阅读说明：本技术 血管内医疗系统 (intravascular medical system ) 是由 D.瓦勒 M.吉尔瓦里 于 2019-06-10 设计创作，主要内容包括：本发明题为“具有用于在血管内医疗系统中使用的无创伤凝块绕开配置的远侧端部的导丝”。本发明提供了一种用于与位于目标血管中的凝块一起使用的血管内医疗系统。该系统包括由芯线形成的导丝。该导丝在纵向上从近侧端部延伸到相对的无创伤凝块绕开配置的远侧端部；并且,导丝的无创伤凝块绕开配置的远侧端部的侧向横向于导丝的纵向限定。无创伤凝块绕开配置的远侧端部被设计成防止对目标血管的内壁造成伤害,并且阻止将导丝的任何部分插入到穿枝血管中。(The invention is entitled "a guidewire having a distal end configured for atraumatic clot bypass for use in an intravascular medical system. The present invention provides an intravascular medical system for use with a clot located in a target blood vessel. The system includes a guidewire formed from a core wire. The guidewire extends longitudinally from a proximal end to an opposite atraumatic clot bypass configuration distal end; and, a lateral direction of the distal end of the guidewire in an atraumatic clot bypass configuration is defined transverse to a longitudinal direction of the guidewire. The distal end of the atraumatic clot bypass arrangement is designed to prevent damage to the inner wall of the target vessel and to prevent insertion of any portion of the guidewire into the perforator vessel.)

1. an intravascular medical system for use with a clot located in a target blood vessel, the system comprising:

a guidewire formed from a core wire, the guidewire extending longitudinally from a proximal end to an opposite atraumatic clot-bypassing configuration distal end; and, a lateral direction of a distal end of the guidewire in the atraumatic clot bypass configuration is defined transverse to the longitudinal direction of the guidewire; wherein a distal end of the atraumatic clot bypass configuration is designed to prevent damage to an inner wall of the target vessel and to inhibit insertion of any portion of the guidewire into a perforator vessel.

2. The intravascular medical system of claim 1, wherein a distal end of the atraumatic clot bypass configuration of the guidewire meets the following condition:

(i) The atraumatic clot of the guidewire is conformable in a lateral direction complementary to a contour of the inner wall of the target vessel when passing between the inner wall of the target vessel and the clot; and is

(ii) The lateral widest width of the atraumatic clot bypassing distal end of the guidewire is reducible when in a compressed state under application of an external mechanical force.

3. The intravascular medical system of claim 2, further comprising:

a microcatheter having a lumen defined longitudinally therethrough from a proximal end thereof to an opposite distal end thereof, said lumen having an inner diameter;

Wherein the guidewire is receivable through the lumen of the microcatheter; and is

When in an uncompressed state not subjected to external mechanical forces, the atraumatic clot of the guidewire has a widest width in the lateral direction around a distal end that is greater than twice the inner diameter of the lumen.

4. The intravascular medical system of claim 1, wherein a distal end of the atraumatic clot bypass arrangement of the guidewire is a flattened distal portion of the core wire, the flattened distal portion having a flat geometry and a thickness less than an outer diameter of a remaining non-flattened portion of the core wire.

5. The intravascular medical system of claim 4, wherein the flattened distal portion of the core wire has a paddle-like geometry.

6. The intravascular medical system of claim 4, wherein the flattened distal portion has at least one aperture defined therein.

7. The intravascular medical system of claim 1, wherein a distal end of the atraumatic clot bypass configuration of the guidewire is a core wire that is pre-shaped or pre-formed into a geometric shape.

8. The endovascular medical system defined in claim 7, wherein the geometry of the pre-shaped or pre-shaped core wire is a closed loop.

9. The intravascular medical system of claim 8, wherein the closed loop forms a lemon shape.

10. The intravascular medical system of claim 7, wherein the geometry of the distal end of the atraumatic clot bypass configuration is an open loop when in a non-compressed state free of application of external mechanical force, the open loop forming a curved segment with a free terminating end greater than 180 °; and a distal end of the atraumatic clot bypass configuration is in a prolapsed configuration when in the non-compressed state free from the external mechanical force.

11. the intravascular medical system of claim 1, wherein the guidewire and the distal end of the atraumatic clot bypass arrangement are separate components assembled together.

12. A method of using an intravascular medical system for use with a clot located in a target blood vessel, the intravascular medical system comprising a microcatheter having a lumen defined longitudinally therethrough from a proximal end thereof to an opposite distal end thereof, the lumen having an inner diameter; the intravascular medical system further includes a guidewire formed from a core wire and receivable through the lumen of the microcatheter, the guidewire extending longitudinally from a proximal end to an opposite atraumatic clot bypass configured distal end; a lateral direction of a distal end of the guidewire in the atraumatic clot bypass configuration is defined transverse to the longitudinal direction of the guidewire; wherein a distal end of the atraumatic clot bypass configuration is configured to prevent damage to an inner wall of the target vessel and to inhibit insertion of any portion of the guidewire into a vessel of a perforator; the method comprises the following steps:

Advancing a distal end of the atraumatic clot bypass arrangement of the guidewire through the target vessel to a position facing a proximal side of the clot;

tracking the microcatheter over the guidewire received within the lumen of the microcatheter to the location facing the proximal side of the clot;

Passing a distal end of the atraumatic clot bypass configuration of the guidewire between the inner wall of the target vessel and the clot from a location proximal of the clot to a location facing distal of the clot without any portion of the atraumatic clot bypass configuration distal end of the guidewire penetrating the clot;

guiding the microcatheter over the guidewire received within the lumen of the microcatheter to the location facing the distal side of the clot.

13. The method of claim 12, wherein a distal end of the atraumatic clot bypass configuration satisfies the following condition:

(i) the atraumatic clot bypass distal end of the guidewire in an uncompressed state has a widest width in the lateral direction of a distal end of the atraumatic clot bypass configuration of the guidewire greater than twice the inner diameter of the lumen of the microcatheter;

(ii) the atraumatic clot of the guidewire is conformable in the lateral direction complementary to a contour of the inner wall of the target vessel, bypassing a distal end of a deployment when advanced in the target vessel between the inner wall of the target vessel and the clot; and is

(iii) wherein the diameter of the widest width in the lateral direction of the distal end of the guidewire in which the atraumatic clot circumventing configuration is reducible when subjected to an external force so as to be receivable within the lumen of the microcatheter.

14. The method of claim 12, wherein a distal end of the atraumatic clot bypass arrangement of the guidewire is a flattened distal portion of the core wire, the flattened distal portion having a flat geometry and a thickness less than a diameter of a remaining non-flattened portion of the core wire.

15. the method of claim 12, wherein the distal end of the guidewire in the atraumatic clot bypass configuration is a pre-shaped or pre-shaped geometrically shaped core wire.

16. the method of claim 15, wherein the geometric shape is a closed loop.

17. The method of claim 15, wherein the closed loop forms a lemon shape.

18. The method of claim 15, wherein the geometry of a distal end of the atraumatic clot bypass configuration is an open loop when in a non-compressed state free of application of external mechanical force, the open loop forming a curved segment with a free terminating end greater than 180 °; and a distal end of the atraumatic clot bypass configuration is in a prolapsed configuration when in the non-compressed state free from external mechanical forces.

19. The method of claim 12, further comprising the steps of: when withdrawn into the lumen of the microcatheter, the atraumatic clot that laterally crimps the guidewire bypasses the distal end of the deployment, reducing its diameter to less than the inner diameter of the lumen of the microcatheter.

20. The method of claim 12, wherein the guidewire and the distal end of the atraumatic clot bypass arrangement are separate components assembled together.

Technical Field

The present invention relates to an intravascular medical system advanceable through a vasculature having a distal end configured to minimize trauma to vasculature tissue and branch vessels. In particular, the present invention relates to a guidewire for recanalizing an occluded cerebral artery following an acute ischemic stroke, wherein the guidewire comprises a distal end configured for atraumatic clot bypass.

Background

Disclosure of Invention

One aspect of the present invention relates to an improved guidewire for use in intravascular medical procedures (e.g., mechanical thrombectomy) that blocks access to one of the perforator vessels by configuring the distal tip or end of the guidewire, but readily traverses, passes, or surrounds the blockage between the blockage and the inner wall of the target vessel without damaging the tissue of the target neurovascular.

another aspect of the invention relates to an intravascular medical system for use with a clot located in a target blood vessel. The system includes a guidewire formed from a core wire. The guidewire extends longitudinally from a proximal end to an opposite atraumatic clot bypass configuration distal end; and, a lateral direction of the distal end of the guidewire in an atraumatic clot bypass configuration is defined transverse to a longitudinal direction of the guidewire. The distal end of the atraumatic clot bypass arrangement is designed to prevent damage to the inner wall of the target vessel and to prevent insertion of any portion of the guidewire into the perforator vessel.

Yet another aspect of the invention relates to a method for using an intravascular medical system for use with a clot located in a target blood vessel. An intravascular medical system includes a microcatheter having a lumen defined longitudinally therethrough from a proximal end thereof to an opposite distal end thereof, wherein the lumen has an inner diameter. In addition, the intravascular medical system also includes a guidewire formed from the core wire and receivable through the lumen of the microcatheter. The guidewire extends longitudinally from a proximal end to an opposite atraumatic clot bypass configuration distal end; a lateral direction of a distal end of the guidewire in the atraumatic clot bypass configuration is defined transverse to the longitudinal direction of the guidewire. According to the invention, the distal end of the atraumatic clot bypass configuration is configured to prevent damage to the inner wall of the target vessel and to prevent insertion of any portion of the guidewire into the perforator vessel. A method for using the system of the present invention includes advancing a distal end of an atraumatic clot bypass arrangement of a guidewire through a target vessel to a position facing a proximal side of the clot. The microcatheter is then tracked over a guidewire received within the lumen of the microcatheter to a position facing the proximal side of the clot. Passing the distal end of the atraumatic clot bypass configuration of the guidewire from a position proximal to the clot to a position facing distal to the clot between an inner wall of the target vessel and the clot without causing any portion of the atraumatic clot bypass configuration of the guidewire to penetrate the clot. The microcatheter is then guided over a guidewire received within the lumen of the microcatheter to a position facing the distal side of the clot. Microcatheters may also be used to provide support for distal access, guidance, or introduction of an intermediate catheter. The guidewire can now be removed and a mechanical thrombectomy device, such as a stent retriever or any other clot retrieval device, can be advanced through the microcatheter to the target site of the occlusion and used to retrieve the clot or occlusion to the guide catheter or sheath.

Drawings

The above and other features of the present invention will become more apparent from the following detailed description of exemplary embodiments thereof and the accompanying drawings, in which like reference numerals refer to like elements throughout the several views, and in which:

FIG. 1 is an exemplary prior art conventional mechanical thrombectomy system including a guidewire having a conventional distal tip or end that is undesirably introduced into a bifurcated vessel after crossing a clot, obstruction, or blockage;

Fig. 2A is an exemplary illustration of a guidewire having a distal tip or end in an atraumatic clot bypass configuration, wherein the distal tip or end in the atraumatic clot bypass configuration is a core wire bent into a lemon-shaped configuration with a central opening or ferrule, in accordance with the present disclosure; wherein the guidewire in fig. 2A is shown in a relaxed or uncompressed state (not subject to application of external mechanical force);

FIG. 2B is a cross-sectional view of the distal tip or end of the atraumatic clot bypass configuration of the guidewire of FIG. 2A taken along line 2B-2B;

fig. 3A is another exemplary illustration of a distal tip or end of an atraumatic clot bypass configuration of a guidewire according to the present disclosure, wherein the distal end or tip of the atraumatic clot bypass configuration is a core wire bent into a sheepdog-shaped configuration; wherein the guidewire in fig. 3A is shown in a relaxed or uncompressed state (not subject to application of external mechanical force);

FIG. 3B is a cross-sectional view of the distal tip or end of the atraumatic clot bypass configuration of the guidewire of FIG. 3A taken along line 3B-3B;

Fig. 4 is an exemplary illustration of a mechanical thrombectomy system of the present invention, wherein the distal tip of the atraumatic clot-bypassing configuration of the guidewire of fig. 2A is advanced through the target vessel between the target vessel wall and the occlusion, wherein the distal tip or end of the atraumatic clot-bypassing configuration of the guidewire is prevented from entering the perforator vessel after traversing or surrounding the clot;

fig. 5A is yet another exemplary illustration of the distal tip or end of the atraumatic clot bypass configuration of the guidewire according to the present disclosure, wherein the distal tip or end of the atraumatic clot bypass configuration of the guidewire is a flattened portion of the core wire cut or stamped into a paddle shape; the paddle-shaped distal tip or end is shown in a relaxed or uncompressed state in fig. 5A (without application of external mechanical force);

FIG. 5B is a cross-sectional view of the distal tip or end of the paddle-shaped atraumatic clot bypass configuration of the guidewire of FIG. 5A taken along line 5B-5B;

fig. 6 depicts the paddle-shaped atraumatic clot of the guidewire of fig. 5A in a relaxed or uncompressed state (not subject to application of external mechanical force) bypassing the distal end or tip of the configuration and a microcatheter guided over the guidewire received within the lumen of the microcatheter;

fig. 7 depicts the distal end or tip of the paddle-shaped atraumatic clot bypass configuration of the guidewire of fig. 5 in a compressed state (i.e., external mechanical force applied by the inner wall of the microcatheter lumen) as the guidewire is retracted or pulled back through the microcatheter; opposing lateral edges of the distal end or tip of the paddle-shaped atraumatic clot bypass arrangement are wrapped, crimped or rolled toward one another, reducing its diameter to be receivable within the inner diameter of the lumen of the microcatheter;

Fig. 8A-8C show the distal end or tip of the paddle atraumatic clot bypass configuration of the guidewire of fig. 5A when advanced between the inner wall of the target vessel and the clot across, around, or through the clot, wherein the shape of the distal end or tip of the paddle atraumatic clot bypass configuration of the guidewire is complementary to the shape of the inner wall of the target vessel;

fig. 9 is a cross-sectional view of the blood vessel taken along line 9-9 of fig. 8B, showing how the distal end or tip of the paddle-shaped atraumatic clot bypass configuration of the guidewire of fig. 5A conforms to the shape of the inner wall of the blood vessel;

Fig. 10A is one exemplary configuration of the distal tip or end of a flat paddle atraumatic clot bypass configuration of the core wire of the guidewire in a relaxed or uncompressed state (not subject to application of external mechanical force);

FIG. 10B is a cross-sectional view of the distal tip or end of the flat paddle atraumatic clot bypass configuration of the guidewire of FIG. 10A taken along line 10B-10B;

fig. 11A is another exemplary configuration of the distal tip or end of a flat paddle atraumatic clot bypass configuration defining a core wire with a closed perimeter ferrule or open guidewire, with a single central portion removed; wherein the distal tip or end of the flat paddle atraumatic clot bypass configuration of the core wire of the guidewire is in a relaxed or uncompressed state (not subject to application of external mechanical force);

FIG. 11B is a cross-sectional view of the distal tip or end of the flat paddle atraumatic clot bypass configuration of the guidewire of FIG. 11A taken along line 11B-11B;

fig. 12A is another exemplary configuration of a distal tip or end of a flat paddle atraumatic clot bypass configuration of a core wire of a guidewire defining a plurality of openings (each of which has a closed perimeter) with portions removed; wherein the distal tip or end of the flat paddle atraumatic clot bypass configuration of the core wire of the guidewire is in a relaxed or uncompressed state (not subject to application of external mechanical force);

FIG. 12B is a cross-sectional view of the distal tip or end of the flat paddle atraumatic clot bypass configuration of the guidewire of FIG. 12A taken along line 12B-12B;

FIG. 13 is a partial cross-sectional view of a guidewire core having one or more coils disposed about an outer surface thereof;

FIG. 14 is a partial cross-sectional view of a guidewire core covered by a polymeric sheath/coating or outer layer;

FIG. 15A is a partial perspective view of a prior art J-tip of a guidewire;

Fig. 15B depicts the prior art J-tip guidewire of fig. 15A as approaching (proximal to) the clot; and

fig. 15C depicts the prior art J-tip guidewire of fig. 15A prolapsing as it passes through the clot such that the curved loop section passes first through the clot rather than the free terminating end.

Detailed Description

The term "distal" or "proximal" is used hereinafter in relation to a description of a position or orientation relative to a treating physician or medical interventionalist. "distal" or "distally" is a location that is remote from the physician or in a direction away from the physician or interventionalist. "proximal" or "proximally" is a location near or in a direction toward the doctor or interventionalist. The terms "occlusion", "clot" or "occlusion" are used interchangeably.

As shown in fig. 4, the mechanical thrombectomy system 5 of the present invention includes a microcatheter 10, the microcatheter 10 having a lumen 25 defined longitudinally therethrough the microcatheter 10 from a distal end 20 thereof to an opposite proximal end thereof. The microcatheter 10 itself may be received or advanced through a lumen 25 'longitudinally defined through a distal access, intermediary or guide catheter 10'. The guidewire 30 formed from a core wire has a distal end or tip 40 and opposing proximal ends defining a longitudinal direction therebetween. Laterally is defined transversely to the longitudinal direction of the guide wire. In accordance with the present invention, the distal end or tip 40 of the guidewire 30 has an atraumatic clot bypass configuration. According to the present invention, the term "non-invasive clot bypassing configuration" may be any geometric shape and preferably satisfies the following three conditions. The first condition is that the distal end of the guidewire, in a relaxed or uncompressed state, in a non-invasive clot bypass configuration, has a widest transverse width in a lateral direction (i.e., transverse to a longitudinal direction extending from the proximal end to the distal end of the guidewire) that is greater than an inner diameter of a lumen of a microcatheter through which the guidewire is received. Preferably, the widest lateral width is about twice the inner diameter of the microcatheter. Thus, for a microcatheter having an inner diameter of 0.021 ", the preferred range of the widest lateral width is about 0.030" to about 0.050 ". This enlarged widest transverse width of the distal end or tip of the guidewire prevents its insertion into a bifurcated vessel, thus preventing injury or damage to the vascular tissue therein. The second condition is that the distal end of the atraumatic clot bypass arrangement of the guidewire is laterally conformal to complement the contour of the inner wall of the target vessel. Thus, when the guidewire is advanced through the target vessel between the inner wall of the target vessel and the occlusion, through, around or across the occlusion, the guidewire does not penetrate any portion of the occlusion and the guidewire is atraumatic (does not cause injury or damage) to the target vessel wall. A third condition to be met by the distal end of the atraumatic clot bypass arrangement of the guidewire is that its widest transverse width in the lateral direction may decrease in diameter to fit within the lumen of the microcatheter when subjected to an external mechanical force.

The distal end or tip 40 of the atraumatic clot bypass arrangement of the guidewire 30 may be preformed or pre-shaped by a physician or interventionalist. Non-superelastic materials (i.e., shape memory alloy materials that do not meet the definition of superelastic shape memory materials provided below) may be used, allowing a physician or interventionalist to pre-form the distal end or tip of the core-wire proximal to its atraumatic distal tip. Otherwise, core wires made of superelastic shape memory materials, such as nickel titanium alloy (NiTi) (i.e., shape memory alloy materials that can be reversibly deformed to very high strains (up to about 10%)), can be pre-formed, for example, by heat-setting during the manufacturing process. The entire guidewire may include such superelastic material as its core wire, making it more durable and therefore suitable for repeated use, if multiple passes through an occlusion, clot or blockage are required.

Many variations or configurations of the distal end or tip 40 of the inventive guidewire 30 configured for atraumatic clot bypass are contemplated. Several illustrative examples are shown in the drawings and described in detail below. Other configurations are possible, and thus the present invention is not limited to only those examples shown and described.

Fig. 2A is an enlarged partial view of the distal end or tip 40 of the exemplary pre-shaped atraumatic clot bypass configuration of the guidewire 30 of fig. 4 when in a relaxed or uncompressed state (i.e., without application of external mechanical force). In this exemplary embodiment, the distal end or tip 40 of the atraumatic clot bypass configuration of the core wire of the guidewire is pre-shaped to resemble a lemon-shaped configuration forming a closed loop. A single ferrule or opening 45 is defined in the distal end or tip 40 of the atraumatic clot bypass configuration. Depicted in fig. 2B is a cross-sectional view through the widest transverse width in the lateral direction of the preformed core wire taken along line 2B-2B of fig. 2A.

Fig. 3A and 3B depict enlarged partial views of a distal end or tip 40 'of another exemplary atraumatic clot bypass configuration, where the core wire 30' is preformed as an open loop configured as a hook or shepherd. When the atraumatic clot forming the preformed hook or shepherd of the guide wire bypasses the deployed distal end or tip 40', the free terminating end 41 extends in a direction back towards the proximal end of the guide wire to form a curved open ring section of greater than 180 ° (when in a relaxed, non-compressed state free from application of external mechanical forces). This configuration prevents atraumatic clots of the guidewire from entering the transmuted vessel bypassing any portion of the distal end of the configuration. In addition, the tip of the core wire of the present invention curves back toward the proximal end (i.e., prolapses), forming a curved open loop section of greater than 180 degrees, providing a curved surface rather than a single point (as with the blunt tip of the conventional guidewire shown in fig. 1). The surface of the preformed distal end is atraumatic to prevent damage to the target vessel tissue while ensuring that the guidewire passes between the occlusion and the inner wall of the target vessel, rather than penetrating the occlusion itself.

in the embodiment shown in fig. 3A, prior to inserting the free terminal end 41 into the lumen 25 at the proximal end of the microcatheter 10, the physician or interventionalist grasps the free terminal end 41 and straightens the pre-formed hook or shepherd distal end or tip. The distal end or tip of the guidewire maintains its straightened configuration or state as it is advanced through the lumen of the microcatheter. Upon exiting from the distal end of the microcatheter, the distal end 40' of the guidewire automatically reverts to its original bent pre-formed hook or shepherd line configuration, as shown in fig. 3A (relaxed or uncompressed state not subjected to the application of external mechanical force).

Instead of pre-forming or pre-shaping the core wire to form the desired geometry as shown in fig. 2A and 3A, the distal portion of the core wire (having a circular lateral cross-section) may alternatively be flattened and then cut or stamped into the desired geometry to form the distal end or tip of the atraumatic clot bypass configuration. In the exemplary embodiment shown in fig. 5A, hereinafter referred to as a "flat paddle" 40, "the core wire is flattened such that it is substantially planar and has a reduced thickness relative to the circular diameter of the remainder of the core wire (the non-flattened portion). Once flattened to a desired thickness, the planar distal end or tip is then cut or stamped into a desired shape (e.g., paddle shape) to form a thin support structure or substrate 50, which typically has a thickness range of about 0.0005 "to about 0.010", preferably about 0.001 "to about 0.005". Alternatively, the paddle-shaped distal end or tip may be achieved by assembling a pre-formed planar paddle-shaped distal end or tip having the same specific thickness range on the end of the individual core wire, such as by welding, or bonding. The two separate parts assembled or joined together are particularly suitable for applications in which the pre-formed planar blade and the core wire of the blade to be assembled are made of different materials. As shown in the cross-sectional view in fig. 5B, an outer covering or layer 55 may be applied to the outer surface of the support structure 50. The outer cover or layer 55 may include one or more covers, coatings or films. For example, the outer covering or layer 55 may comprise a polymeric jacket applied directly to the outer surface of the support structure or substrate 50, with or without a lubricious coating, such as a hydrophilic material, applied directly to the outer surface of the polymeric jacket. The outer sheath may also include a radiopaque filler to enhance fluoroscopic visibility of the tip.

the planar paddle-shaped distal end or tip 40 "may have an asymmetric design along its longitudinal axis 60 (fig. 6) extending in a direction from the proximal end to the distal end of the guidewire. This asymmetric design helps to wind, crimp or roll the opposing lateral edges of the paddle-shaped distal end or tip toward each other into a tube or cylinder as the guidewire is retracted back through the lumen 25 of the microcatheter 10. Thus, the guidewire can be retracted or pulled back through the distal end of the microcatheter with minimal force. This wrapping, curling or rolling of the lateral edges of the planar paddle shaped distal end or tip 40 "within the lumen of the microcatheter is similar to rolling a person's tongue. Fig. 7 is a partial view of the planar paddle-shaped distal end or tip 40 "being retracted or pulled back into the lumen of the microcatheter through its distal end 20 such that the lateral edges of the paddle are wrapped, curled or rolled toward each other. When wrapped, rolled or rolled about one another, the opposing lateral edges may, but need not, be in physical contact with one another. Furthermore, it is contemplated and within the intended scope of the invention that the lateral edges overlap each other when wound, rolled or rolled, which advantageously allows for a wider width paddle to fit within the lumen of the microcatheter. Upon exiting the lumen 25 of the microcatheter 10, the paddle-shaped distal end or tip 40 "of the guidewire automatically returns to its previous planar relaxed or uncompressed state (not subject to the application of external mechanical forces) (as shown in fig. 5A).

the paddle is dimensioned such that its widest transverse width (WW) in the lateral direction 65 (transverse width transverse to the longitudinal direction 60 from the proximal end to the distal end of the guidewire) is greater than the Inner Diameter (ID) of the lumen 25 of the microcatheter 10 when in a relaxed or uncompressed state as shown in fig. 5A and 6 (not subject to application of external mechanical forces), and wider than the diameter of the transected blood vessel that the paddle is intended to prevent guidewire entry. The maximum transverse width is about twice the inner diameter of the microcatheter. For example, for a microcatheter having an inner diameter of about 0.021 ", the paddle having the widest lateral width (WW) when in the relaxed or uncompressed state is preferably in the range of about 0.030" to about 0.050 ".

Based on the material used and its flat thickness, the paddle distal end is also sufficiently flexible so that when the guidewire is retracted or pulled back through the microcatheter, the smaller Inner Diameter (ID) of the lumen exerts an external mechanical force on the paddle distal end causing it to curl and reduce in diameter to less than the inner diameter of the lumen. Despite its large size, in this compressed state, the paddle can easily pass through the lumen 25 of the microcatheter 10, as shown in fig. 7. In this compressed state, the Widest Diameter (WD) of the wound, crimped or rolled paddle-shaped distal end is slightly less than the Inner Diameter (ID) of the lumen 25 of the microcatheter 10.

after cutting, stamping, or assembling into its paddle shape (fig. 10A and 10B), the flat distal end of the core-wire may be further modified by removing (e.g., cutting or stamping) material within the flat paddle form. Removal of such material from the flat paddle-shaped distal end or tip advantageously: (i) increasing flexibility so that the distal end or tip of the guidewire can be more easily navigated between the clot and the inner wall of the target vessel, while also minimizing the force required to retract or pull back the paddle-shaped distal end or tip through the microcatheter lumen; and (iii) is more suitable for integrating a polymeric sheath or other outer covering, layer or film over the flat paddle-shaped distal end or tip. . A single central portion may be removed from the flat paddle distal end tip. In the example shown in fig. 11A and 11B, the shape of the single eyelet or opening 45' conforms to the shape of the outer perimeter of the paddle. It should be noted that the opening 45' need not be centrally located, nor need it conform to the shape of the paddle. Another example is shown in fig. 12A and 12B, where material is removed from within the paddle form in more than one area defining four openings 45 ". The paddle may be designed with any number of one or more openings, as desired, each opening may, but need not, conform to the shape of the other openings and/or the shape of the outer contour of the paddle.

Fig. 8A-8C are partial illustrations of the flat paddle distal guidewire of fig. 5A as it passes through a retained clot or occlusion 3 in a blood vessel. As shown in the cross-sectional view of fig. 9, the flat paddle-shaped distal end 40 "of the guidewire passes over or around the clot 3 at the interface between the clot and the inner wall of the target vessel without penetrating any portion of the clot 3. Since the paddle-shaped distal end forms a surface rather than a point, the guidewire can be easily navigated between the inner wall of the target vessel and the clot without damaging the tissue of the target vessel. Furthermore, the enlarged width of the paddle when in a relaxed or uncompressed state (not subject to the application of external mechanical forces) ensures that the guidewire does not enter the transmuted vessel after passing through, across or around the clot. As shown in fig. 9, the paddle-shaped distal end of the guidewire readily conforms to the inner wall of the vessel. This ability can reduce the force required to traverse or surround the clot and more easily traverse or surround more challenging fibrin-rich or dense clots.

to facilitate visibility, the core wire of the guidewire may be covered with a radiopaque material that is visible under imaging (e.g., under fluoroscopy). For example, a polymer sheath or outer covering 70 containing radiopaque additives or fillers may be applied directly to the outer surface of the guidewire 30 (fig. 14) and/or an outer coil 75 (e.g., made of platinum alloy or other radiopaque material) wrapped around the outer surface of the guidewire 30, as shown in fig. 13.

In operation, such as during a thrombectomy procedure or treatment, a physician or interventionalist introduces a guidewire having a distal end or tip configured for atraumatic clot bypass according to the present invention intravascularly into a target vessel, typically into an artery located in the groin. The guidewire is advanced through the vasculature to a position proximal to the target clot, blockage or obstruction. Once the guidewire is properly positioned, the microcatheter is tracked over the guidewire, which is passed through a lumen defined axially through the microcatheter. The distal tip of the atraumatic clot bypass arrangement of the guidewire of the present invention is advanced first through the clot and then a microcatheter. Because the atraumatic clot of the present invention bypasses the distal end or tip of configuration and size, the guidewire easily surrounds or traverses the clot without damaging neurovascular tissue of the target vessel, but prevents the guidewire from entering the transmuted vessel when it reaches the distal side of the clot. Once the distal end of the guidewire is properly positioned on the distal side of the clot, the microcatheter is tracked to its distal side over the guidewire surrounding or traversing the clot. With the microcatheter positioned on the distal side of the clot, the guidewire may be retracted or withdrawn proximally back through the microcatheter while the microcatheter remains in place. Microcatheters may also be used to provide support for distal access, guidance, or introduction of an intermediate catheter. A mechanical thrombectomy device such as a stent retriever or any other clot retrieval device may be advanced through the microcatheter to the target site of the occlusion and used to retrieve the clot or occlusion to the guide catheter or sheath.

The guidewire of the present invention has been illustrated and described for use in mechanical thrombectomy, but is applicable to all neurovascular or intravascular medical procedures employing guidewires.

Thus, while there have been shown, described, and pointed out fundamental novel features of the invention as applied to a preferred embodiment thereof, it will be understood that various omissions, substitutions, and changes in the form and details of the systems/devices illustrated, and in their operation, may be made by those skilled in the art without departing from the spirit and scope of the invention. For example, it is expressly intended that all combinations of those elements and/or steps which perform substantially the same function in substantially the same way to achieve the same results are within the scope of the invention. Substitutions of elements from one described embodiment to another are also fully intended and contemplated. It should also be understood that the drawings are not necessarily drawn to scale, but that they are merely conceptual in nature. It is the intention, therefore, to be limited only as indicated by the scope of the claims appended hereto.

Each of the issued patents, pending patent applications, patent publications, journal articles, books, or any other references cited herein is incorporated by reference in its entirety.