit. Having ribs, for example, may provide this limited range of motion. The ribs and/or tethers may limit movement of the blood permeable unit. Connecting the tether to the device may then provide a gradual traction and may in particular improve the sealing, since the forces on the periphery caused by the pulsating pressure changes are evenly distributed during the pulsating flow of the heartbeat.
The ribs may be e.g. yokes extending proximally over the blood permeable unit. "above" refers to the filtered side of the cell downstream of the blood flow through the cell. "below" thus represents the opposite side in this context. The yoke may preferably extend in the longitudinal direction of at least a part of the device. The distal tether end may be directly attached to the rib. The distal tether end may be guided to the outer circumference by guide units at the ribs, thereby providing an advantageous distribution of traction. The "over" positioned ribs may at the same time limit the movement of the blood permeable unit, thereby avoiding contact with tissue (e.g. the orifice) and avoiding debris generation by such contact avoidance. The devices of examples of the present disclosure may include additional ribs above and/or below the selectively
The device may include multiple tethers, or a single tether that splits distally into multiple strands. In one example, two tethers or strands are distally attached to the outer perimeter in a Y-shape from the base of the device.
The device may include at least one eyelet, wherein one or more of the tethers pass through the at least one eyelet. The eyelet may preferably be provided at the pivot point and/or the base of the device. Contact of the tether with tissue (e.g., an aperture) is thus avoided due to the eyelet, and debris is avoided by preventing the tether from contacting the tissue when the tether is tensioned.
The blood infiltration unit may be flexible. Such as a flat (substantially planar) membrane having a defined porosity or pores. The tether may be distally connected to the membrane. The applied traction force may thus raise the membrane out of the plane of the membrane, such that a volcano shape, for example, is formed at the location of the connection of the tether to the membrane. The volcano shape can advantageously increase the efficiency of the device. The volcano-shaped top may be arranged to extend into the aperture into a portion of the side branch. The trapping of particles can thus be provided by the internal funnel shape of the volcano into which the blood flows. The result is improved filter efficiency.
The traction unit may alternatively or additionally comprise a passive traction unit. The passive traction unit is not operated by the operator, but automatically provides a stabilizing force and improves the peripheral seal. The passive traction unit may be a spring. It may have a shape memory element, e.g. a portion of a frame, activated by body temperature, for providing traction against the delivery portion or device. For example, the device may include a "winglet" extending from the periphery of the device having shape memory. Another example is a shape memory spring that is activated to tension the tether, for example, from the base of the device. A portion of the tether may be provided as a shape memory portion. Such a tether may be delivered in an elongated shape and then changed to a memory-induced shape, thereby shortening the tether to provide tension. The memory-inducing shape may be a helical coil shape, additionally allowing memory activation of the elasticity of the tether, which is particularly advantageous for pressure and/or motion compensation.
The device may have a flange unit extending radially outwardly from the outer periphery of the device (e.g. from the frame). The flange unit may be angled with respect to the plane of the blood permeable unit for creating a pre-tension counter-force to the provided traction force. The flange unit may provide a further improved seal, since the seal is supported by the blood pressure in the aorta. The flange unit may be made of fabric. The fabric may be a woven fabric. The fabric may be woven from PTFE thread which provides advantageous sealing and biocompatibility. The fabric may be arranged as a hoop around the frame of the device. The hoop may extend in a direction opposite the filter membrane attached to the frame. The flange unit serves to avoid the circumference of the device from recessing towards the inner wall tissue. This is particularly advantageous because embolic particles may collect in such recesses. These agglomerated particles may then be flushed into the side branch when the device is removed. Avoiding particle aggregation at the periphery reduces this potential problem.
The tissue apposition maintaining unit may comprise a pushing unit and the force comprises a pushing force against the frame, the periphery and/or the blood permeable unit. The pushing unit provides a pushing force and presses the outer periphery toward the inner wall.
The tissue apposition maintaining unit may include a magnetic element and the force includes a magnetic force.
According to another aspect of the present disclosure, a method (900) of positioning a catheter device (500) in an aortic arch is disclosed, comprising transluminal delivery (901) of an embolic protection device (200), such as a deflector and/or a filter, in the aortic arch, the embolic protection device being connected to a transluminal delivery unit (130) extending proximally from a connection point (131) of the embolic protection device; positioning (902) the anti-embolic protection device in the aortic arch, comprising: expanding (903) a frame of the device in the aortic arch and flattening a blood permeable unit; juxtaposing (904) the periphery of the embolic protection device with the inner wall of the aortic arch to cover the ostium of the side branch comprising at least the carotid artery for preventing embolic particles from passing therethrough into the side branch to the brain of the patient; and applying (905) a stabilizing force by at least one tissue apposition maintenance unit (300, 350) extending from the catheter into the aortic arch and attached to the embolic protection device at a maintenance point (502), wherein the stabilizing force is applied at the embolic protection device away from the connection point, e.g. at the periphery, and when the catheter device is positioned at the aortic arch, the force is towards the inner wall of the aortic arch providing the stabilizing force towards the inner wall of the aortic arch, away from the heart, and in a direction perpendicular to the longitudinal extension direction of the periphery, such that tissue apposition of the periphery to the inner wall of the aortic arch is supported by the stabilizing force for improved stability and peripheral sealing. In this way, the peripheral to aortic arch tissue apposition is supported by the force.
This method is less iatrogenic than the known methods. Which improves the sealing of the outer circumference of the embolic protection device. It also prevents debris from being generated from the orifice in the aortic arch.
The supported apposition improves apposition of the periphery to an inner wall of the aortic arch such that the improved apposition improves the periphery-to-inner wall seal.
A force may be applied in a substantially proximal direction relative to the device to improve the seal.
Applying the force may include applying a traction force by the traction unit. Traction may include pulling the outer circumference of the device toward the inner wall to lock the device in place in the aortic arch. The traction may be applied by at least one tether distally connected to the frame, the periphery and/or the blood permeable unit for providing the traction.
The device may be delivered to the aortic arch through one of the side branch vessels, such as the brachiocephalic artery, the left carotid artery, or the left subclavian artery from the right subclavian artery. It may be delivered to the aortic arch through the descending aorta (e.g., in the femoral artery), for example, in the side passage of the main catheter. It can be delivered to the aortic arch through the wall of the ascending aorta, a method known as the "direct aorta" method.
According to another aspect of the disclosure, a method (1000) of preventing emboli flowing in an aortic arch from entering a side branch thereof includes advancing (1001) an embolic protection device toward the aortic arch; and manipulating (1002) the embolic protection device so as to cover the aperture of each side branch vessel, comprising: applying (1003) a force to the embolic protection device to improve the sealing of the embolic protection device at the periphery, comprising: applying a force at the embolic protection device by a distal guide element (350) offset from the connection point, the distal guide element (350) connected between a distal maintenance point of the embolic protection device and a distal connection point (501) on the catheter; wherein the embolic protection device allows blood to flow from the aortic arch into each side branch tube, but prevents emboli from entering the first and second side branch tubes without obstructing the lumen of the aortic arch.
According to another aspect of the present disclosure, a method for restricting the flow of emboli from the aorta into the carotid artery is provided. The method includes delivering an embolic protection device to the aortic arch to expand between the ascending and descending aorta to position the embolic protection device or components thereof into the aortic arch to prevent embolic debris from entering the carotid artery. Further, it comprises proximally tensioning at least one tether assembly distally connected to the embolic protection device, thereby controlling the degree of apposition of the embolic protection device to the inner tubular wall of the aortic arch and the degree of fluid sealing.
In accordance with yet another aspect of the present disclosure, a method (1100) for performing an endovascular procedure on a heart, the method comprising: delivering (1101) an embolic protection device to the aortic arch through a wall of the ascending aorta or through one of the following vessels to position the embolic protection device into the aortic arch to prevent embolic debris from entering the carotid artery, the vessel comprising: a brachiocephalic artery from the right subclavian artery, the left carotid artery, the left subclavian artery, or the descending aorta, for example in the femoral artery; applying (1101) a stabilizing force to the embolic protection device to improve sealing of the embolic protection device at the periphery, comprising applying a force at the embolic protection device, offset from the point of connection, by at least one tissue apposition maintaining unit, other than the delivery axis of the embolic protection device, thereby controlling the degree of apposition and fluid sealing of the embolic protection device against the inner vessel wall of the aortic arch by the force; delivering (1102) a first catheter to the heart through the descending aorta, left subclavian artery or aortic vessel wall at the aortic arch to affect at least one step associated with an endovascular procedure on the heart, the stabilizing force being applied (1103) by tensioning at least one distal guiding element (350) connected between a distal maintenance point of the embolic protection device and a distal connection point (501) on the catheter, wherein said delivering the first catheter comprises placing a balloon mounted on the first catheter, expanding the balloon in the ascending aortic arch.
The force applying step may include proximally tensioning at least one tether assembly or pushing unit distally connected to the embolic protection device.
The step of delivering the embolic protection device can be performed translumenally, and the step of delivering the first catheter can be performed after the step of delivering the embolic protection device.
Delivering the first catheter may include placing a balloon mounted on the first catheter, expanding the balloon in the ascending aortic arch to lock the distal end of the first catheter in place. The balloon may have an annular shape with a filter between the conduit and an inner ring of the annular shape.
The embolic protection device used in the method may extend from the distal end of the second catheter or a separate channel of the first catheter, such that the position of the embolic protection device may be independently adjusted from the position of the first catheter.
Delivery of the first catheter may be performed simultaneously with delivery of the embolic protection device via a separate channel of the first catheter, independent of the endovascular procedure.
Endovascular surgery on the heart may include steps related at least to the removal of a heart valve, the placement of a prosthetic heart valve, or the repair of a heart valve. The embolic protection device can be removed from the aortic arch after performing the endovascular procedure.
Further embodiments of the disclosure are defined in the dependent claims, wherein features for the second and subsequent aspects of the invention are mutatis mutandis to the first aspect.
Some examples of the present disclosure provide a low profile of the embolic protection device within the aorta that allows for the passage of a sheath, catheter or wire used in endovascular procedures on the heart due to the tether.
Some examples of the present disclosure also provide for avoiding anchors, arms, arches extending from devices, etc., which may cause tissue damage/cause debris to be scraped off and washed away.
Some examples of the present disclosure avoid contact of additional portions of the embolic protection device with the inner wall tissue of the aorta or side branch vessels, particularly adjacent to or near the ostia in the aortic arch.
The term "maintain" as used herein refers to support, assist, hold, lift, etc. According to particular embodiments, the apposition may be supported, assisted or assisted by a pushing or pulling force to provide tissue apposition of the maintenance device according to the present disclosure.
The term "tether" as used herein should not be confused with a safety tether, which is a simple safety line used to allow retrieval of the embolic protection device, if desired. The tethers, as used herein, are devices that allow for controlled tensioning of the entire boltThe plug protects the wires of the device or selected portions thereof. Traction is applied proximally to the tether for tensioning the device to the internal vessel. The tether distal end is connected or attached to the embolic protection device such that the traction support device is anchored to the inner tubular wall. In this way, the fluid flow at the periphery of the device is controllable and can be stopped completely by the degree of traction on the tether, so that blood passes only through the blood permeable unit of the device. The term "tether" or "strand" as used herein refers to a material made of any non-degradable material (e.g., polycarbonate, Polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyvinylidene fluoride (PVDF), polypropylene, porous urethane, nitinol, fluoropolymerCobalt chromium alloy (CoCr) and para-aramid
Or fabrics, e.g. nylon, polyesterOr silk fabric)) such as rope, fiber, yam (yams), filaments, anchor rope, and thread.An apparatus comprising an improved embodiment of the invention comprises: a collapsible embolic protection device designed for temporary transvascular delivery to the aortic arch of a patient, the device having a protection unit comprising a selectively permeable material or unit adapted to prevent embolic material from entering with blood flow a plurality of aortic side branch vessels in the aortic arch, wherein the protection unit is permanently or releasably (for assembly prior to introduction into the body) attached to the transvascular delivery unit at or near a connection point or region disposed at the selectively permeable unit; and a first support for the protection unit arranged at least partially at the periphery of the selectively permeable unit. In the expanded state of the device, the connection point is enclosed by or integral with the first support, wherein the transvascular delivery unit is connected off-center to the protection unit at the connection point. In some embodiments, the connection point or area, or attachment point, is enclosed by the first support.
The connection point may be provided at the selectively permeable unit or at the first support.
The connection point may be provided on a surface of a selectively permeable unit designed to be oriented from inside the aortic arch and at a distance from the ostia area towards the aortic side branch vessels when the protective unit is positioned in the aortic arch.
In some embodiments, the selectively permeable unit comprises a first portion designed to expand in a first direction from the connection point towards the descending aorta of the aortic arch and a second portion designed to expand in a second direction (opposite to the first direction) from the connection point towards the ascending aorta of the aortic arch when the protective device is positioned in the aortic arch in the expanded state.
In some embodiments, the selectively permeable unit is arranged to expand asymmetrically from the connection point in a first direction towards a descending aorta of the aortic arch and in a second direction towards an ascending aorta of the aortic arch when the protection unit is positioned in the aortic arch in an expanded state.
The term "collapsible" as used in the context of the present application means that the size of the device can be reduced to a smaller size such that it can be arranged in a tubular delivery unit, e.g. a catheter. The collapsible unit is expandable when released or pushed out of the delivery unit. Expandable includes self-expanding, via shape memory effects and/or resilient. The collapsible unit is re-collapsible for withdrawal into the delivery unit and removal from the patient.
It should be emphasized that the term "comprises/comprising" when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.
Drawings
These and other aspects, features and advantages of embodiments of the present invention will be apparent from and elucidated with reference to the following description of embodiments of the invention, taken in conjunction with the accompanying drawings, in which:
FIG. 1 is a schematic view of a protective device attached to a transvascular delivery unit in a deployed, deployed configuration within an aortic arch, the device including a tether;
FIG. 2 is a perspective view of a embolic protection device having a tether;
FIG. 3 is a top plan view of the embolic protection device with a tether;
FIG. 4 is a schematic view of an embolic protection device delivered in a catheter, outside the catheter, and in the aortic arch;
FIG. 5 is an enlarged and detailed schematic view of the apparatus of FIG. 4;
FIG. 6 is a schematic view of an embolic protection device delivered in a catheter, outside the catheter, and in the aortic arch;
FIG. 7 is an enlarged and detailed schematic view of the apparatus of FIG. 6;
FIG. 8 is a top plan view of a embolic protection device having a plurality of tethers;
FIGS. 9A and 9B are schematic views of a catheter with a side channel and a tethered embolic protection device delivered via a side branch vessel;
FIG. 10 is a schematic view of a catheter delivered via a transfemoral artery with a side passage and an embolic protection device with a tether;
FIG. 11 is a schematic view of a catheter with a side channel and an embolic protection device delivered via a side channel with a hinge and tether;
FIG. 12 is a schematic view of a transfemoral catheter with side access and an embolic protection device with multiple tethers;
FIG. 13 is a schematic view of a catheter with a side channel and a embolic protection device delivered via the femoral artery with a pushing unit;
FIG. 14 is a schematic view of a embolic protection device having a flange unit 400;
FIG. 15 is a flow chart of a method 600;
FIGS. 16a-c are schematic views of a catheter device according to an embodiment of the present invention;
17a-c are schematic illustrations of a catheter device according to an embodiment of the present invention;
18a-e are schematic illustrations of a catheter device according to an embodiment of the present invention;
19a-b are schematic views of a catheter device according to an embodiment of the present invention;
FIGS. 20a-c are schematic views of a catheter device according to an embodiment of the present invention;
FIG. 21 is a flow chart illustrating a method according to an embodiment of the invention; and
22a-b are flow diagrams illustrating methods according to embodiments of the invention;
fig. 23a-d are schematic views of a catheter device according to an embodiment of the present invention.
Detailed Description
Specific examples of the present invention will be described below with reference to the accompanying drawings. This invention may, however, be embodied in different forms and should not be construed as limited to the embodiments set forth herein, but rather by the provision of such embodiments as to enable a full and complete disclosure of the invention and to fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbering refers to like elements.
Fig. 1 is a schematic view of an
Fig. 2 is a perspective view of the embolic protection device with a wire-type support 133. The two branches of the metal wire cross each other at a cross 196 towards the
The provided collapsible
The example
The protective unit 140 includes a selectively permeable material or
Depending on the characteristics of the selectively
The first support member 133 is shaped to be juxtaposed with tissue of a vessel wall portion of the
The embolic protection device is typically delivered transvascularly to the aortic arch via a
According to one aspect of the present disclosure, a collapsible, transluminal delivery
The tissue apposition maintaining unit provides for tissue apposition supporting the
The offset to the connection point may be, for example, at the
When the device is positioned in the aortic arch, a force (also referred to as a stabilizing force) is applied or directed against the inner wall of the
In this manner, tissue apposition of the
For example, the traction force so applied may pull the outer periphery of the device toward the inner wall. This force supports the above-described locking of the device into place upon implantation of the device.
Thus, the
The
In an example, the device may be delivered via the side channel 7 of the catheter 2 (e.g., through the femoral artery). Such a side channel catheter 2 is described in patent application PCT/EP2012/0058384, which patent application PCT/EP2012/0058384 was disclosed in WO2012152761 after the priority date of the present application, the entire content of which is incorporated herein by reference for all purposes. The catheter may also be improved by a plurality of side channels, one of which 7 is provided for delivering the
In an example, the
The device may in an example be delivered through the wall of the
The
The tethers, or more precisely, the drawstrings, are arranged to control the degree of sealing of the periphery. The tether provides for guiding the apposition of aortic tissue/cerebral arteries. The tether may provide active traction by a pulling action on the tether associated (distally attached) with the embolic protection device.
The tether may be longitudinally movably arranged with respect to the
The
The
The at least one
The blood
The device may have an attachment point where the distal end of the tether is connected to the device and through which traction may be transferred peripherally to the device. Optionally, one or more radiopaque fiducial markers may be provided at the device. A fiducial marker may be provided at the attachment point. Such radiopaque elements may be secured to or incorporated into the intravascular device, such as to the frame 133, selectively permeable unit, yoke, skeleton or other radiating support, tether, eyelet, or the like, to identify the orientation of the
In some examples, the tether extends proximally through the ostium into a selected side branch vessel such that the traction forces center the device relative to the ostium. When pull on the
The device may include a plurality of tethers attached along the peripheral distal end. Alternatively or additionally, a single proximal lead may be split distally into multiple (sub-) leads. For example, the tether may branch in a Y-shape. A single tether to be operated proximally may then distribute traction distally to the embolic protection device through its two distal points.
Fig. 8 shows an example with multiple endpoints. Multiple tethers may be used or combined with a tether having multiple distal ends. The plurality of tethers may converge at the proximal end of the device, such as at its base 330 (fig. 7, 8). In this way, the device provides a gradual force that is evenly distributed along the periphery of the device. The device may in this way advantageously adapt to the inner shape of the
In some examples, the device may have an internal structure or external skeleton, such as at least one rib 135 extending between different (preferably opposing) points of engagement at the periphery, with the tether attached distally to the rib. The
There may be a plurality of such ribs 135 in the device.
For example, the internal structure (e.g., ribs 135) may allow the operator to control the position of the device within the aortic arch and allow the operator to push, press or pull the device against certain features of the aortic arch, e.g., to press the device against the aortic arch wall a distance above the ostia of one or more side vessels. The outer skeleton may be connected to the inner structure. The outer scaffolding can be framework 133 and can provide additional structural support to the device and can help create a seal between the selectively
The
A
For example, the valve or wings of the device may be disposed upstream with respect to aortic blood flow. Alternatively or additionally, the
The tissue apposition sustaining unit may restrict the movement of the blood
The ribs 135 may be a yoke extending proximally over the blood
The
The
The blood permeable unit may be flexible. For example a flat membrane with a defined porosity or pores. The porosity or pores may be part of or contained in a fine wire mesh or net, or a perforated film. For example, having a diameter of 50-950 microns (e.g., 50, 60, 70, 80, 85, 90, 100, 12)0. 135, 150, 250, 350, 450, 550, 650, 750, 850, 950 or more microns). The perforated membrane may be perforated prior to introduction into the device. The film may also be perforated after the device is added, for example by laser drilling or by electrical sparking. In embodiments where a perforated membrane is present, the pores may have a constant or varying pore form, a constant or varying porosity, and/or a constant or varying pore size. The blood
The tether may be distally attached to the membrane. The applied traction force may thereby raise the membrane out of the plane of the membrane, such as into a volcano shape, including raising the attachment location of the tether to the membrane. The volcano shape can advantageously increase the efficiency of the device. The volcano-shaped top may be arranged to extend into the aperture into a portion of the side branch. The capture of particles can thus be improved by the internal funnel shape of the volcano into which the blood flows. The result is that the filtration efficiency will be improved.
The traction unit may comprise a passive traction unit. The passive traction unit is not operated by an operator but automatically provides improved sealing. The passive traction unit may be a spring. It may have a shape memory element, e.g. a portion of a frame, activated by body temperature, for providing traction against the delivery portion or device. For example, the device may include a "winglet" extending from the periphery of the device having shape memory. Another example is a shape memory spring that is activated to tighten the tether, for example, from the base of the device. A portion of the tether may be provided as a shape memory portion. Such a tether may be delivered in an elongated shape and then changed to a memory-induced shape, thereby shortening the tether to provide tension. The memory-inducing shape may be a helical coil shape that additionally allows for the elasticity of the memory-activated tether, which is particularly advantageous for pressure and/or motion compensation.
The device may have a flange unit 400 extending radially outward from the
Figure 10 is a schematic showing a catheter delivered trans-femoral artery through a side channel and an anti-embolic protection device with a tether, the device including a hinge portion 340 allowing translation of the tractive force upward toward the aortic inner wall tissue, as shown. The tractive force is thereby converted into a thrust force.
The tissue apposition maintaining unit may comprise a pushing unit 350 (fig. 13), and the force comprises a pushing force against the frame, the periphery and/or the blood permeable unit. The pushing unit provides the pushing force and presses the outer periphery toward the inner wall.
The tissue apposition maintaining unit may include a magnetic element, and the force includes a magnetic force.
This magnetic force may be provided as follows: the
The repulsive magnetic force can be obtained based on the same principle, but the polarities of the first and second magnetic elements are the same. When the
Magnetic elements may be provided in addition to or in addition to tethers, push rods, etc.
The medical devices described herein are typically packaged in sterile containers for distribution to medical professionals for use. The article may be sterilized using various methods (e.g., electron beam radiation, gamma radiation, ultraviolet radiation, chemical sterilization, and/or using aseptic manufacturing and packaging procedures). For example, the article may be marked with an appropriate date by which the article is expected to remain in a fully functional state. The components may be packaged individually or together.
For convenience, the various devices described herein may be packaged together in a kit. The kit may also include labels, such as instructions for use and/or warnings, such as information specified for inclusion by the food and drug administration. Such labels may be located on the outside of the package and/or on a separate paper within the package.
The
In the example of method 600,
In the method 600 of preventing embolic material from entering a side branch vessel with blood flow from the aortic arch of a patient, a collapsible
The
Expanding may include asymmetrically deploying the
Positioning the
The method comprises enclosing a plurality of ostia of the
Thus, the
Thus, the method simultaneously separates the first fluid space of the aortic side branch vessels from the second fluid space in the aortic arch when the
The method may comprise pulling the expanded
Further, the method includes a step 700 of applying a force to the device through at least one tissue apposition sustaining unit other than the delivery shaft of the device. The force is applied to the device away from the attachment point, for example at the periphery. When the device is positioned in the aortic arch, the force is directed towards the inner wall of the aortic arch. In this manner, tissue apposition from the periphery to the inner wall of the aortic arch is supported by the force.
This method is less iatrogenic than the known methods. Which further improves the sealing of the outer circumference of the embolic protection device. It also prevents debris from being generated from the orifice in the aortic arch, which may be a problem with some known embolic protection devices.
The stented apposition improves apposition of the periphery to an inner wall of the aortic arch such that the improved apposition improves a periphery-to-inner wall seal.
The force may be applied in a substantially proximal direction relative to the device to improve the seal.
Applying the force may include applying a traction force by the traction unit. The traction force may include pulling the outer circumference of the device toward the inner wall to lock the device in place in the aortic arch. The traction may be applied by at least one tether distally connected to the frame, the periphery and/or the blood permeable unit to provide traction.
The device may be delivered to the aortic arch through one of the side branch vessels, such as the brachiocephalic artery, the left carotid artery, or the left subclavian artery from the right subclavian artery. It may be delivered to the aortic arch through the descending aorta (e.g., in the femoral artery), for example, in the side channel of the main catheter. It can be delivered to the aortic arch through the wall of the ascending aorta, a method known as the "direct aorta" method.
The
The
The
The step of applying force may comprise proximally tensioning at least one tether member distally connected to the embolic protection device.
The step of delivering the embolic protection device can be performed translumenally, and the step of delivering the first catheter can be performed after the step of delivering the embolic protection device.
Delivering the first catheter may include placing a balloon mounted on the first catheter, expanding the balloon in the ascending aortic arch to lock the distal end of the first catheter in place. The balloon may be annular with a filter between the catheter and the inner ring of annular shape.
The embolic protection device used in the method may extend from the distal end of the second catheter or a separate channel of the first catheter, such that the position of the embolic protection device may be independently adjusted from the position of the first catheter.
Delivery of the first catheter may be performed simultaneously with delivery of the embolic protection device via a separate channel of the first catheter, independent of the endovascular procedure.
Endovascular surgery on the heart may include steps related at least to the removal of a heart valve, the placement of a prosthetic heart valve, or the repair of a heart valve. This may include treating heart valve disease, such as valvuloplasty, including percutaneous valvuloplasty. The procedure may be a transcatheter aortic heart valve (TAVI) involving implantation of a collapsible aortic heart valve using minimally invasive techniques.
The embolic protection device can be removed from the aortic arch after performing the endovascular procedure.
Catheter device comprising an embolic protection unit
Fig. 16a-c, 17a-c, 18a-c, 19a-b, 20a-c show a catheter device (500) comprising: an elongate sheath (503) having a lumen and a distal end for positioning at a heart valve (6); an embolic protection device (200) for temporary positioning in the aortic arch to deflect embolic debris from the ascending aorta to the descending aorta, the embolic protection device being connectable to a transluminal delivery unit (130) extending proximally from a connection point (131) and having: a frame with a periphery, a blood permeable unit located within the periphery for preventing embolic particles from entering the patient's brain through its side branch vessels with the blood flow downstream of the aortic arch; and at least one tissue apposition maintenance unit (300, 350) extending from the catheter into the aortic arch and attached to the embolic protection device at a maintenance point (502) for applying a stabilizing force at the embolic protection device (e.g. at the periphery) away from a connection point and for providing the stabilizing force towards an inner wall of the aortic arch, away from the heart and in a direction perpendicular to the longitudinal extension of the periphery when the catheter device is positioned in the aortic arch such that tissue apposition of the periphery to the inner wall of the aortic arch is supported by the force for improved stability and peripheral sealing.
The stabilizing force may comprise a tractive force and said apposition sustaining unit may comprise an active tractive unit having at least one operable tether (300) distally connected at said sustaining point offset from said connection point, e.g. to said frame, periphery and/or blood permeable unit, for providing said tractive force.
The mechanical tissue apposition maintaining unit may comprise a pushing unit (350) and said force comprises a pushing force against said frame, periphery and/or blood permeable unit for providing said pushing force and pressing said periphery against said inner wall.
The at least one tether or pushing unit may be longitudinally elastic, whereby said force is variable for compensating physiological movement of said aortic arch relative to said embolic protection device while maintaining said tissue apposition. This provides the advantages as described above.
The blood permeable unit may have at least one guiding unit (e.g. eyelet) near the distal end for receiving the tether or pushing unit, wherein the tether or pushing unit is attached to the blood permeable unit, flange or periphery at the distal end. This provides the advantages as described above.
The embolic protection device may have an attachment point to which the distal end of the tether or pushing unit is attached, and optionally, a radiopaque fiducial marker at the attachment point. This provides the advantages as described above.
The tether in operation may extend proximally through the ostium into the selected side branch vessel such that the traction forces center the device relative to the ostium and pull the device toward the inner wall to lock the device in place, whereby the device is self-aligning relative to the ostium of the selected side branch vessel. This provides the advantages as described above.
The catheter device may include a plurality of tethers attached distally along the periphery. This provides the advantages as described above.
The frame may comprise at least one rib extending between different points of engagement at said periphery, wherein said tether or pushing unit is distally attached to said rib. This provides the advantages as described above.
The different joints may be opposite joints. This provides the advantages as described above.
The rib may be a yoke extending proximally over said blood permeable unit. This provides the advantages as described above.
The yoke may extend in a longitudinal direction of at least a part of said embolic protection device. This provides the advantages as described above.
The catheter device may include multiple tethers, or a single tether split distally into multiple strands. This provides the advantages as described above.
Two tethers or strands may be attached to the periphery in a Y-shaped distal end from the base of the embolic protection device. This provides the advantages as described above.
The catheter device may comprise at least one eyelet, wherein one or more of said tether or pushing unit passes through the at least one eyelet. This provides the advantages as described above.
One or more of the tethers may pass through at least one eyelet at a pivot point at the base of the device. This provides the advantages as described above.
The blood permeable unit may be flexible, such as a flat membrane with a defined porosity or pores, and the tether or pushing unit is distally attached to the membrane such that the pulling or pushing force, when applied, lifts the membrane from the plane of the membrane. This provides the advantages as described above.
The traction or thrust, when applied, may lift the membrane from the plane of the membrane such that a volcano shape of the membrane is provided at the attachment location of the tether or pushing unit to the membrane. This provides the advantages as described above.
The traction unit or the propulsion unit may comprise a passive traction unit for providing said traction or thrust. This provides the advantages as described above.
The passive traction or pushing unit may be a spring or a shape memory element. This provides the advantages as described above.
The outer periphery may include a flange unit extending radially outward from the frame. This provides the advantages as described above.
The flange unit may be angled with respect to the plane of the blood permeable unit for pre-tensioning counteracting the provided stabilizing force. This provides the advantages as described above.
The tissue apposition maintaining unit may include a magnetic element and the stabilizing force includes a magnetic force. This provides the advantages as described above.
16a-c, 17a-c, 18c, 19a-b, the pushing unit comprises a distal guiding element (350) connected between the maintenance point of the embolic protection device and a distal connection point (501) on the catheter, wherein the distal guiding element has a delivery state in which the embolic protection device is collapsed and substantially in line with the sheath of the catheter, and a deployed state in which the embolic protection device is expanded, whereby the outer circumference is substantially in apposition with the aortic arch, thereby guiding the embolic protection device towards the inner wall when the distal guiding element is moved from the delivery state to the deployed state. This improves the sealing of the embolic protection device against the aortic wall, as the guiding element effectively guides the protection device to the correct position. This movement of the guide element and the associated force exerted by the guide element is illustrated by
The distal guide element may be connected to a distal portion of the embolic protection device at the maintenance point. By having a support at the distal portion of the embolic protection device, as shown in fig. 16a-c, the alignment of the embolic protection device can be improved. Alternatively or additionally, a further guide element (350') may be provided along the length of the embolic protection device as shown in fig. 18 c.
The distal guide element may comprise a shape memory material and may be resiliently movable from the delivery state to the deployed state by an effort toward the deployed state when unconstrained. This allows an effective and simple deployment of the guide element and thus an effective and simple expansion of the embolic protection device. The resilient guide element may allow the embolic protection filter to move relative to the catheter device, thereby following the motion of the beating heart and maintaining a seal.
Alternatively or additionally, the distal guide element may be movable from the delivery state to the deployed state by a pushing action of the delivery unit. Thus, the delivery unit may effectively release the anti-embolic protection device along with the guiding element for safe deployment.
The distal guide element is pivotally movable about the distal attachment point. This allows for efficient deployment from the catheter.
The distal guide element may be formed as a support post for the embolic protection device against the catheter. Thereby maintaining an enhanced support of the filter without risk of damaging the tissue, as is the case with prior art devices, wherein the stabilizing element is in direct contact with the tissue. Thus, the risk of tissue damage and emboli release that may occur is greatly reduced when the tissue is directly accessed with the buttress.
The catheter device may include an opening (504) through which the embolic protection device may be deployed. This allows the low-profile catheter device to slide smoothly in the aortic arch and allows more space to be available outside the catheter.
The opening may extend substantially along the length of the embolic protection device in the longitudinal direction of the sheath. This allows for easier release of the anti-embolic protection device.
By pushing the delivery unit in the distal direction, the embolic protection device may be delivered out of the opening, whereby the distal guiding element assumes the deployed state for guiding and supporting the frame against the wall. Thereby achieving ease of deployment while providing a compact and easy to use device.
The catheter device may comprise a longitudinal compartment (505) for said embolic protection device. The embolic protection device can thus have dedicated space before release, which can determine that the embolic protection device is properly positioned before release and can also avoid interference with other components or operating tools.
The embolic protection device may be preloaded in the longitudinal compartment. This further increases the certainty that the embolic protection device is correctly positioned and simplifies the procedure as it only needs to be expanded.
The embolic protection device is movable through the opening from a compressed shape in the compartment. The compartment is sized to fit the compressed filter, and the opening may be sized to restrain the filter in a compressed shape and allow the filter to be delivered therethrough, as pushed by a delivery unit, through a dilator as described below, or by removing a restraining portion positioned above the compartment.
The catheter device may comprise a longitudinal dilator (506) movable in the sheath, wherein the longitudinal compartment is arranged in the longitudinal dilator, as shown in fig. 17 b. This effectively provides space for the compressed embolic protection device, which can then be removed once the embolic protection device is deployed and the dilator is withdrawn, again making the catheter device compact and easy to use.
The opening may be disposed in the sheath, and the embolic protection device may be advanced out of the longitudinal compartment through the opening when the longitudinal dilator is retracted in a proximal direction. Thus, as described above, release of the embolic protection device and its deployment, removal of the compartment, and withdrawal of the dilator are provided in a single operational step for an enhanced and safer procedure.
Alternatively as shown in fig. 17c, or in addition, the catheter device may include an outer restraining sheath (507) radially outward of the sheath and adapted to restrain the embolic protection device in a compressed shape, the outer restraining sheath being retractable to release the embolic protection device to a deployed state. This also provides an effective way of deploying the anti-embolic protection device, which provides a safe procedure and increases patient safety.
The catheter device may comprise an outer restraining sheath (507) radially outside the sheath and adapted to restrain the embolic protection device in a compressed shape, the outer restraining sheath being retractable in a proximal direction to release the embolic protection device to a deployed state, whereby the distal guide element assumes the deployed state for guiding and supporting the frame against the wall.
The catheter device may comprise a centering unit (508, 508') adapted to center the catheter in the ascending aorta, wherein the centering unit comprises a radially expandable structure. This allows the distal part of the catheter to be positioned correctly on the heart, which is essential for performing the correct procedure. Thereby providing a catheter allowing optimal positioning while effectively protecting the side vessels of the aortic arch from the synergistic effect of any emboli released from the procedure, which optimizes and increases the safety of all procedures performed through the aortic arch and reduces the risk of subsequent complications.
The radially expandable structure may comprise inflatable balloons 509, 509', 509 ". This allows for safe centering and soft apposition of the tissues.
The inflatable balloon may comprise a plurality of inflatable elements (509, 509', 509 ") circumferentially disposed around a radial perimeter of the catheter, as shown in fig. 18 b. Thus, by being circumferentially disposed, for example uniformly disposed by having similar angles between each expandable element, a safe and effective center of positioning is provided. The device may include only one or two expandable elements. In this case, the expandable element may advantageously be attached to the catheter at a position 512 (fig. 18c) which will strive to push most against the wall portion of the aortic arch when the catheter strives towards its relaxed linear shape, i.e. towards the left part of fig. 18c (indicated by 512). Thus, a single or double expandable portion located near this side of the catheter may be sufficient to push the catheter towards the center of the aortic arch. Two expandable portions may increase the stability of the catheter position over one expandable portion. An expandable portion may occupy less space in the aortic arch. The free space can be increased by using an expansion portion which in the expanded state expands mainly only in the radial direction, for example shaped as a balloon which is mainly elongated in the radial direction, contrary to the example of an approximately spherical shape shown in fig. 18 b. As described below, the expandable structure may also be formed from another flexible material, such as NiTinol or plastic (discussed further below), which does not need to be expanded, but rather pushed radially outward, such as a strip or band of material extending longitudinally of the catheter, or an expandable mesh.
The expandable structure may be substantially constrained to the outer surface of the catheter in a smooth manner, as shown in fig. 18 d. This results in less friction towards the tissue wall when advancing the catheter. With a balloon, the balloon may be formed of a compliant material having a very smooth surface without wrinkles when not inflated.
The plurality of expandable elements may be individually and independently expandable. Thus, the position of the distal tip of the catheter device may be adjusted relative to the heart by selectively expanding and contracting different radial elements.
The radially
The catheter may comprise a distal centering unit (508, 508') adapted to center the catheter in the ascending aorta and a proximal centering unit (not shown) adapted to center the catheter in the descending aorta, wherein the proximal centering unit comprises a radially expandable structure. This may further improve the positioning of the catheter.
The catheter device as described above may be used for transvascular delivery of a medical device to a patient's heart valve region or for stabilization of an instrument for treatment thereof, such as an electrophysiology procedure or an ablation procedure.
Fig. 23a-c show a central support structure 510 extending across the frame 133. This central structure 510 may increase the apposition force against the aortic arch, and it may also support the blood permeable material itself so that a good seal is obtained. The central structure may extend through the frame 133 at any location between the proximal and distal ends of the frame 133. In fig. 23a and 23c, a
Fig. 23d shows that the blood
Fig. 21 shows a method (900) of positioning a catheter device (500) in an aortic arch, the method comprising transluminal delivery (901) of an embolic protection device (200), such as a deflector and/or a filter, in the aortic arch, said embolic protection device being connected to a transluminal delivery unit (130) extending proximally from a connection point (131) of said embolic protection device.
Positioning (902) the anti-embolic protection device in the aortic arch, comprising:
expanding (903) the frame of the device in the aortic arch and flattening the primary blood permeable unit,
juxtaposing (904) the periphery of the embolic protection device with the inner wall of the aortic arch to cover the ostium of the side branch comprising at least the carotid artery for preventing embolic particles from passing therethrough into the side branch to the brain of the patient; and
applying (905) a stabilizing force by at least one tissue apposition maintenance unit (300, 350) extending from the catheter into the aortic arch and attached to the embolic protection device at a maintenance point (502), wherein, when the catheter device is positioned within the aortic arch, the force is applied biasedly to the connection point at the embolic protection device (e.g. at the periphery) and towards an inner wall of the aortic arch to provide the stabilizing force towards the inner wall of the aortic arch, away from the heart and in a direction perpendicular to the longitudinal extension of the periphery such that tissue apposition of the periphery to the inner wall of the aortic arch is supported by the stabilizing force to improve stability and peripheral sealing.
The apposition of the struts improves apposition of the periphery to the inner wall of the aortic arch such that the improved apposition provides improved sealing of the periphery to the inner wall.
The method may comprise applying said stabilizing force in a substantially proximal direction with respect to said device for said improved sealing.
Applying the stabilizing force may include applying a traction force by a traction unit.
The method may include pulling the outer periphery of the device away from the heart by the traction force towards the inner wall to lock the device in place in the aortic arch.
The method may comprise applying said traction force through at least one tether distally connected to said frame, periphery and/or blood permeable unit to provide said traction force.
An embolic protection device may be delivered to the aortic arch via one of the side branch vessels, e.g. the brachiocephalic artery from the right subclavian artery, the left carotid artery, the left subclavian artery, or the descending aorta, e.g. in the femoral artery, or through the ascending aorta. Applying the stabilizing force may include applying (906) a pushing force by a pushing unit.
Applying the pushing force may include guiding (907) the embolic protection device from a collapsed state to a deployed state in which the embolic protection device is expanded into apposition with the inner wall of the aortic arch by a distal guide element (350), which distal guide element (305) is connected between the maintenance point of the embolic protection device and a distal connection point (501) on the catheter. This provides the advantages as described above.
The method may include supporting (908) a distal end of the frame with the distal guide element. This provides the advantages as described above.
The method may comprise pushing (909) the embolic protection device out of a longitudinal compartment (505) in the catheter by the delivery unit, whereby the distal guide element assumes a deployed state for guiding and supporting the frame against the wall. This provides the advantages as described above.
The method may comprise pushing (910) the embolic protection device out of a longitudinal compartment (505) arranged in the dilator (506) and movable in the catheter, when retracting the longitudinal dilator (506) in a proximal direction. This provides the advantages as described above.
The method may comprise centering (911) the catheter in the ascending aorta using a centering unit (508, 508', 509', 509 ") comprising a radially expandable structure. This provides the advantages as described above.
The method may include centering (912) the catheter with a plurality of expandable elements (509, 509', 509 ") disposed circumferentially about a radial periphery of the catheter. This provides the advantages as described above.
The method may include centering (913) the catheter with a shape memory material that is resiliently movable from a compressed constrained shape to an expanded deployed state when unconstrained by an effort to move toward the deployed state, wherein the shape memory material is axially disposed about a radially outer periphery of the catheter in the deployed state to center the catheter in the ascending aorta. This provides the advantages as described above.
The method may include transvascularly delivering (914) a medical device to a cardiac valve region of a patient or stabilizing an instrument for treatment thereof (e.g., treatment by electrophysiology surgery (915) or ablation surgery (916)).
Fig. 22a shows a method (1000) of preventing emboli flowing in an aortic arch from entering a side branch thereof, comprising advancing (1001) embolic protection towards the aortic arch; and
manipulating (1002) the protective device such that it covers the ostia of each side branch vessel, comprising:
applying (1003) a force to the protection device to improve the sealing of the device at its periphery, including applying a force bias to the connection point of the device through a distal guide element (350), the distal guide element (350) being connected between a distal maintenance point of the anti-embolic protection device and a distal connection point (501) on the catheter;
wherein the protective device allows blood to flow from the aortic arch into each side branch tube, but prevents emboli from entering the first and second side branch tubes without obstructing the lumen of the aortic arch.
Fig. 22b shows a method (1100) for performing an endovascular procedure on a heart, the method comprising:
delivering (1101) an embolic protection device to the aortic arch through one of the following vessels: a brachiocephalic artery, a left carotid artery, a left subclavian artery, or a descending aorta from the right subclavian artery (e.g., in the femoral artery); or through the wall of the ascending aorta; to position the embolic protection device in the aortic arch to prevent embolic debris from entering the carotid artery;
applying (1101) a stabilizing force to the protective device to improve sealing of the device at its periphery, including biasing the application of a force to a connection point at the device by at least one tissue apposition maintaining unit, other than a delivery shaft of the device, to control the degree of apposition and fluid sealing of the inner vessel wall of the aortic arch by the force;
and delivering (1102) a first catheter to the heart through an aortic vessel wall at the descending aorta, left subclavian artery or aortic arch to affect at least one step associated with an endovascular procedure on the heart;
applying (1103) the stabilizing force by tensioning at least one distal guide element (350) connected between a distal maintenance point of the embolic protection device and a distal connection point (501) on the catheter,
wherein the delivering the first catheter comprises placing a balloon mounted on the first catheter, expanding the balloon in the ascending aortic arch.
The balloon may be a ring-shaped balloon having a filter between the catheter and the inner ring of the ring shape.
The embolic protection device may extend from the distal end of the second catheter or a separate channel of the first catheter, such that the position of the embolic protection device may be adjusted independently of the position of the first catheter.
Delivering the first catheter may be performed simultaneously with said delivering the embolic protection device, wherein the embolic protection device is delivered through a separate channel of the first catheter, independent of the endovascular procedure.
Endovascular surgery on the heart may include at least one step associated with removing a heart valve, placing a prosthetic heart valve, or repairing a heart valve.
The embolic protection device can be removed from the aortic arch after performing the endovascular procedure.
The present invention has been described in detail with reference to the specific embodiments. However, other embodiments than the above described are equally possible within the scope of the invention. Different method steps than those described above, performing the method by hardware or software, may also be provided within the scope of the invention. The different features and steps of the invention may be combined in other combinations than those described. The scope of the invention is only limited by the appended patent claims.
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