Intravascular device with expandable filter and sheath

Abstract

This is a catheter with a filter, configured for use in the treatment of vascular abnormalities. The filter element is configured to capture embolus in the patient's blood vessels, is expandable from a collapsed state, and may have a retractable proximal portion to accommodate the insertion of an endovascular treatment device. The catheter is configured to facilitate the insertion of an endovascular treatment device into the catheter lumen by expanding radially, thereby reconfiguring the catheter from a normal state in which the main lumen defines a first dimension to an expanded state in which the main lumen defines a second dimension larger than the first dimension.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 472,855, filed on June 14, 2023, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure provides various systems for treating vascular abnormalities (e.g., occlusions, stenoses, etc.), including one or more medical devices (e.g., catheters, tubular members, and other such elongated members) that can be used individually or in combination with each other, and methods of using such systems in the course of intravascular procedures.

Background Art

[0003] The direct or indirect adverse effects on health associated with the presence of solids (e.g., thrombi) in an individual's vasculature are well - documented and have led to the development of various intravascular systems and treatment methods. However, there remains potential for improvement in the treatment of such vascular abnormalities.

Summary of the Invention

Means for Solving the Problems

[0004] In one aspect of the present invention, an intravascular system configured to be inserted into a patient's blood vessel is disclosed. The intravascular system includes a first tubular member having a main lumen and configured to expand radially so as to immediately expand the main lumen when a medical device is inserted, reconfiguring the first tubular member from a first form in which the main lumen defines a first dimension to a second form in which the main lumen defines a second dimension that is larger than the first inner cross - sectional dimension.

[0005] In some embodiments, the first tubular member may be of a substantially elastic structure. The first tubular member may include, in some embodiments, rubber, latex, or spandex.

[0006] In some embodiments, the first tubular member may be configured to revert to a first form after the medical device has been removed.

[0007] In some embodiments, the first tubular member may be reconfigured from a second to a third form after the medical device has been removed. In some embodiments, the first tubular member may define a third dimension in the third form that is larger than the first dimension but smaller than the second dimension.

[0008] In some embodiments, the intravascular system may further include a filter element supported by a first tubular member. The filter element may include a semipermeable membrane. In some embodiments, the filter element may be reconfigurable between a collapsed form and an expanded form that captures an embolus in the patient's blood vessel.

[0009] In some embodiments, at least a portion of the filter element may include a stretchable material that allows the filter element to expand as a medical device passes through it.

[0010] In some embodiments, the filter element may include a proximal portion attached to a first tubular member and a distal portion. In some embodiments, at least the proximal portion of the filter element may be expandable. In some embodiments, the proximal portion of the filter element may include a first material, and the distal portion of the filter element may include a second material. The first and second materials may have substantially equivalent elasticity. In some embodiments, the second material may have lower elasticity than the first material. In some embodiments, the filter element and the first tubular member may include at least one common elastic material.

[0011] In some embodiments, the intravascular system may further include a positioning member having a non-annular cross-sectional shape.

[0012] In some embodiments, the medical device may include a replacement valve.

[0013] In some embodiments, the first tubular member may include at least one steerable segment.

[0014] In some embodiments, the first tubular member may be configured to change its angular position by rotational deflection.

[0015] Another aspect of the present invention discloses an intravascular system configured to be inserted into a patient's blood vessel. The intravascular system includes a first tubular member and a filter element defining a passage, the passage extending through the filter element. The filter element includes a proximal portion attached to the first tubular member and a distal portion. The filter element includes a semipermeable membrane and is reconfigurable from a collapsed state to an expanded state that captures an embolus in the patient's blood vessel, and at least the proximal portion of the filter element includes a first stretchable material to accommodate insertion of a medical device into the passage.

[0016] In some embodiments, the medical device may include a replacement valve.

[0017] In some embodiments, the first tubular member may include an elastic structure. The first tubular member may include rubber or spandex. The first tubular member may include a second stretchable material. In some embodiments, the first stretchable material may have lower elasticity than the second stretchable material.

[0018] Another aspect of the present disclosure discloses an intravascular system comprising a first member having a filter element to which a semipermeable membrane is attached, and a second member that can be inserted laterally into the first member. The filter element is capable of expanding to contact the second member and is reconfigurable between a collapsed form and an expanded form for capturing emboli.

[0019] The second member may, in some embodiments, include an annular or non-annular shape. The second member may include at least one flattened section. In some embodiments, the second member may include an elliptical cross-sectional shape.

[0020] In some embodiments, the second member may include a body that defines a lumen. In some embodiments, the body and the lumen may have dissimilar shapes.

[0021] Another aspect of the present invention discloses a catheter configured for use in the treatment of vascular abnormalities. The catheter includes a filter element configured to define a main lumen and capture an embolism in the patient's blood vessels. The catheter is configured to facilitate insertion of an endovascular treatment device into the main lumen by radial expansion, thereby reconfiguring the catheter from a normal configuration in which the main lumen defines a first dimension to an expanded configuration in which the main lumen defines a second dimension greater than the first dimension.

[0022] In some embodiments, the catheter may include at least one guide rail, which is located within the main lumen and is configured to engage with an endovascular treatment device to facilitate the insertion of the endovascular treatment device into the catheter and its advancement within the main lumen.

[0023] In some embodiments, the catheter may include at least one reinforcing rib, which is configured to prevent the overall length of the catheter from changing while the catheter expands radially.

[0024] In some embodiments, the catheter may include an inelastic structure such that its expanded shape is largely maintained after the removal of the intravascular treatment device. In some embodiments, the catheter may include an elastic structure such that the catheter is biased toward its normal shape.

[0025] In some embodiments, the catheter may include at least one stretchable material. The catheter may include, in some embodiments, at least one of rubber, latex, and spandex.

[0026] In some embodiments, the catheter may be configured to return to its normal form after the intravascular treatment device is removed.

[0027] In some embodiments, the catheter may be configured to be reconfigured into a partially expanded form after the intravascular treatment device is removed, in which the main lumen defines a third dimension that is greater than the first dimension and less than the second dimension.

[0028] In some embodiments, the catheter may be configured such that the third dimension is in the range of about 105% to about 195% of the first dimension.

[0029] In another aspect of the present invention, an intravascular system is disclosed that includes a main catheter defining a main lumen and an internal catheter extending through the main lumen. The main catheter includes a filter element that is reconfigurable from a collapsed form in which the main catheter is configured to be inserted into a patient's blood vessel to an expanded form in which the filter element is configured to capture emboli within the patient's blood vessel. The internal catheter is configured to facilitate the reconfiguration of the filter element from the collapsed form to the expanded form by axially moving from a retracted position to a forward position relative to the main catheter.

[0030] In some embodiments, the internal catheter may include at least one thickened location, in which case the internal catheter defines a non-uniform cross-sectional dimension to increase the rigidity, strength, or stability of the internal catheter.

[0031] In some embodiments, the intravascular system further includes an outer sheath configured to receive the main catheter, the outer sheath extending around the main catheter.

[0032] In some embodiments, the main catheter and the outer sheath may be configured to move axially relative to each other.

[0033] In some embodiments, the internal catheter may include a retainer configured to receive a filter element. When the internal catheter is in a retracted position, the retainer can constrain the filter element and maintain its collapsed shape by expanding around it. When the internal catheter is in an advanced position, the retainer may be positioned distal to the filter element, thereby allowing the filter element to reconfigure from its collapsed shape to an expanded shape.

[0034] In some embodiments, the retainer may be configured to completely conceal the filter element when the internal catheter is in a retracted position, and in other embodiments, the retainer may be configured to partially conceal the filter element when the internal catheter is in a retracted position.

[0035] In some embodiments, the retainer may be connected to the filter element. The retainer may be connected to the filter element by at least one flangable member, which is configured to restrain relative movement between the internal catheter and the main catheter until sufficient axial force is applied. At least one flangable member may be configured to rupture as the internal catheter moves from a retracted position to an advanced position.

[0036] In some embodiments, the retainer may be reconfigurable from an expanded to a compressed state while the internal catheter is moving from a retracted position to an advanced position.

[0037] In some embodiments, the retainer may include an elastic structure such that the retainer is biased toward a compressed form, thereby automatically reconfiguring from an expanded form to a compressed form as soon as the internal catheter moves from a retracted position to an advanced position.

[0038] In some embodiments, the retainer may include at least one stretchable material.

[0039] In some embodiments, the internal catheter may include a scinting mechanism, which facilitates the reconfiguration of the retainer from an expanded to a compressed form. The internal catheter may further include at least one extension fixed to the retainer, which extends proximal to the retainer and covers the filter element when the internal catheter is in a retracted position. The internal catheter may include a plurality of extensions arranged in a configuration that partially overlaps each other.

[0040] In some embodiments, at least one extension may be biased radially inward so that as soon as the internal catheter moves from a retracted position to an advanced position, at least one extension automatically deflects radially inward. At least one extension may include an elastic structure.

[0041] In some embodiments, the internal catheter may include a scinting mechanism that deflects at least one extension radially inward.

[0042] According to common practice, various features in drawings may not be depicted to the correct scale and may be enlarged or reduced as appropriate for clarity. [Brief explanation of the drawing]

[0043] [Figure 1] This diagram shows an intravascular system, comprising a main catheter having a filter element, according to one embodiment of the present invention, and illustrates how it is inserted into a patient's blood vessel during an intravascular procedure. [Figure 2] This is a cross-sectional view of a main catheter according to one embodiment of the present invention. [Figure 3]Figure 1 shows a cross-sectional view of the main catheter along line 3-3, and the main catheter is shown in a first embodiment, configured so that various embodiments of an intravascular treatment device can be inserted into the main catheter. [Figure 4A] This is a cross-sectional view of the main catheter in a second configuration in which an endovascular treatment device has been inserted. [Figure 4B] This is a side view of the main catheter, shown in a second configuration with an endovascular treatment device inserted. [Figure 5] This is a cross-sectional view of the main catheter, shown in a third configuration after the removal of the endovascular treatment device. [Figure 6] This is a cross-sectional view of a main catheter according to one embodiment of the present invention, the main catheter including one or more reinforcing ribs. [Figure 7] This is a cross-sectional view of a main catheter according to one embodiment of the present invention, the main catheter including one or more guide rails. [Figure 8] This is a partial top view of the main catheter, showing the filter element in a collapsed state. [Figure 9] Figure 8 is a partial top view of the main catheter, showing the filter element in an expanded form. [Figure 10] One embodiment of an intravascular system is shown, which includes a positioning member configured to guide a filter element to engage with a blood vessel during an intravascular procedure. [Figure 11] Another method using the intravascular system shown in Figure 10 is presented. [Figure 12] This is a cross-sectional view of the positioning member along line 12-12 in Figure 10. [Figure 13] This is a cross-sectional view of a positioning member according to one embodiment of the present invention. [Figure 14] This is a cross-sectional view of a positioning member according to one embodiment of the present invention. [Figure 15] This is a cross-sectional view of a positioning member according to one embodiment of the present invention. [Figure 16]Another embodiment of the intravascular system is shown, which includes an outer sheath extending around the main catheter. [Figure 17] This is a cross-sectional view of the outer sheath and main catheter along line 17-17 in Figure 16. [Figure 18] A partial proximal perspective view of the outer sheath, shown with a series of stylets. [Figure 19] This is a partial plan view of a main catheter according to one embodiment of the present disclosure, the main catheter comprising one or more steerable segments, as shown in the first embodiment. [Figure 20] This is a cross-sectional view of the main catheter along line 20-20 in Figure 19. [Figure 21] This is a partial plan view showing the main catheter as seen in Figure 19, in a second configuration. [Figure 22] This is a partial perspective view of a main catheter according to one embodiment of the present disclosure, in which the main catheter is configured to rotate and deflect. [Figure 23] This diagram illustrates one embodiment of an intravascular system including an internal catheter, which has a retainer extending through the main catheter and is shown in a retracted position. [Figure 24] Figure 23 shows the intravascular system, with the internal catheter indicated to be in an advanced position. [Figure 25] Figure 23 shows the intravascular system, and the internal catheter is according to one embodiment of the present invention. [Figure 26] Figure 23 shows the intravascular system, and the internal catheter is according to one embodiment of the present invention, and includes one or more extensions extending proximal from the retainer. [Modes for carrying out the invention]

[0044] This disclosure describes various devices, systems, and methods for treating vascular abnormalities (e.g., occlusion, stenosis, etc.) in patients' legs, arms, torso, neck, head, etc. For example, this disclosure describes a main catheter (sometimes referred to herein as a sheath or tubular member) configured to facilitate the insertion of an endovascular treatment device by expanding radially. To capture an embolism in a patient's blood vessel, the catheter (sheath / tubular member) includes a filter element having a semipermeable membrane that can be reconfigured between a collapsed form and an expanded form.

[0045] This expandable sheath can also be used as one piece ("first piece") of a multiport filter system for capturing and removing blood clots, debris, etc. Applications include, but are not limited to, capturing blood clots during thrombectomy (for example, being deployed from the internal jugular vein or subclavian vein by a filter in the inferior vena cava during ileal / lower limb and / or inferior vena cava thrombectomy, and / or being deployed from the femoral vein by a filter in a rostral vein leading to the heart during thrombectomy for deep vein thrombosis of the upper limb and / or head / neck). It can also be used from arterial access (mostly transfemoral artery) to deploy a filter in the ascending aorta during aortic valve replacement and / or other left ventricular procedures.

[0046] In some embodiments, the main catheter may be provided as a component of an intravascular system that also includes a positioning member that can be inserted alongside the main catheter. During use of the intravascular system, as soon as the filter element is reconfigured from a collapsed state to an expanded state, the filter element comes into contact with the positioning member and is positioned alongside the blood vessel.

[0047] As an addition or alternative, the intravascular system may include an outer sheath configured to receive a main catheter (for example, to facilitate the delivery of the main catheter and filter element), and / or an inner catheter extending within the main catheter and configured to perform axial movement related to the main catheter. More specifically, in such embodiments, the inner catheter facilitates the reconfiguration of the filter element between a collapsed and expanded form by being repositionable between a retracted and an advanced position.

[0048] Referring to Figure 1, an intravascular system 10 is shown, which is configured for use in the treatment of vascular abnormalities. The intravascular system 10 is configured to be inserted into a patient's blood vessel V and includes a (first) intravascular treatment (medical) device 100, the device 100 is configured as a (first) main catheter (tubular member) 102, the main catheter 102 having a defined length L and having a proximal (proximal end) 104 and a distal (distal end) 106, an outer wall 108 defining a main (central, working) lumen 110, the outer wall 108 extending continuously between the proximal 104 and distal 106 of the main catheter 102, and a filter element 112 supported by the distal 106 of the main catheter 102 (for example, at or adjacent to the distal 106).

[0049] In the embodiment shown in Figure 1, the outer wall 108 of the main catheter 102 is shown to be solid. However, as shown in Figure 2, embodiments are also envisioned in which the outer wall 108 may include one or more internal channels 114 (at least one of each), and the internal channels 114 are configured to receive auxiliary (additional) medical devices 116 (e.g., guidewires 118, additional catheters, etc.). In the embodiment shown in Figure 2, four internal channels 114i to 114iv are shown to be included. Naturally, the specific number of channels 114 may be more or less than four, as long as it does not deviate from the scope of the present invention. Thus, embodiments with more or fewer internal channels 114 are also envisioned herein and do not exceed the scope of the present invention.

[0050] The main lumen 110 defines a (first, initial) internal transverse dimension (e.g., diameter) D1 (Figure 3) and is configured to receive a (second) intravascular treatment (medical) device 120 (e.g., a (second) catheter 122, a replacement valve 124, a thrombectomy device, etc.), the external transverse dimension (e.g., diameter) D0 being greater than the internal transverse dimension D1 (this will be described in more detail later). In the illustrated embodiment, the main catheter 102 is configured such that the internal transverse dimension D1 is substantially in the range of 0.05 Fr to 32 Fr. However, embodiments in which the internal transverse dimension D1 may fall outside the scope of this disclosure are also envisioned herein and are not beyond the scope of the invention. The main lumen may be circular in transverse dimensions, or it may have other non-circular shapes (e.g., elliptical).

[0051] In some embodiments, the main catheter 102 may be configured to expand radially (for example, immediately upon insertion of the (second) endovascular treatment device 120) to enlarge the main lumen 110, thereby reconstructing the catheter from a first (normally contracted) form (Figure 3) to a second (expanded, enlarged) form (Figures 4A and 4B). More specifically, in the first embodiment, the main lumen 110 defines an internal transverse dimension D1, and in the second embodiment, the main lumen 110 defines a (second, next) internal transverse dimension (e.g., diameter) D2, the internal transverse dimension D2 being larger than the internal transverse dimension D1 and (approximately) equal to the external transverse dimension D0 of the (second) endovascular treatment device 120. The catheter 102 may be circular in transverse dimensions, or it may have other non-circular shapes (e.g., elliptical). Figure 4B shows the distal region of the inserted medical device expanding, illustrating how the catheter expands as it advances. In another embodiment, another region of the catheter may expand like the distal region (for example, in the longitudinal direction), thereby causing other regions of the main catheter to expand / stretch as they pass through.

[0052] To facilitate such reconstruction of the main catheter 102, the main catheter 102 may contain any suitable material or combination of materials. In one embodiment, the main catheter 102 may have an inelastic structure so that the second form is (almost) maintained after the (second) endovascular treatment device 120 is removed. However, alternatively, the main catheter 102 may have an elastic structure so that it is biased toward the first form so that the main catheter 102 automatically moves toward the first form (Figure 3) after the (second) endovascular treatment device 120 is removed. For example, the main catheter 102 may contain one or more elastic (expandable, stretchable) materials (e.g., rubber, latex, resin, and / or spandex, etc.) (for example, it may be formed in part or whole from these materials).

[0053] The stretchable resin or other material may have a braid (or strand) of wire, or a braid (or strand) of PET, or other non-metallic fibers, or a braid in which some strands are metallic and some strands are non-metallic (e.g., PET) in varying proportions. The braided fibers may protrude slightly from the resin along the inner diameter, which can act as a “rail” on which an object (e.g., a device, tissue, etc.) slides, minimizing friction with the surface of the stretchable material. The fibers may also have a braided form that is not stretched or pulled, thereby reducing friction compared to when the structure is distorted by tensile force.

[0054] In some embodiments, an internal hydrophilic coating may be applied to the fiber / twisted wire or other material to reduce friction.

[0055] In such embodiments, the main catheter 102 may revert to its first form (Figure 3) after the removal of the (second) endovascular device 120. Alternatively, after the removal of the (second) endovascular device 120, the main catheter 102 may be reconfigured into a third (partially expanded) form, in which the main lumen 110 defines a (third) internal transverse dimension (e.g., diameter) D3 (Figure 5), which is greater than the internal transverse dimension D1 (Figure 3) and smaller than the internal transverse dimension D2 (Figure 4). Depending on the specific material used in the manufacture of the main catheter 102, D3 may be in the range of (approximately) 105% to (approximately) 195% of D1.

[0056] In some embodiments, the main catheter 102 may be configured such that its outer cross-sectional dimension (e.g., diameter) D remains (approximately) constant during expansion (and contraction) of the main catheter 102 (for example, during reconstruction of the main catheter 102 from a first form (Figure 3) to a second form (Figure 4), and during reconstruction of the main catheter 102 from a second form to a first form). Thus, in these embodiments, the lumen expands (by thinning the catheter wall thickness), but the external shape remains constant. However, in other embodiments, it is also conceivable that the main catheter 102 may be configured such that its outer cross-sectional dimension D changes while it is elongating (and shortening) in the axial direction. More specifically, the main catheter 102 may be configured such that its outer cross-sectional dimension D increases during reconstruction of the main catheter 102 from a first form to a second form, and decreases during reconstruction of the main catheter 102 from a second form to a first form.

[0057] After a medical device has passed through the main catheter 102 (for example, after the medical device has been removed from the main lumen), the main catheter 102 can bounce back to various shapes / sizes. In some embodiments, the main catheter 102 can bounce back to at least 50% of its original shape. In other embodiments, the main catheter 102 can bounce back to at least 80% of its original shape, and in yet another embodiment, it can bounce back to at least 90%. In yet another embodiment, the main catheter 102 can bounce back to more than 90% or more than 95%. It is also conceivable that it may bounce back to other percentages between approximately 50% and approximately 100% (completely bounce back), for example, in some embodiments, the main catheter can bounce back to less than 50% of its original size. Therefore, the catheter (sheath / tubular member) can expand from its normal inner diameter when a larger device passes through it, allowing the device to pass through, and has recoil / memory to bounce back to a certain percentage of the stretched / expanded inner / outer diameter.

[0058] Referring to Figure 6, in some embodiments, the main catheter 102 may include one or more reinforcing ribs 126 (at least one) to suppress (if not completely prevent) axial elongation and / or axial shortening (e.g., changes in the length L (Figure 1) of the main catheter 102) during radial expansion (and contraction) (e.g., during insertion and removal of the (second) intravascular treatment device 120). In the illustrated embodiment, the reinforcing rib 126 is embedded (located) within the outer wall 108 of the main catheter 102 and extends axially (longitudinally) along the length L of the main catheter 102. However, naturally, the reinforcing rib 126 may be included in any suitable location (e.g., outside the main catheter 102 (on the outer wall 108), within the main lumen 110, or elsewhere) and may be configured in any suitable manner. For example, embodiments in which the reinforcing rib 126 extends at an acute or right angle to the length L of the main catheter 102 are also envisioned herein, as are embodiments in which the reinforcing rib 126 may extend helically along the length L of the main catheter 102.

[0059] The reinforcing rib 126 may include any suitable material or combination of materials, whether similar to (e.g., the same as) or different from (e.g., not the same as) the material used to manufacture other parts of the main catheter 102 (e.g., the outer wall 108). For example, in one particular embodiment, the reinforcing rib 126 may include synthetic fibers (e.g., Kevlar®) (e.g., part or all of it may be formed therefrom).

[0060] As an addition or alternative, the main catheter 102 may include one or more guide rails 128 (at least one) located (extending) within the main lumen 110. The guide rails 128 extend between the proximal 104 and distal 106 of the main catheter 102 (Figure 1) and are configured to engage (contact) with the (second) endovascular treatment device 120 (and / or other device) to facilitate the insertion of the (second) endovascular treatment device 120 (and / or other device) into the main catheter 102 and its advancement within the main lumen 110. In the illustrated embodiment, four guide rails 128i to 128iv are shown, but naturally, the specific number of guide rails 128 may be more or less than four. Thus, embodiments with more or fewer guide rails 128 are envisioned herein and are not beyond the scope of the invention.

[0061] In some embodiments, the catheter (sheath / tubular member) may have one or more folded seams (like those of a Chinese fan) which are widened when expansion is required to increase its diameter.

[0062] These ribs and / or guide rails may be provided in various catheter embodiments disclosed herein.

[0063] The main catheter may take the form of a vascular sheath or vascular port for surgical procedures (e.g., robotic surgery, laparoscopic surgery, bronchoscopy, gastric ulcer surgery, gastrointestinal surgery, etc.). Veterinary applications are also envisioned.

[0064] The filter element 112 includes a semipermeable membrane 130 (Figure 1) (e.g., a net, mesh, or other such suitable structure) and is configured to capture emboli or other such debris within the patient's blood vessel V. As seen in Figure 1, the filter element 112 includes a proximal portion 132 and a distal portion 134, the proximal portion 132 being supported by (connected to) the distal portion 106 of the main catheter 102, and the distal portion 134 flaring radially outward (e.g., relative to the proximal portion 132) and thus having a larger diameter than the distal portion. Furthermore, the filter element 112 defines a passage 136 which extends through the filter element 112 and communicates with the main lumen 110 of the main catheter 102, which facilitates the insertion (and / or insertion and penetration) of the (second) intravascular treatment device 120 (and / or other devices) into the main catheter 102 and the filter element 112 (e.g., via the passage 136), and into the vessel V to access the target treatment site. The filter element 112 may be delivered in a compressed state and may expand on its own when released from restraint, or it may be mechanically expandable by a balloon or the like.

[0065] The filter element 112 may be partially or fully expandable so that, upon deployment, it automatically reconfigures from a collapsed (inserted) form (Figure 8) to an expanded (deployed) form (Figures 1, 9), in which the main catheter 102 is inserted into the patient's blood vessel V (Figure 1), with the filter element 112 defining a (first, initial) cross-sectional dimension (e.g., diameter) DF1, and in the expanded (deployed) form, the filter element 112 defines a (second, subsequent) cross-sectional dimension (e.g., diameter) DF2 (Figure 9), where the cross-sectional dimension DF2 is greater than the cross-sectional dimension DF1. More specifically, as seen in Figure 1, in the expanded form, the filter element 112 is configured to engage (contact) with the blood vessel V and capture the embolus within the patient's blood vessel.

[0066] In some embodiments, the filter element 112 may be partially or entirely elastic in structure so that it reconfigures from a collapsed form (Figure 8) to an expanded form (Figure 9) immediately upon insertion of a medical device (e.g., a second intravascular treatment device 120 (Figure 3)) and from an expanded form to a collapsed form immediately upon removal of the medical device (e.g., a second intravascular treatment device 120). For example, in an embodiment, to accommodate the insertion of a second intravascular treatment device 120 into the passage 136, at least a portion of the filter element 112 (e.g., the proximal portion 132) may include one or more expandable (stretchable) materials (e.g., at least the proximal portion 132 of the filter element 112 is expandable).

[0067] In some embodiments, the main catheter 102 and the filter element 112 may comprise one or more common (e.g., equivalent or identical) elastic (expandable, stretchable) manufacturing materials. Alternatively, the main catheter 102 (e.g., the outer wall 108) may comprise a first elastic material, and the filter element 112 may comprise a second elastic material, the second elastic material may be more or less elastic than the first elastic material.

[0068] As an addition or alternative, the proximal portion 132 of the filter element 112 may contain a first material, and the distal portion 134 of the filter element 112 may contain a second, different material. For example, the first and second materials may have approximately equivalent elasticity. Alternatively, the second material may have lower elasticity than the first material.

[0069] In some embodiments, the expandable catheter / sheath may be integrated with the filter.

[0070] Referring now to Figures 10 and 11, in some embodiments the intravascular system 10 may further include a positioning member 200, which may be used to guide the filter element 112 into engagement (contact) with the blood vessel V. More specifically, the positioning member 200 is inserted into the blood vessel V so as to be positioned between the main catheter 102 and the blood vessel V, and positioned laterally (e.g., (approximately) parallel) to the main catheter 102. The positioning member 200 may be positioned in various orientations depending on the specific shape, location, size, etc., of the blood vessel V. For example, the positioning member 200 may be positioned adjacent to the patient's aortic arch A, as seen in Figure 10, or on the opposite side of the patient's aortic arch A (e.g., adjacent to the patient's brachiocephalic artery I), as seen in Figure 11.

[0071] As soon as the positioning member 200 is inserted and the filter element 112 is reconfigured to its expanded form, the filter element 112 expands and contacts the positioning member 200, thereby positioning the filter element 112 alongside the blood vessel V, thereby allowing the filter element 112 to conform more closely to the patient's anatomical structure and reducing blood flow through the surrounding (outer) blood vessel V around the filter element 112. Thus, the positioning member 200 moves the filter element 112 to guide (e.g., increase) blood flow through the filter element 112. The positioning member 200 may contact either or both of the filter element 112 and the main catheter 102.

[0072] The positioning member 200 includes a proximal portion (proximal end) 202 and a distal portion (distal end) 204, and a body 206 (Figure 12) that defines the (central) lumen 208. In the illustrated embodiment, the positioning member 200 is configured such that the body 206 and the lumen 208 each include the same (approximately) annular (e.g., circular, round) outer and inner cross-sectional shapes, respectively, as seen in Figure 12. However, embodiments in which the body 206 and / or the lumen 208 may include a non-annular cross-sectional shape are also envisioned herein (for example, to further enhance the positioning member 200's ability to engage (contact) the filter element 112 with the blood vessel V). For example, in the embodiment of the positioning member 200 shown in Figure 13, the outer cross-sectional shape of the body 206 is (approximately) elliptical, and the inner cross-sectional shape of the lumen 208 is (approximately) annular (for example, in this case, the body 206 and the lumen 208 each include (or include other dissimilar shapes) the same (dissimilar) outer cross-sectional shape and the inner cross-sectional shape of the body 208). In the embodiment of the positioning member 200 shown in Figure 14, the outer cross-sectional shape of the body 206 and the inner cross-sectional shape of the body 208 are (approximately) elliptical (for example, in this case, the body 206 and the lumen 208 each include the same (dissimilar) outer cross-sectional shape and the inner cross-sectional shape). In another embodiment of the positioning member 200 shown in Figure 15, the body 206 includes (at least one) one or more flat (e.g., (approximately) planar) sections 210.

[0073] The shape of the positioning member 200 is assumed to be (approximately) uniform or variable between the proximal portion 202 and the distal portion 204. For example, the body 206 may have one or more non-annular sections between (approximately) annular sections.

[0074] To facilitate the insertion and removal of the main catheter 102, in some embodiments the intravascular system 10 may include an outer sheath (tubular member, catheter) 300, as shown in Figure 16. The outer sheath 300 defines a (primary) lumen 302 configured to receive the main catheter 102, and extends around the main catheter 102, allowing relative (axial) movement between the outer sheath 300 and the main catheter 102. In some embodiments, the outer sheath 300 may be configured to crush a filter element 112, thereby reconfiguring the filter element 112 from an expanded to a crushed state (for example, to facilitate the insertion of the main catheter 102 into a blood vessel V (Figure 1) and / or the removal of the main catheter 102 from the blood vessel V), thereby the outer sheath 300 functions as a restraining (tightening) member (mechanism). As an addition or alternative, the intravascular system 10 may include a scinting mechanism 12 (Figure 1) (e.g., a lasso, snare, etc.) for facilitating the reconstruction of the filter element 112 from an expanded form to a collapsed form (e.g., before the main catheter 102 is removed from the blood vessel V), as described in U.S. Patent Application No. 17 / 210,778 (Publication No. 2021 / 0236257) and U.S. Patents No. 11,439,492 and No. 11,877,752, which are incorporated herein by reference in their entirety. In some embodiments, a compression mechanism, such as an outer sheath, may be provided to compress the flared filter in preparation for removal from the body, and this compression mechanism includes at least one wire that travels substantially through a section of the wall of the catheter (primary tubular member). In some embodiments, at least one wire travels through a section of the wall of the catheter and along at least a portion of the circumference of the filter. A mechanism for moving at least one wire may be provided at the proximal end of the outer tubular member, where the proximal end is on the side opposite the filter at the distal end. This mechanism may be activated from outside the patient's body and is operable (e.g., movable) to crush the filter by applying force to move its at least one wire.

[0075] The outer sheath 300 may include one or more secondary or tertiary lumens (at least one) in addition to the lumen 302. Additionally or alternatively, the intravascular system 10 may include one or more stylets 400 (Figure 18) (at least one), which are configured to be removably inserted into the outer sheath 300 to facilitate insertion of the outer sheath 300 into the vessel V (Figure 1). For example, it is assumed that the stylet 400 has variable stiffness (e.g., malleability), and that the stylet 400 may be provided as a kit with the main catheter 102 (Figures 16, 17) and the outer sheath 300. While the embodiment shown in Figure 18 is shown to include three stylets 400i to 400iii, the specific number of stylets 400 included in the intravascular system 10 may be more or less than three, as long as it does not deviate from the scope of this disclosure. Therefore, embodiments with more than three stylets 400 and embodiments with fewer stylets 400 are also envisioned in this specification and do not exceed the scope of the present invention.

[0076] The various devices described herein are envisioned to include (optionally) one or more steerable segments (zones), which are deflectable by one or more (at least one) pull wires extending (embedded) within their walls, thereby allowing the device to be reconfigured between various forms. Additionally or alternatively, the various devices described herein may include (optionally) an integrated visualization device or system (e.g., a camera) to facilitate imaging during surgery. For example, referring to Figures 19-21, the main catheter 102 may include a plurality of segments 138 and one or more (at least one) pull wires 140 to facilitate articular movement and reconfiguration of the main catheter 102 (for clarity, the filter element 112 is omitted in Figures 19-21). More specifically, in the particular embodiment shown in the illustration, the main catheter 102 includes at least one (e.g., multiple) inactive (passive) segments 138i and at least one (e.g., multiple) active (steerable, deflectable, articulate) segments 138a connected to multiple pull wires 140. The inactive segments 138i and active segments 138a are arranged in a staggered pattern along the longitudinal axis X defined by the main catheter 102, thereby alternating the inactive segments 138i and active segments 138a in the catheter 102. It is also conceivable that, instead of one or more pull wires that are pulled proximal to bend / steer the active segments or portions of the catheter, one or more push wires that can be pushed distally to bend / steer the active segments or portions of the catheter may be provided along the catheter.

[0077] In the particular embodiment shown, each active segment 138a is connected to a corresponding (single) tension wire 140 extending through (for example, within) the outer wall 108 (for example, so that the tension wire 140 is embedded in the outer wall 108 of the catheter 102), and so the number of tension wires 140 is the same as the number of active segments 138a. As soon as an axial (tensile) force is applied to each of the tension wires 140, the corresponding active segment 138a deflects (articulates) to reconfigure (actively steer) the catheter 102 between a first (initial, normal) configuration (Figure 19) in which the catheter 102 is (almost) linear, and a second (next, deflected) configuration (Figure 21) in which the catheter 102 is non-linear.

[0078] Using a single pull wire 140 for connection to each active segment 138a reduces the number of pull wires 140 required, thereby reducing complexity in both the manufacture and operation of the catheter 102. In another embodiment, it is also conceivable that multiple pull wires 140, each independently movable, may be included. In the particular embodiment shown, each pull wire 140 is received in a corresponding channel 142 (Figure 20) that extends (approximately) parallel to the longitudinal axis X within the outer wall 108 of the catheter 102.

[0079] To facilitate the application of axial force to the tension wire 140, in some embodiments, the catheter 102 may include (or be connected to) a plurality of corresponding activation mechanisms 144 (for example, in which case the number of tension wires 140 and the number of activation mechanisms 144 would be the same). In a particular embodiment shown, the catheter 102 includes a (first) activation mechanism 144i connected to the tension wire 140i and a (second) activation mechanism 144ii connected to the tension wire 140ii. The activation mechanisms 144 may include any structure or mechanism (e.g., a rotating wheel, a pulley system, etc.) suitable for the intended purpose of applying the axial force to the tension wire 140 necessary to deflect the catheter 102 as needed or desired. In some embodiments, the active segments 138a, the pull wires 140, and the activation mechanism 144 may be configured (and connected) so that each pull wire 140 can act individually to deflect (steer) the corresponding segment 138a in only one direction. In another embodiment, the pull wires 140 may be provided on various circumferential surfaces of the catheter 102 to facilitate steering in various directions.

[0080] In a particular embodiment shown in the illustration, the catheter 102 includes a first inactive segment 138i1, a first active segment 138a1 located distal to segment 138i1, a second inactive segment 138i2 located distal to segment 138a1, and a second active segment 138a2 located distal to segment 138i2. Furthermore, the catheter 102 includes a first tensile wire 140i and a second tensile wire 140ii located within a channel 142 (Figure 20). However, it is also conceivable that the first and second tensile wires 140i and 140ii may be located within separate channels 142 (for example, in which case the number of channels 142 and the number of tensile wires 140 would be the same).

[0081] The tension wires 140i and 140ii are connected to segments 138a1 and 138a2, respectively, at connection points 146i and 146ii (in addition to the activation mechanisms 144i and 144ii), which facilitates the reconfiguration of the catheter 102 between the first form (Figure 19) and the second form (Figure 21). More specifically, as soon as the catheter 102 is reconfigured, the active segments 138ai and 138aii define the first and second bends 148i and 148ii, respectively (Figure 21), which may be substantially equivalent (e.g., identical) or non-equivalent, depending, for example, the specific form of segments 138a1 and 138a2, the manufacturing materials used within the catheter 102, the specific requirements of the catheter 102 as defined by the surgery, and other factors. In Figure 21, bends 148i and 148ii are shown to be (approximately) equal to 90 degrees, but depending on the specific morphology of segments 138a1 and 138a2, surgical requirements, the patient's specific anatomical structure, and other factors, bends 148i and 148ii may be substantially in the range of approximately 0 to approximately 270 degrees. For example, segment 138a1 may be configured such that bend 148i is substantially in the range of approximately 0 to approximately 180 degrees (e.g., approximately 90 to approximately 180 degrees), and segment 138a2 may be configured such that bend 148ii is substantially in the range of approximately 0 to approximately 270 degrees (e.g., approximately 90 to approximately 270 degrees).

[0082] In the illustrated embodiment, the connection points 146i and 146ii are shown to be (approximately) aligned in angle (for example, along the circumference of catheter 102), which facilitates the deflection of segments 138a1 and 138a2 in equivalent (e.g., identical) directions, as seen in Figure 21. However, it is also conceivable that the connection points 146i and 146ii may be diverged in angle, in which case the deflection of segments 138a1 and 138a2 in different directions is facilitated. For example, the connection points 146i and 146ii may be (approximately) opposite in orientation, in which case the bends 148i and 148ii are defined by curvatures that are (approximately) opposite in direction to segments 138a1 and 138a2, respectively.

[0083] Referring now to Figure 22, the main catheter 102 may include one or more (second) tension wires 150 (at least one) connected to (anchored) it, which may be auxiliary to or replace the tension wire 140 (Figures 19-21) (for clarity, the filter element 112 is omitted in Figure 22). The tension wires 150 facilitate the selective application of torsional force (torsion force) to the main catheter 102, and thus the rotational deflection of the main catheter 102 along its entire length or a portion of its length, in order to change the angular position of the main catheter 102. Unlike the tension wire 140, the tension wire 150 extends non-parallel to the longitudinal axis X of the main catheter 102. In the particular embodiment shown, for example, the main catheter 102 includes a single tension wire 150, which is spirally wound around the longitudinal axis X. However, naturally, the number of tension wires 150 may vary in different embodiments, without departing from the present disclosure (for example, the main catheter 102 is envisioned to include two tension wires 150, three tension wires 150, or any other number of tension wires 150). Such rotation (i.e., rotational deflection) by torsion wires and steering by other wires are disclosed in conjunction with other systems in U.S. Patent Application No. 17 / 214,021 (Publication No. 2021 / 0259860), and these deflection features are applicable to the catheters disclosed herein, as well as the entirety of U.S. Patent Application No. 17 / 214,021 (Publication No. 2021 / 0259860), which is incorporated herein by reference. The steering characteristics disclosed in International Publications PCT / US2022 / 051599 and PCT / US2021 / 023855 are also incorporated herein in their entirety by reference, to be used in conjunction with the catheters disclosed herein.

[0084] The tension wire 150 may extend around the entire or a portion of the longitudinal axis X, that is, it may extend 360 degrees, less than 360 degrees, or more than 360 degrees (more than one full turn).

[0085] In some embodiments, the tension wire 150 may have a (approximately) linear form in a first portion of the main catheter 102 and a helical form in a second portion of the main catheter 102 (e.g., the distal portion 106 of the main catheter 102) to achieve rotational deflection of the second portion of the main catheter 102.

[0086] Referring now to Figures 23 and 24, in some embodiments the intravascular system 10 may further include a (third) intravascular therapeutic (medical) device 500, which is configured as an internal (second) catheter (tubular member) 502. The internal catheter 502 may be an auxiliary or substitute for the outer sheath 300 (Figures 16, 17) and is configured to facilitate the deployment of a filter element 112 and the reconfiguration of the filter element 112 between a collapsed form and an expanded form (e.g., expansion and compression of the filter element 112), which will be described in more detail later.

[0087] The internal catheter 502 extends within the main catheter 102 (for example, through the main lumen 110) and is movable (axially) between a retracted position (Figure 23) and an advanced position (Figure 24) relative to the main catheter 102. The internal catheter 502 includes a body 504, which has a proximal (proximal end) 506 and a distal (distal end) 508, and a retainer 510 fixed to the body 504. In some embodiments, such as those illustrated, the body 504 of the internal catheter 502 defines a (central, working) lumen 512, which extends continuously between its proximal 506 and distal 508 and is configured to receive the guidewire 118 (Figure 2) described above, in which case the internal catheter 502 (and the main catheter 102) can be delivered to a target therapeutic site through a blood vessel V (Figure 1) by the guidewire 118.

[0088] The body 504 may include one or more secondary or tertiary lumens (at least one). Additionally or alternatively, the body 504 may be configured to accept one or more stylets 400 (Figure 18) (at least one) to further facilitate the insertion of the internal catheter 502 into the blood vessel V.

[0089] As an addition or alternative, the body 504 may include one or more steerable segments (zones) (at least one) that can be deflected by one or more pull wires (at least one), and / or the body 504 may be configured to rotate deflect to change the angular position of the internal catheter 502, as described above with respect to the main catheter 102.

[0090] The retainer 510 includes a (free) proximal portion (proximal end) 514 and a distal portion (distal end) 516 fixed to the distal portion 508 of the body 504, thereby extending the retainer 510 proximally from the distal portion 516. The retainer 510 has a (approximately) conical shape and is configured to receive the filter element 112. More specifically, when the internal catheter 502 is in a retracted position (Figure 23), the retainer 510 (e.g., its proximal portion 514) expands around the filter element 112, thereby constraining the filter element 112 and maintaining its collapsed shape (this is to facilitate, for example, delivery of the main catheter 102 and the filter element 112 to the target therapeutic site in the blood vessel V (Figure 1)). In contrast, when the internal catheter 502 is in the forward position (Figure 24), the retainer 510 is located distal to the filter element 112, which allows the filter element 112 to be (automatically) reconfigured into an expanded form.

[0091] The retainer 510 may be configured to completely conceal the filter element 112 in the retracted position, as shown in Figure 23. Alternatively, the retainer 510 may be configured to partially conceal the filter element 112 in the retracted position, as shown in Figure 25 (for example, in which case the proximal portion 514 of the retainer 510 is axially positioned between the proximal portion 132 and the distal portion 134 of the filter element 112).

[0092] Furthermore, the retainer 510 may be configured such that the proximal portion 514 of the retainer 510 defines an outer cross-sectional dimension (e.g., diameter) DR, which is larger than the outer cross-sectional dimension D of the main catheter 102. In contrast, as shown in Figure 25, embodiments are also envisioned in which the retainer 510 may be configured such that the outer cross-sectional dimension DR is smaller than the outer cross-sectional dimension D, and similarly, embodiments are also envisioned in which the retainer 510 may be configured such that the outer cross-sectional dimension DR is (approximately) equal to the outer cross-sectional dimension D.

[0093] In some embodiments, the retainer 510 may be connected to the main catheter 102 (e.g., the filter element 112) by one or more flangable members 518 (at least one), as shown in Figure 23. The flangable members 518 restrain (if not completely) unintended relative movement between the internal catheter 502 and the main catheter 102, and thus unintended (e.g., premature) deployment (expansion) of the filter element 112. However, as soon as sufficient (axial) force is applied to the internal catheter 502 and / or the main catheter 102 (e.g., while the internal catheter 502 is moving from a retracted position (Figure 23) to an advanced position (Figure 24)), the flangable members 518 are ruptured, thereby allowing relative movement between the internal catheter 502 and the main catheter 102, and thus deployment (expansion) of the filter element 112. Embodiments in which there is no (direct, fixed) connection whatsoever between the retainer 510 and the main catheter 102 (e.g., the filter element 112) are also envisioned herein, but this is not beyond the scope of the disclosure.

[0094] In the illustrated embodiment, the flangable member 518 is shown to be positioned axially between the proximal 514 and distal 516 of the retainer 510, but of course, the flangable member 518 may connect the retainer 510 to the main catheter 102 at any suitable position.

[0095] In some embodiments, the internal catheter 502 (e.g., body 504) may include one or more thickened locations 520 (Figure 24) (at least one), in which case the body 504 defines a cross-sectional dimension (e.g., diameter) DI, which is not uniform between its proximal 506 and distal 508. The thickened locations 520 enhance the rigidity, strength, and / or stability of the internal catheter 502 and thus support the application of (axial) forces to the internal catheter 502 during repositioning between the retracted position (Figure 23) and the advanced position (Figure 24). Embodiments in which the thickened locations 520 may be omitted (e.g., embodiments in which the cross-sectional dimension DI between the proximal 506 and distal 508 of the body 504 may be (approximately) uniform) are also envisioned herein, but this is not beyond the scope of the invention.

[0096] In some embodiments, the retainer 510 may be reconfigurable from an expanded (first, unclamped) form (Figure 23) to a compressed (second, clamped) form (Figure 24) while the internal catheter 502 is moving from a retracted position to an advanced position. More specifically, when the internal catheter 502 is in the retracted position, the retainer 510 is in the expanded form, in which case the proximal portion 514 of the retainer 510 extends around the filter element 112 to keep the filter element 112 in a compressed form. In contrast, when the internal catheter 502 is in the advanced position, the retainer 510 is in the compressed form, and the proximal portion 514 of the retainer 510 is positioned axially away from the filter element 112.

[0097] In some embodiments, the retainer 510 may be biased toward a compressed form (for example, radially inward toward the body 504 of the internal catheter 502), in which case, as soon as the internal catheter 502 moves from the retracted position to the advanced position, the retainer 510 is (automatically) reconfigured from an expanded form (Figure 23) to a compressed form (Figure 24) to facilitate the removal of the internal catheter 502 by retracting it proximal through the main catheter 102. For example, at least a portion of the retainer 510 (for example, its proximal portion 514) may be elastic. In such embodiments, as soon as the internal catheter 502 moves to the advanced position, the proximal portion 514 of the retainer 510 may engage (contact, adapt) with the outer surface 522 of the body 504 of the internal catheter 502, thereby further facilitating the removal of the internal catheter 502 by retracting it proximal.

[0098] As an addition or alternative, the internal catheter 502 may include a scinting mechanism 600 (e.g., a lasso (snare), etc.) to facilitate the reconstruction of the retainer 510 from an expanded form to a compressed form, as described above with respect to the filter element 112.

[0099] Referring now to Figure 26, in some embodiments the internal catheter 502 may further include one or more extensions 524 (at least one). The extension 524 includes a (free) proximal portion (proximal end) 526 and a distal portion (distal end) 528 fixed to the proximal portion 514 of the retainer 510 (for example, in this case the distal portion 528 of the extension 524 is axially positioned between the proximal portion 132 and the distal portion 134 of the filter element 112). The extension 524 extends proximal from the retainer 510 and covers the filter element 112 and the distal portion 106 of the main catheter 102 when the internal catheter 502 is in a retracted position, thereby further facilitating the delivery of the main catheter 102 and the filter element 112 to the target treatment site in the blood vessel V (Figure 1). In contrast, when the internal catheter 502 is in the advanced position, the extension 524 is positioned axially away from the filter element 112 (for example, in this case, the proximal portion 526 of the extension 524 is positioned distally away from the distal portion 134 of the filter element 112).

[0100] In the illustrated embodiment, the internal catheter 502 includes a plurality of extensions 524 arranged in a configuration that partially overlaps each other. Embodiments in which the internal catheter 502 includes a single extension 524 extending circumferentially (e.g., continuously) around the filter element 112 and the distal portion 134 of the main catheter 102 are also envisioned herein, but this is not beyond the scope of the invention.

[0101] In some embodiments, the extension 524 may be connected to the main catheter 102 (e.g., filter element 112) by one or more of the aforementioned flangable members 518 (Figure 23) (at least one), which may replace or supplement the retainer 510 that (releasably) connects to the filter element 112. In such embodiments, the flangable member 518 may be positioned at any suitable location (for example, in which case the flangable member 518 is positioned axially between the proximal 526 and distal 528 of the extension 524). Embodiments in which there is no (direct, fixed) connection at all between the extension 524 and the main catheter 102 (e.g., filter element 112) are also envisioned herein, but this is not beyond the scope of the disclosure.

[0102] In some embodiments, the extension 524 may be biased inward (for example, toward the body 504 of the internal catheter 502), in which case, as soon as the internal catheter 502 moves from the retracted position to the advanced position, the extension 524 (automatically) deflects radially inward to facilitate the removal of the internal catheter 502 by retracting it proximal through the main catheter 102. For example, at least a portion of the extension 524 (for example, its proximal portion 526) may be of an elastic structure. In such embodiments, it is assumed that as soon as the internal catheter 502 moves to the advanced position, the proximal portion 526 of the extension 524 may engage (contact, adapt) with the outer surface 522 of the body 504 of the internal catheter 502, thereby further facilitating the removal of the internal catheter 502 by retracting it proximal.

[0103] As an addition or alternative, the extension 524 may be changed to a radially inward orientation by a scinting mechanism 700 (e.g., a lasso (snare), etc.), as described above with respect to the filter element 112 and retainer 510 (Figure 24).

[0104] As an addition or alternative, in some embodiments, it is envisioned that the extension 524 may be inverted while the internal catheter 502 is retracted proximal, in order to facilitate the removal of the internal catheter 502 from the main catheter 102. More specifically, in such embodiments, the extension 524 may be reconfigured so that as soon as the internal catheter 502 is retracted, the distal portion 528 of the extension 524 is positioned distal to the distal portion 134 of the filter element 112.

[0105] In some embodiments, a catheter with a filter at its tip can be inserted into the ascending aorta by a transfemoral approach (or other approach) to deliver valves and other treatments while being protected from embolization by the filter. The catheter may optionally have an external catheter through which the treatment is delivered. The external catheter crushes the filter when it is retracted into the external catheter or when it advances so as to cover the filter. The external catheter, and / or the catheter with a filter at its tip, may have at least one steerable zone, which is controlled in the manner described above (for example, by at least one wire embedded substantially or completely in the wall of at least a portion of each catheter).

[0106] Those skilled in the art will understand that the various embodiments of the Invention described herein and shown in the accompanying drawings constitute non-limiting examples, and that any of the embodiments described herein may be further equipped with additional components and features, without departing from the scope of the Disclosure. Furthermore, as those skilled in the art will understand, elements and features illustrated or described in relation to one embodiment may be combined with elements and features of another embodiment, including any of the embodiments described in U.S. Patent Application No. 17 / 210,778 (Publication 2021 / 0236257) and U.S. Patent Application No. 116 / 501,593 (Publication 2020 / 0390015), without departing from the scope of the Invention, and that those skilled in the art will understand the further features and advantages of the Disclosure based on the provided description. Variations, combinations, and / or modifications to any of the embodiments and / or features of the embodiments described herein, which are within the scope of the Invention, and which may be alternative embodiments resulting from combining, incorporating, and / or omitting any of the features of the disclosed embodiments.

[0107] In the description so far, the spatial relationships between the various structures shown in the attached drawings may be referenced, and the spatial orientation of each structure may also be referenced. However, as will be understood by those skilled in the art after fully reading this disclosure, the structures described herein may be positioned and oriented in any way suitable for their respective intended purposes. Accordingly, the use of terms such as “above,” “below,” “upper,” “lower,” “inner,” “outer,” “left,” “right,” “upward,” “downward,” “inward,” and “outward” should be understood to indicate the relative relationships between structures and / or the spatial orientation of structures. As will also be understood by those skilled in the art, such terms may be used in the context of examples given by the corresponding drawings.

[0108] Additionally, terms such as "approximately," "substantially," etc., should be understood as encompassing variations of the order of 25%, taking into account variations within any numerical range or concepts associated with such variations (e.g., to take into account manufacturing tolerances and / or design deviations). For example, the term "generally parallel" should be understood as referring to a configuration in which the components in question are oriented to define an angle between them equal to 182° ± 25% (e.g., an angle in the range of (approximately) 135° to (approximately) 225°). Similarly, the term "generally orthogonal" should be understood as referring to a configuration in which the components in question are oriented to define an angle between them equal to 90° ± 25% (e.g., an angle in the range of (approximately) 67.5° to (approximately) 112.5°). Therefore, the term "generally parallel" should be understood to encompass forms in which the related components are arranged in a parallel relationship. Similarly, the term "generally orthogonal" should be understood to encompass forms in which the related components are arranged in a perpendicular relationship.

[0109] Terms such as "first," "second," and "third" may be used herein to indicate various operations, elements, components, areas, and / or sections, but these operations, elements, components, areas, and / or sections are not limited by the use of these terms in that they are used to distinguish one operation, element, component, area, or section from another. Accordingly, unless otherwise specified, the first operation, element, component, area, or section may be referred to as the second operation, element, component, area, or section, as long as it does not deviate from the scope of the present invention.

[0110] All claims are incorporated herein as further disclosures and represent embodiments of the present invention. The phrases “at least one of A, B, and C” and “A and / or B and / or C” should be interpreted as encompassing A alone, B alone, C alone, or any combination of A, B, and C, respectively.

Claims

1. An intravascular system for insertion into a patient's blood vessel, the intravascular system includes a first tubular member, the first tubular member having a main lumen, and is configured to expand radially so as soon as a medical device is inserted, the main lumen expands, thereby reconfiguring the first tubular member from a first configuration in which the main lumen defines a first dimension to a second configuration in which the main lumen defines a second dimension larger than the first dimension.

2. The intravascular system according to claim 1, wherein the first tubular member is substantially elastic and comprises at least one of rubber, latex, or spandex.

3. The intravascular system according to claim 1, wherein the first tubular member is configured to return to the first form after the medical device has been removed.

4. The intravascular system according to claim 1, wherein the first tubular member is reconfigured from the second to the third form after the medical device has been removed, and in the third form, the first tubular member defines a third dimension that is larger than the first dimension but smaller than the second dimension.

5. The intravascular system according to claim 1, further comprising a filter element supported by the first tubular member and extending distally from the first tubular member, the filter element comprising a semipermeable membrane that allows blood cells and serum to pass through and captures embolus, and is reconfigurable between a collapsed form for delivery and an expanded form within the patient's blood vessels.

6. The intravascular system according to claim 5, wherein at least a portion of the filter element includes a stretchable material that allows the filter element to expand when the medical device is passing through the filter element.

7. The intravascular system according to claim 5, wherein the filter element includes a proximal portion attached to the first tubular member and a distal portion, and at least the proximal portion is expandable.

8. The intravascular system according to claim 5, wherein the proximal portion of the filter element comprises a first material, and the distal portion of the filter element comprises a second material, the second material having lower elasticity than the first material.

9. The intravascular system according to claim 5, wherein the filter element and the first tubular member include at least one common elastic material.

10. The intravascular system according to claim 5, further comprising a positioning member that can be inserted into the blood vessel, wherein the positioning member contacts one or both of the first tubular member or the filter element to move the position of the filter element.

11. The intravascular system according to claim 1, wherein the medical device includes a replaceable valve.

12. The intravascular system according to claim 1, wherein the first tubular member includes at least one steerable segment.

13. The intravascular system according to claim 1, wherein the first tubular member is configured to change its angular position by rotational deflection.

14. The intravascular system according to claim 1, wherein the first tubular member bounces back to at least 50% of the first form after the medical device has been removed from the main lumen.

15. The intravascular system according to claim 1, wherein the first tubular member bounces back to at least 90% of the first form after the medical device has been removed from the main lumen.

16. The intravascular system according to claim 1, wherein the first tubular member reverts completely back to the first form after the medical device has been removed from the main lumen.

17. The intravascular system according to claim 5, further comprising a compression mechanism for compressing the filter element from its expanded state in order to remove it from the blood vessel.

18. The intravascular system according to claim 17, wherein the compression mechanism includes at least one wire, the at least one wire passing through a section of the wall of the first tubular member, traveling along at least a portion of the circumference of the filter element, and at the proximal end of the first tubular member, the at least one wire is operable to apply force to compress the filter element.

19. An intravascular system configured to be inserted into a patient's blood vessel, A first tubular member and A filter element comprising a proximal portion attached to a first tubular member and defining a passage extending through the filter element, and a distal portion, wherein the filter element comprises a semipermeable membrane and is reconfigurable from a collapsed form for delivery to an expanded form for capturing embolus in the patient's blood vessels, and at least the proximal portion of the filter element comprises a first stretchable material for accommodating insertion of a medical device into the passage, Intravascular systems including the vascular system.

20. The intravascular system according to claim 19, wherein the medical device includes a replaceable valve.

21. The intravascular system according to claim 19, wherein the first tubular member includes an elastic structure.

22. The intravascular system according to claim 21, wherein the first tubular member comprises rubber, latex, or spandex.

23. The intravascular system according to claim 19, wherein the first tubular member includes a second stretchable material.

24. The intravascular system according to claim 23, wherein the first stretchable material has lower elasticity than the second stretchable material.

25. The intravascular system according to claim 19, wherein the distal portion of the filter has lower elasticity than the proximal portion.

26. The intravascular system according to claim 19, wherein the filter element flares outward from a small diameter at the mounting location on the first tubular member to a larger diameter at the distal end, and the filter element is delivered in a compressed state and immediately expands to a large flare size upon delivery.

27. A catheter configured for use in the treatment of vascular abnormalities, wherein the catheter includes a filter element configured to define a main lumen and capture an embolism in the patient's blood vessels, and the catheter is configured to facilitate the insertion of an endovascular treatment device into the main lumen by radially expanding, thereby reconfiguring the catheter from a normal configuration in which the main lumen defines a first dimension to an expanded configuration in which the main lumen defines a second dimension greater than the first dimension.

28. The catheter according to claim 27, wherein the catheter includes at least one guide rail, the at least one guide rail is positioned within the main lumen and is configured to engage with the endovascular treatment device to facilitate the insertion of the endovascular treatment device into the catheter and the advancement of the endovascular treatment device within the main lumen.

29. The catheter according to claim 27, wherein the catheter includes at least one reinforcing rib, the at least one reinforcing rib being configured to prevent the overall length of the catheter from changing while the catheter expands radially.

30. The catheter according to claim 27, wherein the catheter includes an inelastic structure such that the expanded form is substantially maintained after the removal of the intravascular treatment device.

31. The catheter according to claim 27, wherein the catheter includes an elastic structure such that the catheter is biased toward the normal form.

32. The catheter according to claim 31, wherein the catheter comprises at least one stretchable material.

33. The catheter according to claim 31, wherein the catheter is configured to return to its normal form after the intravascular treatment device has been removed.

34. The catheter according to claim 27, wherein the catheter is configured to be reconfigured into a partially expanded form after the removal of the intravascular treatment device, and in the partially expanded form, the main lumen defines a third dimension that is greater than the first dimension and smaller than the second dimension.

35. The catheter according to claim 34, wherein the catheter is configured such that the third dimension is substantially in the range of about 105% to about 195% of the first dimension.

36. A main catheter comprising a main lumen defining a main lumen and including a filter element, wherein the filter element is reconfigurable from a collapsed form for insertion into a patient's blood vessel to an expanded form configured to capture an embolism within the patient's blood vessel, An internal tubular member, wherein the internal tubular member extends through the main lumen and is configured to facilitate the reconstruction of the filter element from the compressed form to the expanded form by moving axially from a retracted position to an advanced position relative to the main catheter, Intravascular systems including the vascular system.

37. The intravascular system according to claim 36, wherein the internal tubular member includes at least one thickened portion, in which case the internal tubular member increases one or more of the rigidity, strength, or stability of the internal tubular member by defining non-uniform cross-sectional dimensions.

38. The intravascular system according to claim 36, further comprising an outer sheath configured to receive the main catheter, wherein the outer sheath extends around the main catheter, and the main catheter and the outer sheath are configured to move axially relative to each other.

39. The intravascular system according to claim 36, wherein the internal tubular member includes a retainer configured to receive the filter element.

40. The intravascular system according to claim 39, wherein the retainer extends around the filter element when the internal tubular member is in the retracted position, constraining the filter element and maintaining the compressed shape of the filter element, and the retainer is positioned distal to the filter element when the internal tubular member is in the advanced position, allowing the filter element to be reconfigured from the compressed shape to the expanded shape.

41. The intravascular system according to claim 40, wherein the retainer is configured to completely conceal the filter element when the internal tubular member is in the retracted position.

42. The intravascular system according to claim 40, wherein the retainer is configured to partially conceal the filter element when the internal tubular member is in the retracted position.

43. The intravascular system according to claim 40, wherein the retainer is connected to the filter element.

44. The intravascular system according to claim 43, wherein the retainer is connected to the filter element by at least one flangable member, the at least one flangable member is configured to restrain relative movement between the internal tubular member and the main catheter until sufficient axial force is applied, and the at least one flangable member is configured to rupture as the internal catheter moves from the retracted position to the advanced position.

45. The intravascular system according to claim 40, wherein the retainer is reconfigurable from an expanded form to a compressed form while the internal tubular member moves from the retracted position to the advanced position.

46. The intravascular system according to claim 40, wherein the retainer includes an elastic structure such that the retainer is biased toward the compression configuration, so that as soon as the internal tubular member moves from the retracted position to the forward position, the retainer automatically reconfigures from the expanded configuration to the compression configuration.

47. The intravascular system according to claim 40, wherein the internal tubular member includes a scinting mechanism, the scinting mechanism facilitates the reconstruction of the retainer from the expanded form to the compressed form.

48. The intravascular system according to claim 36, wherein the internal tubular member further includes at least one extension fixed to the retainer, the at least one extension extending proximal to the retainer and covering the filter element when the internal tubular member is in the retracted position.

49. The intravascular system according to claim 48, wherein the at least one extension is biased radially inward, so that as soon as the internal tubular member moves from the retracted position to the forward position, the at least one extension automatically deflects radially inward.

50. The intravascular system according to claim 36, wherein the catheter is expandable to a second transverse dimension immediately after the medical device passes through the catheter.

51. The intravascular system according to claim 50, wherein the catheter is expandable after the internal tubular member is removed.

52. The intravascular system according to claim 36, wherein the filter element immediately includes a flared shape upon expansion, in which case the filter element expands radially outward from the main catheter to define a transverse dimension larger than the corresponding transverse dimension defined by the main catheter, and the filter element is semipermeable to allow blood cells and serum to pass through and capture embolus.

53. The intravascular system according to claim 36, wherein the filter is configured to capture an embolus in the ascending aorta during delivery of a replacement aortic valve or other medical device.

54. The intravascular system according to claim 50, wherein after the medical device inserted and expanding the main lumen is removed, the catheter springs back to at least 50% of its initial form.

55. The intravascular system according to claim 50, wherein after the medical device inserted and expanding the main lumen is removed, the catheter springs back to at least 90% of its initial form.

56. The intravascular system according to claim 50, wherein after the medical device inserted and used to expand the main lumen is removed, the catheter reverts completely back to its original form.

57. A first member having a filter element to which a semipermeable membrane is attached, wherein the filter element is reconfigurable between a collapsed form and an expanded form for capturing an embolus, A second member that can be inserted alongside the first member, wherein the filter element can expand to contact the second member, Intravascular systems including the vascular system.

58. The intravascular system according to claim 25, wherein the second member includes an annular shape.

59. The intravascular system according to claim 57, wherein the second member includes an annular shape.

60. The intravascular system according to claim 57, wherein the second member includes at least one flattened compartment.

61. The intravascular system according to claim 57, wherein the second member includes an elliptical cross-sectional shape.

62. The intravascular system according to claim 57, wherein the second member includes a body defining a lumen, and the body and the lumen have dissimilar shapes.

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