Dilation and crossing tool for intravascular treatment

Abstract

An intravascular treatment device includes a catheter (101), and an exterior cage (102) fixed to a distal end of the catheter, the exterior cage radially expandable and including a stepped geometry portion of reduced diameter at a distal end thereof. The intravascular treatment device further includes a rod (107) extending within the catheter, the rod movable within the catheter so to extend through the distal end of the catheter into the exterior cage, and an inner actuation feature (105) having a proximal end fixed to the rod. The inner actuation feature is movable by the rod between a retracted state in which the inner actuation feature is contained within exterior cage and the cage is not radially expanded, and an advanced state in the inner actuation feature extends through the stepped geometry portion of the exterior cage so as to radially expand the exterior cage.

Description

DILATION AND CROSSING TOOL FOR INTRAVASCULAR TREATMENTFIELD

[0001] The inventive concepts generally relate to catheters used in intravascular procedures, and more particularly, to a dilation and crossing tool that may be used for intravascular treatment.BACKGROUND

[0002] Intravascular diseases, such as atherosclerosis, are common health issues that can lead to serious complications like heart attacks and strokes. These diseases are often characterized by the buildup of plaque or other obstructions within the blood vessels, which can restrict blood flow and cause damage to the surrounding tissues. One common treatment for these conditions is balloon angioplasty, a procedure in which a small balloon is inserted into the affected vessel and inflated to displace the obstruction and widen the vessel lumen, thereby improving blood flow.

[0003] However, balloon angioplasty has several limitations. For instance, the balloon's relatively large blunt profile at the leading edge can make it difficult to cross tightly stenosed vessels or total vessel occlusions. Furthermore, the time it takes to inflate and deflate the balloon can lead to long delay times between subsequent dilations, making it challenging to take an iterative gradual approach to working through a tightly stenosed lesion or total vessel occlusion.

[0004] In many cases, physicians may have to use different tools to first cross the lesion and create a large enough lumen before being able to go back with a balloon to further treat the lesion. This can complicate the procedure and increase the time it takes to complete. Moreover, there are some lesions that may not be able to be crossed by any other tool currently on the market, limiting the treatment options for some patients.SUMMARY

[0005] According to an aspect of the inventive concepts, an intravascular treatment device is provided. The intravascular treatment device includes a catheter, and an exterior cage fixed to a distal end of the catheter, the exterior cage radially expandable and including a stepped geometry portion of reduced diameter at a distal end thereof. The intravascular treatment device further includes a rod extending within the catheter, the rod movable within the catheter so to extend through the distal end of the catheter into the exterior cage, and an inner actuation feature having a proximal end fixed to the rod. The inner actuation feature is movable by the rod between a retracted state in which the inner actuation feature is contained within exterior cage and the cage is not radially expanded, and an advanced state in the inner actuation feature extends through the stepped geometry portion of the exterior cage so as to radially expand the exterior cage.

[0006] A distal end of the inner actuation feature may be tapered, and a diameter of the stepped geometry portion of the exterior cage in the retracted state of the inner actuation feature may be equal to or less than a diameter of the inner actuation feature.

[0007] A maximum diameter of the exterior cage in the advanced state of the inner actuation feature may be at least double a maximum diameter of the exterior cage in the retracted state of the inner actuation feature.

[0008] The exterior cage may be comprised of a shape memory material such as Nitinol.

[0009] The exterior cage may include cage connection features spaced around a longitudinal axis device and extending lengthwise between the catheter and stepped geometry portion. In this case, a maximum diameter of cage connection features in the advanced state of the inner actuation feature may be at least double a maximum diameter of defined by the cage connection feature in the retracted state of the inner actuation feature.

[0010] The intravascular treatment device may further include a handle fixed to a proximal end of the catheter, and a plunger movable within the handle and fixed to a proximal end of the rod. The plunger may be spring-loaded.BRIEF DESCRIPTION OF DRAWINGS

[0011] The above and other aspects and features of the inventive concepts will become readily apparent from the detailed description that follows, with reference to the accompanying drawings, in which:

[0012] FIG. 1 depicts the catheter with a contracted exterior cage in accordance with embodiments of the inventive concepts;

[0013] FIG. 2 illustrates the catheter with a partially expanded exterior cage in accordance with embodiments of the inventive concepts;

[0014] FIG. 3 shows the catheter with a fully expanded cage and an extend distal tip in accordance with embodiments of the inventive concepts;

[0015] FIGS . 4 through 22 are views for reference in describing an exemplary procedure utilizing the catheter of FIGS. 1 through 3; and

[0016] FIG. 23 through 25 depict an example of a cross-tool handle that may be used to control the catheter of the inventive concepts.DETAILED DESCRIPTION

[0017] In the following detailed description, for purposes of explanation and not limitation, representative embodiments disclosing specific details are set forth m order to provide a thorough understanding of the present teachings. However, it will be apparent to one having ordinary skill m the art having had the benefit of the present disclosure that other embodiments according to the present teachings that depart from the specific details disclosed herein remain within the scope of the appended claims. Moreover, descriptions of well-known apparatuses and methods may be omitted to avoid obscuring the description of the example embodiments. Such methods and apparatuses are clearly within the scope of the present teachings. Further, throughout the drawings, like reference numbers refer to the same or similar elements. It is noted that elements of the figures may not be drawn to scale, and that relative sizes of elements may be exaggerated for clarity.

[0018] The terminology used herein is for purposes of describing particular embodiments only, and is not intended to be limiting. The defined terms are m addition to the technical and scientific meanings of the defined terms as commonly understood and accepted m the technical field of the present teachings. As used in the specification and appended claims, the terms ‘a’, ‘an’ and ‘the’ include both singular and plural referents, unless the context clearly dictates otherwise. Thus, for example, ‘a device’ includes one device and plural devices. Further, for example, when one element is described as being “connected to” another element, the one element may be directly connected to the other element, or indirectly connected to the other element m an operative manner.

[0019] The present disclosure provides a novel device, referred to as a Rapid Dilation and Crossing Tool, designed to address the challenges associated with traditional balloon angioplasty. This device is particularly beneficial in the treatment of intravascular diseases, where it is often difficult to cross and treat tightly stenosed vessels or total occlusions. The Rapid Dilation and Crossing Tool is designed with a small profile sharp leading edge, which aids in crossing and treating these challenging areas. Furthermore, the device allows for rapid dilation and contraction, a feature that enhances its effectiveness in treating these conditions.

[0020] FIG. 1 illustrates an example of the Rapid Dilation and Crossing Tool of embodiments of the inventive concepts.

[0021] Referring to FIG. 1, the Rapid Dilation and Crossing Tool of this example includes a catheter shaft 101 and an exterior cage 102. Here, the exterior cage 102 is illustrated in a contracted state. As will be explained below, the exterior cage 102 is configured to expand radially, providing a dilation action similar to that of a balloon used in angioplasty.

[0022] A proximal end of the exterior cage 102 connected to the catheter shaft 101. Further, as shown in the example of FIG. 1 , the exterior cage 102 is defined by cage connection features 103 spaces around a longitudinal axis of the catheter and extending lengthwise between the catheter shaft 101 and a diametrical step of the exterior cage 104. The diametrical step 104, as shown, is defined by a distal end of the exterior cage 102having a diameter that is reduced in a step-wise manner. The cage’s diametrical step 104 may be designed to help keep the device aligned with the direction of the vessel and keep the distal tip 106 a controlled distance away from the vessel wall to help avoid perforation of the vessel.

[0023] It is noted that the exterior cage 102 may include multiple diametrical steps, rather than a single diametrical step 104 shown in FIG. 1. Further, the inventive concepts are not limited to any particular shape and / or angle of the step or steps formed at the distal end of the exterior cage 102.

[0024] The Rapid Dilation and Crossing Tool also includes an inner actuation feature 105. In FIG. 1 , the inner actuation feature 105 is shown in a retracted position. In this state, exterior cage 102 is in its contracted state (i.e., non-expanded state). As will be described below, the inner actuation feature 105 is configured to pass through a center of the diametrical step 104 of the exterior cage 102, thereby causing the exterior cage 102 to expand.

[0025] As will be described below, the inner actuation feature 105 a distal tip (not visible in FIG. 1). The distal tip may be designed to have a small profile and a relative sharp leading edge. This sharp leading edge may aid in crossing and treating tightly stenosed vessels or total occlusions.

[0026] As will be shown in FIGS. 2 and 3, the Rapid Dilation and Crossing Tool may be designed to be used in conjunction with a rod extending movable within and through the catheter and attached to a proximal end of the inner actuation feature 105.

[0027] FIG. 2 illustrates the catheter of FIG. 1 in its partially extended state.

[0028] Referring to FIG. 2, the inner actuation feature 105 is partially advanced by a rod 107 through the center of diametrical step of the exterior cage 102. This partial advancement of the inner actuation feature 105 cause the exterior cage 102 to expand partially. The partial expansion of the exterior cage 102 may be beneficial in situations where a full expansion is not immediately feasible or desirable, such as when the device is in proximity to a tightly stenosed vessel or total occlusion.

[0029] In some cases, the partial advancement of the inner actuation feature 105 and the corresponding partial expansion of the exterior cage 102 may allow for a more gradual and controlled approach to crossing and treating a lesion. This gradual approach may be particularly beneficial in situations where the lesion is hard or calcified, requiring a more careful and controlled dilation.

[0030] In some embodiments, the partial advancement of the inner actuation feature 105 may be achieved by manually pushing the rod 107 attached to the inner actuation feature 105. In other embodiments, the partial advancement of the inner actuation feature 105 may be achieved through a motorized mechanism, which may allow for a more precise control over the degree of advancement and the speed of the dilation motion. In either case, the exterior cage 102 is configured to expand radially in a controlled maimer as the inner actuation feature 105 is partially advanced. This controlled radial expansion may help to keep the device aligned with the direction of the blood vessel 401 and may help to avoid perforation of the vessel wall.

[0031] FIG. 3 illustrates the catheter of FIGS. 1 and 2 in its fully extended state.

[0032] Referring to FIG. 3, the inner actuation feature 105 has been pushed forward in a fully advanced position by the rod 107. This full advancement of the inner actuation feature 105 causes the exterior cage 102 to expand fully. The full expansion of the exterior cage 102 may be beneficial in situations where a larger dilation is desirable, such as when the device has successfully crossed a lesion 501 and a larger lumen is desired for improved blood flow.

[0033] As suggested above, the full advancement of the inner actuation feature 105 may be achieved by manually pushing the rod 107 attached to the inner actuation feature 105. Alternatively, the full advancement of the inner actuation feature 105 may be achieved through a motorized mechanism, which may allow for a more precise control over the degree of advancement and the speed of the dilation motion. In either case, this controlled radial expansion may help to keep the device aligned with the direction of the blood vessel 401 and may help to avoid inadvertent perforation of the vessel wall a distal tip 106 of the inner actuation feature 105.

[0034] The distal tip 106 of the inner actuation feature 105 may be designed to create a pilot hole in the lesion as the inner actuation feature 105 is fully advanced. As will be described by way of example below, the pilot hole may serve as a guide for the subsequent advancement of the device, facilitating the crossing and treatment of a lesion.

[0035] An exemplary procedure utilizing the catheter of FIGS. 1 through 3 with now be described with reference to FIGS. 4 through 22.

[0036] Referring to FIG. 4, the Rapid Dilation and Crossing Tool in its contracted state is navigated within a blood vessel 401 up to a lesion 501 that is to be crossed. The navigation of the device within the blood vessel 401 may be facilitated by the diametrical step in the exterior cage 102 described above. It is noted that the navigation of the device within the blood vessel 401 may be monitored using imaging techniques such as fluoroscopy, ultrasound, or other suitable imaging modalities.

[0037] Referring to FIG. 5, the Rapid Dilation and Crossing Tool is actuated to expand the exterior cage 102 to help orient and stabilize the device the blood vessel 401. In addition, the distal tip 106 of the inner actuation feature 105 is driving into the lesion 501. As the distal tip 106 penetrates the lesion 501, it creates an initial pilot channel (or pilot hole). This pilot channel may serve as a guide for the subsequent advancement of the device, facilitating the crossing and treatment of the lesion 501.

[0038] Referring to FIG. 6, the distal tip 106 of the inner actuation feature 105 is retracted, revealing the initial pilot channel 601 that has been created in the lesion 501. The retraction of the distal tip 106 may be achieved by pulling back on the rod 107 attached to the inner actuation feature 105.

[0039] Referring to FIG. 7, the Rapid Dilation and Crossing Tool is again advanced in its contracted state. As shown, the diametrical step of the exterior cage 102 may be advanced either fully or partially in the pilot channel 601. As such, in some embodiments, the diameter of the diametrical step of the exterior cage 102 is less than or equal to the diameter of the inner actuation feature.

[0040] Referring to FIG. 8, the Rapid Dilation and Crossing Tool is actuated to expand the exterior cage 102 and advance the distal tip 106 of the inner actuation feature 105further into the lesion 501. As a result, another pilot channel is formed (or the original pilot channel is lengthened) which may serve as a guide for the subsequent advancement of the device, facilitating the crossing and treatment of the lesion 501. In addition, portions of the lesion 501 in the vicinity of the original pilot hole are removed or loosened by expansion of the exterior cage 102.

[0041] Referring to FIG. 9, the distal tip 106 of the inner actuation feature 105 is retracted back into the exterior cage 102, revealing the new pilot channel 601 that has been created in the lesion 501. The retraction of the distal tip 106 may be achieved by pulling back on the rod 107 attached to the inner actuation feature 105.

[0042] Referring to FIG. 10, the Rapid Dilation and Crossing T ool is yet again advanced in its contracted state. As before, the diametrical step of the exterior cage 102 may be advanced either fully or partially in the previously formed pilot channel 601.

[0043] Referring to FIG. 11, the Rapid Dilation and Crossing Tool is actuated again to expand the exterior cage 102 and advance the distal tip 106 of the inner actuation feature 105 further into the lesion 501. As a result, still another pilot channel is formed (or the original pilot channel is lengthened) which may serve as a guide for the subsequent advancement of the device, facilitating the crossing and treatment of the lesion 501. In addition, portions of the lesion 501 in the vicinity of the second formed pilot hole are removed or loosened by expansion of the exterior cage 102.

[0044] Referring to FIG. 12, the distal tip 106 of the inner actuation feature 105 is retracted back into the exterior cage 102, revealing another new pilot channel 601 that has been created in the lesion 501. The retraction of the distal tip 106 may be achieved by pulling back on the rod 107 attached to the inner actuation feature 105.

[0045] Referring to FIG. 13, the Rapid Dilation and Crossing Tool is again advanced in its contracted state. As before, the diametrical step of the exterior cage 102 may be advanced either fully or partially in the previously formed pilot channel 601.

[0046] Referring to FIG. 14, the Rapid Dilation and Crossing Tool is actuated again to expand the exterior cage 102 and advance the distal tip 106 of the inner actuation feature 105. In this example, it is assumed that the inner actuation features has penetrated throughto the other side the lesion 501. And, as before, portions of the lesion 501 in the vicinity of the previous formed pilot holes are removed or loosened by expansion of the exterior cage 102.

[0047] Referring to FIG. 15, the distal tip 106 of the inner actuation feature 105 is retracted back into the exterior cage 102. The retraction of the distal tip 106 may be achieved by pulling back on the rod 107 attached to the inner actuation feature 105.

[0048] Referring to FIG. 16, the Rapid Dilation and Crossing Tool is again advanced in its contracted state. Here, the diametrical step of the exterior cage 102 may be advanced to the other side of the lesion 501.

[0049] Referring to FIG. 17, the Rapid Dilation and Crossing Tool is actuated again to expand the exterior cage 102 and advance the distal tip 106 of the inner actuation feature 105. As a result, additional portions of the lesion 501 in the vicinity of the previously formed pilot holes are removed or loosened by expansion of the exterior cage 102.

[0050] Referring to FIG. 18, the distal tip 106 of the inner actuation feature 105 is retracted back into the exterior cage 102. The retraction of the distal tip 106 may be achieved by pulling back on the rod 107 attached to the inner actuation feature 105.

[0051] Referring to FIG. 19, the Rapid Dilation and Crossing Tool is again advanced in its contracted state. Here, the diametrical step of the exterior cage 102 may be advanced to the other side of the lesion 501.

[0052] Referring to FIG. 20, the Rapid Dilation and Crossing Tool is actuated again to expand the exterior cage 102 and advance the distal tip 106 of the inner actuation feature 105. As a result, additional portions of the lesion 501 in the vicinity of the previously formed pilot holes are removed or loosened by expansion of the exterior cage 102.

[0053] Referring to FIG. 21, the distal tip 106 of the inner actuation feature 105 is retracted back into the exterior cage 102. The retraction of the distal tip 106 may be achieved by pulling back on the rod 107 attached to the inner actuation feature 105.

[0054] Referring finally to FIG. 22, the Rapid Dilation and Crossing Tool is removed from the vessel.

[0055] FIG. 23 through 25 depict an example of a cross-tool handle that may be used to control the catheter of the inventive concepts.

[0056] Referring collectively to FIGS. 23 through 25, the cross-tool handle 701 may be ergonomically designed to fit comfortably in a user's hand. The handle 701 may include finger grips 702 and 703, which may be designed to accommodate the fingers of the user's hand. The finger grips 702, 703 may provide a secure grip for the user, facilitating the operation of the device.

[0057] In addition, the handle 701 may include a plunger 704. The plunger 704 may be spring-loaded (using a compression spring 705), allowing it to return to its original position after being pushed. The spring-loaded plunger 704 may be attached directly to the rod 107 (described above) while the outer casing of the catheter 101 is connected to the handle 701. In this maimer, the rod 107 is allowed to advance and retract within the catheter by operation of the plunger 704. As such, spring-loaded plunger 704 is operative to extend and retract the inner actuation feature 105, thereby controlling the expansion and contraction of the exterior cage 102.

[0058] The handle 701 may include a thumb plate 706 at the bottom of the spring-loaded plunger 704. The thumb plate 706 may be designed to be depressed by the user's thumb, allowing the user to easily push the plunger 704 to actuate the device. The thumb plate 706 may provide a comfortable and secure grip for the user's thumb, facilitating the operation of the device.

[0059] FIG. 24 depicts the cross-tool handle in use with the plunger in a noncompressed state. In this state, the rod 107 is retracted and the inner actuation feature 105 is contained within the exterior cage 102 (e.g., as in FIG. 1).

[0060] FIG. 25 depicts the cross-tool handle in use with the plunger in a compressed state. In this state, the rod 107 is advanced and the inner actuation feature 105 extends through the exterior cage 102 (e.g., as in FIG. 3).

[0061] As suggested previously, the inventive concepts are not limited to manual control of the rod 107 and inner actuation feature 105. Likewise, operation of the plunger 107 may be achieved through a motorized mechanism.

[0062] Separately, it is noted that the exterior cage 102 may be made of a shape memory material such as Nitinol. Further, although not shown, the exterior cage may include a barbed feature on portions of the cage to prevent the device from sliding backward during actuation. Further, the exterior cage 102 may be configured to expand to at least double its original diameter when the inner actuation feature 105 is fully advanced.

[0063] Still further, although not shown, a guide wire lumen may included which extends through the center of the tool. In this manner, a guide wire may be left behind after clearing a lesion.

[0064] While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive; the invention is not limited to the disclosed embodiments. Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims. While representative embodiments are disclosed herein, one of ordinary skill in the art will appreciate that many variations that are in accordance with the present teachings are possible and remain within the scope of the appended claim set. The invention therefore is not to be restricted except within the scope of the appended claims.

Claims

WHAT IS CLAIMED IS:

1. An intravascular treatment device, comprising: a catheter; an exterior cage fixed to a distal end of the catheter, the exterior cage radially expandable and including a stepped geometry portion of reduced diameter at a distal end thereof; a rod extending within the catheter, the rod movable within the catheter so to extend through the distal end of the catheter into the exterior cage; and an inner actuation feature having a proximal end fixed to the rod, wherein the inner actuation feature is movable by the rod between a retracted state in which the inner actuation feature is contained within exterior cage and the cage is not radially expanded, and an advanced state in the inner actuation feature extends through the stepped geometry portion of the exterior cage so as to radially expand the exterior cage.

2. The intravascular treatment device of claim 1, wherein a distal end of the inner actuation feature is tapered.

3. The intravascular treatment device of claim 2, wherein a diameter of the stepped geometry portion of the exterior cage in the retracted state of the inner actuation feature is equal to or less than a diameter of the inner actuation feature.

4. The intravascular treatment device of claim 1, wherein a maximum diameter of the exterior cage in the advanced state of the inner actuation feature is at least double a maximum diameter of the exterior cage in the retracted state of the inner actuation feature.

5. The intravascular treatment device of claim 1, wherein the exterior cage is comprised of a shape memory material.

6. The intravascular treatment device of claim 1, wherein the shape memory material is Nitinol.

7. The intravascular treatment device of claim 1 , wherein the exterior cage includes cage connection features spaced around a longitudinal axis device and extending lengthwise between the catheter and stepped geometry portion.

8. The intravascular treatment device of claim 1, wherein a maximum diameter of cage connection features in the advanced state of the inner actuation feature is at least double a maximum diameter of defined by the cage connection feature in the retracted state of the inner actuation feature.

9. The intravascular treatment device of claim 1, further comprising: a handle fixed to a proximal end of the catheter; and a plunger movable within the handle and fixed to a proximal end of the rod.

10. The intravascular treatment device of claim 9, wherein the plunger is spring- loaded.

11. An intravascular treatment device, comprising: a catheter; an exterior cage fixed to a distal end of the catheter, the exterior cage radially expandable and including a stepped geometry portion of reduced diameter at a distal end thereof; and an inner actuation feature movable along a longitudinal axis of the device and independently of the catheter and exterior cage, wherein the device is configured to alternate between a retracted state and an advanced state,wherein retracted state the inner actuation feature is contained within exterior cage and the cage is not radially expanded, and wherein in the advanced state the inner actuation feature extends partially through the stepped geometry portion of the exterior cage so as to radially expand the exterior cage.

12. The intravascular treatment device of claim 11 , wherein a distal end of the inner actuation feature is tapered.

13. The intravascular treatment device of claim 12, wherein a diameter of the stepped geometry portion of the exterior cage in the retracted state of the inner actuation feature is equal to or less than a diameter of the inner actuation feature.

14. The intravascular treatment device of claim 11, wherein a maximum diameter of the exterior cage in the advanced state of the inner actuation feature is at least double a maximum diameter of the exterior cage in the retracted state of the inner actuation feature.

15. The intravascular treatment device of claim 11, wherein the exterior cage is comprised of a shape memory material.

Images