Intervention systems and associated devices and methods

Abstract

Devices and systems for engaging with occlusions within body tubular lumenes are disclosed herein. According to several embodiments, the technology includes an extension member having a proximal end portion, a distal end portion, and a longitudinal axis extending between them. The distal end portion of the extension member may be configured to be positioned within a body tubular lumen in close proximity to the occlusion. The device further includes an occlusion engaging element positioned at the distal end portion of the extension member, the occlusion engaging element comprising a tapered body and ribs spirally wound around the outer surface of the tapered body. The occlusion engaging element is configured to be rotated in contact with the occlusion to advance the occlusion engaging element into the occlusion or retract the occlusion engaging element out of the occlusion.

Description

Technical Field

[0001] (Cross - reference to Related Applications) This application claims the benefit of priority of U.S. Provisional Application No. 63 / 489,727, filed Mar. 10, 2023, which is incorporated herein by reference in its entirety.

[0002] This technology generally relates to the treatment of occluded body lumens. In particular, the devices and methods relate to engaging and / or traversing an occlusion.

Background Art

[0003] Deep vein thrombosis (DVT) is a condition involving a thrombus in a deep vein, usually occurring in leg veins but also potentially in arm veins. Symptoms include pain, swelling, tenderness, and / or discoloration in the affected limb. If untreated, this can lead to worsening and complications of symptoms such as post - thrombotic syndrome with symptoms of chronic pain, swelling, and skin discoloration, or very severe and life - threatening conditions such as pulmonary embolism (PE). Pharmacological treatments include anticoagulant drug therapy or thrombolytic agents. More recently, percutaneous catheters for more rapid removal of thrombus have been developed to remove obstructions and prevent PE. These include, in some cases, catheters that can deliver thrombolytic agents to the site of the thrombus in combination with aspiration and / or fragmentation of the thrombus into smaller pieces. Other catheters mechanically capture and remove thrombus without thrombolytic agents, thereby reducing the bleeding risk posed by these drugs. An early example of this is the Fogarty balloon thrombectomy catheter. More recent examples include the ClotTriever® (Inari Medical, Irvine, CA), RevCore® (Inari Medical, Irvine, CA), and ReVene® thrombectomy catheters (Vetex Medical, Galway, Ireland).

[0004] Unfortunately, many of these therapies have limited success against partial or complete occlusions caused by chronic thrombosis (i.e., thrombi lasting for a period of one or two months). When thrombi remain in the limbs over periods of several months, the initial thrombus deforms into a more rigid, acute fibrin structure and / or chronic collagen structure that adheres more firmly to the wall. Chronic thrombi can take the form of fibrous trabeculae or membranes (also known as venous adhesions) that extend across and within the venous lumen. Furthermore, the thrombus becomes more firmly attached to the wall. Catheter-based thrombolytic or thrombectomy devices have a lower success rate in removing these occlusions. Venous adhesions can also hinder optimal treatment of venous occlusion with balloon angioplasty or stent placement because the fibrous structure prevents permanent stretching of the vessel wall. There is a need for improved intravascular thrombectomy devices that can successfully remove chronic thrombi. [Overview of the project] [Means for solving the problem]

[0005] overview The subject art is illustrated according to various aspects described below, including, for example, with reference to Figure 1A-11. Various embodiments of aspects of the subject art are described for convenience as numbered embodiments (1, 2, 3, etc.). These are provided as embodiments and do not limit the subject art. 1. A device for engaging with an obstruction in a body lumen, the device is An extension member having a proximal end portion, a distal end portion, and a longitudinal axis extending between the proximal and distal end portions, wherein the distal end portion of the extension member is configured to be positioned within the body lumen in close proximity to the occlusion, A closing engagement element disposed at the distal end of an extension member, the closing engagement element comprising a tapered body and a rib spirally wound around the outer surface of the tapered body, and Equipped with, A device in which an occlusion engaging element is configured to rotate while in contact with an occlusion, thereby advancing the occlusion engaging element into the occlusion or retracting the occlusion engaging element out of the occlusion. 2. The device according to Example 1, wherein the tapered body and ribs comprise separate components, and the ribs are bonded to the outer surface of the tapered body. 3. The device according to Example 1, wherein the rib is integrally formed with the tapered body such that the rib has a helical projection of the tapered body. 4. The device according to any one of Examples 1-3, wherein the tapered body extends between a proximal end and a distal end and has a length measured between them, and the ribs extend along the entire length of the tapered body. 5. The device according to any one of Examples 1-3, wherein the tapered body extends between a proximal end and a distal end and has a length measured between them, and the rib extends along only a portion of the length of the tapered body. 6. The device according to any one of Examples 1-5, wherein the tapered body extends between the proximal and distal ends, and the tapered body has a rounded distal end. 7. The device according to any one of Examples 1-5, wherein the tapered body extends between a proximal end and a distal end, and the tapered body has a flat distal end. 8. The device according to any one of Examples 1-7, wherein the rib has a circular or oval axial cross-sectional shape. 9. The device according to any one of Examples 1-7, wherein the rib has a triangular axial cross-sectional shape. 10. The device according to any one of Examples 1-7, wherein the rib has a square or rectangular axial cross-sectional shape. 11. The rib pitch is variable, as described in any one of Examples 1-10. 12. The device according to any one of Examples 1-10, wherein the rib pitch is substantially constant. 13. The device according to any one of Examples 1-12, wherein the occlusion engagement element is tightly coupled to the extension member such that rotational and / or translational movement of the extension member causes a corresponding rotational and / or translational movement of the occlusion engagement element. 14. The device according to any one of Examples 1-13, wherein the extension member is a solid rod. 15. The device according to any one of Examples 1-14, wherein the extension member is a tubular shaft that defines a lumen through which it passes. 16. The device according to any one of Examples 1-15, wherein the tapered body defines a lumen extending through it. 17. The device according to any one of Examples 1-16, wherein the tapered body has a solid structure and does not define a lumen extending through it. 18. A device for engaging with an obstruction in a body lumen, the device being An extension member having a proximal end portion, a distal end portion, and a longitudinal axis extending between the proximal and distal end portions, wherein the distal end portion of the extension member is configured to be positioned within the body lumen in close proximity to the occlusion, A closing engagement element is positioned at the distal end of an extension member, the closing engagement element comprising a tapered body, the tapered body defining a groove that extends spirally around the outer surface of the tapered body, Equipped with, A device in which an occlusion engaging element is configured to rotate while in contact with an occlusion, thereby advancing the occlusion engaging element into the occlusion or retracting the occlusion engaging element out of the occlusion. 19. The device according to Example 18, wherein the tapered body extends between a proximal end and a distal end and has a length measured between them, and the groove extends along the entire length of the tapered body. 20. The device according to Example 19, wherein the tapered body extends between the proximal and distal ends and has a length measured between them, and the groove extends along only a portion of the length of the tapered body. 21. The device according to any one of Examples 18-20, wherein the tapered body extends between the proximal and distal ends, and the tapered body has a rounded distal end. 22. The device according to any one of Examples 18-21, wherein the tapered body extends between a proximal end and a distal end, and the tapered body has a flat distal end. 23. The groove pitch is variable, as described in any one of Examples 18-22. 24. The device according to any one of Examples 18-23, wherein the groove pitch is substantially constant. 25. The device according to any one of Examples 18-24, wherein the occlusion engagement element is tightly coupled to the extension member such that rotational and / or translational movement of the extension member causes a corresponding rotational and / or translational movement of the occlusion engagement element. 26. The device according to any one of Examples 18-25, wherein the extension member is a solid rod. 27. The device according to any one of Examples 18-26, wherein the extension member is a tubular shaft that defines a lumen through which it passes. 28. The device according to any one of Examples 18-27, wherein the tapered body defines a lumen extending through it. 29. The device according to any one of Examples 19-28, wherein the tapered body has a solid structure and does not define a lumen extending through it. 30. A method for advancing an intravascular medical device into or through a vascular occlusion using rotational motion, performed in conjunction with a distal tip having a spiral or spiral geometric shape. 31. The method according to Example 30, wherein the rotational motion of the distal tip is performed while the distal tip is positioned across the guidewire. [Brief explanation of the drawing]

[0006] Many aspects of this disclosure can be better understood by referring to the following drawings. The components in the drawings are not necessarily to scale. Instead, the focus is on clearly illustrating the principles of this disclosure.

[0007] [Figure 1A] Figure 1A is a side view of the distal portion of a therapeutic device configured according to this technology.

[0008] [Figure 1B]FIG. 1B is an axial cross-sectional view taken along line 1B-1B of the occluding engagement element of the treatment device shown in FIG. 1A.

[0009] [Figure 2] FIGS. 2, 3, and 4 show various embodiments of an occluding engagement element constructed in accordance with the present technology. [Figure 3] FIGS. 2, 3, and 4 show various embodiments of an occluding engagement element constructed in accordance with the present technology. [Figure 4] FIGS. 2, 3, and 4 show various embodiments of an occluding engagement element constructed in accordance with the present technology.

[0010] [Figure 5] FIGS. 5A-5F are axial cross-sectional views of an exemplary rib constructed in accordance with the present technology.

[0011] [Figure 6] FIGS. 6A-6D illustrate a method of using the occluding engagement element of the present technology to cross an occlusion within a blood vessel.

[0012] [Figure 7] FIGS. 7, 8, 9, and 10 show various embodiments of an occluding engagement element constructed in accordance with the present technology. [Figure 8] FIGS. 7, 8, 9, and 10 show various embodiments of an occluding engagement element constructed in accordance with the present technology. [Figure 9] FIGS. 7, 8, 9, and 10 show various embodiments of an occluding engagement element constructed in accordance with the present technology. [Figure 10] FIGS. 7, 8, 9, and 10 show various embodiments of an occluding engagement element constructed in accordance with the present technology.

[0013] [Figure 11] FIG. 11 shows the introduction region of an occluding engagement element constructed in accordance with the present technology.

BEST MODE FOR CARRYING OUT THE INVENTION

[0014] Detailed explanation This technology is broadly relevant to the field of intravascular medical devices, involving application to any device that can benefit from mechanically assisted transverse vascular occlusion. In some embodiments, the occlusion engagement element of this technology may be used in conjunction with a device or group of devices intended to debulk intraluminal material such as thrombi or collagen-based post-thrombotic material from deep veins of the venous system. The occlusion engagement element of this technology can be used with a variety of intervention devices and for a variety of treatments, such as mechanical thrombectomy catheters, atherosclerotic catheters, venous stents, hyperbaric balloons, distal protective baskets, transverse catheters, and others.

[0015] Many endovascular medical devices are designed to track through blood vessels via a guidewire to their intended site of use. The devices are often designed with non-traumatic or tapered tips to facilitate tracking and prevent damage to vascular structures. In some cases, occlusion within the affected vessel can substantially block the lumen, limiting the passage of the guidewire and / or device. Various procedural techniques may be employed to attempt to overcome the occlusion, but these can still result in significant procedural delays or inability to traverse completely.

[0016] In one specific example, DVT or post-thrombotic syndrome (PTS) can result in partial to complete occlusion of the deep venous system. This includes occlusion of intrinsic vessels such as the iliofemoral, femoral, or popliteal veins, or iliofemoral vein stents. The composition of the occlusive material can vary considerably; fresher thrombi primarily have a fibrin-based composition, while more advanced post-thrombotic tissue has a collagen-dominant composition. Furthermore, the structure of the occlusion can range from complete luminal occlusion to reticular trabeculae / adhesion reticular tissue within the lumen.

[0017] Treatment for DVT or PTS conditions often involves advancing a catheter-based therapeutic device into the blood vessel via a guidewire to debulking and remove occlusive material. However, under certain conditions, the guidewire or device may be extremely difficult to advance through the occlusion, depending on the severity of the disease or the tissue composition.

[0018] The use of a distal catheter tip having a helical or spiral geometric shape can benefit this process by providing a mechanical method for advancing the distal tip and the catheter. By positioning the distal catheter tip to contact the occlusion and rotating it, the helical or spiral geometric shape can become engaged with the tissue, allowing penetration into the occlusive material using a screw mechanism. Continued rotation of the distal tip feature can further advance the tip into the occlusion and provide a rigid guide from which the guidewire can be progressively advanced.

[0019] This technology includes a distal catheter tip with an occlusion engagement element having a helical or spiral-shaped screw geometry for improved catheter tracking and advancement through an occluded blood vessel. The tip geometry provides a radially oriented inclined surface for mechanical engagement between the distal tip and the occluding material. When rotated, the distal tip slides forward into or out of the occluding material, based on the orientation of the tip geometry and the direction of rotation. The magnitude of axial / linear movement per rotation depends on the pitch of the helical or spiral geometry and its ability to maintain engagement between the tip and the occluding material.

[0020] Figure 1A shows the distal portion of a therapeutic device 100 configured according to the present technology. Figure 1B is an axial cross-sectional view of the occlusion engagement element shown in Figure 1A, obtained along line 1B-1B. As shown in Figures 1A and 1B, the therapeutic device 100 may comprise an extension member 110 and an occlusion engagement element 101 positioned at the distal end portion 110b of the extension member 110. The occlusion engagement element 101 may be configured to be positioned within a body lumen (e.g., a blood vessel including an artery or vein) at a treatment site adjacent to an occlusion within a body lumen. In some embodiments, the occlusion engagement element 101 comprises a body 102 and ribs 104 spirally wound around the outer surface of the body 102. The therapeutic device 100 is advanced to the treatment site (see, for example, Figures 6A-6D) and configured to position the distal portion of the occlusion engagement element 101 in contact with the proximal side of the occlusion. The treatment device 100 can then be operated to rotate the occlusion engaging element 101 while in contact with the occlusion, thereby advancing the occlusion engaging element 101 into the occlusion or retracting the occlusion engaging element 101 out of the occlusion. The helical rib 104 resists pressure (normal to the radially outer surface of the rib 104) by converting mechanical torque into linear force and utilizing the friction and wedge action of each turn of the rib 104.

[0021] The extension member 110 may have a proximal portion (not shown) configured to be positioned at an external location for user manipulation. In some embodiments, the extension member 110 and / or the occlusion engagement element 101 may be configured to advance across a guidewire to the treatment site. In these and other embodiments, the extension member 110 may comprise a tubular shaft defining a lumen that extends through it and is continuous with a lumen 114 (see Figure 1B) that extends through the occlusion engagement element 101. In other embodiments, the extension member 110 and / or the occlusion engagement element 101 may comprise a solid structure (e.g., without a lumen).

[0022] At least a portion of the body 102 of the occlusion engagement element 101 may be tapered distally to facilitate advance into and retraction from the occlusion. For example, as shown in Figure 1A, in some embodiments, the body 102 may comprise a cylindrical proximal region 108 and a tapered (e.g., conical) distal region 106 extending distally from the proximal region 108. The cylindrical proximal region 108 may be directly coupled to the distal end portion of the extension member 110. For example, the distal end portion 110b of the extension member 110 may be located within the lumen defined by the proximal region 108 of the occlusion engagement element 101. In some embodiments, the distal end portion 110b of the extension member 110 is positioned across and / or around the proximal region 108 of the occlusion engagement element 101 (e.g., the proximal region 108 is positioned within the lumen of the extension member 110). In yet another embodiment, the proximal region 108 of the occluding engagement element 101 may be configured to engage with one or more complementary features on the distal end portion 110b of the extension member 110. For example, the proximal region 108 of the occluding engagement element 101 may include a projection configured to be received by a recess on the distal end portion 110b of the extension member 110 (or vice versa). Other engagement means, such as key and keyway structures, may also be possible.

[0023] While the occlusion engagement elements disclosed herein, including the occlusion engagement element 101, are shown with a tapered distal region, any of the occlusion engagement elements of the Art may have a substantially constant diameter along their length such that no portion of the occlusion engagement element is tapered. It should be understood that all features described herein with reference to the tapered embodiment apply equally to occlusion engagement elements having a uniform diameter.

[0024] In some embodiments, the occlusion engagement element 101 is tightly coupled to the extension member 110 so that torque or rotational force applied to the extension member 110 is directly transmitted to the occlusion engagement element 101. In other embodiments, the occlusion engagement element 101 can be mechanically discoupled from the extension member 110 so that rotation and / or translation of the extension member 110 does not cause corresponding rotation and / or translation of the occlusion engagement element 101. For example, the occlusion engagement element 101 may be coupled to a separate delivery member (not shown) which is responsible for causing translation and / or rotation of the occlusion engagement element 101. The separate delivery member may be positioned within the lumen of the extension member 110, or extend parallel to the extension member 110, so that the extension member 110 is positioned within the lumen of the delivery member.

[0025] In some embodiments, the cross-sectional dimensions of the proximal region 108 of the main body 102 vary along its length. In some embodiments, the entire length of the closure engagement element 101 (e.g., both the proximal and distal regions 108, 106) can be tapered, or the entire length can have a substantially constant diameter. As shown in Figure 1A, in some embodiments, the rib 104 may extend only along the tapered distal region 106. In other embodiments, the rib 104 may extend around both the proximal and distal regions 108, 106. In some cases, the rib 104 may extend only along a portion of the tapered distal region 106 (e.g., as described below with reference to Figure 3). In some embodiments, the rib 104 extends proximal beyond the closure engagement element 101 and partially or completely wraps around the distal portion of the extension member 110 (one or more loops).

[0026] The body 102 of the occlusion engagement element 101 may terminate distally at a distal surface 112 surrounding the distal opening (if the occlusion engagement element 101 is hollow). The distal surface 112 may be flat or rounded (as shown). In some embodiments, the body 102 may include an introduction member to facilitate initial gripping and / or engagement of the occlusion, as will be discussed in more detail below with reference to Figure 11.

[0027] The rib 104 can extend helically around all or part of the length of the body 102 according to a pitch P measured between successive loops and a helical angle α measured between the longitudinal axis L of the device 100 and the rib 104. The pitch P may be the same or vary between successive loops, and the helical angle α may be the same or vary between successive loops. Furthermore, the rib 104 may have a clockwise or counterclockwise orientation. The pitch P may be selected according to the desired forward speed (a larger pitch will advance the occlusion engagement element 101 faster / translate it further per turn), gripping force (a larger pitch may reduce the gripping force of the occlusion engagement element against the occlusion), and precision (a finer pitch allows for more precise adjustment). Similarly, the helical angle α may be selected according to the desired efficiency (a larger helical angle has less friction loss and therefore has higher efficiency) and torque input (a larger helical angle requires more torque to rotate the occlusion engagement element 101).

[0028] Although it is only one of many embodiments, Figure 2 shows a therapeutic device 200 having an occlusion engagement element 201 similar to the occlusion engagement element 101 described with reference to Figures 1A and 1B, but the rib 104 has a pitch that varies along the length of the tapered distal region 106. The rib 104 can be wound around the body 102 such that pairs of loops are spaced apart from adjacent pairs of loops at a distance greater than the distance between individual loops comprising a pair of loops. In other words, the rib 104 can have alternating pitches between successive windings between a first pitch P1 and a second pitch P2 less than the first pitch P1.

[0029] As yet another embodiment, Figure 3 shows a therapeutic device 300 having an occlusion engagement element 301 similar to the occlusion engagement element 101 described with reference to Figures 1A and 1B, but the ribs 104 have a pitch that is substantially zero (e.g., tightly wound with small spaces between consecutive windings). Such a design may be advantageous in providing greater precision when penetrating occlusive material and may be more flexible. Also, as demonstrated in Figure 3, the tapered distal region 106 may have a first portion 124 along which the ribs 104 are wound, and a second portion 126 distal to the first portion 124 that does not have the ribs 104. While this variant is shown with respect to the occlusion engagement element 101 having substantially zero pitch, it should be understood that such designs (including the first portion 124 with ribs and the second portion 126 without ribs) may be utilized on occlusion engagement elements with any pitch or helical angle along the first portion 124.

[0030] In some embodiments, the occlusion engagement element 101 and / or body 102 may have one or more fluted regions to facilitate the removal of occluding material as the occlusion engagement element advances into the occlusion. Figure 4 shows a non-exclusive embodiment of an occlusion engagement element 401 having multiple flutes 122 extending longitudinally along the body 102. In some embodiments, the body 102 includes a single flute. The flute 122 may extend along all or part of the length of the body 102 and / or occlusion engagement element 101. In some embodiments, the flute may extend helically around the body 102, for example, between continuous turns of ribs 104. To form the flute, one or more portions of the body 102 and / or ribs 104 may be removed.

[0031] As shown in Figure 1A, the rib 104 extends radially away from the outer surface of the body 102. Figures 5A–5F show non-exclusive embodiments of different cross-sectional profiles of the rib 104. In all embodiments, the rib 104 includes a radially outermost surface 500 and side walls 502 extending downward from the outermost surface 500 to the body 102. As shown in Figure 5A, in some embodiments, the rib 104 has a circular cross-sectional shape (or oval in some embodiments) with a rounded outermost surface 500 and rounded side walls 502 that are concave toward each other. As shown in Figure 5B, the rib 104 may have a square cross-sectional shape (or rectangular in some embodiments) with a substantially flat and / or linear outermost surface 500 and substantially flat or linear side walls 502. As shown in Figure 5C, in some embodiments, the rib 104 may have a triangular cross-sectional shape comprising two substantially linear sidewalls 502 angled toward each other in the direction away from the body 102. In these and other embodiments, the outermost surface 500 may comprise a sharpened or blunted (e.g., rounded) edge 500 where the two sidewalls 502 meet. As shown in Figure 5D, in some embodiments, the rib 104 may have curved sidewalls 502 that extend substantially parallel to each other away from the body 102 and then curve toward each other until they meet an outermost surface 500 which may comprise a sharp or blunt edge. The curved portions of the sidewalls 502 may be concave toward each other so that the rib 104 presents a sidewall surface that is convex toward the closure. Figure 5E depicts another exemplary embodiment in which the sidewalls 502 have a substantially linear proximal portion 502a followed by a curved distal portion 502b. The distal portions 502b are curved toward each other, thereby presenting a concave sidewall to the occlusion. The sidewall 502 can contact the outermost surface 500, which may have a sharpened or blunted edge. As shown in Figure 5F, in some embodiments, the sidewall 502 has a substantially linear proximal portion 502a followed by a curved distal portion 502b. In contrast to the sidewall 502 in Figure 5E, in Figure 5F, the sidewalls are curved toward each other, and therefore present a concave surface to the occlusion.Furthermore, unlike the embodiment shown in Figure 5E, the side walls 502 curve away from each other, so the outermost surface 500 has a substantially linear or flat non-traumatic surface (rather than a narrow edge).

[0032] In some embodiments, the ribs 104 may comprise a structure initially supplied separately from the body 102 and fixed to the outer surface of the body 102 during manufacturing. For example, the ribs 104 may comprise a composite strand or strip of biocompatible or non-biocompatible metal, polymer, or material (e.g., wire, strip cut from a sheet of material, 3D printed strip), which is attached to the body 102. In other embodiments, the ribs 104 and the body 102 comprise a structure formed collectively (e.g., integrally with each other) such that the ribs 104 become an extension of the material of the body 102. The ribs may be partially or completely formed of a radiopaque material or may include a radiopaque coating.

[0033] The ribs 104 and the body 102 may be made of the same or different materials and / or may have the same or different material properties. For example, in some embodiments, the ribs 104 may be formed from metal, while the body 102 may be formed from a polymer. According to one embodiment, the body 102 may be more flexible and / or softer than the ribs 104. In other embodiments, the body 102 and the ribs 104 may be substantially equal in rigidity / flexibility and / or softness / hardness. The ribs 104 and / or the body 102 may be formed by forging, casting, stretching, insert molding, overmolding, machining, 3D printing, and / or other methods.

[0034] The length and cross-sectional dimensions of the occlusion engagement element 101 can be adjusted for the desired use and depending on the size of the extension member 110 and the guide wire (if any) intended to be used in conjunction with the system. In some embodiments, the proximal end of the body 102 may have a cross-sectional dimension of about 0.130 inches to about 0.150 inches, and the distal end of the body 102 (at the distal surface 112) may have a cross-sectional dimension of about 0.020 inches to about 0.070 inches.

[0035] The rib 104 may have a fixed diameter or may be expandable / collapseable. For example, the rib 104 may be inflated along its length to increase the cross-sectional dimensions of the rib 104. In other embodiments, the rib 104 may be mechanically actuated to extend radially away from the body 102.

[0036] Figures 6A–6D illustrate exemplary methods of using the therapeutic device of this technology to penetrate and / or traverse an occlusion O within a blood vessel V. Other applications are also possible, as mentioned above.

[0037] According to several methods of use, the treatment device 100, including the extension member 110 and the occlusion engagement element 101, can be advanced along a guidewire GW to a treatment site adjacent to the occlusion O. The guidewire GW can be positioned, for example, immediately proximal to or in contact with the occlusion O, which is blocking the passage of the guidewire GW (as shown in Figure 6A). As shown in Figure 6B, the device 100 can then be advanced along the guidewire GW until the distal portion of the occlusion engagement element 101 contacts the occlusion O. As depicted in Figure 6C, the occlusion engagement element 101 can then be rotated in a first direction (indicated by the arrow) to advance the occlusion engagement element 101 into the occlusion O. As discussed above, rotation of the occlusion engagement element 101 can be achieved by rotating the extension member 110 (if there is a rigid connection between the occlusion engagement element 101 and the extension member 110), or by rotating a separate delivery member (not shown) that extends through or across the extension member 110 and is rigidly coupled to the occlusion engagement element 101. With continued rotation and forward movement, the occlusion engagement element is eventually positioned on the distal side of the occlusion, as shown in Figure 6D.

[0038] Figure 7 shows the distal portion of a therapeutic device 700 configured according to the present technology. As shown in Figure 7, the therapeutic device 700 may comprise an extension member 110 and an occlusion engagement element 701 positioned at the distal end portion 110b of the extension member 110. The occlusion engagement element 701 may be configured to be positioned within a body lumen (e.g., a blood vessel including an artery or vein) at a treatment site adjacent to an occlusion within the body lumen. In some embodiments, the occlusion engagement element 701 comprises a body 702 having a groove 704 that spirally wraps around the outer surface of the body 702. The therapeutic device 700 is configured to be advanced to the treatment site and to position the distal portion of the occlusion engagement element 701 in contact with the proximal side of the occlusion. The therapeutic device 700 can then be operated to rotate the occlusion engagement element 701 while in contact with the occlusion, thereby advancing the occlusion engagement element 701 into the occlusion or retracting the occlusion engagement element 701 out of the occlusion.

[0039] In some embodiments, the cross-sectional dimensions of the proximal region 708 of the main body 702 vary along its length. In some embodiments, the entire length of the occlusion engagement element 701 (e.g., both the proximal and distal regions 708, 706) can be tapered, while in other embodiments, the entire length of the occlusion engagement element 701 can have a substantially constant diameter. As shown in Figure 7, in some embodiments, the groove 704 may extend only along the tapered distal region 706. In other embodiments, the groove 704 may extend around both the proximal and distal regions 708, 706. In some cases, the groove 704 may extend only along a portion of the tapered distal region 706. For example, the tapered distal region 706 of the occlusion engagement element 701 may have a proximal portion containing a helical groove and a distal portion without a groove.

[0040] The grooves 704 can be formed by subtractive manufacturing, additive manufacturing, insert molding, casting, and other suitable methods. The body 702 can be formed from biocompatible or non-biocompatible metals, polymers, and / or suitable composite materials.

[0041] The groove 704 can extend helically around all or part of the length of the body 702, according to a pitch P measured between successive loops and a helical angle α measured between the longitudinal axis L of the device 700 and the groove 704. The pitch P can be the same or vary between successive loops. In just one of many embodiments, Figure 8 shows a therapeutic device 800 having an occlusion engagement element 801, similar to the occlusion engagement element 701 described with reference to Figure 7, but with a pitch P less than that of the occlusion engagement element 701.

[0042] The helical angle α of the groove 704 may be the same or vary between consecutive loops, and the groove 704 may have a clockwise or counterclockwise orientation. The pitch P may be selected according to the desired forward speed (a larger pitch will cause the occlusion engagement element 701 to advance faster / translate further per turn), gripping force (a larger pitch may reduce the gripping force of the occlusion engagement element against the occlusion), and precision (a finer pitch allows for more precise adjustment). Similarly, the helical angle α may be selected according to the desired efficiency (a larger helical angle has less friction loss and therefore has higher efficiency) and torque input (a larger helical angle requires more torque to rotate the occlusion engagement element 701).

[0043] In some embodiments, the occlusion engagement element 701 and / or the body 702 may have one or more fluted regions to facilitate the removal of occluding material as the occlusion engagement element 701 advances into the occlusion. The occlusion engagement element 701 may have one or more flutes (not shown) extending longitudinally along the body 702, as described above with reference to Figure 4.

[0044] Figure 9 shows the distal portion of another therapeutic device 900 configured according to the present technology. As shown in Figure 9, the therapeutic device 900 may comprise an extension member 110 and an occlusion engagement element 901 positioned at the distal end portion 110b of the extension member 110. The occlusion engagement element 901 may be configured to be positioned within a body lumen (e.g., a blood vessel including an artery or vein) at a treatment site adjacent to an occlusion within the body lumen. In some embodiments, the occlusion engagement element 901 comprises a proximal region 908 and a distal region 906. The proximal region 908 may comprise a cylindrical portion, while the distal region 906 may comprise a helical structure 920 that forms a plurality of loops around the longitudinal axis of the device 900, with helical gaps 922 defined between the successive loops (similar to a corkscrew). The helical structure 920 defines a cross-sectional dimension that decreases distally, and therefore can be given a tapered shape (thereby the loop becoming progressively smaller). In other embodiments, the helical structure 920 can have a substantially constant diameter.

[0045] In some variations, all or part of the proximal region 908 has a cross-sectional dimension that is tapered distally, so that the helical structure 920 is positioned between two structures having a continuous outer surface. In other embodiments, the occlusion engagement element 901 does not include a cylindrical proximal region 908 and is formed entirely from the helical structure 920.

[0046] Similar to other therapeutic devices disclosed herein, the therapeutic device 900 is configured to be advanced to the treatment site and to position the distal portion of the occlusion engaging element 901 in contact with the proximal side of the occlusion. The therapeutic device 900 can then be operated to rotate the occlusion engaging element 901 while in contact with the occlusion, thereby advancing the occlusion engaging element 901 into the occlusion or retracting the occlusion engaging element 901 out of the occlusion.

[0047] The cross-sectional shape of the helically extending member forming the helical structure 920 can be any suitable shape, such as a rounded shape (e.g., circle, oval, etc.), a square, rectangle, polygon, or any other suitable shape. The helically extending member may have one or more sharpened edges, or rounded edges and / or non-traumatic edges. The distal surface 912 of the helical structure 920 may be obtuse, pointed, or tapered.

[0048] The occlusion engagement element 920 can be coupled to the distal end portion of the extension member 110 by a structure and method similar to those described above with reference to Figures 1A and 1B. The helical structure 920 can be formed by subtractive manufacturing, additive manufacturing, insert molding, casting, and other preferred methods. The helical structure 920 can be formed from biocompatible or non-biocompatible metals, polymers, and / or preferred composite materials.

[0049] Figure 10 shows a therapeutic device 1000 having an occlusion engagement element 1001, similar to the occlusion engagement element 901 described with reference to Figure 9, but with a nose cone 924 positioned at the distal end of the helical structure 920. Thus, the tapered distal region 906 may have a first portion 1024 comprising the helical structure 920 and a second distal portion 1026 of the first portion 1024 having a continuous outer surface defining a lumen and / or cavity within it. The nose cone 924 may have an opening 926 at its distal tip.

[0050] Figure 11 shows the distal portion of an occlusion engagement element 1101 of a therapeutic device 1100 configured according to the present technology. As shown in Figure 11, any distal end of the occlusion engagement element 1101 of the present technology may include one or more introduction features configured to initiate occlusion engagement and penetration. In some embodiments, the introduction region comprises a plurality of distinct ridges 1132 at the distal end of the body 1102. The ridges 1132 may project distally away from the distal end and, in some cases, may be tapered distally with respect to the distal edge 1134. Other variations are also possible.

[0051] The technology may further include an occlusion engagement element having multiple articulated segments. The segments may be configured to rotate and / or pivot by a limited amount relative to each other, allowing for bending of the occlusion engagement element along the longitudinal axis. Each segment may be relatively rigid and may define a central opening that allows a guidewire to pass through it.

[0052] conclusion Other embodiments in addition to those described herein are also within the scope of the Art. In addition, some other embodiments of the Art may have different configurations, components, or techniques than those described herein. Those skilled in the art will therefore understand that the Art may have other embodiments with additional elements, or that the Art may have other embodiments without some of the features shown and described above with reference to Figure 1A-11.

[0053] The description of embodiments of this technology is not intended to be exhaustive or to limit the technology to any specific form disclosed above. Where the context allows, singular or plural terms may also include plural or singular terms, respectively. Specific embodiments of the technology and examples relating to the technology are described above for illustrative purposes, but as those skilled in the art will recognize, various equivalent modifications are possible within the scope of the technology. For example, while the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0054] As used herein, the terms “generally,” “substantially,” “about,” and similar terms are used as approximations, not as terms of degree, and are intended to take into account the inherent variability in measured or calculated values ​​that would be recognized by those skilled in the art.

[0055] Furthermore, unless the word “or” is explicitly limited to referring to a list of two or more items and meaning only a single item that is exclusive from the other items, the use of “or” in such a list shall be interpreted as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. In addition, the term “comprising” is used throughout to mean including at least the listed (single or multiple) features so as not to exclude any more than a number of identical features and / or other features of additional types. Also, while specific embodiments are described herein for illustrative purposes, it should be understood that various modifications can be made without departing from the Art. Furthermore, while advantages associated with certain embodiments of the Art are described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily have to exhibit such advantages in order to fall within the scope of the Art. Accordingly, the present disclosure and the associated Art may encompass other embodiments not expressly shown or described herein.

Claims

1. A device for engaging with an obstruction in a body lumen, wherein the device is An extension member having a proximal end portion, a distal end portion, and a longitudinal axis extending between the proximal end portion and the distal end portion, wherein the distal end portion of the extension member is configured to be positioned within the body lumen in close proximity to the occlusion, A closing engagement element disposed at the distal end portion of the extension member, wherein the closing engagement element comprises a tapered body and a rib spirally wound around the outer surface of the tapered body, and Equipped with, A device in which the blocking engagement element is configured to rotate while in contact with the blocking, thereby advancing the blocking engagement element into the blocking or retracting the blocking engagement element out of the blocking.

2. The device according to claim 1, wherein the tapered body and the rib comprise separate components, and the rib is bonded to the outer surface of the tapered body.

3. The device according to claim 1, wherein the rib is formed integrally with the tapered body such that the rib has a helical projection of the tapered body.

4. The device according to any one of claims 1 to 3, wherein the tapered body extends between a proximal end and a distal end and has a length measured between them, and the rib extends along the entire length of the tapered body.

5. The device according to any one of claims 1 to 3, wherein the tapered body extends between a proximal end and a distal end and has a length measured between them, and the rib extends along only a portion of the length of the tapered body.

6. The device according to any one of claims 1 to 5, wherein the tapered body extends between a proximal end and a distal end, and the tapered body has a rounded distal end.

7. The device according to any one of claims 1 to 5, wherein the tapered body extends between a proximal end and a distal end, and the tapered body has a flat distal end.

8. The device according to any one of claims 1 to 7, wherein the rib has a circular or oval axial cross-sectional shape.

9. The device according to any one of claims 1 to 7, wherein the rib has a triangular axial cross-sectional shape.

10. The device according to any one of claims 1 to 7, wherein the rib has a square or rectangular axial cross-sectional shape.

11. The device according to any one of claims 1 to 10, wherein the pitch of the ribs is variable.

12. The device according to any one of claims 1 to 10, wherein the pitch of the ribs is substantially constant.

13. The device according to any one of claims 1 to 12, wherein the closing engagement element is tightly coupled to the extension member such that rotational movement and / or translation of the extension member causes a corresponding rotational movement and / or translation of the closing engagement element.

14. The device according to any one of claims 1 to 13, wherein the extension member is a solid rod.

15. The device according to any one of claims 1 to 14, wherein the extension member is a tubular shaft that defines a lumen through which it passes.

16. The device according to any one of claims 1 to 15, wherein the tapered body defines a lumen extending through it.

17. The device according to any one of claims 1 to 16, wherein the tapered body has a solid structure and does not define a lumen extending through it.

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