ATHERECTOMY DEVICES INCLUDING SEALED DRIVE SHAFTS

Abstract

An atherectomy device (100) for removing occlusive material from the vasculature of a subject includes a sheath (116) and a drive shaft (216) disposed within the sheath. The drive shaft (216) couples to a cutting element (118). The drive shaft (216) is rotatable relative to the sheath (116) to rotate the cutting element (118). The drive shaft (216) and the sheath (116) define therebetween a material removal passageway (218) for receiving the occlusive material. The drive shaft (216) includes a coil (504) having an inner lumen (512). A jacket (516) is disposed outwardly of the coil (504), and the jacket (516) inhibits the occlusive material in the material removal passageway (218) from passing through the coil and entering the inner lumen (512).

Claims

1. An atherectomy device for removing occlusive material from a subject, the atherectomy device comprising: a distal cutter assembly, comprising: a housing; a cutting element carried by the housing and comprising at least one cutting blade, the cutting element being rotatable relative to the housing to cause the at least one cutting blade to cut the occlusive material and move the occlusive material into the housing; a catheter coupled to the distal cutter assembly, the catheter comprising: a sheath; a drive shaft disposed within the sheath and coupled to the cutting element, the drive shaft being rotatable relative to the sheath to rotate the cutting element relative to the housing, and the drive shaft and the sheath defining therebetween a material removal passageway for receiving the occlusive material from the housing, the drive shaft comprising: a coil comprising an inner lumen; and a jacket disposed outwardly of the coil, the jacket inhibiting the occlusive material in the material removal passageway from passing through the coil and entering the inner lumen.

2. The atherectomy device of claim 1, wherein the jacket comprises a polymer.

3. The atherectomy device of claim 2, wherein the polymer is a hydrophobic polymer.

4. The atherectomy device of claim 3, wherein the hydrophobic polymer is one of polytetrafluoroethylene (PTFE) and fluorinate ethylene propylene (FEP).

5. The atherectomy device of claim 1, wherein the coil is an inner coil, and further comprising an outer coil disposed outwardly from the inner coil, the outer coil configured to proximally move the occlusive material in the material removal passageway upon rotation of the drive shaft relative to the sheath, and wherein the jacket is disposed between the inner coil and the outer coil.

6. The atherectomy device of claim 5, further comprising an intermediate coil disposed between the inner coil and the jacket.

7. An atherectomy device for removing occlusive material from a subject, the atherectomy device comprising: a distal cutter assembly, comprising: a housing; a cutting element carried by the housing and comprising at least one cutting blade, the cutting element being rotatable relative to the housing to cause the at least one cutting blade to cut the occlusive material and move the occlusive material into the housing; a catheter coupled to the distal cutter assembly, the catheter comprising: a sheath configured to receive the occlusive material from the housing; a drive shaft disposed within the sheath and coupled to the cutting element, the drive shaft being rotatable relative to the sheath to rotate the cutting element relative to the housing, the drive shaft comprising: an inner coil comprising an inner lumen; an outer coil disposed outwardly from the inner coil, the outer coil configured to proximally move the occlusive material in a material removal passageway disposed between the drive shaft and the sheath upon rotation of the drive shaft relative to the sheath; and a sealing layer disposed between the inner coil and the outer coil, the sealing layer inhibiting the occlusive material in the material removal passageway from passing through the inner coil and entering the inner lumen.

8. The atherectomy device of claim 7, wherein the sealing layer comprises a polymer.

9. The atherectomy device of claim 8, wherein the polymer is a hydrophobic polymer.

10. The atherectomy device of claim 9, wherein the hydrophobic polymer is one of polytetrafluoroethylene (PTFE) and fluorinate ethylene propylene (FEP).

11. The atherectomy device of claim 7, further comprising an intermediate coil disposed between the inner coil and the sealing layer.

12. An atherectomy device for removing occlusive material from a subject, the atherectomy device comprising: a distal cutter assembly, comprising: a housing; a cutting element carried by the housing and comprising at least one cutting blade, the cutting element being rotatable relative to the housing to cause the at least one cutting blade to cut the occlusive material and move the occlusive material into the housing; a catheter coupled to the distal cutter assembly, the catheter comprising: a sheath configured to receive the occlusive material from the housing; a drive shaft disposed within the sheath and coupled to the cutting element, the drive shaft being rotatable relative to the sheath to rotate the cutting element relative to the housing, the drive shaft comprising: an inner coil comprising an inner lumen; an outer conveyor disposed outwardly from the inner coil, the outer conveyor configured to proximally move the occlusive material in a material removal passageway disposed between the drive shaft and the sheath upon rotation of the drive shaft relative to the sheath; and a sealing layer disposed between the inner coil and the outer conveyor, the sealing layer inhibiting the occlusive material in the material removal passageway from passing through the inner coil and entering the inner lumen.

13. The atherectomy device of claim 12, wherein the sealing layer comprises a polymer.

14. The atherectomy device of claim 13, wherein the polymer is a hydrophobic polymer.

15. The atherectomy device of claim 14, wherein the hydrophobic polymer is one of polytetrafluoroethylene (PTFE) and fluorinate ethylene propylene (FEP).

16. The atherectomy device of claim 12, further comprising an intermediate coil disposed between the inner coil and the sealing layer.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure may be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below.

[0031] FIG. 1 is a side view of an atherectomy system according to an embodiment of the present disclosure.

[0032] FIG. 2A is a detail side view of a distal portion of the atherectomy system of FIG. 1.

[0033] FIG. 2B is a detail perspective view of the distal portion of the atherectomy system of FIG. 1.

[0034] FIG. 2C is a detail transverse sectional view of the distal portion of the atherectomy system of FIG. 2A.

[0035] FIG. 3A is a perspective view of a distal cutting element of the atherectomy system of FIG. 1.

[0036] FIG. 3B is a side view of the distal cutting element of FIG. 3A.

[0037] FIG. 4A is a perspective view of a proximal cutting element of the atherectomy system of FIG. 1.

[0038] FIG. 4B is a front view of the proximal cutting element of FIG. 4A.

[0039] FIG. 5 is a transverse sectional view of a drive shaft of the atherectomy system of FIG. 1.

[0040] It should be understood that the drawings are not necessarily to scale. In certain instances, details that are not necessary for an understanding of the disclosure or that render other details difficult to perceive may have been omitted. It should be understood, of course, that the disclosure is not necessarily limited to the particular embodiments illustrated herein.

DETAILED DESCRIPTION

[0041] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

[0042] The present disclosure relates generally to devices, systems, and methods for mechanical atherectomy. Referring to FIG. 1, there is shown an exemplary embodiment of the atherectomy systems described herein. The atherectomy system 100 includes an intravascular atherectomy device 102 and a guide wire 104 over which the atherectomy device 102 may be deployed. In some embodiments, the guide wire 104 is silicon-coated or non-coated (bare), or otherwise free of a polytetrafluoroethylene (PTFE) coating. Atherectomy systems according to some embodiments of the present disclosure comprise a guide wire 104 that includes a PTFE coating, or atherectomy systems according to some embodiments of the present disclosure lack a guide wire 104.

[0043] With continued reference to FIG. 1, the atherectomy device 102 generally includes a handle 106 and a catheter 108. The handle 106 is configured to be grasped and manipulated by a user (for example, a medical professional) during an atherectomy procedure. The catheter 108 is coupled to and extends distally relative to the handle 106. The catheter 108 is configured to be positioned in the vasculature of a subject (for example, a patient) during an atherectomy procedure to facilitate removal of occlusive material (for example, plaque) therefrom. In some embodiments and as illustrated, a distal portion 110 of the catheter 108 has a curved shape or configuration. In some embodiments, the distal portion 110 of the catheter 108 normally has a curved configuration (“normally” being understood as the catheter 108 not being subjected to any external contact forces due to, for example, contact with blood vessel walls) and may be deflected to other configurations. In other embodiments, the distal portion 110 of the catheter 108 normally has a straight shape or configuration and may be deflected to other configurations. In some embodiments, the catheter 108 is selectively rotatable about a catheter rotational axis 112 relative to the handle 106 to facilitate appropriately positioning and or “sweeping” the distal portion 110 of the catheter 108 during an atherectomy procedure. In some embodiments and as illustrated, the handle 106 carries a rotatable knob or dial 114 for selectively rotating the catheter 108 relative to the handle 106. The catheter 108 includes an outer sheath 116, and the outer sheath 116 couples to a cutter assembly 118 that extends distally therefrom. The cutter assembly 118 is described in further detail below.

[0044] FIGS. 2A-2C illustrate the distal portion 110 of the catheter 108, including, among other components, the outer sheath 116 and the cutter assembly 118. The cutter assembly 118 includes a ferrule 200 that couples to the outer sheath 116 and extends distally therefrom. The cutter assembly 118 further includes a housing 202 that couples to the ferrule 200 and extends distally therefrom. The housing 202 rotatably carries cutting elements. Referring specifically to FIGS. 2B-2C, the housing 202 rotatably carries a first, or distal, cutting element 204 and a second, or proximal, cutting element 206. Rotation of the first cutting element 204 and the second cutting element 206 about a rotation axis 208 in a rotational direction 209 relative to the housing 202 causes the cutting elements 204, 206 to cut occlusive material and convey the occlusive material into the housing 202 (a process also referred to as “debulking”).

[0045] Still referring to FIGS. 2B-2C, the first cutting element 204 generally extends distally from the second cutting element 206 and the housing 202. The first cutting element 204 includes a central opening 210 (see FIG. 2C) for coupling to the second cutting element 206.

[0046] The second cutting element 206 is generally disposed within the housing 202 and, in some embodiments and as illustrated, may be completely disposed within the housing 202. The second cutting element 206 is also generally disposed proximally from the first cutting element 204, although the second cutting element 206 includes a shaft or stem 212 that is received in the central opening 210. The stem 212 may couple to the first cutting element 204 in various manners. For example, the stem 212 may couple to the first cutting element 204 via welding. In some embodiments and as illustrated, the stem 212 extends distally relative to the first cutting element 204. The stem 212 includes an inner lumen 214 for receiving a guide wire 104 (shown elsewhere).

[0047] Referring specifically to FIG. 2C, the atherectomy device 102 further includes a rotatable drive shaft 216 that couples the first cutting element 204 and the second cutting element 206 to a prime mover (for example, a motor carried by the handle 106 — not shown). That is, the prime mover rotates the drive shaft 216, which in turn rotates the first cutting element 204 and the second cutting element 206 to facilitate cutting occlusive material and conveying the occlusive material into the housing 202. In some embodiments, the cutter assembly 118 captures the cut occlusive material from the blood without the use of vacuum aspiration. In other embodiments, vacuum aspiration may assist capture of the cut occlusive material. In either case, the housing 202 delivers the cut occlusive material to a material removal passageway 218 formed between the outer sheath 116 and the drive shaft 216. The occlusive material moves proximally through the material removal passageway 218 due to features of the drive shaft 216, as described in further detail below, and/or vacuum aspiration, and the occlusive material is thereby removed from the vasculature of the subject.

[0048] Referring to FIGS. 3A-3B, the first cutting element 204 includes one or more first, or distal, cutting flutes or blades 300 that extend distally relative to the housing 202 (shown elsewhere). In some embodiments and as illustrated, the first cutting element 204 includes two cutting blades 300. In some embodiments and as illustrated, one or more of the first cutting blades 300 extend helically relative to the rotation axis 208.

[0049] Referring now to FIGS. 4A-4B, the second cutting element 206 includes one or more second, or proximal, cutting flutes or blades 400. In some embodiments, the second cutting element 206 has two times the number of blades 400 as the first cutting element 204 (shown elsewhere). In some embodiments and as illustrated, the second cutting element 206 includes four cutting blades 400. In some embodiments and as illustrated, one or more of the second cutting blades 400 extend helically relative to the rotation axis 208.

[0050] FIG. 5 illustrates a transverse sectional view the drive shaft 216. The drive shaft 216 generally includes a distal end coupling 500 that couples to the cutter assembly 118 (shown elsewhere), a proximal end coupling 502 that couples to the prime mover (not shown), and a coiled section 504 that extends between and couples the distal end coupling 500 to the proximal end coupling 502. The distal end coupling 500 is a generally cylindrical component that receives a portion of the coiled section 504. The distal end coupling 500 may be welded to and couple to the coiled section 504 via a distal solder joint 506. The distal end coupling 500 may be formed of a metal, such as stainless steel, and more specifically 304 stainless steel. Similarly, the proximal end coupling 502 is a generally cylindrical component that receives a portion of the coiled section 504. The proximal end coupling 502 may be welded to and couple to the coiled section 504 via a proximal solder joint 508. The proximal end coupling 502 may be formed of a metal, such as stainless steel, and more specifically 304 stainless steel.

[0051] With continued reference to FIG. 5, the coiled section 504 includes several components that provide flexibility to the drive shaft 216 and inhibit penetration by occlusive material. More specifically, the coiled section 504 includes an inner coil 510 that defines, together with the distal end coupling 500 and the proximal end coupling 502, an inner lumen 512 configured to receive the guide wire 104 (shown elsewhere). The inner coil 510 may have about 10 filars, and each filar may have a diameter of about 0.004 inches. The inner coil 510 may be right-hand wound. The inner coil 510 may be formed of a metal, such as stainless steel, and more specifically 304 stainless steel. The coiled section 504 also includes an intermediate coil 514 disposed radially outwardly from the inner coil 510. The intermediate coil 514 may have about 10 filars, and each filar may have a diameter of about 0.004 inches. The intermediate coil 514 may be left-hand wound. The intermediate coil 514 may be formed of a metal, such as stainless steel, and more specifically 304 stainless steel.

[0052] The coiled section 504 further includes a jacket 516, also referred to as an intermediate jacket and a sealing layer, disposed radially outwardly from the intermediate coil 514. The jacket 516 may extend over the majority of the length of the coiled section 504, more specifically, from the distal solder joint 506 to the proximal solder joint 508. The jacket 516 provides a seal for the intermediate coil 514 and the inner coil 510 or, stated another way, the jacket 516 inhibits the occlusive material in the material removal passageway 218 (shown elsewhere) from passing through the intermediate coil 514, through the inner coil 510, and entering the inner lumen 512. The jacket 516 may be formed of, for example, one or more polymers, more specifically a hydrophobic polymer, such as PTFE or fluorinate ethylene propylene (FEP). The jacket 516 may be formed over the intermediate coil 514, for example, in a heat-shrinking process, an extrusion process, or the like.

[0053] In some embodiments, the jacket 516 provides one or more advantages. For example, by inhibiting occlusive material from penetrating the drive shaft 216, the jacket 516 causes rotational friction between the drive shaft 216 and the guide wire 104 to remain relatively low and/or constant during use of the atherectomy device 102. In some embodiments, an atherectomy device 102 including the jacket 516 may be subjected to rotational friction between the drive shaft 216 and the guide wire 104 during use of the atherectomy device 102 that is reduced by about 96 percent compared to a similar atherectomy device lacking the jacket 516. As another example, the jacket 516 provides damping and reduces vibration of the drive shaft 216. As yet another example, the jacket 516 permits the inner lumen 512 of the drive shaft 216 to be used as a delivery lumen for providing, for example, a fluid to the subject, such as a therapeutic agent, nitroglycerin, saline solution, contrast solution, or the like.

[0054] Still referring to FIG. 5, the drive shaft 216 further includes an outer coil 518, also referred to as an outer conveyor or a screw pump, disposed radially outwardly from the jacket 516. The outer coil 518 conveys occlusive material proximally in the material removal passageway 218 as the drive shaft 216 rotates relative to the sheath. The outer coil 518 may have one filar, and the filar may have a diameter of about 0.006 inches (that is, 0.006 inches±0.001 inches). The outer coil 518 may have a pitch of about 0.030 inches. The outer coil 518 may be right-hand wound. The outer coil 518 may be formed of a metal, such as stainless steel, and more specifically 304 stainless steel.

[0055] The foregoing discussion has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Summary for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and/or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and/or configurations of the disclosure may be combined in alternate aspects, embodiments, and/or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and/or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0056] Moreover, though the description has included description of one or more aspects, embodiments, and/or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, for example, as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and/or configurations to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.